DEPARTMENT OF HEALTH AND HUMAN SERVICES of the 45 CFR … · the Federal Register is the official...

ThisHHS‐approveddocumentisbeingsubmittedtotheOfficeoftheFederalRegister(OFR)forpublicationandhasnotyetbeenplacedonpublicdisplayorpublishedintheFederalRegister.ThisdocumentmayvaryslightlyfromthepublisheddocumentifminoreditorialchangesaremadeduringtheOFRreviewprocess.ThedocumentpublishedintheFederalRegisteristheofficialHHS‐approveddocument.

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4153‐01‐P

DEPARTMENTOFHEALTHANDHUMANSERVICES

OfficeoftheSecretary

45CFRPart88

RIN0945‐AA10

ProtectingStatutoryConscienceRightsinHealthCare;Delegationsof

Authority

AGENCY:OfficeforCivilRights(OCR),OfficeoftheSecretary,HHS.

ACTION:FinalRule.

SUMMARY:TheUnitedStateshasalonghistoryofprovidingprotectionsinhealth

careforindividualsandentitiesonthebasisofreligiousbeliefsormoral

convictions.CongresshaspassedmanysuchlawsapplicabletotheDepartmentof

HealthandHumanServices(“HHS”orthe“Department”)andtheprogramsor

activitiesitfundsoradministers,someofwhicharethesubjectofexistingHHS

regulationsat45CFRpart88.Thisfinalrulerevisesexistingregulationstoensure

vigorousenforcementofFederalconscienceandanti‐discriminationlawsapplicable

totheDepartment,itsprograms,andrecipientsofHHSfunds,andtodelegate

overallenforcementandcomplianceresponsibilitytotheDepartment’sOfficefor

CivilRights(“OCR”).Inaddition,thisfinalruleclarifiesOCR’sauthoritytoinitiate

compliancereviews,conductinvestigations,superviseandcoordinatecompliance

bytheDepartmentanditscomponents,anduseenforcementtoolsotherwise

availableinexistingregulationstoaddressviolationsandresolvecomplaints.In


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ordertoensurethatrecipientsofFederalfinancialassistanceandotherDepartment

fundscomplywiththeirlegalobligations,thisfinalrulerequirescertainrecipients

tomaintainrecords;cooperatewithOCR’sinvestigations,reviews,orother

proceedings;andsubmitwrittenassurancesandcertificationsofcompliancetothe

Department.ThefinalrulealsoencouragestherecipientsofHHSfundstoprovide

noticetoindividualsandentitiesabouttheirrightbefreefromcoercionor

discriminationonaccountofreligiousbeliefsormoralconvictions.

DATES:EffectiveDate:Thisruleiseffective[INSERTDATE60DAYSAFTER

PUBLICATIONINTHEFEDERALREGISTER].

FORFURTHERINFORMATIONCONTACT:SarahBaykoAlbrechtat(800)368–

1019or(800)537–7697(TDD).

SUPPLEMENTARYINFORMATION:

ElectronicAccess

ThisFederalRegisterdocumentisalsoavailablefromtheFederalRegister

onlinedatabasethroughFederalDigitalSystem(FDsys),aserviceoftheU.S.

GovernmentPrintingOffice.Thisdatabasecanbeaccessedviatheinternetat

http://www.gpo.gov/fdsys.

I.Background

Thisdocumentadoptsasfinal,withchangesinresponsetopubliccomments,

arevisedpart88,ProtectingStatutoryConscienceRightsinHealthCare;

DelegationsofAuthority.Thispreambletothefinalruleprovidesabrief


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backgroundoftherule,summarizesthefinalruleprovisions,anddiscussesindetail

thecommentsreceivedontheproposedrule.1

A.StatutoryHistory

Thefreedomsofconscienceandofreligiousexercisearefoundationalrights

protectedbytheConstitutionandnumerousFederalstatutes.Congresshasactedto

protectthesefreedomswithparticularforceinthehealthcarecontext,anditis

theselawsthatarethesubjectofthisfinalrule.Specifically,thisfinalruleconcerns

Federallawsthatprovide:

•Conscienceprotectionsrelatedtoabortion,sterilization,andcertainother

healthservicesapplicabletotheDepartmentofHealthandHumanServicesand

recipientsofcertainFederalfundsencompassedby42U.S.C.300a–7(the“Church

Amendments”);

•Conscienceprotectionsforhealthcareentitiesrelatedtoabortionprovision

ortraining,referralforsuchabortionortraining,oraccreditationstandardsrelated

toabortion(the“Coats‐SnoweAmendment,”42U.S.C.238n);

•Protectionsfromdiscriminationforhealthcareentitiesthatdonotprovide,

payfor,providecoverageof,orreferforabortionsunderprogramsfundedbythe

Department’sappropriationsacts(e.g.,DepartmentsofLabor,HealthandHuman

Services,andEducation,andRelatedAgenciesAppropriationsAct,2019,Div.B.,sec.

507(d),Pub.L.No.115‐245,132Stat.2981(Sept.28,2018)(the“Weldon

Amendment”);id.,sec.209);

183FR3880(2018).


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•ProtectionsfromdiscriminationunderthePatientProtectionand

AffordableCareAct(“ACA”)forhealthcareentitiesthatdonotprovideanyhealth

careitemorservicefurnishedforthepurposeofcausing,orforthepurposeof

assistingincausing,thedeathofanyindividual,suchasbyassistedsuicide,

euthanasia,ormercykilling,applicabletotheFederalGovernmentandanyStateor

localgovernmentthatreceivesFederalfinancialassistance(42U.S.C.18113);and

conscienceprotectionsforproviders,organizations,ortheiremployeesregarding

counselingregardingthesame(42U.S.C.14406(1));

•ConscienceprotectionsregardingexemptionsapplicabletotheACA’s

individualmandate(26U.S.C.5000A;42U.S.C.18081);

•ConscienceprotectionsundertheACAforqualifiedhealthplansrelatedto

coverageofabortion,andforindividualhealthcareprovidersandhealthcare

facilitiesthatdonotprovide,payfor,providecoverageof,orreferforabortions(42

U.S.C.18023(b)(1)(A)and(b)(4));

•ConscienceprotectionsforMedicareAdvantageorganizationsandMedicaid

managedcareorganizationswithmoralorreligiousobjectionstocounselingor

referralforcertainservices(42U.S.C.1395w‐22(j)(3)(B)and1396u‐2(b)(3)(B));

•Conscienceprotectionsrelatedtotheperformanceofadvanceddirectives

(42U.S.C.1395cc(f),1396a(w)(3),and14406(2));

•Conscienceandnondiscriminationprotectionsfororganizationsrelatedto

GlobalHealthPrograms,totheextentsuchfundsareadministeredbytheSecretary

ofHHS(the“Secretary”)(22U.S.C.7631(d));


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•ConscienceprotectionsattachedtoFederalfunding,totheextentsuch

fundingisadministeredbytheSecretary,regardingabortionandinvoluntarily

sterilization(22U.S.C.2151b(f),see,e.g.,theConsolidatedAppropriationsAct,2019,

Pub.L.116‐6,Div.F,sec.7018(the“Helms,Biden,1978,and1985Amendments”));

•Conscienceprotectionsfromcompulsoryhealthcareorservicesgenerally

(42U.S.C.1396fand5106i(a)),andunderspecificprogramsforhearingscreening

(42U.S.C.280g‐1(d)),occupationalillnesstesting(29U.S.C.669(a)(5));vaccination

(42U.S.C.1396s(c)(2)(B)(ii)),andmentalhealthtreatment(42U.S.C.290bb‐36(f));

and

•Protectionsforreligiousnonmedicalhealthcareprovidersandtheir

patientsfromcertainrequirementsunderMedicareandMedicaidthatmayburden

theirexerciseoftheirreligiousbeliefsregardingmedicaltreatment(e.g.,42U.S.C.

1320a‐1(h),1320c‐11,1395i‐5,1395x(e),1395x(y)(1),1396a(a),and1397j‐1(b)).

Forpurposesofthisfinalrule,theselawswillbecollectivelyreferredtoas

“Federalconscienceandanti‐discriminationlaws.”

Congresshasrecognizedthatmodernhealthcarepracticesmaygiveriseto

conflictswiththereligiousbeliefsandmoralconvictionsofpayers,providers,and

patientsalike.Theexistenceofmoralandethicalobjectionsonthepartofhealth

carecliniciansaboutparticipatingin,assistingwith,referringfor,orotherwise

beingcomplicitincertainproceduresiswelldocumentedbyethicists.2Religious

2See,e.g.,FarrA.CurlinM.D.,etal.,Religion,Conscience,andControversialClinicalPractices,NewEng.J.Med.593–600(2007);StephenJ.Genuis&ChrisLipp,EthicalDiversityandtheRoleofConscienceinClinicalMedicine,2013Int’l.J.FamilyMed.1,9(2013);Harris,etal.,Obstetrician–Gynecologists’


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institutionsandentities,too,haveexpressedobjectionstotheprovisionofor

participationininsurancecoverageforcertainproceduresorservices,suchas

abortion,sterilization,andassistedsuicide.Toaddresstheseproblems,Congress

hasrepeatedlylegislatedconscienceprotectionsforindividualsandinstitutions

providinghealthcaretotheAmericanpublic,asoutlinedbelow.

TheChurchAmendments.TheChurchAmendmentswereenactedatvarious

timesduringthe1970sinresponsetodebatesoverwhetherjudiciallyrecognized

rightstoabortions,sterilizations,orrelatedpracticesmightleadtotherequirement

thatindividualsorentitiesparticipateinactivitiestowhichtheyhavereligiousor

moralobjections.TheChurchAmendmentsconsistoffiveprovisions,codifiedat42

U.S.C.300a–7,thatprotectthosewhoholdreligiousbeliefsormoralconvictions

regardingcertainhealthcareproceduresfromdiscriminationbyentitiesthat

receivecertainFederalfunds,andinhealthserviceprogramsandresearchactivities

fundedbyHHS.Notably,theChurchAmendmentscontainprovisionsexplicitly

protectingtherightsofbothindividualsandentities.

First,paragraph(b)oftheChurchAmendmentsprovides,withregardto

individuals,thatnocourt,publicofficial,orotherpublicauthoritycanusean

individual’sreceiptofcertainFederalfundingasgroundstorequiretheindividual

toperform,orassistin,sterilizationproceduresorabortions,ifdoingsowouldbe

ObjectionstoandWillingnesstoHelpPatientsObtainanAbortion118Obstet.&Gyn.905(2011);ArmandH.MathenyAntommaria,AdjudicatingRightsorAnalyzingInterests:Ethicists’RoleintheDebateOverConscienceinClinicalPractice,29Theor.Med.Bioeth.201,206(2008);WilliamW.Bassett,PrivateReligiousHospitals:LimitationsUponAutonomousMoralChoicesinReproductiveMedicine,17J.Contemp.HealthL.&Pol’y455,529(2001);PeterA.Clark,MedicalEthicsatGuantanamoBayandAbuGhraib:TheProblemofDualLoyalty,34J.L.Med.&Ethics570(2006).


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contrarytohisorherreligiousbeliefsormoralconvictions.42U.S.C.300a‐7(b)(1).

Paragraph(b)furtherprohibitsthosepublicauthoritiesfromrequiringanentity,

basedontheentity’sreceiptofFederalfundsundercertainHHSprograms,(1)to

permitsterilizationsorabortionsintheentity’sfacilitiesiftheperformanceofsuch

proceduresthereviolatestheentity’sreligiousbeliefsormoralconvictions,or(2)to

makeitspersonnelavailableforsuchproceduresifcontrarytothepersonnel’s

religiousbeliefsormoralconvictions.42U.S.C.300a‐7(b)(2).Theindividualsand

entitiesprotectedbythisprovisionarerecipientsofgrants,contracts,loans,orloan

guaranteesunderthePublicHealthServiceAct(42U.S.C.201etseq.),andthose

entities’personnel.3

Second,subparagraph(c)(1)oftheChurchAmendmentsappliestodecisions

onemployment,promotion,orterminationofemployment,aswellasextensionof

stafforotherprivilegeswithrespecttophysiciansandotherhealthcarepersonnel.

42U.S.C.300a‐7(c)(1).Thissubparagraphprohibitscertainentitiesfrom

discriminatinginthesedecisionsbasedonanindividualdecliningtoperformor

assistinanabortionorsterilizationbecauseofthatindividual’sreligiousbeliefsor

moralconvictions.42U.S.C.300a‐7(c)(1).Italsoprohibitsthoseentitiesfrom

discriminatinginsuchdecisionsbasedonanindividual’sperformanceofalawful

abortionorsterilizationprocedure,oronanindividual’sreligiousbeliefsormoral

convictionsaboutsuchproceduresmoregenerally.Id.Likeparagraph(b),any

3TheChurchAmendmentsalsoreferencetheCommunityMentalHealthCentersAct,Pub.L.88‐164,77Stat.282(1963),andtheDevelopmentalDisabilitiesServicesandFacilitiesConstructionAmendmentsof1970,Pub.L.91‐517,84Stat.1316(1970).However,thosestatuteswererepealedbysubsequentstatuteand,accordingly,arenotreferencedhere.


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recipientsofagrant,contract,loan,orloanguaranteeunderthePublicHealth

ServiceActmustcomplywithsubparagraph(c)(1).

Third,subparagraph(c)(2)oftheChurchAmendmentsappliestothe

recipientsoftheDepartment’sgrantsorcontractsforbiomedicalorbehavioral

researchunderanyprogramadministeredbytheSecretary.42U.S.C.300a‐7(c)(2).

Thissubparagraphprohibitsdiscriminationbysuchentityagainstphysiciansor

otherhealthcarepersonnelinemployment,promotion,orterminationof

employment,aswellasdiscriminationintheextensionofstafforotherprivileges,

becauseofanindividual’sperformanceorassistanceinanylawfulhealthserviceor

researchactivity,decliningtoperformorassistinanysuchserviceoractivitybased

onreligiousbeliefsormoralconvictions,ortheindividual’sreligiousbeliefsor

moralconvictionsrespectingsuchservicesoractivitiesmoregenerally.42U.S.C.

300a‐7(c)(2).

Fourth,paragraph(d)oftheChurchAmendmentsappliestoanypartofa

healthserviceprogramorresearchactivityfundedinwholeorinpartundera

programadministeredbytheSecretary.Forthesehealthserviceprogramsor

researchactivities,noindividualshallberequiredtoperformorassistinthe

performanceofanypartoftheprogramorresearchactivityifdoingsowouldbe

contrarytohisorherreligiousbeliefsormoralconvictions.42U.S.C.300a‐7(d).

Fifth,paragraph(e)oftheChurchAmendmentsappliestohealthcare

trainingorstudyprograms,includinginternshipsandresidencies.Paragraph(e)

prohibitsanyentityreceivingcertainfundsfromdenyingadmissionto,orotherwise


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discriminatingagainst,applicantsfortrainingorstudybasedontheapplicant’s

reluctanceorwillingnesstocounsel,suggest,recommend,assist,orinanyway

participateintheperformanceofabortionsorsterilizationscontraryto,or

consistentwith,theapplicant’sreligiousbeliefsormoralconvictions.42U.S.C.300a‐

7(e).Anyrecipientofagrant,contract,loan,loanguarantee,orinterestsubsidy

underthePublicHealthServiceActortheDevelopmentalDisabilitiesAssistance

andBillofRightsActof2000(42U.S.C.15001etseq.)mustcomplywithparagraph

(e).

TheCoats‐SnoweAmendment.Enactedin1996,section245ofthePublic

HealthServiceAct(alsoknownasthe“Coats‐SnoweAmendment”or“Coats‐

Snowe”)appliesnondiscriminationrequirementstotheFederalgovernment,andto

StateorlocalgovernmentsreceivingFederalfinancialassistance.42U.S.C.238n.

Suchgovernmentsmaynotdiscriminateagainstanyhealthcareentitythatrefuses

toundergotrainingin,requireorprovidetrainingin,orperformabortions;referfor

abortionsorabortiontraining;ormakearrangementsforanyofthoseactivities.42

U.S.C.238n(a)(1)–(2).Furthermore,thosegovernmentsmaynotdiscriminate

againstahealthcareentitybecausetheentityattendsorattendedahealthcare

trainingprogramthatdoesnot(ordidnot)performabortions;require,provide,or

referfortrainingintheperformanceofabortions;ormakearrangementsforany

suchtraining.42U.S.C.238n(a)(3).Thelawdefinestheterm“healthcareentity”as

including(and,therefore,notlimitedto)anindividualphysician,apostgraduate


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physiciantrainingprogram,andaparticipantinaprogramoftraininginthehealth

professions.42U.S.C.238n(c)(2).

Inaddition,Coats‐Snoweappliestoaccreditationofpostgraduatephysician

trainingprograms.Therefore,theFederalgovernment,andStateorlocal

governmentsreceivingFederalfinancialassistance,maynotdenyalegalstatus

(includingalicenseorcertificate)orfinancialassistance,services,orotherbenefits

toahealthcareentitybasedonanapplicablephysiciantrainingprogram’slackof

accreditationduetotheaccreditingagency’srequirementsthatahealthcareentity

performinducedabortions;require,provide,orreferfortraininginthe

performanceofinducedabortions;ormakearrangementsforsuchtraining,

regardlessofwhethersuchstandardprovidesexceptionsorexemptions.42U.S.C.

238n(b)(1).Additionally,thestatuterequiresthegovernmentinvolvedtoformulate

regulationsorothermechanisms,orenterintoagreementswithaccrediting

agencies,asarenecessarytocomplywiththisaccreditationprovisionofCoats‐

Snowe.Id.

TheWeldonAmendment.TheWeldonAmendment(or“Weldon”)was

originallyadoptedin2004andhasbeenreadopted(orincorporatedbyreference)

ineachsubsequentappropriationsactfortheDepartmentsofLabor,Healthand

HumanServices,andEducation.See,e.g.,DepartmentofDefenseandLabor,Health

andHumanServices,andEducationAppropriationsAct,2019,andContinuing

AppropriationsAct,2019,Pub.L.No.115‐245,Div.B.,sec.507(d).Weldonprovides

thatnoneofthefundsmadeavailableintheapplicableLabor,HHS,andEducation


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appropriationsactbemadeavailabletoaFederalagencyorprogram,ortoaState

orlocalgovernment,ifsuchagency,program,orgovernmentsubjectsany

institutionalorindividualhealthcareentitytodiscriminationonthebasisthatthe

healthcareentitydoesnotprovide,payfor,providecoverageof,orreferfor

abortions.E.g.,DepartmentofDefenseandLabor,HealthandHumanServices,and

EducationAppropriationsAct,2019,andContinuingAppropriationsAct,2019,Pub.

L.No.115‐245,Div.B.,sec.507(d).Weldonstatesthattheterm“healthcareentity”

includesanindividualphysicianorotherhealthcareprofessional,ahospital,a

provider‐sponsoredorganization,ahealthmaintenanceorganization,ahealth

insuranceplan,oranyotherkindofhealthcarefacility,organization,orplan.Id.

ConditionsonFederallyAppropriatedFundsRequiringCompliancewith

FederalConscienceandAnti‐DiscriminationLaws.InadditiontoWeldon,current

appropriationsactsincludeotherhealthcareconscienceprotections.Forexample,

oneprovision,usinglanguagesimilartotheWeldonAmendment,prohibitsthe

DepartmentfromdenyingparticipationinMedicareAdvantagetoanotherwise

eligibleentity,suchasaprovider‐sponsoredorganization,becausetheentity

informstheSecretaryitwillnotprovide,payfor,providecoverageof,orprovide

referralsforabortions.DepartmentofDefenseandLabor,HealthandHuman

Services,andEducationAppropriationsAct,2019andContinuingAppropriations

Act,2019,Pub.L.115‐245,Div.B,sec.209,132Stat.2981.

ThePatientProtectionandAffordableCareAct’sConscienceandAssociated

Anti‐DiscriminationProtections.Passedin2010,thePatientProtectionand


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AffordableCareAct(ACA)alsoincludesseveralconscienceandassociatedanti‐

discriminationprotections.

Section1553oftheACAprohibitstheFederalgovernment,andanyStateor

localgovernmentorhealthcareproviderthatreceivesFederalfinancialassistance

undertheACA,oranyACAhealthplans,fromdiscriminatingagainstanindividual

orinstitutionalhealthcareentitybecauseoftheindividualorentity’sobjectionto

providinganyhealthcareitemsorserviceforthepurposeofcausingorassistingin

causingdeath,suchasbyassistedsuicide,euthanasia,ormercykilling.42U.S.C.

18113.Section1553designatesOCRtoreceivecomplaintsofdiscriminationonthat

basis.Id.

Section1303declaresthattheACAdoesnotrequirehealthplanstoprovide

coverageofabortionservicesaspartof“essentialhealthbenefitsforanyplanyear.”

42U.S.C.18023(b)(1)(A).Furthermore,noqualifiedhealthplanofferedthroughan

ACAexchangemaydiscriminateagainstanyindividualhealthcareprovideror

healthcarefacilitybecauseofthefacilityorprovider’sunwillingnesstoprovide,pay

for,providecoverageof,orreferforabortions.42U.S.C.18023(b)(4).Andsection

1303oftheACAmakesclearthatnothinginthatActshouldbeconstruedto

undermineFederallawsregarding—(i)conscienceprotection;(ii)willingnessor

refusaltoprovideabortion;and(iii)discriminationonthebasisofthewillingness

orrefusaltoprovide,payfor,cover,orreferforabortionortoprovideorparticipate

intrainingtoprovideabortion.42U.S.C.18023(c)(2)(A)(i)–(iii).Qualifiedhealth

plans,asdefinedunder42U.S.C.18021,offeredonanyExchangecreatedunderthe


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ACA,arerequiredtocomplywith§88.3(f)(2)(i)and(f)(2)(ii),whichfaithfully

appliestheplaintextofsection1303oftheACA.42U.S.C.18023.

Finally,undersection1411oftheACA,42U.S.C.18081,HHSisresponsible

forissuingcertificationstoindividualswhoareentitledtoanexemptionfromthe

individualresponsibilityrequirementimposedunderInternalRevenueCode

sec.5000A,includingwhensuchindividualsareexemptbasedonahardship(such

astheinabilitytosecureaffordablecoveragewithoutabortion),4aremembersofan

exemptreligiousorganizationordivision,5orparticipateina“healthcaresharing

ministry.”6Seealso26U.S.C.5000A(d)(2).Undersection1311(d)(4)(H)oftheACA,

42U.S.C.18031(d)(4)(H),healthbenefitexchangesareresponsibleforissuing

certificatesofexemptionconsistentwiththeSecretary’sdeterminationsunder

section1411oftheACA.

OtherProtectionsRelatedtothePerformanceofAdvanceDirectivesorAssisted

Suicide.Beforepassageofsection1553oftheACA,Congresshadpassedother

conscienceprotectionsrelatedtoassistedsuicide.Section7oftheAssistedSuicide

FundingRestrictionActof1997(Pub.L.105‐12,111Stat.23)clarifiedthatthe

4SeeGuidanceonHardshipExemptionsfromtheIndividualSharedResponsibilityProvisionforPersonsExperiencingLimitedIssuerOptionsorOtherCircumstances,CenterforConsumerInformationandInsuranceOversight,CentersforMedicare&MedicaidServices(CMS),April9,2018.https://www.cms.gov/CCIIO/Resources/Regulations‐and‐Guidance/Downloads/2018‐Hardship‐Exemption‐Guidance.pdf.Asdiscussedinthedescriptionof§88.3(g)below,Congressreducedthepenaltyin26U.S.C.5000Aforalackofminimumessentialcoverageto$0.SUPPORTforPatientsandCommunitiesAct,Pub.L.No.115‐271,section4003,26U.S.C.5000A(d)(2)(2018).5Organizationsthatarereligiouslyexemptincludethosewithestablishedtenetsorteachingsinoppositiontoacceptanceofthebenefitsofanyprivateorpublicinsurance.26U.S.C.1402(g)(1).6A“healthcaresharingministry”isanorganization,describedinsection501(c)(3)andtaxedundersection501(a)oftheInternalRevenueCode,comprisingmemberswhoshareacommonsetofethicalorreligiousbeliefsandwhosharemedicalexpensesamongmembersinaccordancewiththosebeliefswithoutregardtotheStateinwhichamemberresidesorisemployed.26U.S.C.5000A(d)(2)(B).


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PatientSelf‐DeterminationAct’sprovisionsstatingthatMedicareandMedicaid

beneficiarieshavecertainself‐determinationrightsdonot(1)requireanyprovider,

organization,oranyemployeeofsuchproviderororganizationparticipatinginthe

MedicareorMedicaidprogramtoinformorcounselanyindividualaboutarightto

anyitemorservicefurnishedforthepurposeofcausingorassistingincausingthe

deathofsuchindividual,suchasassistedsuicide,euthanasia,ormercykilling;or(2)

applytooraffectanyrequirementwithrespecttoaportionofanadvancedirective

thatdirectsthepurposefulcausingof,orassistanceincausing,thedeathofan

individual,suchasbyassistedsuicide,euthanasia,ormercykilling.42U.S.C.14406

(bycross‐referenceto42U.S.C.1395cc(f)(Medicare)and1396a(w)(Medicaid));see

also42U.S.C.1395cc(f)(4)(bycross‐referenceto42U.S.C.14406);1396a(w)(3),

1396a(a)(57);1396b(m)(1)(A);and1396r(c)(2)(E).7Thoseprotectionsextendto

MedicaidandMedicareproviders,suchashospitals,skillednursingfacilities,home

healthorpersonalcareserviceproviders,hospiceprograms,Medicaidmanaged

careorganizations,healthmaintenanceorganizations,Medicare+Choice(now

MedicareAdvantage)organizations,andprepaidorganizations.

ProtectionsRelatedtoCounselingandReferralsUnderMedicareAdvantage

Plans,MedicaidPlans,andManagedCareOrganizations.CertainFederalprotections

prohibitorganizationsofferingMedicare+Choice(nowMedicareAdvantage)plans

7SimilarprotectionsexistundertheDepartment’sregulationsapplicabletohospitals,nursingfacilities,andothermedicalfacilities,See,e.g.,42CFR489.102(c)(2);MedicareAdvantage,42CFR422.128(b)(2)(ii);andMedicareHealthMaintenanceOrganizationsandComprehensiveMedicalPlans,42CFR417.436(suchorganizations,plans,andtheiragentsarenotrequiredtoimplementadvancedirectivesiftheprovidercannotdoso“asamatterofconscience”andStatelawallowssuchconscientiousobjection).


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andMedicaidmanagedcareorganizationsfrombeingcompelledundercertain

circumstancestoprovide,reimbursefor,orcover,anycounselingorreferralservice

inplansoveranobjectiononmoralorreligiousgrounds.42U.S.C.1395w‐

22(j)(3)(B)(Medicare+Choice);42U.S.C.1396u‐2(b)(3)(B)(Medicaidmanagedcare

organization).Departmentregulationsprovidethatthisconscienceprovisionfor

managedcareorganizationsalsoappliestoprepaidinpatienthealthplansand

prepaidambulatoryhealthplansundertheMedicaidprogram.42CFR

438.102(a)(2).

FederalConscienceandAnti‐DiscriminationProtectionsApplyingtoGlobal

HealthPrograms.TheDepartmentadministerscertainprogramsunderthe

President’sEmergencyPlanforAIDSRelief(PEPFAR),towhichadditional

conscienceprotectionsapply.Specifically,recipientsofforeignassistancefundsfor

HIV/AIDSprevention,treatment,orcareauthorizedbysection104AoftheForeign

AssistanceActof1961(22U.S.C.2151b‐2),22U.S.C.7601‐7682,orunderany

amendmentmadebytheTomLantosandHenryJ.HydeUnitedStatesGlobal

LeadershipAgainstHIV/AIDS,Tuberculosis,andMalariaReauthorizationActof

2008(Pub.L.110‐293),cannotberequired,asaconditionofreceivingsuchfunds,

(1)to“endorseorutilizeamultisectoralorcomprehensiveapproachtocombating

HIV/AIDS,”or(2)to“endorse,utilize,makeareferralto,becomeintegratedwith,or

otherwiseparticipateinanyprogramoractivitytowhichtheorganizationhasa

religiousormoralobjection.”22U.S.C.7631(d)(1)(B).Thegovernmentalsocannot

discriminateagainstsuchrecipientsinthesolicitationorissuanceofgrants,


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contracts,orcooperativeagreementsfortherecipients’refusaltodoanysuch

actions.22U.S.C.7631(d)(2).

ExemptionsfromCompulsoryMedicalScreening,Examination,Diagnosis,or

Treatment.Thisruleincorporatesfourstatutoryprovisionsthatprotectparents

who,onthebasisofconscience,objecttotheirchildrenbeingforcedtoreceive

certaintreatmentsorhealthinterventions.First,underthePublicHealthService

Act,certainsuicidepreventionprogramsarenottobeconstruedtorequire“suicide

assessment,earlyintervention,ortreatmentservicesforyouth”iftheirparentsor

legalguardianshavereligiousormoralobjectionstosuchservices.42U.S.C.290bb‐

36(f);section3(c)oftheGarrettLeeSmithMemorialAct(Pub.L.108‐355,118Stat.

1404,reauthorizedbyPub.L.114‐255atSec.9008).Second,authoritytoissue

certaingrantsthroughtheHealthResourcesandServicesAdministration(HRSA),

CentersforDiseaseControlandPrevention(CDC),andtheNationalInstitutesof

Health(NIH)maynotbeconstruedtopreemptorprohibitStatelawswhichdonot

requirehearinglossscreeningfornewborn,infantsoryoungchildrenwhose

parentsobjecttosuchscreeningbasedonreligiousbeliefs.42U.S.C.280g‐1(d).

Third,certainStateandlocalchildabusepreventionandtreatmentprograms

fundedbyHHSarenottobeconstruedascreatingaFederalrequirementthata

parentorlegalguardianprovideachildanymedicalserviceortreatmentagainst

thereligiousbeliefsofthatparentorlegalguardian.42U.S.C.5106i(a).Fourth,in

providingpediatricvaccinesfundedbyFederalmedicalassistanceprograms,


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providersmustcomplywithanyStatelawsrelatingtoanyreligiousorother

exemptions.42U.S.C.1396s(c)(2)(B)(ii).

ConscienceClausesRelatedtoReligiousNonmedicalHealthCare.Since1965,

CongresshasprovidedaccommodationsinMedicareandMedicaidforpersonsand

institutionsobjectingtotheacceptanceorprovisionofmedicalcareorservices

basedonabeliefinareligiousmethodofhealingthroughapprovalofreligious

nonmedicalhealthcareinstitutions(RNHCIs).RNHCIsdonotprovidestandard

medicalscreenings,examination,diagnosis,prognosis,treatment,orthe

administrationofmedications.42U.S.C.1395x(ss)(1).Instead,RNHCIsfurnish

nonmedicalitemsandservicessuchasroomandboard,unmedicatedwound

dressings,andwalkers,8andtheyprovidecareexclusivelythroughnonmedical

nursingpersonnelassistingwithnutrition,comfort,support,moving,positioning,

ambulation,andotheractivitiesofdailyliving.9

CongresshasacknowledgedRNHCIsthroughseveralstatutes.Forexample,

althoughsuchinstitutionswouldnototherwisemeetthemedicalcriteriafor

Medicareproviders,see42U.S.C.1395x(e)(definitionof“hospital”),1395x(y)(1)

(definitionof“skillednursingfacility”),1395x(k),and1320c‐11(exemptionsfrom

othermedicalcriteriaandstandards),Congressexpresslyincludedthemwithinthe

definitionofdesignatedMedicareproviders.CongressprohibitedStatesfrom

excludingRNHCIsfromlicensurethroughimplementationofStatedefinitionsof

8https://www.medicare.gov/coverage/rnhci‐items‐and‐services.html.9https://www.cms.gov/Medicare/Provider‐Enrollment‐and‐Certification/CertificationandComplianc/RNHCIs.html.


18

“nursinghome”and“nursinghomeadministrator,”42U.S.C.1396g(e),andCongress

exemptedRNHCIsfromcertainMedicaidrequirementsformedicalcriteriaand

standards.42U.S.C.1396a(a)(exemptingRNHCIsfrom42U.S.C.1396a(a)(9)(A),

1396a(a)(31),1396a(a)(33),and1396b(i)(4)).Finally,Congresspermittedpatients

atRNHCIstofileanelectionwithHHSstatingthattheyare“conscientiously

opposedtoacceptanceof”medicaltreatment,thatisneitherreceivedinvoluntarily

norrequiredunderFederalorStatelaworthelawofapoliticalsubdivisionofa

State,onthebasisof“sincerereligiousbeliefs,”yetremaineligibleforthe

nonmedicalcareandservicesordinarilycoveredunderMedicare,Medicaid,and

CHIP.See,e.g.,42U.S.C.1395x(e),1395x(y),and1395i‐5(Medicareprovisions).

Federalcourtshaveupheldtheconstitutionalityofsuchreligiousaccommodations.

See,e.g.,Kongv.Scully,341F.3d1132(9thCir.2003);Children’sHealthcarev.MinDe

Parle,212F.3d1084(8thCir.2000).

Congresshasalsoprovidedparticularaccommodationsforpersonsand

institutionsthatobjecttomedicalservicesanditems.Section6703(a)oftheElder

JusticeActof2009(Pub.L.111‐148,124Stat.119)providesthatElderJusticeand

SocialServicesBlockGrantprogramsmaynotinterferewithorabridgeanelder

person’s“righttopracticehisorherreligionthroughrelianceonprayeralonefor

healing,”whenthepreferenceforsuchrelianceiscontemporaneouslyexpressed,

previouslysetforthinalivingwillorsimilardocument,orunambiguouslydeduced

fromsuchperson’slifehistory.42U.S.C.1397j‐1(b).Additionally,theChildAbuse

PreventionandTreatmentAct(CAPTA)specifiesthatitdoesnotrequire(thoughit


19

alsodoesnotprevent)aStatefindingofchildabuseorneglectincasesinwhicha

parentorlegalguardianreliessolelyorpartiallyuponspiritualmeansratherthan

medicaltreatment,inaccordancewithreligiousbeliefs.42U.S.C.5106i(a)(2).

B.RegulatoryHistory

TheDepartmentengagedinrulemakingtoenforcesomeoftheseFederal

conscienceandanti‐discriminationlawsonpreviousoccasions:inthe2008final

ruleat45CFRpart88(the“2008Rule,”73FR78072,78074(Dec.19,2008)),inthe

revocationandreplacementofthatRulein2011(the“2011Rule”),andinexisting

CMSregulationsat42CFRparts422and438,whichimplement1395w‐22(j)(3)(b)

and1396u‐2(b)(3)(B),respectively.10Thissectionofthepreamblebriefly

summarizesthefirsttwoactions.

2008Rule.TheDepartmentissuedanoticeofproposedrulemakingin2008

toenforce,andclarifytheapplicabilityof,theChurch,Coats‐Snowe,andWeldon

Amendments.73FR50,274(Aug.26,2008)(August2008ProposedRule).That

proposedrulerecognized(1)inconsistentawarenessofFederalconscienceand

anti‐discriminationprotectionsamongfederallyfundedrecipientsandprotected

personsandentities;and(2)theneedforgreaterenforcementmechanismsto

ensurethatDepartmentfundsdonotsupportmorallycoerciveordiscriminatory

policiesorpracticesinviolationoffederallaw.

TheDepartmentreceiveda“largevolume”ofcommentsontheAugust2008

ProposedRule.See73FRat78,074.Commentscamefromawidevarietyof

10Forinstance,theprohibitionagainstcoercionin42USC1395w‐22(j)(3)(section1852oftheSocialSecurityAct)isregulatedwithintheMedicareProgramat42CFR422.206(b),(d).


20

individualsandorganizations,includingprivatecitizens,individualandinstitutional

healthcareproviders,religiousorganizations,patientadvocacygroups,professional

organizations,universitiesandresearchinstitutions,consumerorganizations,and

StateandFederalagenciesandrepresentatives.Commentsdealtwitharangeof

issuessurroundingtheproposedrule,includingwhethertherulewasneeded,what

individualswouldbeprotectedbytheproposedrule,whatserviceswouldbe

coveredbytheproposedrule,whetherhealthcareworkerswouldusethe

regulationtodiscriminateagainstpatients,whatsignificantimplementationissues

couldbeassociatedwiththerule,whatlegalargumentscouldbemadeforand

againsttherule,andwhatcostimpactsoftheproposedrulecouldbeanticipated.

Manycommentsconfirmedtheneedtopromulgatearegulationtoraiseawareness

ofFederalconscienceandanti‐discriminationprotectionsandprovidefortheir

enforcement.

TheDepartmentrespondedtothosesubstantivecommentsandissuedafinal

ruleonDecember19,2008,codifyingtheruleat45CFRpart88(“2008Rule”),

whichconsistedofsixsections:

Section88.1statedthatthepurposeofthe2008Rulewas“toprovideforthe

implementationandenforcement”oftheChurch,Coats‐Snowe,andWeldon

Amendments.ItspecifiedthatthoseAmendmentsandtheimplementingregulations

“[we]retobeinterpretedandimplementedbroadlytoeffectuatetheirprotective

purposes.”


21

Section88.2ofthe2008Ruledefinedseveraltermsusedinpart88and

applicabletovariousprovidernondiscriminationprotections,namely,theterms

“AssistinthePerformance,”“Entity,”“HealthCareEntity,”“HealthServiceProgram,”

“Individual,”“Instrument,”“Recipient,”“Sub‐recipient,”and“Workforce.”

Section88.3ofthe2008Rulesetforththescopeofapplicabilityofthe

sectionsandparagraphsofpart88astheyrelatedtoeachconsciencelaw

implementedinthe2008Rule.

Section88.4ofthe2008Rulesetforththesubstantiverequirementsand

applicationsoftheChurch,Coats‐Snowe,andtheWeldonAmendments.

Section88.5ofthe2008Rulerequiredcoveredfederallyfundedentitiesto

providewrittencertificationofcompliancewiththelawsencompassedbythe2008

Rule.

Section88.6ofthe2008RuledesignatedHHSOCRtoreceivecomplaints

basedonthethreespecifiedFederalconscienceandanti‐discriminationlaws,and

directedOCRtocoordinatehandlingthosecomplaintswiththeDepartmental

componentsfromwhichthecoveredentityreceivesfunding.

ProposedChangesin2009ResultinginNewFinalRulein2011.OnMarch10,

2009,withtheadventofanewAdministration,theDepartmentproposedtorescind,

initsentirety,the2008Rule.74FR10,207(Mar.10,2009)(2009ProposedRule).

TheDepartmentdeclaredthatcertaincommentsontheAugust2008ProposedRule

raisedanumberofquestionswarrantingfurtherreviewofthe2008Ruletoensure

itsconsistencywiththatAdministration’spolicy.TheDepartmentinvitedfurther


22

commentstoreevaluatethenecessityforregulationsimplementingtheFederal

conscienceandanti‐discriminationlaws.Inresponsetotheproposaltorescindthe

2008Rule,forwhichtheDepartmentreceivedsupportingcomments,the

Departmentalsoreceivedcommentsstatingthathealthcareworkersshouldnotbe

requiredtoviolatetheirreligiousbeliefsormoralconvictions;expressingconcern

thathealthcareproviderswouldbecoercedintoviolatingtheirconsciences;and

identifyingthe2008RuleasprotectingFirstAmendmentreligiousfreedomrights,

thecapacitytoupholdthetenetsoftheHippocraticOath,andtheethicalintegrityof

themedicalprofession.Numerouscommentersidentifiedconcernsthattherewould

benoregulatoryschemetoprotectthelegalrightsaffordedtohealthcareproviders,

includingmedicalstudents.76FR9968,9971(Feb.23,2011)(2011Rule).

OnFebruary23,2011,theDepartmentrescindedmostofthe2008Ruleand

finalizedanewrule.76FR9968.The2011Ruleleftinplacesection“88.1Purpose,”

butremovedtheword“implementation,”describingthe2011Rule’spurposeas

“provid[ing]fortheenforcement”oftheChurch,Coats‐Snowe,andWeldon

Amendments.Itthenremovedthe2008Rule’ssections88.2through88.5,

redesignatedthe2008Rule’s§88.6as§88.2,andmodifiedthatsectiontoconsistof

twosentences,statingthatOCRisdesignatedtoreceivecomplaintsbasedonthe

Federalhealthcareproviderconscienceprotectionstatutes,andwillcoordinatethe

handlingofcomplaintswiththeDepartmentalfundingcomponent(s)fromwhich

theentitywithrespecttowhichacomplainthasbeenfiled,receivesfunding.


23

Thepreambletothe2011Rulestated,“TheDepartmentsupportsclearand

strongconscienceprotectionsforhealthcareproviderswhoareopposedto

performingabortions.”76FRat9969.TheDepartmentrecognized,“Thecomments

receivedsuggestedthatthereisaneedtoincreaseoutreacheffortstomakesure

providersandgranteesareawareofthesestatutoryprotections.Itisalsoclearthat

theDepartmentneedstohaveadefinedprocessforhealthcareproviderstoseek

enforcementoftheseprotections.”76FRat9969.Accordingly,thesummaryofthe

2011Rulestatedthat“enforcementoftheFederalstatutoryhealthcareprovider

conscienceprotectionswillbehandledbytheDepartment’sOfficeforCivilRights,in

conjunctionwiththeDepartment’sfundingcomponents.”76FRat9968.The

DepartmentannouncedthatOCRwasbeginningtolead“aninitiativedesignedto

increasetheawarenessofhealthcareprovidersabouttheprotectionsprovidedby

thehealthcareproviderconsciencestatutes,andtheresourcesavailableto

providerswhobelievetheirrightshavebeenviolated.”76FRat9969.The2011

RuleprovidedthatOCRwould“collaboratewiththefundingcomponentsofthe

Departmenttodeterminehowbesttoinformhealthcareprovidersandgrantees

abouthealthcareconscienceprotections,andthenewprocessforenforcingthose

protections.”Id.

II.OverviewoftheFinalRule

A.OverviewofReasonsfortheFinalRule

Afterreviewingthepreviousrulemakings,commentsfromthepublic,and

OCR’senforcementactivities,theDepartmenthasconcludedthatthereisa


24

significantneedtoamendthe2011Ruletoensureknowledgeof,compliancewith,

andenforcementof,Federalconscienceandanti‐discriminationlaws.The2011Rule

createdconfusionoverwhatisandisnotrequiredunderFederalconscienceand

anti‐discriminationlawsandnarrowedOCR’senforcementprocesses.Since

November2016,therehasbeenasignificantincreaseincomplaintsfiledwithOCR

allegingviolationsofthelawsthatwerethesubjectofthe2011Rule,comparedto

thetimeperiodbetweenthe2009proposaltorepealthe2008RuleandNovember

2016.TheincreaseunderscorestheneedfortheDepartmenttohavetheproper

enforcementtoolsavailabletoappropriatelyenforceallFederalconscienceand

anti‐discriminationlaws.11

AllegationsandEvidenceofDiscriminationandCoercionHaveExistedSince

the2008RuleandIncreasedOverTime.The2008Rulesoughttoaddressan

environmentofdiscriminationtoward,andattemptedcoercionof,thosewhoobject

tocertainhealthcareproceduresbasedonreligiousbeliefsormoralconvictions.12

YetinFebruary2009,theDepartmentannounceditsintenttorescindthe2008Rule

justonemonthafteritseffectivedate.13Itcompletedthatrescissionin2011,despite

11Since2011,conscienceandcoercioninhealthcarehavebeenthesubjectsofsignificantlitigationattheStateandlocallevel.Recently,theSupremeCourtheldthattheStateofCalifornialikelyviolatedtheFreeSpeechrightsofprolifepregnancyresourcecentersthatdonotprovideinformationaboutwheretoobtainabortionsbyadoptingastatutethatrequiredthem,amongotherthings,topostnoticestowhichtheyobjected.SeeNat’lInst.ofFamilyandLifeAdvocatesv.Becerra,138S.Ct.2361(Jun.26.2018).1273FRat78,073.13RobStein,“ObamaPlanstoRollBack‘Conscience’RuleProtectingHealthCareOfWorkersWhoObjecttoSomeTypesofCare,”TheWashingtonPost(Feb.28,2009)http://www.washingtonpost.com/wp‐dyn/content/article/2009/02/27/AR2009022701104.html(writingthat“Theadministration'splans,revealedquietlywithatersepostingonaFederalwebsite,unleashedafloodofheatedreaction”).


25

significantevidenceofanenvironmentofdiscriminationandcoercion,including

thousandsofpubliccommentsduringtherulemakingsthatledtothe2008and

2011Rulesdescribingthatenvironment.Forexample,a2009articleintheNew

EnglandJournalofMedicineargued,“Qualmsaboutabortion,sterilization,andbirth

control?Donotpracticewomen’shealth.”14Ina2009surveyof2,865membersof

faith‐basedmedicalassociations,39%reportedhavingfacedpressureor

discriminationfromadministratorsorfacultybasedontheirmoral,ethical,or

religiousbeliefs.15Additionally,32%ofthesurveyrespondentsreportedhaving

beenpressuredtoreferapatientforaproceduretowhichtheyhadmoral,ethical,

orreligiousobjections.Some20%ofmedicalstudentsinthatpollsaidthatthey

wouldnotpursueacareerinobstetricsorgynecologybecauseofperceived

discriminationandcoercioninthatspecialtyagainsttheirbeliefs.Intotal,91%of

respondentsreportedthatthey“wouldratherstoppracticingmedicinealtogether

thanbeforcedtoviolate[their]conscience.”

Commentsreceivedduringtherulemakingthatledtothe2011Rulewere

consistentwiththissurvey.Multiplecommentersreportedthatsomehospitalshad

forcedhealthcareproviderstosignaffidavitsagreeingtoparticipateinabortionsif

asked.16Oneobstetrician/gynecologistcommentedthathehadbeenpressuredto

14JulieD.Cantor,M.D.,J.D.,“ConscientiousObjectionGoneAwry—RestoringSelflessProfessionalisminMedicine,”360NewEnglandJ.Med.1484–85(April9,2009).15ThePollingCompany,Inc./WomanTrend,HighlightsofThePollingCompany,Inc.PhoneSurveyoftheAmericanPublic,fieldedMarch31,2009throughApril3,2009),https://www.cmda.org/library/doclib/pollingsummaryhandout.pdf(lastvisitedJan.18,2018);seealsoPublicCommentfromJonathanImbody,ChristianMedicalAssociation,(“CMAComment”),availableathttps://www.regulations.gov/document?D=HHS‐OCR‐2018‐0002‐64461.16CommentNos.HHS‐OPHS‐2009‐0001‐0739,‐52648,‐52677.


26

participateinabortionsandabortioncounselingduringhisentiretimeinhealth

care—frommedicalschool,throughhisresidency,andduringprivatepractice.17

Medicalandnursingstudents,intwenty‐fivecomments,expressedtheirreluctance

toenterthehealthcarefieldasawhole,andparticularlyspecialtiessuchas

obstetrics,familymedicine,andeldercare,wheretheirobjectionstoabortionor

euthanasiamightnotberespected.18Atleastninetycommenterssaidthat,ifforced

tochoosebetweentheircareersorviolatingtheirconscience,theywouldquittheir

jobs.19Tensofthousandsofcommentstothe2009proposedruleexpressedconcern

17CommentNo.HHS‐OPHS‐2009‐0001‐0868.18CommentNos.HHS‐OPHS‐2009‐0001‐0026,‐1035,‐10522,‐12117,‐14427,‐34439,‐11404(“futurephysician”concernedaboutshortages),‐35236(granddaughterenteringthemedicalprofessionwillchangecareerpath),‐11579(sonenteringthemedicalprofession),‐14435(concernedmotherofmedicalstudent),‐18783(spoketostudentwhoisdistraughtandmayleave),‐5571,‐41431(sisterisamedicalstudent),‐5638,‐0068,‐1791(studentwouldquitjob),‐2750(exacerbateshealthcareissues),‐5255(opposedandhasusedexemption),‐7058,‐7276,‐7671,‐5270(hasalreadyseenothersleavetheprofessionoverpressurefortheirbeliefs),‐5638,‐5566(nursewhochosenottospecializeinobstetricsandgynecologyforfearofpressure),‐5566(nursewhochosenottoenterobstetricsandgynecologybecauseofpressuretoperformabortions).19Almost90commentsarecitedhere,butthisismerelyasampleofthetotal.SeeCommentNos.HHS‐OPHS‐2009‐0001‐0540,‐0017,‐0264,‐0350,‐0356,‐0485,‐0540,‐0880,‐0881,‐0902,‐0917,‐0932,‐10154,‐15148,‐20381(womaninCaliforniawhosedaughterisanurse),‐23290(alreadylefttheprofession),‐32951,‐9188,‐47007(patient’sdoctorsaidhewouldretire),‐14287,‐19128,‐9873,‐29603(physicianstatingmanywillretire),‐50498(patient’sdoctorsaidhewouldretire),‐27384,‐44458,‐18837,‐14216,‐18015,‐18015,‐34140(alreadyretiredbutwouldhaveretiredearlier),‐32593,‐15341,‐14837,‐8582,‐16541,‐11579(patient’sdoctorsaidhewouldretire),‐0229,‐51896(childrenwouldbeforcedtoleave),‐32009(otherphysicianswillbedrivenout),‐10280(physicianwithobjections),‐19029,‐33116,‐50663,‐3675,‐24456,‐11327,‐19221,‐34888(nursesayingotherswillleave),‐14535(daughterwillleavetheprofession),‐21679(fourmembersinthefamilywhomayleave),‐0283,‐0340,‐0905,‐9272,‐0055(willgiveupservingunderservedpopulation),‐10862(twosisterswhoarenurseswillleave,hospitalshutdown),‐17401,‐29674(sonwhoisaphysicianwillbeforcedout),‐26795(physicianwhosaysdoctorswillbeforcedout),‐25742,‐49731,‐15087,‐13138,‐17563,‐0006(refusetoacceptviolationofbeliefsinpractice),‐0815,‐7665,‐8091,‐2598(privatefamilyphysicianwhointentionallyavoidedobstetricsbecauseitwasmadeclearthat“pro‐lifecandidatesneednotapply”;alsocitesstrongpressureinuniversitiesandorganizationsinfavorofabortionprovision,andisconcernedphysicianswillleavethepracticemore.),‐3564,‐0199,‐5230(discriminationalreadypresent),‐6603,‐1397(nursewhohasbeenforcedtodothingsagainstherconscienceinthepastbeforethe2008Rulecameintoeffect,andwhowillquitifputinthatscenarioagain),‐1100(nursewhosaysotherswillleavethepractice),‐6669,‐0272,‐0925,‐0125,‐4668,‐6709,‐7900,‐2544,‐3535,‐1852,‐7684,‐1381.


27

that,withoutrobustenforcementofFederalconscienceandanti‐discrimination

laws,individualswithconscientiousobjectionssimplywouldnotenterthehealth

carefield,orwouldleavetheprofession,andhospitalswouldshutdown,

contributingtotheshortageofhealthcareprovidersoraffectingthequalityofcare

provided.20Thousandsalsofearedpersonnelwithobjectionswouldbeterminated

orotherwiseunabletofindemployment,training,oropportunitiestoadvancein

theirfields.21

Commentersalsoidentifiedacultureofhostilitytoconscienceconcernsin

healthcare.22Someexpressedconcernthattherescissionofthe2008Rulewould

contributetotheseproblemsbyinappropriatelypoliticizing,andinterferingin,the

practiceofmedicineandindividualproviders’judgment.23Thousandsofcomments

frommedicalpersonnelstatedtheirdisagreementwiththerescission,oftenstating

thattheyhadrequestedexemptionsinthepastandwereconcernedrescission

20CommentNos.HHS‐OPHS‐2009‐0001‐20613,‐43039,‐27699,‐42804,‐6001,‐10850,‐27147,‐50621,‐52878,‐19586,‐40775,‐4824,‐27384,‐11138,‐52997,‐53001,‐4460,‐12878,‐12575,‐43364,‐27262,‐42942,‐26426,‐38158,‐43672,‐52381,‐32173,‐16541,‐19751,‐2697,‐52935,‐6369,‐44571,‐53022,‐48387,‐21990,‐50837,‐42069,‐14662,‐51974,‐45449,‐17364,‐5370,‐2922,‐15005,‐18783,‐23376,‐50685,‐17401,‐52946,‐11206,‐33828,‐38997,‐3925,‐21036,‐50894,‐27155,‐10529,‐47113,‐7266,‐22291,‐4016,‐0204,‐8788,‐25608,‐52932,‐39199,‐12340,‐52950(formletterwith1916copies),‐31897,‐52984(formletterwith62copies),‐53081(formletterwith22copies),‐52968(formletterwith9532copies),‐52961(patientsconcernedaboutaccesstopro‐lifedoctors:formletterwith3272copies),‐53098(patientsconcernedefforttopushpeopleout:formletterwith976copies),‐52977(formletterwith3516copies),‐53021(formletterwith4842copies),‐52949(formletterwith688copies),‐53039(formletterwith742copies),‐0476.21CommentNos.HHS‐OPHS‐2009‐0001‐0558,‐10144,‐53026(claimsdocumentationofunaddresseddiscrimination),‐52985(claimsdocumentationofunaddresseddiscrimination),‐52960(claimsdocumentationofunaddresseddiscrimination),‐52735(lackofknowledgeaboutrights),‐53048(evidenceofdiscrimination),‐53047(evidenceofdiscrimination:formletterwith3196copies),‐52960(evidenceofdiscrimination:formletterwith1685copies),‐53028(evidenceofdiscrimination:formletterwith2002copies).22CommentNos.HHS‐OPHS‐2009‐0001‐0739,‐52677,‐26812,‐53013(formletterwith8472copies).23CommentNo.HHS‐OPHS‐2009‐0001‐10280,‐2486,‐46903,‐19125,‐36940,‐12020,‐41551.


28

wouldmakeithardertorequestexemptionsinthefuture.24Hundredsof

commentersexpressedconcernovertheexclusionandmarginalizationofhealth

careentitiesandemployeesholdingreligiousbeliefsormoralconvictions,andfears

thatthemoralagencyofthemedicalprofessionwaseroding.25

Accordingtonewsreports,in2010,NassauUniversityMedicalCenter

disciplinedeightnurseswhentheyraisedobjectionstoassistingintheperformance

ofabortions.26NursesinIllinoisandNewYorkfiledlawsuitsagainstprivate

hospitalsallegingtheyhadbeencoercedtoparticipateinabortions.Mendozav.

Martell,No.2016‐6‐160(Ill.17thJud.Cir.June8,2016);Cenzon‐DeCarlov.Mount

SinaiHosp.,626F.3d695(2dCir.2010).Anurse‐midwifeinFloridaallegedshehad

beendeniedtheabilitytoapplyforapositionatafederallyqualifiedhealthcenter

duetoherobjectionstoprescribinghormonalcontraceptives.Hellwegev.Tampa

FamilyHealthCtrs.,103F.Supp.3d1303(M.D.Fla.2015).TwelvenursesinNew

Jerseysuedapublichospitaloverapolicyallegedlyrequiringthemtoassistin

abortionsandfordiscipliningonenursewhoraisedaconscientiousobjectiontothe

same.Complaint,Danquahv.UniversityofMedicineandDentistryofNewJersey,No.

2:11‐cv‐6377(D.N.J.Oct.31,2011).Manyreligioushealthcarepersonnelandfaith‐

24CommentNos.HHS‐OPHS‐2009‐0001‐3107,‐15617,‐19496,‐27506,‐9586,‐35721,‐49748,‐1650,‐19965,‐18365,‐23095,‐6332,‐3405,‐1762,‐4395,‐4569,‐6890,‐0729,‐0943,‐1490,‐2994,‐3248,‐3419,‐5341,‐6479,‐7079,‐4525,‐7093,‐2486,‐2039,‐7750,‐6270,‐1903,‐3293,‐3405,‐1127,‐5505,‐1823,‐4939,‐5881,‐4529,‐5829,‐1773,‐2220,‐2345,‐3089,‐7163,‐7471,‐3840,‐0389,‐1933,‐3493,‐3088,‐5088,‐5702.25CommentNos.HHS‐OPHS‐2009‐0001‐52974(formletterwith428copies).26LIHospitalissuesabortionapologytonurses,N.Y.Post(Apr.28,2010),http://nypost.com/2010/04/28/li‐hospital‐issues‐abortion‐apology‐to‐nurses.


29

basedmedicalentitieshavefurtherallegedthathealthcarepersonnelarebeing

targetedfortheirreligiousbeliefs.27

In2016,theAmericanCongressofObstetriciansandGynecologists(ACOG)

reaffirmedapriorethicsopinionthatrecommended,“Physiciansandotherhealth

careprofessionalshavethedutytoreferpatientsinatimelymannertoother

providersiftheydonotfeelthattheycaninconscienceprovidethestandard

reproductiveservicesthattheirpatientsrequest,”and“Inresource‐poorareas...

[p]roviderswithmoralorreligiousobjectionsshouldeitherpracticeinproximityto

individualswhodonotsharetheirviewsorensurethatreferralprocessesarein

placesothatpatientshaveaccesstotheservicethatthephysiciandoesnotwishto

provide.”28

PubliccommentsreceivedontheproposedrulepublishedinJanuary2018

sharedadditionalanecdotesofcoercion,discriminatoryconduct,orotheractions

potentiallyinviolationofFederalconscienceandanti‐discriminationlaws.

Commentersalsosharedtheirassessmentsoftheknowledge,orlackthereof,among

thegeneralpublic,healthcarefield,healthcareinsuranceindustry,and

27See,e.g.,RomanCatholicDioceseofAlbanyv.Vullo,No.02070‐16(N.Y.AlbanyCountyS.Ct.May4,2016);Meansv.U.S.ConferenceofCatholicBishops,No.1:15‐CV‐353,2015WL3970046(W.D.Mich.2015);ACLUv.TrinityHealthCorporation,178F.Supp.3d614(E.D.Mich.2016);Mintonv.DignityHealth,No.17‐558259(Calif.Super.Ct.Apr.19,2017);Chamorrov.DignityHealth,No.15‐549626(Calif.Super.Ct.Dec.28,2015).SeealsoU.S.ConferenceofCatholicBishops,EthicalandReligiousDirectivesforCatholicHealthServices(Nov.17,2009)(identifyingCatholicobjectionstoperformingabortions,tuballigations,andhysterectomies).28https://www.acog.org/Clinical‐Guidance‐and‐Publications/Committee‐Opinions/Committee‐on‐Ethics/The‐Limits‐of‐Conscientious‐Refusal‐in‐Reproductive‐Medicine(reaffirmingACOG,“TheLimitsofConscientiousRefusalinMedicine,”CommitteeOpinionNo.385,110ObstetGyn.1479(2007))The2007ACOGopinionhad,atleastinpart,promptedthe2008Rule.Then‐HHSSecretaryLeavittwrotetoACOGandtheAmericanBoardofObstetricsandGynecology(ABOG)andnotedthattheinteractionbetweentheACOGopinionandABOGcertificationrequirementscouldconstituteaviolationofFederalconscienceandanti‐discriminationlaws.


30

employmentlawfieldoftherightsandobligationsthatthisruleimplementsand

enforces.ExamplesaredetailedintheRegulatoryImpactAnalysisaspartofthe

Department’sanalysisunderExecutiveOrders12,866and13,563regardingthe

needforthisrule.

RecentlyEnactedStateandLocalGovernmentHealthCareLawsandPolicies

HaveResultedinNumerousLawsuitsbyConscientiousObjectors.TheDepartmenthas

alsowitnessedanincreaseinlawsuitsagainstStateandlocallawsthatplaintiffs

allegeviolateconscienceorunlawfullydiscriminate.Forexample,manyStateand

localgovernmentshaveenactedlegislationrequiringhealthcareprovidersoffering

pregnancyresourcesasanalternativetoabortiontopostnoticesrelatedto

abortion,towhichplaintiffsobjectedonFirstAmendmentandanalogousgrounds.

TheSupremeCourtheldthatCalifornia’sversionofsuchalawlikelyviolatedthe

FirstAmendmentfreespeechrightsofcentersthatobjecttoabortioninNational

InstituteofFamilyandLifeAdvocatesv.Becerra,No.16‐1140,585U.S.____,138S.Ct.

2361(Jun.26,2018)(“NIFLA”).29

CourtshavealsoenjoinedsimilarordinancesinNewYorkCity;Austin,Texas;

MontgomeryCounty,Maryland;Baltimore,Maryland;Illinois;andHawaii.Greater

BaltimoreCenterforPregnancyConcerns,Inc.v.MayorandCityCouncilofBaltimore,

879F.3d101,105(4thCir.2018),cert.denied,138S.Ct.2710,(2018)(holdingthat

Baltimoreordinancerequiringpregnancyresourcecentertostateabortionservices

29OnJanuary18,2019,OCRissuedaNoticeofViolationtotheStateofCaliforniaforOCRComplaintNos.16‐224756and18‐292848,findingthatCalifornia’sversionofsuchalawviolatedtheWeldonandCoats‐SnoweAmendments,asdiscussedinfra.


31

arenotavailableintheirfacilitiesviolatedtheFreeSpeechClause);EvergreenAss’n,

Inc.v.CityofNewYork,740F.3d233(2dCir.2014)(affirminganinjunction,based

ontheFirstAmendment,ofordinanceprovisionsrequiringdisclosuresabout

whetherpregnancyresourcecentersreferforabortionandconveyingcityhealth

department’srecommendationtoconsultalicensedmedicalprovider);Austin

LifeCarev.CityofAustin,No.1:11‐cv‐00875‐LY(W.D.Tex.Jun.23,2014)

(permanentlyenjoiningenforcementofordinanceasvoidforvagueness);Centro

Tepeyacv.MontgomeryCounty,5F.Supp.3d745(D.Md.Mar.7,2014)(applying

strictscrutinyinfindingthatordinanceviolatedpregnancyresourcecenter’sFirst

Amendmentrights);PregnancyCareCenterofRockfordv.Rauner,No.2016‐MR‐741

(Ill.17thJud.Cir.Dec.20,2016)(preliminaryinjunctionenteredonfreespeech

grounds);Prelim.Inj.,Nat’lInstit.ofFamilyandLifeAdvocatesv.Rauner,No.3:16‐cv‐

50310(N.D.Ill.Sept.29,2016)(preliminaryinjunctionenteredonfreespeech

grounds);CalvaryChapelPearlHarborv.Chin,No.1:17‐cv‐00326‐DKW‐KSC(D.

Haw.Sept.20,2018)(permanentinjunctionandfinaljudgment).

BeforeNIFLA,severalcourtshadrejectedchallengestoCalifornia’slaw.See,

e.g.,MountainRighttoLifev.Harris,No.5:16‐cv‐00119(C.D.Cal.July8,2016)

(denyingpreliminaryinjunction);AWoman’sFriendPregnancyResourceClinicv.

Harris,153F.Supp.3d1168(E.D.Cal.Dec.21,2015);LivingwellMedicalClinicv.

Harris,No.3:15‐cv‐04939,2015WL13187682(N.D.Cal.Dec.18,2015).

SomeoftheplaintiffsintheselawsuitsalsofiledcomplaintswithOCR

allegingthatthestatelawsviolatetheWeldon,Coats‐Snowe,and/orChurch


32

Amendments.ComplaintsfiledwithOCRagainsttheStateofCalifornia,alleging

California’sReproductiveFreedom,Accountability,ComprehensiveCare,and

TransparencyAct(FACTAct)(Cal.Health&SafetyCodeAnn.sections123470,et

seq.)violatedFederalconscienceandanti‐discriminationlaws,wererecently

resolvedwithafindingbyOCRthattheStateofCaliforniaviolatedtheWeldonand

Coats‐SnoweAmendments.30OCRdeterminedthat“California’senactmentofthe

FACTActviolate[d]theWeldonandCoats‐SnoweAmendmentsbydiscriminating

againsthealthcareentitiesthatobjecttoreferringfor,ormakingarrangementsfor,

abortion.”31

ComplaintsfiledwithOCRagainsttheStateofHawaii,allegingHawaii

RevisedStatutesection321‐561(b)‐(c)violatedFederalconscienceandanti‐

discriminationlaws,wererecentlysatisfactorilyresolvedwhenHawaiiAttorney

GeneralClareE.ConnorsissuedaMemorandumtotheDepartmentoftheAttorney

GeneralfortheStateofHawaiistating,“theDepartmentwillnotenforcesection

321‐561(b)‐(c),HRS,againstanylimitedservicepregnancycenters,asdefinedin

section321‐561(a),HRS;”thememorandumalsostatedthatit“shallremainin

effectindefinitelyoruntilsuchtimeasthereisachangeinthelawsdiscussedabove

warrantingreconsideration.”32InherlettertoOCRregardingtheMemorandum,

30LetterfromRogerT.Severino,Dir.,Dep’tofHealth&HumanServ’s.OfficeforCivilRights,toXavierBecerra,Att’y.Gen.,StateofCal.(Jan.18,2019),availableathttps://www.hhs.gov/sites/default/files/california‐notice‐of‐violation.pdf.31Id.at9.32MemorandumfromHaw.Att’y.Gen.ClareE.ConnorstotheDep’t.oftheAtt’y.Gen.,StateofHaw.2(Mar.15,2019)(onfilewithHHSOCR).


33

AttorneyGeneralConnorsalsosaidthat“theDepartmentwilladvisetheHawai’i

Legislatureofitsdecisionnottoenforcesection321‐561(b)‐(c),HRS,againstany

limitedservicepregnancycenter.”33AttorneyGeneralConnorstookappropriate

correctiveactioninHawaiitoassurecurrentandfuturecompliancewiththe

WeldonandCoats‐SnoweAmendments,astheyapplytoHawaiiRevisedStatute

section321‐561(b)‐(c),andthecomplaintsregardingthisprovisionwereresolved

withouthavingtofindHawaiiinviolationofFederalconscienceandanti‐

discriminationlaws.34

SomeStateshavealsosoughttorequirehealthinsuranceplanstocover

abortions,triggeringadditionalconscience‐relatedlawsuits.California,forexample,

sentalettertoseveninsurancecompaniesseekingtoenforceaCalifornialegal

requirementthattheinsurersincludeabortioncoverageinplansusedbypersons

whoobjectedtosuchcoverage.SeeLetterfromCaliforniaDepartmentofManaged

HealthCare,Re:LimitationsorExclusionsofAbortionServices(Aug.22,2014)

(interpretingstatestatutes,regulations,andcourtdecisions).35Thestateof

Californiaestimatesthatatleast28,000individualssubsequentlylosttheir

abortion‐freehealthplans,andhousesofworshiphavechallengedCalifornia’s

policyincourt.SeeFoothillChurchv.Rouillard,2:15‐cv‐02165‐KJM‐EFB,2016WL

33LetterfromHaw.Att’y.Gen.ClareE.Connors,toLuisE.Perez,DeputyDir.oftheConscience&ReligiousFreedomDiv.,OfficeforCivilRights,U.S.Dep’tofHealth&HumanServs.(Mar.15,2019)(onfilewithHHSOCR).34LetterfromRogerT.Severino,Dir.,Dep’tofHealth&HumanServ’s.OfficeforCivilRights,toClareE.Connors,Att’y.Gen.,StateofHaw.(Mar.21,2019),availableathttps://www.hhs.gov/sites/default/files/hawaii‐ocr‐notice‐of‐resolution‐final.pdf.35https://www.dmhc.ca.gov/Portals/0/082214letters/abc082214.pdf.


34

3688422(E.D.Cal.July11,2016);SkylineWesleyanChurchv.CaliforniaDepartment

ofManagedHealthCare,No.3:16‐cv‐00501‐H‐DHB(S.D.Cal.2016).TheNewYork

StateDepartmentofFinancialServiceshassimilarlysoughttorequireindividual

andsmallgroupemployers,regardlessofthenumberofemployeesoranyreligious

affiliation,toprovideinsurancecoverageforabortions,promptingadditional

lawsuits.See,e.g.,RomanCatholicDioceseofAlbanyv.Vullo,No.02070‐16(N.Y.

AlbanyCountySup.Ct.May4,2016).

Overthepastseveralyears,anincreasingnumberofjurisdictionsinthe

UnitedStateshavelegalizedassistedsuicide.SeeDistrictofColumbiaB21‐0038

(Feb.18,2017),ColoradoProp.106(Dec.16,2016);CaliforniaABX2‐15(June9,

2016);18VermontAct39(May20,2013)(“Act39”).InVermont,forexample,Act

39statesthathealthcareprofessionalsmustinformpatients“ofallavailable

optionsrelatedtoterminalcare.”18Vt.Stat.Ann.section5282.WhentheVermont

DepartmentofHealthconstruedAct39torequireallhealthcareprofessionalsto

counselforassistedsuicide,individualhealthcareprofessionalsandassociationsof

religioushealthcareproviderssuedVermont,allegingaviolationoftheir

consciencerights.Compl.,VermontAllianceforEthicalHealthCare,Inc.v.Hoser,No.

5:16‐cv‐205(D.Vt.Apr.5,2017)(dismissedbyconsentagreement).Morerecently

still,thefamilyofaCaliforniacancerpatientsuedUCSFMedicalCenterforalleged


35

elderabusebecausethecancerpatientdiedaftertheoncologistsonstaffdeclinedto

participateinassistedsuicide,butbeforeshecouldobtainanewphysician.36

Finally,someStateshavepassedlawsappearingtorequirehealthcare

professionalstoprovidereferralsforimplementationofadvancedirectiveswithout

accommodationforreligiousbelieformoralconviction.SeeIowaCodeAnn.

section144D.3(5)(2012)(requiringthatproviderstake“allreasonablestepsto

transferthepatienttoanotherhealthcareprovider,hospital,orhealthcarefacility”

evenwhenthereisanobjectionbasedon“religiousbeliefs,ormoralconvictions”);

IdahoCodeAnn.39‐4513(2)(2012)(requiringthataprovider“make[]agoodfaith

efforttoassistthepersoninobtainingtheservicesofanotherphysicianorother

healthcareproviderwhoiswillingtoprovidecareforthepersoninaccordance

withtheperson'sexpressedordocumentedwishes”).

SincetheDepartmentissuedtheproposedConscienceRulein2018,OCR

issuedaNoticeofViolationtotheStateofCaliforniaforOCRComplaintNos.16‐

224756and18‐292848,findingthatCalifornia’sFACTActviolatedtheWeldonand

Coats‐SnoweAmendments,asdiscussedsupra.Beyondthisfinding,inthisfinalrule,

theDepartmentdoesnotopineonorjudgethelegalmeritsorsufficiencyofanyof

theabove‐citedlawsuitsorchallengedlaws.Theyarediscussedheretoillustratea

notablenumberofdisputesaboutallegedviolationsofhealthcareconscience,

broadlyunderstood,bystateandlocalgovernments.Theyalsoillustratetheneed

36BobEgelko,California’sassisted‐dyingloophole:Somedoctorswon’thelppatientsdie,SanFranciscoChronicle(Aug.12,2017),http://www.sfchronicle.com/news/article/California‐s‐assisted‐dying‐loophole‐Some‐11761312.php.


36

forgreaterclarityconcerningthescopeandoperationoftheFederalconscienceand

anti‐discriminationlawsthatarethesubjectofthisfinalrule.TheDepartment

anticipatesthatthisfinalrulewillresultingreaterpublicfamiliaritywithFederal

conscienceandanti‐discriminationlaws,andmayinformbothStateandlocal

governmentsandhealthcareinstitutionsoftheirobligations,andindividualand

institutionalhealthcareentitiesoftheirrights,underthoselaws.

ConfusionExistsAbouttheScopeandApplicabilityofFederalConscienceand

Anti‐DiscriminationLaws.EventhoughFederalconscienceandanti‐discrimination

lawsarecurrentlyineffect,thepublichassometimesbeenconfusedabouttheir

applicabilityinrelationtootherFederal,State,orlocallaws.Oneofthepurposesof

the2008RulewastoaddressconfusionabouttheinteractionbetweenFederal

conscienceandanti‐discriminationlawsandotherFederalstatutes.

Forinstance,someadvocacyorganizationshavefiledlawsuitsclaimingthat

FederalorStatelawsrequireprivatereligiousentitiestoperformabortionsand

sterilizationsdespitetheexistenceoflongstandingconscienceandanti‐

discriminationprotectionsonthistopic.SeeMeansv.U.S.ConferenceofCatholic

Bishops,No.1:15‐CV‐353,2015WL3970046(W.D.Mich.2015)(abortion);ACLUv.

TrinityHealthCorp.,178F.Supp.3d614(E.D.Mich.2016)(abortion);Mintonv.

DignityHealth,No.17‐558259(Cal.Super.Ct.Apr.19,2017)(hysterectomy);

Chamorrov.DignityHealth,No.15‐549626(Cal.Super.Ct.Dec.28,2015)(tubal

ligation).Apatientalsosuedasecularpublichospitalforaccommodatingdoctors’

andnurses’religiousobjectionstoabortioninallegedviolationofaStatelaw,


37

Washington’sReproductivePrivacyAct.Coffeyv.Pub.Hosp.Dist.No.1,20‐15‐2‐

00217‐4(Wash.2015).

CongresshasexercisedthebroadauthorityaffordedtoitundertheSpending

ClausetoattachconditionsonFederalfundstoprotectconsciencerights.Such

conditionsoverrideconflictingprovisionsofStatelawforStatesthatacceptthe

conditionedfundsaccordingtothetermsofthestatutesapplicabletosuchfunding

streams.Stateshavelongbeenabletoharmonizeandcomplywithother“cross‐

cutting”anti‐discriminationlawsimposedthroughsuchconditionsonfederal

financialassistance.See,e.g.,TitleVIoftheCivilRightsActof1964,42U.S.C.2000d

etseq.,andTitleIXoftheEducationAmendmentsof1972,20U.S.C.1681etseq.The

DepartmentseekstoclarifythescopeandapplicationofFederalconscienceand

anti‐discriminationlawsinthisfinalruleasithaswithotheranti‐discrimination

laws.See45CFRpart80(TitleVI)andpart86(TitleIX).

CourtsHaveFoundNoAlternativePrivateRightofActiontoRemedyViolations.

Thegovernment,ratherthanprivateparties,hasthecentralroleinenforcementof

Federalconscienceandanti‐discriminationlaws.Inlawsuitsfiledbyhealthcare

providersforallegedviolationsofcertainoftheselaws,courtshavegenerallyheld

thatsuchlawsdonotcontain,orimply,aprivaterightofactiontoseekrelieffrom

suchviolationsbynon‐governmentalcoveredentities.Thus,adequategovernmental

enforcementmechanismsarecriticaltotheenforcementoftheselaws.

ThecaseofaNewYorknursewhoallegedthataprivatehospitalforcedher

toassistinanabortionoverherreligiousobjectionsillustratesthepoint.Thenurse


38

filedalawsuitinFederalcourtin2009,buthercasewasdismissedontheground

thatshedidnothaveaprivaterighttofileacivilactionagainstsuchahospital

undertheChurchAmendments.Cenzon‐DeCarlov.MountSinaiHospital,626F.3d

695(2dCir.2010).TheSecondCircuitaffirmedthedismissal,holdingthatthe

ChurchAmendments“maybeastatuteinwhichCongressconferredanindividual

right,”butthatCongresshadnotimpliedaremedytofilesuitagainstprivateentities

inFederalcourt.Id.at698‐99.AfterthedismissaloftheFederallawsuit,thenurse

thenfiledacaseinStatecourt,butthatcasetoowasdismissedforlackofaprivate

rightofaction.Cenzon‐DeCarlov.MountSinaiHosp.,962N.Y.S.2d845(Sup.Ct.Kings

County2010),aff’dby957N.Y.S.2d256(App.Div.2012).Thenursethenfileda

complaintwithOCRonJanuary1,2011,andOCRresolvedthecomplaintafterthe

hospitalchangeditswrittenpolicyforhealthcareprofessionals.

SimilarresultsoccurredinaFederallawsuitbroughtbyanursein2014,

allegingthatahealthcenterhadviolatedtheChurchAmendmentswhenitdenied

hertheabilitytoapplyforapositionasanursebecausesheobjectedtoprescribing

abortifacients.Hellwegev.TampaFamilyHealthCenters,103F.Supp.3d1303(M.D.

Fla.2015).LikethecourtinNewYork,thecourtheldthattheChurchAmendments

“recognizeimportantindividualrights”butdonotconferaremedytobringsuit

againstaprivateentityinFederalcourt.Id.at1310.Morerecently,aFederaldistrict

courtinIllinoisheldthatthereisnoprivaterightofactionforadoctorwhoalleges

thattheStaterequiredhertoreferforabortionsinviolationoftheCoats‐Snowe


39

Amendment.Orderat4,Nat’lInstit.ofFamilyandLifeAdvocates,v.Rauner,No.3:16‐

cv‐50310(N.D.Ill.July19,2017),ECFNo.65.

Inlightofthesedecisionsandtheincreaseinconscience‐basedchallengesto

Stateandlocallawsinthehealthcarecontext,OCRhasasingularandcritical

responsibilitytoprovideclearandappropriateinterpretationofFederalconscience

andanti‐discriminationlaws,toengageinoutreachtoprotectedpartiesandcovered

entities,toconductcompliancereviews,toinvestigateallegedviolations,andto

vigorouslyenforcethoselaws.

AddressingConfusionCausedbyOCRSub‐RegulatoryGuidance.Thisfinalrule

alsoresolvesconfusioncausedbysub‐regulatoryguidanceissuedthroughOCR’s

high‐profileclosureofthreeWeldonAmendmentcomplaintsagainsttheStateof

Californiafiledin2014.37OnJune21,2016,OCRdeclareditfoundnoviolation

stemmingfromCalifornia’spolicyrequiringthathealthinsuranceplansinclude

coverageforabortionbasedonthefactsallegedinthethreecomplaintsithad

received.38OCR’sclosureletterconcludedthattheWeldonAmendment’sprotection

ofhealthinsuranceplansincludedissuersofhealthinsuranceplansbutnot

institutionsorindividualswhopurchaseorareinsuredbythoseplans.Eventhough

California’spolicyresultedincomplainantslosingabortion‐freeinsurancethatwas

consistentwiththeirbeliefsandthatinsurerswerewillingtoprovide,theletter

concludedthatnonequalifiedasanentityorpersonprotectedundertheWeldon

37OCRComplaintNos.14‐193604,15‐193782,and15‐195665.38LetterfromOCRDirectortoComplainants(June21,2016)availableathttp://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf.


40

Amendmentbecausenonewasaninsuranceissuer.Relyingonaninterpretationof

legislativehistory,insteadoftheWeldonAmendment’stext,OCRalsodeclaredthat

healthcareentitiesarenotprotectedunderWeldonunlesstheypossessa“religious

ormoralobjectiontoabortion,”andconcludedthattheinsuranceissuersatissue

didnotmeritprotectionbecausetheyhadnotraisedanyreligiousormoral

objections.Finally,OCRcalledintoquestionitsabilitytoenforcetheWeldon

AmendmentagainstaStateatallbecause,accordingtotheletter,todosocould

“potentially”requiretherevocationofFederalfundstoCaliforniainsucha

magnitudeastoviolateStatesovereigntyandconstituteaviolationofthe

Constitution.39

TheDepartmentdoesnotopineupon,andhasnotyetmadeajudgmenton,

thecompatibilityofCalifornia’spolicywiththeWeldonAmendment.But

clarificationisinorderwithrespecttothegeneralinterpretationsoftheWeldon

AmendmentofferedinOCR’sclosureofcomplaintsagainstCalifornia’sabortion

coveragerequirement.TheDepartmenthasengagedinfurtherconsiderationofthis

generalmatterandhasalsofurtherreviewedFederalconscienceandanti‐

discriminationlaws,theirlegislativehistory,andtherecordofrulemakingand

publiccomments.Basedonthisreview,theDepartmentindicated,inthepreamble

totheproposedrule,thattheabove‐mentionedsub‐regulatoryguidanceissuedby

OCRwithrespecttointerpretationoftheWeldonAmendmentnolongerreflectsthe

39Inreachingthisconclusion,thelettercitedadvicefrom“HHS’OfficeofGeneralCounsel,afterconsultingwiththeDepartmentofJustice,”butHHShasnotlocatedanywrittenlegalanalysisfromeithertheHHSOfficeoftheGeneralCounselortheDepartmentofJusticedespiteadiligentsearch.


41

Department’spositionon,andinterpretationof,theWeldonAmendment.The

Departmentcontinuestoholdtheviewsitexpressedonthatissueinthepreamble

totheproposedrule,see83FRat3890–91,andhasreflectedthoseviewsinits

analysiscontainedintheNoticeofViolationtotheStateofCaliforniaforOCR

ComplaintNos.16‐224756and18‐292848,discussedsupra,inwhichOCRdiscussed

therationalebehinditsdeterminationthat“California’senactmentoftheFACTAct

violate[d]theWeldon…Amendment[]bydiscriminatingagainsthealthcareentities

thatobjecttoreferringfor,ormakingarrangementsfor,abortion.”40

TheDepartmentisconcernedthatsegmentsofthepublichavebeen

dissuadedfromcomplainingaboutreligiousdiscriminationinthehealthcare

settingtoOCRastheresult,atleastinpart,oftheseundulynarrowinterpretations

oftheWeldonAmendment.Forexample,FoothillChurch,locatedinGlenMorrow,

California,expressedconcernthatfilingacomplaintwithOCRaboutCalifornia’s

abortion‐coveragerequirementwaspointlessbecausetheDepartmenthadalready

closedthreesimilarcomplaints,findingnoviolationofFederalconscienceandanti‐

discriminationlaws.SeeFoothillChurchv.Rouillard,No.2:15‐cv‐02165‐KJM‐EFB,

2016WL3688422(E.D.Cal.July11,2016).

Withthisfinalrule,theDepartmentseekstoeducateprotectedentitiesand

coveredentitiesastotheirlegalrightsandobligations;toencourageindividualsand

organizationswithreligiousbeliefsormoralconvictionstoenter,orremainin,the

40LetterfromRogerT.Severino,Dir.,Dep’tofHealth&HumanServ’s.OfficeforCivilRights,toXavierBecerra,Att’y.Gen.,StateofCal.,at9(Jan.18,2019),availableathttps://www.hhs.gov/sites/default/files/california‐notice‐of‐violation.pdf.


42

healthcareindustry;andtopreventothersfrombeingdissuadedfromfiling

complaintsduetopriorOCRcomplaintresolutionsorsub‐regulatoryguidancethat

nolongerreflecttheviewsoftheDepartment.

AdditionalFederalConscienceandAnti‐DiscriminationLaws.Finally,in

additiontoalloftheconcernsdiscussedabove,theDepartmentisusingthis

rulemakingtoaddressvariousotherconscienceprotectionandanti‐discrimination

lawsnotdiscussedinthe2008and2011Rules.Someoftheseprovisionswere

enactedafter2008.Allprovideadditionalprotections,suchasforhealthcare

providersandpatients,fromcoercionanddiscriminationincludingthatstemming

frommoralconvictionsorreligiousbeliefs.

B.StructureoftheFinalRule

Thisfinalrulegenerallyreinstatesthestructureofthe2008Rule,includes

furtherdefinitionsofterms,andprovidesrobustcertificationandenforcement

provisionscomparabletoprovisionsfoundinOCR’sothercivilrights

regulations.ThisfinalrulealsoencouragescertainrecipientsofFederalfinancial

assistancefromtheDepartmentorofFederalfundsfromtheDepartmenttonotify

individualsandentitiesprotectedunderFederalconscienceandanti‐discrimination

laws(suchasemployees,applicants,orstudents)oftheirFederalconsciencerights.

Inaddition,thisfinalrulerequirescertainsuchentitiestoassureandcertifytothe

Departmenttheircompliancewiththerequirementsoftheselaws.Italsosetsforth

inmoredetailtheinvestigativeandenforcementresponsibilityofOCR,alongwith


43

thetoolsatOCR’sdisposalforcarryingoutitsresponsibilitywithrespecttothese

laws.

CongresshasimposedobligationsontheDepartmentandfundingrecipients

throughthesestatutes,andtheDepartmentis,therefore,requiredtoensureitsown

complianceandthecomplianceofitsfundingrecipients.In2008and2011,the

SecretarydelegatedtoOCRtheauthoritytoreceivecomplaintsofdiscrimination

undertheChurch,Coats‐Snowe,andWeldonAmendments,incoordinationwith

DepartmentcomponentsthatprovideFederalfinancialassistance.Congresslater

designatedOCRasresponsibleforreceivingcomplaintsundersection1553ofthe

ACA.Manyoftheremainingstatutesthatarethesubjectoftheproposedruledonot

haveanyimplementingregulations.TotheextentnotalreadydelegatedtoOCR,the

Secretaryis,therefore,delegatingtoOCRenforcementauthority–thatis,the

authoritytoreceivecomplaints,and,inconsultationandcoordinationwiththe

fundingcomponentsoftheDepartment,investigateallegedviolationsandtake

appropriateenforcementaction–overthoseadditionalFederalstatutesaswellas

thestatutescoveredbythe2008and2011Rules.

Thecomplianceandenforcementsectionsspecifyinmuchgreaterdetailthan

eitherthe2008Ruleor2011RulehowOCRwill,inconsultationandcoordination

withHHSfundingcomponents,enforcetheFederalconscienceandanti‐

discriminationlaws.Implementationoftherequirementssetforthinthisfinalrule

willbeconductedinthesamewaythatOCRimplementsothercivilrights

requirements(suchastheprohibitionofdiscriminationonthebasisofrace,color,


44

ornationalorigin),whichincludesoutreach,investigation,compliance,technical

assistance,andenforcementpractices.Enforcementwillbebasedoncomplaints,

referrals,andotherinformationOCRmayreceiveaboutpotentialviolations,suchas

newsreportsandOCR‐initiatedcompliancereviewsandcommunicationsactivities

iffactssufficetosupportaninvestigation.IfOCRbecomesawareofapotential

violationofFederalconscienceandanti‐discriminationlaws,OCRwillinvestigate,in

coordinationwiththeDepartmentcomponentprovidingFederalfinancial

assistanceorFederalfundstotheinvestigatedentity.IfOCRconcludesanentityis

notincompliance,OCR,inconsultationandcoordinationwiththeDepartment

fundingcomponent(s),willassistcoveredentitieswithcorrectiveactionor

compliance,orrequireviolatorstocomeintocompliance.If,despitethe

Department’sassistance,correctiveactionisnotsatisfactoryorcomplianceisnot

achieved,OCR,incoordinationwiththefundingcomponent,mayconsideralllegal

optionsavailabletotheDepartment,toovercometheeffectsofsuchdiscrimination

orviolations.Enforcementmechanismswherevoluntaryresolutioncannotbe

reachedincludeterminationofrelevantfunding,eitherinwholeorinpart,funding

clawbackstotheextentpermittedbylaw,voluntaryresolutionagreements,referral

totheDepartmentofJustice(inconsultationandcoordinationwiththe

Department’sOfficeoftheGeneralCounsel),orothermeasures,assetforthin

applicableregulations,procedures,andfundinginstruments.Thisfinalruleclarifies

thatrecipientsareresponsiblefortheirowncompliancewithFederalconscience

andanti‐discriminationlawsandimplementingregulations,aswellasforensuring


45

theirsub‐recipientscomplywiththeselaws.Thisfinalrulealsoclarifiesthatparties

subjecttoOCRinvestigationhaveadutytocooperateandpreservedocumentsand

toreporttotheirDepartmentfundingcomponent(s)iftheyaresubjecttoa

determinationbyOCRofnoncompliance.Finally,thisfinalrulespecifiesthatOCR

mayremedyclaimsofintimidationandretaliationagainstthosewhofilea

complaintorassistinanOCRinvestigation.

III.AnalysisandResponsetoPublicCommentsontheProposedRule

HHSreceivedover242,000commentsinresponsetothenoticeofproposed

rulemaking(NPRM).41HHSconsideredallcommentsfiledinaccordancewiththe

AdministrativeProcedureActandtheinstructionsprovidedintheNPRMpublished

intheFederalRegisteronJanuary26,2018.

TheDepartment’sevaluationofthecommentsledtoanumberofchanges

betweentheNPRMandthisfinalrule.Thepubliccommentsandthechangesmade

inissuingthisfinalrulearediscussedbelow.

A. GeneralComments

TheDepartmentreceivedmanycommentsontheproposedrulethat

expressedgeneralsupportoroppositionanddidnotincludesubstantiveor

technicalcommentaryupontherule.

Comment:TheDepartmentreceivedcommentsexpressingconcernaboutthe

impactoftheruleonaccesstocareinruralcommunities,underprivileged

41Thecommentsareavailableathttps://www.regulations.gov/docket?D=HHS‐OCR‐2018‐0002.WhileRegulations.govshows72,417publicsubmissionswerereceived,manycommentsubmissionsattachedhundredsorthousandsofindividualcomments,resultinginover242,000actualcomments.


46

communities,orothercommunitiesthatareprimarilyservedbyreligious

healthcareprovidersorfacilities.

Response:AccesstocareisacriticalconcernoftheDepartment.The

Departmentdoesnotbelievethisrulewillharmaccesstocare.Whenthe

Departmentpromulgatedthe2008Ruleprotectingconsciencerightsinhealthcare,

itaddressedcommentsabouttherule’simpactonaccesstocare.42Inthatresponse,

theDepartmentstatedthattheregulationdidnotexpandthescopeofexisting

Federalconscienceandanti‐discriminationlaws,andnotedthatimplementation

andenforcementofsuchlawswouldhelpalleviatethecountry’sshortageofhealth

careproviders.43TheDepartmentalsoobservedthatitwascontradictorytoargue,

asmanycommentersdid,boththattherulewoulddecreaseaccesstocareandthat

thethen‐currentconscienceprotectionsforprovidersweresufficient:Ifthe

Department’snewrulewoulddecreaseaccesstocarebecauseofanincreasein

providers’exerciseofconscientiousobjections,itwouldseemthatthestatutory

protectionsthatexistedbeforetheregulationdidnotresultinprovidersfully

exercisingtheirconsciencesasprotectedbylaw.44

TheDepartmentagreeswithitspreviousresponse.TheFederalconscience

andanti‐discriminationlawspre‐existtheseregulations.Theyproviderightsand

protectionstohealthcareproviders,includinginruralcommunities,

4273FRat78080–81(Dec.19,2008).4373FRat78081.44Id.


47

underprivilegedcommunities,orothercommunitiesthatareprimarilyservedby

religioushealthcareprovidersorfacilities(together,“underservedcommunities”).

Thereappearstobenoempiricaldata,however,onhowpreviouslegislative

orregulatoryactionstoprotectconsciencerightshaveaffectedaccesstocareor

healthoutcomes.Studieshavespecificallyfoundthatthereisinsufficientevidence

toconcludethatconscienceprotectionshavenegativeeffectsonaccesstocare.45

TheDepartmentisnotawareofdatainitspossession,inthepubliccomments,orin

thepublicdomainthatprovidesawaytoestimatehowmanyhealthcareproviders

eitheringeneralorinunderservedcommunitiesare—andarenot—exercisingtheir

consciencerightsandprotections,eventhoughtheyareencompassedbyFederal

conscienceandanti‐discriminationlaws,noristheDepartmentawareofdatato

determinehowmanyproviders,amongthose,wouldexercisetheirconscience

rightsandprotectionsoncethisruleisfinalized,andbecauseitisfinalized.

Becauseenforcementoftherulewillremovebarrierstoentryintothehealth

careprofessions,itisreasonabletoassumethattherulemay,infact,inducemore

peopleandentitiestoenterorremaininthehealthcarefield.Onabroadlevel,this

effectisreasonablylikelytoincrease,notdecrease,accesstocare,including—and

perhapsespecially—inunderservedcommunities.TheDepartmentisnotawareof

45SeeChavkinetal.,“Conscientiousobjectionandrefusaltoprovidereproductivehealthcare:AWhitePaperexaminingprevalence,healthconsequences,andpolicyresponses,”123Int’lJ.Gynecol.&Obstet.3(2013),S41–S56(“[I]tisdifficulttodisentangletheimpactofconscientiousobjectionwhenitisoneofmanybarrierstoreproductivehealthcare....[C]onscientiousobjectiontoreproductivehealthcarehasyettoberigorouslystudied.”);K.Morrell&W.Chavkin,“Conscientiousobjectiontoabortionandreproductivehealthcare:areviewofrecentliteratureandimplicationsforadolescents,”27Curr.Opin.Obstet.Gynecol.5(2015),333–38(“[T]hedegreetowhichconscientiousobjectionhascompromisedsexualandreproductivehealthcareforadolescentsisunknown.”).


48

data,includingfrompubliccommenters,thatwouldprovideausefulbasisfora

quantitativeestimateofhowmanymoreproviderswouldenterthehealthcarefield,

orserveunderservedcommunities,asaresultofthisrule,norwhatthe

correspondingincreaseofaccesstocaremightbe.However,nopubliccommenter

providedanydatathatunderminesthereasoningthatleadstheDepartmentto

believethattherulewillhavesuchaneffect.Andseveralfactorssupportthe

Department’sposition.

First,predictionsthattherulewillreduceservicesinunderserved

communitiesmaybebasedonincorrectassumptions.AstheDepartmenthasmade

clear,theruledoesnotexpandthesubstantiveprotectionsofFederalconscience

andanti‐discriminationlaws.Thus,totheextentcommentersbelievetherulewould

reduceservicesinunderservedcommunities,thatwouldseemtobebasedonan

assumptionthattherearehealthcareprovidersinunderservedcommunitieswho

areprotectedbytheselawsbutareofferingservicestowhichtheyobjectanyway

(forexample,abortionsorabortionreferrals)becausethelawsareinadequately

enforced.Thatisnotnecessarilyacorrectassumption.Suchhealthcareproviders

mightberespondingtoathreattotheirconscientiouspractice,notbyofferingthe

servicesdespitetheirobjections,butbyleavingthehealthcarefieldoraparticular

practiceareainvolvingthatservice.Onepollsuggeststhatover80%ofreligious

healthcareprovidersinunderservedcommunitieswouldlikelylimittheirscopeof

practiceiftheywererequiredtoparticipateinpracticesandprocedurestowhich


49

theyhavemoral,ethical,orreligiousobjections,ratherthanprovidetheservices.46

Ifthatiscorrect,improvingenforcementofFederalconscienceandanti‐

discriminationlawsmightreduceinfringementofconscienceprotections,notby

reducingtheavailabilityofservicessuchasabortion,butbyincreasingthe

availabilityofotherservicesbyencouragingprovidersnottoself‐limittheir

practicesinunderservedcommunities.

Second,andrelatedly,therulemightresultinanincreaseinthenumberof

providersoverall,orincertainspecialtieswithinthehealthcarefield.Individuals

andentitiesmayhavechosennottoenterthehealthcarefieldbecausethey

anticipatedtheywouldbepressuredtoviolatetheirconsciences.Insomecases,that

decisionmaybetheresultofdiscriminationoccurringduringmedicaltraining,such

asmedicalstudents’experiencesofdiscriminationonthebasisoftheirreligious

beliefsormoralconvictions,47orbypressuresfacedbyinstitutionsbecauseoftheir

religiousidentityormoralconvictions.Reducingthatdiscriminationandpressure

mayleadtomoreindividualandinstitutionalhealthcareprovidersoverall,which

couldhelpincrease,ratherthandecrease,servicesforunderservedcommunities.

Anotherwaythiseffectmaymanifestitselfisiftheaveragefacilityhasaccessto

morehighlyqualifiedcandidatesbecausethereisalargerpoolofmedical

46TheCMAcommentcitedpolldatafrom2009and2011,whichfoundthat82%ofmedicalprofessionals“saiditwaseither‘very’or‘somewhat’likelythattheypersonallywouldlimitthescopeoftheirpracticeofmedicineifconscienceruleswerenotinplace.Thiswastrueof81%ofmedicalprofessionalswhopracticeinruralareasand86%whoworkfull‐timeservingpoorandmedically‐underservedpopulations...91%agreed,‘Iwouldratherstoppracticingmedicinealtogetherthanbeforcedtoviolatemyconscience.’”47TheCMAcommentcitedapollfindingthattwentypercentofrespondingfaith‐basedmedicalstudentschosenottopursueacareerinobstetrics/gynecologybecauseofperceivedcoercionanddiscriminationinthatfield.


50

professionalsfromwhichtochoose.Havingmoreprovidersoverall,sothatthefield

asawholeprovidesawideanddiverserangeofservices,ispreferabletohaving

fewerproviders,particularlywithrespecttounderservedareas.

Third,therulemaypreventsomehealthcareprovidersfromleavingthe

field.Acertainproportionofdecisionsbycurrentlypracticinghealthprovidersto

leavetheprofessionmaybemotivatedbysuchpressure.48Withtherule’sadded

emphasisonenforcingprotectionsforrightsofconscience,fewerindividualsmay

leavetheprofession,andinturntheymayhelpmeetunmetneedsforcare.In

addition,insomeinstanceswhereaproviderobjects,basedonconscience,to

providingaservice,theremaybesomeunderservedcommunitieswhereother

providerswhohavenosuchobjectionsareavailabletoprovidetheservice.By

contrast,withoutenforcementofFederalconscienceandanti‐discriminationlaws,

someproviderswithreligiousbeliefsormoralconvictionscouldclosetheirdoors

(ratherthanviolatetheirconsciences),leavingacommunityevenmore

underservedthaniftheproviderwereinpractice.

Therulemightallowanincreaseintheprovisionofhealthcarebyreligious

institutionsaswell,notjustindividuals.Religioushospitalsorclinics,forexample,if

theyareassuredgreaterenforcementoftheirrightstopracticemedicineconsistent

withtheirreligiousbeliefs,mayfinditworthwhiletoexpandtoservemorepeople,

48TheChristianMedicalAssociationandFreedom2CarepollofMay3,2011,foundthat82%ofmedicalprofessionals“saiditwaseither‘very’or‘somewhat’likelythattheypersonallywouldlimitthescopeoftheirpracticeofmedicineifconscienceruleswerenotinplace.Thiswastrueof81%ofmedicalprofessionalswhopracticeinruralareasand86%whoworkfull‐timeservingpoorandmedically‐underservedpopulations...91%agreed,‘Iwouldratherstoppracticingmedicinealtogetherthanbeforcedtoviolatemyconscience.’”


51

includinginunderservedcommunities.Somecommenterscontendthiscouldlead

religioushospitalstomoveintounderservedcommunitiesandcrowdoutother

providerswhomightnothaveobjectionstocertainservices.TheDepartmentisnot,

however,awareofdatademonstratingthattheexpansionofhealthcareservicesby

religiousproviders,particularlyinunderservedcommunities,wouldcrowdout

otherproviderswhoperformservicesthattheydonot,andmarketforcesordinarily

wouldnotdictatethatresult.Again,theDepartmentisnotawareofdata

demonstratingthedireresultspredictedbysomecommenters.

Inaddition,therelationshipbetweenreligiousorotherconscientiously

objectingprovidersandunderservedcommunitiesmaybefarmorecomplexthan

assumedbythepredictionthatthisrulewilldecreaseservices.Therearereasonsto

believethatmanypersonswhomightmakeuseofprotectionsunderFederal

conscienceandanti‐discriminationlawsarealreadymorelikelytobelocatedin

certainunderservedareas,andthattheirpatientsaresimilarlylikelytosharetheir

viewsonissuessuchasabortion.AccordingtothePewResearchCenter,for

example,“urbandwellersarefarmorelikelythantheirruralcounterpartstosay

abortionshouldbelegalinallormostcases.”49Thissuggeststhattheenforcement

ofFederalconscienceandanti‐discriminationlawsisnotlikelytobethecauseof

religiousandotherobjectingprovidersbeinglocatedinruralcommunities,butthat

suchprovidersarealreadyinthosecommunities,andCongresspassedtheselawsto

49PewResearchCenter,“WhatUnitesandDividesUrban,Suburban,andRuranCommunities”(May22,2018),availableathttps://www.pewsocialtrends.org/2018/05/22/what‐unites‐and‐divides‐urban‐suburban‐and‐rural‐communities/.


52

protectthem,amongotherindividualsandentities,frombeingdrivenoutof

practice,whichcouldexacerbatethelackofaccesstohealthcareoverallinthose

communities.

Thereisalsoreasontobelievethatreligiousinstitutionsandindividualsare

disposedtoserveinunderservedcommunitiesbecauseofelementsoftheir

religiousmissionbesidesobjectionsprotectedbyFederalconscienceandanti‐

discriminationlaws.Forexample,variouscommenterscontendthereasonwhy

Catholichospitalsareoverrepresentedinservingcertainunderservedpopulations

isbecausethehospitalsaremotivatedbytheirCatholicbeliefstoserveunserved,

underserved,underprivileged,orminoritycommunities,andthesecommenters

arguethatCatholichospitals(and,byextension,otherreligiousproviders)provide

anoverallbenefittounderservedcommunities.50Thisoverallbenefitisconsistent

withCongress’sapparentintent,intheFederalconscienceandanti‐discrimination

laws,toensurethatthehealthcaresystemremainsopentothevibrant

participationofreligiousandotherproviders,withoutbarriersthatcanbecreated

bydiscriminationagainstthem,orinfringementsoftheirconscientiousbeliefs.Any

50Ascension,REF:DocketHHS‐OCR‐2018‐0002,ProtectingStatutoryConscienceRightsinHealthCare;DelegationsofAuthority(Mar.27,2018)(“Asthelargestnon‐profithealthsystemintheU.S.andtheworld’slargestCatholichealthsystem,Ascensioniscommittedtodeliveringcompassionate,personalizedcaretoall,withspecialattentiontopersonslivinginpovertyandthosemostvulnerable.InFY2017,Ascensionprovidedmorethan$1.8billionincareofpersonslivinginpovertyandothercommunitybenefitprograms.”);CatholicHealthAssociation,REF:RIN0945‐ZA03ProtectingStatutoryConscienceRightsinHealthCare;DelegationsofAuthority:ProposedRule,83Fed.Reg.3880,January26,2018(Mar.27,2018)(“AsaCatholichealthministry,ourmissionandourethicalstandardsinhealthcarearerootedinandinseparablefromtheCatholicChurch’steachingsaboutthedignityofeachandeveryhumanperson,createdintheimageofGod.Accesstohealthcareisessentialtopromoteandprotecttheinherentandinalienableworthanddignityofeveryindividual.ThesevaluesformthebasisforoursteadfastcommitmenttothecompellingmoralimplicationsofourheathcareministryandhavedrivenCHA’slonghistoryofinsistingonandworkingfortherightofeveryonetoaffordable,accessiblehealthcare.”).


53

lossofsuchprovidersbecauseofthelackofenforcementofFederalconscienceand

anti‐discriminationlawscoulddecreaseaccesstocareforunderserved

communities.Therefore,whenothercommenterscontendthatwomenofcolor

wouldbedisproportionatelyharmedbythisruleduetothesignificantservices

providedbyCatholichospitals,theydonotseemtoaccountforthefactthat,without

thosehospitals’overallabilitytoexercisetheirreligiousmission,theywouldnotbe

providinghealthcareservicestothosecommunitiesinthefirstplace.

TheDepartmentalsodisagreeswiththeassumptionthattherule’s

enforcementofFederalconscienceandanti‐discriminationlawswillresultinharm,

orinmoreharmthanthebenefitsthatderivefromimplementingFederallaws.As

explainedintheRegulatoryImpactAnalysis,infraatpartIV.C.3.vii,theDepartment

expectstheruletoenhance,notimpede,accesstocareinareaswithfewer

providers,suchasruralcommunities.TheDepartmentisnotawareofdata

establishingtheviewsofcommenterswhosaytherulewillreduceservicesin

underservedcommunities,orofdataestablishingquantitativelyhowmuchtherule

willincreaseandenhanceaccesstohealthcareservicesinunderserved

communities.TheDepartmentconcludes,instead,thatitisreasonabletoagreewith

commenterswhobelievetherulewillnotdecreaseaccesstocare,andmayincrease

it.

TheDepartmentfindsthatfinalizingtheruleisappropriatewithoutregard

towhetherdataexistsonthecompetingcontentionsaboutitseffectonaccessto

services.Mostsignificantly,finalizingtheruleisappropriatebecauseitenforces


54

Federalconscienceandanti‐discriminationlaws,whichrepresentCongress’s

consideredjudgmentthattheserightsareworthprotectingeveniftheyimpact

overallorindividualaccesstoaparticularservice,suchasabortion.Butfinalizing

theruleisalsoappropriatebecausetheDepartment’sbeliefthattherulewill

enhanceaccesstocareisbasedonreasonable,informedassumptionsunrebuttedby

publiccommentssubmittedinoppositiontotherule.Ultimately,theDepartment

believesthatthisrulewillresultinmorehealthcareprovideroptionsand,thus,

betterhealthcareforallAmericans.TheDepartmentthusbelievesthatitis

appropriatetofinalizethisruletoenforceFederalconscienceandanti‐

discriminationlaws,eventhoughtheDepartmentandcommentersdonothavedata

capableofquantifyingallofitseffectsontheavailabilityofcare.

Comment:TheDepartmentreceivedcommentsstatingthatprotectinghealth

careprofessionals’moralandreligiousconvictionsplaceshealthcareproviders

abovepatients.

Response:TheDepartmentdisagrees.First,thisfinalruleprovidesforthe

enforcementofprotectionsestablishedbythepeople’srepresentativesinCongress;

theDepartmenthasnoauthoritytooverrideCongress’sbalancingofthe

protections.Second,protectinghealthcareproviders’rightsofconscienceensures

thathealthcareproviderswithdeeplyheldreligiousbeliefsormoralconvictions

arenotdrivenoutofthehealthcareindustry—and,therefore,madeunavailableto

serveanypatientsandprovideanyhealthcareservices—becauseoftheirrefusalto

participateincertainobjected‐toactivities,suchasabortion,sterilization,or


55

assistedsuicide.Third,theDepartmentbelievestheprovider‐patientrelationshipis

bestservedbyopencommunicationofconscienceissuessurroundingtheprovision

ofhealthcareservices,includinganyconscientiousobjectionsprovidersorpatients

mayhavetoproviding,assisting,participatingin,orreceivingcertainservicesor

procedures.Byprotectingadiversityofbeliefsamonghealthcareproviders,these

protectionsensurethatoptionsareavailabletopatientswhodesire,andwouldfeel

mostcomfortablewith,aproviderwhosereligiousbeliefsormoralconvictions

matchtheirown.Evenwhereapatientandproviderdonotsharethesamereligious

beliefsormoralconvictions,itisnotnecessarilythecasethatpatientswouldwant

providerstobeforcedtoviolatetheirreligiousbeliefsormoralconvictions.

Comment:TheDepartmentreceivedcommentsexpressingconcernthatthe

proposedrulewouldexpandFederalconscienceandanti‐discriminationstatutesto

coverareasbeyondthescopeofthestatutes.Severalcommentersraisedconcerns

aboutexpandingprotectiontoHIVtreatment,pre‐exposureprophylaxis,and

infertilitytreatment.

Response:TheDepartmentdraftedtheproposedruletotrackthescopeof

eachstatute’scoveredactivitiesasCongressdraftedthem,withoutbeingunduly

broadorundulynarrow.Forexample,wherethescopeoflawsthatarethesubject

ofthisregulationislimitedtocertainenumeratedprocedures,thefinalrulemakes

clearthatOCRwillonlypursueenforcementunderthoselawswithrespecttothose

enumeratedprocedures.


56

TheDepartmentisunawareofanycasesclaimingdenialofserviceregarding

theseproceduresbroughtunderanyofthestatutesimplementedbythisrule.Public

commentsreceivedbytheDepartmentdidnotcitesuchcases.Intheeventthatthe

DepartmentreceivesacomplaintwithrespecttoHIVtreatment,pre‐exposure

prophylaxis,orinfertilitytreatment,theDepartmentwouldexaminethefactsand

circumstancesofthecomplainttodeterminewhetheritfallswithinthescopeofthe

statuteinquestionandtheseregulations.

Discussionofthisrule’spotentialapplicationwithregardtogender

dysphoriaislocatedinthesection‐by‐sectionanalysisregardingcommentsonthe

ChurchAmendments,infraatpartIII.B.

Comment:TheDepartmentreceivedmanycommentsexpressingconfusion

orconcernastohowtheproposedrulewouldinteractwithorbeinconflictwith

otherFederallaws,suchastheEmergencyMedicalTreatmentandActiveLaborAct

(EMTALA)andFederalanti‐discriminationstatutes(suchassection1557ofthe

ACA).

Response:ThisfinalruleprovidestheDepartmentwiththemeanstoenforce

Federalconscienceandanti‐discriminationlawsinaccordancewiththeirtermsand

totheextentpermittedunderthelawsoftheUnitedStatesandtheConstitution.

Thisfinalrule,likethe2008Ruleandthe2011Rule,doesnotgointodetailasto

howitsprovisionsmayormaynotinteractwithotherstatutesorinallscenarios,

butOCRintendstoreadeverylawpassedbyCongressinharmonytothefullest

extentpossiblesothatthereismaximumcompliancewiththetermsofeachlaw.


57

WithrespecttoEMTALA,theDepartmentgenerallyagreeswithitsexplanationin

thepreambletothe2008Rule51thattherequirementunderEMTALAthatcertain

hospitalstreatandstabilizepatientswhopresentinanemergencydoesnotconflict

withFederalconscienceandanti‐discriminationlaws.TheDepartmentintendsto

givealllawstheirfullestpossibleeffect.

Comment:TheDepartmentreceivedcommentsstatingthattheDepartment

shouldwithholdFederalfinancialassistancefromanystatethatdoesnotprovide

forreligiousexemptionstovaccination.

Response:Thisruleisonlyintendedtoprovideenforcementmechanismsfor

theFederalconscienceandanti‐discriminationlawsthatCongresshasenacted.The

creationofanewsubstantiveconscienceprotectionisoutsideofthescopeofthis

rulemaking.Withrespecttovaccinationinparticular,thisruleprovidesfor

enforcementof42U.S.C.1396s(c)(2)(B)(ii),whichrequiresprovidersofpediatric

vaccinesfundedbyFederalmedicalassistanceprogramstocomplywithanyState

lawsrelatingtoanyreligiousorotherexemptions.Underthestatute’splaintext,

thisprotectionappliesonlytotheextentaStatealreadyprovides(or,inthefuture,

choosestoprovide)suchanaccommodation,anddoesnotrequireaStatetoadopt

suchanaccommodation.

Comment:TheDepartmentreceivedcommentsstatingthattheproposed

rule’senforcementmechanismswillnotmeaningfullyfurtherconscienceprotection

becauseexistinglawsprotectingreligiousbeliefsormoralconvictionsaresufficient.

5173FRat78087‐88.


58

Response:TheDepartmentdisagrees,andbelievesthattherulewouldmakea

meaningfuldifferenceintermsofcompliance,ascomparedtothestatusquo.This

ruleprovidesappropriateenforcementmechanismsinresponsetoasignificant

increaseincomplaintsallegingviolationsofFederalconscienceandanti‐

discriminationlaws.Eachlawthatisthesubjectofthisrulemeaningfullydiffers

fromthenext.Moreover,theDepartmentbelievessomelawshaveneverbeen

enforced,notnecessarilybecauseofwidespreadcompliancewithotheroverlapping

laws,butbecausetheDepartmenthasdevotednomeaningfulattentiontothose

laws,hasnotconductedoutreachtothepubliconthem,andhasnotadopted

regulationswithenforcementproceduresforthem.

Comment:TheDepartmentreceivedacommentrequestingthatthe

Departmentclarifythathealthcareprovidersmayestablishsystemstohelpmeet

patients’healthcareneedswhenaproviderholdsareligiousbelieformoral

convictionthatmayaffecttheserviceorprocedurethatapatientisseeking.

Response:Nothingintheruleprohibitsanentityfromprovidingalawful

serviceitwantstoprovide,evenasitrespectstherightsofpersonnelwhomaybe

protectedbyFederallawsfrombeingrequiredtoprovide,orassistin,theservice.

Asdiscussedlaterinthispreamble,theruleprovidesincentivesfor(butdoesnot

mandate)noticesthatparallelnoticeprovisionsunderotheranti‐discrimination

regulations.TheDepartmentbelievesthattheprovider‐patientrelationshipisbest

servedbyopencommunicationofconscienceissuessurroundingtheprovisionof

healthcareservices,sothattheconsciencesofpatients,providers,andemployees


59

arerespectedwheneverpossibleorrequired.Nothingintheruleprecludessuch

communicationorsystemsthatencouragesuchcommunication.Forexample,

providersmayincludenoticesinpatientintakematerialsnotifyingpatientsthata

provider’sserviceprovisionisgovernedbycertainethicalorreligiousprinciples.

Providersmayalsoencouragecommunicationofmoralorreligiousviewsby

patientswithrespecttotreatmentinordertorespectpatients’wishestotheextent

itismutuallyacceptableorrequired.TheDepartmentdeclinestomandateany

particulartimelineorforminwhichaproviderorpatientmustraisethesesensitive

issues.TheDepartmentencouragesproviders,iftheyareworkingwith,or

employing,healthcareprofessionalswhomayhavereligiousormoralobjections,

especiallywithregardtocertainproceduresortreatments,toopenlydiscussthese

issuesandhaveprocessesinplacetoidentifyandrespectadiversityofviews,

furthertheprovisionofhealthcare,andcomplywiththelaw.Thefinalrule’s

modificationstothedefinitionof“discrimination”permitemployersofsuch

personneltoaccommodatetheprofessionals’religiousormoralobjections,without

interferingintheemployer’sdeliveryofhealthservices.

Comment:TheDepartmentreceivedcommentsquestioningwhetherthe

Departmenthasauthoritytoissueregulationsimplementingsomeorallofthe

Federalconscienceandanti‐discriminationlawsencompassedbythisrule.

Response:TheFederalconscienceandanti‐discriminationlawsencompassed

bythispart,includingtheChurchAmendments,section245ofthePublicHealth

ServiceAct,andtheWeldonAmendment,require,amongotherthings,thatthe


60

DepartmentandrecipientsofDepartmentfundsrefrainfromdiscriminatingagainst

institutionalandindividualhealthcareentitiesthatdonotparticipateincertain

medicalproceduresorservices,includingcertainhealthservicesorresearch

activitiesfundedinwholeorinpartbytheFederalgovernment.

CompliancebytheDepartment.InherentinCongress’sadoptionofthe

statutesthatrequirecompliancebytheDepartment,bydepartmentalprograms,

andbyrecipientsofFederalfundsfromtheDepartmentistheauthorityofthe

Departmenttotakemeasurestoensureitsowncompliance.Asexplainedmorefully

below,compliancereviews,complaintinvestigation,andrecord‐keepingare

standardmeasuresforensuringcompliancewithconditionsCongresshasimposed

upontheDepartmentandonrecipientsofFederalfunds,includingstatutory

nondiscriminationrequirements.Moreover,5U.S.C.301empowerstheheadofan

Executivedepartmenttoprescriberegulations"forthegovernmentofhis

department,theconductofhisemployees,thedistributionandperformanceofits

business,andthecustody,use,andpreservationofitsrecords,papers,and

property."

Compliancethroughfundinginstrumentsandagreements.Inlargepart,the

rule’senforcementmechanismsconcerningentitiesthatreceivefundsfromthe

Departmentinvolveplacingtermsandconditionsthatimplementfederallawin

contracts,grants,andotherfederalfundinginstrumentsandagreements.HHShas

theauthoritytoimposetermsandconditionsinitsgrants,contracts,andother

fundinginstruments,toensurerecipientscomplywithapplicablelaw,includingthe


61

aforementionedFederalconscienceandanti‐discriminationlaws.TheDepartment,

furthermore,willenforcesuchtermsandconditionsrequiringcompliancewithsuch

conscienceandanti‐discriminationlawinaccordancewithexistingstatutes,

regulationsandpoliciesthatgovernsuchinstruments,suchastheFederal

AcquisitionRegulation;theUniformAdministrativeRequirements,CostPrinciples,

andAuditRequirementsforHHSAwards(HHSUAR),45CFRpart75;regulations

applicabletoCMSprograms;theassociatedregulationsrelatingtosuspensionand

debarment;aswellasanyotherregulationsorproceduresthatgovernthe

Department’sabilitytoimposeandenforcetermsandconditionsonfunding

recipientstocomplywithFederalrequirements.

Grantsandcooperativeagreements.Withrespecttograntsandcooperative

agreements,theHHSUAR,45CFRpart75,requiresadherencebyawardrecipients

toallapplicableFederalstatutesandregulations.Forexample,section75.300(a)

requiresthattheDepartmentadministerFederalawardstoensurethatFederal

fundingandassociatedprograms“areimplementedinfullaccordancewithU.S.

statutoryandpublicpolicyrequirements:Including,butnotlimitedto,those

protectingpublicwelfare,theenvironment,andprohibitingdiscrimination.”The

regulationalsorequirestheDepartmenttocommunicatetonon‐Federalentitiesall

policyrequirementsandincludethemintheconditionsoftheaward.45CFR

75.300(a).

Furthermore,section75.371setsforthremediesfornon‐compliancewhere

theawardrecipient“failstocomplywithFederalstatutes,regulations,ortheterms


62

andconditionsoftheFederalaward.”Theseremediesincludedisallowance,

withholding,suspension,andterminationoffunding.45CFR75.371.TheHHSUAR

alsocontainsprovisionsrelatingtorecordkeeping(45CFR75.503)andprogram

specificaudits(45CFR75.507),whichtheDepartmentmayinvokewhenenforcing

granttermsandconditionsthatoperatetoimplementtheFederalconscienceand

anti‐discriminationlaws.Inaddition,FederalgrantrecipientsmustalsosignOMB‐

approvedassuranceswhichcertifycompliancewithallFederalstatutesrelatingto

non‐discriminationandallapplicablerequirementsofallotherFederallaws

governingtheprogram.

Insum,theDepartment’senforcementoftheFederalconscienceandanti‐

discriminationlawsforgranteeswillbeconductedthroughthenormalgrant

compliancemechanismsapplicabletograntsorotherfundinginstruments,with

OCRcoordinatingitsinvestigationandcomplianceactivitieswiththefunding

component.IftheDepartmentbecomesawarethatastateorlocalgovernmentora

healthcareentitymayhaveundertakenactivitiesthatmayviolateanystatutory

conscienceprotection,theDepartmentwillworktoassistsuchgovernmentor

entitytocomplywith,orcomeintocompliancewith,suchrequirementsor

prohibitions.If,despitetheDepartment'sassistance,complianceisnotachieved,the

Departmentwillconsideralllegaloptionsasmaybeprovidedunder45CFRparts

75(HHSUAR)and96(regulationsaddressingHHSblockgrantprograms),as

applicable.


63

Contracts.WithrespecttoFederalcontractsandcontractors,theFederal

PropertyandAdministrativeServicesActof1949(“FPASA”)authorizesthe

promulgationoftheFederalAcquisitionRegulation(“FAR”).40U.S.C.121(c).The

FAR,inturn,authorizesagencyheadsto“issueorauthorizetheissuanceofagency

acquisitionregulationsthatimplementorsupplementtheFARandincorporate,

togetherwiththeFAR,agencypolicies,procedures,contractclauses,solicitation

provisions,andformsthatgovernthecontractingprocessorotherwisecontrolthe

relationshipbetweentheagency,includinganyofitssuborganizations,and

contractorsorprospectivecontractors.”48CFRsubparagraph1.301‐(a)(1).In

addition,Federalagenciesarerequiredtopreparetheirsolicitationsandresulting

contractsutilizingauniformcontractformat,whichpermitsagenciestoincludea

clearstatementofany“specialcontractrequirements”thatarenotincludedinits

standardgovernmentcontractclausesorinothersectionsoftheuniformcontract

format.48CFR15.204‐2‐(h).Finally,pursuanttotheFARandotherlegal

authorities,theDepartmenthasestablishedtheDepartmentofHealthandHuman

ServicesAcquisitionRegulation(“HHSAR”)[48C.F.R.parts300through370],which

establishesuniformdepartmentalacquisitionpoliciesandproceduresthat

implementandsupplementtheFAR.TheHHSARcontainsdepartmentalpolicies

thatgoverntheacquisitionprocessorotherwisecontrolacquisitionrelationships

betweentheDepartment’scontractingactivitiesandcontractors.TheHHSAR

contains(1)requirementsoflaw;(2)HHS‐widepolicies;(3)deviationsfromFAR

requirements;and(4)policiesthathaveasignificanteffectbeyondtheinternal


64

proceduresoftheDepartmentorasignificantcostoradministrativeimpacton

contractorsorofferors.See48CFR301.101(b);seealso48CFR301.103(b)(“The

AssistantSecretaryforFinancialResources(ASFR)prescribestheHHSARunderthe

authorityof5U.S.C.301andsection205(c)oftheFederalPropertyand

AdministrativeServicesActof1949,asamended(40U.S.C.121(c)(2)),asdelegated

bytheSecretary[].”).Asaresult,theDepartmenthasampleauthoritytoinclude

termsandconditionsinitscontractsconsistentwiththeFederalconscienceand

anti‐discriminationlaws.Furthermore,theFederalAcquisitionRegulationprovides

avarietyofmechanismsthatmaybeusedtoenforcesuchcontractprovisions(e.g.,

48CFRpart49“TerminationofContracts”).Thus,theDepartmentintendsto

implementandenforcecontracttermsontheFederalconscienceandanti‐

discriminationlawsthroughtheFARandHHSARandotherFederallawsand

regulationsthatgoverntheadministrationandperformanceofFederalcontracts.

Otherrulemakingauthorities.UndertheACAsection1321(a),42U.S.C.

18041,theDepartmenthastheauthoritytopromulgateregulationsimplementing

theACAconscienceprovisions.Section1321(a)providesauthoritytotheSecretary

toissueregulationssettingstandardsformeetingtherequirementsunderTitleIof

theACA,andtheamendmentsmadebyTitleI,withrespecttotheestablishmentand

operationofExchanges(includingSHOPExchanges),theofferingofqualifiedhealth

plansthroughsuchExchanges,theestablishmentofthereinsuranceandrisk

adjustmentprogramsunderpartV,andsuchotherrequirementsastheSecretary

determinesappropriate.ThisprovisionauthorizestheSecretarytopromulgate


65

regulationssettingstandardsforregulatedentitiestomeettheconscience

protectionrequirementsinACAsections1303(b)(1)(A)&(b)(4),1411,and1553,

42U.S.C.18023(b)(1)(A)&(b)(4),18081,18113,allofwhicharelocatedinTitleIof

theACA.

WithrespecttotheMedicare,Medicaid,andChildren’sHealthInsurance

Program(CHIP),section1102oftheSocialSecurityAct,42U.S.C.1302,authorizes

theSecretaryto“makeandpublishsuchrulesandregulations,notinconsistentwith

thisAct,asmaybenecessarytotheefficientadministrationofthefunctionswith

which[he]ischargedunderthisAct.”ThisprovidestheSecretarywithauthorityto

promulgateregulationsthatprovideforcompliancebyparticipantsintheMedicare,

Medicaid,andCHIPprograms,includingMedicareproviders,StateMedicaidand

CHIPprograms,etc.,withapplicableFederalconscienceandanti‐discrimination

laws.

Furthermore,withrespecttofundinginstrumentsadministeredbythe

CentersforMedicare&MedicaidServices(CMS),includinginstrumentsor

agreementsauthorizedbytheSocialSecurityActandACA,theSecretaryhasthe

authorityundersection1115(a)(2)oftheSocialSecurityActtoauthorizeFederal

matchingfundsinexpendituresbyStateMedicaidagenciesthatwouldnot

otherwisebeeligibleforFederalmatchinginordertocarryoutademonstration

projectthatpromotestheobjectivesoftheMedicaidorCHIPprograms.Under

section1115AoftheSocialSecurityAct,Federalfundsareavailabletotest

innovativepaymentandservicedeliverymodelsexpectedtoreducecoststo


66

Medicare,Medicaid,orCHIP,whilepreservingorenhancingthequalityofcare

furnishedtothebeneficiariesoftheseprograms.TheSecretaryhastheauthorityto

includetermsandconditionsaddressingFederalconscienceandanti‐discrimination

lawsincertainfundinginstrumentsoragreementsundertheseauthorities.The

Secretaryalsohastheauthoritytoimposetermsandconditionsincertaingrant

instrumentsundersomeofitsgrantauthorities,suchasthegrantsavailableto

StatesforACAimplementationundersection2794(c)(2)(B)ofthePublicHealth

ServiceAct.Inaddition,theSecretaryhastheauthoritytoincludesuch

requirements,throughrulemaking,withrespecttoStateMedicaidprograms

generally,Medicaidmanagedcareorganizations(section1902(a)(4)oftheSocial

SecurityAct),MedicareAdvantageorganizations(section1856(b)(1)oftheSocial

SecurityAct)andMedicarePartDsponsors(section1857(e)(1)oftheSocial

SecurityAct),othertypesofMedicareprovidersandsuppliersofitemsand

services,52andQualifiedHealthPlansofferingindividualmarketcoverageonState

exchanges.

52ThroughdelegationfromtheSecretary,CMShasstatutoryauthoritytoplaceconditionsonparticipationinitsprogramsunderthefollowingauthorities:

1.Skillednursingfacilities(SNFs)—section1819(d)(4)(B)oftheAct[42U.S.C.1395i‐3(d)(4)(B)].2.Medicaidnursingfacilities(NFs)—section1919(d)(4)(B)oftheAct[42U.S.C.1396r(d)(4)(B)].3.Hospitals—section1861(e)(9)oftheAct[42U.S.C.1395x(e)(9)].4.Psychiatrichospital—section1861(f)(2)oftheAct[42U.S.C.1395x(f)(2)],crossreferencing1861(e)(9).5.Longtermcarehospital—section1861(ccc)(3)oftheAct[42U.S.C.1395x(ccc)(3)],crossreferencingsection1861(e).6.Homehealthagencies(HHAs)—section1861(o)(6)oftheAct[42U.S.C.1395x(o)(6)].7.RehabilitationagenciesandClinicsasprovidersofphysical,occupationaltherapyandspeechlanguagepathologyservices—section1861(p)(4)(A)(v)oftheActand1861(p)(4)flushlanguage[42U.S.C.1395x(p)(4)].


67

TotheextentthattermsandconditionsrelatingtoFederalconscienceand

anti‐discriminationlawsareincorporatedintoCMS’sinstrumentsoragreements,

CMSwouldhavetheauthoritytoenforcesuchtermspursuanttotherelevant

enforcementmechanismforeachinstrumentoragreement.Forexample,with

respecttoaspecialtermandconditionunderasection1115demonstration,the

demonstrationcouldbeterminatedforafailuretocomplywithatermand

condition.Withrespecttosection1115A,itwoulddependonthelegalinstrument

used.Forcooperativeagreements,theenforcementmechanismwouldbeFederal

grantslaw.Foraddendatoexistingcontracts,theenforcementmechanismwouldbe

Federalprocurementlaw.Forparticipationagreementsandregulations—through

whichCMMIoperatesmostofitssection1115Amodels—CMScouldenforcethese

requirementsunderthetermsoftheagreementorregulationitself(whichallow

CMStotakecertaincorrectiveactions,uptoandincludingterminationofanon‐

compliantparticipantfromthemodel)and,undercertaincircumstances,under

generalCMSregulations(e.g.,regardingrecoupments).InthecaseofaCMSgrant

8.Comprehensiveoutpatientrehabilitationfacilities(CORFs)—section1861(cc)(2)(J)oftheAct[42U.S.C.1395x(cc)(2)(J)].9.Hospice—section1861(dd)(2)(G)oftheAct[42U.S.C.1395x(dd)(2)(G)].10.Communitymentalhealthcenters(CMHCs)—section1861(ff)(3)(B)(iv)oftheAct[42U.S.C.1395x(ff)(3)(B)(iv)].11.Religiousnonmedicalhealthcareinstitution(RNHCIs)—section1861(ss)(1)(J)oftheAct[42U.S.C.1395x(ss)(1)(J)].12.Portablex‐raysuppliers—1861(s)(3)oftheAct[42U.S.C.1395x(s)(3)]13.Independentclinicallaboratories—section353(f)(1)(E)ofthePublicHealthAct[42U.S.C.263a(f)(1)(E)](authorizingtheSecretarytomakeadditionalregulations“necessarytoassureconsistentperformancebysuchlaboratoriesofaccurateandreliablelaboratoryexaminationsandprocedures”).14.Ruralhealthclinics(RHCs)—section1861(aa)(2)(K)oftheAct[42U.S.C.1395x(aa)(2)(K)].15.Intermediatecarefacilitiesforindividualswithintellectualdisabilities(ICF/IIDs)—section1861(e)(9)oftheAct[42U.S.C.1395x(e)(9)].


68

program,itwoulddependonthetermsincludedinthegrantaward,butgrantfunds

couldbesubjecttoforfeitureinsomeinstances.Medicaidrequirementsimposed

throughrulemakingwouldbeenforcedthroughacomplianceactionundersection

1902(a)(4)oftheSocialSecurityAct.ForMedicareAdvantageorPartCcontracts,

thereareintermediatesanctions,civilmoneypenalties,andpotentialcontract

terminationforviolationsofcontractrequirements.InthecaseofMedicare

providersandsuppliers,enforcementcouldinvolvelossofaprovideragreementor

certification.

Debarmentandsuspension.Finally,theDepartmentnotesthatithasthe

authority,whereappropriate,toinitiatedebarmentorsuspensionproceedings

againstentitiesthatareotherwiseeligibletoreceiveFederalfundingpursuantto

grantsandcooperativeagreements,contractsandotherfundinginstruments.See,

e.g.,48CFRpart9.4;2CFRpart376.Entitiesthataredebarred,suspended,or

proposedfordebarmentarealsoexcludedfromconductingbusinesswiththe

Governmentand,thus,aregenerallynoteligibletoreceiveFederalfundsduringthe

durationofthesuspensionordebarment.TheDepartmentnotesthat,underthe

FAR,anentitymaybedebarredforthe“[c]ommissionofanyotheroffense

indicatingalackofbusinessintegrityorbusinesshonestythatseriouslyanddirectly

affectsthepresentresponsibilityofaGovernmentcontractororsubcontractor.”48

CFR9.406‐2(a)(5).Inaddition,acontractormaybedebarredfora“[w]illfulfailure

toperforminaccordancewiththetermsofoneormorecontracts.”48CFR9.406‐

2(b).Thus,theDepartmentwillconsiderwhethersuspensionordebarmentmaybe


69

appropriatewhenenforcingtermsandconditionsimplementingtheFederal

conscienceandanti‐discriminationlaws.

Receiptandprocessingofcomplaints.Withregardtothereceiptand

processingofcomplaintsofviolationsoftheFederalconscienceandanti‐

discriminationlaws,itiswellsettledincaselawthateveryagencyhastheinherent

authoritytoissueinterpretiverulesandrulesofagencypracticeandprocedure.1

RichardJ.Pierce,Jr.,AdministrativeLawTreatise§6.4(4thed.2002).Thisruledoes

notsubstantivelyalteroramendtheobligationsoftherespectivestatutes,JEM

Broad.v.FCC,22F.3d320(D.C.Cir.1994),andthedefinitionsofferedinthisruleare

reasonablydrawnfromtheexistingstatutes.Hoctorv.Dept.ofAgriculture,82F.3d

165(7thCir.1996).Asaresult,theDepartmentandOCRhaveauthoritytoissue

interpretationsregardingtheFederalconscienceandanti‐discriminationlaws,

manyofwhichhavebeenplacedintheDepartment’sprogramstatutes.

Comment:TheDepartmentreceivedacommentrequestingthatlong‐term

careandpost‐acuteprovidersbeexemptedfromtherulebecausesuchentitiesare

alreadyheavilyregulated.

Response:TheDepartmentdeclinestoprovidethisexemption.Therule

providesforappropriateenforcementofstatutesprotectingfoundationalcivil


70

rights,andCongressdidnotexemptlong‐termcareorpost‐acuteprovidersfrom

thesecivilrightslaws.

B.Section‐by‐SectionAnalysis53

Purpose(§88.1)

IntheNPRM,theDepartment’s“Purpose”sectionsetforththeobjectivethat

theproposedregulationwould,whenfinalized,providefortheimplementationand

enforcementofFederalconscienceandanti‐discriminationlaws.Italsostatedthat

thestatutoryprovisionsandregulationscontainedinthispartaretobeinterpreted

andimplementedbroadlytoeffectuatetheirprotectivepurposes.TheDepartment

didnotreceivecommentsonthissectionbeyondthegeneralcommentsaddressed

above.Section88.1ofthefinalrulereflectstechnicaleditstoreplacetheword

“persons”with“individuals,”forclarity,andtorefertothesetofstatutes

encompassedbythisrulecollectivelyasthe“Federalconscienceandanti‐

discriminationlaws,whicharelistedinsection88.3ofthispart.”Throughoutthe

finalrule,theDepartmenthasmadechangestorefertothosestatutesas“Federal

conscienceandanti‐discriminationlaws,”ratherthan“Federalconscience

protectionandassociatedanti‐discriminationlaws.”

SummaryofRegulatoryChanges:TheDepartmentbelieves,asdiscussed

above,thattherearevariousreasonswhythisruleisneededandappropriateto

providefortheimplementationandenforcementofFederalconscienceandanti‐

discriminationlaws.Inaddition,theDepartmentbelievesitisappropriateto

53Unlessindicatedotherwise,theDepartmentadoptstheregulationtextasproposed.


71

interprettherulesbroadly,withinthescopeofthetextsetforthineachstatute,to

effectuatetheirprotectivepurposes.Generally,itisappropriatetobroadlyinterpret

lawsenactedtoprotectcivilrightsandpreventdiscrimination.Forthereasons

describedintheproposedrule54andabove,andconsideringthecomments

received,theDepartmentfinalizesthissectionasproposed,butwithtechnicaledits

toreplacetheword“persons”with“individuals,”addtheterm“certain”inregardto

healthcareservices,removetheterm“forexample”and“comprehensively”in

relationtothedegreeoftheprotections,forclarity,andtorefertothestatutespart

88addressesas“Federalconscienceandanti‐discriminationlaws,whicharelisted

insection88.3ofthispart.”

Definitions(§88.2)

IntheNPRM,theDepartmentproposeddefinitionsofvariousterms.The

commentsandtheresponsesapplicabletoeachdefinitionaresetforthbelow.

AdministeredbytheSecretary.TheDepartmentproposedthatafederally

fundedprogramoractivityis“administeredbytheSecretary”whenitis“subjectto

theresponsibilityoftheSecretaryoftheU.S.DepartmentofHealthandHuman

Services,asestablishedviastatuteorregulation.”TheDepartmentdidnotreceive

commentsspecificallyonthisdefinition.

Inproposingthedefinitionfor“administeredbytheSecretary,”the

Departmentnotedthatthe2008Rulehadnotdefinedthephrase,andthatthe

proposeddefinitionwasintendedtoaddclarity.Uponfurtherreviewandin

5483FR3880,3892.


72

considerationofgeneralcommentsreceivedconcerningwhethertheproposedrules

aresufficientlyclear,theDepartmenthasconcludedthattheproposeddefinition

doesnotaddsubstantialclaritytotheplainmeaningofthephrase“administeredby

theSecretary.”Nocommenterssubmittedcommentsonthisquestion,which

suggeststhatthereisnoconfusionaboutthemeaningofthisphrase.The

Departmentisfinalizingthisrulewithoutadoptingtheproposeddefinition,orany

definition,of“administeredbytheSecretary.”IntheeventthattheDepartmentis

askedtoconsiderthemeaningofthisphraseinitsapplicationoftherule,the

Departmentwillapplythestandardcanonsofstatutoryconstruction.

SummaryofRegulatoryChanges:Forthereasonsdescribedabove,the

Departmentfinalizestherulewithoutadefinitionofthephrase“administeredby

theSecretary.”

AssistinthePerformance.TheDepartmentproposedthat“assistinthe

performance”means“toparticipateinanyprogramoractivitywithanarticulable

connectiontoaprocedure,healthservice,healthprogram,orresearchactivity,so

longastheindividualinvolvedisapartoftheworkforceofaDepartment‐funded

entity.”Thedefinitionspecifiedthat“[t]hisincludesbutisnotlimitedtocounseling,

referral,training,andotherarrangementsfortheprocedure,healthservice,health

program,orresearchactivity.”TheDepartmentreceivedcommentsonthis

definition,includingcommentsgenerallysupportiveoftheproposeddefinitionand

generallyopposedtoit.Becausecommentsevidencedsignificantconfusionoverthe

proposeddefinition,theDepartmentamendsthedefinition,asdescribedfurther


73

below.

Comment:TheDepartmentreceivedcommentssuggestingthatthedefinition

of“assistintheperformance”isunnecessarybecauseemployeesmaintainthe

optiontoseekemploymentelsewhere.

Response:TheDepartmentdisagrees.Congressestablishedrequirements,

includingtheprotectionsinterpretedbythisfinalrule,forrecipientsofcertain

FederalfinancialassistanceorparticipantsincertainFederalprograms.Those

obligationsarenotobviatedmerelybecauseanemployeewhodesirestomakeuse

oftheprotectionsthatCongressprovidedcould,instead,findemployment

elsewhere.Indeed,forcingapersontofindemploymentelsewhere(whichincludes

asaresultofbeingfired),becausetheymakecertainprotectedobjectionsto

procedures,orbecauseoftheirreligiousbeliefsormoralconvictions,isa

quintessentialexampleofthediscriminationandcoercionthattheselawsprohibit.

Theexistenceofnumerouscommentsemployingthislineofreasoningprovides

additionalevidenceoftheneedforthisfinalrule,sothattheDepartmentmaybetter

educatebothrecipientsandthepubliconthelaw,andmayensurevigorous

enforcementwhereeducationprovesinsufficienttoachievecompliance.


“articulableconnection”standardistoobroadandwouldpermitobjectionsby

personswhomcertaincommenterscontendhaveonlyatangentialconnectiontothe

objected‐toprocedureorhealthserviceprogramorresearchactivity.Some

commentersincludedexamplessuchasapersonpreparingaroomforanabortion


74

orschedulinganabortion.

Response:TheDepartmentbelievesthattheprofferedexamplesareproperly

consideredaswithinthescopeoftheprotectionsenactedbyCongressforthosewho

choosetoassistandthosewhochoosenottoassistintheperformanceofan

abortion.Schedulinganabortionorpreparingaroomandtheinstrumentsforan

abortionarenecessarypartsoftheprocessofprovidinganabortion,anditis

reasonabletoconsiderperformingtheseactionsasconstituting“assistance.”

Thedefinitionwillensureasufficientconnectionbetweentheconductfor

which(orfromwhich)theconscientiousobjectorisseekingreliefandthe

protectionsCongressestablishedinlaw.Thisapproachwouldensurethathealth

careworkersarenotdrivenfromthehealthcareindustrybecauseofconflictswith

theirreligiousbeliefsormoralconvictionsinconnectionwithpracticesassetforth

byCongress,suchasabortion.Itwouldalsodissuadeemployersfromattemptingto

skirtprotectionsthroughimproperlynarrowinterpretationsoftheterm.

Nevertheless,inresponsetoconcernsaboutthepotentialoverbreadthand

needforincreasedclarityofthedefinition,theDepartmentfinalizesthedefinition

withachangetothefirstsentence,sothatitreads:toassistintheperformance

means“totakeanactionthathasaspecific,reasonable,andarticulableconnection

tofurtheringaprocedureorapartofahealthserviceprogramorresearchactivity

undertakenbyorwithanotherpersonorentity.”TheDepartmentbelievesthat

replacingthephrase“toparticipateinanyactivity”withthephrase“totakean

action”moreclearlyandpreciselyexplainstheconductcoveredby“assistinthe


75

performance.”Thephrase“undertakenbyorwithanotherpersonorentity”

distinguishes“assisting”from“performing,”asassistingimpliesworkingwith

another.Thischangewouldalsoensurethatanyarticulableconnectionmustalsobe

“reasonable”and“specific.”Itwould,therefore,precludevagueorattenuated

allegationsthatdonotsupportaclaimofassistinginaprocedureorhealthservice

programorresearchactivity.Forexample,ahealthcareworkerwhoobjectsto

beingscheduledtoconductphysicalsonsomepatients,whenabortionsare

scheduledonthesamedayforunrelatedpatientselsewhereinthebuilding,would

nothaveaclaimofbeingcoercedinto“assisting”withanabortion,barring

additionalfacts.Conversely,whereaproviderrequiresthedesignationand

availabilityofabackupdoctorwheneveranabortionistobeperformed,that

designationmayconstituteassistanceintheperformanceofanabortionevenifno

complicationsariserequiringthebackupdoctortointerveneduringorafteran

abortioninaparticularinstance.Inaddition,theDepartmentclarifiesthatthe

activitiesneedonlytoregard“partofahealthserviceprogramorresearchactivity,”

incontrastto,forexample,furtheringthehealthserviceprogramasawhole.

TheDepartmentbelievesthesechangesadequatelyrespondtocommenters

whocontendtheproposeddefinitionof“assistintheperformance”isinsufficiently

clear,withoutnarrowingthedefinitiontoexcludeactionsthatdoconstitute

assistanceintheperformance.TheDepartmentbelievesthedefinitioninthefinal

rule,whilestillrequiringOCRtoweighthefactsandcircumstancesofeachcase,

providesadditionalclarity.Congressdidnotdefine“assistintheperformance.”The


76

Departmentconsiderednotfinalizingadefinitionof“assistintheperformance,”but

withoutanydefinition,theremaybeconfusionaboutwhatthetermincludes,with

differentemployersinterpretingitmorebroadlyormorenarrowly.Forexample,in

theDanquahlawsuit,wherenursescontendedtheywererequiredtoassistabortion

casesinviolationoftheChurchAmendments,apublichospitalreceivingPublic

HealthServiceActfundsfiledabriefinFederalcourtstatingthat“toadminister

routinepreandpost‐operativecare”toabortionpatientsdoesnotconstitute

assistingintheperformanceofanabortionundertheChurchAmendments.55

Withouttakingapositiononthefactsofthatcase,theDepartmentdisagreeswitha

narrowinterpretationofassistingintheperformancethatexcludespre‐andpost‐

operativesupporttoascheduledabortionprocedure.TheDepartmentbelievesthat

theconfusionamongcoveredentitiesandmembersofthepublicaboutwhat

constitutesassistanceintheperformanceofahealthservicemakesitappropriate

fortheDepartmenttodefine“assistintheperformance”withthechangesasset

forthinthisfinalrule.

Comment:TheDepartmentreceivedacommentrequestingthat“articulable

connection”bereplacedwith“reasonableconnection”because“articulable

connection”maybeabusedbypersonsarticulatingconnectionsthatareirrational.

Response:TheDepartmentagreesinpart,totheextentthatthe

reasonablenessstandardshouldbeincludedinthedefinition.Asstatedabove,in

responsetosimilarconcernsaboutpotentialoverbreadth,theDepartmenthas

55Defs.’BriefinOpp.ToPls.’App.ForPrelim.Inj.at26,Danquah,No.2:11‐cv‐06377‐JLL‐MAH,doc.#26(D.N.J.filedNov.22,2011).


77

modifiedthesentencecontainingthephrase,“toparticipateinanyprogramor

activitywithanarticulableconnectiontoaprocedure,”toaddtheword

“reasonable,”andotherlanguagetolimititsscopeandaddgreaterspecificity.

Specifically,thefinalruledescribes“totakeanactionthathasaspecific,reasonable,

andarticulableconnectiontofurtheringaprocedureorhealthserviceprogramor

researchactivityundertakenbyorwithanotherpersonorentity.”Thisstandard

wouldprecludeirrationalassertionsthatanactionconstitutesassistinginthe

performanceofaprocedure,becauseitrequirestheactiontohaveaspecific,

reasonable,andarticulableconnectiontofurtheringtheprocedure.Ifthe

connectionbetweenanactionandaprocedureisirrational,thereisnoactual

connectionbywhichtheactionspecificallyfurtherstheprocedure.TheDepartment

doesnotinterpretthelanguagetopermitirrationalapplications.

Comment:TheDepartmentreceivedacommentsuggestingthatthe

“articulableconnection”standardbereplacedwithastandardthatconnectsthat

assistancetotheclinicalsettingandincludesacomplete,notillustrative,listof

activitiessubjecttotheprotections.

Response:TheDepartmentbelievesthisconcernisadequatelyaddressedby

thechangesdescribedabovetoclarifythedefinitionof“assistintheperformance.”

TheDepartmentdisagreeswiththerecommendedapproachbecausethestatutory

protectionsforobjectingtoassistingintheperformanceofproceduresencompasses

situationsbeyondthenarrowscopeproposedbythecommenter.Forexample,an

unlawfullycoercedassistanceinanabortionisnolessunlawfulifthecoerciontakes


78

placeoutsideaparticularclinicalsetting,asopposedtowithinsuchclinicalsetting.

Furthermore,creatinganexhaustivelistofpotentiallyprotectedconductdoesnot

allowforvariationsfromStatetoState,orevenclinictoclinic,inhowprocedures

arehandled.Suchanapproachalsodoesnotconsiderthediversewaysinwhich

protectedmoralorreligiousobjectionsmaymanifest,andwouldnotaccountfor

changesinpracticesovertime.

Comment:TheDepartmentreceivedcommentsstatingthatthescopeof

personsprotectedbythedefinitionof“assistintheperformance”istoobroad

becauseitextendsbeyondhealthcareprofessionalsandincludesothermembersof

theworkforce.

Response:TheDepartmentacknowledgesthatinclusionofareferenceto

workforcemembersinthedefinitionof“assistintheperformance”hascaused

confusionamongcommenters.TheDepartmenthasconcludedthisreferenceisnot

necessarybecausethescopeofpersonsandentitiesprotectedfrombeingforcedto

“assistintheperformance”ofanobjectedtoprocedureisalreadygovernedby

provisionsintherelevantlawandthisrule.Accordingly,theDepartmentis

finalizingthedefinitionof“assistintheperformance”todeletethereferenceto

workforcemembers.Similarly,theDepartmentisremovingthereferenceto“any

programoractivity”aspartofthedefinitionof“assistintheperformance”because

thenewlanguageinthedefinition—“totakeanactionthathasaspecificarticulable

connection”—makesthereferenceto“anyprogramoractivity”unnecessary.The


79

Departmentisalsoremovingthereferenceto“healthprogramoractivity”because

thattermisnolongerdefinedinthefinalrule,asdiscussedfurtherbelow.


definitionof“assistintheperformance”wouldcoverambulancedrivers.

Response:EMTsandparamedicsaretreatedlikeotherhealthcare

professionalsunderthisdefinition.Federalconscienceandanti‐discriminationlaws

wouldapplytothem,ornot,basedonwhethertheelementsofthelaw(andthis

finalrule)aresatisfiedinaparticularcircumstance.Totheextentthecommenters

contendthatthekindsofactionsthatambulancecrewsperformnevercountas

assistingintheperformanceofaprocedureencompassedbyaFederalconscience

oranti‐discriminationlaw,theDepartmentdeclinestotakesuchacategorical

approach.Asdiscussedearlier,whereEMTALAmightapplyinaparticularcase,the

DepartmentwouldapplybothEMTALAandtherelevantlawunderthisrule

harmoniouslytotheextentpossible.EMTsandparamedicsaretrainedmedical

professionals,notmere“drivers.”Ifcommenterscontendthatdrivingapatienttoa

procedureshouldneverbeconstruedtobeassistingintheperformanceofa

procedure,theDepartmentdisagreesandbelievesitwoulddependonthefactsand

circumstancesofeachcase.Forexample,theDepartmentbelievesdrivingaperson

toahospitalorclinicforascheduledabortioncouldconstitute“assistinginthe

performanceof”anabortion,aswouldphysicallydeliveringdrugsforinducing

abortion.


80

Totheextentcommentersarereferringtoemergencytransportationof

personsexperiencingunforeseencomplicationsafter,forexample,anabortion

procedure,theDepartmentdoesnotbelievesuchascenariowouldimplicatethe

definitionof“assistintheperformanceof”anabortion,becausethecomplicationsin

needoftreatmentwouldbeanunforeseenandunintendedbyproductofa

completedprocedure.Further,theDepartmentisnotawareofanyentitiesor

medicalprofessionalsthatwouldobjecttotreatingsomeone,ortransporting

someonetotreatment,underthesecircumstances.

Totheextentcommentersarereferringtoemergencytransportationof

personswithconditionssuchasanectopicpregnancy,wherethepotential

proceduresperformedatthehospitalmayincludeabortion,thequestionofwhether

suchtransportationfallsunderthedefinitionof“assistintheperformance”would

dependonthefactsandcircumstances.However,asageneralmatter,the

Departmentdoesnotbelievethatmerespeculationthatanobjected‐toserviceor

proceduremayoccursufficestoestablishaspecificandreasonableconnection

betweentheobjected‐toserviceorprocedureandtheactoftransportingthe

patient.

TheDepartment’sexistingregulationimplementingEMTALAat42C.F.R.

489.24definesEMTALA’sstatutorylanguage“comestotheemergency

department”56toincludeanindividualwhoisenroutetoahospitalinanambulance

ownedandoperatedbythehospital,withlimitedexceptions,aswellas,incertain

5642U.S.C.1395dd(a).


81

circumstances,anindividualwhoisenroutetoahospitalinanambulancethatis

notownedandoperatedbythehospital.57FederalAppealsCourtsintheNinthand

FirstCircuitshaveexaminedtheDepartment’sregulatorydefinitionof“comestothe

emergencydepartment,”andhaveupheldtheDepartment’sregulatorydefinition

forEMTALAasreasonable,andhavedistinguishedotherFederalCircuits’cases

interpretingEMTALAbydifferentiatingthecasesbytheirfactsorbythenatureof

thecourts’analyses.58

Comment:TheDepartmentreceivedcommentsstatingthattheinclusionof

counselingandreferralinthedefinitionof“assistintheperformance”wasnotthe

intentofCongressinenactingtheChurchAmendments.Somecommenterspointed

todifferinglanguageintheChurch,Weldon,andCoats‐SnoweAmendmentsto

supportthisassertion.

Response:Congressdidnotdefinethephrases“assistintheperformance,”

“counsel,”or“recommend”intheChurchAmendments;“refer”or“referral”in

WeldonorCoats‐Snowe;or“makearrangementsfor”inCoats‐Snowe.Some

commenterscontendthatthemeaningofthesetermsarecompletelydistinctand

shouldneverbeinterpretedasoverlapping.TheDepartmentdisagrees.When

Congressenactedparagraphs(b)and(c)(1)oftheChurchAmendmentsin1973,

andparagraphs(c)(2)and(d)in1974,itusedthephrase“assistinthe

5742CFR489.24(b)(3)‐(4).58Moralesv.SociedadEspanoladeAuxilioMutuoyBeneficencia,524F.3d54,60‐61(1stCir.2008)(holdingthattheHHSregulatorydefinitioncomportswithEMTALA’spurposeandremedialframeworkanddistinguishingcasesfromtheFifthandSeventhCircuits);Arringtonv.Wong,237F.3d1066,1073‐74(9thCir.2001)(same).


82

performance”regardingcertainmedicalprocedures.Congressthenenacted

paragraph(e)in1979toprotectapplicantsformedicaltrainingorstudyfrom

discriminationbasedontheirreluctanceorwillingness“tocounsel,suggest,

recommend,assist,orinanywayparticipateintheperformanceofabortionsor

sterilizations.”

Counselingandreferralarecommonandwellunderstoodformsofassistance

thatmateriallyhelppeoplereachdesiredmedicalends.Indeed,becausereferrals

aresotightlyboundtotheultimateperformanceofmedicalprocedures,Congress

bannedmanyformsofreferralfeesor“kickbacks”amongprovidersreceiving

MedicareandMedicaidreimbursements.SeetheMedicareandMedicaidPatient

ProtectionActof1987,asamended,42U.S.C.1320a‐7b(the"Anti‐Kickback

Statute")andtheEthicsinPatientReferralsActof1989,asamended,42U.S.C.

1395nn(the“StarkLaw”).Similarly,counselingofsomeformregardingabortionis

oftenrequiredbeforetheprocedurecanbeperformed,asisthecasein33states,59

andmanyhospitalsandhealthcarefacilitieslikelyrequiresomekindofcounseling

asaprerequisitetoabortionoftheirownaccord.

Basedonthetext,structure,andpurposeofthestatutesatissue,the

Departmentinterprets“assistintheperformance”broadlyanddoesnotbelievethe

presenceofmorespecifictermsofassistanceelsewhereintheChurchAmendments,

orinotherlawsthatarethesubjectofthisrule,narrowsthemeaningofthephrase.

ItwouldbecontrarytothestructureandhistoryoftheChurchAmendmentsto

59CounselingandWaitingPeriodsforAbortion,GuttmacherInstitute(Oct.1,2018),https://www.guttmacher.org/state‐policy/explore/counseling‐and‐waiting‐periods‐abortion.


83

interpretprovisionsprotectingconscienceinthestudyofabortionprocedures

significantlymorebroadlythanprovisionsprotectingconscienceintheactual

performanceofanabortionprocedure.

TheDepartment,however,doesnotbelievethateveryformofcounseling,

training,orreferral(asdefinedunderthisrule)necessarilyconstitutesassistancein

theperformanceofaprocedureunderthisrule.TheDepartment,therefore,finalizes

thedefinitionof“assistintheperformance”bychangingthesecondsentenceto

read“Thismayincludecounseling,referral,training,orotherwisemaking

arrangementsfortheprocedureorhealthserviceprogramorresearchactivity,

dependingonwhetheraidisprovidedbysuchactions.”


definitionof“assistintheperformance”combinedwiththelanguageof42U.S.C.

300a‐7(d)couldimpactcounselingorreferralsforLGBTpersons.

Response:Severalprovisionsofstatutesthatarethesubjectofthisruleare

specifictoabortion,sterilization,assistedsuicide,orotherprocedures,andprovide

specificprotections.In42U.S.C.300a‐7(d)(and300a‐7(c)(2)),Congressdirected

theprotectionofconscientiousobjectionsincontextsnottiedtospecifictreatments.

Whenthepreviousadministrationfinalized45CFRpart88in2011,itaffirmedits

commitmenttoenforceFederalconscienceandanti‐discriminationlaws,including

42U.S.C.300a‐7(d).(76FRat9972).TheDepartmentcontinuesandexpandson

thatcommitmentinthisrule.TheDepartmentdoesnotpre‐judgematterswithout


84

thebenefitofspecificfactsandcircumstances,andparticularclaimsunder42U.S.C.

300a‐7(d)willbeevaluatedonacase‐by‐casebasis.

Nevertheless,theDepartmentbelievesthatsomecommentersmay

misunderstandthescopeofparagraph(d).Generally,theprotectionsofparagraph

(d)followthefundsprovidedbyanyprogramadministeredbytheSecretary.But

paragraph(d)doesnotencompasseverymedicaltreatmentorserviceperformed

byanyentityreceivingfederalfundsfromHHSforwhateverpurpose.Instead,

Congressnarrowlyfocusedparagraph(d)toprohibitthecoercionofpersons“in

performanceof”healthserviceprogramsfundedunderaprogramadministeredby

theSecretary.Asexplainedmorefullyinresponsetoothercommentsbelowwith

respecttoparagraph(d),manymedicaltreatmentsandservicesperformedby

healthcareprovidersarenot“partof”ahealthserviceprogramreceivingfunding

fromHHS.Insuchcircumstances,paragraph(d)wouldnotapply.


definitionof“assistintheperformance”willresultinconscientiousobjectors

refusingtoprovideinformationtopatientsaboutobjected‐totreatmentoptions,

potentiallyinviolationofprinciplesofinformedconsent.

Response:TheDepartmentdisagreesthattherulewouldviolateprinciplesof

informedconsent.Medicalethicshavelongprotectedrightsofconsciencealongside

theprinciplesofinformedconsent.TheDepartmentdoesnotbelievethat

enforcementofconscienceprotections,manyofwhichhavebeeninplacefornearly

fiftyyears,violatesorunderminestheprinciplesofinformedconsent.Thisrulewill


85

notchangetheobligationthat,absentexigentcircumstances,doctorssecure

informedconsentfrompatientsbeforeengaginginamedicalprocedure.

SummaryofRegulatoryChanges:Forthereasonsdescribedintheproposed

rule60andabove,andconsideringthecommentsreceived,theDepartmentadopts

thedefinitionof“assistintheperformance”withchangestoreadthatitmeans“to

takeanactionthathasaspecific,reasonable,andarticulableconnectionto

furtheringaprocedureorhealthserviceprogramorresearchactivityundertakenby

orwithanotherpersonorentity.”Thedefinitionspecifiesthat”[t]hismayinclude

counseling,referral,training,orotherwisemakingarrangementsfortheprocedure

orhealthserviceprogramorresearchactivity,dependingonwhetheraidis

providedbysuchactions.”Thisnewdefinitionremoves“solongastheindividual

involvedisapartoftheworkforceofaDepartment‐fundedentity”foraccuracyand

clarityandmakesotherminorlanguagechanges,forexample,changing“includes

butisnotlimitedto”to“mayinclude.”

Department.TheDepartmentproposedthat“Departmentmeansthe

DepartmentofHealthandHumanServicesandanycomponentthereof.”The

Departmentdidnotreceivecommentsonthisdefinition.


rule61andabove,theDepartmentadoptsthedefinitionof“Department”as

proposed.

6083FR3880,3892(statingthereasonsfortheproposeddefinitionof“assistintheperformance,”exceptforthemodificationsadoptedherein).6183FR3880,3892.


86

DiscriminateorDiscrimination.TheDepartmentproposed“discriminateor

discrimination,”tomeanoneoffourcategoriesofadverseactionsortreatment,for

whicheachsubparagraphortypeofactionwithineachsubparagraphwouldapply

aspermittedbytheapplicablestatute.Subparagraph(1)addressedprohibited

adverseactionsortreatment,aspermittedbytheapplicablestatute,asthose

actionsrelatetoanygrant,contract,subcontract,cooperativeagreement,loan,

license,certification,accreditation,employment,title,orothersimilarinstrument,

position,orstatus.Subparagraph(2)addressedprohibitedadverseactionsor

treatment,aspermittedbytheapplicablestatute,asthoseactionsrelatetoany

benefitorprivilege.Forbothsubparagraphs,prohibitedadverseactionsor

treatmentincludedthosetowithhold,reduce,exclude,terminate,restrict,or

otherwisemakeunavailableordenythecategorieslistedinsubparagraphs(1)and

(2).Subparagraph(3)addressedtheuseofanycriterion,methodofadministration,

orsiteselection,includingtheenactment,application,orenforcementoflaws,

regulations,policies,orproceduresdirectlyorthroughcontractualorother

arrangements,thattendstosubjectindividualsorentitiesprotectedundertherule

toanyadverseeffectdescribedinthisdefinition,orhastheeffectofdefeatingor

substantiallyimpairingaccomplishmentofahealthprogramoractivitywithrespect

toindividuals,entities,orconductprotectedundertherule.Finally,subparagraph

(4)ofthedefinitionsetforthacatch‐allforwhichdiscriminateordiscrimination

meanstootherwiseengageinanyactivityreasonablyregardedasdiscrimination,

includingintimidationorretaliatoryaction.


87

TheDepartmentreceivedcommentsonthisdefinition,includingcomments

generallysupportingoropposingtheproposeddefinition.

Comment:TheDepartmentreceivedcommentsstatingthatthedefinitionof

“discriminateordiscrimination”wouldencompasssituationsinwhichstatesapply

neutrallawsofgeneralapplicabilitythatrequiretheperformanceofabortion,and

suchcommentersdisagreedthataneutrallawofgeneralapplicabilitycanbe

deemedanactofdiscrimination.

Response:Theterm“neutrallawofgeneralapplicability”isalegaltermofart

thatderivesfromcaselawinterpretingtheFreeExerciseClauseoftheFirst

Amendment.Whatrendersalaw“neutral”intheFreeExercisecontextisthatthe

lawisnotbyitstext,history,motive,oroperationtargetedattheprotectedactivity

ofreligiousexercise.Ifcommentersarecontendingthatstatesthatmightotherwise

beprohibitedbyaFederalconscienceoranti‐discriminationlawfrom

discriminatingagainstdoctorswhorefusetoperformabortionsmaynonethelessdo

sopursuanttoaneutralstatelawofgeneralapplicability,theDepartmentdisagrees.

StatesthatacceptapplicableFederalfundsandtherebysubjectthemselvesto

Federalconscienceandanti‐discriminationlawscannotevadetherequirementsof

thoselawsthroughneutrallawsofgeneralapplicability.Forexample,theWeldon

AmendmentflatlypreventsStatelawsfromdiscriminatingagainstdoctorsbecause

theydonotperformabortionsagainsttheirwillregardlessofwhetherthelawis

“neutrally”wordedorapplied.Subjectingpersonstopenaltiesoradversetreatment

becausetheydeclinetoperformabortionsisaformofdiscriminationencompassed


88

bytheWeldonAmendment.Evenifastatelawweretoimposepenaltieson

OB/GYNsbecausetheydeclinetoperformanylawfulproceduretheyarecompetent

toperform(theDepartmentisnotawareofsuchalaw),andthatlawwereusedto

imposepenaltiesonOB/GYNsbecausetheydonotperformabortions,thatwould

alsoconstitutediscriminationencompassedbytheWeldonAmendment.TheCoats‐

SnoweAmendmentsimilarlyprohibitsdiscriminationagainstahealthcareentity,

suchasanindividualphysician,who(amongotherthings)declinestoperform

abortions.Additionally,underboththeCoats‐SnoweandWeldonAmendments,

protectedentitiesandindividualsneednotspecifyamotive,orprovidea

justification,fordeclining.

Subparagraph(c)(1)oftheChurchAmendmentsprovidesthatacovered

entitycannotdiscriminateagainstanyphysicianorotherhealthcarepersonnel(1)

becauseheorsheperformedorassistedintheperformanceofasterilizationor

abortionprocedure,(2)becauseheorsherefusedtosoperformorassist“onthe

groundsthat”doingso“wouldbecontrarytohis[orher]religiousbeliefsormoral

convictions,”or(3)“becauseofhisreligiousbeliefsormoralconvictionsrespecting

sterilizationproceduresorabortions.”Thelastprovisioncoverscircumstances

whereacoveredentity’smotiveisarguablydrivenbyanti‐religiousanimus.Butthe

secondprohibitionofdiscriminationdoesnotrelyonanimusonthepartofthe

entitycommittingthediscrimination;itrestssolelyonwhetherthepersonrefused

toperformorassistedintheperformanceofasterilizationorabortionprocedureon

thegroundsoftheperson’sreligiousbeliefsormoralconvictionswithrespectto


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suchprocedures.Therefore,undersubparagraph(c)(1),acoveredentitycannot

discriminateagainstadoctor,forexample,becauseofhisorherrefusaltoperform

abortionsonthegroundsofreligiousbeliefsormoralconvictionsregardlessof

whetherthecoveredentity’sdiscriminationisaccompaniedbyanti‐religious

animus,orwhethertheentitywouldalsopenalizedoctorswhorefusetoperform

abortionsfornon‐protectedreasons.NothinginthelegislativehistoryoftheChurch

AmendmentssuggeststhatCongressintendedtopermitentitiesreceiving

applicablefundstocoercereligiouslyormorallymotivateddoctorstoperform

abortions,solongasthoseentitiesalsorequiredoctorswhodonothavequalms

aboutabortionstoperformthem.

Consequently,theDepartmentconcludesthattheconceptofdiscrimination,

asusedinFederalconscienceandanti‐discriminationlaws,canencompassa

situationwhereastatetakesadverseactionagainstadoctorbecauseofthedoctor’s

refusaltoperformanabortion,evenunderageneralor“neutral”lawmandatingthe

performanceofabortions.

Comment:TheDepartmentreceivedcommentsstatingthatthephrase“any

activityreasonablyregardedasdiscrimination”isoverbroadorimpermissibly

vague.

Response:Discriminationstandardsusuallydonotlimitthemselvestoan

exclusivelistofdiscriminatoryactions,becauseadverseactionbasedonprohibited

groundscantakevariousformsdependingonthefactsandcircumstancesofthe

case.Thisruleencompassesseveralstatutesbarringdiscrimination.Assuch,the


90

Departmentbelievesitisappropriateforthisdefinitiontoencompassanarrayof

actionsthatmightbetakenagainstapersononthebasisofsuchperson’sexerciseof

therightsprotectedbyFederalconscienceandanti‐discriminationlaws.Onthe

otherhand,theDepartmentagreesinpartwithcommentersthatthelanguage“any

activityreasonablyregardedasdiscrimination”doesnotprovidepreciseguidance

onthescopeofthedefinition.ThereforetheDepartmentwillfinalizethedefinition

of“discriminateordiscrimination”bydeletingproposedsubparagraph(4).The

Departmentwillalsochangetheword“means”to“includes”intheopeningphrase

ofthediscriminationdefinition,andchangethephrase“aspermittedbythe

applicablestatute”to“totheextentpermittedbytheapplicablestatute.”Thiswill

maintainthedefinition’sdescriptionoftypesofdiscrimination,andensurethatthe

definitiononlyappliestotheextentitisauthorizedbytheapplicablestatute,while

alsorenderingthedescriptionsinthedefinitionnon‐exclusive,soOCRcanconsider

otheractionsthatmightconstitutediscriminationinviolationofanapplicable

Federalconscienceandanti‐discriminationlawtowhichthispartapplies.

Anyallegationofdiscriminationunderthelawstowhichthispartapplies

willbeconsideredinlightofareasonableinterpretationofapplicablelawandan

applicationofthatlawtothefacts.Bymakingthedefinitioninclusive,insteadof

exclusive,byuseoftheword“includes,”thedefinitionwillnotexcludethetypesof

actionsthatconstitutediscriminationbutmightnotfallsquarelyintooneofthe

descriptionssetforthinsubparagraphs(1)to(3)ofthedefinition.Additionally,in

lightofthelanguageaddedtoaddressconcernswithrespecttohowthisdefinition


91

interactswithreasonableaccommodations,theDepartmentbelievesthatmaking

thedefinitioninclusive,whileeliminatingproposedsubparagraph(4),ensuresthat

thedefinitionisnotoverlybroad.


definitionof“discriminateordiscrimination”conflictswithorisinconsistentwith

otherFederallawssuchasTitleVIIoftheCivilRightsActandTitleXofthePublic

HealthServiceAct.

Response:TheDepartmentdisagreesthattheseregulationsconflictwith

statutesapplicabletotheTitleXfamilyplanningprogramunderthePublicHealth

ServiceAct.TheDepartmentagreesthatregulationsfinalizedin2000governingthe

TitleXprogram,whichinsomecasesrequiredreferrals,information,and

counselingaboutabortion,conflictedwithcertainFederalconscienceandanti‐

discriminationlawsand,consequently,withthisrule.TheDepartment

acknowledgedthisconflictinthepreambletothe2008Rule(73FRat78087),inthe

preambletothenoticeofproposedrulemakingfortheTitleXregulationsin2018

(83FR25502,25506(June1,2018)),andinthepreambletotheTitleXfinalrule

publishedin2019(84FR7714,7716(March4,2019)).Inallthreeinstancesthe

DepartmentstateditwouldoperatetheTitleXprogramincompliancewithFederal

conscienceandanti‐discriminationlaws,notwithstandingthelanguageofthe2000

TitleXregulations.62TherecentlypublishedTitleXfinalrulerevisedthe2000Title

62Inaddition,inthepreambletothe2000TitleXregulations,theDepartmentacknowledgedtheimplicationsoftheChurchAmendmentwhenitaddressedacommentthattherequirementtoprovideoptionscounseling‘‘shouldnotapplytoemployeesofagranteewhoobjecttoprovidingsuch


92

XregulationstoeliminatethatconflictandachieveconsistencywithFederal

consciencestatutes.NothingintheTitleXstatuteitselforinappropriations

restrictionsapplicabletoTitleXfundingrequiresabortionreferrals,counseling,or

information.ThisincludesCongress’sdirectivethat,inTitleXprograms,“all

pregnancycounselingshallbenondirective.”63Thatprovisiondoesnotaddress

referralsorinformation,onlycounseling,anddoesnotrequirepregnancy

counseling,butmerelyspecifiesthat,ifpregnancycounselingoccurs,itshallbe

nondirective—andnowtheregulationpermits,butdoesnotrequireabortion

counselingandinformation(andbarsabortionreferrals).Accordingly,thisruleis

consistentwithbothTitleXandtheFederalconscienceandanti‐discrimination

laws.64

counselingonmoralorreligiousgrounds,’’andrejectedit,contendingthatitisnotnecessarybecause,undertheChurchAmendments,‘‘granteesmaynotrequireindividualemployeeswhohavesuchobjectionstoprovidesuchcounseling,’’but‘‘insuchcasesthegranteesmustmakeotherarrangementstoensurethattheserviceisavailabletoTitleXclientswhodesireit.’’65FR41270,41274(July3,2000).Atthetime,theDepartmentapparentlydidnotconsidertheimplicationsoftheCoats‐SnoweAmendment,adoptedin1996,withrespecttoTitleXgranteesandapplicants;theWeldonAmendmentwasadoptedsubsequently.63SeeDepartmentofDefenseandLabor,HealthandHumanServices,andEducationAppropriationsAct,2019andContinuingAppropriationsAct,2019,PublicLaw115‐245,Div.B,132Stat.2981,3070–71.64TheDepartmentacknowledgesthat,asofthedateofpublicationofthisfinalrule,severaldistrictcourtshaveissuedpreliminaryinjunctions,onanationwidebasis,againsttheenforcementorimplementationofthe2019TitleXfinalrule,andrequiringtheTitleXprogramtomaintainthestatusquounderthe2000TitleXregulations.ThoseinjunctionsdonotpurporttootherwiseenjointheDepartment’senforcementoftheFederalconscienceandanti‐discriminationlaws.Sinceatleast2008,underthe2000TitleXregulations,theDepartmenthasrecognizedthatitcannot,byregulation,requireabortioncounselingorreferralbyaTitleXapplicant,grantee,project,clinic,orproviderwheresuchrequirementwouldconstituteaviolationofoneormoreoftheFederalconscienceandanti‐discriminationlaws,andtheDepartmenthasstatedthatitoperatestheTitleXprogramaccordingly.The2019TitleXfinalrulememorializedHHS’slongstandingrecognitionthatFederalconscienceandanti‐discriminationlawsbarenforcementofcertainrequirementsofthe2000TitleXregulations,butthe2019TitleXfinalruledidnotalterHHS’spreexistingpolicydatingbackatleastto2008ofnotenforcingrequirementsofthe2000regulationswheretheymayconflictwiththefederalconsciencestatutesasexplainedinthisrule.Thisrule,similarly,doesnotalterthat


93

WithrespecttoTitleVII,theDepartmentagreeswithsomecommentersthat

thedefinitionof“discriminateordiscrimination”asproposeddoesnotfunctionin

thesamewayastheapproachsetforthinTitleVII,specificallyregardingpartsof

thereasonableaccommodationofreligionstandardsetforthunderTitleVII.The

Departmentbelievescomponentsofthatapproachareappropriateinthiscontext

andisthereforeaddinganewsubparagraph(4)tothedefinitionof“discriminateor

discrimination”toproperlyrecognizethatthevoluntaryacceptanceofaneffective

accommodationofprotectedconduct,religiousbeliefs,ormoralconvictions,will

not,byitself,constitutediscrimination.Further,theDepartmentwilltakeinto

accountanentity’sadoptionandimplementationofpoliciestoaccommodate

objectingpersonsinmakingdeterminationsofdiscrimination.TheDepartment

findsthisapproachappropriatebecauseitisgenerallyconsistentwiththetextand

intentofFederalconscienceandanti‐discriminationlawstorespectobjections

basedonreligiousbeliefsbyaccommodatingthem.TheDepartment’sapproachwill

differfromTitleVII,however,bynotincorporatingtheadditionalconceptofan

“unduehardship”exceptionforreasonableaccommodationsunderTitleVII.Despite

havingpreviouslyenactedTitleVII,Congressdidnotadoptanunduehardship

exceptionfortheprotectionsfoundinFederalconscienceandanti‐discrimination

lawsthatarethesubjectofthisrule.TheDepartmentbelievesCongress’sdecision

totakeadifferentapproachinTitleVIIascomparedtoFederalconscienceandanti‐

statusquo,butsetsforthgeneralprocessesforenforcementoftheFederalconscienceandanti‐discriminationlaws.TheDepartmentwillimplementallofitsprogramsconsistentwiththeFederalconscienceandanti‐discriminationlawsandwithanyapplicablecourtorders.


94

discriminationlawsisconsistentwiththefactthatTitleVII’scomprehensive

regulationofAmericanemployersappliesinfarmorecontexts,andismorevast,

variable,andpotentiallyburdensome(and,therefore,warrantingofgreater

exceptions)thanthemoretargetedconsciencestatutesthatarethesubjectofthis

rule,whicharehealthcarespecific,andoftenprocedurespecific,andwhichare

specifictotheexerciseofCongress’sSpendingClauseauthority.Therefore,the

Departmentdeemsitappropriatetorecognizethat,whenappropriate

accommodationsaremadeforobjectionsprotectedbyFederalconscienceandanti‐

discriminationlaws,thoseaccommodationsdonotthemselvesconstitute

discrimination.TheDepartmentalsofindsitappropriatenottoadopttheundue

hardshipexceptionforenforcingFederalconscienceandanti‐discriminationlaws

becauseCongresschosenottoplacethatlimitationontheprotectionssetforthin

theFederalconscienceandanti‐discriminationlaws.


proposeddefinitionof“discriminateordiscrimination”wouldprohibitemployers

fromaccommodatingreligiousobjectionsbyplacingtheconscientiousobjectorina

differentposition,potentiallyrequiringthedouble‐staffingofcertainpositions.

Response:TheDepartmentagreeswiththisconcerninpart.Asdiscussed

above,theDepartmentisaddinglanguageinresponsetopubliccommentsto

acknowledgethereasonableaccommodationsthatentitiesmakeforpersons

protectedbyFederalconscienceandanti‐discriminationlaws.Inthisway,the

Departmentrecognizesthatstaffingarrangementscanbeacceptable


95

accommodationsincertaincircumstances.TheDepartmenthasaddressedthis

throughtheadditionofanewsubparagraph(4)inthedefinitionof“discriminateor

discrimination”thatrecognizestheeffectiveandtimelyaccommodationofan

employee(whichmayincludenon‐retaliatorystaffrotations)asnotconstituting

discrimination.Additionally,toaddressconcernsraisedbythesecommenters,the

Departmentisaddingnewsubparagraphs(5)and(6)toclarifythat,withinlimits,

employersmayrequireaprotectedemployeetoinformthemofobjectionsto

referringfor,participating,orassistingintheperformanceofspecificprocedures,

programs,research,counseling,ortreatmentstotheextentthereisareasonable

likelihood65thattheprotectedentityorinvidivdualmaybeaskedingoodfaithto

referfor,participatein,orassistintheperformanceofsuchconduct,andthatthe

employermayusealternatestafformethodstoprovideorfurtheranyobjected‐to

conduct,subjecttocertainlimitationsdesignedtoprotecttheobjectingperson.

Ontheotherhand,asageneralmatter,itisnotanacceptablepracticeunder

Federalconscienceandanti‐discriminationlawsforcoveredentitiestodeem

personswithreligiousormoralobjectionstocoveredpractices,suchasabortion,to

bedisqualifiedforcertainjobpositionsonthatbasis.Forexample,ahospital

receivingPublicHealthServiceActfundscouldnotdeemadoctororanursewitha

religiousobjectiontoperformingabortionstobeineligibletopracticeobstetricsand

gynecologyonthatbasis.AnimportantpurposeoflawssuchastheChurch

65Forexample,nursesassignedexclusivelytonursinghomesforelderlypatientswouldnotbeexpectedtoreferorassistintheperformanceofanysterilizationproceduresorabortions,and,thus,itwouldbeinappropriateforanentitysubjecttotheprohibitionsinthisruletorequiresuchnursestodisclosewhetherornottheyhaveanyobjectionstoreferringorassistinginsuchprocedures.


96

Amendmentsistopreventfieldssuchasobstetricsandgynecologyfrombeing

purgedofpro‐lifepersonneljustbecauseabortionislegalandsomehealthcare

entitiesperformthem.Inthissense,theDepartmentdisagreeswithcommenters

whoessentiallycontendthatpro‐lifemedicalpersonnelcanbeplacedoutsideof

women’shealthpositionsforthatreason.TheDepartmentneednotaddressinthis

rulewhetheracoveredentitycoulddisqualifyapersonwithreligiousormoral

objectionstocoveredpracticesifsuchcoveredpracticesmadeuptheprimaryor

substantialmajorityofthedutiesoftheposition,astheDepartmentisnotawareof

anyinstancesinwhichindividualswithreligiousormoralobjectionstosuch

practiceshavesoughtoutsuchjobs.

Overall,undernewsubparagraph(6)ofthedefinition,takingstepstouse

alternatestafformethodstoprovidefororfurthertheobjected‐toconductwould

notrunafoulofthedefinitionofdiscrimination,orconstituteaprohibitedreferral,if

theemployerorprogramdoesnotrequireanyadditionalactionbytheobjecting

individualorhealthcareentityandifsuchmethodsdonotexcludeindividualsfrom

areasorfieldsofpracticeonthebasisoftheirprotectedobjections.Theemployer

mayalsoinformthepublicoftheavailabilityofalternatestafformethodstoprovide

orfurthertheobjected‐toconduct,ifdoingsodoesnotconstituteretaliationor

otheradverseactionagainsttheobjectingindividualorhealthcareentity.For

example,anemployermaypostsuchanoticeandaphonenumberinareception

areaoratapointofsale,butmaynotliststaffwithconscientiousobjectionsby

nameifsuchsinglingoutconstitutesretaliation.


97

Thedefinitionalsoclarifiesthatemployerscannotuseinformationgained

fromthisprocesstodiscriminateagainstanyprotectedentityoremployee,andany

attemptsto,forexample,askquestionsofprospectiveemployeesorgrant

applicantsconcerningpotentialobjectionsbeforehiringoragrantawardwill

requireapersuasivejustificationbecauseoftheriskofunlawfulbutdifficult‐to‐

detect“screening”ofapplicants.

TheDepartmentbelievesthesemodificationstothescopeofprohibited

discriminationunderthisfinalrulestriketherightbalancebyrespectingthe

interestsofemployersandentitiesthatwishtoprovideservicesallowedbytheir

consciences;respectingtheinterests,privacy,andconscienceofpatientsand

customers;andrespectingtheconscienceofemployeesandhealthcareentities

protectedbythelawspassedbyCongressthatarethesubjectofthisrule.


definitionof“discriminateordiscrimination”wouldturnanyadverseactiontaken

againstaprotectedpartyforanyreasonintoperseunlawfuldiscrimination.

Response:TheDepartmentdisagrees.Thedefinitionof“discriminateor

discrimination”doesnottriggerviolationsbasedonanyadverseactionwhatsoever,

butmustbereadinthecontextofeachunderlyingstatuteatissue,anyotherrelated

provisionsoftherule,andthefactsandcircumstances.Inthisrule,theprohibition

ondiscriminationisalwaysconditionedon,andappliedinthecontextof,violatinga

specificrightorprotection,andeachprotectedrightistypicallyassociatedwitha

particularFederalfundingstreamorstreams.Forexample,in§88.3(c)(2),


98

“discrimination”isunlawfulwhendone“onthebasisthatthehealthcareentity”—

theprotectedentityintheprovision—“doesnotprovide,payfor,providecoverage

of,orreferfor,abortion.”Thus,anadverseactiontakenforreasonswholly

unrelatedtoabortionorthehealthcareentity’sactionsorbeliefsobjectingto

abortionwouldnotconstituteaviolationunderthisprovision.Inaddition,asnoted

above,whetheranactionisregardedasadverseissubjecttoastandardof

reasonableness.

Comment:TheDepartmentreceivedcommentssuggestingthatthedefinition

of“discriminateordiscrimination”shouldnotincludeelementsofdisparateimpact.

Becausecircuitcourtsofappealshandledisparateimpactanalysisdifferently,its

inclusionherewillleadtoconfusionanddifferingoutcomesdependingonthe

circuitinwhichtheconductoccurred,andincludingelementsofdisparateimpact

wouldcreateincentivestomanipulatedatainordertobringillegitimatecomplaints.

Response:TheDepartmentagreesinpartanddisagreesinpart.Because

thereisuncertaintyaboutwhichlaws,orpartsoflaws,implementedbythisrule

mayormaynotsupportadisparateimpactclaim,theDepartmentischoosingto

finalizetherulewithoutexplicitlyincludingtermstraditionallyassociatedwith

disparateimpacttheories.Itisspecificallyreplacingthephrase“adverseeffects”

with“adversetreatment”andisdeleting“otherwise,”“tendsto,”and“defeatsor

substantiallyimpairsaccomplishmentofahealthprogramoractivity”aselements

ofthedefinitionof“discrimination.”However,becausethedefinitionof

“discrimination”asadoptedinthisfinalruleisnon‐exclusive,asdiscussedabove,


99

OCRisnotprejudginganycomplaintsofviolationsofpart88thatarebasedona

claimofdisparateimpact,andwillconsiderthecircumstancesofeachcomplaint

andapplyeachstatuteaccordingtoitstextandanyapplicablecourtprecedents.


definitionof“discriminateordiscrimination”iseitherunconstitutionalorviolates

precedentialdefinitionsofwhatconstitutesdiscrimination.

Response:TheDepartmentdisagreesthatthedefinitionof“discriminateor

discrimination”finalizedinthisrulegenerallyviolateslegalstandards,

constitutionalorotherwise,astowhatconstitutesdiscrimination.Thereisno

universaldefinitionofdiscriminationthatgovernsallFederalstatutes.

Discriminationcantakedifferentformsdependingontheparticularcontextand

languageofeachstatuteprohibitingit.TheDepartmentneverthelesshasdrawn

substantiallyfromdefinitionsandinterpretationsof“discrimination”foundinother

anti‐discriminationstatutesandcaselaw,andhasmadevariouschangesin

responsetopubliccomments.TheDepartmentbelievesthatthedefinitionfinalized

herereasonablydescribesformsandmethodsofdiscriminationthatarelikelytobe

encounteredinthecontextoftheFederalconscienceandanti‐discriminationlawsat

issueinthisrule,andthatareencompassedbytheprotectionssetforthinthose

statutesandthisrule.


rule66andabove,andconsideringthecommentsreceived,theDepartmentfinalizes

6683FR3880,3892‐93(statingthereasonsfortheproposeddefinitionof“discriminateordiscrimination,”exceptforthemodificationsadoptedherein).


100

thedefinitionof“discriminateordiscrimination”(withadditionalminorchangesfor

accuracyandclarity);changing“means”to“includes;”limitingthedefinition“tothe

extent”permittedbythestatute;changing“exclude”to“excludefrom;”deleting

“otherwise”fromsubparagraphs(1)and(2);adding“orimposeanypenalty”tothe

endofsubparagraph(2);insubparagraph(3),deleting“defeatingorsubstantially

impairingaccomplishmentofahealthprogramoractivity,”changing“tendsto

subject”to“subjects,”andadding“ongroundsprohibitedunderanapplicable

statuteencompassedbythispart;”deletingtheproposedsubparagraph(4)and

addingnewsubparagraph(4)asdescribedaboveregardingentitiesthat“shallnot

beregardedashavingengagedindiscrimination;”addingsubparagraph(5)as

describedaboveallowinganentitysubjecttoanyprohibitioninthispartto“require

aprotectedentitytoinformthemofobjections;”andaddingsubparagraph(6)as

describedaboveaddressingwhatactionsbytheentitysubjecttothispart“would

not,byitself,constitutediscrimination.”

Entity.TheDepartmentproposedthat“Entitymeansa‘person’asdefinedin

1U.S.C.1;oraState,politicalsubdivisionofanyState,instrumentalityofanyState

orpoliticalsubdivisionthereof,oranypublicagency,publicinstitution,public

organization,orotherpublicentityinanyStateorpoliticalsubdivisionofanyState.”

TheDepartmentreceivedcommentsonthisdefinition.

Comment:TheDepartmentreceivedcommentsrequestingthatthedefinition

of“entity”includenon‐profitreligiouscorporationsaswell.

Response:Non‐profitreligiouscorporationsarealreadyencompassedbythe


101

definitionof“person”in1U.S.C.1.SeeBurwellv.HobbyLobbyStores,Inc.,134S.Ct.

2751,2768(2014).

Comment:TheDepartmentreceivedacommentnotingthatthedefinitionof

“entity”doesnotmentionforeigngovernments,theUnitedNations,andrelated

bodies.Thecommentproposedexplicitlyexcludingforeigngovernmentsandthe

UnitedNationsfromthedefinitionof“entity”becauseofsovereigntyconcerns.

Response:TheDepartmentagreesthattheterm“entity”shouldaddress

foreigngovernments,foreignnongovernmentalorganizations,intergovernmental

organizations(suchastheUnitedNations),andrelatedbodies,buttheDepartment

disagreesthattheyshouldbeexplicitlyexcluded.SomeoftheFederalconscience

statutestobeenforcedbytheDepartmentmayimplicateforeignentities,67but

Congressdidnotexemptcertainkindsofforeignentitiesthatwouldotherwisebe

covered.Accordingly,thedefinitionof“entity”ismodifiedtoclarifythat“entity”

mayincludeaforeigngovernment,foreignnongovernmentalorganization,or

intergovernmentalorganization(includingtheUnitedNationsanditsaffiliated

agencies).Thefederalstatutesatissueapplytheirprotectionstothefundsatissue,

regardlessofwhetherthosefundsareawardedtodomesticorforeignentities.If

foreignentitieswishnottobeboundbytheseconscienceprotections,theymay

choosenottoaccepttherelevantfunds.

67SuchasfundsadministeredbytheSecretaryofHealthandHumanServicesundersection104AoftheForeignAssistanceActof1961(22U.S.C.2151b‐2);underChapter83ofTitle22oftheU.S.Code;orundertheTomLantosandHenryJ.HydeUnitedStatesGlobalLeadershipAgainstHIV/AIDS,Tuberculosis,andMalariaReauthorizationActof2008.


102

Comment:TheDepartmentreceivedacommentstatingthatthedefinitionof

“entity”wouldpermitanyemployertodenyitsemployeescoverageforabortionor

otherobjected‐toservices,evenifotherwiserequiredbylaw.Othercomments

expressedconcernthatdefining“entity”toincludestateorlocalgovernments

expandscoveredentitiesbeyondthehealthcareindustry.

Response:TheDepartmentdisagrees.Thedefinitionsectionmustbereadin

conjunctionwithothersectionsoftherulewhendeterminingwhetherany

particularentitymustcomplywithanyparticularprovisionoftherule.Forexample,

thefactthatprivateemployersareatypeoforganizationthatfallsunderthe

definitionof“entity”doesnotmakeeveryprivateemployerinAmerica

automaticallysubjecttotheFederalprotectionstatutesforwhichthisruleprovides

enforcementmechanisms.Similarly,thefactthatnaturalpersonsfallunderthe

definitionofentitydoesnotmeanthateverypersoninAmericaisautomatically

grantedprotectionundertherule.Rather,obligationsandprotectionsapplyonlyto

thoseentitiesthataresubjecttoarelevantprovisionofastatuteundertherule.

EachprovisioninthisfinalrulethataddressesaFederalconsciencestatutehasa

subparagraphtitled“Applicability”(see§88.3),whichspecifieswhetheranentityis

subjecttoanygivenprovisionofaFederalstatuteatissue.Forsomestatutesor

someportionsofstatutes,theApplicabilitysubparagraphbyitsowntermsmayonly

implicatecertaintypesofentitiesoronlyentitiesreceivingcertaintypesoffunding.


103



thedefinitionof“entity”byincluding“or,asapplicable,aforeigngovernment,

foreignnongovernmentalorganization,orintergovernmentalorganization(suchas

theUnitedNationsoritsaffiliatedagencies).”TheDepartmentalsoaddstheterm

“theDepartment”tothedefinitionof“entity,”forclarity.

Asdescribedfurtherbelow,toensureuniformity,theDepartmentalso

modifiesthedefinitionsof“recipient”and“sub‐recipient”toinclude,asapplicable,a

foreigngovernment,foreignnongovernmentalorganization,orintergovernmental

organization(suchastheUnitedNationsoritsaffiliatedagencies).

Federalfinancialassistance.TheDepartmentproposedthatFederal

financialassistancealignwiththedefinitionofthistermintheDepartment’s

regulationsimplementingTitleVIoftheCivilRightsActof1964at45CFR80.13,

whichincludestheprovisionofassistanceofFederalfundsandnon‐cashassistance,

suchasthedetailofFederalpersonnel.TheDepartmentreceivedcommentsonthis

term.

Comment:TheDepartmentreceivedacommentstatingthattheusesofthe

word“arrangement”andthe“provisionofassistance”weredifficulttointerpret,

andthatthedefinitionof“Federalfinancialassistance”shouldclarifywhetherit

“includesanyclaimforpayment,paymentsinexchangeforhealthcareservices,or

applicationstoparticipateinaFederalprogramthroughwhichpaymentwouldbe

6883FR3880,3893(statingthereasonsfortheproposeddefinitionof“entity,”exceptforthemodificationsadoptedherein).


104

made.”

Response:TheDepartmentdisagrees.Theproposeddefinitionof“Federal

financialassistance”mirrorsthedefinitionusedintheDepartment’sregulations

implementingTitleVIandisintendedtocarrythesamemeaningasithas

traditionallybeenunderstoodtocarryintheapplicationofthoseregulations.See45

CFR80.13(f).TheDepartmentbelievesthatentitiessubjecttothisregulationwillbe

sufficientlyfamiliarwiththatmeaningtounderstanditsapplicationinthisfinalrule.

Further,numerousfederalcourtshaverecognizedthatfederalfinancialassistance

encompassessubsidies,butnotfairmarketvaluecompensationpaidinreturnfor

services.See,e.g.,Jarnov.Lewis,256F.Supp.2d499,504(E.D.Va.2003);DeVargas

v.Mason&Hanger‐SilasMasonCo.,911F.2d1377,1382(10thCir.1990);Cookv.

BudgetRent‐a‐Car,502F.Supp.494(S.D.N.Y.1980);Shotzv.AmericanAirlines,420

F.3d1332(11thCir.2005);Venkatramanv.REISystems,417F.3d418(4thCir.

2005).Inlightofthecomments,theDepartmentfinalizesthisdefinitionwitha

minorclarifyingchangetoavoidacirculardefinition,byreplacing“funds,support,

oraid”with“subsidy”insubparagraph(5)ofthedefinition.



thedefinitionof“Federalfinancialassistance”asproposed,withamodificationin

subparagraph(5)toremovereferencestoa“Federal”agreementand“arrangement”

sothatthetextnowrefersto“anyagreementorothercontractbetweentheFederal

6983FR3880,3893(statingthereasonsfortheproposeddefinitionof“Federalfinancialassistance,”exceptforthemodificationsadoptedherein).


105

governmentandarecipient,”andtoclarifytheterminologybyreferringto

“provisionofasubsidytotherecipient”toavoidacirculardefinitionrelatedtothe

provisionof“assistance.”

Healthcareentity.TheDepartmentproposedthat“healthcareentity”

includesanindividualphysicianorotherhealthcareprofessional;healthcare

personnel;aparticipantinaprogramoftraininginthehealthprofessions;an

applicantfortrainingorstudyinthehealthprofessions;apost‐graduatephysician

trainingprogram;ahospital;alaboratory;anentityengaginginbiomedicalor

behavioralresearch;aprovider‐sponsoredorganization;ahealthmaintenance

organization;ahealthinsuranceplan(includinggrouporindividualplans);aplan

sponsor,issuer,orthird‐partyadministrator;oranyotherkindofhealthcare

organization,facility,orplan.TheDepartmentalsoproposedthatthetermmayalso

includecomponentsofStateorlocalgovernments.TheDepartmentproposeda

singledefinitionoftheterm”healthcareentity,”atermusedintheWeldon

Amendment,theCoats‐SnoweAmendment,andACAsection1553.TheDepartment

receivedcommentsonthisdefinition.

Comment:TheDepartmentreceivedacommentstatingthat“healthcare

entity”shouldincludesocialworkersandschoolsofsocialwork.

Response:TheDepartmentdeclinestomakeanexplicitinclusionofsocial

workersandschoolsofsocialworktothedefinitionofhealthcareentity.Itis

unclearinmanycircumstancesthatsuchentitiesdeliverhealthcare.The

Department’sintentioninthisdefinitionistoprovideanon‐exclusivelistofentities


106

Congresshasintendedtoincludeasahealthcareentity.Becausethelistisnon‐

exclusive,theremaybecircumstanceswhereasocialworkerisconsideredahealth

careentityunderaFederalconscienceoranti‐discriminationlaw,butthatwill

dependonthefactsandthecircumstancesineachcaseastheyarise.

Comment:TheDepartmentreceivedcommentsquestioninghowentitiesthat

arenotnaturalpersonscanholdmoralorreligiousbeliefs.

Response:Federallawroutinelyrecognizescorporations,organizations,or

othernon‐naturalpersonsasholdersoflegalrightsandsubjecttolegalobligations.

TheFederalGovernmenthaslongrecognizedtheFreeSpeechandFreeExercise

rightsofnon‐profitorganizationswithcharitablemissionsrelatedtothereligious

beliefsormoralconvictionsofitsmembers,andhasrecognizedtheFreeSpeech

rightsofpubliccorporations.CitizensUnitedv.FEC,558U.S.310,365(2010).The

definitionof“person”thatisprotectedundertheReligiousFreedomRestorationAct

includesbothnaturalandnon‐naturalpersons(corporations,partnerships,etc.).70

InHobbyLobby,havingfoundthatthetextoftheReligiousFreedomRestorationAct,

42U.S.C.2000bb‐2000bb‐4(“RFRA”),doesnotprecludeitsapplicationto

corporations,theSupremeCourtheldthatacloselyheldfor‐profitcorporationcan

assertthereligiousbeliefsofitsowners.Morespecifically,fromtheenactmentof

70See,e.g.,42U.S.C.2000bb‐1(“Governmentshallnotsubstantiallyburdenaperson'sexerciseofreligioneveniftheburdenresultsfromaruleofgeneralapplicability,exceptasprovidedinsubsection(b).”);1U.S.C.1(“IndeterminingthemeaningofanyActofCongress,unlessthecontextindicatesotherwise...thewords“person”and“whoever”includecorporations,companies,associations,firms,partnerships,societies,andjointstockcompanies,aswellasindividuals.”);Burwellv.HobbyLobbyStores,Inc.,134S.Ct.2751,2768(2014)(“WeseenothinginRFRAthatsuggestsacongressionalintenttodepartfromtheDictionaryActdefinition....”).


107

thefirstparagraphoftheChurchAmendmentsin1973,Federalconscienceandanti‐

discriminationlawshaverecognizedthatentitiessuchashospitalscanpossess

“religiousbeliefsormoralconvictions”whenprohibitingtheirfacilitiesfrombeing

usedforabortionsorsterilizations.Inaddition,theCoats‐SnoweandWeldon

Amendments,andACAsection1553,protectorganizationsorinstitutionsas“health

careentities”whentheyobjecttocertainactivitiesconcerningabortionorassisted

suicidewithoutregardtothemotivationfortheobjection.BoththeCoats‐Snowe

andWeldonAmendmentscontaindefinitionsof“healthcareentity”thatinclude,as

examples,bothnaturalpersonsandcorporatepersons.Thesameistrueofthe

definitionof“healthcareentity”inACAsection1553.

Finally,religiousfaithandmoralconvictionsareoftentheorganizing

principleforentitiescoveredinthisrule,andnaturalpersonsformthese

organizationsforthepurposeofassertingtheirfaithorconvictionsmoreforcefully

andeffectivelyinthepublicrealm.AstheSupremeCourthasrecognized,thereis

nothingaboutorganizinginagroupthatdiminishestherightstheywouldenjoyas

individuals.71Therefore,theDepartmentconsidersitappropriatetofinalizethe

definitionofhealthcareentitiestoincludenon‐naturalpersons.

71See,e.g.,HobbyLobby,134S.Ct.at2768(“Whenrights,whetherconstitutionalorstatutory,areextendedtocorporations,thepurposeistoprotecttherightsofthesepeople[whoconstitutethecorporation]…Andprotectingthefree‐exerciserightsofcorporationslikeHobbyLobby…protectsthereligiouslibertyofthehumanswhoownandcontrolthosecompanies.”);CitizensUnited,558U.S.at391–93(Roberts,C.J.,concurring)(“[T]heindividualperson'srighttospeakincludestherighttospeakinassociationwithotherindividualpersons...[TheFirstAmendment’s]textoffersnofootholdforexcludinganycategoryofspeaker,fromsingleindividualstopartnershipsofindividuals,tounincorporatedassociationsofindividuals,toincorporatedassociationsofindividuals.”).


108


definitionof“healthcareentity”exceedstheDepartment’sstatutoryauthority

undertheWeldonAmendmentandtheCoats‐SnoweAmendment.

Response:TheWeldonandCoats‐SnoweAmendmentsandACAsection1553

eachprovideadefinitionof“healthcareentity”thatcontainsanon‐exhaustivelistof

entitiesthatare“healthcareentities.”TheCoats‐SnoweAmendmentsaysthat

“healthcareentity”“includesanindividualphysician,apostgraduatephysician

trainingprogram,andaparticipantinaprogramoftraininginthehealth

professions.”TheWeldonAmendmentandACAsection1553statethattheterm

“includesanindividualphysicianorotherhealthcareprofessional,ahospital,a

provider‐sponsoredorganization,ahealthmaintenanceorganization,ahealth

insuranceplan,oranyotherkindofhealthcarefacility,organization,orplan.”All

threelawsusetheword“includes,”whichmeansthelistsofsuchentitiesinthe

definitionsarenon‐exhaustive,andotherentitiescouldalsobe“healthcareentities”

undertheplainmeaningofthetermasusedinthosestatutes.TheCoats‐Snowe

Amendmentalsousesacatch‐allphraseforentitiesin“anyotherprogramof

traininginthehealthprofessions.”TheWeldonAmendmentandACAsection1553

likewiseincludecatch‐allprovisionssuchas“otherhealthcareprofessional”and

“anyotherkindofhealthcarefacility,organization,orplan.”Thus,indefiningthe

termforpurposesofthisrule,itisconsistentwiththestatutorytexttolistcertain

entitiesthatarenotexplicitlymentionedinthestatutes,becausethestatutorylists

arenon‐exhaustive;includingthoseentitiesisconsistentwiththeplainmeaningof


109

thetermssetforthinthosestatutes.Asexplainedinthefollowingdiscussion,

however,theDepartmentisfinalizingthedefinitionofhealthcareentitytobetter

conformthedefinitiontothevaryingtextsofthespecificFederalconscienceand

anti‐discriminationlawsthatusetheterm.

Comment:TheDepartmentreceivedcommentsstatingthattheinclusionof“a

plansponsor”inthedefinitionof“healthcareentity”wouldsubjectallemployers

whosponsorgrouphealthplanstotheconsciencestatutesusingthatterm.Other

commenterscontendedthelawsusingthosetermsdidnotintendtoprotectplan

sponsorsthatarenototherwisehealthcareentities.Othercommenterssuggestthat

theterm“healthcareentity”shouldnotbethesamefortheCoats‐Snowe

Amendment,theWeldonAmendment,andACAsection1553.

TheDepartmentreceivedothercommentssupportingtheinclusionof“plan

sponsor”and“thirdpartyadministrator”inthedefinitionof“healthcareentity.”

Onecommentexpressedthatfaith‐basedorganizationsthatfundhealthplans

shouldnotberequiredtofundservicesorproceduresthatviolatetheirreligious

beliefs.

Response:Commenterscontendingthatincludingparticulartypesofentities

inthedefinitionof“healthcareentity”wouldrequiresuchentitiestocomplywith

theCoats‐SnoweAmendment,theWeldonAmendment,orACAsection1553are

incorrect.Theterm“healthcareentity”isusedinthosestatutes—andinthisfinal

rule—tospecifynotwhichentitymustcomplywiththestatute,butwhichkindsof

entitiesareprotectedfromdiscrimination.Thus,includinganentityintheterm


110

“healthcareentity”underthosestatutesdoesnotexpandoraffectwhich

governmentalornon‐governmentalfundrecipientsmustcomplywiththose

statutes.

TheDepartmentconcludesitisappropriatetoinclude“aplansponsor”inthe

definition“healthcareentity”forpurposesoftheWeldonAmendmentandACA

section1553.TheWeldonAmendmentexplicitlyprotectsentitiesthatdonotpay

fororprovidecoverageofabortions,andincludes“healthinsuranceplans,orany

otherkindofhealthcarefacility,organization,orplan”withinitsownillustrative

listofprotectedhealthcareentities.ACAsection1553appliestogovernment

entitiesreceivingFederalfinancialassistanceundertheACA,andanyhealthplan

createdundertheACA.Itusesthesamedefinitionof“healthcareentity”asthe

WeldonAmendment,inspecifyingthathealthcareentitiescannotbesubjectto

discriminationforchoosingnottoprovidecertainitemsorservicesrelatedto

assistedsuicide.Becausethefocusofbothlawsincludesprotectionofhealthplans,

itisconsistentwiththeirlanguageandscopetoinclude“aplansponsor”asa

protected“heathcareentity.”Intheactionofsponsoringahealthplanorhealth

coverage,theplansponsorengagesinanimportantfunctionwithrespecttohealth

care.Althoughthesponsor,theplan,andtheissuerarealldistinctentities,

sponsoringaplanandpayingforcoverage(byanissuer,inthecaseofafully

insuredplan)orforhealthcareservices(inthecaseofaself‐insuredplan)arepart

andparceloftheprovisionofhealthcoverageunderagrouphealthplan.The

WeldonAmendmentiswrittentoprohibitdiscriminationagainst,amongothers,


111

entitiesthatdonotprovideabortioninhealthcoverage;ACAsection1553is

similarlywrittentoprotectentitiesfrombeingrequiredtoprovidecertainhealth

careitemsorservicesinconnectionwithhealthplansandtheACA.Bothlawsdefine

healthcareentitytoincludethecatch‐allphrase“anyotherkindofhealthcare

facility,organization,orplan,”inordertoprotectabroadrangeofentitiesthat

mightbeengagedinprovidingcoverageorservicesandsubjecttodiscrimination

fornotprovidingorcoveringabortionorassistedsuicide,respectively.Therefore,

treatingaplansponsorasaprotectedhealthcareentityisconsistentwiththetextof

theWeldonAmendmentandACAsection1553.

Infurtherconsiderationofpubliccomments,however,theDepartmenthas

concludedthatthedefinitionof“healthcareentity”shouldbedifferentforthe

Coats‐SnoweAmendmentthanfortheWeldonAmendmentandACAsection1553,

includingwithrespecttowhethertoincludeaplansponsor.TheCoats‐Snowe

Amendment,whileprovidinganon‐exclusivelistofentitiesandindividuals

includedintheterm“healthcareentity,”containsadifferentlistofentitiesand

individualsthanthatsetforthintheWeldonAmendmentandACAsection1553.

Moreover,thenatureandscopeofprotectionssetforthintheCoats‐Snowe

Amendment—whichcanassistinunderstandingtheintendedrangeofprotected

healthcareentities—alsodiffer.TheCoats‐SnoweAmendmentfocusesgenerallyon

theperformanceof,trainingfor,andreferralforabortions,whereastheWeldon

Amendmentfocusesmorebroadlyonnotjustprovidingandreferringfor,butalso

providingcoverageof,andpaymentfor,abortions.SimilartotheWeldon


112

Amendment,andunliketheCoats‐SnoweAmendment,ACAsection1553focuseson

thecontextofhealthplansandcoverageinadditiontotheprovisionofitemsand

services.Consequently,theDepartmentconcludesthatitisappropriatetofinalizea

definitionofhealthcareentityfortheCoats‐SnoweAmendmentthatissomewhat

differentfromthedefinitionapplicabletotheWeldonAmendmentandACAsection

1553,andtonotincludeinthedefinitionforpurposesoftheCoats‐Snowe

Amendmententitiespertainingspecificallytothehealthinsuranceandcoverage

context,namely,aprovider‐sponsoredorganization,ahealthmaintenance

organization,ahealthinsuranceplan(includinggrouporindividualplans),aplan

sponsor,anissuer,orathird‐partyadministrator.Likewise,theDepartmentdeems

itappropriatenottolistinthedefinitionapplicabletotheCoats‐SnoweAmendment

thecatch‐allphrasethatisinthestatutorytextoftheWeldonAmendmentandACA

section1553:“orthird‐partyadministrator;oranyotherkindofhealthcare

organization,facility,orplan.”

Otherwise,theDepartmentdeemsitappropriatetoincludeinboth

definitionsofhealthcareentitytheproposedrule’snon‐exhaustiveenumerationof

variousindividualandorganizationalentitiesthatengageinhealthcarepracticesor

services:“anindividualphysicianorotherhealthcareprofessional;healthcare

personnel;aparticipantinaprogramoftraininginthehealthprofessions;an

applicantfortrainingorstudyinthehealthprofessions;apost‐graduatephysician

trainingprogram;ahospital;amedicallaboratory;[or]anentityengagingin


113

biomedicalorbehavioralresearch.”72BecausetheDepartmentintendedthese

entitiestobehealthcareentities,andtheterm“laboratory”couldbeinterpretedto

includelaboratoriesthatarenotrelatedtohealthcare,theDepartmentfinalizesthe

term“laboratory”inthesedefinitionstoaddtheword“medical”toclarifyitshealth

carescope.

Theseentitiesarehealthcareentitiesundertheordinarymeaningofthat

termbecausetheyareengagedinhealthcarepractices,training,orresearch.They

arealsosimilartothetypesofindividualsandentitieslistedinthenon‐exclusive

listsofhealthcareentitiesintheCoats‐SnoweAmendment,theWeldon

Amendment,andACAsection1553.Allthreestatuteslistindividualsandpersonnel

inthehealthprofessions,notjustcorporateentities.Thisdemonstratesthat

Congressexplicitlyintendedthetermhealthcareentityinallthreetoprotect

individuals,notjustorganizationalentities.Allthreedefinitionsalsolist

organizationalentities,andofcoursetheyallcontainthebasicterm“healthcare

entity,”whichmustbeinterpretedtoencompasstermsincludedinitsordinary

meaning.

Finally,theproposeddefinitionof“healthcareentity”concludesby

specifyingthatit“mayalsoincludecomponentsofStateorlocalgovernments.”To

clarifythemeaningofthissentence,theDepartmentfinalizesitwithachangein

eachdefinitionof“healthcareentity,”toread:“Asapplicable,componentsofState

72Thatisnottosaythatcertaintypesofhealthplanscouldnotalsobehealthcareproviders,e.g.,staffmodelhealthmaintanenceorganizations.


114

orlocalgovernmentsmaybehealthcareentitiesunder”theCoats‐Snowe

Amendment,theWeldonAmendment,andACAsection1553.

Comment:TheDepartmentreceivedacommentstatingthatpharmaciesand

pharmacistsaresometimesnotunderstoodtobehealthcareprovidersandasking

thatpharmacistsandpharmaciesbeincludedintheprovisionsofthisrule.

Response:TheDepartmentacceptsthisrecommendationandisincluding

pharmaciesandpharmacistsinthedefinitionsof“healthcareentity.”Apharmacyis

ahealthcareentity,consideringtheordinarymeaningofthatterm,becauseit

providespharmaceuticalsandinformation,whicharehealthcareitemsand

services.Regardingpharmacists,becauseCongressspecifiedthattheterm“health

careentity”intheCoats‐SnoweAmendment,theWeldonAmendment,andACA

section1553,includescertainindividualsinthehealthprofessions,anddoesnot

provideanexclusivedefinition,theDepartmentdeemsitappropriatetoinclude

pharmacists,whoarealsohealthcareprofessionals.Whetheraparticular

protectioninthosethreelawsappliestoapharmacistorpharmacyinaparticular

case,orwhetheritappliestoanyoftheexamplesinthesedefinitions,isaseparate

questionthatwillbedeterminedinthecontextofthefactualandlegalissues

applicabletothesituation.Forthepurposeofspecifyingwhetherapharmacistor

pharmacycouldpossiblybecoveredbythetermhealthcareentityinthesethree

laws,dependingonthecircumstances,theDepartmentdeemsitappropriateto

includetheminthelistofindividualsandentitiessetforthinthesedefinitions.


115

Comment:TheDepartmentreceivedcommentssuggestingthat“healthcare

entity”shouldincludepublicschooldistrictsthatprovideon‐campusmedicalcare

ormanagevaccinationrecords.

Response:Thedefinitionspecifiesthat“healthcareentity”alsoincludes

componentsofStateorlocalgovernments.TheDepartmentdoesnotbelievethe

definitionsneedtospecifyfurtherthatpublicschooldistrictsprovidingon‐campus

medicalcareareincluded.TheDepartmentwillevaluatetheapplicabilityoftherule

topublicschoolentitieswithhealthcarefunctionsaccordingtothefactsand

circumstancesofeachcaseastheyariseandtheapplicablelaws.

Comment:TheDepartmentreceivedacommentproposingthat“healthcare

entity”excludeoccupationaltherapists.

Response:Totheextentthatoccupationaltherapistsarehealthcare

personnelqualifyingas“otherhealthcareprofessionals,”theDepartmentdisagrees

thattheywouldbenecessarilyexcludedfromprotection.Whilesomequestions

concerningwhoqualifiesforprotectioninaparticularcircumstancearerelatively

straightforward,suchasphysiciansundercertainconscienceprotectionlaws,some

questionsarecloseranddependonthefactsandtheapplicablelaw.The

Department,therefore,declinestomakeexplicitexclusions,suchasforoccupational

therapists,tothedefinitionsofhealthcareprofessionals,andwillinsteadconsider

individualcasesbasedonthefactsandcircumstancespresentedineachcaseasthey

ariseandtheapplicablelaw.


116


“healthcarepersonnel”exceedsthedefinitionof“healthcareentity”underthe

WeldonAmendmentorotherlawsusingthatterm.

Response:TheDepartmentdisagrees.Thelistofindividuals,personsand

entitiesincludedasa“healthcareentity”intheWeldonAmendmentandACA

section1553includes“anindividualphysician,”andalsothecatch‐allphrases“or

otherhealthcareprofessional.”TheCoats‐SnoweAmendmentsaystheterm

includes“individualphysician”and“aparticipantinaprogramoftraininginthe

healthprofessions.”Becausetheterm“healthcareentity”includesindividuals,and

thedefinitionsarenon‐exclusive,theDepartmentdeemsitappropriatetoinclude

otherindividualswhoarehealthcarepersonnel.Including“healthcarepersonnel”

and/or“healthcareprofessional”inthedefinitionof“healthcareentity”is,

therefore,consistentwithCongress’sexplicitinclusionofindividualpersonsinthe

healthcarefield.DoingsoeffectuatestheremedialpurposesoftheCoats‐Snowe

Amendment,theWeldonAmendment,andACAsection1553,andisconsistentwith

theirtexts.

Comment:TheDepartmentreceivedcommentsrequestingthat“healthcare

professional”and“healthcarepersonnel”bedefinedterms.

Response:TheDepartmentdeclinestodefinetheseterms.TheDepartment

believesitisappropriatetodetermineremainingpotentialquestionsaboutthe

scopeandapplicationoftheterm“healthcareentity”basedonananalysisoffacts

andcircumstancespresentedineachcaseastheyarise.Regardinghealthcare


117

professionals,stateandlocallawmightalsoberelevantconcerningwhichpersons

areconsideredhealthcareprofessionals.Becausethoselawsdiffer,theDepartment

considersitappropriatenottospecifyasingledefinitionofhealthcareprofessional

orhealthcarepersonnelinthisrule.PartsoftheChurchAmendmentsusetheterms

“personnel”and“healthcarepersonnel,”butdonotdefinethoseterms.Although

thisrulealsodoesnotdefinethoseterms,theDepartmentbelievesthisrule

providessomeadditionalclaritytotheapplicationofFederalconscienceandanti‐

discriminationlaws.



thedefinitionof“healthcareentity”withchangestobifurcatethedefinitioninto

two:oneapplicableforpurposesoftheCoats‐SnoweAmendment,andtheother

applicableforpurposesoftheWeldonAmendmentandACAsection1553.Both

definitionsaddpharmaciesandpharmacists.Bothaddtheword“medical”before

theterm“laboratory”tomoreclearlydescribeitshealthcarescope,andbothnote

that“asapplicable,componentsofStateorlocalgovernmentsmaybehealthcare

entities.”ThedefinitionapplicabletotheCoats‐SnoweAmendmentomitstheterms

“aprovider‐sponsoredorganization;ahealthmaintenanceorganization;ahealth

insuranceplan(includinggrouporindividualplans);aplansponsor,issuer,or

third‐partyadministrator;oranyotherkindofhealthcareorganization,facility,or

plan.”

7383FR3880,3893(statingthereasonsfortheproposeddefinitionof“healthcareentity,”exceptforthemodificationsadoptedherein).


118

Healthprogramoractivity.TheDepartmentproposedthat“Health

programoractivity”includestheprovisionoradministrationofanyhealth‐related

services,healthserviceprogramsandresearchactivities,health‐relatedinsurance

coverage,healthstudies,oranyotherservicerelatedtohealthorwellness,whether

directlythroughpayments,grants,contracts,orotherinstruments,through

insurance,orotherwise.

Undertheproposedruletheterms“healthprogramoractivity”and“health

serviceprogram”differedmainlyinthattheformerincluded“theprovisionor

administrationofanyhealth‐relatedservices,”whilethelatterincludedany“planor

programthatprovideshealthbenefits.”Because“healthserviceprogram”couldbe

seenasnarrower,thephrasehealthprogramoractivityincorporated“health

serviceprogram”explicitlyaspartofitsdefinition.TheDepartmentaskedfor

comment“onwhetherthetermsmeanthesamethingandshouldorcouldbe

definedinterchangeablyforpurposesofthisregulation.”74

TheDepartmentdidnotreceivespecificcommentsonthisquestion,butthe

commentsreceivedregardingthetwodefinitionsgenerallytreatedthetwophrases

asidentical.UponfurtherconsiderationtheDepartmenthasconcludedthatthere

areinsufficientgroundsfordefiningsuchsimilartermsdifferentlyundertherule.

TheDepartmentisfinalizingtherulewithoutdefining“healthprogramor

activity”becauseotherrevisionshaveeliminatedtheuseofthephraseinthe

regulationtextasfinalized.However,forreasonsexplainedbelow,theDepartment

7483FR3880,3894.


119

adopts(withminoredits)thedefinitionproposedfor“healthprogramoractivity”as

thedefinitionfor“healthserviceprogram.”Allquestionsandresponsesto

commentsconcerning“healthprogramoractivity”applyfullyand“transfer”to

“healthserviceprogram.”


“healthprogramoractivity”shouldexplicitlyincludevaccinationprogramsorthe

processingofvaccinationrecords.

Response:Becauseofthebroadscopeofwhatcouldconstitutea“health

programoractivity”(now“healthserviceprogram”),theDepartmentdeclinesto

attemptacomprehensivelistingofexamplesofsuchprogramsoractivitiesand

insteadreliesonthegeneralstandardproposed.TheDepartmentbelieves

vaccinationprogramswouldreasonablybeconsideredahealthprogramoractivity

(orahealthserviceprogram)andnotesthatoneofthestatutesthatisthesubjectof

thisruleconcernsvaccinationexplicitly(42U.S.C.1396s(c)(2)(B)(ii)).


“healthprogramoractivity”(now“healthserviceprogram”),whencombinedwith

thedefinitionof“assistintheperformance”and“refer,”couldresultindisparate

impactagainstwomen,LGBTpersons,andreligiousminorities.

Response:TheDepartmentdisagrees.Thisruleimplementsunderlying

statutoryrequirementsandprohibitionssetforthbyCongress.Thetermsdefinedin

thisruledonotapplytowomen,LGBTpersons,orreligiousminoritiesinanyway

thatdiffersfromhowCongressappliedthetermsinthestatutesitadopted.Tothe


120

extentcommenterscontendthatsomeFederalconscienceandanti‐discrimination

lawsthemselvesadverselyimpactwomenbecausetheyconcernabortion,the

Departmentdisagrees,butisinanyeventrequiredtoimplementandenforce

Federalconscienceandanti‐discriminationlawsasCongresswrotethem.


theterm“healthprogramoractivity”(now“healthserviceprogram”),isoverly

broad;and,whencombinedwithsection104AoftheForeignAssistanceActof

1961,couldresultinotherwiseunauthorizeddiscriminationagainstminority

groupsorpersonsinsextraffickinginprogramsfundedundersection104A.

Response:TheDepartmentdisagrees.Therelevantlanguageofsection104A,

“anyprogramoractivity”(22U.S.C.7631(d)(1)(B)),isbroaderthan,andclearly

includes,any“healthserviceprogram.”AstheDepartmentonlyadministerssection

104Afunds(asrelevanttothisrule)withrespecttohealth,thedefinitionof“health

programoractivity”isnotintendedtolimit,andinnowaylimits,anyprotection

fromdiscriminationprovidedinsection104AoftheForeignAssistanceActof1961.

Additionally,nothingin22U.S.C.7631(d)(1)(B)exemptscertainprogramsor

activitiesfromitsconscienceprotections.


rule,75aboveandbelow,andconsideringthecommentsreceived,theDepartment

adoptsthedefinitionof“healthprogramoractivity”asproposedasthedefinitionof

“healthserviceprogram,”exceptmakesatechnicaleditforclaritybyreplacing

7583FR3880,3893‐94(statingthereasonsfortheproposeddefinitionof“healthprogramoractivity,”exceptforthemodificationsadoptedherein).


121

commaswithsemicolonsafter“directly,”thephrase“throughpayments,grants,

contracts,orotherinstruments,”andafter“throughinsurance.”Additionally,it

deletesthereferenceto“healthserviceprogram”fromtheproposeddefinitionas

circular.

Healthserviceprogram.TheDepartmentproposedthat“Healthservice

programincludesanyplanorprogramthatprovideshealthbenefits,whether

directly,throughinsurance,orotherwise,andisfunded,inwholeorpart,bythe

Department.ItmayalsoincludecomponentsofStateorlocalprograms.”The

Departmentreceivedcommentsonthisdefinition.


“healthserviceprogram”expandsthescopeoftheFederalconscienceandanti‐

discriminationlaws“toincludevirtuallyanymedicaltreatmentorservice,

biomedicalandbehavioralresearch,andhealthinsurance.”

Response:TheDepartmentdisagrees.Amongthestatutesthatarethesubject

ofthisrule,thephrase“healthserviceprogram”appearsonlyonce,inparagraph(d)

oftheChurchAmendments.Thatparagraphaddressestherightofpersonsto

declineto“performorassistintheperformance”of“anypart”ofahealthservice

programorresearchactivityfundedinwholeorinpartunderaprogram

administeredbytheSecretaryofHHSifsuchperformanceorassistancewouldbe

contrarytotheperson’sreligiousbeliefsormoralconvictions.Manycommenters’

objectionstothisdefinitionarefundamentallyobjectionstothetextofparagraph

(d)oftheChurchAmendmentsaspassedbyCongress.TheDepartmentbelievesthat


122

othercommentersmaymisunderstandthescopeofparagraph(d).Generally,the

protectionsofparagraph(d)followthefundsprovidedbyanyprogram

administeredbytheSecretary.Butparagraph(d)doesnotencompassevery

medicaltreatmentorserviceperformedbyanyentityreceivingfederalfundsfrom

HHSforwhateverpurpose.Instead,Congressnarrowlyfocusedparagraph(d)to

prohibitthecoercionofpersons“inperformanceof”healthserviceprograms

fundedunderaprogramadministeredbytheSecretary.Manymedicaltreatments

andservicesperformedbyhealthcareprovidersarenot“partof”ahealthservice

programreceivingfundingfromHHS.Insuchcircumstances,paragraph(d)would

notapply.

Thisdistinctioncanbeillustratedbyconsideringtheparalleltermusedin

paragraph(d),“researchactivity.”Forexample,ifanentityreceivesagrantfroma

programadministeredbyHHStoconductresearchonanewcancertreatment,

paragraph(d)oftheChurchAmendmentswouldprotectindividualsinvolvedinthe

performanceofanypartofthatresearchactivity.Butiftheentityengagesinother

researchactivitiesthatarenotfundedbyHHS(i.e.,notrelatedtothecancer

treatmentforwhichtheresearchgrantwasissuedinthisexample),paragraph(d)

wouldnotapplytothoseotheractivities.Thiswouldholdtrueevenifother

statutoryprovisionsthatarethesubjectofthisrulewouldapplytothoseother

researchactivities.

Similarly,Medicaidisfundedinwholeorinpartunderaprogram

administeredbytheDepartment.Nevertheless,ifahealthcareproviderreceives


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Medicaidreimbursementsforsomemedicaltreatments,butisprovidingother

medicaltreatmentsthatarenotbeingreimbursedbyMedicaidorotherwisefunded

bytheDepartment,theprovider—withrespecttothenon‐Medicaidtreatment—is

notperforming“partofahealthserviceprogram”fundedbyaprogram

administeredbyHHS.BecauseMedicaidgenerallyprovidesreimbursementsfor

particulartreatments,notforamedicalpracticeoverall,providingatreatmentnot

reimbursedbyMedicaidwouldgenerallynotbe“partofahealthserviceprogram...

fundedinwholeorinpartunder”Medicaidforthepurposesofparagraph(d)ofthe

ChurchAmendments,eveniftheoverallmedicalpracticealsoreceivesMedicaid

reimbursementsforothertreatments.

TheDepartmentintendstoenforceparagraph(d)oftheChurch

Amendmentsconsistentwiththetextofthestatute.Itwouldbeinappropriatefor

theDepartmenttodefine“healthserviceprogram”toexcludeprogramsthatinvolve

healthservicesandthatarefunded(inwholeorinpart)underaprogram

administeredbyHHS,whenCongressspecifiedthatparagraph(d)oftheChurch

Amendmentscoverssuchprograms.TheDepartmentbelievesthatthespecific

limitationsinparagraph(d)concerningthecircumstancesinwhichitapplieshas

already(underthestatute)preventedtherealizationofmanyoverbreadthconcerns

raisedbycommenters,andwillcontinuetodosounderthisrule,notwithstanding

theplainlybroadmeaningoftheterm“healthserviceprogram”itself.


“healthserviceprogram”shouldonlyapplyinthecontextofbiomedicalresearch.


124

Response:TheDepartmentdisagrees.Congressusedthedisjunctivephrase

“healthserviceprogramorresearchactivity”inparagraph(d)oftheChurch

Amendments.Nothinginthephraseoritscontext(thesurroundingtext)indicates

thattheprotectionprovidedbyCongressislimitedonlytobiomedicalresearch.If

“healthserviceprogram”meantonlyresearchactivities,thenCongress’sadditionof

“orresearchactivity”wouldbesuperfluous.Further,inaseparateprovisionofthe

ChurchAmendmentsenactedatthesametimeasparagraph(d),subparagraph

(c)(2),Congressprovidedspecificprohibitionsforentitiesthatreceivegrantsor

contracts“forbiomedicalorbehavioralresearch”alone,withoutincludinghealth

serviceprograms.ThisdemonstratesthatCongress’sinclusionoromissionof

“healthserviceprogram”wasaconsidereddecisionintendedtohavesubstantive

effect.

SummaryofRegulatoryChanges:TheDepartmentaskedforcommenton

whether“healthprogramoractivity”and“healthserviceprogram”shouldorcould

bedefinedinterchangeablyforpurposesofthisregulation76butreceivednospecific

commentsonthequestion.UponfurtherconsiderationtheDepartmenthas

concludedthatthereareinsufficientgroundsfordefiningsuchsimilarterms

differentlyundertherule.

TheDepartment’sdefinitionfor“healthserviceprogram”intheproposed

rulemirroredthedefinitionoftheterminthe2008Rule.77The2008Rule,inturn,

incorporatedthephrase“healthbenefits”intothedefinitionof“healthservice

7683FR3880,3894.77Id.


125

program”byborrowingfromSection1128B(f)(1)oftheSocialSecurityAct’s(42

U.S.C.1320a–7b(f)(1))definitionof“federalhealthcareprogram”—therationale

beingthat“federalhealthcareprogram”wassimilarenoughto“healthservice

program,”towarranttheborrowing.Withrespecttotheinclusionof“health

benefits,”inthedefinitionof“healthserviceprogram,”thiswasappropriatebecause

thefederalhealthserviceprogramsimplementedundertheSocialSecurityActare

programsadministeredbytheSecretary—and,thus,consistentwiththelanguageof

theChurchAmendment.However,theSocialSecurityActisnot(andwasnot)the

exclusivebasisfordefiningthescopeof“healthserviceprogram.”TheDepartment

believesthatitisalsoappropriatetoconsiderthePublicHealthServiceAct(PHSA)

asasourcefordefiningtheterm“healthserviceprogram”because,1)theChurch

AmendmentsthemselvescitethePHSAtohelpestablishwhatprogramsarecovered

and2)thePHSAusesthephrase“healthserviceprogram”and“healthservices”

numeroustimes.Forexample,thePHSAprovidesgrantauthoritytoassistStates

andotherpublicentities“inmeetingthecostsofestablishingandmaintaining

preventivehealthserviceprograms”(42U.S.C.247b),andgrantstheSecretary

permissiontoenterintocontractsto“furnishhealthservicestoeligibleIndians”(42

U.S.C.238m).

Theterms“healthservices”and“healthserviceprogram,”asusedbythe

PHSA,clearlyincludetheprovisionofhealthcareorhealthbenefits,buttheyalso

includehealth‐relatedservices.Forexample,thePHSAusesthephrase

“environmentalhealthservices”todescribeprogramsthatdealwiththedetection


126

andalleviationof“unhealthfulconditions”associatedwithwatersupply,chemical

andpesticideexposures,airqualityorexposuretolead.42U.S.C.254b(b)(2)(C).

Thesearehealth‐relatedprograms.Moreover,thePHSAusesthephrase“health

serviceprograms”explicitlyandincludes“preventive”programswithinitsambit

including—forexample,programsfor“thecontrolofrodents”and“forcommunity

andschool‐basedfluoridationprograms.”42U.S.C.300w–3(a)(1)(B).Theseare

health‐relatedprograms.

Inlightoftheabove,andforthesakeofconsistencyandtoavoidconfusion,

theDepartmentfinalizestheterm“healthserviceprogram”asequivalentto“health

programoractivity”(withminorchanges).TheDepartmentisnolongerincludinga

definitionof“healthprogramoractivity”butinlightofpubliccomments,is

finalizingadefinitionof“healthserviceprogram”withchangesthatincorporate

someoftheelementsofbothterms,basedonconcernsraisedaboutbothdefinitions

inthepubliccomments.Thefinalizeddefinitionstatesthat“healthserviceprogram

includestheprovisionoradministrationofanyhealthorhealth‐relatedservicesor

researchactivities,healthbenefits,healthorhealth‐relatedinsurancecoverage,

healthstudies,oranyotherservicerelatedtohealthorwellness,whetherdirectly;

throughpayments,grants,contracts,orotherinstruments;throughinsurance;or

otherwise.”

Individual.TheDepartmentproposedthat“Individualmeansamemberof

theworkforceofanentityorhealthcareentity.”TheDepartmentreceived

commentsonthisdefinition.


127


“individual”shouldinclude“personsexercisingtheirrightofinformedconsentto

declineahealthcareserviceonthebasisofreligionorconscience.”

Response:Uponconsideringthiscommentandreviewingtheuseoftheword

“individual”throughouttheproposedrule,theDepartmentagreesthatthetermhas

multiplemeaningsdependingonthecontextofitsuseintheruleandinapplicable

statutes.Sometimesitreferstomembersoftheworkforceofanentityorhealthcare

entity,andothertimesitreferstopersonswhoarenothealthcareprovidersand

yetareprotectedbytheFederalconscienceandanti‐discriminationlawsatissuein

thisrule,suchasanindividualwhomakesuseofareligiousnonmedicalhealthcare

institutionoranindividualwho“isconscientiouslyopposedtoacceptanceofthe

benefitsofanyprivateorpublicinsurance.”Because“individual”hasmultiple

meaningsthroughouttherule,andthemeaningof“individual”isclearineach

instancefromitscontext,theinclusionofadefinitionfor“individual”introduces

unnecessaryconfusion.Consequently,theDepartmentisdecidingnottofinalizethe

proposeddefinition,oranydefinition,oftheword“individual”inthefinalrule.As

“individual”isnolongeradefinedterm,additionalcommentsonthedefinitionof

theword“individual”areeitheraddressedbythatchange,ornotnecessaryto

addressfurther.

SummaryofRegulatoryChanges:Forthereasonsdescribedabove,and

consideringthecommentsreceived,theDepartmentdoesnotfinalizetheproposed

definitionof“individual”andremovestheword“individual”anditsdefinitionfrom


128

thelistofdefinedterms.

Instrument.TheDepartmentproposedthat“Instrumentisthemeansby

whichFederalfundsareconveyedtoarecipient,andincludesgrants,cooperative

agreements,contracts,grantsunderacontract,memorandaofunderstanding,loans,

loanguarantees,stipends,andanyotherfundingoremploymentinstrumentor

contract.”TheDepartmentdidnotreceivecommentsonthisdefinition.


rule78andabove,theDepartmentadoptsthedefinitionof“instrument”asproposed.

OCR.TheDepartmentproposedthatOCRmeanstheOfficeforCivilRightsof

theDepartmentofHealthandHumanServices.TheDepartmentdidnotreceive

commentsonthisdefinition.


rule79andabove,theDepartmentadoptsthedefinitionof“OCR”asproposed.

Recipient.TheDepartmentproposedthat“RecipientmeansanyState,

politicalsubdivisionofanyState,instrumentalityofanyStateorpolitical

subdivisionthereof,andanypersonoranypublicorprivateagency,institution,

organization,orotherentityinanyStateincludinganysuccessor,assign,or

transfereethereof,towhomFederalfinancialassistanceisextendeddirectlyfrom

theDepartmentoracomponentoftheDepartment,orwhootherwisereceives

FederalfundsdirectlyfromtheDepartmentoracomponentoftheDepartment,but

suchtermdoesnotincludeanyultimatebeneficiary.Thetermmayincludeforeign

7883FR3880,3894.7983FR3880,3894.


129

orinternationalorganizations(suchasagenciesoftheUnitedNations).”The

Departmentreceivedcommentsonthisdefinition.

Comment:TheDepartmentreceivedacommentstatingthatwhilethe

proposeddefinitionof“recipient”recognizesthatanindividualororganization

mustcomplywiththeproviderconscienceregulationsiftheindividualor

organizationreceivesfunds“directlyfromtheDepartmentorcomponentofthe

Department’tocarryoutaprojectorprogram,”theproposedruledoesnotexplain

how“compliancewiththeregulationswouldnotberequiredforproductsor

servicesofferedbytheindividualororganizationthatareunrelatedtotheFederal

funding.”

Response:Fittingwithinthedefinitionofa“recipient”alonedoesnot

necessarilysubjectanentitytoalloftherequirementsofthestatutesimplemented

throughthisrule.Ineachparagraphof§88.3ofthisrule,thereisan“Applicability”

subparagraphanda“Requirementsandprohibitions”subparagraphthatdescribe,in

moreparticularityforeachFederalconscienceandanti‐discriminationlawbeing

implementedbytheparagraph,thescopeofthestatuteand,thus,thisregulation.

Asdiscussedconcerningthedefinitionoftheterm“entity,”theDepartmentis

finalizingtheterms“entity,”“recipient,”and“sub‐recipient”withparallellanguage

toclarifythattheyallmayencompass“aforeigngovernment,foreign

nongovernmentalorganization,orintergovernmentalorganization(suchasthe

UnitedNationsoritsaffiliatedagencies).”



130


thedefinitionof“recipient”withachangetothelastsentence,sothatratherthan

referringonlyto“foreignorinternationalorganizations,”itreads“Thetermmay

includeaforeigngovernment,foreignnongovernmentalorganization,or

intergovernmentalorganization(suchastheUnitedNationsoritsaffiliated

agencies).”

Referralorreferfor.TheDepartmentproposedthat“Referralorreferfor”

bedefinedasincludingtheprovisionofanyinformation(includingbutnotlimited

toname,address,phonenumber,email,website,instructions,ordescription)byany

method(includingbutnotlimitedtonotices,books,disclaimersorpamphletsonline

orinprint),pertainingtoahealthcareservice,activity,orprocedure,including

relatedtoavailability,location,training,informationresources,privateorpublic

fundingorfinancing,ordirectionsthatcouldprovideanyassistanceinaperson

obtaining,assisting,trainingin,funding,financing,orperformingaparticularhealth

careservice,activity,orprocedure,whentheentityorhealthcareentitymakingthe

referralsincerelyunderstandsthatparticularhealthcareservice,activity,or

proceduretobeapurposeorpossibleoutcomeofthereferral.TheDepartment

receivedcommentsonthisdefinition,includinggeneralcommentsinsupportofand

oppositiontotheproposeddefinition.


definitionof“referralorreferfor”shouldbemaintainedasitappropriatelyallows

8083FR3880,3894(statingthereasonsfortheproposeddefinitionof“recipient,”exceptforthemodificationsadoptedherein).


131

healthcareprofessionalstoabidebytheirownprofessionalandethicaljudgments.

Response:TheDepartmentagreesthatthedefinitionof“referralorreferfor”

isappropriate,exceptfortheadditionofrelativelyminornarrowingandclarifying

changesasdiscussedbelow.


definitionof“referralorreferfor”exceedsthescopeoftheWeldonAmendmentor

theCoats‐SnoweAmendment.

Response:TheDepartmentdisagrees.NeithertheWeldonnorCoats‐Snowe

Amendmentdefines“referral”or“referfor.”Thedefinitionisareasonable

interpretationofthesetermsandfaithfullyeffectuatesthetextandstructureof

Congress’sprotectionofhealthcareprofessionalsandentitiesfrombeingcoerced

orcompelledtofacilitateconduct(withrespecttoWeldonandCoats‐Snowe,

concerningabortion)thatmayviolatetheirlegallyprotectedrightsthroughthe

forcedprovisionofreferrals.Forexample,intheWeldonAmendmentandsection

1303oftheACA,Congressdidnotmerelyprotecttheactionofdecliningtoreferto

anabortionprovider,butofdecliningtorefer‘‘for’’abortionsgenerally.Thismore

broadlyprotectsadecisionnottoprovidecontactinformationorguidancelikelyto

assistapatientinobtaininganabortionelsewhere.

Therule’sdefinitionof“referral”or“referfor”alsocomportswithdictionary

definitionsoftheword“refer,”suchastheMerriam‐Webster’sdefinitionof“tosend

ordirectfortreatment,aid,information,ordecision.”Refer,Merriam‐Webster.com,

availableathttps://www.merriam‐webster.com/dictionary/refer(lastaccessed


132

April9,2019)(emphasisadded);seealsoRefer,Dictionary.com,availableat

https://www.dictionary.com/browse/refer(lastaccessedApril9,2019)(defining

referas“todirectforinformationoranythingrequired”and“tohandoverorsubmit

forinformation,consideration,decision,etc.”).

Thisinterpretationproperlyservestheremedialpurposesofthese

protections.Recentattemptsatcoercedreferralsforabortion,suchasCalifornia’s

ReproductiveFACTAct,havetakentheformofcompelleddisplayofinformation

discussingtheavailabilityofState‐subsidizedabortions.Thepurpose,design,and

effectofsuchdisplaysofinformationispreciselytoassistpatientsinobtaining

abortionsiftheysochoose.Asdiscussedelsewhereinthisrule,OCRfoundthatthe

FACTAct’scompelleddisplayofsuchinformationtomembersofthepublicisatype

ofreferringorreferral“for”abortionthatCongressprohibitedintheWeldonand

Coats‐SnoweAmendments.81

Nevertheless,theDepartmenthasmadesignificantmodificationstothe

definitionof“discrimination”thataddresstheconcernsraisedbycommenters

concerningthedefinitionofreferral.Specifically,theDepartmentrecognizesgreater

latitudeforaccommodationproceduresbyemployersandentitiesandhasadded

additionalexclusionsandexemptionsundertherule.Indoingso,therulenarrows

thescopeofpossiblebasesofaviolationundertherule.

81LetterfromRogerT.Severino,Dir.,Dep’tofHealth&HumanServ’s.OfficeforCivilRights,toXavierBecerra,Att’y.Gen.,StateofCal.(Jan.18,2019),availableathttps://www.hhs.gov/sites/default/files/california‐notice‐of‐violation.pdf.


133

Forexample,theruleallowsanemployer,whenthereisareasonable

likelihooditmayaskitsemployeesingoodfaithtoreferfor,participatein,orassist

intheperformanceofpotentiallyobjectedtoconduct,torequireitsemployeeto

informitofanyobjections.Thus,ahospitalthatregularlyperformselective

abortionsmayaskanursehiredtoworkintheOB/GYNdepartmentifheorshe

anticipateshavinganyobjectionstoassistingintheperformanceofelective

abortionstoallowthehospitaltomakeappropriate,non‐discriminatorystaffing

arrangements.Barringotherfacts,ifthenurserefusestoanswer,theDepartment

wouldnottreatanyresultantadverseactionbytheemployeragainstthenurseas

“discrimination”undertherule.

Thesesignificantchangestotherule’sdefinitionofdiscriminationrespect

thelawsprovidedbyCongressandtheinterestsofallparties—employers,health

careentities,andindividualphysicians—whowishtoprovideservicesallowedby

lawaccordingtotheirconsciences.

Additionally,theDepartmentagreesthatsomeproposedtermsinthe

definitionofreferorreferralwereunnecessarilybroad,andthereforethe

Departmentfinalizesthedefinitionwithnarrowingeditsassetforthinresponseto

commentsregardingspecificphrasesdiscussedbelow.


definitionof“referralorreferfor”wouldinterferewithlegalandethicaldutiesof

doctorstoprovideinformationtotheirpatients.


134

Response:TheDepartmentdisagrees.Therulesdonotprohibitanydoctoror

healthcareentityfromprovidinginformationtotheirpatients—orreferringfora

medicalserviceortreatment—iftheyfeeltheyhaveamedical,legal,ethical,or

otherdutytodoso.Therulessimplyenforceexistinglawsthatpreventdoctorsor

otherprotectedentitiesfrombeingforcedtoreferforabortionsagainsttheirwillor

judgment.Therule’sdefinitionof“referralorreferfor”ensuresthatdoctorscanuse

theirownprofessional,medical,andethicaljudgmentwithoutbeingcoercedby

entitiesreceivingFederalfundstoviolatetheirmoralorreligiousconvictions.To

theextentaStatesubjecttothisrule(under,forexample,theCoats‐Snowe

AmendmentortheWeldonAmendment)legallymandatesthatprotected

individualsandentitiesreferforabortion,Congresshasindicatedsuchmandates

areinconsistentwithFederallaw.


definitionof“referralorreferfor”wouldviolatetherequirementthatpatients

receiveinformedconsentbeforeperformingtreatments.

Response:Asimilarobjectionisdiscussedaboveconcerningthedefinitionof

“assistintheperformance”anditsinclusionofreferrals.TheDepartmentdisagrees

withtheobjection.Federalconscienceandanti‐discriminationlawsspecifically

shieldcertainpersonsandentitiesfrombeingrequiredtoprovidereferralsfor

abortion.Indeed,medicalethicshavelongprotectedrightsofconsciencealongside

theprinciplesofinformedconsent.TheDepartmentdoesnotbelievethat

enforcementofconscienceprotections,manyofwhichdatetotheeraofRoev.Wade


135

andDoev.Bolton,violatesorunderminestheprinciplesofinformedconsent.This

finalrulewillnotchangeexistinglawsrequiringdoctorstosecureinformedconsent

frompatientsbeforeperformingmedicalprocedures.


definitionof“referralorreferfor”conflictswithTitleXofthePublicHealthService

Act.

Response:Asdiscussedabove,theDepartmentconcludedin2008andagain

inthepreambletotheproposedruleinthisrulemakingthatthe2000Regulations

governingtheTitleXprogram,whichrequiredTitleXprojectsandprovidersto

provideabortioncounseling,informationandreferralsincertaincircumstances,

conflictwithcertainFederalconscienceandanti‐discriminationlaws.Notably,that

requirementwasimposedbytheDepartment,notbyCongressinTitleXitself,

whichhaslongprohibitedtheuseofTitleXfunds“inprogramswhereabortionisa

methodoffamilyplanning.”42U.S.C.300a‐6.TheDepartmenthasamendedthe

TitleXregulationstoremovetherequirementsforabortioncounseling,information,

andreferrals,whilepermittingtheprovisionofnondirectivecounselingon,and

informationabout,abortion.Underthe2019finalrulegoverningtheTitleX

program,theTitleXregulationsnolongerconflictwithFederalconscienceandanti‐

discriminationlawsorthisfinalrule.Regardless,astheDepartmentrecognizedin

the2008Rule,aFederalregulatoryrequirementthataTitleXapplicant,grantee,

program,orclinic–arecipientofFederalfundsincarryingoutaHHSprogram–

provideabortioncounseling,information,andreferralscannotbeenforcedagainst


136

suchentitieswhoserefusaltodosoisprotectedbyapplicableFederalconscience

andrelatednondiscriminationstatutes.

Comment:TheDepartmentreceivedcommentsstatingthatincluding“the

provisionofanyinformation...byanymethod”inthedefinition“referral”or“refer

for”goesbeyondthemeaningofthosewordsinthestatutes.

Response:Thedefinition’sbreadthreflectsthefactthatconscientious

objectionsto,orthenonperformanceof,actsthatfacilitatetheconductofathird

partymaytakemanyformsandoccurinmanycontexts.Nevertheless,the

Departmentagreesthatthephrases“anyinformation”and“anymethod”aswellas

“anyassistance”areunnecessarilybroad,andthereforedeletesthethree

appearancesoftheword“any”fromthedefinition.Theruleinsteadreliesonthe

non‐exhaustivelistofillustrationstoguidethescopeofthedefinition.Additionally,

therulepermitsthedescriptionofspecificmethodsoftransmittinginformation,

namely,“anymethod(includingbutnotlimitedtonotices,books,disclaimersor

pamphlets,onlineorinprint),”andreplacesthelistwiththeclearerandmore

concisestatementof“inoral,written,orelectronicform.”


definitionof“referralorreferfor”couldpermitaprovidertoturnawayapatient

experiencingcomplicationsfromanobjected‐tomedicaldrug,device,orservice

withoutprovidinganyinformation.

Response:Totheextentthecommentsconcernprovidersthatdeclineto

volunteercertaininformationormakereferralstootherproviders,theapplicability


137

oftherulewouldturnontheindividualfactsandcircumstancesofeachcase.In

makingadetermination,theDepartmentwillconsidertherelationshipbetweenthe

treatmentsubjecttoareferralrequestandtheunderlyingserviceorprocedure

givingrisetotherequest.TheDepartment,however,isnotawareofanyproviders

thatwouldrefusetotreatorreferapersonwithunforeseenandunintended

complicationsarisingfrom,forexample,anabortionprocedurethattheprovider

wouldnotperform.


definitionof“referralorreferfor”couldresultinahealthcareprofessionalrefusing

toreferawomanfortreatmentofovariancancerbecausesterilizationwouldbea

“possibleoutcomeofthereferral.”

Response:TheDepartmentagreesthat“possibleoutcomeofthereferral”is

unnecessarilybroad.TheDepartmentisthereforechangingtheword“possible”to

“reasonablyforeseeable,”whichstillrecognizesrobustprotectiontoconscientious

objectorsasprovidedbyCongress,butrequiresastrongerconnectionbetweenthe

referralandtheobjected‐toactivityorresult.TheDepartmentalsofinalizesthe

definitionwithachangetoeliminatesubjectivelanguageconcerningwhatanentity

“sincerelyunderstands”outofsimilarconcernsaboutoverbreadth.

Comment:TheDepartmentreceivedacommentsuggestingthat“referralor

referfor”shouldbedefinedas“activefacilitationofaccess.”

Response:TheDepartmentdisagreesandbelievessuchadefinitionwould

riskimproperlynarrowingtheprotectionsprovidedbyCongress.Forexample,


138

California’sReproductiveFACTAct(whichtheSupremeCourtruledinNIFLAlikely

violatestheConstitution,138S.Ct.at2371–76),involvedarequirementthathealth

carefacilitiesopposedtoabortiontellwomenthatthestatemayprovidefreeorlow

costabortion,andprovidethewomenaphonenumberforfurtherinformationon

howtoaccessthoseabortions.AfterinvestigatingcomplaintsrelatedtotheFACT

Act,theDepartmentfoundthatmandatingthecommunicationofsuchinformation

tomembersofthepublicisatypeofreferringorreferral“for”abortionthat

Congressprohibitedinconscienceprotectionstatutes.82Narrowingthedefinitionto

the“activefacilitationofaccess”maysubjectmanyhealthcareproviderstocoercive

requirementsthattheDepartmenthasalreadyfoundviolatethelaw.Thedefinition

finalizedherebetterincludesthefullrangeofreferralactivitiesprotectedby

Congress.


“referralorreferfor,”whenappliedtoemployeesofhealthplans,couldhinder

peoplewhoareattemptingtodeterminewhatservicesarecoveredbytheir

insuranceplansandwhatdoctorsareintheirplansorcouldbeusedtonotprocess

claimsforobjected‐toservicesunderahealthplan.Thecommentssuggested

limitingconscienceprotectionstohealthplansthemselvesratherthanincludingthe

plans’employees,exemptingadministrativetasksperformedbyahealthplan’s

82LetterfromRogerT.Severino,Dir.,Dep’tofHealth&HumanServ’s.OfficeforCivilRights,toXavierBecerra,Att’y.Gen.,StateofCal.(Jan.18,2019),availableathttps://www.hhs.gov/sites/default/files/california‐notice‐of‐violation.pdf.


139

employees,orlimitingthedefinitionof“referralorreferfor”tonotincludehealth

plansortheiremployees.

Response:TheDepartmentreplacedsubparagraph(4)tothedefinitionof

“discriminateordiscrimination”tomakeclearthatemployerscanuse,andare

encouragedtopursue,accommodationprocedureswithprotectedemployees.

Additionally,theDepartmentaddedsubparagraphs(5)and(6)tothedefinitionof

discriminationtoclarifythat,withinlimits,employersmayrequireprotected

employeestoinformthemofobjectionstoreferringfor,participatingin,orassisting

intheperformanceofspecificprocedures,programs,research,counseling,or

treatmentstotheextentthereisareasonablelikelihood83thattheprotectedentity

ormembermaybeaskedingoodfaithtoreferfor,participatein,orassistinthe

performanceofsuchconduct.

Consistentwiththetermsofsubparagraphs(5)and(6)ofthedefinitionof

discriminationregardingadvancenoticebyanemployeeofthepotentialfora

conscientiousobjection,anemployermaysimilarlyrequireanemployeetonotify

theminatimelymannerofanactualconscientiousobjectionthattheemployeehas

toaspecificact,intheday‐to‐daycourseofwork,thattheemployeewould

otherwisebeexpectedtoperform.84

83Forexample,nursesassignedexclusivelytonursinghomesforelderlypatientswouldnotbeexpectedtoreferorassistintheperformanceofanysterilizationproceduresorabortions,andthus,itwouldbeinappropriateforanentitysubjecttotheprohibitionsinthisruletorequiresuchnursestodisclosewhetherornottheyhaveanyobjectionstoreferringorassistinginsuchprocedures.84TheDepartmentnotesmateriallegalandfactualdistinctionsbetween,ontheonehand,anemployerrequiringanemployeetonotifyitofaconscientiousobjectioncoveredbythisruleand,ontheother,theaccommodationprocessforreligiousemployersintheDepartment’spreviousregulationsmandatingemployercoverageofcontraceptionandsterilization.80FR41318(July14,


140

Employersandprogramsthatsubsequentlytakestepstousealternatestaff

ormethodstoprovidefororfurthertheobjected‐toconductwouldnotbe

consideredtoengageindiscrimination–norwouldtherequirementforthe

objectingentitytoprovidenoticetotheemployerorprogrambeconsidereda

referral–iftheemployerorprogramdoesnottakeanyadverseactionagainstthe

objectingpersonorentity,ifsuchmethodsdonotexcludepersonsfromfieldsof

practiceonthebasisoftheirprotectedobjections,andiftheemployerorprogram

doesnotrequireanyadditionalactionbytheobjectingpersonorentitybeyondthe

2015).NumerousreligiousorganizationsbroughtchallengesunderRFRAconcerningthe“accommodation”processpromulgatedunderthoserules.RFRApreventstheFederalGovernmentfromsubstantiallyburdeningaperson’sreligiousexerciseunlessinfurtheranceofacompellinggovernmentalinterestandinthemannerleastrestrictiveofthatexercise.Undertheaccommodation,objectingreligiousorganizationsthatself‐insuredwouldhavebeenrequiredtonotifyeitherthethird‐partyadministratoroftheirhealthplan,viaacertainprescribedform,orHHS,viaalettercontainingcertainprescribedinformation,oftheirobjectiontoincludingcontraceptionandsterilizationintheirhealthplans.Plaintiffsinthosecasesarguedthatprovidingsuchnoticewoulditselfhaveviolatedtheirreligiousbeliefs.Butacrucialelementoftheplaintiffs’argumentinthecontextofself‐insuredplanswasthatthenotice,viaeithermethod,wasaprerequisitewithoutwhichtheplan’sthird‐partyadministratorwouldlacklegalauthoritytodelivertheobjected‐tocoverage.“Ifaself‐insuredreligiousorganizationusesForm700,theformbecomes‘aninstrumentunderwhichtheplanisoperated[andis]treatedasadesignationofthe[third‐partyadministrator]astheplanadministratorundersection3(16)ofERISA[,29U.S.C.1002(33),]foranycontraceptiveservicesrequiredtobecovered.29CFR2510.3‐16(b).Form700authorizesthe[third‐partyadministrator]to‘provideorarrangepaymentsforcontraceptiveservices…29CFR2590.715‐2713A(b)(2)…Iftheself‐insuredreligiousorganizationinsteadself‐certifiesbyHHSNotice,DOL’sensuingnotificationtothe[third‐partyadministrator]alsooperatesto‘designate’the[third‐partyadministrator]‘asplanadministrator’underERISAforcontraceptivebenefits.79Fed.Reg.at51,095;seealso29CFR2510.3‐16(b).”SharpeHoldingsv.U.S.Dept.ofHealth&HumanServices,801F.3d927,935(8thCir.2015).Theprovisionofnoticetriggeredcoverageoftheobjected‐tocontraceptivesbythereligiousemployer’sthirdpartyadministrator,thus–intheeyesoftheobjectingreligiousemployers–makingthemcomplicitinagravewrong. Theprovisionofnoticebyanemployeetoheremployerdiffersfromtheaccommodation’snoticerequirementinkeyrespects.First,absentunusualcircumstances,burdensplacedbyaprivateemployeronanemployee’sreligiousexercisewouldnotbesubjecttothestringentdemandsofRFRA.Second,undertheaccommodation,thethird‐partyadministratorofanobjectingemployer’sself‐insuredplanwouldhavehadnolegalobligationtoprovidetheobjected‐tocoverageabsenttheemployer’sprovisionofnotice,butifunderthisruleanobjectingemployeerefusestoprovideheremployerwithnoticeofherobjection,heremployerwouldneverthelessretainitsauthorityandabilitytoprovidetheobjected‐toservicewithouttheemployee’sinvolvement.


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provisionofnoticediscussedabove.Theemployermayalsoinformthepublicofthe

availabilityofalternatestafformethodstoprovideorfurthertheobjected‐to

conductifitdoesnotconstitutetakinganyadverseactionagainsttheobjecting

personorentity.

TheDepartmentbelievesthatincorporatingthesesignificantlimitationsto

thescopeofdiscriminationand,thus,addressingissuesthatmayariseforan

employerwhenahealthcareentityobjectstomakingareferral,solvesconcerns

suchasthoseraisedbythiscomment.


definitionof“referralorreferfor,”becauseitappliestopublicnotices,would

prohibitCalifornia’sReproductiveFACTAct,“whichrequiresfacilitiesspecializing

inpregnancy‐relatedcaretodisseminatenoticestoallclientsabouttheavailability

ofpublicprogramsthatprovidefreeorsubsidizedfamilyplanningservices,

includingprenatalcareandabortion.”

Response:Asdiscussedabove,theDepartmenthasalreadyfoundthatthe

FACTActviolatedtheWeldonandCoats‐SnoweAmendments,andtheSupreme

Court,inNIFLA,138S.Ct.at2371–76,ruledthatitlikelyviolatestheFirst

Amendment’sfreespeechprotectionsfortargetingpro‐lifehealthcareentitiesand

compellingthemtoprovideinformationabouthowtoobtainabortions.


definitionof“referralorreferfor”conflictswiththeDeConciniAmendment,which

states,“[I]nordertoreducerelianceonabortionindevelopingnations,funds[to


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carryouttheprovisionsofchapters1and10ofpartIoftheForeignAssistanceAct

of1961]shallbeavailableonlytovoluntaryfamilyplanningprojectswhichoffer,

eitherdirectlyorthroughreferralto,orinformationaboutaccessto,abroadrange

offamilyplanningmethodsandservices”(ConsolidatedAppropriationsAct,2019,

Pub.L.116‐6,Div.F,sec.7018).

Response:TheDepartmentdisagrees.TheDeConciniAmendment’sreference

to“abroadrangeoffamilyplanningmethodsandservices”doesnotinclude

abortion.Rather,theamendmentitselfcontrastsabortionwiththatbroadrangeof

familyplanningmethodsandservicesandexcludesabortionasamethodoffamily

planning.Anotherprovisobarstheuseof“fundsmadeavailableunderthisAct...to

payfortheperformanceofabortionasamethodoffamilyplanningortomotivate

orcoerceanypersontopracticeabortions”and“[t]hatnothinginthisparagraph

shallbeconstruedtoalteranyexistingstatutoryprohibitionsagainstabortion

undersection104oftheForeignAssistanceActof1961.”TheDepartmentbelieves

thebestreadingofthatamendmentisthatthebroadrangeoffamilyplanning

methodsandservicesisviewedasanalternativetoabortion,notthatthe

amendmentmandatesreferralsforabortionasiftheyarepartoffamilyplanning.In

thecontextofforeignassistance,sincethe1980s,fourdifferentpresidential

administrationshaveimplementedpoliciestoprohibitforeignassistanceforfamily

planningtogotoentitiesthatperformoractivelypromoteabortionasamethodof


143

familyplanning,andCongresshasbeenawareofthosepolicies.85Furthermore,the

DeConciniAmendment’sdiscussionofabroadrangeoffamilyplanningmethods

andservicesisnearlyidenticaltothescopeoftheTitleXstatute,42U.S.C.300.In

thatcontext,Congressmadeclearthatitdoesnotconsiderabortiontobeamethod

offamilyplanningand,infact,prohibitstheuseofFederalfundsinprogramswhere

abortionisamethodoffamilyplanning.See42U.S.C.300a‐6.


“referralorreferfor”couldpermitahealthcareprovidertorefusetoeverrefera

patienttoanOB/GYNforanyreasonbecauseafuturepossibleoutcomeofsucha

referralcouldbethatthepatientseeksanabortionorsterilizationfromthe

OB/GYN,eventhoughthedirectreferralisnotforsuchservice.

Response:Thecommenters’concernsseemfar‐fetched,butare,nevertheless,

addressedbythechangefromtheword“possibleoutcome”to“reasonably

foreseeableoutcome,”whichrequiresastrongerconnectionbetweenthereferral

andtheobjected‐toconduct.TheDepartmentdoesnotfindtheretobereasonto

foreseethatobjectorswouldusetheWeldonorCoats‐SnoweAmendmentsorthese

rulestorefusetoreferwomentoeveryOB/GYN.



85U.S.PolicyStatementfortheInternationalConferenceonPopulation,10Population&Dev.Rev.574,578(1984)(reproducingthePolicyStatementoftheUnitedStatesofAmericaattheUnitedNationsInternationalConferenceonPopulation,alsoknownastheMexicoCityPolicy).8683FR3880,3894‐95(statingthereasonsfortheproposeddefinitionof“referralorreferfor,”exceptforthemodificationsadoptedherein).


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thedefinitionof“referralorreferfor”withchangesasdescribedabove.The

commentsleadtheDepartmenttobelievethetextasoriginallyproposedwas

undulylong,confusing,andrepetitiveandthereforefinalizesthedefinitionwith

numerousstylisticchangesanddeletionsandnonsubstantivereorderingoftextto

substantiallyimprovereadability.TheDepartmentalsofinalizestheruletoclarify

thatassistancerelatedtoa“program”isalsoencompassedbythedefinitioninorder

totracktheuseofthatphraseinstatutes,includingtheWeldonandCoats‐Snowe

Amendments,thatprotectagainstforcedreferralsincertainprograms.Therevised

definitionincludestheprovisionofinformationinoral,written,orelectronicform

(includingnames,addresses,phonenumbers,emailorwebaddresses,directions,

instructions,descriptions,orotherinformationresources),wherethepurposeor

reasonablyforeseeableoutcomeofprovisionoftheinformationistoassistaperson

inreceivingfundingorfinancingfor,trainingin,obtaining,orperforminga

particularhealthcareservice,program,activity,orprocedure.

State.TheDepartmentproposedthat“Stateincludes,inadditiontothe

severalStates,theDistrictofColumbia.Forthoseprovisionsrelatedtoorrelying

uponthePublicHealthServiceAct,theterm‘State’includestheseveralStates,the

DistrictofColumbia,theCommonwealthofPuertoRico,Guam,theNorthern

MarianaIslands,theU.S.VirginIslands,AmericanSamoa,andtheTrustTerritoryof

thePacificIslands.ForthoseprovisionsrelatedtoorrelyingupontheSocial

SecurityAct,suchasMedicaidortheChildren’sHealthInsuranceProgram,theterm

‘State’followsthedefinitionof,State,foundat42U.S.C.1301.”TheDepartmentdid


145

notreceivecommentsonthisdefinition.


rule87andabove,theDepartmentadoptsthedefinitionof“State”withonechange,

omitting“follows”andreplacingitwith“shallbedefinedinaccordancewith.”

Sub‐recipient.TheDepartmentproposedthatsub‐recipientmeansanyState,


subdivisionthereof,andanypersonoranypublicorprivateagency,institution,

organization,orotherentityinanyStateincludinganysuccessor,assign,or

transfereethereof,towhomFederalfinancialassistanceisextendedthrougha

recipientoranothersub‐recipient,orwhootherwisereceivesFederalfundsfrom

theDepartmentoracomponentoftheDepartmentindirectlythrougharecipientor

anothersub‐recipient,butsuchtermdoesnotincludeanyultimatebeneficiary.The

termmayincludeforeignorinternationalorganizations(suchasagenciesofthe

UnitedNations).TheDepartmentreceivedcommentsonthisdefinition.

Comment:TheDepartmentreceivedacommentstatingthattheproposed

definitionof“sub‐recipient”isoverlybroadandcouldbereadtoincludeevery

contractingpartywitharecipientofFederalfinancialassistance.Thecommenter

proposesthat“sub‐recipient”shouldbelimited“tothoseforwhomthereisadirect

pass‐throughofFederalfinancialassistanceandwhoareidentifiedassub‐recipients

ofsuchdollarsincontractswiththedirectrecipient.”

Response:TheDepartmentagreesthatthedefinitionshouldbeclarifiedso

8783FR3880,3895


146

thatitdoesnotincludeeveryentitythatcontractswitharecipientofFederal

financialassistance.TheDepartment,therefore,finalizesthisdefinitionwitha

changetothedefinitionof“sub‐recipient”replacingthephrase“towhomFederal

financialassistanceisextendedthrougharecipientoranothersub‐recipient,”with

“towhomthereisapass‐throughofFederalfinancialassistancethrougharecipient

oranothersub‐recipient.”TheDepartmentdisagrees,however,thatasub‐recipient

mustbeexplicitlydeclaredasasub‐recipientinacontract(oragrant).Requiring

explicitdesignationasasub‐recipientcouldpermitsub‐recipientsinfacttoavoid

suchdesignationbycontractingaroundsuchdesignation.

Asdiscussedconcerningtheterm“entity,”theDepartmentisfinalizingthe

terms“entity,”“recipient,”and“sub‐recipient”withparallellanguagetoclarifythat

theyallmayencompass“aforeigngovernment,foreignnongovernmental

organization,orintergovernmentalorganization(suchastheUnitedNationsorits

affiliatedagencies).”



thedefinitionof“sub‐recipient”changing“and”to“or,”replacingthephrase“to

whomFederalfinancialassistanceisextendedthrougharecipientoranothersub‐

recipient,orwhootherwisereceivesFederalfundsfromtheDepartmentora

componentoftheDepartmentindirectlythrougharecipientoranothersub‐

recipient”with“towhomthereisapass‐throughofFederalfinancialassistanceor

8883FR3880,3895(statingthereasonsfortheproposeddefinitionof“sub‐recipient,”exceptforthemodificationsadoptedherein).


147

FederalfundsfromtheDepartmentthrougharecipientoranothersub‐recipient,”

andtochangethelastsentencepreviouslyreferringto“foreignorinternational

organizations”toread,“Thetermmayincludeaforeigngovernment,foreign


UnitedNationsoritsaffiliatedagencies).”

Workforce.TheDepartmentproposedthatworkforcemeansemployees,

volunteers,trainees,contractors,andotherpersonswhoseconduct,inthe

performanceofworkforanentityorhealthcareentity,isunderthedirectcontrolof

suchentityorhealthcareentity,whetherornottheyarepaidbytheentityorhealth

careentity,aswellashealthcareprovidersholdingprivilegeswiththeentityor

healthcareentity.TheDepartmentreceivedcommentsonthisdefinition.


volunteers,trainees,andcontractorswithinthedefinitionof“workforce”istoo

broad.

Response:TheDepartmentdoesnotagree.Undertherevisedruletext

adoptedinthisfinalrule,thedefinedterm“workforce”isusedinalimitednumber

ofplacesandforlimitedpurposesrelatedtovoluntarynoticeprovisionsinthisrule.

Limiting“workforce”toemployeesfailstoacknowledgethecomplexityofthehealth

caresystem.TheDepartmentadaptedtheproposeddefinitionfromthedefinitionof

“workforce”intheregulationsimplementingtheHIPAAadministrative

simplificationprovisions,includingtheHIPAAPrivacyRule.See45CFR160.103

(definitionof“workforce”).Thatdefinitionhasworkedwelltoensure,amongother


148

things,theprotectionoftheprivacyandsecurityofprotectedhealthinformation.

JustasisthecasewiththeHIPAARules,compliancewithFederalconscienceand

anti‐discriminationlawswouldnotbeappropriatelycomprehensiveifonlythe

employeesofcoveredentitieswereprotected,orifinstitutionalentitieschoseto

avoidprovidingnoticetocontractors,volunteers,andtrainees.

Comment:TheDepartmentreceivedacommentsuggestingthatvolunteers

andcontractorsbeincludedinthedefinitionof“workforce”onlyiftheyare

performingorassistingintheperformanceofhealthcareactivities.

Response:TheDepartmentdisagrees.Asstatedabove,thedefinedterm

“workforce”isusedinonlyalimitednumberofplacesandforlimitedpurposes

undertherule.Generally,thestatutesenforcedundertheserulesapplytohealth

careactivitiesandentities,butwheretheydonot,thetermsofthestatutegovern.


rule89andabove,andconsideringthecommentsreceived,theDepartmentadopts

thedefinitionof“workforce”asproposed.

Applicablerequirementsandprohibitions(§88.3)

TheDepartmentproposedastatute‐by‐statuterecapitulationofthe

substantiveprovisionsofeachstatutethatisthesubjectofthisrule,andofthe

applicabilityandscopeofrequirementsandprohibitionsofeachsuchstatute.The

proposed“Applicability”provisionsoutlinedthespecificrequirementsofthe

Federalconscienceandanti‐discriminationlawsthatapplytovariouspersonsand

8983FR3880,3895.


149

entities.Theseprovisionsweretakenfromtherelevantstatutorylanguageand

woulddirectcoveredentitiestotheappropriatesectionsthatcontaintherelevant

requirementsthatformthebasisofthisregulation.

The“RequirementsandProhibitions”provisionsexplainedtheobligations

thattheFederalconscienceandanti‐discriminationlawsimposeontheDepartment

andonentitiesthatreceiveapplicableFederalfinancialassistanceandotherFederal

fundingfromtheDepartment.Theseprovisionsweretakenfromtherelevant

statutorylanguage.TheDepartmentreceivedcommentsonthissection.The

responsestocommentsareprovidedbelowfollowingtheproposedapplicability

andrequirementsandprohibitionsprovisionsforeachFederalconscienceandanti‐

discriminationlaw.

OneconformingrevisiontotheproposedrulethattheDepartmenthasmade

throughoutthe“RequirementsandProhibitions”provisionsistoremove§88.5of

45CFRpart88(provisionofnotice)fromthelistofsectionswithwhichapplicable

personsandentitiesmustcomply.Asdescribedinthesection‐by‐sectionanalysis

for§88.5ofthisrule,theprovisionofanoticeofrightsofFederalconscienceand

anti‐discriminationlawsisnolongerarequirementfortheDepartmentand

recipients.

AnotherconformingrevisiontotheproposedrulethattheDepartmenthas

madethroughoutthe“RequirementsandProhibitions”provisionsistomodifythe

phrase“entitiestowhom”varioussubparagraphsapply”to“entitiestowhich.”The

Departmentbelievestheword“which”avoidsconfusionregardingthenatureand


150

scopeofentitiestowhomtheruleapplies.

88.3(a).TheChurchAmendments.TheDepartmentreceivedcomments

generallysupportiveoftheChurchAmendmentsandsupportiveoftheinclusionof

theChurchAmendmentsintherule,aswellascommentsopposedtotheChurch

AmendmentsthemselvesortotheDepartment’senforcementofthem.

Comment:TheDepartmentreceivedcommentsstatingthattheproposedrule

onlyprotectshealthcareproviderswhoholdmoralorreligiousconvictionsagainst

theprovisionofabortionorsterilization,butprovidesnoprotectionforhealthcare

providerswhosemoralorreligiousconvictionsmotivatethemtoprovideabortions

orsterilizations.

Response:Totheextentthecommenters’concernsreflectanaccurate

readingoftheChurchAmendments,theseconcernsraisedbythecommentersarea

resultofchoicesCongressitselfmade.Thisfinalrulereasonablyinterpretsthe

protectionsthatCongressestablished,butitcanneithereliminatenortransformthe

policyjudgmentsembeddedinthetextoftheChurchAmendmentsorofanyother

applicablelaw.TotheextenttheChurchAmendmentsapplybecausesomeone

performedorassistedintheperformanceofalawfulsterilizationprocedureor

abortion,thisrulewouldenforcethoseprovisionstotheextentconsistentwith

otherstatutoryandconstitutionalrequirements.See,e.g.,§88.3(a)(2)(iv),(v),(vii).

Comment:TheDepartmentreceivedcommentsstatingthatproposed

subparagraphs88.3(a)(2)(v)and(vi),whichapply42U.S.C.300a‐7(c)(2)and(d),


151

aretoobroad,andthat42U.S.C.300a‐7(d)shouldbeorhasbeeninterpretedto

provideprotectionsonlyforparticipationinabortionorsterilizationprocedures.

Response:TheDepartmentdisagreesthatthesesubparagraphsshouldbe

limitedtosituationsinvolvingabortionandsterilization.Paragraphs(b),(c)(1),and

(e)oftheChurchAmendmentsclearlyspecifytheyapplyconcerningabortionsor

sterilizations.Butparagraphs(c)(2)and(d)donotusethatlanguage;instead,as

Congressspecified,theyencompass“anylawfulhealthserviceorresearchactivity”

or“anypartofahealthserviceprogramorresearchactivity,”respectively.The

DepartmentisrequiredtoimplementthestatutesaswrittenbyCongress.Reading

paragraphs(c)(2)and(d)toaddressonlyabortionandsterilizationprocedures

wouldnarrowthescopeofthosestatutoryprovisionsincontraventionoftheclear

textofthestatute.Furthermore,courtopinionsinterpreting42U.S.C.300a‐7(d)

havevariedintheirinterpretations,butrecognizethatitappliestomorethan

abortionorsterilizationprocedures.90

Regardingthebreadthandaccuracyof§88.3overall,however,the

Departmentfinalizestheparagraphwithchangestomoreaccuratelyreflectthe

statutorytext.Withrespectto§88.3(a)(2)(v),however,theDepartmentagreesthat

theproposedrulewasimpreciseinomittingonelimitingphrasethatCongresshad

90See,e.g.,Vt.AllianceforEthicalHealthcare,Inc.v.Hoser,274F.Supp.3d227,232(D.Vt.2017)(“Section300a‐7(d)isoneofseveralso‐calledChurchAmendments.Itexcusesindividualsengagedinhealthcareorresearchfromanyobligationtoperformabortionsorotherprocedureswhichmayviolatereligiousbeliefsormoralconvictions.”(emphasisadded));FranciscanAlliance,Inc.v.Burwell,227F.Supp.3d660,683(Dec.31,2016)(“TheChurchAmendmentforbidsrequiringanyindividual‘toperformorassistintheperformanceofanypartofahealthserviceprogram...ifhisperformanceorassistanceintheperformanceofsuchpartofsuchprogram...wouldbecontrarytohisreligiousbeliefsormoralconvictions.’”(alterations)).


152

includedinsubparagraph(c)(2)oftheChurchAmendments.Theproposedrule

ended§88.3(a)(2)(v)with,“becauseofhisorherreligiousbeliefsormoral

convictions,”whilethestatutereads,“becauseofhisreligiousbeliefsormoral

convictionsrespectinganysuchserviceoractivity.”TheDepartmentfinalizesthis

subparagraphtoaddthephrase“respectinganysuchserviceoractivity”that

Congressincludedinthispartofthestatute.

Comment:TheDepartmentreceivedacommentstatingthattheruleshould

clarifythattheprotectionsprovidedbyCongressunder42U.S.C.300a–7(b)and(c)

applyonlytoabortionsandsterilizationsinthecircumstancesprovidedforinthe

statute.

Response:Paragraphs(b)and(c)(1)oftheChurchAmendmentsspecifythat

theyapplyinthecontextofabortionandsterilizationproceduresspecifically.

Subparagraph(c)(2)hasabroaderreach,encompassing“anylawfulhealthservice

orresearchactivity.”Asdiscussedinresponsetothesimilarcommentaskingthat

(c)(2)and(d)beinterpretedtoencompassonlyabortionandsterilizations,

Congresslimitedparagraphs(b),(c)(1),and(e)toabortionsandsterilizations,but

useddifferentlanguageinparagraphs(c)(2)and(d).Theruletracksthetextof

paragraphs(b)and(c)(1)accordingly,asestablishedbyCongress.Subparagraphs

88.3(a)(2)(i)‐(iv)and(vii)oftheruleexplicitlyrelatetoabortionsorsterilizations,91

while§88.3(a)(2)(v)‐(vi)relatetoanylawfulhealthserviceorresearchactivity.92

91Subparagraph88.3(a)(2)(i)implementssubparagraph(b)(1)oftheChurchAmendments;subparagraphs88.3(a)(2)(ii)and(iii)implementsubparagraph(b)(2)oftheChurchAmendments;andsubparagraph88.3(a)(2)(iv)implementssubparagraph(c)(1)oftheChurchAmendments.92Subparagraph88.3(a)(2)(v)implementssubparagraph(c)(2)oftheChurchAmendment.


153

Comment:TheDepartmentreceivedcommentsaskingforclarification

whethertheprovisionsin§88.3(a)thatrelatetosterilizationincludeonly

intentionalsterilizations,orwhethertheyalsoincludeproceduresorservicesthat

havesterilizationasasideeffect,suchashysterectomiesperformedforreasons

otherthansterilization,orchemotherapy.

Response:CongressdidnotprovideadefinitionofsterilizationintheChurch

Amendments,orfurtherspecifythescopeofobjectionsunderthosestatutes,but

providedbroadprotectionsforreligiousandmoralobjectionstosterilization

procedures.Generallyspeaking,theDepartmentunderstandstheterm

“sterilization”asusedintheChurchAmendmentstoencompasstheordinary

meaningofthatterm,anddoesnotunderstandthetermtoincludetreatmentofa

physicaldiseasewheresterilizationisanunintendedsideeffectofthetreatment,

suchaschemotherapytotreatuterinecancerortesticularcancer.Totheextentthat

aChurchAmendmentcomplaintwithrespecttosterilizationisfiled,the

Departmentwouldexaminethefactsandcircumstancesofeachsuchclaimto

determinewhetheranactfallswithinthescopeofthestatuteandtheseregulations.

Comment:TheDepartmentreceivedcommentsaskingforclarificationabout

whetherprovisionsin88.3(a)applytosterilizationsperformedinthecontextof

genderdysphoria.

Response:TheDepartmentisawareofthreecasesbroughtatleastinpart

undertheChurchAmendments,inwhichtheclaimantsarguedthattheChurch

Amendments’sterilizationprovisionsprotecttheclaimants’conscientious


154

objectionstoperforminggenderdysphoriarelatedsurgery.Inonecase,Franciscan

Alliance,Inc.v.Burwell,227F.Supp.3d660(Dec.31,2016),enforcementofthe

challengedregulation,whichplaintiffscontendedwouldhaverequiredthe

performanceofproceduressuchashysterectomiestotreatgenderdysphoria,was

preliminarilyenjoinedonothergrounds.Intheothertwo,consolidatedasReligious

SistersofMercy,etal.,v.Burwell,No.3:16‐cv‐386(D.N.D.2017),whichchallenged

thesameregulation,thecourtissuedanorderstayingenforcementoftheregulation

inlightofthenationwidepreliminaryinjunctionissuedinFranciscanAlliance.Inthe

eventtheDepartmentreceivesanysuchcomplaints,theDepartmentwillconsider

themonacase‐by‐casebasis.

Comment:TheDepartmentreceivedcommentscontendingthatthe

paragraphsoftheruleconcerningtheChurchAmendmentsweretoobroadordid

notfaithfullyapplythestatutorytext.

Response:TheDepartmentintended§88.3tofaithfullyapplythetextof

applicablestatutes,includingtheChurchAmendments.Asaresultofcomments,the

Departmentbecameawareofinstancesinwhichtheproposedruletextdidnot

accuratelyreflectthecontentofthestatute.Accordingly,theDepartmentfinalizes

therulewithchangestomoreaccuratelyreflectthestatute.Specifically,in

§88.3(a)(2)(ii)and(a)(2)(iii),concerningsubparagraphs(b)(2)(A)and(B)ofthe

ChurchAmendments,theDepartmentfinalizestherulebychangingthephrase

“entitiestowhomthisparagraph...appliesshallnotrequireanyentityfunded

underthePublicHealthServiceAct”to“thereceiptofagrant,contract,loan,orloan


155

guaranteeunderthePublicHealthServiceActbyanyentitydoesnotauthorize

entitiestowhichthissubparagraph...appliestorequiresuchentityto....”

TheDepartmentalsofinalizes§88.3(a)(1)(vi)bychanging“Anyentitythat

carriesout”to“Anyentitythatreceivesfundsforanyhealthserviceprogramor

researchactivityunderanyprogramadministeredbytheSecretaryofHealthand

HumanServices.”TheDepartmentmakesthischangetoprovideclarityregarding

whichentitiesarerequiredtocomplywithparagraph(d)oftheChurch

Amendments.

Comment:TheDepartmentreceivedacommentstatingthattheruleshould

clarifythattheprotectionsprovidedbyCongressunder42U.S.C.300a–7(d)apply

onlytoindividuals.

Response:Theruletracksthestatutorylanguage.Namely,subparagraph

88.3(a)(2)(vi)statesthatcoveredentities“shallnotrequireanyindividual...”

(emphasisadded)toactcontrarytotheirreligiousbeliefsormoralconvictionsin

theperformanceofcertainhealthserviceprogramsorresearchactivities.The

Departmentmaintainssuchlanguageinthisfinalrule.


rule93andabove,andconsideringthecommentsreceived,theDepartmentmakes

certainchangesinthisparagraphinthisfinalrule.TheDepartmentfinalizes§

88.3(a)(1)(vi)bychanging“Anyentitythatcarriesout”to“Anyentitythatreceives

fundsforanyhealthserviceprogramorresearchactivityunderanyprogram

9383FR3880,3895(statingthereasonsfortheproposed§88.3(a),exceptforthemodificationsadoptedherein).


156

administeredbytheSecretaryofHealthandHumanServices.”TheDepartment

finalizes§88.3(a)(2)(ii)and(iii)bychangingtheword“entity”to“recipient”where

applicable,inordertoavoidconfusionpotentiallycreatedbytheuseoftheword

“entity”toreferbothtoprotectedentitiesandientitiesobligatedtocomplywith

88.3(a).Additionally,in§88.3(a)(2)(i)–(vii),concerningparagraphsand

subparagraphsoftheChurchAmendments,theDepartmentfinalizessubparagraphs

(a)(2)(i)–(vii)bychangingthelanguageofeachsubparagraphtoadoptthestatutory

textascloselyaspossibleinrelevantpart,includingbyaddingthewords

“respectinganysuchserviceoractivity”totheendof§88.3(a)(2)(v);amending§

88.3(a)(2)(i)toclarifythatthestatuteenforcesaruleofconstructionregardingthe

receiptofcertainFederalfinancialassistance;byrephrasingtherequirementsto

statethatthereceiptofrelevantfunds“doesnotauthorizeentitiestowhichthis

subparagraph[]appliestorequire”practicesspecifiedby42U.S.C.300a‐7(b);

addingintheparentheticalfromthestatute,“(includingapplicantsforinternships

andresidencies)”,to§88.3(a)(2)(vii);andreplacingshortformdescriptionsofthe

statutorytextwiththefullstatutorytext,suchasbychangingthewords“doingso”

in§88.3(a)(2)(v)to“hisperformanceorassistanceintheperformanceofsuch

serviceoractivity.”TheDepartmentalsoeliminatessomearticlesandterms,like

“the”and“orher,”andreplacestheterm“whom”withtheterm“which”for

readabilityandaccuracy.

88.3(b).Coats‐SnoweAmendment.TheDepartmentreceivedcomments

generallysupportiveoftheCoats‐SnoweAmendmentandsupportiveofthe


157

inclusionoftheCoats‐SnoweAmendmentintherule,aswellascommentsopposed

totheCoats‐SnoweAmendmentortherule’simplementationofthatstatute.

Comment:TheDepartmentreceivedcommentsonthedefinitionofterms

usedbytheCoats‐SnoweAmendment,suchaswhatconstitutesa“healthcare

entity.”Allsuchcommentsareaddressedintheresponsestocommentson

definitionsunder§88.2.

Comment:TheDepartmentreceivedacommentstatingthattheCoats‐Snowe

Amendmentwasonlya“narrowresponsetoaspecificproblem”—correctinga

loopholethatcouldhaveconditionedFederalfinancialassistanceontheprovision

ofabortionsindirectlythroughtheAccreditingCouncilonGraduateMedical

Education’saccreditationstandardsforobstetricsandgynecologygraduate

programs—notapronouncementofnewnationalpolicyand“cannotjustifythe

rulemakingauthoritytheDepartmentclaimsintheNPRM.”

Response:TheDepartmentdisagrees.WhiletheCoats‐SnoweAmendment

mayhavebeenmotivatedbythesituationinvolvingtheAccreditingCouncilon

GraduateMedicalEducation’saccreditationstandardsforobstetricsandgynecology

graduatemedicaleducationprogramsandstandardsforthereceiptofFederal

financialassistancebasedonaccreditation,theplainlanguageofthetextofthe

Coats‐SnoweAmendmentisbroaderthanthatsituation.Whileparagraph(b)ofthe

Coats‐SnoweAmendmentaddressestheaccreditationandtreatmentof

postgraduatephysiciantrainingprograms(andphysicianstrainedinsuch

programs)thatareorarenotaccreditedbyaccreditingagenciesthatrequirethe


158

performanceandtrainingintheperformanceofinducedabortions,paragraph(a)of

theCoats‐SnoweAmendmentestablishesfarbroaderprotectionsforhealthcare

entitiesthatrefuse,amongotherthings,toprovideorundergotraininginthe

performanceofinducedabortions,toperformsuchabortions,ortoprovide

referralsforsuchtrainingorsuchabortions.TheAmendmentwas,thus,drafted

withseparatelanguagetoprovidebothgeneralprotections,relatingtothetraining,

performanceof,andreferralforabortions,andspecificprotections,relatingto

governmentaltreatmentofphysiciansandphysiciantrainingprogramswherethe

accreditationagencyhadaccreditationstandardsthatrequiresperformanceor

trainingintheperformanceofinducedabortion.

Thisrulemustbegovernedbythetextofthelaw,notlegislativeintentor

legislativehistorythatmayormaynothavebeenreflectedinthetextpassedby

CongressandsignedbythePresident.TheDepartmentfindsitappropriateforthis

ruletofollowthetextoftheCoats‐SnoweAmendment,andnottonarrowitsscope

basedonwhatmayhavebeentheimpetusfortheintroduction,passageor

enactmentofthestatute.TheDepartmentintendstoprovideenforcement

mechanismsfortheprotectionsthatCongressactuallyenacted.

Comment:TheDepartmentreceivedcommentsstatingthattheCoats‐Snowe

Amendmentonlyprovidesprotectionsforentitiesthatobjecttoabortionsfor

religiousormoralreasons.

Response:TheDepartmentdisagrees.AsthetextoftheChurchAmendments

makesclear,whenCongresswantstolimitaprotectiontosituationsinwhichthe


159

protectedpartyactsorrefusestoactonthebasisofreligiousbeliefsormoral

convictionsspecifically(asdistinctfromotherreasons),itexplicitlyincludessucha

limitation.ThetextoftheCoats‐SnoweAmendment,unlikethetextoftheChurch

Amendments,doesnotincludeanysuchlimitation.Itencompassesobjections

concerningsuchactivitiesastraining,performing,providingreferralsfor,ormaking

arrangementsforreferralsforabortionsorabortiontraining,withoutspecifying

thattheobjectionsareonlyprotectediftheyarebasedonreligiousbeliefsormoral

convictions.LimitingtheapplicationoftheCoats‐SnoweAmendmenttoonly

situationsinwhichtheprotectedentityisactingonthebasisofreligiousbeliefsor

moralconvictionswouldbetoaddnarrowinglanguagetotheCoats‐Snowe

AmendmentthatCongressdidnotinclude.

Comment:TheDepartmentreceivedacommentstatingthatpartsof

proposed§88.3couldaffecttheabilityofindependentinstitutionstosetstandards

foraccreditationorlicensure.

Response:TheDepartmentagreesinpart.Asothercommentershavenoted,

onepurposeleadingtoenactmentoftheCoats‐SnoweAmendmentwastoprevent

statesfrombasingtheiraccreditationorlicensuredecisionsongroundsthat

eliminatemedicalschoolsortheirgraduatesfromthemedicalprofessiononthe

basisthattheyrefusetobeinvolvedinabortion.TheCoats‐SnoweAmendment

preventsstatesthatreceiveFederalfinancialassistancefromengagingin

discriminationthatwould,forexample,refuseaccreditationtomedicalschools,or

licensuretophysiciansornurses,becausetheydidnotprovidetrainingfor,trainon,


160

orperform,abortions.TheAmendmentdoesnotdirectlyregulateanynon‐

governmentalentity.Theamendment,however,wouldprecludeastatefromrelying

onaprivateentity’srefusaltoaccreditonthebasesjustdescribedinorderto,

amongotherthings,denyrecognitiontothemedicalschoolasamedicalschool,or

todenyrecognitionofthemedicaldegreeofagraduateofthatschool.

TheDepartmentfinalizes§88.3withotherchangesfromtheproposedrule

toincludelanguagefromthestatuteasfollows.Specifically,theproposedruledid

notreflect,assetforthinsubparagraph(b)(1)ofthestatute,that“thegovernment

involved,”meaningFederal,State,orlocal,“shallformulatesuchregulationsor

othermechanisms,orenterintosuchagreementswithaccreditingagencies,asare

necessarytocomplywiththissubsection.”Inresponsetocomments,the

Departmenthasincludedlanguageattheendof§88.3(b)(2)(ii)reflectingthis

relevantstatutorytext.



§88.3(b)withthefollowingchanges.

FurtherconsiderationledtheDepartmenttodeterminethattheproposed

textof§88.3(b)(1)(i)presentedconcernsregardingthescopeofentitiestowhich

theproposed§88.3(b)wouldapply.Accordingly,theDepartmentisfinalizing

§88.3(b)(1)(i)toread“TheDepartmentisrequiredtocomplywith”inlieuofthe

9483FR3880,3895(statingthereasonsfortheproposed§88.3(b),exceptforthemodificationsadoptedherein).


161

proposedrule’sstatementthat“TheFederalgovernment,includingtheDepartment,

isrequiredtocomplywith.”

TheDepartmentremovesreferencesto“individualorinstitutional”in§

88.3(b)(2)(i),inordertoavoidconfusionregardingthedefinitionoftheterm

“healthcareentity.”WhiletheDepartmentmakesthischange,itisnotintendedto

changethescopeofprotectionprovidedbytheCoats‐SnoweAmendment(andthis

finalrule)–namely,bothindividualsandorganizations(orinstitutions)that

constitutehealthcareentities.TheDepartmentalsoremovesareferenceto“require

attendeesto”in(b)(2)(i)(C)inordertomoreaccuratelytrackthelanguageofthe

statute.TheDepartmentfinalizes§88.3(b)(2)(ii)bychanging“anaccreditation

standardorstandards”to“accreditationstandards”andchanging“suchstandard

provides”to“suchstandardsprovide;”andadding“thatrequireanentityto”in

ordertomoreclearlyarticulatetherequirementsofthestatute.Finally,inorderto

fullyincorporatethetextoftheCoats‐SnoweAmendment,theDepartmentalsoadds

thesentence“Entitiestowhichthissubparagraph(b)(2)(ii)appliesandwhichare

involvedinsuchmattersshallformulatesuchregulationsorothermechanisms,or

enterintosuchagreementswithaccreditingagencies,asarenecessarytocomply

withthissubparagraph.”

Additionally,theDepartmentremovestheFederalgovernmentfromthe

applicabilitysectionin88.3(b)(1)(i)butleaves“theDepartment.”Althoughthe

relevantstatutoryprovisionappliestotheFederalgovernment,thisruleconcerns


162

theactivitiesandprogramsfundedoradministeredbytheDepartmentratherthan

theentireFederalgovernment.

88.3(c).WeldonAmendment.TheDepartmentreceivedcommentsonthis

paragraph,includingcommentsgenerallysupportiveoftheWeldonAmendment

andsupportiveoftheinclusionoftheWeldonAmendmentintheproposedrule,as

wellascommentsopposedtotheWeldonAmendmentitselfortheproposedrule’s

implementationoftheAmendment.

Comment:TheDepartmentreceivedcommentsonthedefinitionofterms

usedbytheWeldonAmendment,suchaswhatconstitutesa“healthcareentity.”All

suchcommentsareaddressedaboveintheresponsestocommentsondefinitions

under§88.2.

Comment:TheDepartmentreceivedcommentsstatingthattheWeldon

AmendmentdoesnotprovideauthorityfortheDepartmenttoimposeanyburdens

orobligationsonhealthcareentities,suchastherequirementofanassuranceof

complianceandthenoticerequirement.

Response:Assurancerequirementstoremedypastdiscriminationorprevent

futurediscriminationarecommonregulatoryfeaturesofanti‐discriminationlaws

likethosethatarethesubjectofthisruleandsuchauthorityhasbeenaffirmedby

theSupremeCourt.SeeGroveCityCollegev.Bell,465U.S.555(1984)(affirming

partialterminationofinstitution’sFederalfundsforrefusingtosignaTitleIX

assuranceofcomplianceform).Inresponsetocomments,theDepartmenthas

revisedtheproposednoticeprovisionsfrombeingarequirementtobeingone


163

factorthatOCRconsidersinitsdeterminationsastowhetheracoveredentityisin

violationofthispart.Commentsconcerningassuranceandnoticeprovisionsare

discussedinmoredetailbelowin§§88.4and88.5,proposingtoimposethose

provisions.


impermissiblyextendstheWeldonAmendmenttoapplytonon‐governmental

entities,andthattheproposedruledisagreeswiththepositiontakenbythe

governmentinNationalFamilyPlanningandReproductiveHealthAssociationv.

Gonzales,391F.Supp.2d200(D.D.C.2005),regardingwhethertheWeldon

Amendmentextendstonon‐governmentalentitiesthroughthoseentities’receiptof

Federalfinancialassistance.

Response:TheDepartmentagreesthat,asproposed,§88.3waswordedto

extendtheWeldonAmendmenttonon‐governmentalentitiesinwaysnot

encompassedbythetextoftheAmendmentaswritten.Thiswasduetothe

inclusionofsubparagraph(c)(1)(iii)inthatsection,whichrequiredcompliance

withtheWeldonAmendmentby“anyentity”thatreceivesfundstowhichthe

WeldonAmendmentapplies.Thissubparagraphwouldrendersuperfluous

subparagraphs(c)(1)(i)and(c)(1)(ii),whichrequirecompliancewiththeWeldon

AmendmentbytheDepartmentanditsprogramsandbyanyStateorlocal

governmentthatreceivesfundstowhichtheWeldonAmendmentapplies.The

Departmentisthereforefinalizingsubparagraph88.3(c)(1)byremoving

subparagraph(c)(1)(iii).


164

TheDepartmentnotes,however,thattheconductandactivitiesof

contractorsengagedbytheDepartment,aDepartmentalprogram,oraStateorlocal

governmentisattributabletosuchDepartment,program,orgovernmentfor

purposesofenforcementorliabilityundertheWeldonamendment.

Comment:TheDepartmentreceivedcommentsstatingthattheDepartment

cannotengageinpermanentrulemakingbasedonanannualappropriations

amendmentthatmayormaynotbereenactedwitheachappropriationsact.

Response:TheDepartmentdisagrees.TheDepartmenthasoutlined,above,

theauthoritythatitreliesupontopromulgateregulationscontainingthe

substantiverequirementsestablishedintheWeldonAmendment.TheDepartment

furthernotesthatithaspromulgatedrulesbasedontheWeldonAmendmentin

2008and2011andhasoperatedundersuchrulesbasedinpartontheannual

appropriationsamendmentcited.TheDepartmenthassimilarlyissuedregulations

toimplementannualappropriationsamendments,suchastheHydeAmendment.95

Subparagraphs88.3(c)(1)(i)and(c)(1)(ii)ofthisrulespecifythatcomplianceis

onlyeffective“underanappropriationsact...thatcontainstheWeldon

Amendment.”Therefore,theprovisionsofthisruleenforcingtheWeldon

AmendmentwillonlybeapplicabletoaStateorlocalgovernmentthatreceives

fundssubjecttosuchappropriation.IfCongressweretosubstantiallychangeornot

renewtheWeldonAmendment,thefinalrulewouldnotapplytothatextent.

95See,e.g.42CFR.441.202,441.203,441.206(prohibitingtheuseofFederalfundsunderMedicaidtopayforabortionsexceptwhencontinuationofthepregnancywouldendangerthemother'slife).


165


Amendmentcannotbeinterpretedtopreventstatesfromrequiringabortion

coverage,becausetheAffordableCareAct,at42U.S.C.18023(c)(1),states,“Nothing

inthisActshallbeconstruedtopreemptorotherwisehaveanyeffectonStatelaws

regardingtheprohibitionof(orrequirementof)coverage,funding,orprocedural

requirementsonabortions.”

Response:TheWeldonAmendmentisnotpartoftheAffordableCareAct.

Therefore,42U.S.C.18023(c)(1),whichstates,“[n]othinginthisAct”shallbe

construedtohaveaneffectonstatelawsrequiringabortioncoverage,doesnot

applytotheWeldonAmendment.Moreimportantly,ACA§1303alsoprovidesthat

“[n]othinginthisActshallbeconstruedtohaveanyeffectonFederallaws

regarding—(i)conscienceprotection;(ii)willingnessorrefusaltoprovideabortion;

and(iii)discriminationonthebasisofthewillingnessorrefusaltoprovide,payfor,

cover,orreferforabortionortoprovideorparticipateintrainingtoprovide

abortion.”42U.S.C.18023(c)(2).Inaddition,theWeldonAmendmenthasbeen

renewedmorerecentlythanCongressenactedtheAffordableCareAct,and

thereforeisgenerallyoweddeferenceifthetwolawsdidconflict,whichtheydonot.


Amendment,asevidencedbyitslegislativehistory,doesnotapplytorefusals

unrelatedtoconscience‐based(thatis,religiousormoral)objections,suchaspurely

financialoroperationalmotives.


166

Response:TheDepartmentdisagrees,forsimilarreasonsdescribedabovein

responsetocommentsarguingforanarrowinterpretationoftheCoats‐Snowe

Amendment.AsthetextoftheChurchAmendmentsmakesclear,whenCongress

wantstolimitaprotectiontosituationsinwhichtheprotectedpartyactsorrefuses

toactonthebasisofreligiousbeliefsormoralconvictions,itexplicitlyincludessuch

limitationinthetextofthestatute.ThetextoftheWeldonAmendment,unlikethe

textoftheChurchAmendments,doesnotincludeanysuchlimitation.Onitsface,the

WeldonAmendmentencompassesadecisionbyahealthcareentitynottoprovide,

payfor,providecoverageof,orreferforabortions,withoutspecifyingthatsuch

decisionsmustbebasedonreligious,moral,conscientious,oranyotherparticular

motive.LimitingtheapplicationoftheWeldonAmendmentonlytosituationsin

whichthehealthcareentityisactingonthebasisofconscientious,moralor

religiousconvictionswouldbetorefusetoapplytheWeldonAmendmentaccording

tothetextenactedbyCongress.

Comment:TheDepartmentreceivedcommentsaskingforclarificationthat

theWeldonAmendmentonlyapplieswithrespecttoabortions.

Response:TheDepartmentagreeswiththecommenter.Thetextofthe

proposedrulealreadymakesclearthat,asstatedinthetextoftheWeldon

Amendmentandasdescribedinthisrule,theWeldonAmendmentonlyprotects

againstdiscriminationonthebasisthatahealthcareentitydoesnotprovide,pay

for,providecoverageof,orreferforabortions.


167


rulewouldimpermissiblyextendtheWeldonAmendment’sprotectionbeyondthe

abortioncontexttoprotectrefusalstoprovide,payfor,providecoverageof,orrefer

for“anylawfulhealthservice.”

Response:TheDepartmentdisagrees.Nothingintheproposedruleorinthis

finalruleextendsprotectionsundertheWeldonAmendmentoutsideoftheabortion

context.As§88.3(c)(2)states,“Theentitiestowhomthissubparagraph(c)(2)

appliesshallnotsubjectanyinstitutionalorindividualhealthcareentityto

discriminationonthebasisthatthehealthcareentitydoesnotprovide,payfor,

providecoverageof,orreferfor,abortion”(emphasisadded).Theregulatory

provisionintheproposedruleandinthisfinalrulethatmakesreferenceto“any

lawfulhealthservice”addressesandwouldimplementsubparagraph(c)(2)ofthe

ChurchAmendments,whichprohibitscertaindiscriminationagainstaphysicianor

otherhealthcarepersonnelbecause,amongotherthings,“heperformedorassisted

intheperformanceofanylawfulhealthserviceorresearchactivity.”96



§88.3(c)asproposed,exceptforchangestothecitationtothemostcurrentPublic

LawwheretheWeldonAmendmentmaybefound,andtheremovalofproposed

96See42U.S.C.300a‐7(c)(2);compare45CFR88.3(a)(2)(v)(implementingChurch(c)(2)with45CFR88.3(c)(implementingWeldonAmendment).9783FR3880,3895(statingthereasonsfortheproposed§88.3(c),exceptforthemodificationsadoptedherein).


168

subparagraph(c)(1)(iii).Additionally,theDepartmentisaddingthephrase“andits

programs”after“theDepartment”totrackthestatutorylanguagemoreclosely.

88.3(d).MedicareAdvantage,DepartmentofDefenseandLabor,Health

andHumanServices,andEducationAppropriationsAct,2019andContinuing

AppropriationsAct,2019,Pub.L.115‐245,Div.B,sec.209.TheDepartmentdid

notreceivecommentsonthisparagraph.TheDepartmenthasupdatedthetitleof

thisparagraphforthemostrecentappropriationsriderforthecurrentfiscalyear.

Forclarityandaccuracy,in(d)(1),theDepartmentchanged“undertheMedicare

Advantageprogram”toread“withrespecttotheMedicareAdvantageprogram,”

andupdatedthecitationtherein.


rule98andabove,theDepartmentfinalizes§88.3(d)primarilyasproposed,but

updatestheheaderandcitationsin(d)(1)toreflectthecitationforthis

appropriationsrideforFY2019,andreplaced“under,”andadds“informsthe

Secretarythatit”forclarityin(d)(2).

88.3(e).Section1553oftheAffordableCareAct,42U.S.C.18113.The

Departmentreceivedcommentsonthisparagraph,includingcommentsgenerally

supportiveofsection1553oftheAffordableCareActandsupportiveofthe

inclusionofsection1553intherule,aswellascommentsopposingthatsectionand

theDepartment’senforcementofit.

9883FR3880,3895.


169

Comment:TheDepartmentreceivedcommentsstatingthatsection1553

cannotallowahealthcareprofessionaltoomitinformationabout“allchoices”

availableatend‐of‐lifebecauseapatienthasarighttobeinformed.

Response:TheDepartmentdisagreeswiththiscomment.Congressspecified

insection1553thatahealthcareentityisprotectedinitsdecisionnottoprovide

“anyhealthcareitemorservicefurnishedforthepurposesofcausing,orforthe

purposeofassistingincausing”assistedsuicide,euthanasia,ormercykilling.The

Departmentisunawareofanyfederalrequirementthatanindividualorhealthcare

entityprovideinformationaboutaservicethatitdoesnotprovide.Medicalethics

havelongprotectedrightsofconsciencealongsidetheprinciplesofinformed

consent.TheDepartmentdoesnotbelievethatenforcementofconscience

protections,manyofwhichdatetotheeraofRoev.WadeandDoev.Bolton,violates

orunderminestheprinciplesofinformedconsent.Infact,inRoetheSupremeCourt

favorablycitedanAmericanMedicalAssociationresolutiononabortionaffirming

“[t]hatnophysicianorotherprofessionalpersonnelshallbecompelledtoperform

anyactwhichviolateshisgoodmedicaljudgment.Neitherphysician,hospital,nor

hospitalpersonnelshallberequiredtoperformanyactviolativeofpersonally‐held

moralprinciples.”99Similarly,inDoetheCourtspokefavorablyaboutGeorgia’s

statutorylanguagegivingahospitalthefreedomnottoadmitapatientforan

abortion,andprotectingaphysicianorotherhospitalemployee“formoralor

religiousreasons”fromparticipatinginanabortionprocedure.100TheDepartment

99410U.S.at143–44.100410U.S.at197–98.


170

interpretssection1553asspecificallyencompassingthedecisionbyahealthcare

entitynottoprovideinformationabout,orreferralsfor,assistedsuicide.101

Comment:TheDepartmentreceivedacommentstatingthat,whileCongress

explicitlygrantedtheDepartmenttheauthoritytopromulgateregulationsto

implementsection1557oftheACA,Congressdidnotprovidesuchagrantfor

section1553,butonlygavetheDepartmenttheauthorityto“receivecomplaintsof

discrimination”undersection1553.

Response:AsdiscussedsupraatpartIII.A,multiplestatutesandregulations

authorizetheDepartmenttoissuetheserules—includingwithrespecttoACA

section1553—toensurethattheDepartmentandcoveredentitiescomplywith

Federalconscienceandanti‐discriminationlawsthatapplytocertainFederal

funding.Withrespecttosection1553specifically,thatsectionimposesspecific

provisions,includingconstructionprovisions,andmandatesthattheDepartment’s

OfficeforCivilRightsimplementsection1553byreceivingcomplaints.Thisrule

followsthatlanguageandprovidesDepartmentalmechanismsforactingupon

complaintsundersection1553.Suchauthorityisimplicitintheauthoritytoreceive

complaintssetforthin1553.Ifthatwerenotthecase,OCRwouldnotbeableto

complywithCongress’sdirectionundersection1553tohandleandrespondto

101Areferralisahealthcareservice,andthephrase“assistingincausing”isreasonablyinterpretedtocarrythesamemeaningas“assistinginperforming,”whichtheDepartmentinterpretstoincludetheactofreferring.


171

complaintsitreceives,makingtheauthoritydesignatedtoOCRinsection1553mere

surplusage,hollow,orinoperative.102

Thefactthatsection1557oftheAffordableCareActspecificallyauthorized,

butdidnotrequire,theDepartmenttoissueregulationstoimplementthatsection,

doesnotnegatetheauthorityCongressprovidedtheSecretaryunder5U.S.C.301

andtheotherstatutoryandregulatoryauthoritiescitedsupraatpartIII.Atocarry

outthedutiesCongressdesignatedtoOCRundersection1553oftheACA.In

particular,asdiscussedabove,section1321(a)oftheACAauthorizesthe

Departmentto“issueregulationssettingstandardsformeetingtherequirements

under[titleIoftheACA]withrespectto...theofferingofqualifiedhealthplans

throughsuchExchanges...and...suchotherrequirementsastheSecretary

determinesappropriate.”Section1321(a),thus,providestheDepartmentwiththe

authoritytoissueregulationssettingsettingstandardformeetingtherequirements

establishedinsection1553,whichispartoftitle1oftheACA.



§88.3(e)asproposedwithminortechnicalchangesforclarityandadherencetothe

textofsection1553oftheACA,forexamplechanging“anyamendment”to“an

amendment”andclarifyingthat“theAct”referstothe“PatientProtectionand

AffordableCareAct.”Subparagraph(1)(iv)clarifiesthattheamendmentwouldhave

102SeeHibbsv.Winn,542U.S.88,101(2004)(statutesshouldbeconstruedsoastoavoidrenderingsuperfluousanystatutorylanguage;“statuteshouldbeconstruedsothateffectisgiventoallitsprovisions,sothatnopartwillbeinoperativeorsuperfluous,voidorinsignificant....”).10383FR3880,3895.


172

been“madebythePatientProtectionandAffordableCareAct,”andsubparagraph

(2)deletes“provided,that.”

88.3(f).Section1303oftheAffordableCareAct,42U.S.C.18023.The

Departmentreceivedcommentsonthisparagraph,includingcommentsgenerally

supportiveofsection1303oftheAffordableCareActandsupportiveofthe

inclusionofsection1303intherule,aswellascommentscriticalofthisproposed

paragraph.

Comment:TheDepartmentreceivedacommentstatingthattheinclusionof

section1303oftheACAinthisruleisredundant,astheconscienceprotections

providedforinsection1303arealsoprovidedbyotherconscienceprotection

statutes,andbytheReligiousFreedomRestorationAct,42U.S.C.2000bbetseq.

Response:TheDepartmentdisagrees.Section1303containsseveraldistinct

provisionsrelatingtoconscienceandconscienceprotections,insection1303.While

section1303(c)(2)referencesandpreservestheapplicabilityoffederallaws

regardingconscienceprotection,104section1303(b)(1)and(b)(4)provide

standaloneconscienceprotectionsthatareindependentofotherfederalconscience

protectionprovisions.Whilethelanguageusedinsection1303(b)(1)and(b)(4)is

similartootherconscienceprotectionstatutes,theseprovisionsprovide

independentconscienceprotectionsbothwithrespecttogovernmental

requirementsofqualifiedhealthplans,andwithrespecttoqualifiedhealthplans’

10442U.S.C.18023(c)(2)(“[n]othinginthisActshallbeconstruedtohaveanyeffectonFederallawsregarding—(i)conscienceprotection;(ii)willingnessorrefusaltoprovideabortion;and(iii)discriminationonthebasisofthewillingnessorrefusaltoprovide,payfor,cover,orreferforabortionortoprovideorparticipateintrainingtoprovideabortion”).


173

discriminationagainstindividualhealthcareprovidersandhealthcarefacilities.

Additionally,wereotherFederalconscienceandanti‐discriminationlawstobe

revoked,theconscienceprotectionsinsection1303(b)(1)and(b)(4)oftheACA

couldremainineffect.TheDepartmentdoesnotpresumethatseparateFederal

conscienceandanti‐discriminationlawsenactedbyCongressareredundant.Itisa

principleofstatutoryconstructionthateffectshouldbegiventooverlapping

statutesaslongasthereisno“positiverepugnance”betweenthem.See,e.g.,

ConnecticutNat’lBankv.Germain,503U.S.249,253(1992).Andthereisnosuch

positiverepugnancehere.



§88.3(f)asproposed,withatechnicalcorrectiontoreflectthat42U.S.C.

18023(b)(1)(A)isaruleofconstructionregardingTitleIofthePatientProtection

andAffordableCareAct,ratherthanasubstantiveprohibition.Insubparagraph

(2)(i),theDepartmentclarifiesthattheentitiesshallnot“construeanythinginTitle

IofthePatientProtectionandAffordableCareAct(oranyamendmentmadeby

TitleIofthePatientProtectionandAffordableCareAct)to.”

88.3(g).Section1411oftheAffordableCareAct,42U.S.C.18081.The

Departmentdidnotreceivecommentsonthisparagraph.

TheDepartmentintended§88.3tofaithfullyapplythetextofapplicable

statutes,includingsection1411oftheAffordableCareAct,whileatthesametime,

10583FR3880,3895.


174

providingclaritytoregulatedpersonsandentities.Tothisend,thefinalrule

clarifiesin§88.3(g)(2)thattheDepartmentisrequirednotonlytoprovidea

certificationdocumentingareligiousexemptionfromtheindividualresponsibility

requirementandpenaltyundertheAffordableCareAct,whichappearedinthe

proposedrule,butalsotocoordinatewithStateHealthBenefitExchanges(State

Exchanges)intheimplementingofthecertificationrequirementsof42U.S.C.

18031(d)(4)(H)(ii)whereapplicable.TheDepartmentworkscloselywithState

ExchangestoimplementtheAffordableCareAct,andforclarity,thefinalrule

reflectsthatcoordination.Forsimilarreasons,theDepartmentmodified

88.3(g)(2)(i)toreflectchangesCongressmadeto26U.S.C.5000Athroughsection

4003oftheSUPPORTforPatientsandCommunitiesAct,whichbecamelawOctober

24,2018.106Thosechangesretainedareferencein26U.S.C.5000Ato26U.S.C.

1402(g)(1),whichsetsoutvariousconditionsforeligibilityfortheconscience

exemptionfromtheindividualresponsibilityrequirement.Amongthoseconditions

isarequirementthatthereligioussectordivisionthereoftowhichtheapplicantfor

theexemptionbelongsmusthavebeeninexistenceatalltimessinceDecember31,

1950.TheDepartmenthasomittedthisparticularrequirementfrom88.3(g)(2)(i)

outofconcernthatitmayconflictwiththeEstablishmentClause.

TheDepartmentunderstandsthatPublicLaw115‐97(December22,2017)

reducedthepenaltyin26U.S.C.5000Aforalackofminimumessentialcoverageto

106SUPPORTforPatientsandCommunitiesAct,Pub.L.No.115‐271,section4003,26U.S.C.5000A(d)(2)(2018).


175

zerodollars,107andthattheimplicationsofthislawisthesubjectofsubstantial

litigation.TheDepartment,nevertheless,believesitisprudenttoimplementthe

certificationrequirementsasproposedbecauseweunderstandthelawstillrequires

individualstosubmitproofofessentialcoverageorbecertifiedasexemptdespite

thepenaltybeingzeroedout.


rule108andabove,theDepartmentfinalizes§88.3(g)asproposed,withtechnical

correctionstoreflectthattheindividualstowhomtheDepartmentgrants

certificationsunder42U.S.C.18081areindividualswhohaveappliedforsuch

certificationsandtoensurethelanguagefollowsthatofthestatute,atypographical

correctiontochangethereferenceto“5000A(2)(B)(ii)”to“5000A(d)(2)(B)(i),”

modificationstocomportwithCongress’srevisionsto42U.S.C.5000A(d)through

theOctober24,2018,enactmentoftheSUPPORTforPatientsandCommunitiesAct,

whichbroadenstheapplicationoftheexemptionanddiscussesexclusions

regardingwhatconstitutesmedicalhealthservices,andtheDepartmentadds

clarificationfortheDepartmenttocomplywiththeapplicableprohibitionsin

coordinationwithStateExchanges.

88.3(h).Counselingandreferralprovisionsof42U.S.C.1395w‐

22(j)(3)(B)and1396u‐2(b)(3)(B)).TheDepartmentreceivedcommentsonthis

paragraph.

107BudgetFiscalYear,2018,Pub.L.No.115‐97,PartVIII,section11081,131Stat.2092(Dec.22,2017).10883FR3880,3895.


176

Comment:TheDepartmentreceivedacommentstatingthat,whilethe

statutorytextof42U.S.C.1395w‐22(j)(3)(B)and1396u‐2(b)(3)(B)established

rulesofconstruction,theproposedruleconvertedthesestatutesintofreestanding

exemptions.

Response:TheDepartmentagreesthattheproposedruleisworded

impreciselytotreat42U.S.C.1395w‐22(j)(3)(B)and1396u‐2(b)(3)(B)as

freestandingexemptions,ratherthanasrulesofconstructionassetforthinthe

statutorytext.TheDepartment,therefore,modifiesthefinalruleaccordinglyto

conformtothestatutorytext.



§88.3(h)(2)(i)byreferringtoregulationsthatalsoimplementthestatutes

containingtherequirementsandprohibitions,forexamplebyadding“construe42

U.S.C.1395w‐22(j)(3)(A)or42CFR422.206(a)to,”;bydeleting“offeraplanthat

provides,reimbursesfor,orprovides”andreplaceitwith“provide,reimbursefor,

orprovide,”;inserting“offeringtheplan”totheendofsubparagraph(2)(i);and

addingsubparagraph(h)(2)(i)(B)regardingmakinginformationavailableto

prospectiveenrolleesandenrollees.TheDepartmentalsomadechangesto

subparagraph(h)(2)(ii)bychangingthephrase“shallnotrequireaMedicaid

managedcareorganizationtoprovide”to“shallnotconstrue42U.S.C.1396u‐

2(b)(3)(A)or42CFR438.102(a)(1)torequire,”;deleting“objectstotheprovision

10983FR3880,3895(statingthereasonsfortheproposed§88.3(h),exceptforthemodificationsadoptedherein).


177

ofsuchserviceonmoralorreligiousgrounds,”;andaddingsubparagraphs

(2)(ii)(A)‐(B),(A)statingtheorganizationobjectsonmoralorreligiousgroundsand

(B)regardingthepoliciestoprospectiveenrolleesandenrollees.

88.3(i).AdvanceDirectives,42U.S.C.1395cc(f),1396a(w)(3),and14406.

TheDepartmentreceivedcommentsonthisparagraph.

Comment:TheDepartmentreceivedacommentstatingthat42U.S.C.

1395cc(f)requiresthatcertainentitiesmaintainwrittenpoliciesandproceduresto

informpatientsoftheir“individualrightsunderStatelawtomakedecisions

concerningsuchmedicalcare,includingtherighttoacceptorrefusemedicalor

surgicaltreatmentandtherighttoformulateadvanceddirectives,”buttheproposed

rule“attempt[s]torewritethisprovisionbyprohibitingthisstatutefrombeing

construedtorequirecoveredentitiestoprovidefullinformationtopatientsabout

servicestowhichtheymayobject.”

Response:TheDepartmentdisagrees.Thisfinalruleprovidesforthe

enforcementof42U.S.C.14406,whichstates,“...section1395cc(f)...shallnotbe

construed(1)torequireanyproviderororganization,oranyemployeeofsucha

providerororganization,toinformorcounselanyindividualregardinganyrightto

obtainanitemorservicefurnishedforthepurposeofcausing,orthepurposeof

assistingincausing,thedeathoftheindividual,suchasbyassistedsuicide,

euthanasia,ormercykilling....”Thisstatutorylanguageisadoptedalmostverbatim

into§88.3(i)(2)(i).Farfrom“attempt[ing]torewritethisprovision,”thisrule

merelyadoptsCongress’sruleofconstructionprovisionasCongressenactedit.


178

Comment:TheDepartmentreceivedcommentsstatingthatadvance

directivesshouldbefollowedregardlessofaphysician’spersonalobjections.

Response:Paragraph88.3(i)providesfortheimplementationand

enforcementofprovisionsat42U.S.C.1395cc(f),1396a(w)(3),and14406,which

assurethatapplicableFederallaws(relatingtoMedicareandMedicaid)arenot

usedcontrarytostatutetoprohibithealthcareprovidersfromexercisingtheir

rightsofconsciencewithrespecttoadvancedirectives,includingwithrespectto

assistedsuicide.Thisprovisiondoesnotaffectstatelawsgoverningthe

enforceabilityofadvancedirectives.But,ingeneral,theDepartmentbelievesthat

protectinghealthcareproviders’rightsofconsciencewithrespecttoadvance

directivesensuresthatdoctors,nurses,andotherpersonsinthehealthcare

industryarenotforcedtochoosebetweencontinuingtoserveashealthcare

providersandremainingfaithfultotheirdeepestconvictions.Suchconscience

protectionensuresdiversityinthehealthcareindustryandmaximizesthenumber

ofhealthcareprofessionalsintheUnitedStates,whichhelpsallpatients.



§88.3(i)withachangetocorrectatypographicalerrorin§88.3(i)(2)(i),where

“1395a(w)”shouldinsteadread“1396a(w)(3).”

88.3(j).GlobalHealthPrograms,22U.S.C.7631(d).TheDepartment

receivedcommentsonthisparagraph.

11083FR3880,3895.


179

Comment:TheDepartmentreceivedcommentsinoppositiontothe

Department’senforcementofFederalconscienceandanti‐discriminationlaws

outsideoftheUnitedStates,becausepopulationsservedbyU.S.foreignaidoften

havelessfinancialresourcesandaccesstofewermedicalprovidersthanpersonsin

theUnitedStates.

Response:TheDepartmentdisagreeswiththeunderlyingpremiseofthis

comment.Asdescribedabove,theDepartmentbelievesthatenforcingstatutory

consciencerightswillincrease,notdecrease,theavailabilityofqualitymedicalcare

becauseitwillpreventtheexclusionofhealthcareprofessionalsmotivatedbydeep

religiousbeliefsormoralconvictionstoserveothers,oftenthemost

underprivileged.Moreover,thisrulemerelyprovidesfortheenforcementoflaws

enactedbyCongressthat,bytheirownterms,mayapplyabroad.

Comment:TheDepartmentreceivedacommentstatingthattheprovisions

withrespecttoforeignpolicymayleadtoconfusionastowhichlawsproperly

governforeignaid.

Response:Uponreviewingthetextofthisparagraph,theDepartmenthas

revisedthelanguagetomakeitclearertowhichentitiestherequirementsapply,

andthecircumstancesinwhichtheyapply,andtomorecloselytrackthelanguage

enactedbyCongress.Theproposedrulewouldhaveappliedtherequirementsof

thisparagraphtotheDepartmentandrecipientsofrelevantfederalfinancial

assistance.However,22U.S.C.7631(d)doesnotimposerequirementsonwhat

recipientsofassistancecanandcannotdo;rather,itimposesrequirementsonthe


180

conditionsthatmaybeplacedonreceiptofassistance.Thestatutedoesnotprovide

adescriptionoftheentitiesthatthestatutegoverns—i.e.,entitiesthatareina

positiontoplaceconditionsonthereceiptofassistanceofassistance.The

Departmentbelievesthatclassofentitiesisbestdescribedasthosethatare

authorizedtoobligatetheassistance.Accordingly,theDepartmentismodifying

88.3(j)(1)toapplytotheDepartmentandentitiesthatareauthorizedbystatute,

regulation,oragreementtoobligateFederalfinancialassistanceundersection104A

oftheForeignAssistanceActof1961(22U.S.C.2151b–2),underChapter83ofTitle

22oftheU.S.CodeorundertheTomLantosandHenryJ.HydeUnitedStatesGlobal


2008,totheextentsuchFederalfinancialassistanceisadministeredbythe

Secretary,andisdeletingthereferenceregardingtheFederalfinancialassistance

being“forHIV/AIDSprevention,treatment,orcaretotheextentadministeredby

theSecretary.”



§88.3(j)withtechnicalchangesclarifyingthelanguageregardingtowhichentities

therequirementsapply,andthecircumstancesinwhichtheyapply,tomoreclosely

followthelanguageofsuchstatutesandamendmentsasenactedbyCongress,

eliminatingin(2)(i)“TotheextentadministeredbytheSecretary”andinserting

“Requireanorganization,includingafaith‐basedorganization,thatisotherwise

11183FR3880,3895(statingthereasonsfortheproposed§88.3(j),exceptforthemodificationsadoptedherein).


181

eligibletoreceiveassistance,”deleting“requireapplicantsfor”andreplacingitwith

“totheextentsuchassistanceisadministeredbytheSecretary,...asaconditionof

suchassistance.”TheDepartmentalsochanged“applicant”to“organization”and

removed“asaconditionofassistance”in(2)(i)(B),andmadesignificanteditsto

(2)(ii)foraccuracyregardingthestatutorytextandreferencestoother

subparagraphsofthispart.

88.3(k).TheHelms,Biden,1978,and1985Amendments,22U.S.C.

2151b(f);e.g.,ConsolidatedAppropriationsAct,2019,Pub.L.116‐6,Div.F,sec.

7018.TheDepartmentreceivedcommentsonthisparagraph.

Comment:TheDepartmentreceivedacommentstatingthattheprovisions

withrespecttoforeignpolicymayleadtoconfusionastowhichlawsproperly

governforeignaid.

Response:Uponreviewingthetextofthisparagraph,theDepartmenthas

revisedthelanguagetomakeitclearerastowhichlawsandamendmentsare

implicatedbythisparagraph,andtomorecloselytrackthestatutorylanguage

enactedbyCongress.Forclarity,theheadingoftheparagraphhasbeenrevisedto

refertoeachofthefourseparatestatutoryprovisionsimplementedbythe

paragraph,ratherthanonlytotheHelmsAmendment.Forconsistencywiththe

statute,theparagraphincludesanewsubparagraphinthe“Applicability”

subparagraphidentifyingasadistinctclassofcoveredentitiesthoseentitiesthat

areauthorizedtoobligateorexpendtheFederalfinancialassistanceinquestion,

separatefromentitiesthatmerelyreceivesuchFederalfinancialassistance.The


182

paragraphalsonowspecifiesthattheFederalfinancialassistanceinquestionfor

thisparagraphisthatwhichisappropriatedforthepurposesofcarryingoutpartI

oftheForeignAssistanceActof1961.

Theproposedrulewouldhaveappliedtherequirementsofthisparagraphto

theDepartmentandrecipientsofrelevantfederalfinancialassistance.However,22

U.S.C.2151b(f)andsection7018oftheConsolidatedAppropriationsActof2019

imposebothrequirementsonwhatrecipientsofassistancecanandcannotdoand

alsorequirementsontheentitiesprovidingthatassistancetorecipients.Thestatute

doesnotprovideadescriptionoftheentitiesthatprovideassistancetorecipients.

TheDepartmentbelievesthatclassofentitiesisbestdescribedasthosethatare

authorizedtoobligatetheassistance.Accordingly,theDepartmentismodifying

88.3(k)(1)toapplytotheDepartment,torecipientsofrelevantassistance,andto

entitiesthatareauthorizedbystatute,regulation,oragreementtoobligatethe

relevantassistance.Additionally,consideringthatthe1985Amendment112hasbeen

includedinannualappropriationsactsratherthancodifiedasastatute,the

Departmentismodifyingthedescriptionofcoveredentities’obligationsunder

88.3(k)(2)toclarifythattherule’sprovisionsregardingthe1985Amendmentapply

onlytofundsunderanappropriationsactcontainingthe1985Amendment.

112See,e.g.,theConsolidatedAppropriationsAct,2019,Pub.L.116‐6,Div.F,sec.7018(“NoneofthefundsmadeavailabletocarryoutpartIoftheForeignAssistanceActof1961,asamended,maybeobligatedorexpendedforanycountryororganizationifthePresidentcertifiesthattheuseofthesefundsbyanysuchcountryororganizationwouldviolateanyoftheaboveprovisionsrelatedtoabortionsorinvoluntarysterilizations.”)


183



§88.3(k)withtechnicalchangesclarifyingthecitationsandlanguageastowhich

statutesandamendmentsarereferenced,andtomorecloselyfollowthelanguageof

suchstatutesandamendmentsasenactedbyCongress,andaddingclaritythrough

citationstosubparagraphswithinthispart.

88.3(l).NewbornandInfantHearingLossScreening,42U.S.C.280g‐1(d).

TheDepartmentreceivedcommentsonthisparagraph.

Comment:TheDepartmentreceivedacommentaskingthattheruleinterpret

42U.S.C.280g‐1(d)toprovideanaffirmativeconscienceexemptionforparentswho

donotwanttheirchildrentoreceiveahearinglossscreening.

Response:42U.S.C.280g‐1(d)isaruleofconstructionthattheDepartmentis

unabletoconvertintoanaffirmativeexemption.TheDepartmentcan,however,

enforcesuchrulestoassurethatentitiesadministeringthestatutedonotmisapply

thestatutetothedetrimentoftheconsciencerightsofparentsandtheirchildren.


wouldendangerpublichealthbyprovidingconscienceprotectionsforparentsto

objecttocompulsorymedicalproceduressuchashearinglossscreenings.

Response:TheDepartmentdisagrees.42U.S.C.280g‐1(d)isaruleof

construction,andthisfinalruledoesnotconvertitintoanaffirmativeFederal

exemption.Thisrule’senforcementprovisionsdonotcreatearightforparentsto

11383FR3880,3895.


184

objecttoahearinglossscreeningfortheirchildrengenerallyorasagainstother

StateorFederallaws.Rather,theyonlypreventinterpretingthisFederallawto

overridestatelawsthatalreadyprovideareligiousexemptionregardingthe

screeningatissue.



§88.3(l)withminorchangestoensureclarityandconsistencywiththestatute,for

examplebydeleting“newborninfantsoryoung,”changingarticles,andmaking

otherminorchanges.

88.3(m).MedicalScreening,Examination,Diagnosis,Treatment,orOther

HealthCareorServices,42U.S.C.1396f.TheDepartmentreceivedcommentson

thisparagraph.

Comment:TheDepartmentreceivednumerouscommentssupportingthe

rule’sprovisionofenforcementmechanismsfor42U.S.C.1396f.

Othercommentersopposedtheenforcementmechanisms,allegingthey

createanaffirmativemandatethataStateagencythatadministersaStateMedicaid

Planmaynotcompelanypersontoundergoanymedicalscreening,examination,

diagnosis,ortreatmentifsuchpersonobjectsonreligiousgrounds.

Response:TheDepartmentdisagreeswithcommentersopposingthe

paragraph.42U.S.C.1396fisaruleofconstruction,andthisruledoesnotconvertit

intoanaffirmativeFederalexemption.Thisrule’senforcementprovisionsdonot

11483FR3880,3895.


185

createafreestandingrightforpersonsortheirfamiliestobefreetodeclinecertain

medicalscreeningsortreatments.Rather,theyonlypreventaninterpretationof42

U.S.C.1396fasrequiringstatestocompeltheacceptanceofsuchscreeningor

treatmentwhentheMedicaidstatutehasnosuchrequirement.



§88.3(m)asproposed.

88.3(n).OccupationalIllnessExaminationsandTests,29U.S.C.669(a)(5).

Comment:TheDepartmentreceivedcommentsgenerallysupportingthe

conceptofconscienceprotectionsforoccupationalmedicalexaminations,

immunizations,andtreatments,andothercommentsgenerallyopposingthat

concept.TheDepartmentdidnotreceivespecificcommentsonparagraph88.3(n)

oritsimplementationoftheruleofconstructiondescribedin29U.S.C.669(a)(5).

Response:AlthoughCongressgrantedHHSauthoritytoconductresearch,

experiments,anddemonstrationsrelatedtooccupationalillnessesinthe

OccupationalSafetyandHealthActof1970,suchauthoritydidnotincludethe

powertorequire“medicalexamination,immunization,ortreatmentforthosewho

objecttheretoonreligiousgrounds,exceptwheresuchisnecessaryforthe

protectionofthehealthorsafetyofothers.”29U.S.C.669(a)(5).TheDepartmentis

requiredtoabidebythislimitation,andconsidersitappropriatetoissueafinalrule

ensuringcompliance.

11583FR3880,3895.


186



§88.3(n)withminorchanges,forexample,deleting“Withrespecttooccupational

illnessexaminationsandtests,theentities”andreplacingitwith“Entities.”

88.3(o).Vaccination,42U.S.C.1396s(c)(2)(B)(ii).TheDepartmentreceived

commentsonthisparagraph.

Comment:TheDepartmentreceivedcommentssuggestingthatthescopeof

thisparagraphbeexpandedbeyondpediatricvaccinestoencompassallvaccines,or

thatitshouldbeexpandedtocreateapersonalrighttodeclinevaccinationsbased

onmoralorreligiousobjections.

Response:TheDepartmentisawareofcomplaintsassertingreligiousor

moralobjectionstoadministeringorreceivingvaccines,including,forexample,

objectionstoadministeringorreceivingvaccinesderivedfromabortedfetaltissue.

Becauseparagraph88.3(o)oftheruleprovidesenforcementmechanismsfor42

U.S.C.1396s,itisthereforelimitedtothescopeof42U.S.C.1396s.As42U.S.C.

1396sappliesonlytothepediatricvaccineprogramunderMedicaid(theVaccines

forChildrenProgram),theDepartmentisunabletoexpandthescopeofthis

paragraphbeyondsuchprograms.Likewise,as42U.S.C.1396srequirescompliance

withreligiousorotherexemptionsunderstatelawwithrespecttopediatric

vaccines,theDepartmentisunabletoexpandthisruleprovisiontopreemptstate

lawsthatdonotprovidesuchconscienceprotections.

11683FR3880,3895.


187

Comment:TheDepartmentreceivedcommentsaskingforclarificationasto

howtheproposedparagraph88.3(o)interactswithstatelawssuchasschool

immunizationrequirements.

Response:Uponreviewingtheproposedparagraph88.3(o),theDepartment

agreesthatthelanguagecanbeclarifiedregardinghowtheparagraphmight

interactwithstatelaw.TheDepartmentthereforefinalizes§88.3(o)tomore

accuratelyreflectthetextof42U.S.C.1396s(c)(2)(B)(ii)bychangingthe

applicabilityoftherequirementofsubparagraph88.3(o)(2)toreflectthestatute’s

requirementthat,underanyState‐administeredpediatricvaccinedistribution

program,theprovideragreementexecutedbyanyproviderregisteredtoparticipate

intheprogramincludestherequirementthattheprogram‐registeredprovider

complywithapplicableStatelaw,includinganysuchlawrelatingtoanyreligiousor

otherexemption.Inordertofurtherclarifythescopeof88.3(o),theDepartment

finalizesthisparagraphtospecifythatapplicableState“law”mayincludeState

statutory,regulatory,orconstitutionalprotectionsforconscienceandreligious

freedom,whereapplicable.



§88.3(o)withchangestoensureitfollowsthelanguageof42U.S.C.

1396s(c)(2)(B)(ii),whichappliestoprogram‐registeredprovidersofpediatric

vaccines,nottostatesgenerally,andtospecifythatapplicableStatelawmayinclude

11783FR3880,3895(statingthereasonsfortheproposed§88.3(o),exceptforthemodificationsadoptedherein).


188

Statestatutory,regulatory,orconstitutionalprotectionsforconscienceandreligious

freedom,whereapplicable.

88.3(p).SpecificAssessment,PreventionandTreatmentServices,42U.S.C.

290bb‐36(f),5106i(a).

Comment:TheDepartmentreceivedcommentsonthisparagraphexpressing

concernthattheprovisionofconscienceprotectionsforparentswhoobjecttoyouth

suicideassessmentsfortheirchildrenshouldbebalancedwiththerisktothechild’s

life.

Response:Paragraph88.3(p)isaruleofconstructionthatpreventspersons

orentitiesadministeringprogramsunder42U.S.C.290bb–36or42U.S.C.5106i(a)

fromrelyingontheparticularstatutesatissuetorequireassessmentsortreatments

thatconflictwithreligiousbelief.Theprovisionsinthisrulerelatedtothesestatutes

donot,however,preventorinterferewithanyotherStateorFederallawthat

reachesadifferent(orthesame)conclusiononthesequestions.

Inreviewingthisparagraphinlightofthecommentsreceivedonit,however,

theDepartmenthasdeterminedthatsubparagraph(p)(2)(iii)needstobemodified

tomorecloselytrackthestatutorylanguage,inordertoensureitoperatesasarule

ofconstructionconsistentwith42U.S.C.290bb‐36(f).



11883FR3880,3895(statingthereasonsfortheproposed§88.3(p),exceptforthemodificationsadoptedherein).


189

§88.3(p)withchangestosubparagraph(p)(2)(iii)tomorecloselytrackthe

languageof42U.S.C.290bb‐36(f),whichestablishesitasaruleofconstruction.

88.3(q).Religiousnonmedicalhealthcare,42U.S.C.1320a–1,1320c‐11,

1395i‐5,1395x(e),1395x(y)(1),1396a(a),and1397j‐1(b).TheDepartment

receivedcommentsonthisparagraph.

Comment:TheDepartmentreceivedcommentsopposedtotheprovisionof

Federalfundstoreligiousnonmedicalhealthcarefacilitiesbecausesuchfunding

couldbeinterpretedaslegitimatingsuchfacilities,resultinginpatientsofsuch

facilitiesnotseekingothertreatmentoptions.

Response:WhethertopermitFederalfundstobeusedtopayreligious

nonmedicalhealthcarefacilitiesforparticularservicesprovidedtoMedicareor

MedicaidbeneficiarieshasbeendeterminedbyCongressthrough42U.S.C.1320a‐1,

1320c‐11,1395i‐5,1395x(e),1395x(y)(1),1396a(a),and1397j‐1(b),andthe

Departmentisunabletoalterthatdecision.Thepurposeofincludingthese

provisionsintheproposedruleandthisfinalruleisonlytoprovideenforcement

mechanismsforthedeterminationofCongresswithrespecttofundingofreligious

nonmedicalhealthcarefacilities.Nevertheless,theDepartmentbelievesthatmostif

notallpersonswhomakeuseofreligiousnonmedicalhealthcarefacilitiesdoso

becausetheyholdreligiousobjectionstothereceiptofmedicalcareandwouldbe

unwillingtoseekothertreatmentoptionsregardlessofthereligiousnonmedical

healthcarefacilities’fundingstatus.


190

Comment:TheDepartmentreceivedcommentsexpressingconcernthat

providingconscienceprotectionsforattendeesofreligiousnonmedicalhealthcare

facilitiescouldpreventpeople,particularlychildren,fromaccessingnecessary

medicalhealthcare.

Response:Thisruleonlyprovidesforenforcementmechanismsfor

conscienceprotectionstatutesthatCongresshasenacted,anddeterminationsof

policymattersraisedbythesecommentsareoutsidethescopeofthisrulemakingto

theextenttheyconflictwithdecisionsmadebyCongress.Thatsaid,thisprovision

regardingreligiousnonmedicalhealthcaredoesnotpreventpeoplefromaccessing

care,butrather,hasaroleinenablingpeopletoaccesscarethatdoesnotviolate

theirreligiousbeliefs,whichwillbenefitallpatientpopulations,includingchildren.

Comment:TheDepartmentreceivedacommentstatingthatexempting

religiousnonmedicalhealthcarefacilitiesfromstatestandardsforcleanlinessand

qualityofcarepotentiallythreatensthequalityofcarethatattendeesofsuch

facilitiesreceive.Thecommenterproposedstrikingtheseprovisionsfromtherule

andensuringthatreligiousnonmedicalhealthcarefacilitiesadheretothesame

standardsasotherskillednursingfacilitiesandproviders.

Response:Requiringreligiousnonmedicalhealthcarefacilitiestoadhereto

thesamestandardsasotherskillednursingfacilitiesandproviderswould

contradictCongress’sdeterminationtoexemptreligiousnonmedicalhealthcare

facilities,asprovidedforin42U.S.C.1396a(a)andasupheldinChildren’sHealthcare

IsaLegalDuty,Inc.v.MinDeParle,212F.3d1084(8thCir.2000)(“[S]tateplans


191

maynotestablishstateagencyoversightofthequalityofcareprovidedinRNCHIs

[sic].”).TheDepartment,therefore,rejectsthisproposal.

Nonetheless,theDepartmentrecognizesthatthestructureanddescriptionof

therelevantexemptionsinparagraph88.3(q)wasunclearinmanyrespects,andso

theDepartmentmakessubstantialchangestothe“Requirementsandprohibitions”

tocorrectandclarifyparagraph88.3(q)tomoreaccuratelydescribetheactivities

fromwhichtheapplicablecoveredentitiesarerequiredtoexemptreligious

nonmedicalhealthcareinstitutions,includingachangetomorefullyincorporatethe

exemptionestablishedin42U.S.C.1396(a)(31).


exemptionsforreligiousnonmedicalhealthcarefacilitiesconcerningMedicarePart

AfundingbeexplicitlyappliedtoMedicareAdvantageaswellbecause,while

MedicareAdvantageisrequiredtoprovidecoverageforallservicesthatarecovered

byMedicarePartAandPartB,manyMedicareAdvantageorganizationsdonot

recognizereligiousnonmedicalhealthcare.

Response:Asnotedbythecommenter,becauseMedicareAdvantage

organizationsarerequiredtocoverservicescoveredbyMedicarePartsAandB

pursuantto42U.S.C.1395w‐22(a)(1)(A),theexemptionsforreligiousnonmedical

healthcarefacilitiesrelatedtoMedicarePartAfundingapplytoMedicare

Advantageaswell.Becausetheapplicabilitysubparagraphsofparagraph88.3(q)

followthestatutorylanguageconcerningreligiousnonmedicalhealthcare


192

exemptions,theDepartmentdeclinestoadoptthecommenter’ssuggested

modification.


rule119andabove,andconsideringthecommentsreceived,theDepartmentmade

significantchangestothestructureof§88.3(q)toclarifyapplicablestatutesand

subparagraphs,correcttypographicalerrors,andmorecloselytrackthestatutory

language.TheDepartmentmoreclearlyarticulateswhichsubparagraphsare

applicabletodifferententitiesby,forexample,changing“(q)(2)(i)through(iii)”so

thatitnowclearlystates“(q)(2)(i),(ii),(iii),and(iv).”TheDepartmentadded“(h)”

tothereferenceto42U.S.C.1320a‐1toclarifytheparticularparagraphcontaining

relevantinformation.TheDepartmentclarifiedin(1)(ii)thatsomestateagencies

arerequiredtocomply,in(1)(iii)thatentitiesreceivingFederalfinancialassistance

fromMedicarehavecomplianceobligations,andin(1)(iv)thatentitiesincluding

statesthatreceiveFederalfinancialassistancefromMedicaidhavecompliance

obligations,andin(1)(v)clarifiedtheauthorityrelatedtoanelder’srighttopractice

hisorherreligionthroughrelianceonprayeraloneissubtitleBofTitleXXofthe

SocialSecurityAct(42U.S.C.1397j–1397m‐5)andeliminatedwhatwasthelast

paragraphregardingtheElderJusticeBlockGrants.Theparagraphincorporates

multiplereferencesto42U.S.C.1395x(ss)(1),whichdefinesareligiousnonmedical

healthcareinstitution,toaddclaritytotheregulation.Theparagraphclarifiesthe

applicationofvariousprovisionstoentitiesthatmakeanagreementwiththe

11983FR3880,3895(statingthereasonsfortheproposed§88.3(q),exceptforthemodificationsadoptedherein).


193

SecretaryoftheDepartmentpursuantto42U.S.C.1320a‐1(b),orreceiveFederal

financialassistancefromMedicare,Medicaid,orSubtitleBofTitleXXoftheSocial

SecurityAct(42U.S.C.1397j–397m‐5).Last,theDepartmentremovedthe

referencesrequiringcompliancewith§88.5,ascompliancewiththatsectionisnow

voluntary.

AssuranceandCertificationofComplianceRequirements(§88.4)

Inthe“AssuranceandCertificationofCompliance”sectionoftheproposed

rule,theDepartmentproposedtorequirecertainrecipientsofFederalfinancial

assistanceorotherFederalfundsfromtheDepartmentorthattheDepartment

administerstosubmitwrittenassurancesandcertificationsofcompliancewiththe

Federalconscienceandanti‐discriminationlaws,asapplicable,aspartoftheterms

andconditionsofacceptanceofFederalfinancialassistanceorotherFederalfunding

fromtheDepartment.TheDepartmentstateditsbeliefthatbothanassuranceanda

certificationprovideimportantprotectionstopersonsandentitiesundertheselaws

andwouldbeconsistentwithrequirementsunderothercivilrightslaws.The

DepartmentnoteditsconcernthatthereisalackofknowledgeonthepartofStates,

localgovernments,thehealthcareindustry,andthepublicoftherightsofprotected

personsandentities,andthecorrespondingobligationsoncoveredentities

providedbyFederalconscienceandanti‐discriminationlaws.

Section88.4proposedtorequirecertainapplicantsforFederalfinancial

assistanceorotherFederalfundsfromtheDepartmenttowhichthispartappliesto

submitassurancesandcertificationsofcompliancewithFederalconscienceand


194

anti‐discriminationlawsandthispart.TheDepartmentproposedthatcovered

applicantsoperationalizetheassuranceandcertificationrequirementbyfiling

revisedversionsofapplicablecivilrightsforms,suchastheHHS‐690Assuranceof

ComplianceFormonceperyearandincorporatesuchfilingbyreferenceinallother

applicationssubmittedthatyear,ratherthanforeveryapplicationthatyear.Tothis

end,andasconsistentwithothercivilrightsregulationsrequiringassurancesor

certifications,theDepartmentproposedin§88.4(b)(6)topermitanapplicantto

incorporatetheassurancebyreferenceinsubsequentapplicationstothe

Department.Theproposedruleexplainedthatboththeassuranceandcertification

wouldconstituteaconditionofcontinuedreceiptofFederalfinancialassistanceor

otherFederalfundsfromtheDepartment.Withrespecttothecertificationrequired

inproposed§88.4(a)(2),proposed§88.4(b)(7)clarifiedthat,aswithotheranti‐

discriminationlaws,aviolationoftherequirementsofthecertificationmayresultin

enforcementbytheDepartment,asprovidedin§88.7ofthispart.

NotingtheneedtoincreasepublicawarenessofFederalconscienceandanti‐

discriminationlaws,theDepartmentsolicitedpubliccommentonthevarious

optionsavailableforpubliceducationandoutreach.

Proposedparagraph(b)identifiedspecificrequirementsfortheproposed

assuranceandcompliancerequirements:(b)(1)addressedthetimingtosubmitthe

assuranceforcurrentapplicantsorrecipientsasoftheeffectivedateofthispart;

(b)(2)addressedtheformandmannerofsuchsubmittals;and(b)(3)addressedthe

durationofobligationsforboththeassuranceandcertification.


195

Proposedsubparagraph88.4(b)(2)explainedthatapplicantswouldsubmit

assuranceandcertificationformsinanefficientmannerspecifiedbyOCR,in

coordinationwiththerelevantDepartmentcomponent,oralternativelyina

separatewriting.

TheDepartmentproposedthatitscomponentsbegivendiscretiontophase

inthewrittenassuranceandcertificationrequirementbynolaterthanthe

beginningofthenextfiscalyearfollowingtheeffectivedateoftheregulation.The

DepartmentstateditsintenttoworkwithrecipientsofFederalfinancialassistance

orotherFederalfundsfromtheDepartmenttoensurecompliancewiththe

requirementsorprohibitionspromulgatedinthisregulation.Iftheapplicantor

recipientwouldfailorrefusetofurnisharequiredassuranceorcertification,the

DepartmentproposedthatOCR,incoordinationwiththerelevantDepartment

component,wouldbeauthorizedtoeffectcompliancebyanyoftheremedies

providedin§88.7.SeeGroveCityCollege,465U.S.555(affirmingpartialtermination

ofinstitution’sFederalfundsforrefusingtosignaTitleIXassuranceofcompliance

form).

TheDepartmentalsoproposedthat,whilebothrecipientsandsub‐

recipients,asdefinedherein,mustcomplywiththesubstantiverequirementsof

Federalconscienceandanti‐discriminationlaws,asapplicable,sub‐recipientswould

notbesubjecttotherequirementsof§88.4regardingassuranceandcertifications

ofcompliance.TheDepartmentinvitedcommentonwhetherthisapproachstrikes

theappropriatebalancebetweenachievementofthisrulemaking’spolicyobjectives


196

andavoidanceofundueburdenonthehealthcareindustry.

Proposedparagraph88.4(c)alsocontainedseveralimportantexceptions

fromtheproposedrequirementsforwrittenassuranceandcertificationof

compliance,including(1)physicians,physicianoffices,andotherhealthcare

practitionersparticipatingonlyinPartBoftheMedicareprogram;(2)recipientsof

FederalfinancialassistanceorotherFederalfundsfromtheDepartmentawarded

undercertaingrantprogramscurrentlyadministeredbytheAdministrationfor

ChildrenandFamilies,whosepurposeisunrelatedtohealthcareprovisionas

specified;(3)recipientsofFederalfinancialassistanceorotherFederalfundsfrom

theDepartmentawardedundercertaingrantprogramscurrentlyadministeredby

theAdministrationonCommunityLiving,whosepurposeisunrelatedtohealthcare

provisionasspecified;and(4)IndianTribesandTribalOrganizationswhen

contractingwiththeIndianHealthServiceundertheIndianSelf‐Determinationand

EducationAssistanceAct.TheDepartmentsoughtpubliccommentonwhether

furtherexceptionsshouldbemadetotherequirementsof§88.4incontextswhere

therequirementswouldbeundulyburdensomeorincontextsunrelatedtohealth

careormedicalresearch.TheDepartmentreceivedcommentsonthissection,

includinggeneralcommentsinsupportofthissection.

Comment:TheDepartmentreceivedcommentsrequestingthatexemptions

forreligiousbeliefsormoralconvictions,suchasforvaccinations,beincludedin

formHHS‐690.


197

Response:TheDepartment’simplementationoftheassuranceand

certificationofcompliancewilladdresstheFederalconscienceandanti‐

discriminationlawsimplicatedbythisrule.Becausenoneofthestatutesthatthis

ruleimplementscreateacross‐the‐boardexemptionsonthebasisofreligiousbeliefs

ormoralconvictionstovaccinationrequirements,theassuranceandcertificationof

compliancerequirementdoesnoteither.

Comment:TheDepartmentreceivedcommentsrequestingthatany

assuranceofcompliancebeacquiredthroughformHHS‐690toavoidtheincreased

administrativeburdenofaddingnewformsorprocedures.

Response:TheDepartmentagreeswiththisproposalandisworkingtoobtain

PaperworkReductionActclearanceforupdatestotheHHS‐690formentitled

AssuranceofCompliance,whichpreviouslyhadOMBPRAclearanceasOMBNo.

0945‐0006.(TheDepartment’soperationalizationofthecertificationofcompliance

requiredin§88.4(a)(1)isdescribedintheRIAandPRAportionsofthisrule.)

TheHHS‐690formenablesanapplicanttoprovideanassurancethatitwill

complywithcertainFederalcivilrightslawsandregulations“inconsiderationof

andforthepurposeofobtainingFederalgrants,loans,contracts,property,

discounts,orotherFederalfinancialassistance”fromtheDepartment.120Bysigning

theassuranceofcompliance,theapplicant“agreesthatcompliancewiththis

assuranceconstitutesaconditionofcontinuedreceiptofFederalfinancial

120U.S.Dep’tofHealth&HumanServs.,AssuranceofCompliance,HHS690,https://www.hhs.gov/sites/default/files/hhs‐690.pdf.


198

assistance,andthatitisbindingupontheApplicant,itssuccessors,transfereesand

assigneesfortheperiodduringwhichsuchassistanceisprovided.”121

Asfinalized,section88.4(b)(1)requiresentitiesthatarealreadyrecipientsas

oftheeffectivedateoftheruleandapplicantstosubmittheassuranceandthe

certificationasaconditionofanyapplicationorreapplicationforfundstowhichthe

ruleapplies.Pursuanttothefinalized§88.4(b)(6),itwouldbepermissibleto

incorporateassurancesandcertificationsbyreferenceinsubsequentapplications,

whichisconsistentwiththeDepartment’sGrantsPolicyStatement,whichstates

thatbecauserecipientsfileanassuranceofcomplianceform“fortheorganization

and...not...foreachapplication,”arecipientwithasignedassuranceonfile

assuresthroughitssignatureontheawardapplicationthatithasasignedForm690

onfile.122

TheDepartmentproposedtoaddaprovisiontosubparagraph88.4(b)(1)

thatwouldrequiresubmissionoftheassurancemorefrequentlythanatthetimeof

applicationiftheapplicantorrecipientfailstomeetarequirementoftherule,orif

OCRortherelevantDepartmentcomponenthasreasontosuspectorcauseto

investigatethepossibilityofsuchfailure.Forinstance,OCRmayhavereasonto

suspectthroughitsinvestigationsorthenumberofcomplaintsreceivedthata

particularrecipientisnotcomplyingwiththeFederalconscienceandanti‐

discriminationlawsortheruleandconsequentlyaskstherecipienttosignan

121Id.122U.S.Dep’tofHealth&HumanServ.,HHSGrantsPolicyStatement,I‐31(Jan.2007),https://www.hhs.gov/sites/default/files/grants/grants/policies‐regulations/hhsgps107.pdf.


199

assuranceofcomplianceformoffcyclefromthenormalgrantsprocess.Toforgoas‐

neededassurancesoutsideoftheapplicationprocessjeopardizesOCR’sandthe

Department’sflexibilitytoensurethattheFederalfinancialassistanceorother

FederalfundsthattheDepartmentawardsareusedinamannercompliantwith

Federalconscienceandanti‐discriminationlawsandthisrule.


certificationofcompliancecontainadditionallanguage,suchasexplicitprotections

forLGBTpatients.

Response:Thescopeofthisruleandthecertificationsofcompliancesought

hereinarelimitedtotheFederalconscienceandanti‐discriminationlaws.

Certificationswithrespecttoothertopicsorlawsnotthesubjectofthisruleare

outsidethescopeofthisrulemaking.

Comment:TheDepartmentreceivedacommentstatingthatconditioning

receiptofFederalfinancialassistanceorFederalfundsonreceiptofanassurance

andcertificationisunnecessaryinlightoftheproposedenforcementmechanisms

providedby§88.7.

Response:TheDepartmentdoesnotagree.Thiscollectionofassurancesand

certificationswouldfacilitatetheDepartment’sobligationtoensurethattheFederal

financialassistanceorotherFederalfundsthattheDepartmentawardsareusedina

mannerthatcomplieswithFederalconscienceandanti‐discriminationlawsandthis

rule.TheDepartmentisaccountabletotheAmericanpublicforprotectingthe

integrityofFederalfinancialassistanceandotherFederalfundsthatthe


200

Departmentawards.TheDepartment’sadministrationofarequirementforaperson

orentityatthetimeofapplicationorreapplicationtoassureandcertifycompliance

withFederalconscienceandanti‐discriminationlawsandthefinalrule

demonstratesthatthepersonorentitywasawareofitsobligationsunderthose

lawsandtherule.

Inaddition,thiscollectionofassurancesandcertificationswould

operationalizetheobligationsofpersonsandentitiestocomplywithapplicable

Federalconscienceandanti‐discriminationlaws.Asdiscussedabove,the

Departmenthastheauthoritytoplacetermsandconditionswithrespecttothe

Federalconscienceandanti‐discriminationlawsinanyinstrumentHHSissuesorto

whichitisaparty(e.g.,grants,contracts,orotherHHSagreements).ADepartment

componentextendinganawardmustcommunicateandincorporatestatutoryand

publicpolicyrequirementsandobligatetherecipienttocomplywithFederalstatues

and“publicpolicyrequirements,including...those...prohibiting

discrimination.”123Morespecifically,theDepartmentcomponent“must

communicate...allrelevantpublicpolicyrequirements,includingthoseingeneral

appropriationsprovisions,andincorporatethemeitherdirectlyorbyreferencein

thetermsandconditionsoftheFederalaward.”124Toexecutethisobligation,the

Departmentalcomponentmayrequirearecipient“tosubmitcertificationsand

representationsrequiredbyFederalstatutes,orregulations....”125

12345CFR75.300(a).124Id.125Id.section75.208.


201

Furthermore,theproposedrequirementsof§88.4areconsistentwiththe

requirementsofotherFederalcivilrightslawsandwouldbringFederalconscience

andanti‐discriminationlawsintoparitywiththoseothercivilrightslaws.Although

institutinganenforcementactionagainstanentityiseffectiveinensuringthatthe

enforced‐againstentityisawareofitsrequirementsunderthestatutesimplemented

throughthisrule,therequirementofanassuranceandcertificationofcompliance

wouldensurethatsuchawarenessissharedbyentitiessubjecttoproposed§88.4

beforeviolationsoccurandmayhelppreventthem.

Comment:TheDepartmentreceivedacommentstatingthattherequirement

thatcoveredentitiesprovideassurancesandcertificationsofcompliancecouldlead

tothird‐partyquitamlawsuitsparalleltotheDepartment’senforcementactions.

Response:Whetherathird‐partymaybringorprevailinaquitamlawsuit

withrespecttoanassuranceorcertificationrequiredbythisruleisalegalquestion

dependentonstatutesandprecedentgoverningquitamlawsuitsandisbeyondthe

scopeofthisrulemaking.TheDepartmentdoesnotconsiderthepossibilitythat

suchlawsmayapplyasasufficientreasonnottorequireassuranceorcertification

ofcompliancewithFederalconscienceandanti‐discriminationlawsinorderto

achievethegoalsdescribedinthisFinalRuleforrequiringsuchassuranceor

certification.


ruleisunclearastowhetherapersonthatfallswithinoneoftheexemptcategories

describedinsubparagraphs88.4(c)(1)and(2)remainsexemptifsuchperson


202

receivesFederalfundsunderaseparateagencyorprogram.

Response:TheDepartmentdoesnotagreethattheproposedruleisunclear

astowhethersuchapersonwouldremainexempt.Proposedparagraph88.4(c)

statesthatcertainpersonsorentitiesshallnotberequiredtocomplywith

subparagraphs(a)(1)and(2)ofparagraph88.4(c)“providedthatsuchpersonsor

entitiesarenotrecipientsofFederalfinancialassistanceorotherFederalfunds

fromtheDepartmentthroughanotherinstrument,program,ormechanism,other

thanthosesetforthinsubparagraphs(c)(1)through(4)ofthisparagraph.”

Therefore,apersonwhowouldbeexemptunderoneoftheseprovisions,but

receivesFederalfinancialassistanceorotherFederalfundsfromanon‐exemptHHS

program,isnolongerexempt.

“Federalfinancialassistance”asusedinthephrase“Federalfinancial

assistanceorotherFederalfundsfromtheDepartment”shouldbereadtomean

suchassistancefromtheDepartment.Therefore,apersonthatfallswithinoneof

theexemptcategoriesdescribedinsubparagraphs88.4(c)(1)and(2)remains

exemptifsuchpersonreceivesFederalfinancialassistancefromanagencyor

departmentotherthanHHS.


ruleisunclearbecause,whiletherulestatesthatitisappropriatetoexempt

clinicianswhoarepartofStateMedicaidprograms,suchcliniciansarenotincluded

intheexemptionsofparagraph88.4(c).


203

Response:Theexclusioninparagraph88.4(c)doesnotneedtoexplicitly

exemptStateMedicaidprogramcliniciansbecausesuchparticipantsarealready

excludedfrom§88.4’sapplicationbyvirtueofbeingsub‐recipientsofthe

Department,notrecipients.StatesarethedirectrecipientsofMedicaidfundingfrom

theDepartment,andStatesmayofferMedicaidbenefitsonafee‐for‐service(FFS)

basis,throughmanagedcareplans,orboth.RegardlessofthemodelthattheStates

use,cliniciansaresub‐recipientsasthistermisusedinthisrule.Underthefee‐for‐

servicemodel,theStatepaysthecliniciansdirectlyandunderthemanagedcare

model,aStatepaysafeetoamanagedcareplan,whichinturnpaystheclinicianfor

theservicesabeneficiarymayrequirethatarewithinthemanagedcareplan’s

contractwiththeStatetoserveMedicaidbeneficiaries.126The2008Ruleexpressly

exemptedStateMedicaidprogramcliniciansbecausethecertificationrequirement

appliedtorecipientsandsub‐recipients;127incontrast,thecertificationrequirement

inthisruleappliestorecipientsonly.128

Comment:TheDepartmentreceivedacommentstatingthat,whilesome

pharmaciesandpharmacistsparticipateinMedicarePartB,theexemptionfor

healthcarepractitionersinparagraph88.4(c)doesnotexplicitlyinclude

126See,e.g.,ProviderPaymentandDeliverySystems,MACPAC,https://www.macpac.gov/medicaid‐101/provider‐payment‐and‐delivery‐systems/(lastvisitedJan.29,2019).12773FRat78101.128Compare2008Rule,73FRat78098(requiringsub‐recipientstoprovidetheCertificationofCompliancesetoutintheruleaspartofthesub‐recipient’soriginalagreementwiththerecipient)with§88.4(a)(1)–(2)infra(requiringanapplicantorrecipienttosubmitanassuranceandcertification).


204

pharmacistsandpharmacies,and“healthcarepractitioners”maynotbeunderstood

toincludepharmacistsorpharmacies.

Response:TheDepartmentagreeswiththecommenter’sobservationand,

accordingly,willfinalizesubparagraph88.4(c)(1)toexplicitlyincludepharmacists

andpharmacieswithintheexemptioniftheyparticipateinMedicarePartBandare

nototherwisesubjecttothispart.

Comment:TheDepartmentreceivedacommentaskingthattheexemptionin

paragraph88.4(c)beexpandedtoincludeparticipantsinMedicarePartCaswellas

PartB.

Response:Incontrasttodoctorsandotherhealthcarepractitionerswho

participateinMedicarePartBandareconsideredrecipientsunderthisrulebecause

theseprovidersreceivedirectpaymentsfromtheCentersforMedicare&Medicaid

Services,MedicarePartC(MedicareAdvantage)providersarenotrecipients,as

definedbythisrule,butinsteadaresub‐recipients.UndertheMedicarePartC

program,HHSmakespaymentstotheprivateplan,whichistherecipientforthe

purposeofMedicarePartC,andtheplanpaystheprovider,whichunderthisrule

wouldbeconsideredasub‐recipient.129Therefore,paragraph88.4(c)doesnotneed

toexemptMedicarePartCprovidersbecause,asathresholdmanner,the

assurancesandcertificationsrequirementof§88.4donotapplytoproviders

129SeeMedicareAdvantageProgramPaymentSystem,MEDPAC1(Oct.2016),http://www.medpac.gov/docs/default‐source/payment‐basics/medpac_payment_basics_16_ma_final.pdf(describingthepaymentsystem).


205

participatinginMedicarePartC.ThesameistrueofparticipantsinMedicarePart

D.130

Comment:TheDepartmentreceivedacommentaskingthattheassurance

andcertificationofcomplianceprovisionsbecomeeffectiveoneyearafterthefinal

ruleispublishedorprovideaone‐yearsafeharbortoentitiesthatmakeagoodfaith

efforttoinformtheiremployeesabouttheFederalconscienceandanti‐

discriminationlawsandcomeintocompliance.

Response:Althoughultimateresponsibilityforcomplianceresideswith

coveredentities,OCRplanstodosignificantoutreachandpubliceducationto

informcoveredentitiesoftheirobligationsandtimelines.Recipientsarealsofreeto

informtheiremployeesaboutFederalconscienceandanti‐discriminationlaws

throughpoliciesandproceduresorinternalcommunicationsefforts,suchasby

postingnoticesofrightsunderFederalconscienceandanti‐discriminationlaws,

usingthemodelinAppendixAto45CFRpart88.Section88.5ofthisrulenolonger

requiresrecipientstopostnotices,butOCRwillconsiderthepostingofnoticesas

non‐dispositiveevidenceofcomplianceifOCRweretoinvestigatetherecipients’

compliancewithFederalconscienceandanti‐discriminationlaws.Becausethe

noticeprovisionisbeingfinalizedasavoluntarybestpracticethatservesasnon‐

dispositiveevidenceofcompliance,thereisnodeadlineforpostingofnotices.


130Seeid.


206


§88.4withthefollowingchanges:achangetosubparagraph(b)(1),deleting

“applicantsorrecipients”andreplacingwith“entities”foraccuracy;achangeto

subparagraph(b)(1)toinsert“oranyapplicants”andtoinsert“applicationor”to

clarifythatnewapplicantsareincluded;achangetosubparagraph(b)(1),regarding

timing,toclarifythatsubmissionofassuranceandcertificationsmayberequiredon

amorefrequentbasisif“OCRortherelevantDepartmentcomponenthasreasonto

suspectorcausetoinvestigatethepossibilityof[a]failure”tomeetarequirementof

thispart;changestosubparagraph(b)(6)toclarifythatbothpriorassurancesand

certificationsmaybeincorporatedbyreference;achangetotheendof

subparagraph(b)(7)byaddingthephrase“includingbyreferraltotheDepartment

ofJustice,incoordinationwiththeDepartment’sOfficeofGeneralCounsel,where

appropriate”asdiscussedabove;achangetosubparagraph(b)(8)toreplace

“remedies”with“mechanisms”foraccuracy;andachangetosubparagraph(c)(1)to

includepharmaciesandpharmacistsinthelistofMedicarePartBexclusions.

NoticeofRightsunderFederalConscienceandAnti‐DiscriminationLaws(§

88.5)

TheNPRMproposedrequiringtheDepartmentandrecipientstonotifythe

public,patients,andworkforce,whichmayincludestudentsorapplicantsfor

employmentortraining,oftheirprotectionsundertheFederalconscienceandanti‐

discriminationlawsandthisrule.

13183FR3880,3896‐3897(statingthereasonsfortheproposed§88.4,exceptforthemodificationsadoptedherein).


207

Forconsistencywithothernoticerequirementsincivilrightsregulations,

paragraph(a)of§88.5proposedtorequiretheDepartmentandrecipientstopost

thenoticeprovidedinAppendixAoftheproposedrulewithin90daysofthe

effectivedateofthispart.Thisproposednoticewouldadvisepersonsandentities

abouttheirrightsandtheDepartment’sand/orrecipients’obligationsunder

Federalconscienceandanti‐discriminationlaws.Thenoticewouldprovide

informationabouthowtofileacomplaintwithOCR.TheDepartmentsought

commentonwhethertherearecategoriesofrecipientsthatshouldbeexempted

fromthisrequirementtopostsuchnotices.Theproposedruledidnotproposeto

requiresub‐recipientstopostthenotice.

TheproposedrulewouldrequireallDepartmentcomponentsandrecipients

tousethenoticetextinAppendixAoftheproposedrule.TheDepartmentinvited

commentonwhethertheproposedruleshouldpermitrecipientstodrafttheirown

noticesforwhichthecontentmeetscertaincriteriaanddoesnotcompromisethe

intentof§88.5.

Proposedparagraph(b)setforthtwocategoriesoflocationswherethe

noticewouldberequiredtoappear:ontheDepartment’sandrecipient’swebsite(s),

andinaphysicallocationofeachDepartmentandrecipientestablishmentwhere

noticestothepublicandnoticestotheirworkforcearecustomarilyposted.With

regardtothephysicalposting,subparagraph(b)(2)wouldimposereadability

requirementswithoutidentifyingprescriptivefont‐sizeorotherdisplay

requirements.


208

Proposedparagraph(c)wouldincentivizerecipientstodisplaythenoticein

locationsotherthantheirwebsitesandphysicalestablishments.TheDepartment

explainedthat,intheeventthattheOCRDirector,pursuanttotheenforcement

authorityproposedin§88.7,investigatesorinitiatesacompliancereviewofa

recipient,theOCRDirectorwouldconsider,asoneofmanyfactorswithrespectto

compliance,whethertherecipientpostedthenoticeinthedocumentsdescribedin

subparagraphs(c)(1)–(3),asapplicable.Becausethispartregulatesadiverserange

ofrecipients,theDepartmentidentifiedthreecategoriesofdocumentsmost

commonacrossallrecipientsforproposedlistinginparagraph(c).TheDepartment

soughtcommentontheproposedapproachofparagraph(c)andonthecategories

ofdocumentsidentifiedinsubparagraphs(c)(1)–(3).

Finally,paragraph(d)of§88.5proposedtopermitrecipientstocombinethe

textofthenoticerequiredinparagraph(a)withothernoticesunderthecondition

thattherecipientsretainallofthelanguageprovidedinAppendixAoftheproposed

ruleinanunalteredstate.TheDepartmentrequestedcommentonwhetherthe

proposedparagraph(d)struckthebestbalancebasedonrecipients’experiences.

TheDepartmentreceivedcommentsonthissection,includingcommentsthatwere

generalexpressionsofsupportoroppositiontoproposed§88.5.

Comment:TheDepartmentreceivedcommentsobjectingtotheburdensof

requirednotices,andstatingthatnoneoftheFederalconscienceandanti‐

discriminationlawsgivetheDepartmentauthoritytoissuethenoticerequirements

of§88.5.


209

Response:TheDepartmenthasconsideredtheseandothercomments

objectingtothenoticerequirementsoftheproposedrule.EachFederalconscience

andanti‐discriminationlawrequirestheDepartmentandcoveredentitiestocomply

withitssubstantiveprovisions.Noticeofrightsunderthoseprovisionsisan

importantmeansofensuringpropercompliance.Noticesarealsocommonlyusedin

ensuringcompliancewithotherFederalcivilrightsprotections.

Atthesametime,theDepartmentappreciatesthepotentialburdenofsuch

noticesandthefactthattheyarenotexplicitlyrequiredbystatute.Inresponseto

commentsconcerningnoticerequirements,theDepartmentisfinalizing§88.5to

changethenoticeprovisionfromarequirementtoavoluntaryactionandtoaccept

self‐draftingofnoticestoprovidegreatertailoringtoindividualcircumstances.

Ininvestigatingcomplaintsandinitiatingcompliancereviews,OCRwill

considertheextenttowhichentitiespostnotices,aswellastheinclusionofsuch

noticesinthetypeofdocumentsidentifiedintheproposedruleat§88.5(c),

accordingtotherule’snoticeprovisionsasnon‐dispositiveevidenceofcompliance

withthesubstantiveprovisionsofthisruleapplicabletosuchentities.Theexistence

ornotofpostedorpublishednoticesmayalsobeconsideredinthedeterminationof

potentialcorrectiveactionincasesofviolation.

TheDepartmentbelievesthatthechangeofthenoticeprovisionsofthisrule

fromarequirementtoavoluntaryactiontobeconsideredincomplaint

investigationsaddressesanyconcernsabouttheDepartment’sauthorityto

implementmandatorynoticeprovisions.Providingguidanceonnoticesand


210

consideringnoticeswithrespecttoenforcement,includingcorrectiveaction,are

mattersconcerningthegovernmentoftheDepartmentandtheperformanceof

DepartmentbusinessasauthorizedbytheauthoritiesdiscussedsupraatpartIII.A.

Comment:TheDepartmentreceivedacommentstatingthat,althoughthe

commenterapprovesofthenoticeproposedinAppendixAoftheNPRM,the

commenterbelievesthatrecipientsshouldbefreetodrafttheirownnoticeifthey

desire,solongastheyclearlystatewhatprotectionsareavailableunderthelaw.

Thecommenterproposesthatpermittingrecipientstodrafttheirownnoticewill

permitthemtotailorthenoticetotheiruniquesettingsandavoidpossible

unintentionalmisrepresentationsthatmayarisebasedontheirstatus.The

commenterproposesthatanysuchrecipient‐draftednoticecouldberequiredto

statewherethetextofAppendixAmaybefoundortoprovidesuchtextupon

request.

Response:TheDepartmentagreesthatrecipientsshouldbepermittedto

drafttheirownnoticessoastoavoidmisrepresentationsandtotailortheirnoticeto

theirparticularcircumstancesandismodifying§88.5toacknowledgeandaccept

self‐draftednoticestoprovidegreaterflexibility.

Comment:TheDepartmentreceivedacommentstatingthatrecipientsshould

notbepermittedtodeviatefromthetextoftheproposednoticeinAppendixA,

becausedeviationsfromthetextofAppendixAcoulddescribeFederalconscience

andanti‐discriminationlawsinsubtlyincorrectmannersandtheDepartmentwould


211

beforcedtoexpendadditionalresourcestodeterminewhethermyriadnoticesare

accurate.

Response:WhiletheDepartmentagreesthatafixednoticeavoidstheconcern

thatarecipient‐draftednoticewillsubtlymisstatetheprotectionsprovidedbythe

ruleandmitigatesthetimeandexpenseofensuringthatself‐draftednoticesare

accurate,theDepartmentisconvincedbyothercommentersthatpermitting

recipientstodrafttheirownnoticesispreferable,soastoprovidegreaterflexibility

andavoidstatementsthatmightbefalseormisleadinginthecontextof,and

consideringthestatusof,aparticularrecipient.Totheextentthatcoveredentities

misstatestatutoryprotectionsinthedraftingoftheirownnotices,theyrisksuch

misstatementbeingconsideredbytheDepartmentnegativelyduringcomplaint

investigationorcompliancereviews.

Comment:TheDepartmentreceivedacommentstatingthatrecipientsshould

bepermittedtocombinethisnoticewithothernotices.

Response:Undertheproposedparagraph88.5(d),anentitywouldbe

permittedtocombinethisnoticewithothernotices“ifitretainsallofthelanguage

providedinAppendixAofthispartinanunalteredstate.”BecausetheDepartment

hasmadethenoticeprovisionvoluntaryandpermitsrecipientstodrafttheirown

notices,therequirementthatsuchcombinationmaintainthelanguageofAppendix

A“inanunalteredstate”isremoved.

Comment:TheDepartmentreceivedcommentsstatingthatrequiringthatthe

noticesbepostedbyApril26,2018,isunreasonable.TheDepartmentalsoreceived


212

commentsaskingthat§88.5notberequireduntiloneyearafterthefinalruleis

published.

Response:Becausethenoticeprovisionisbeingfinalizedasavoluntary

practicethatservesasnon‐dispositiveevidenceofcomplianceininvestigationsand

compliancereviews,thenoticeprovisionnolongerhasatimeframeinwhichsuch

noticesmustbeposted.

Comment:TheDepartmentreceivedcommentsstatingthatthebroad,

generallanguageproposedinAppendixAcouldleadahealthcareproviderto

believethattheymayviolateFederalnon‐discriminationlawsortheEmergency

MedicalTreatmentandActiveLaborAct.

Response:TheDepartmentdisagrees.Thebroadnatureoftheproposed

languageinAppendixAspecificallyavoidsimplyingthatprovidershavea

categorical,unconditionalrightunderFederallawtoexerciseconscientious

objections.Thenoticetextisclearthatonly“certainhealth‐carerelatedtreatments,

research,orservices”arecoveredbytheFederalconscienceandanti‐discrimination

laws,andonlystatesthatproviders“may,”inagivencircumstance,beprotectedby

therule.NothinginthelanguageoftheproposednoticestatesthatotherFederal

lawsarewaived.TheAppendixcontinuestoserveasavalidmodelnotice.


noticeshouldrequirementionofanexemptionforvaccinations.

Response:Asstatedabove,theDepartmenthaschangeditsapproachtothe

noticeprovisions,andtheyarenowvoluntaryandflexible.Inaddition,withrespect


213

tovaccination,thisruleprovidesforenforcementof42U.S.C.1396s(c)(2)(B)(ii),

whichrequiresprovidersofpediatricvaccinesfundedbyFederalmedicalassistance

programstocomplywithanyStatelawsrelatingtoanyreligiousorother

exemptions,butthisruledoesnotcreateanewsubstantiveconscienceprotection

concerningvaccination,nordoesitrequireaStatetoadoptsuchanaccommodation.

Ininvestigatingacomplaintorconductingacompliancereview,OCRwillconsider

anentity’svoluntarypostingofanoticeofnondiscriminationasnon‐dispositive

evidenceofcompliancewiththeapplicablesubstantiveprovisionsofthispart,to

theextentsuchnoticesareprovidedaccordingtotheprovisionsofthissectionand

arerelevanttotheparticularinvestigationorcompliancereview.

Comment:TheDepartmentreceivedacommentstatingthatthestatutes

referencedbytheproposednoticeinAppendixAdonotapplytohealthplan

employeesand,thus,theproposednoticeisoverlybroad.

Response:WhiletheDepartmentdisagreesthatthestatutesreferencedbythe

proposednoticecannotapplytohealthplanemployees,theDepartmentagreesthat

theproposedAppendixAcouldbemisleadingforaparticularentity,andhas

modifiedboth§88.5toprovidegreaterflexibilityastocontentandAppendixAto

provideamoreaccuratemodelnoticeastotheprotectionsprovidedbytheFederal


Comment:TheDepartmentreceivedacommentstatingthatifapatientsees

theproposednotice,suchpatientmaybelesslikelytoengageinopenconversation

withthepatient’shealthcareproviderforfearthatserviceswillbedenied.


214

Response:TheDepartmentdisagreesthatastatementoftherequirementsof

certainFederalcivilrightslawswilldiscouragepatientsfromengaginginopen

conversationwiththeirhealthcareproviders.First,theoverwhelmingnumberof

patient‐physicianinteractionsdonotinvolveissuesthatarelikelytoraisereligious

ormoralconsiderations.Second,knowingthathealthcareprovidersarefreeto

workaccordingtotheirownconsciencescouldencouragepatientstoengagein

openconversation,eitherbyraisingthesubjectwhereitmightnothaveotherwise

beendiscussed,orbecauseapatientmaypreferahealthcareproviderwithvalues

consistentwiththeirown.Third,asdiscussedpreviously,compliancewiththe

Federalconscienceandanti‐discriminationlawsandthisimplementingrulewould

likelyincreasethediversityofprovidersandhealthcareprofessionals,thus

providingpatientsmoretailoredoptionsandhigherqualityserviceonaverage.

Finally,theDepartmentdoesnotbelievethat,whenmembersofthepublicare

simplyinformedaboutFederallaws,theyaretherebydissuadedfromengagingin

conversationwiththeirhealthcareproviders.


wasunclearastowhoisresponsibleforpostingthenoticerequiredby§88.5.

Response:Paragraph88.5(a)statesthat“theDepartmentandeachrecipient”

shouldpostthenoticetext.Becausethenoticeprovisionsintherulewillnowbe

voluntary,thisprovisionisdeletedfromparagraph88.5(a)asfinalized.

Nevertheless,becausethevoluntarypostingofnoticesmaybeconsideredbythe

Departmentinitshandlingofcomplaintsandcompliancereviews,entities


215

specificallysubjecttothisrule(suchascertainrecipientsofFederalfunds)wouldbe

theappropriatepartiesforensuringthatsuchnoticesarepostediftheychoseto

postthem.

Comment:TheDepartmentreceivedcommentsstatingthathealthinsurance

issuersshouldnotberequiredtoprovidethenoticetothepublic.

Response:Totheextentthecommenterstookthispositionbecausetheydid

notbelievethattheprotectionsoftheFederalconscienceandanti‐discirmination

lawswouldapplytohealthinsuranceissuers,theDepartmentdisagreeswithsuch

assumption.Thenoticeprovisionisbeingfinalizednotasarequirement,butas

guidanceonbestpracticesthattheDepartmentwillconsiderincomplaint

investigationandcompliancereviews.CertainFederalconscienceandanti‐

discriminationlawsclearlyimplicatehealthinsuranceissuers;accordingly,in

investigationofcomplaintsorcompliancereviewsinvolvinghealthinsurance

issuers,theDepartmentmayconsiderwhethertheissuerhaspostedsuchanotice

asnon‐dispositiveevidenceofcompliancewiththerule.Ifahealthinsuranceissuer

issubjecttoprovisionsoftherule,asatleastsomewillbe,noticeprovidedbyan

insurertobothitsemployeesandthepublicareappropriatefactorstoconsideras

evidenceofcompliancewiththisrule.

Comment:TheDepartmentreceivedacommentstatingthatrequiringthe

proposednoticetobedisplayedinemergencyroomsmayviolatetheEmergency

MedicalTreatmentandActiveLaborActbecausepatientswhoseethenoticemay

leavebeforetheyaretreated.


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Response:TheDepartmentdisagrees.Theregulationsenactedunderthe

EmergencyMedicalTreatmentandActiveLaborActat42CFR489.20(q)(1)require

thatpublicnoticesbepostedinemergencyroomstoinformpatientsofthe

requirementsofEMTALA.Furthermore,whiletheDepartmentdisagreesthata

noticeofFederalconscienceandanti‐discriminationlawswouldinanyway

discourageapatientseekingemergencytreatment,apatient’svoluntaryrefusalto

seektreatmentwouldnotbeaviolationofEMTALA.

Comment:TheDepartmentreceivedacommentproposingthat,insteadof

specifyingparticularlocationsforthenoticetobeplaced,theruleinsteadrequire

coveredentitiestoprovidethenoticeusingthesamemeansthatsuchentities

regularlyusetoprovideimportantnotices.

Response:TheDepartmentbelievesthattheproposedrule’sspecificitywith

respecttohowtoplacethenoticeprovidesappropriateguidanceonhowto

effectivelycommunicateitscontenttotheintendedaudiences.Becausethenotice

provisionsarenowvoluntary,butthepostingofsuchnoticeswouldbeconsidered

aspositiveevidenceofcompliance,coveredentitieswillhaveflexibilityregarding

whether,how,andwheretheypostnotices.Atthesametime,ifentitiespostnotices

onlyincontextsorwayswherepersonstowhomthenoticesaredirectedarenot

likelytoreceivethebenefitofthenotices,theDepartmentwilltakethatinto

considerationininvestigationsandcompliancereviews.Thenoticeprovisions

underthisfinalruleprovideappropriatesuggestionsforeffectiveplacementwhile

stillacknowledgingthatnotallcircumstancesareidentical.


217

Comment:TheDepartmentreceivedcommentsstatingthatthereshouldbe

noexceptionstothenoticerequirementin§88.5.

Response:TheDepartmentappreciatesthecomments,buthasdecidednotto

finalizethenoticeprovisionasarequirement.Thenoticeprovisionisbeingfinalized

asavoluntarybestpracticethattheDepartmentwillconsiderincomplaint

investigationandcompliancereviews.



§88.5withchangessothatnoticesarenotrequired,butwillbeavoluntarybest

practicethatmaydemonstratecomplianceinanyOCRinvestigation.Therule

specifiesthatOCRmay,ininvestigatingcomplaintsandconductingcompliance

reviews,considertheextenttowhichcoveredentitiespostnoticesaccordingtothe

rule’snoticeprovisionsasnon‐dispositiveevidenceofcompliancewithsubstantive

provisionsoftheruleapplicabletocoveredentities.Thesectionalsonowpermits

recipientstodrafttheirownversionofthenotice,ortocombinethenoticewith

othernon‐discriminationnotices,toallowgreateraccuracy,flexibility,andtailoring

totheirparticularcircumstances.TheDepartmentalsochangesthesectiontoreflect

that,whileguidanceregardingparticularplacementofnoticesremainsafactorfor

complianceconsiderationpurposes,allnoticeplacementprovisionsmaynotbe

applicableorappropriatetoallcoveredentities.TheDepartmentalsochangesthe

sectiontoremovetherequirementthatthenoticebepostedwithin90daysofthe



218

publishingoftherule,or,withrespecttonewrecipients,within90daysof

becomingarecipient,toreflectthatpostingofthenoticeisvoluntaryandthatthere

isnomandatedtimeframewithinwhichanoticemustbeposted.TheDepartment

alsochangesthesectiontoinclude,insubparagraphs(b)(3)–(4),“theDepartment”

inadditiontorecipients,foradditionalclarity.Finally,theDepartmentmakesa

technicalchangetorelocatetheproposedrule’sprovisionregardingthereadability

ofthenoticetextfromsubparagraph(b)(2)intheproposedruletosubparagraph

(b)(6)inthefinalrule.

ComplianceRequirements(§88.6)

Thissectionoftheproposedruleidentifiedspecificrequirementsfor

compliancewiththeFederalconscienceandanti‐discriminationlaws.The

Departmentproposedtosubjectrecipientstotheimpositionoffundingrestrictions

andotherappropriateremediesiftheyorasub‐recipientisfoundtohaveviolateda

Federalconscienceandanti‐discriminationlaw.TheDepartmentproposedto

requirerecipients,sub‐recipients,andagencycomponentstomaintainrecords

evidencingcompliancewiththeselawsandtheproposedruleandtorequiresuch

entitiestocooperatewithanyOCRcompliancerevieworinvestigation(includingby

producingdocumentsorparticipatingininterviews).Theproposedrulefurther

wouldrequirerecipientsandsub‐recipientstoinformanyDepartmentalfunding

component,andtodisclose,onapplicationsforDepartmentalfunding,theexistence

ofanyOCRcompliancereview,investigation,orcomplaintundertherule.This

sectionalsoaddressedclaimsintheeventacoveredentityintimidatesorretaliates


219

againstthosewhocomplaintoOCRorparticipateinorassistinanOCRenforcement

action.TheDepartmentreceivedcommentssuggestingimprovementstothis

section,aswellascommentsgenerallysupportingproposed§88.6.

Comment:TheDepartmentreceivedcommentsstatingthatitisunduly

burdensomeandunnecessarytorequirerecipientstoreporttotheDepartment

fundingcomponentallcompliancereviews,investigations,andcomplaintswhen

theyoccurandtodiscloseanycompliancereview,investigation,orcomplaintfor

fiveyearspriorinanyapplicationforneworrenewedFederalfinancialassistance

orDepartmentalfunding.Commentersnotedthatsuchrequirementsare

burdensomeonthecoveredentities,areunnecessaryifaninvestigationfoundno

violation,andrequirethecoveredentitytoprovidetheDepartmentwith

informationthattheDepartmentshouldalreadyhave.

Response:TheDepartmentagreesthatsuchreportingrequirementsare

unnecessaryinsituationsinwhichaninvestigationhasfoundnoviolation.The

Departmentalsoagreesthattheprovisionofsuchreportstofundingcomponentsof

theDepartmentforalreadyawardedFederalfinancialassistanceorDepartmental

fundingisunnecessarybecausetheOfficeforCivilRightscannotifysuchfunding

componentsatthetimesuchadeterminationofviolationismade.TheDepartment

disagreesthatsuchrecordsofviolationsareunnecessaryastofutureawardsof

FederalfinancialassistanceorDepartmentalfunding,becausetheDepartmentdoes

notmaintainrecordsofallsuchfindingsinamannerthatisgenerallyaccessibleto

fundingcomponentsacrosstheDepartment.


220

Therefore,theDepartmentisrevisingthereportingrequirementsunder§

88.6toreducetheburdenoncoveredentitiesandtoeliminatethereporting

requirementsinsituationsinwhichsuchreportsareunnecessaryorredundant

withactionsthatwillbetakenbytheDepartment.Thefinalruleretainsthe

requirementthatrecipientsorsub‐recipientssubjecttoadeterminationbyOCRof

noncompliancewiththispartmust,inanyapplicationforneworrenewedFederal

financialassistanceorDepartmentalfundingfollowingsuchdetermination,disclose

thedeterminationofnoncompliance.Therulealsoclarifiesthatapplicantsmustalso

discloseOCRdeterminationsmadeagainsttheirsub‐recipientsunderpreviousor

existingcontracts,grants,orotherinstrumentsprovidingFederalfinancial

assistance.Sub‐recipientswouldonlyhavetodisclosefindingsmadeagainstthemif

theyareseekingneworrenewedfundingasrecipientsofHHSfundsorfederal

financialassistance.Thefinalruleshortenstheperiodforreportingfromfiveyears

tothreeyears.

Comment:TheDepartmentreceivedcommentsstatingthatnoneofthe

Federalconscienceandanti‐discriminationlawsauthorizetheDepartmentto

requirerecord‐keeping,conductcompliancereviews,orinvestigatecomplaints.

Response:AsdiscussedsupraatpartIII.A,variousstatutesandregulations

authorizetheDepartmenttoissuetheseregulations.TheDepartment,andentities

towhichthisruleapplies,arerequiredbystatutetocomplywithvariousFederal

conscienceandanti‐discriminationlaws.InherentinCongress’sadoptionofthe

statutesthatrequiretherecipientsofFederalfundsfromtheDepartmenttocomply


221

withcertainFederalhealthconsciencestatutesistheauthorityoftheDepartmentto

takemeasurestoensurecompliance.Further,complaintinvestigation,compliance

reviews,andrecord‐keepingarestandardmeasuresthattheDepartmentemploys

withrespecttothegrantsandcontractsthatitissues—toensurecompliancewith

requirementsimposedbyCongresswithrespecttoparticularprogramsandon

recipientsofFederalfunds,includingstatutorynon‐discriminationrequirements.

Below,theDepartmentdiscussesinmoredetailobjectionstotheDepartment’s

authoritytoconductcompliancereviews.

Issuingthisruleasfinalizedprovidesfortheapplicationandimpositionof

standardDepartmentalterms,conditions,andprocedurestoensurecomplianceby

recipientswithstatutorynon‐discriminationrequirements,pursuanttothe

Department’sauthoritiesdiscussedsupraatpartIII.A.Thoseauthoritiesallow,

amongotherthings,theimpositionoftermsandconditionsongrantawards,

contracts,andotherfundinginstruments,andauthorizetheDepartmenttorequire

certaininformationfromentitiesapplyingforsuchfunds.

Comment:TheDepartmentreceivedcommentsrequestingmorespecificity

astohowlongrecordsshouldbemaintained,inwhatformormannertheyshould

bemaintained,andwhatcontentsuchrecordsshouldinclude.

Response:TheDepartmentagreesthatgreaterspecificityastotherecords

thatshouldbemaintained,howlongsuchrecordsshouldbemaintained,andin

whatformatsuchrecordsshouldbekeptisappropriate.ThereforetheDepartment

willfinalizetherulewithmodificationsspecifyingthatrecords(1)shallbe


222

maintainedforaperiodofthreeyearsfromthedatetherecordwascreated,was

lastinforce,orwasobtained,bytherecipientorsub‐recipient;(2)shallcontainany

informationmaintainedbytherecipientorsub‐recipientthatpertainsto

discriminationonthebasisofreligiousbelieformoralconviction,includingany

complaints;statements,policies,ornoticesconcerningdiscriminationonthebasis

ofreligiousbelieformoralconviction;proceduresforaccommodatingemployees’

orotherprotectedindividuals’religiousbeliefsormoralconvictions;andrecordsof

requestsforsuchreligiousormoralaccommodationandtherecipientorsub‐

recipient’sresponsetosuchrequests;and(3)maybemaintainedinanyformand

mannerthataffordsOCRwithreasonableaccesstotheminatimelymanner.These

modificationsareconsistentwithrecordkeepingrequirementsemployedinother

civilrightsregulations.Forexample,theDepartmentofJusticeimposedthree‐year

recordmaintenanceforself‐evaluations133requiredunderregulations

implementingsection504oftheRehabilitationAct,andtheDepartmentorthe

DepartmentofJusticeimposedsimilarrequirementsinregulationsunderTitleIIof

theAmericanswithDisabilitiesAct,theAgeDiscriminationActof1975,andTitleIX

oftheEducationAmendmentsof1972.134AndHHSregulationsunderTitleVI,Age

DiscriminationActof1975,andTitlesVIandXVIofthePublicHealthServiceAct

133See,e.g.,“Apublicentityshall,withinoneyearoftheeffectivedateofthispart,evaluateitscurrentservices,policies,andpractices,andtheeffectsthereof,thatdonotormaynotmeettherequirementsofthispartand,totheextentmodificationofanysuchservices,policies,andpracticesisrequired,thepublicentityshallproceedtomakethenecessarymodifications.”28CFR35.105(a).134See45CFR84.6(c)and85.11(c),28CFR35.105(c),45CFR90.43(b),and45CFR86.3(d),respectively.


223

generallyrequirethatarecipientmaintainrecordsnecessarytodeterminewhether

therecipienthascompliedwiththelaw.135


requirementsof§88.6notgointoeffectuntilatleastoneyearafterthepublication

ofthefinalrule.

Response:TheDepartmentbelievesthatcoveredentitieswillhavesufficient

timetobeginabidingbytherequirementsof§88.660daysafterthepublicationof

thisfinalrule.Totheextentthatentitieshavespecificreasonswhytheycannot

complywithinthattimeframe,theDepartmentwillconsiderexercisingenforcement

discretionandtakethosereasonsintoconsiderationduringanyinvestigationof

complaintsthatmayarise.

Comment:TheDepartmentreceivedcommentsrequestingthatthe

impositionoffundingrestrictionsorotherremediesonrecipientsbasedontheir

sub‐recipients’violationsofFederalconscienceandanti‐discriminationlawsbe

madediscretionaryinsteadofmandatorybecausesomerecipientsmayhavelimited

controlovertheirsub‐recipients.

Response:Aswithotheranti‐discriminationregulationsOCRenforces,such

astheAgeDiscriminationAct(45CFR90),TitleIX(45CFR86),andTitleVI(45CFR

80),thisruleassuresthatfederalfundschanneledfromrecipientstosub‐recipients

donotbecomeimmunetotheprotectionsprovidedbyconscienceandassociated

anti‐discriminationlaws.TheDepartment,however,agreesthattheruleshould

135See45CFR80.6(b),45CFR90.42(a)and91.31,and42CFR124.605(b),respectively.


224

reflectgreaterenforcementdiscretion,andwillfinalize§88.6(a)bychanging“shall”

withrespecttotheimpositionoffundingrestrictions“and”otherremediestoread

“may”and“or,”respectively.



§88.6withsubstantialchangesasdescribedabove,bymakingatechnicalcorrection

toprovideOCRwithgreaterenforcementdiscretionconcerningtheresponsibilityof

recipientsforviolationsoftherulebysub‐recipients,bychanging“shall”to“may”in

subparagraph(a);byprovidinggreaterspecificityastotherecordscoveredentities

arerequiredtomaintainandforhowlonginsubparagraphs(b)(1)‐(3);bymakinga

technicalcorrectiontoprovidegreaterclarityonhowacoveredentity’sfailureto

cooperatemayresultinanOCRreferraltotheDepartmentofJusticebyinserting“in

coordinationwiththeDepartment’sOfficeofGeneralCounsel”insubparagraph(c);

bymakingatechnicalcorrection,inkeepingwiththeDepartment’sintentfor§88.6

tomirrorTitleVIenforcementregulationswhereapplicable,toaddaprovision

regardingthetimeandmannerofOCR’saccesstorecords,andtheapplicabilityof

confidentialityandprivacyconcernstoOCR’saccessinsubparagraph(c);by

shorteningfromfiveyearstothreeyearsinsubparagraph(d)theperiodfor

disclosinginanyapplicationforneworrenewedFederalfinancialassistanceor

DepartmentalfundinganydeterminationbyOCRofnoncompliancetoreducethe

burdenoncoveredentities;byrevisingreportingrequirementsinsubparagraph(d)

13683FR3880,3898(statingthereasonsfortheproposed§88.6,exceptforthemodificationsadoptedherein).


225

toreducetheburdenoncoveredentitiesbyeliminatingreportingrequirementsin

situationsinwhichsuchreportsareunnecessaryorredundantwithactionstaken

bytheDepartment,suchasdisclosingtheexistenceofcomplaints,compliance

reviews,orinvestigationsinanyapplicationforneworrenewedFederalfinancial

assistanceorDepartmentalfunding;andbymakingatechnicalcorrectionattheend

ofsubparagraph(d)toclarifythatrecipientsdiscloseanyOCRdeterminationsmade

againsttheirsub‐recipients.

EnforcementAuthority(§88.7)

ThissectionoftheproposedrulereaffirmedthedelegationtoOCRofthe

Department’sauthoritytoenforcetheFederalconscienceandanti‐discrimination

laws,incollaborationwiththerelevantDepartmentcomponents.TheDepartment

alsonotedthatOCRhasbeenexpresslydelegatedtheauthoritytoenforcethe

Church,Coats‐Snowe,andWeldonAmendmentssincethe2008Rule,whichwas

reaffirmedinthe2011Rule.Enforcementofsection1553isalsoexpressly

delegatedtoOCRintheACA.TheNPRMprovidednoticethattheSecretary

delegatedtoOCRtheauthoritytoenforceallFederalconscienceandanti‐

discriminationlawsthatwerethesubjectoftheproposedrule.

ThissectionalsoproposedtospecifythatOCR’senforcementauthority

wouldincludetheauthoritytohandlecomplaints,performcompliancereviews,

investigate,andseekappropriateaction(incoordinationwiththeleadershipofany

relevantHHScomponent)thattheDirectordeemsnecessarytoremedythe

violationofFederalconscienceandanti‐discriminationlawsandtheproposed


226

regulation,asallowedbylaw.Theproposedtextof§88.7ofthispartwouldprovide

OCRdiscretioninchoosingthemeansofenforcement,frominformalresolutionto

morerigorousenforcementleadingto,forexample,fundingtermination,as

appropriatetotheparticularfacts,law,andavailabilityofresources.

TheDepartmentalsoproposedtoexplicitlyestablishitsauthorityto

investigateandhandle(a)allegedviolationsandconductcompliancereviews

whetherornotaformalcomplainthasbeenfiled,and(b)“whistleblower”

complaints,orcomplaintsmadeonbehalfofothers,whetherornottheparticular

complainantisapersonorentityprotectedbyFederalconscienceandanti‐

discriminationlaws.

Inthissectionoftheproposedrule,theDepartmentproposedtoadoptthe

enforcementproceduresforothercivilrightslaws,suchasTitleVIandsection504

oftheRehabilitationAct,fortheFederalconscienceandanti‐discriminationlaws.

TheDepartmentsolicitedcommentsonwhatadministrativeproceduresor

opportunitiesfordueprocesstheDepartmentshould,asamatterofpolicy,ormust,

asamatteroflaw,provide(1)withrespecttotheremedialandenforcement

measuresthattheDepartmentmayconsiderimposingorutilizinginresponsetoa

failureorthreatenedfailuretocomplywithFederalconscienceandanti‐

discriminationlawsorthispart,(2)beforetheDepartmentmayterminateFederal

financialassistanceorotherFederalfundsfromtheDepartment,or(3)beforethe

Departmentmayimplementanyoralloftheremedialmeasuresidentifiedin§

88.7(i)(3)oftheproposedrule.Forexample,commentwasrequestedonwhether


227

theproposedruleshouldestablishnotice,hearing,andappealproceduressimilarto

thoseestablishedintheDepartment’sregulationsimplementingTitleVIoftheCivil

RightsActof1964,at45CFR80.8–80.10.TheDepartmentalsorequestedcomment

onwhetherandinwhatcircumstancesitwouldbeappropriatetorequireremedies

againstarecipientfortheviolationsofasub‐recipient,oragainstentities’

subsidiariesthatarefoundtobeinviolationofanyFederalconscienceandanti‐

discriminationlawortheproposedregulation.

TheDepartmentreceivedcommentsonthissection,includingthose

generallysupportingtheproposed§88.7.

Comment:TheDepartmentreceivedcommentsstatingthattheFederal

conscienceandanti‐discriminationlawsdonotprovidetheDepartmentwiththe

authoritytoconductcompliancereviewsunderthesestatutesortoengageinthe

investigatoryactionsprovidedforin§88.7.TheDepartmentalsoreceiveda

commentstatingthatconductingacompliancereviewwithouthavingreceiveda

complaintisunreasonable.

Response:InherentinCongress’sadoptionofthestatutesthatrequirethe

recipientsofFederalfundsfromtheDepartmenttocomplywithcertainFederal

healthconsciencestatutesistheauthorityoftheDepartmenttotakemeasuresto

ensurecompliance.Thisisespeciallytrueinlightofthefactthatcourtshaverefused

torecognizeprivaterightsofactionundercertainstatutesthatarethesubjectof

thisrule,thusleavingvictimsofunlawfuldiscriminationwithnopossibleremedy

withouttheDepartment’sintervention.Further,underthevariousstatutesand


228

regulationsgoverningHHSgrants,contractsandotherprogramsdiscussedinpart

III.Aaboveconcerningtheauthoritytoissuethisrule,theDepartmenthasauthority

toensurethatbothit,andcoveredentities,arespendingFederalfundsand

operatingprogramsconsistentwithFederallawsapplicabletothosefundsand

programs.TheSecretarysimilarlyhasauthorityunder5U.S.C.301toprescribe

regulationsforthegovernmentoftheDepartmentandthedistributionand

performanceofitsbusiness.ProvidingforDepartmentalprocedurestoensure

compliance,includingtoundertakecompliancereviews,fallsundersuchauthorities.

Asfortheirreasonableness,compliancereviewsareastandardtoolfor

ensuringcompliancewithfederalnondiscriminationstatutes,despitethefactthat

mostfederalnondiscriminationstatutes,suchasTitleVIoftheCivilRightsActof

1964,donotexplicitlymentionthem.ExecutiveOrder12250directedtheAttorney

Generaltoimplementregulationsthataddressedinvestigationsandcompliance

reviewsforthefederalnondiscriminationstatutes.Theorderalsodirectedagencies

administeringfederalnondiscriminationstatutestoimplementdirectives,viaeither

policyguidanceorregulations,consistentwiththeAttorneyGeneral’sregulations.

RegulationssubsequentlypromulgatedbytheDepartmentofJusticeregarding

coordinationofTitleVIcompliance,pursuanttoExecutiveOrder12250,interpret

TitleVIasauthorizingfederalagenciestoconductcompliancereviewsforTitleVI

enforcement.See,e.g.,28CFR42.407(c)(1)(“Federalagenciesshallestablishand

maintainaneffectiveprogramofpost‐approvalcompliancereviewsregarding

approvednewapplications(see28CFR50.3(c)IIA),applicationsforcontinuation


229

orrenewalofassistance(28CFR50.3(c)IIB)andallotherfederallyassisted

programs.”).

Nevertheless,inordertoaddresstheseconcerns,theDepartmentis

finalizing88.7(c)withcertainchangestoclarifythatOCRmayconductcompliance

reviewsbasedoninformationfromacomplaintorothersourcethatcausesOCRto

suspectnon‐compliancebyanentitysubjecttotherule.

Comment:TheDepartmentreceivedcommentsstatingthat,toprovideclarity

forcoveredentitiesandtoensurefairnessofenforcement,potentialpenaltiesset

forthintheruleshouldbeclearanduniform.

Response:TheDepartmentagreeswiththiscommentinpart.Potential

penaltiesvaryamongtheFederalconscienceandanti‐discriminationlawsassetby

Congress.Inaddition,totheextentpenaltiesmaybeimposedinvoluntarily,

regulationssuchasthosethatapplytoHHSgrants,contracts,andCMSprograms

discussedaboveprovideawell‐establishedprocessforenforcingcompliancewith

thetermsandconditionsofgrantsandcontractsandprogrammaticregulationsthat

requirecompliancewithcertainnon‐discriminationprovisions.Consequently,in

ordertoincreasetheclarityanduniformityofinvoluntaryremedialprocesses

appliedthroughthisrule,theDepartmenthasconcludedthatpenaltiesimposed

involuntarilyunderthisrulewillbeimposedthroughthoseapplicableregulations,

suchas45CFRpart75,ortheFARandHHSAR.Thisispreferablebothtoan

independentframeworkmirroringthoseofTitleVIandsection504ofthe

RehabilitationAct,astheDepartmenthadproposed,andtoanewsetofuniform


230

penaltiesasthecommentermayhavebeenproposing.Underthisrule,intheevent

theDepartmentdeemsthatinvoluntaryremediesmaybeappropriate,OCRwill

coordinatewiththerelevantfundingcomponent(s)ofHHSinpursuingsuch

remedies.

Comment:TheDepartmentreceivedacommentstatingthatconductinga

compliancereviewwithouthavingreceivedacomplaintisunreasonable.

Response:TheDepartmentdisagrees.TheDepartment’sOfficeforCivilRights

routinelyconductscompliancereviewstoensurecoveredentitiesfollowthe

requirementsofotherFederalcivilrightslaws,aswellastheHealthInsurance

PortabilityandAccountabilityActof1996anditsassociatedregulations.137

ProvidingforcompliancereviewstoensurethatFederalconscienceandanti‐

discriminationlawsarenotviolatedbringstheDepartment’sabilitytoenforcesuch

lawsintoparitywithothercivilrightslawsthattheDepartmentenforces.

Comment:TheDepartmentreceivedcommentsstatingthatproposed§88.7

doesnotprovideforadequatedueprocess.

Response:TheDepartmentagreesinpart,andisfinalizingtheruletomake

useofremedialprocessesunderotherexistingHHSregulations.Asclarifiedherein,

whereOCRisnotabletoreachavoluntaryresolutionofacomplaintwithacovered

entity,involuntaryenforcementwilloccurbythemechanismsestablishedinthe

Department’sexistingregulations,suchasthosethatapplytogrants,contracts,or

CMSprograms,withOCRcoordinatingwiththerelevantfundingcomponent(s)of

13745CFR160.308.


231

HHS.Inthoseinstances,thedueprocessavailableundertheapplicableregulations

willbeavailabletocoveredentities.Forexample,45CFR75.374providesfor

opportunitiesforgranteestoobject,obtainhearings,andseekappealswhenthe

Departmentoracomponenttakearemedyforgranteenon‐compliance.Consistent

withthisapproach,thelanguageof88.7(a)isfinalizedwithchangestoclarifythat

theDirectorofOCRisauthorizedtopursuevoluntaryresolutionsofcomplaints,and

thatremedialactionbeyondthatwilloccurthroughcoordinationofOCRwith

fundingcomponents,consistentwithapplicablelawsandregulations.


penaltiesviolatetheSpendingClauseoftheConstitutionbecause,forCongressto

placeaconditiononreceiptofFederalfundsbyaState,theconditionplacedonthe

Statemustbeunambiguous,andtheamountinquestioncannotbesogreatthatit

canbeconsideredcoercivetotheState'sacceptanceofthecondition.

Response:TheDepartmentdisagrees.Thesubstantiverequirementsoflaws

enforcedbythisruleweresetforthbyCongress,andtheDepartmentisnotawareof

anysuccessfulSpendingClausechallengetosuchlaws,eventhoughsomeofthose

lawshaveexistedfordecades.TheDepartmentbelievestheconditionsand

requirementsimposedontheStatesbytheFederalconscienceandanti‐

discriminationlawsareunambiguous,andthattheserules,inmirroringthose

requirements,aresimilarlyclear.TheDepartmenthasprovidedacleardescription

ofentitiestowhicheachsuchstatuteapplies,andofwhatisrequiredofeachentity


232

in§88.3ofthisruleandelsewhere.Onlyafteraviolationhasbeenfoundshouldthe

questionoftheappropriateremedyavailableunderthelawbeanswered.

ItistheconsistentpolicyoftheFederalgovernmenttopresumethatstatutes

passedbyCongressandsignedbythePresidentareconstitutional.Funding

remediesincasesofviolationsunderthisrulewillbeappliedconsistentlywiththe

Constitutionandrelevantcaselaw.TheDepartment’sdecisiontofinalizethis

sectiontomakeuseofexistingremedialmechanismsunderlongstandingHHS

regulationsapplicabletocertainfundinginstruments,withOCRcoordinatingwith

HHSfundingcomponents,willalsoensurethatremediesimposedwillbeconsistent

withanyconstitutionalconcerns.

Comment:TheDepartmentreceivedacommentstatingthatreferraltothe

DepartmentofJusticeforadditionalenforcementisnotprovidedforinanyofthe

Federalconscienceandanti‐discriminationlaws.

Response:TheDepartmentofJusticeactsastheDepartment’srepresentative

incourt,andtheDepartmentroutinelyrefersmattersthatrequirelitigationonits

behalf,oronbehalfoftheUnitedStates,totheDepartmentofJusticeincludinglaws

enforcedbyOCR.Furthermore,entitiesthatmakeassurancesorcertificationsof

complianceunder§88.4,orthatmakeotherstatementsorproductionstothe

Departmentunderthispart,dosounderpenaltyof18U.S.C.1001(prohibiting

materiallyfalsestatementsregardinganagencymatter),violationsofwhichmay

warrantreferraltotheDepartmentofJustice.Additionally,theDepartmentof

Justicewouldbetheappropriatepartytoreceivereferralsofpotentialviolationsof


233

42U.S.C.300a–8whichimposescriminalpenaltiesonanyofficeroremployeeofthe

UnitedStates,orofanyentitythatadministersfederallyfundedprograms

(includingstates),andonanypersonreceivingfederalfinancialassistance,who

coercesorendeavorstocoerceanypersontoundergoanabortionorsterilization

procedurebythreateningsuchpersonwiththelossof,ordisqualificationforthe

receiptof,anybenefitorserviceunderaprogramreceivingFederalfinancial

assistance.Asaresult,theDepartmentfinalizestherulebyamendingparagraph

88.7(i)(renumberedasparagraph88.7(h))toclarifythatpossibleappropriate

referralstotheDepartmentofJusticeincludepotentialviolationsof42U.S.C.300a–

8and18U.S.C.1001.

Comment:TheDepartmentreceivedcommentsstatingthathealthcare

entitiesshouldnotbesubjecttothemechanismsin§88.7unlessadiscriminated‐

againstemployeehadprovidedpriornoticetotheentityoftheemployee’sreligious

beliefsormoralconvictions.

Response:WhiletheDepartmentencouragesemployersandemployeesto

openlydiscussreligiousandmoralconvictionsthatmayimpactwhichservicesor

taskstheemployermayaskofemployees,whereFederalconscienceandanti‐

discriminationlawsdonotrequirepriornoticeofreligiousbeliefsormoral

convictions,neitherdoesthisrule.Inothersituationsinvolvingreligious

accommodations,theSupremeCourthasheldthatnoticeisnotrequired.138

138See,e.g.,EEOCv.Abercrombie&FitchStores,Inc.,135S.Ct.2028,2033(2015)(statingthatimportationofanoticerequirementwould“addwordstothelaw”andthatapriorrequestforaccommodation“maymakeiteasiertoinfermotive,butisnotanecessaryconditionofliability.”).


234

Nevertheless,duringcomplaintinvestigationsandcompliancereviews,the

Departmenttakesintoconsiderationfactssuchaswhetherthecoveredentityknew

orshouldhaveknownabouttheobjection.

Comment:TheDepartmentreceivedacommentstatingthatimposingthe

penaltiesdescribedinsubparagraph88.7(j)(3)(renumberedassubparagraph

88.7(i)(3))onthebasisofa“threatenedfailure”tocomportwiththeFederal

conscienceandanti‐discriminationlawsisexcessive.

Response:TheDepartmentagreesandisremovingthephrase“threatened

failure”fromsubparagraph88.7(j)(3)(renumberedassubparagraph88.7(i)(3)).

Comment:TheDepartmentreceivedacommentstatingthat§88.7threatens

allfundingstreamsforanyviolationoftheFederalconscienceandanti‐

discriminationlaws.

Response:TheDepartmentdisagrees.Theonlyfundingstreamsthreatened

byaviolationoftheFederalconscienceandanti‐discriminationlawsarethefunding

streamsthatsuchstatutesdirectlyimplicate.TheDepartmentcannotterminate

fundingforviolationofaFederalconscienceoranti‐discriminationlawunless

Congresshasappliedthatlawtothatfunding.Section88.7isintendedtoprovidea

generaldescriptionoftherangeofpossibleenforcementmechanismsavailableto

theDepartment,notanexhaustivelistofactionstobetakenforeachviolationor

prescribedamounts.Terminationoffundingasapossibleremedyisanecessary

corollaryofCongressionalrequirementsthatcertainfundingnotbeprovidedto

entitiesthatengageinimpermissiblediscrimination.Nevertheless,OCRcommonly


235

investigatescomplaintsundercivilrightslawsthatpermitterminationoffunding

onafindingofaviolation,andyetOCRonlyrarelyimposesterminationoffunding

asapenaltyforsuchviolations.Forexample,underHIPAA,civilmonetarypenalties

arenotuncommon,althoughtheystillrepresenttheminorityofresolutionstocases

whereaviolationwasfoundtothesatisfactionoftheDepartment.Incivilrights

cases,complaintinvestigationsinwhichOCRfindsaviolationareusuallyresolved

bycorrectiveaction.Whatspecificremedyisappropriateinthecaseofaparticular

violationdependsonthefactsandcircumstances,andOCRdoesnotprejudgethose

factsinthisruletosuggestterminationoffundingwillbeeitheracommonoran

uncommonoutcome.TheDepartmentsimplyobservesthat,justbecausetherule

providesforterminationoffundingasapossiblecorrectiveaction,doesnotmean

thatfunding,eitherinwholeorinpart,willbeterminatedinallorevenmostcases.

ItwouldbeprematureandcontrarytothehistoryofOCRenforcementtodeemthis

ruleasarequirementthatOCRterminateall,orevensome,fundingofallentities

foundtohavecommittedaviolation.



§88.7bymakingthechangesdiscussedabove,whichincludeclarifyingthatOCR

willserveacoordinatingrolewithotherDepartmentcomponentswhenremedial

actionsarepursued,andsuchremedieswillbepursuedunderregulations

applicabletorelevantfundinginstruments,ratherthanunderanindependent



236

enforcementframeworksetforthinthisruleashadbeenproposed.Consistentwith

changesmadetothedefinitionof“discrimination”regardingtheapplicabilityof

disparateimpactanalysis,theDepartmentdeletesthephrase“toovercomethe

effectsofviolationsofFederalconscienceandanti‐discriminationlawsandthis

part”from§88.7(a)(8).TheDepartmentdeletesthephrase“fromtimetotime”

from§88.7(c)and,inplaceofthesentence“OCRmayconductthesereviewsinthe

absenceofacomplaint,”addsthesentence“OCRmayinitiateacompliancereviewof

anentitysubjecttothispartbasedoninformationfromacomplaintorothersource

thatcausesOCRtosuspectnon‐compliancebysuchentitywiththispartorthelaws

implementedbythispart.”TheDepartmentalsoaddscertaincriminalstatutesas

possiblebasesofreferralstotheDepartmentofJusticeunder§88.7(h);and

removesthephrase“threatenedfailure”from§88.7(j)(3)oftheproposedrule

(renumberedas§88.7(i)(3)inthisfinalrule).TheDepartmentalsomakesa

technicalcorrection,inordertomaintainconsistencyofterminology,toreplacethe

phrase“cashpayments”with“Federalfinancialassistance"in§88.7(j)(3)(i)ofthe

proposedrule(renumbered§88.7(i)(3)(i)inthisfinalrule);makestechnical

changesto88.7(a);addsreferencetocoordinationwiththeDepartment’sOfficeof

GeneralCounselto88.7(a)(6)and88.7(h);makesastylisticchangeto§88.7(d),

includingthedeletionof“healthcare,”“associated,”“the,”and“butnotlimitedto;”

removesproposed88.7(e),whichdiscusseddestructionofevidence;makesanedit

forclarityandreadabilitytorelocatethephrase“inwholeorinpart”within

subparagraph(i)(3)(v);forgreateraccuracyreplaces“createdbyfederallaw”with


237

“underfederallaworthispart”insubparagraph(i)(3)(vi);andinsertsanew

paragraph88.7(j)tospecificallyaddresshandlingofnoncompliancewith

assurancesandcertifications,asdiscussedabove.

RelationshiptoOtherLaws§88.8

Thissectionwouldclarifytherelationshipbetweenthispartandother

Federal,State,andlocallawsthatprotectreligiousfreedomandmoralconvictions.

Intheproposedrule,thepreambleforthissectionacknowledgedthatmanyState

lawsprovideadditionalconscienceprotectionsforproviderswhohaveobjectionsto

abortion,fertilitytreatments,sterilization,assistedsuicide,andeuthanasia,among

others.TheDepartmentproposedtoupholdthemaximumprotectionfortherights

ofconscienceandthebroadestprohibitionondiscriminationprovidedbyFederal,

State,orlocallaw,asconsistentwiththeConstitution.WhereaStateorlocallaw

providesasmuchorgreaterprotectionthanFederallawforreligiousfreedomand

moralconvictions,theDepartmentproposednottoconstrueFederallawto

preemptorimpairtheapplicationofthatlaw,unlessexpresslyprovided.

TheDepartmentnotedthattheproposedrulewouldnotrelieveOCRofits

obligationtoenforceothercivilrightsauthorities,suchasTitleVIoftheCivilRights

Actof1964,TitleIXoftheEducationAmendmentsof1972,theAgeDiscrimination

Actof1975,section504oftheRehabilitationActof1973,andtheAmericanswith

DisabilitiesActof1990.TheDepartmentaffirmedthatOCRwouldenforceallcivil

rightslawsconsistentwiththeConstitutionandthestatutorylanguage.The

Departmentreceivedcommentsonthissection.


238


conflictedwithotherFederallaws,suchasTitleXofthePublicHealthServiceAct,

thatwereraisedincommentsrelatedtootherprovisionsoftheproposedrule.

Response:Issuesofpotentialstatutoryconflicthavealreadybeenraisedby

othercommentsandansweredinresponsessetforthabove,sotheyarenot

repeatedhere.


violates42U.S.C.18114,asectionoftheACAthatstatesthat,notwithstandingany

otherprovisionofACA,theSecretaryshallnotpromulgateanyregulationthat

createsanyunreasonablebarrierstotheabilityofindividualstoobtainappropriate

medicalcare,impedestimelyaccesstohealthcareservices,interfereswith

communicationsregardingafullrangeoftreatmentoptionsbetweenthepatient

andtheprovider,restrictstheabilityofhealthcareproviderstoprovidefull

disclosureofallrelevantinformationtopatientsmakinghealthcaredecisions,

violatestheprinciplesofinformedconsentandtheethicalstandardsofhealthcare

professionals,orlimitstheavailabilityofhealthcaretreatmentforthefullduration

ofapatient’smedicalneeds.Suchcommentsarguedthattheproposedrulewould

violatethissectionbypermittingproviderstoobservetheirconscienceswhen

respondingtoapatient’srequestforaparticularmedicalserviceortreatment,or

whendeterminingwhetherornottoreferforaparticularmedicalserviceor

treatment,insteadofrequiringproviderstocomplywithsuchrequestsbypatients.

Response:TheDepartmentdisagrees.ACAsection1554,42U.S.C.18114,in


239

nowaynegatestheFederalconscienceandanti‐discriminationlawsenforcedby

thisrule.First,section1554islimitedtoregulationspromulgatedundertheACA.

OnlyaminorityofthelawsimplementedbythisrulearesetforthintheACA—most,

includingforexampletheChurchAmendments,theCoats‐SnoweAmendments,and

theWeldonAmendment,arenotpartoftheACA,andthereforeregulations

implementingthosestatutesarenotaffectedbysection1554.

Second,itisabasicprinciplethatCongress“doesnotalterthefundamental

detailsofaregulatoryschemeinvaguetermsorancillaryprovisions—itdoesnot,

onemightsay,hideelephantsinmouseholes.”Whitmanv.Am.TruckingAss’ns,531

U.S.457,468(2001).ItisimplausiblethatCongressintendedsection1554to

impliedlyrepealfederalconscienceprotectionswhensection1554containsno

referencetoconsciencewhatsoever—andwhen,atthesametimeandinthesame

legislation,Congressaddedseveralnewconscienceprovisions(e.g.,ACAsections

1303(b)(1)(A)and(b)(4),1553),aswellasaprovisionthatnothingintheACAshall

beconstruedtohaveanyeffectonFederallawsregardingconscienceprotection;

willingnessorrefusaltoprovideabortion;anddiscriminationonthebasisofthe

willingnessorrefusaltoprovide,payfor,cover,orreferforabortionortoprovide

orparticipateintrainingtoprovideabortion(e.g.,ACAsection1303(c)(2)).

Third,“itisacommonplaceofstatutoryconstructionthatthespecific

governsthegeneral,”Moralesv.TransWorldAirlines,Inc.,504U.S.374,384(1992).

EachFederalconscienceandanti‐discriminationlawenforcedbythisruleismore

specifictoeachsetofcircumstancesthanissection1554,sothat,totheextentthere


240

couldbeapotentialconflictbetweenthestatutes,themorespecificFederal

conscienceandanti‐discriminationlawsrequirethatsection1554notbe

interpretedtosupersedethem.Forexample,totheextentthisruleenforcesspecific

provisionsoftheACA,suchasACAsections1303(b)(1)(A)and(b)(4)and1553,the

ruleenforcesthoselawsaccordingtotheirowntext.TheDepartmentdisagreeswith

thecommenter’simplicationthat,inACAsection1554,42U.S.C.18114,Congress

intendedtoprohibittheenforcementofACAsections1303(b)(1)(A)and(b)(4)and

1553aswritten.Generally,onepartofastatuteshouldnotbeinterpretedtonegate

manyotherpartsofthesamestatute,becausethatwouldrenderthosepartsofthe

statutemeaningless.

Fourth,evenassumingthatsection1554applies,itmustbeconstruedin

harmonywiththeACAconscienceprovisions,aswellastheotherfederal

conscienceprotections,especiallyinlightofsection1303(c)(2)thatnothinginthe

ACAshallbeconstruedtohaveanyeffectonFederallawsregardingconscience

protection:ThereisapresumptionthatCongressdoesnotsilentlyrepealitsown

statutes,butitintendsmultiplestatutestobereadwithoutconflict.Andthisisthe

mannerinwhichtheDepartmentinterpretssection1554.

Fifth,again,evenassumingthatsection1554applies,thisFinalRuledoesnot

“create[]anyunreasonablebarrierstotheabilityofindividualstoobtain

appropriatemedicalcare.”Theprotectionsenforcedbythisrulearedulyenacted

laws,passedbyCongressandsignedbythePresident.Suchprotectionsare,by

definition,reasonableunder42U.S.C.18114.Further,byremovingorreducing


241

barriersthatdiscouragehealthcareprovidersfromremaininginthehealthcare

industry,thisrulepromotesdiversityandfullparticipationofprovidersinhealth

caregenerallyandinHHS‐fundedprogramsinparticular,andenhancestheability

ofindividualstoobtainappropriatemedicalcare.Asforthecompliancewith42

U.S.C.18114’sprovisionsconcerningtimelyaccesstohealthcareservicesorforfull

durationofaperiodofmedicalneed,thisruledoesnotlimitahealthcareprovider’s

abilitytoprovidetimelycareandappropriatecare,andforthereasonsjust

discussed,shouldresultinagreaternumberofprovidersandthusmoretimelyand

completecareoverall.Additionally,asdiscussedinresponsetoapreviouscomment

above,theEmergencyMedicalTreatmentandLaborAct(EMTALA)wouldnotbe

displacedbytherule,andrequiresprovisionoftreatmentincertainemergency

situationsandfacilities.Asfor42U.S.C.18114’sprovisionsconcerninginformed

consentandinterferencewithcommunicationsandtheabilityfordoctorsand

patientstocommunicatefreely,theDepartmentaddressedsimilarconcernsin

responsetoseveralcommentsaboveandincorporatessuchresponseshereby

reference.Moreover,nothinginthisrulerestrictsthedoctor‐patientrelationshipor

interfereswithdoctor‐patientcommunications.Theunderlyingstatutesenforcedby

thisruleapply,ordonotapply,tocommunicationsbetweenapatientandprovider

oftheirownforce,andthisfinalruledoesnot“interfere”inthosecommunications

merelybyprotectingconsciencerightsestablishedbyCongress.

Comment:TheDepartmentreceivedcommentsallegingthattheproposed

ruleconflictswiththeAmericanswithDisabilitiesAct,42U.S.C.12101etseq.,orthe


242

RehabilitationAct,29U.S.C.701etseq.,becausehealthcareprovidersmayexercise

theirreligiousbeliefsormoralconvictionstorefusetotreatpatientswithHIV,or

maydeclinetoprovideanabortiontoawomanwithalife‐threateningcondition.

Response:TheDepartmentisunawareofanyreligiousorethicalbelief

systemsthatprohibittreatmentofpersonsonthebasisoftheirHIVstatus.

Additionally,theDepartmentdisagreesthatthereisaconflictbetweenthe

requirementsofthisruleandtheAmericanswithDisabilitiesActorthe

RehabilitationActunderthehypotheticalspresented.Noregulationcan,ofitsown

force,supersedestatutesenactedbyCongressunlesssuchstatuteissupersededor

limitedbyanotheractofCongress.ThisrulemerelyprovidestheDepartmentwith

themeanstoadequatelyenforcetheFederalconscienceandanti‐discrimination

lawstotheextentpermissibleunderthelawsoftheUnitedStatesandthe

Constitution.SeeMaherv.Roe,432U.S.464(1977)(holdingthatgovernmentmay

favorchildbirthoverabortionthroughpublicfunding);Harrisv.McRae,448U.S.917

(1980)(upholdinglawslimitingFederalfundingofabortions).

Comment:TheDepartmentreceivedacommentallegingthattheproposed

ruleconflictswithinternationaltreaties,suchastheInternationalCovenantonCivil

andPoliticalRights(“ICCPR”),whichincludesa“righttohealth,”andthe

InternationalCovenantonEconomic,SocialandCulturalRights(“ICESCR”),which

describesfourcomponentsoftherighttohealthasavailability,accessibility,

acceptabilityandquality.


243

Response:TheDepartmentdisagreesthattheproposedruleconflictswiththe

ICCPR.TheICCPRdoesnotincludea“righttohealth”asdescribedbythe

commenter.Instead,theICCPRincludes“publicsafety,order,health,ormorals”asa

permittedlimitationoncertainfundamentalrights,suchasfreespeechand

religiousliberty.140WhentheSenateratifiedtheICCPR,however,itdidsosubjectto

adeclaration“[t]hatitistheviewoftheUnitedStatesthatStatesPartytothe

Covenantshouldwhereverpossiblerefrainfromimposinganyrestrictionsor

limitationsontheexerciseoftherightsrecognizedandprotectedbytheCovenant,

evenwhensuchrestrictionsandlimitationsarepermissibleunderthetermsofthe

Covenant.”141Additionally,theSenateratifiedtheICCPRwiththeunderstanding

thattheICCPRisnotself‐executing.142

TheDepartmentalsodisagreesthattheproposedruleconflictswiththe

ICESCR.First,thedescriptionoftheICESCRprovidedbythecommenterisincorrect.

TheICESCRsimplyrequiresthat“StatesPartiestothepresentCovenantrecognize

therightofeveryonetotheenjoymentofthehighestattainablestandardofphysical

andmentalhealth.”143Additionally,theUnitedStateshasnotratifiedtheICESCR;

140See,e.g.,InternationalCovenantonCivilandPoliticalRightsarts.18–19,adoptedDec.19,1966,999U.N.T.S.171.141SenateComm.onForeignRelations,ReportontheInternationalCovenantonCivilandPoliticalRights,S.Exec.Rep.No.23,23(102dSess.1992)142Id.143InternationalCovenantonEconomic,CulturalandSocialRightsart.12,adoptedDec.16,1966,993U.N.T.S.3.(TheICECSRstatesthatthe“stepstobetakenbytheStatesPartiestothepresentCovenanttoachievethefullrealizationofthisrightshallincludethosenecessaryfor:(a)Theprovisionforthereductionofthestillbirth‐rateandofinfantmortalityandforthehealthydevelopmentofthechild;(b)Theimprovementofallaspectsofenvironmentalandindustrialhygiene;(c)Theprevention,treatmentandcontrolofepidemic,endemic,occupationalandotherdiseases;(d)Thecreationofconditionswhichwouldassuretoallmedicalserviceandmedicalattentionintheeventofsickness.”Id.)


244

thus,itisnotbinding.Nevertheless,becausetheDepartmentbelieves,asdescribed

elsewhereinthispreamble,thatthisrulewillincreaseaccesstoandqualityof

healthcareinAmerica,thisrulefurthersthegoalsoftheICESCR.


ruleviolatedtheEighthAmendmenttotheU.S.Constitutionbecausetheproposed

rulewouldreduceaccesstocareinprisons.

Response:TheDepartmentdisagrees.First,asnotedabove,theDepartment

believesthatthisrulewillresultingreateraccesstohealthcareorgreateroptions

fromawiderandmorediversepoolofmedicalprofessionals.Additionally,the

finalizeddefinitionof“discriminateordiscrimination”ensuresthatafacilitythat

mustrespectconsciencecanusealternativestafftoaccommodateanobjector

withoutviolatingthisrule.


couldharmeffortstoassistpersonswithsubstanceusedisorderbecauseahealth

careprovidermayholdareligiousormoralconvictionthatdruguseshouldbe

treatedasamoralorcriminalmatterinsteadofamedicalmatter.

Response:ThisruledoesnotconflictwithanyFederalstatutesthatwould

requirethetreatmentofpersonssufferingfromsubstanceusedisorder,becauseno

regulationcan,ofitsownforce,supersedestatutesenactedbyCongress.Thisrule

merelyprovidestheDepartmentwiththemeanstoadequatelyenforcetheFederal

conscienceandanti‐discriminationlawstotheextentpermissibleunderthelawsof

theUnitedStatesandtheConstitution.TheDepartmentisunawareofanyfaith


245

communitythatholdstheviewsidentifiedbythecommenter.Tothecontrary,the

Department’sexperiencerevealsthatmanymembersofthefaithcommunityare

activelyinvolvedandvoluntarilyplayanimportantroleineffortstohelpaddress

theopioidcrisisandothersubstanceusedisorders.


wouldviolatetheEqualProtectionClauseoftheConstitutionbypermitting

discriminationagainstwomenseekingabortion.

Response:TheDepartmentdisagrees.NothinginthisrulepermitstheFederal

governmenttodiscriminateagainstapersononthebasisofsuchperson’s

membershipinasuspectclass.Neithertheequalprotectiondoctrinenoranyother

constitutionaldoctrinenegatesanyoftheFederalconscienceandanti‐

discriminationlawspertainingtoabortionthatthisruleenforces.Onthecontrary,

theSupremeCourthasupheldlawslimitingFederalfundingofabortions,evenof

thosedeemedtobemedicallynecessary,againstequalprotectionchallenges.See

Harrisv.McRae,448U.S.917(1980)(upholdingtheHydeAmendmentagainsta

challengeundertheEqualProtectionClausebecausetheHydeAmendmentis

rationallyrelatedtothelegitimategovernmentalinterestinpreservingthelifeof

theunborn);Maherv.Roe,432U.S.464(1977)(holdingthatgovernmentmay

legitimatelyfavorchildbirthoverabortionthroughpublicfunding);Rustv.Sullivan,

500U.S.173(1991)(same).Roev.WadeandDoev.Boltonbothexplicitlyaffirmed

theappropriatenessofconscienceprotections,144and,therefore,thescopeofrights

144410U.S.at143–44;410U.S.at197–98.


246

definedbyeithercasecannotbereadtoconflictwithconscienceprotections

relatingtoabortion.Thisrule,additionally,furthersthelegitimategovernmental

interestinensuringalargeanddiversepoolofhealthcareprovidersbyremoving

obstaclestopersonswhoareinterestedinservingashealthcareprovidersbut

mightbeunwillingtodosoforfearofbeingcoercedtoviolatetheirreligiousbeliefs

ormoralconvictions.

Comment:TheDepartmentreceivedcommentsstatingtheproposedrule

wouldviolatetheEstablishmentClausebyprovidingforanaffirmative

accommodationforreligiousbeliefsthatburdenathirdparty.

Response:TheDepartmentdisagreesthatreligiousaccommodationssuchas

thoseprovidedbyCongressandenforcedbythisruleviolatetheEstablishment

Clause.CongressbeganenactinglawssuchastheChurchAmendmentsin1973,and

noneofthemhavebeeninvalidatedundertheEstablishmentClause.Asthe

SupremeCourtrecognizedinCorporationofPresidingBishopoftheChurchofJesus

ChristofLatter‐daySaintsv.Amos,“thegovernmentmay(andsometimesmust)

accommodatereligiouspracticesand…itmaydosowithoutviolatingthe

EstablishmentClause.”483U.S.327,334(1987)(quotingHobbiev.Unemployment

AppealsComm’nofFla.,480U.S.136,144–45(1987)).Asonecommenternoted,in

Burwellv.HobbyLobbyStores,Inc.,134S.Ct.2751,2781(2014),theSupremeCourt

heldthattheDepartment’sregulationmandatinggrouphealthplanstocover

contraceptivesviolatedtheReligiousFreedomRestorationActbyfailingtoprovide

anexemptionforHobbyLobbytoexerciseitssincerelyheldreligiousbeliefs.The


247

SupremeCourtalsoobservedthatanyburdenonthirdpartiescouldbeaddressedin

otherways,includingthroughtheestablishmentofanewgovernmentalprogramif

necessary.TheCourtheldthatHobbyLobbyitselfdidnothavetobearareligious

burdenmerelybecauseitsreligiousaccommodationmayburdenathirdparty.

Furthermore,thisrulemerelyprovidesfortheenforcementoftheFederal

conscienceandanti‐discriminationlawsasCongressenactedthem.These

protectionsarelimitedtoparticularprograms,particulargovernmental

involvement,andparticularfundingstreams,asCongressdeterminednecessaryto

ensurethatconsciencerightsarerespectedandthathealthcareentitieswithmoral

orreligiousobjectionstocertainmedicalservicesorcertainaspectsofhealth

serviceprogramsorresearchactivitiesarenotdrivenfromthehealthcareindustry.


willconflictwithvariousstatelawsandmedicalstandards.

Response:ThisruledoesnotestablishnewFederallaw,butprovidesforthe

enforcementoflawsenactedbyCongress.TotheextentStateorlocallawsor

standardsconflictwiththeFederallawsthatarethesubjectofthisrule,thefederal

conscienceandantidiscriminationlawspreemptsuchlawsandstandardswith

respecttofundedentitiesandactivities,inaccordancewiththetermsofsuch

federallaws.WithrespecttoStates,StatescandeclinetoacceptFederalfundsthat

areconditionedonrespectingFederalconsciencerightsandprotections.



248


§88.8withoutchange,beyondglobaleditstotheruleasawhole.

RuleofConstruction§88.9

Thissectionproposedthattheprotectionsforreligiousfreedomandmoral

convictionforwhichenforcementmechanismsareprovidedbythispartwouldbe

construedbroadlyandtothemaximumextentpermittedbylawandthe

Constitution.TheDepartmentreceivedcommentsonthissection,including

commentsingeneralsupportoftheproposedsection.

Comment:TheDepartmentreceivedacommentstatingthat§88.9couldbe

moreclearlystatedasfollows:“Thispartshallbeconstruedinfavorofabroad

protectionoffreeexerciseofreligiousbeliefsandmoralconvictions,tothe

maximumextentpermittedbytheConstitutionandthetermsoftheFederal

conscienceprotectionandassociatedanti‐discriminationstatutes.”

Response:TheDepartmentagreesthatthisproposedlanguageisclearerand

ismodifying§88.9tosoread,withsomestylisticchangestotheproposedtext,

characterizingtheFederallawsinquestionas“Federalconscienceandanti‐

discriminationlaws.”



§88.9byrephrasingittoaddclaritysothatitnowsays,“Thispartshallbe

14583FR3880,3899.14683FR3880,3899(statingthereasonsfortheproposed§88.9,exceptforthemodificationsadoptedherein).


249

construedinfavorofabroadprotectionofthefreeexerciseofreligiousbeliefsand

ofmoralconvictions,tothemaximumextentpermittedbytheConstitutionandthe

termsoftheFederalconscienceprotectionandassociatedanti‐discrimination

statutes.”

Severability§88.10

In§88.10,theDepartmentproposedaseverabilityprovisionthatwould

governtheDepartment’sinterpretationandimplementationof45CFRpart88if

anysectionofpart88shouldbeheldinvalidorunenforceable,eitherfaciallyoras

applied.Intheeventthisoccurs,theDepartmentproposedthattheprovisionin

questionbeconstruedinamannerthatgivesmaximumextenttotheforceofthe

provisionaspermittedbylaw.Forinstance,aprovisionheldtobeunenforceableas

appliedtoaparticularcircumstanceshouldbeconstruedsoastocontinuethe

applicationoftheprovisiontodissimilarcircumstances.Proposed§88.10would

providethatiftheprovisionisheldtobeutterlyinvalidorunenforceable,the

provisioninquestionshallbeseverablefrompart88,andtheremainderofpart88

shouldremaininfullforceandeffecttothemaximumextentpermittedbylaw.The

Departmentreceivedacommentonthissection.

Comment:TheDepartmentreceivedacommentstatingthataseverability

clauseisunnecessarybecause,followingconsiderationofpubliccommentstothe

proposedrule,theDepartmentshouldbeawareofanyportionsoftherulethatare

invalidorunenforceable.

Response:TheDepartmentdoesnotagreethattheseverabilityclauseis


250

inappropriate.TheDepartmentconsidersalltheprovisionsofthisfinalruleasbeing

legallysupported,hasfullyconsideredallcommentsreceived,andhasmade

appropriatemodifications,additions,anddeletions.Nevertheless,asageneral

matter,severabilityrepresentstheDepartment’sintentionregardingwhetherthe

ruleshouldgointoeffectifpartsofitareheldinvalidorenjoinedbyacourt.The

Departmentdeemsitappropriatetomaintaintheseverabilityclauseasproposed,

sothatthisrulewillremaininplacetothemaximumextentallowableintheevent

ofadversecourtaction.Inaddition,futureadditionstostatutesenforcedbythisrule

couldrenderpartsoftheruleinapplicable,anditistheDepartment’sintentionthat

suchchangeswillnotinvalidatepartsoftherulethatremainstatutorilysupported.



§88.10withoutchange.

AppendixAtoPart88—NoticeofRightsunderFederalConscienceandAnti‐

DiscriminationLaws

TheDepartmentreceivedcommentsonAppendixAtopart88,whichwere

respondedtoabove,withthecommentsto§88.5.

SummaryofRegulatoryChanges:Forthereasonsdescribedabove,and

consideringthecommentsreceived,theDepartmentfinalizesAppendixAtopart88

toprovideamoreaccuratenoticeastotheprotectionsprovidedbytheFederal

conscienceandanti‐discriminationlaws.Forinstance,theDepartmentreplaces

14783FR3880,3899.


251

proposedtextstatingthattheentity“doesnot”engageincertainactswithlanguage

statingthatentity“complieswith”lawsprohibitingcertainacts.TheDepartment

alsomodifiesthenoticetexttosaythat“Youmayhavetheright”insteadof“You

havetheright,”andreplaces“participatein”with“perform,assistinthe

performanceof.”TheDepartmentalsomakesstylisticchangestotheheadingand

certainportionsofthebodytextofthemodelnoticeinAppendixA.

IV.RegulatoryImpactAnalysis

A.IntroductionandSummary

TheDepartmenthasexaminedtheimpactsofthisfinalruleasrequired

underExecutiveOrder12866onRegulatoryPlanningandReview(September30,

1993),ExecutiveOrder13563onImprovingRegulationandRegulatoryReview

(January18,2011),ExecutiveOrder13771onReducingRegulationandControlling

RegulatoryCosts(January30,2017),theRegulatoryFlexibilityAct(September19,

1980,Pub.L.96‐354,5U.S.C.601‐612),section202oftheUnfundedMandates

ReformActof1995(March22,1995,Pub.L.104‐04),ExecutiveOrder13132on

Federalism(August4,1999),theCongressionalReviewAct(5U.S.C.804(2)),the

AssessmentofFederalRegulationandPoliciesonFamilies(Pub.L.105‐277,section

654,5U.S.C.601(note)),andthePaperworkReductionActof1995(44U.S.C.3501‐

3520).

ThisrulerevisestheregulationthatallowsOCRtoacceptandcoordinatethe

handlingofcomplaintsallegingviolationsoftheWeldon,Coats‐SnoweandChurch

Amendments,threeFederallawsthatcollectivelyprotectconscience,prohibit


252

coercion,andrequirenondiscriminationincertainprogramsandactivitiesoperated

byrecipientsorsub‐recipientsorthatareadministeredbytheSecretary.

Specifically,thisrule:

1)Expandstheregulation’sscopetoencompassthefullpanoplyofFederal

health‐relatedconscienceprotectionandassociatedanti‐discriminationlaws

thatexistacrosstheDepartmentandthattheSecretaryhasdelegatedtoOCR

tohandle,

2)ArticulatesthescopeofenforcementmechanismsavailabletoHHSto

addressnoncompliancewithFederalconscienceandanti‐discrimination

laws,and

3)Requirescertainpersonsandentitiescoveredbythisruletoadhereto

proceduralandadministrativerequirementsthataimtoimprovecompliance

withFederalconscienceandanti‐discriminationlawsandtoachieveparity

withproceduralandadministrativerequirementsofotherFederalcivil

rightsauthoritiesenforcedbyOCR.

Table1.AccountingTableofBenefitsandCostsofAllChanges

PresentValueover5YearsbyDiscountRate(Millionsof2016Dollars)

AnnualizedValueover5YearsbyDiscountRate(Millionsof2016Dollars)

BENEFITS 3Percent 7Percent 3Percent 7PercentQuantifiedBenefits ‐‐ ‐‐ ‐‐ ‐‐Non‐quantifiedBenefitsCompliancewiththelaw;protectionofconsciencerights,thefreeexerciseofreligionandmoralconvictions;morediverseandinclusiveprovidersandhealthcareprofessionals;improvedprovider‐patientrelationshipsthat


253

facilitateimprovedqualityofcare;equity,fairness,nondiscrimination;increasedaccesstocare.COSTS 3Percent 7Percent 3Percent 7PercentQuantifiedCosts $900.7 $731.5 $214.9 $218.5Non‐quantifiedCostsComplianceprocedures(recordkeepingandcompliancereporting)andseekingofalternativeprovidersofcertainobjected‐tomedicalservicesorprocedures.

AnalysisofEconomicImpacts:ExecutiveOrders12866and13563

HHShasexaminedtheeconomicimplicationsofthisfinalruleasrequiredby

ExecutiveOrders12866and13563.ExecutiveOrders12866and13563direct

agenciestoassessallcostsandbenefitsofavailableregulatoryalternativesand,

whenregulationisnecessary,toselectregulatoryapproachesthatmaximizenet

benefits(includingpotentialeconomic,environmental,publichealthandsafety

effects;distributiveimpacts;andequity).TheDepartmentestimatesthatthe

benefitsofthisrule,althoughnotalwaysquantifiableormonetized,justifythe

burdensoftheregulatoryaction.

B.ExecutiveOrder12866

Section6(3)(C)ofExecutiveOrder12866requiresagenciestopreparea

regulatoryimpactanalysis(RIA)formajorrulesthataresignificant.Section3(f)of

ExecutiveOrder12866definesaregulatoryactionassignificantifitislikelyto

resultinarulethatmeetsoneoffourconditions:(1)iseconomicallysignificant,(2)

createsaseriousinconsistencyorotherwiseinterfereswithanactiontakenor

plannedbyanotheragency,(3)materiallyaltersthebudgetaryimpactsof

entitlementgrants,userfees,orloanprogramsortherightsandobligationsofthe


254

recipientsofthesegrantsandprograms,or(4)raisesnovellegalorpolicyissues

arisingoutoflegalmandates,thePresident’spriorities,ortheprinciplessetforthin

ExecutiveOrder12866.Aruleislikelytobeeconomicallysignificantwherethe

agencyestimatesthatitwill(a)haveanannualeffectontheeconomyof

$100millionormoreinanyoneyear,or(b)adverselyandmateriallyaffectthe

economy,asectoroftheeconomy,productivity,competition,jobs,theenvironment,

publichealthorsafety,orState,local,ortribalgovernmentsorcommunities.The

Departmenthasdeterminedthatthisrulewillhaveanannualeffectontheeconomy

of$100millionormoreinoneyearand,thus,iseconomicallysignificant.Therule

alsofurthersapresidentialpriorityofprotectingconscienceandreligiousfreedom.

ExecutiveOrder13798,82FR21675(May4,2017).

C.ExecutiveOrder13563

ExecutiveOrder13563supplementsandreaffirmstheprinciplesof

ExecutiveOrder12866.Section1(b)ofExecutiveOrder13563requiresagenciesto:

•“proposeoradoptaregulationonlyuponareasoneddeterminationthatits

benefitsjustifyitscosts,”

•“tailoritsregulationstoimposetheleastburdenonsociety,”

•“select...regulatoryapproachesthatmaximizenetbenefits,”

•“[as]feasible,specifyperformanceobjectives,ratherthanspecifyingthe

behaviorormannerofcompliancethatregulatedentitiesmustadopt,”and


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•“identifyandassessavailablealternativestodirectregulation,including

providingeconomicincentivestoencouragethedesiredbehavior...or

providinginformationuponwhichthepubliccanmakechoices.”

ExecutiveOrder13563encouragesagenciestopromoteinnovation;avoid

creatingredundant,inconsistent,oroverlappingrequirementsapplicabletoalready

highlyregulatedindustriesandsectors;andconsiderapproachesthatmaintain

flexibilityandfreedomofchoiceforthepublic.Finally,ExecutiveOrder13563

requiresthatagenciesusethebestreasonablyobtainablescientific,technical,and

economicinformationavailableinevaluatingtheburdensandbenefitsofa

regulatoryaction.

TheDepartmentconsideredtheseobjectivesandusedthebestreasonably

obtainabletechnicalandeconomicinformationtodeterminethatthisfinalrule

createsnetbenefits,istailoredtoimposetheleastburdenonsociety,incentivizes

thedesiredbehavior,andmaximizesflexibility.Thisimpactanalysisalsostrivesto

promotetransparencyinhowtheDepartmentderivedtheestimates.Tothisend,

thisRIAnotestheextenttowhichkeyuncertaintiesinthedataandassumptions

affecttheDepartment’sanalyticconclusions.

1.NeedfortheRule

(i)ProblemsThatThisRuleSeekstoAddress

Indevelopingregulatoryactions,“[e]achagencyshallidentifytheproblem

thatitintendstoaddress(including...thefailuresofprivatemarketsorpublic

institutions...)aswellasassessthesignificanceoftheproblem.”E.O.12866,


256

sec.1(b)(1).Inidentifyingtheproblemwarrantingagencyregulatoryaction,“[e]ach

agencyshallexaminewhetherexistingregulations(orotherlaw)havecreated,or

contributedto,theproblem....”E.O.12866,sec.1(b)(2).

Thisruleseekstoaddresstwocategoriesofproblems:(1)inadequate

enforcementtoolstoaddressunlawfuldiscriminationandcoercionfacedby

protectedpersons,entities,orhealthcareentities,and(2)lackofawareness,and,to

theextentthereisawareness,confusion,concerningFederalconscienceprotection

obligationsandassociatedanti‐discriminationrights,ofcoveredentitiesand

individualsandorganizations,respectively,leadingtopossibleviolationsoflaw.The

arrayofissuesdescribedinsupraatpartI.B(describingthefinalrule’sregulatory

history)fallintooneorbothofthesecategories.

Thefirstcategory–inadequateenforcementtoolstoaddressunlawful

discriminationandcoercion–stemsfrominadequatetonon‐existentregulatory

frameworkstoenforceexistingFederalconscienceandanti‐discriminationlaws.

TheabsenceofadequateFederalgoverningframeworkstoremedydiscrimination

mayhaveunderminedincentivesforcoveredpersonsandentitiestoinstitute

proactivemeasurestoprotectconscience,prohibitcoercion,andpromote

nondiscrimination.Althoughsomepubliccommentsarguedthatexistinglawis

sufficienttoprotectconscienceandreligiousfreedom,theDepartmentdisagrees,

giventhemutuallyreinforcingdeficienciesattheFederallevel,whichinclude:

Aninadequate,minimalisticregulatoryschemesetforthintheDepartment’s

2011Rulethatrescindedthecomprehensive2008Rule,whichaddressed


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threeofthe25statutoryprovisionsthatarethesubjectofthisrule.Seesupra

atpartI(describingexistingandpriorversionsoftheruleandidentifying

confusionaboutthescopeandapplicabilityoffederalconscienceandanti‐

discriminationlaws);

AnundulynarrowDepartmentalinterpretationoftheWeldonAmendment

adoptedbyOCRinconnectionwiththe2011Rulethatlimitedthescopeof

prohibiteddiscrimination,contrarytothelanguagethatCongresspassed,see

supraatpartI.B(addressingconfusioncausedbyOCRsub‐regulatory

guidance);and

AlackofstrategiccoordinationacrosstheDepartmenttopromoteawareness

ofFederalprotectionsforconscienceandreligiousfreedominhealthcare,

andtoaddresstheenforcementofFederalconscienceandanti‐

discriminationlawssetforthinauthorizingstatutesofprogramsconducted

oradministeredbyDepartmentalcomponents.SeesupraatpartI.A

(identifyingadditionalFederalconscienceandanti‐discriminationlaws).

Thesecondcategoryofproblems–lackofawarenessand,wherethereis

awareness,confusionconcerningFederalconscienceprotectionobligationsand

associatedanti‐discriminationrights,ofcoveredentitiesandindividualsand

entities,respectively–stemsfrominadequateinformationandunderstandingabout

suchFederallaw,leadingtopossibleviolationsoflaw.Relevantsituationswhere

persons,entities,andhealthcareentitieswithreligiousbeliefsormoralconvictions

maybecoercedorsufferdiscriminationinclude:


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•beingrequiredtoperform,participatein,payfor,providecoveragefor,

counselorreferforabortion,sterilization,euthanasia,orotherhealth

services;148

•participatinginhealthprofessionaltrainingthatpressuresstudents,

residents,fellows,etc.,toperform,assistintheperformanceof,referfor,or

counselfor,abortionorsterilization;

•beingsteeredawayfromacareerinobstetrics,familymedicine,orgeriatric

medicine,whenonehasareligiousormoralobjection,asapplicable,to

abortion,sterilization,physician‐assistedsuicideoreuthanasia;

•beingaskedtoperformorassistincertainserviceswithinthescopeof

one’semploymentbutcontrarytoone’sreligiousbeliefsormoral

convictions.

Commentsreceivedinsupportoftheproposedruledemonstratedthat

personswhoareunlawfullycoercedtoviolatetheirconsciences,orotherwise

discriminatedagainstbecausetheyhaveactedinaccordwiththeirmoral

convictionsorreligiousbeliefs,mayexperiencerealharmsthataresignificantand

sometimesdevastatingpsychologically,emotionally,and/orfinancially.149Thiscan

148California,forexample,sentalettertoseveninsurancecompaniesrequiringinsurerstoincludeabortioncoverageinplansusedbypersonswhoobjectedtosuchcoverage.SeeLetterfromCaliforniaDepartmentofManagedHealthCare,Re:LimitationsorExclusionsofAbortionServices(Aug.22,2014).ThestateofCaliforniaestimatesthatatleast28,000individualssubsequentlylosttheirabortion‐freehealthplans,andmultiplechurcheshavechallengedCalifornia’spolicyincourt.SeeFoothillChurchv.Rouillard,2:15–cv–02165–KJM–EFB,2016WL3688422(E.D.Calif.July11,2016);SkylineWesleyanChurchv.CaliforniaDepartmentofManagedHealthCare,No.3:16–cv–00501–H–DHB(S.D.Calif.2016).149See.e.g.,Compl.Cenzon‐DeCarlov.MountSinaiHosp.,No:09‐3120(E.D.N.Y.Jul.21,2009)at15(“BeingforcedtoassistinthisabortionhascausedMrs.DeCarloextremeemotional,psychological,andspiritualsuffering.”)(dismissedonothergrounds).


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includelossofjobs,lossofpromotionpossibilities,“blackballing”inthemedical

community,denialofacceptanceintoorgraduationfromamedicalschool,denialof

boardcertification,stigmatization,shunningbypeers,andtraumaandstressfrom

forcedviolationsoftheHippocraticOath.Commenterssharedanecdotesofthe

occurrenceandnatureofcoercion,discriminatoryconduct,orotheractions

potentiallyinviolationofFederalconscienceandanti‐discriminationlaws.

Commentersalsosharedtheirassessmentoftheknowledge,orlackthereof,among

thegeneralpublic,healthcarefield,healthcareinsuranceindustry,and

employmentlawfieldoftherightsandobligationsthatthisruleimplementsand

enforces.Examplesfollow.

Numerouscommenterssharedanecdotesofbiasandanimusinthehealth

caresectoragainstindividualswithreligiousbeliefsormoralconvictions

withrespecttoabortion.

Employeessharedthattheyexperienceddiscriminationbasedontheir

objectionstoprescribingabortifacientsorparticipatinginabortionor

assistedsuicide.

Commentersstatedthatmanyhealthcareprofessionals’careersare

jeopardizedbecauseentitiesarecompletelyunawareorwillfullydismissive

ofapplicableFederallawthatprotectsconscience,prohibitscoercion,or

requiresnondiscrimination.


260

Students,fellows,andresidentssharedbeingforcedoutofresidency

programsorfieldsofmedicinebecauseoftheirbeliefsaboutabortionor

contraception.

Commenterssharedthattheyconsideredavoidingobstetricsandgynecology

programsforfearofdiscriminationandsharedpollingdata,whichtheRIA’s

benefitssectiondescribesinfraatpartIV.C.4,documentingdiscrimination

experiencedbymedicalstudentsonthebasisoftheirreligiousbeliefsor

moralconvictions.

CommentersexpressedconcernthatStatesarecoercingpersonsandentities

toviolatetheirreligiousbeliefsormoralconvictionsthroughlawsmandating

healthcoverageforabortion.

Onecommenternotedthatacademicmedicalinstitutionsarenotself‐

policingcompliancewith,oreducatingstudentson,applicableFederal


CommenterssharedbarrierstoobtainingcoveragebyMedicareAdvantage

plansforcareprovidedbyRNHCIs.150Commenterssharedthatplans

justifiedthedenialsofcoverageandpreauthorizationrequestsbecause

medicalprofessionalsdidnotprovidethecare(eventhoughbydefinition,an

RNHCIprovidesnonmedicalcare).

150RNHCIscanparticipateinMedicareandMedicaidaslongastheymeettherequisiteconditionsofcoverageandparticipation.SeesupraatpartI.A(summarizingthehistoryofstatutoryprovisionsregardingRNHCIs,amongotherprovisions,whichthisruleimplementsandenforces).Seealsohttps://www.cms.gov/Medicare/Provider‐Enrollment‐and‐Certification/CertificationandComplianc/RNHCIs.html.


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Somecommentershavesuggestedthatthethirty‐fourcomplaintsthatOCR

receivedbetweenNovember2016andJanuary2018thatallegecoercion,violation

ofconscience,ordiscriminationdonotnecessitatethisfinalrule.151These

commentersmisconstruethereasonsforthisrule;theincreaseincomplaints

receivedbyOCRisoneofthemanymetricsusedtodemonstratetheimportanceof

thisrule.DuringFY2018,themostrecentlycompletedfiscalyearforwhichdataare

available,OCRreceived343complaintsallegingconscienceviolations.152Some

complaintsraiseissuesthataffectmorethanoneaggrievedperson,entityorhealth

careentity;therefore,althoughonepersonmayhavefiledthecomplaint,the

complaintmayrepresenttheconcernsandobjectionsofallnursesatahospital,

multiplepregnancycarefacilitiesorprovidersinaState,orentirepopulations(or

subpopulations)ofStatesorcommunities.

(ii)HowtheRuleSeekstoAddresstheProblems

Thisrulecorrectsthoseproblems.First,theDepartmentrevises45CFRpart

88fromaminimalregulatoryschemetoonecomparabletotheregulatoryschemes

implementingothercivilrightslaws.Suchschemestypicallyincludeadozen

provisions,addressingarangeofconduct.Theseprovisionstypicallyrestatethe

substantiverequirementsandobligationsofthelawsandoftensetforthprocedural

requirements(e.g.,assurancesofcompliance,recordkeepingofcompliance,etc.)to

advancecompliancewithsubstantiverightsandobligations.Inaddition,the

151See83FR3880,3886(proposedJan.26,2018)(tobecodifiedat45CFRpt.88)(summarizingthehistoryofOCRenforcementofconsciencelaws).152ComplaintdatabasedonOCR’ssystemofrecordsasofDecember20,2018.


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regulatoryschemesoutlinetheenforcementprocedurestoprovideregulated

entitiesnoticeoftheenforcementtoolsavailabletoHHSandthetypeofremedies

HHSmayseek.Part88ineffectasaresultofthe2011Rule,bycontrast,wasonly

threesentenceslongandprovidedconsiderablylessnoticeandclarityaboutthe

conductprohibitedunderFederallawandtheenforcementmechanismsavailableto

HHS.

ThisruleconfirmsHHSwillhavetheauthoritytoinitiatecompliancereviews

whereitbelievescomplianceissueshavearisen,conductinvestigations,resolve

complaints,andsuperviseandcoordinateappropriateaction(s)withtherelevant

Departmentcomponent(s)toassurecompliance.Underthisrule,certainpersons

andentitiesmustmaintainrecordsregardingcompliancewithpart88;cooperate

withOCRinvestigations,compliancereviews,interviews,orotherpartsofOCR’s

investigativeprocess;andsubmitwrittenassurancesandcertificationsof

compliancetotheDepartment.Theseproceduralandadministrativerequirements

aresimilartothoseinothercivilrightsregulationsthatpromotecompliancewith,

andenforcementof,theFederalcivilrightslawsthattheregulationsimplement.

Finally,byexpandingthescopeofpart88tocoverthe25statutoryconscienceand

anti‐discriminationlawsapplicabletoHHSthatarethesubjectofthisrule,therule

supportstheDepartment’sstrategiccoordinationwithrespecttocompliancewith,

andenforcementof,theselawsacrosstheDepartment,aswellasprovidingone

locationthatidentifiesallofthehealthcarerelatedconscienceprotectionsand


263

associatedanti‐discriminationlawsenforcedbytheDepartmentsothatregulated

entitieshaveclearknowledgeoftheapplicableconsciencerequirements.

Theinvestigativeandenforcementprocessessetforthbytherulearevital

becauseotheravenuesofreliefareinadequateorunavailable.TheDepartment

solicitedcommentonwhetheralternateremedies,suchaspursuinglitigation,have

beensufficienttoaddressdiscrimination,coercion,orothertreatmentthatthelaws

thatarethesubjectofthisruleprohibit.Manycommentersstatedthatlitigationwas

aninadequateoptionbecauseseveralcourtshavedeclinedtorecognizeaprivate

rightofaction,suchasundertheCoats‐SnoweandChurchAmendments,andhave

concludedthatpersonsmustrelyonOCR’sadministrativecomplaintprocessto

securerelief.153Somecommentersalsoviewedlitigationasunviablegiventhehigh

economiccostsoflitigation,whichmaybeagainstwell‐fundedStatesormedical

providers.

Second,thisrulepromotesvoluntarycompliancewithlawsgoverningthe

abilityofhealthcareentitiestoactinaccordwiththeirlegallyprotectedreligious

beliefsormoralconvictionsbyensuringthathealthcareentitiesareawareof,and

understand,Federalconscienceandanti‐discriminationlaws.Theruleincentivizes

entitiestoprovidenoticeofrightsandobligationsundertherulebyidentifyingthe

provisionofnoticeasnon‐dispositiveevidenceofcompliancethatOCRwillconsider

ifanentityissubjecttoanOCRinvestigationorcompliancereview.Entitieswillbe

153See,e.g.,VermontAll.forEthicalHealthcare,Inc.v.Hoser,274F.Supp.3d227,240(D.Vt.2017);Hellwegev.TampaFamilyHealthCenters,103F.Supp.3d1303,1311‐12(M.D.Fla.2015);Orderat4,NationalInstituteofFamilyandLifeAdvocates,etal.v.Rauner,No.3:16‐cv‐50310(N.D.Ill.July19,2017),ECFNo.65.SeealsosupraatpartII.A(describingthelackofprivateremedies).


264

morelikelytoaccommodateconscienceandassociatedanti‐discriminationrightsif

entitiesunderstandthattheyarelegallyobligatedtodoso.Entitieswillalsobeina

betterpositiontoaccommodatetheserightsiftheyunderstandtheserightsareakin

toothercivilrightsprotectingpeoplefromdiscriminationonthebasisofrace,

nationalorigin,disability,etc.—rightsforwhichentitiesalreadyprovidenoticeand

arefamiliarwithrespecting.

Inaddition,asdescribedinfraatpartIV.C.3.i,theDepartmentanticipatesthat

asubsetofrecipientsthatassureandcertifycomplianceinaccordancewith§88.4

willtakeorganization‐wideaction,suchastoupdatepoliciesandprocedures,

implementstaffingorschedulingpracticesthatrespecttheexerciseofconscience

rightsunderFederallaw,ortakestepstodisseminatetherecipient’spoliciesand

proceduresconcerningtheselaws.Greatertransparencyofpracticesthroughopen

communicationofrecipientandsub‐recipientpolicies“shouldstrengthen

relationshipsbetween...entitiesandtheir...[workforcemembers].”154

Protectionofreligiousbeliefsandmoralconvictionsservesnotonly

individualrights,butalsosocietyasawhole.Protectionsforconsciencehelpensure

asocietyfreefromdiscriminationandmorerespectfulofpersonalfreedomand

fundamentalrightsenshrinedintheFirstAmendmentandFederallaw.The

Departmentsharestheanticipationofmanycommenterswhoreasonedthatthe

rulewillpromoteacultureofrespectforrightsofconscienceandreligiousfreedom

inhealthcarethatiscurrentlylacking.Theboundariesofprotectionforconscience

15473FR78074,78074(2008Rule).


265

maybetestedwhenprotectionsforreligiousbeliefsandmoralconvictionsappear

toimposeacostorcompetewithotherpublicpurposes.155However,aswithother

civilrightslaws,itisinthosecaseswherefidelitytothelawbecomesofparamount

importance.

2.AffectedPersonsandEntities

Thefinalruleaffects(1)personsandentitiesalreadyobligatedtocomply

withtheWeldonAmendment,Coats‐SnoweAmendment,orChurchAmendments

(oracombinationthereof)underthe2008and2011Rules;and(2)personsand

entitiesobligatedtocomplywithatleastoneoftheotherFederalstatutory

provisionsthatthisruleimplements.

(i)ScopeofPersonsandEntitiesCoveredby45CFRPart88in2011Rule

Dependingontheoperationandapplicabilityoftheunderlyingstatutes,the

2011Rule,i.e.,45CFRpart88ascurrentlyineffect,extended,andcontinuesto

extend,broadly.Asexplainedbelow,thediversityofentitiesestimatedascoveredis

duetotheapplicabilityoftheChurchAmendments,whichappliestonon‐

governmental(aswellasgovernmental)entitiesthatoperate“anypartofahealth

serviceprogramorresearchactivityfundedinwholeorinpartunderaprogram

administeredbytheSecretary”156;orreceiveagrant,contract,loan,orloan

155SeeKevinTheriot&KenConnelly,FreetoDoNoHarm:ConscienceProtectionsforHealthcareProfessionals,49Ariz.St.L.J.549,550‐51(2017)(“[T]hegrowingacceptanceofthis‘publicutility’modelofmedicinemeansinpracticethatextantfederalandstatelawsprotectingconscience‐‐mostofwhichcoveronlyalimitedrangeofproceduresandmedicalpractitioners,lackmeaningfulenforcementmechanisms,and...areinadequatetothetaskofprotectingtherighttoconscience[]...”(citationsomitted)).

15642U.S.C.300a‐7(d).


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guaranteeunderthePublicHealthService(PHS)Act,157whichcontainsthirtytitles

andauthorizesdozensofprograms,orundertheDevelopmentalDisabilities

AssistanceandBillofRightsActof2000(DDAct),orreceiveaninterestsubsidy

undertheDDAct.158

(A)TheDepartment

Asaresultofthe2011Rule,45CFRpart88applied,andstillapplies,tothe

DepartmentbecausetheWeldonandCoats‐SnoweAmendments,aswellasspecific

partsoftheChurchAmendments,applytotheDepartment.

TheWeldonAmendmentstatesthat“[n]oneofthefundsmadeavailablein

[theDepartmentsofLabor,HealthandHumanServices,andEducation,andRelated

AgenciesAppropriationsAct,2019]maybemadeavailabletoaFederalagencyor

program...ifsuchagency[or]program...subjectsanyinstitutionalorindividual

healthcareentitytodiscrimination....”159TheDepartmentisaFederalagencythat

receivessubstantialfundsmadeavailableintheDepartmentofDefenseandLabor,

HealthandHumanServices,andEducationAppropriationsAct,2019and

ContinuingAppropriationsAct,2019,whicharethefundsaddressedinWeldon.160

TheDepartmentmustcomplywiththeWeldonAmendment.

TheCoats‐SnoweAmendmentstatesthat“[t]heFederalGovernment...may

notsubjectanyhealthcareentitytodiscriminationonthe[bases]”listedin

15742U.S.C.300a‐7(c).15842U.S.C.300a‐7(e).159E.g.,DepartmentofDefenseandLabor,HealthandHumanServices,andEducationAppropriationsAct,2019andContinuingAppropriationsAct,2019,Pub.L.No.115‐245,Div.B,section507(d),132Stat.2981,3118(September28,2018).160Id.


267

subparagraphs(a)(1)‐(3)of42U.S.C.238n.TheDepartment,aspartoftheFederal

Government,mustcomplywiththeCoats‐SnoweAmendmentinitsoperations.

Paragraphs(d)and(c)(2)oftheChurchAmendmentsapplytocertain

programsadministeredbytheSecretary.Paragraph(d)appliestoallhealthservice

programsorresearchactivitiesfundedinwholeorpartunderprograms

administeredbytheSecretary,regardlessofthesourceoffunding.Subparagraph

(c)(2)appliestoentitiesthatreceivegrantsorcontracts“forbiomedicalor

behavioralresearchunderanyprogramadministeredbytheSecretary.”161The

requirementswould,thus,applytosuchprogramsorresearchactivitiesconducted

by,orfundedbyorthrough,theDepartment.

(B)StateandLocalGovernments

Asaresultofthe2008and2011Rules,45CFRpart88applied,andwill

continuetoapply,toallStateandlocalgovernmentsthatreceiveHHSFederal

financialassistancebyvirtueofseveralstatutoryprovisions.First,theWeldon

AmendmentappliestoStateandlocalgovernmentsthatreceivefundsmade

availableintheannualLabor,HealthandHumanServices,andEducation

AppropriationsAct.162Second,theCoats‐SnoweAmendmentappliestoStateand

localgovernmentsthatreceiveFederalfinancialassistance,includingFederal

financialassistancefromtheDepartment(withoutrestrictiontoanyparticular

16142U.S.C.300a‐7(c)(2)and(d).162See,e.g.,Pub.L.No.115‐245,Div.B,section507(d),132Stat.2981,3118(“Noneofthefundsmadeavailablein[theDepartmentsofLabor,HealthandHumanServices,andEducation,andRelatedAgenciesAppropriationsAct,2019]maybemadeavailabletoa...Stateorlocalgovernment[]ifsuch...government....”).


268

fundingstream),“includ[ing]governmentalpaymentsprovidedasreimbursement

forcarryingouthealth‐relatedactivities.”163Third,severalparagraphsoftheChurch

AmendmentsapplytoStateandlocalgovernments.Paragraph(b)oftheChurch

Amendmentsprohibitscoercionbya“publicauthority,”andtherebyincludesStates

andlocalgovernments.Paragraphs(c)and(e)oftheChurchAmendmentsapplyto

Stateandlocalgovernmentstotheextentthatsuchgovernmentsreceivefundsto

implementprogramsauthorizedinthepubliclawscitedinsuchparagraphs.Finally,

paragraph(d)oftheChurchAmendmentsappliestoaStateorlocalgovernment(or

acomponentthereof)totheextentthatsuchStateorlocalgovernmentreceives

fundingunderanyprogramadministeredbytheSecretary.164

Stateandlocalgovernments(suchascountiesorcities)and

instrumentalitiesofgovernments(suchasStatehealthandhumanservices

agencies)receiveFederalfinancialassistanceorFederalfundsfromtheDepartment

fromavarietyoffinancingstreamsasrecipientsorsub‐recipients.Examplesof

programsandactivitiesforwhichStateandlocalgovernments(insomecases,not

exclusively)receiveFederalfinancialassistanceorFederalfundsfromthe

DepartmentmayincludeMedicaidandtheChildren’sHealthInsuranceProgram;

TitleXprograms,publichealthandpreventionprograms,HIV/AIDSandSTD

preventionandeducation,andsubstanceabusescreening;biomedicaland

behavioralresearchatStateinstitutionsofhighereducation;servicesforolder

16342U.S.C.238n(a),(c)(1).164Id.section300a‐7(d)(“NoindividualshallberequiredtoperformorassistintheperformanceofanypartofahealthserviceprogramorresearchactivityfundedinwholeorinpartunderaprogramadministeredbytheSecretaryofHealthandHumanServices....”).


269

Americans;medicalassistancetorefugees;andadultprotectionservicestocombat

elderabuse.

(C)PersonsandEntities

Asaresultofthe2008and2011Rules,45CFRpart88applied,andstill

applies,torecipientsandsub‐recipientsthatoperate“anypartofahealthservice

programorresearchactivityfundedinwholeorinpartunderaprogram

administeredbytheSecretary”165;orreceiveagrant,contract,loan,orloan

guaranteeunderthePublicHealthService(PHS)Act166ortheDevelopmental

DisabilitiesAssistanceandBillofRightsActof2000(DDAct),orreceiveaninterest

subsidyundertheDDAct.

Examplesofrecipientsandsub‐recipientsmayinclude:

Healthfacilities,includinghospitals,federallyqualifiedhealthcenters,

communityhealthcenters,andmentalhealthclinics;

Health‐relatedschoolsandothereducationentitiesthatprovidehealth

professionstrainingformedicine,oralhealth,behavioralhealth,geriatric

care,nursing,etc.;

Community‐basedorganizationsthatprovidesubstanceabusescreening,

HIV/AIDSpreventionandtreatment,anddomesticviolencescreening;

TitleX‐fundedfamilyplanningclinics;

16542U.S.C.300a‐7(d).166ThePHSActcontainsthirtytitlesandauthorizesdozensofprograms.


270

Privatenon‐profitandfor‐profitagenciesthatprovidemedicalcareto

unaccompaniedminors;

Interdisciplinaryuniversitycentersorpublicornonprofitentities

associatedwithuniversitiesthatreceivefinancialassistanceto

implementtheDDAct167;and

StateCouncilsonDevelopmentalDisabilities168andStates’Protectionand

AdvocacySystemsthatreceivefundstoimplementtheDDAct.169

Severalstatutoryprovisionssupportthisapplication.First,subparagraphs

(c)(1)‐(2)oftheChurchAmendmentsapplytoentitiesthatreceivea“grant,

contract,loan,orloanguaranteeunderthe[PHSAct],”ora“grantorcontractfor

biomedicalorbehavioralresearch.”Second,paragraph(e)oftheChurch

Amendmentsappliestoentitiesthatreceivea“grant,contract,loan,orloan

guarantee,orinterestsubsidy”underthePHSActortheDDAct.170Third,paragraph

(d)oftheChurchAmendmentsappliesto“anypartofahealthserviceprogramor

167E.g.,https://www.acl.gov/node/466.168E.g.,https://www.acl.gov/node/110.https://www.acl.gov/sites/default/files/about‐acl/2017‐12/DDC‐2017.pdf.169E.g.,https://www.acl.gov/sites/default/files/about‐acl/2017‐06/PADD‐2017.pdf.170Id.300a‐7(c)(1)(B)(“Noentitywhichreceivesagrant,contract,loan,orloanguaranteeunderthePublicHealthServiceAct....”);300a‐7(e)(“Noentitywhichreceives...anygrant,contract,loan,[or]loanguarantee...underthePublicHealthServiceAct...ortheDevelopmentalDisabilitiesAssistanceandBillofRightsActof2000may....”).InadditiontothePHSAct,paragraphs(c)(1)and(e)oftheChurchAmendmentsapplytoentitiesthatreceivefundingundertheCommunityMentalHealthCentersAct,42U.S.C.2689etseq.Subparagraph(c)(1)oftheChurchAmendmentsadditionallyappliestoentitiesthatreceivefundingundertheDevelopmentalDisabilitiesServicesandFacilitiesConstructionAct,42U.S.C.6000etseq.Congressrepealedbothoftheselaws.SeeOmnibusReconciliationActof1981,Pub.L.97‐35,TitleIX,sec.902(e)(2)(B),95Stat.560(1981);DevelopmentalDisabilitiesAssistanceandBillofRightsActof2000,Pub.L.106‐402,TitleIV,sec.401(a),114Stat.1737(2000).Thus,therearenoentitiesreceivingfundsunderprogramsauthorizedbythesestatutestoconsiderinthisRIA.


271

researchactivityfundedinwholeorinpartunderaprogramadministeredbythe

SecretaryofHealthandHumanServices.”171Paragraph(d)oftheChurch

Amendmentdoesnottiethefundingsourcetoaparticularappropriation,

instrument,orauthorizingstatute,nordoesthereceiptoffundsunderChurch(d)

automaticallytriggercoverageofallofanentity’soperations.

(ii)PersonsandEntitiesObligatedtoComplywithAdditionalFederalLaws

thatthisRuleImplementsandEnforces

Thisruleonlyaffectspersonsandentitiesobligatedtocomplywithatleast

oneoftheFederalstatutoryprovisionsthatthisruleimplementsandenforces.

Thereissubstantialoverlapbetweenpersonsandentitiescurrentyobligatedto

complywith45CFRpart88,asbasedonthe2011Ruleandpersonsandentities

subjecttoatleastoneoftheadditionalFederallawsthatthisfinalruleenforces.

Thisoverlapoccursbecausesuchpersonsandentitieslargelywere,andcontinueto

be,subjectto45CFRpart88byvirtueoftheChurchAmendments,butalsothe

WeldonAmendmentandtheCoats‐SnoweAmendment,asexplainedabove.Because

ofthissubstantialoverlap,theDepartmentestimatedintheproposedrulethat

OCR’sauthoritytoenforcethefollowingstatutoryprovisionswouldnotaddany

newpersonsandentitiestothecoverageofthisrule:

Provisionsprotectinghealthcareentitiesandindividualsfrom

discriminationwhoobjecttofurtheringorparticipatinginabortion

171Id.section300a‐7(d)(“NoindividualshallberequiredtoperformorassistintheperformanceofanypartofahealthserviceprogramorresearchactivityfundedinwholeorinpartunderaprogramadministeredbytheSecretaryofHealthandHumanServices....”).


272

underMedicareAdvantage,e.g.Pub.L.No.115‐245,Div.B,Tit.II,section

209,132Stat.2981,3090(2018);

ProvisionsoftheAffordableCareActrelatedtoassistedsuicide(42

U.S.C.18113),theACAindividualmandate(26U.S.C.5000A(d)(2)),and

othermattersofconscience(42U.S.C.18023(c)(2)(A)(i)‐(iii),(b)(1)(A)&

(b)(4));

Provisionsregardingconscienceprotectionsforobjectionstocounseling

andreferralforcertainservicesinMedicaidorMedicareAdvantage

(42U.S.C.1395w‐22(j)(3)(B)and1396u‐2(b)(3)(B));

Provisionsregardingconscienceprotectionsrelatedtotheperformance

ofadvanceddirectives(42U.S.C.1395cc(f),1396a(w)(3),and14406);

Provisionsexemptingindividualsfromcompulsoryhealthcareor

servicesgenerally(42U.S.C.1396f&5106i(a)(1))andunderspecific

programsforhearingscreening(42U.S.C.280g‐1(d)),occupational

illnesstesting(29U.S.C.669(a)(5)),vaccination(42U.S.C.

1396s(c)(2)(B)(ii)),andmentalhealthtreatment(42U.S.C.290bb‐36(f));

and

Protectionsforreligiousnonmedicalhealthcarerelatingtohealthfacility

review(42U.S.C.1320a–1),peerreview(42U.S.C.1320c‐11),certain

healthstandards(42U.S.C.1396a(a)(9)(A)),medicalevaluation(42U.S.C.

1396a(a)(31)),medicallicensingreview(42U.S.C.1396a(a)(33)),and

utilizationreviewplanrequirements(42U.S.C.1396b(i)(4)),andby


273

protectingtheexerciseofreligiousnonmedicalhealthcareintheElder

JusticeBlockGrantProgram(42U.S.C.1397j‐1(b))andintheChildAbuse

PreventionandTreatmentAct(42U.S.C.5106i(a)(2)).

Intheproposedrule,theDepartmentestimatedthattheOCRenforcementof

thefollowingFederalstatutoryprovisionscouldaddnewpersonsandentitiestothe

coverageof45CFRpart88:

GlobalHealthProgramsforHIV/AIDSPrevention,Treatment,orCare(22

U.S.C.7631(d)),and

TheHelms,Biden,1978,and1985Amendments,22U.S.C.2151b(f),e.g.,

ConsolidatedAppropriationsAct,2019,Pub.L.116‐6,Div.F,sec.7018.

However,theproposedruleexplainedthatbecauseparagraph(d)ofthe

ChurchAmendmentsdoesnotrequirethatthefundingforthehealthservice

programorresearchactivitybeappropriatedtoHHS,butonlythatitbe“fundedin

wholeorpartunderaprogramadministeredbythe[HHS]Secretary,”funding

appropriatedtootherFederalDepartments,butawardedbyHHSinits

administrationofcertainglobalhealthprogramswouldbecoveredbyparagraph

(d)oftheChurchAmendments.Consequently,HHS’simplementationof22U.S.C.

sections2151b(f)and7631(d)maynotexpandthescopeofpersonsandentities

coveredbythispart.

(iii)Methodology

TheDepartmentquantitativelyestimatedthosepersonsandentitiescovered

bythefinalrulebyrelyingprimarilyonthelatestdataavailablefromtheU.S.Census


274

Bureau’sStatisticsofU.S.Businesses172supplementedwithothersources.The

Departmentinvitedpubliccommentontheproposedrule’smethodologyand

solicitedideasonwhetherthereareothermethodologiesthattheDepartmentcould

considertorefinethescopeofpersonsandentitiesaffectedbythisrule.The

DepartmentreceivedonecommentsuggestingthattheDepartment’smethodology

wasflawedforfailingtoincludeanestimateofthenumberofconsumersofhealth

careaffected,i.e.,patients,andthusdidnotconsiderconsumersofhealthcareinthe

listofpersonsandentitiesshowninfraatTable2.ThepurposeofTable2isto

identifyregulatedentities,notconsumersofhealthcare.Ananalysisofthisrule’s

impactonpersons,entities,andhealthcareentitiesisincludedintherule’sanalysis

ofbenefits,infraatpartIV.C.4.Thefinalrule’smethodsforquantifyingthepersons

andentitiesimpactedarethesamemethodsfromtheproposedrule,whichthe

Departmentdeterminedwasthemostreasonableandreliableapproach.173

TheU.S.CensusBureau’sStatisticsofU.S.BusinessesisbasedontheNorth

AmericanIndustryClassificationSystem(NAICS).174TheNAICSclassifiesall

economicactivityinto20sectorsandbreaksthatinformationdownintosub‐sectors

andindustries.175Essentially,theNAICSgroupsphysicalbusinessestablishments

172https://www.census.gov/data/datasets/2015/econ/susb/2015‐susb.html.TheDepartmentreliedonthedatafiletitled“U.S.&State,NAICS,detailedemploymentsizes(U.S.,6‐digitandstates,NAICSsectors).”Thelatestdataavailableisfrom2015thattheBureaumadeavailableinSeptemberof2017,andthisdatareliedonthe2012NAICScodes,id.,whicharedescribedathttps://www.census.gov/eos/www/naics/2012NAICS/2012_Definition_File.pdf.173See83FR3880,3907(describingvarioussourcesofdataconsideredandreasonsforrejectingotherapproaches).174https://www.census.gov/programs‐surveys/susb/technical‐documentation/methodology.html.175FAQ5,https://www.census.gov/eos/www/naics/faqs/faqs.html#q5.


275

togetherbasedonhowsimilarthelocations’processesareforproducinggoodsor

services.176TheNAICSprovidesinformationonhowmanysingularphysical

locationsexistforaparticularbusinessorindustry(calledan“establishment”),177

howmanyofthoseestablishmentsareundercommonownershiporcontrolofa

businessorganizationorentity(calleda“firm”),178andthenumberofpeoplewho

workinaparticularbusinessorindustry,amongothertypesofinformation.For

instance,ahospitalsystemthathascommonownershipandcontrolovermultiple

hospitalfacilitiesisafirm,andeachhospitalfacilityisanestablishment.

Forthevastmajorityoftherecipientandsub‐recipienttypes,the

DepartmentassumedthatonlyaportionoftheindustrycapturedintheStatisticsof

U.S.BusinessesreceivesFederalfundstotriggercoveragebythisrule(e.g.,“Federal

financialassistance...fromtheDepartmentoracomponentoftheDepartment,or

whootherwisereceivesFederalfundsdirectlyfromtheDepartmentoracomponent

oftheDepartment”).Forinstance,notallphysicianofficesreceiveFFAorotherwise

receiveFederalfundsasarecipientorsub‐recipient.Infact,about68.9percentof

physicianofficesacceptednewMedicaidpatientsbasedon2013datafromthe

NationalElectronicHealthRecordsSurvey.179Approximately83.7percentof

physiciansacceptednewMedicarepatientsbasedonthesamedata.180BecauseOCR

176FAQ1,https://www.census.gov/eos/www/naics/faqs/faqs.html#q1.177https://www.census.gov/eos/www/naics/faqs/faqs.html#q2.178https://www.census.gov/glossary/#term_Firm.179EstherHing,etal.,Nat’lCtr.ForHealthStatistics,CentersforDiseaseControlandPrevention,U.S.Dep’tofHealthandHumanServs.,AcceptanceofNewPatientswithPublicandPrivateInsurancebyOffice‐BasedPhysicians:UnitedStates,2013,DataBriefNo.195,1(Mar.2015).180Id.


276

interpretsthe2011Ruletoapplytophysiciansreceivingreimbursementfor

MedicarePartB,whichisa“healthserviceprogram...fundedinwholeorinpart

underaprogramadministeredbytheSecretaryofHealthandHumanServices”,the

Departmentassumedthatthelowerofthesetwopercentages(69percent)

representsthelower‐boundofphysiciansnationwidesubjecttothe2011Rule.In

theabsenceofevidencewithwhichtogeneratearefinedupper‐boundestimate,the

Departmentassumedthatthe2011Rulecoversallphysiciansnationwideasthe

upper‐bound.

TheDepartmentusedthissamepercentagerange(69to100percent)in

estimatingthecoverageforotherhealthcareindustrysectortypes,suchas

hospitalsandvariousoutpatientcarefacilities.Forthesocialservicesandeducation

industries,whichgenerallyhaveprincipalpurposesotherthanhealthandpatient

care,theDepartmentadoptedrangesmoreappropriateforthoseindustries.Forthe

socialservicesindustries,theDepartmentadoptedarangewith25percentasthe

lower‐boundand100percentastheupper‐boundtocover62.5percentofthe

industryonaverage.Initsnoticeofproposedrulemaking,theDepartmentsought

commentonthismethodology,butreceivednocommentsprovidingasuperior

methodofgeneratingtheseestimates.

TheDepartmentassumessomeportionofthesocialserviceindustrywillbe

coveredbytherule,giventhescopeofthe2011Ruleandtherebythisrule.For

instance,entitiesthatcarryoutsocialservicesprogramsandactivitiesmaydosoin

thecontextofhealthserviceprogramsorresearchactivitiesfundedinwholeorin


277

partunderprogramsadministeredbytheSecretary,ormayreceivefundingthrough

programsadministeredbytheSecretary,aswellasbygrantsorothermechanisms

underthePHSAct181ortheDevelopmentalDisabilitiesAssistanceandBillofRights

Actof2000withinthescopeoftheChurchAmendment’sapplication.

Toestimatethenumberoflocalgovernmentsandeducationalinstitutions,

theDepartmentreliedondatafromotherU.S.CensusBureaustatisticalprogramsor

availableawarddataavailablethroughtheHHSTrackingAccountabilityin

GovernmentGrantsSystem(TAGGS).182Forinstance,inestimatingthenumberof

countiesnationwide,theDepartmentreliedontheU.S.CensusBureau’s2010

CensusGeographicEntityTalliesbyStateandTypetoidentifythetotalcountiesand

equivalentareasfortheU.S.,PuertoRico,theU.S.Territories,andtheIsland

Areas.183

Asanotherexample,theDepartmentreliedondatafromTAGGStoderivea

lower‐boundpercentageofcollegesanduniversitiesthatarerecipients.(Theupper‐

boundassumesalleducationalinstitutionsindustry‐widearerecipients.)Although

mostcollegesanduniversitiesreceiveFederalfinancialassistancefromtheU.S.

DepartmentofEducation,notalluniversitiesarerecipientsofHHSfunds;thus,the

Departmentadoptedalower‐boundestimatetoreflectthatassumption.

Usingthe“AdvancedSearch”functioninTAGGS,HHSidentifiedallawardsto

JuniorColleges,Colleges,andUniversitiesforFY2016andde‐duplicatedtheresults

181ThePHSActcontainsthirtytitlesandauthorizesdozensofprograms.182http://taggs.hhs.gov(lastvisitedAug.24,2017).183https://www.census.gov/geo/maps‐data/data/tallies/all_tallies.html.


278

toobtainasingularlistofuniqueawardeesfromtheDepartment,whichtotaled615.

Becausetheseawardeesincludedsatellitecampusesofcollegeoruniversity

systems,thetotalawardeenumberwasakintothenumberof“establishments”

ratherthan“firms”asthosetermsareusedintheU.S.CensusBureau’sStatisticsof

U.S.Businesses.Similartohowan“establishment”isalocationofa“firm”thathas

commonownershipandcontroloveratleastoneestablishment,asatellitecampus

isonelocationofauniversitysystemwithcommonownershipandcontrolover

multiplecampuslocations.

Toderiveanestimateofeducationalinstitutionsatthe“firm”level,the

DepartmentcomputedtheratiobetweenfirmsandestablishmentsfromtheU.S.

CensusBureau’sStatisticsofU.S.Businesses.184Thisratiois51.32percent(2,457

firms/4,788establishments).TheDepartmentappliedthatratiotothetotal

numberofJuniorColleges,Colleges,andUniversitiesthatreceivedHHSfundingas

“establishments”(0.5132x615awardeeestablishments)togetanestimateof316

firms.Despitethismethod’spotentialcomplexity,theDepartmentfounditthemost

reasonablemethodforestimatingthelower‐boundnumberofcollegesand

universitiesthatareDepartmentrecipients.

(iv)QuantitativeEstimateofPersonsandEntitiesCoveredbythisRule

Table2listseachestimatedtypeofrecipientandtheestimatednumberof

recipientsthatthisfinalrulecovers.Becausethereisuncertaintyastotheuniverse

184SeeU.S.CensusBureau,StatisticsofU.S.Businesses,2015,NAICScode611310(Colleges,Universities,andProfessionalSchools)(identifying2,457firmsand4,788establishmentsnationwide).


279

ofactualpersonsandentitiescovered,Table2capturesthisuncertaintyby

reflectingestimatedrecipientsasarangewithalowerandanupper‐bound.The

footnotesdetailtheassumptionsandcalculationsforeachlineofthetableand

assumecoveragefor69‐100percentoftheindustryunlessotherwisenoted.The

DepartmenthasmadeatechnicalcorrectiontoTable2toincludethenumberof

officesofmiscellaneoushealthpractitioners(e.g.,clinicalpharmacists,dieticians,

registeredpracticalorlicensednurses’offices,ChristianSciencepractitioners’

offices)whooperateprivateorgrouppracticesintheirowncentersorclinicsorin

thefacilitiesofothers,suchashospitals.185

Table2:EstimatedNumberofPersonsandEntitiesCoveredbyThisFinalRule

Type

Coveredby45CFR88in2011Rule?

CoveredbyFinalRule?

Estimate(Low)

Estimate(High)

1 StateandTerritorialGovernments186 Yes Yes 58 582 FederallyrecognizedTribes187 Yes Yes 573 5733 Counties188 Yes Yes 3,234 3,234Hospitals4 General&MedicalSurgical

Hospitals189 Yes Yes 1,859 2,694

185Seetheindustrydescriptionforofficesofmiscellaneoushealthpractitioners,NAICScode921399,https://www.census.gov/cgi‐bin/sssd/naics/naicsrch?code=621399&search=2012NAICSSearch.186Assumescoverageofthe50States,D.C.,PuertoRico,6U.S.Territories,andtheIslandAreas.187AssumesallfederallyrecognizedTribesgetHHSfunds.IndianHealthService,FY2019JustificationofEstimatesforAppropriationsCommitteesCJ‐1(2018),https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.188U.S.CensusBureau,2010CensusGeographicEntityTalliesbyStateandType,https://www.census.gov/geo/maps‐data/data/tallies/all_tallies.html(totalcountiesandequivalentareasfortheU.S.,PuertoRico,theU.S.Territories,andtheIslandAreas).TheDepartmentassumedthateverycountyreceivesFederalfundsasarecipientorasub‐recipient.189U.S.CensusBureau,StatisticsofU.S.Businesses,2015(releasedSept.2017),https://www.census.gov/data/datasets/2015/econ/susb/2015‐susb.html(nationwidecountoffirmsforNAICSCode622110).


280

5 SpecialtyHospitals(e.g.,psychiatric,substanceabuse,rehabilitation,cancer,maternity)190 Yes Yes 553 801

NursingandResidentialCareFacilities6 SkilledNursingFacilities191 Yes Yes 6,316 9,1537 ResidentialIntellectualand

DevelopmentalDisabilityFacilities192 Yes Yes 4,310 6,2468 ContinuingCareRetirement

Communities193 Yes Yes 2,605 3,7759 OtherResidentialCareFacilities(e.g.,

grouphomes)194 Yes Yes 2,247 3,256EntitiesProvidingAmbulatoryHealthCareServices10 EntitiesprovidingHomeHealthCare

Services195 Yes Yes 15,062 21,82911 OfficesofPhysicians(exceptMental

HealthSpecialists)196 Yes Yes 115,673 167,64212 OfficesofPhysicians(MentalHealth

Specialists)197 Yes Yes 7,324 10,61413 OfficesofMentalHealthPractitioners

(exceptPhysicians)198 Yes Yes 14,340 20,78214 OfficesofDentists199 Yes Yes 86,874 125,90415 OfficesofChiropractors200 Yes Yes 26,725 38,73216 OfficesofOptometrists201 Yes Yes 13,775 19,96417 OfficesofPhysical,Occupationaland

SpeechTherapists,andAudiologists202 Yes Yes 17,623 25,540

18 OfficesofPodiatrists203 Yes Yes 5,314 7,70119 OfficesofAllOtherMisc.Health

Practitioners204 Yes Yes 11,502 16,67020 FamilyPlanningCenters205 Yes Yes 999 1,448

190Id.(sumofthenationwidecountoffirmsforNAICSCodes622210and622310).191Id.(relyingonthenationwidecountoffirmsforNAICSCode623110).192Id.(nationwidecountoffirmsforNAICSCode623210).193Id.(nationwidecountoffirmsforNAICSCode623311).194Id.(nationwidecountoffirmsforNAICSCode623990).195Id.(nationwidecountoffirmsforNAICSCode621610).196Id.(nationwidecountoffirmsforNAICSCode621111).197Id.(nationwidecountoffirmsforNAICSCode621112).198Id.(nationwidecountoffirmsforNAICSCode621330).199Id.(nationwidecountoffirmsforNAICSCode621210).200Id.(nationwidecountoffirmsforNAICSCode621310).201Id.(nationwidecountoffirmsforNAICSCode621320).202Id.(nationwidecountoffirmsforNAICSCode621340).203Id.(nationwidecountoffirmsforNAICSCode621391).204Id.(nationwidecountoffirmsforNAICSCode621399).205Id.(nationwidecountoffirmsforNAICSCode621410).


281

21 FreestandingAmbulatorySurgicalandEmergencyCenters206 Yes Yes 2,908 4,214

22 HMOMedicalCenters207 Yes Yes 78 11323 KidneyDialysisCenters208 Yes Yes 305 44224 OutpatientMentalHealthand

SubstanceAbuseCenters209 Yes Yes 3,776 5,47225 DiagnosticImagingCenters210 Yes Yes 3,209 4,65126 MedicalLaboratories211 Yes Yes 2,278 3,30227 AmbulanceServices212 Yes Yes 2,185 3,16728 AllOtherOutpatientCareCenters

(e.g.,centersandclinicsforpaintherapy,communityhealth,andsleepdisorders)213 Yes Yes 3,880 5,623

29 EntitiesProvidingAllOtherAmbulatoryHealthCareServices(healthscreening,smokingcessation,hearingtesting,bloodbanks)214 Yes Yes 2,391 3,465

InsuranceCarriers30 DirectHealthandMedicalInsurance

Carriers215 Yes Yes 607 880EntitiesProvidingSocialAssistanceServices31 EntitiesServingtheElderlyand

PersonswithDisabilities(provisionofnonresidentialsocialassistanceservicestoimprovequalityoflife)216 Yes Yes 9,051 36,205

32 EntitiesProvidingOtherIndividualFamilyServices(e.g.,marriagecounseling,crisisinterventioncenters,suicidecrisiscenters)217 Yes Yes 5,310 21,240

33 EntitiesProvidingChildandYouthServices(e.g.,adoptionagencies,fostercareplacementservices)218 Yes Yes 2,169 8,674

206Id.(nationwidecountoffirmsforNAICSCode621493).207Id.(nationwidecountoffirmsforNAICSCode621491).208Id.(nationwidecountoffirmsforNAICSCode621492).209Id.(nationwidecountoffirmsforNAICSCode621420).210Id.(nationwidecountoffirmsforNAICSCode621512).211Id.(nationwidecountoffirmsforNAICSCode621511).212Id.(nationwidecountoffirmsforNAICSCode621910).213Id.(nationwidecountoffirmsforNAICSCode621498).214Id.(nationwidecountoffirmsforNAICSCode62199).215Id.(nationwidecountoffirmsforNAICSCode524114).216Id.(nationwidecountoffirmsforNAICSCode624120).217Id.(nationwidecountoffirmsforNAICSCode624190).218Id.(nationwidecountoffirmsforNAICSCode624110).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.


282

34 TemporaryShelters(e.g.,shorttermemergencysheltersforvictimsofdomesticviolence,sexualassault,orchildabuse;runawayyouth;andfamiliescaughtinmedicalcrises)219 Yes Yes 805 3,219

35 EmergencyandOtherReliefServices(e.g.,medicalrelief,resettlement,andcounselingtovictimsofdomesticorinternationaldisastersorconflicts)220 Yes Yes 169 675

OtherEntities36 PharmaciesandDrugStores221 Yes Yes 13,490 19,55037 ResearchandDevelopmentin

Biotechnology222 Yes Yes 2,347 3,40238 Colleges,Universities,&Professional

Schools223 Yes Yes 316 2,457Subtotal,subjecttopart88in2011Rule 392,236 613,367

39 HHSawardedfundsappropriatedtotheU.S.Dept.ofState&USAID224 No Yes 65 130

Subtotal,incrementalincreaseinentities 65 130TOTAL,estimatedentitiessubjectto

thisrule

392,301 613,497

219Id.(nationwidecountoffirmsforNAICSCode624221).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.220Id.(nationwidecountoffirmsforNAICSCode624230).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.221Id.(nationwidecountoffirmsforNAICSCode44610).222Id.(nationwidecountoffirmsforNAICSCode541711).223Id.(nationwidecountoffirmsforNAICSCode611310).AsdescribedsupraatpartIV.C.2.iii(methodology),theDepartmentassumes13%‐100%ofinstitutionsofhigher‐educationarecovered.SeesupraatXI.C.2.iiiforadetailedexplanationforhowtheDepartmentsupplementedStatisticsofU.S.BusinessesdatawithawarddatafromtheDepartment’sTrackingAccountabilityinGovernmentGrantsSystem.224U.S.Dep’tofHealth&HumanServs.,TrackingAccountabilityinGovernmentGrantsSystem(TAGGS)http://taggs.hhs.gov(lastvisitedDec.19,2017).HHSidentifieduniqueawardeesforFY2017fromHHSPEPFARimplementingagencies(CDC,HRSA,SAMHSA,NIH,FDA)toforeignnonprofits,foreigngovernments,andinternationalorganizationsandusedthisnumberasalower‐bound.BecausetheDepartmentalsoreceivesfundsappropriatedtoUSAIDthroughoneormorereimbursableagreements,theDepartmentassumedthattherecouldbetwiceasmanyrecipientsandsub‐recipientsafterconsideringtheawardeesfromthesereimbursableagreementsandthusmultipliedandlower‐boundbytwo.


283

Approximately392,236to613,367personsandentitiesweresubjecttopart

88ineffectbasedonthe2011RulebyvirtueoftheWeldon,Coats‐Snoweand

ChurchAmendments.TheDepartmentestimatedthatthenumberofentitiesthat

thisfinalrulecoversthataresubjectto22U.S.C.7631(d)and2151b(f),butnot

paragraph(d)oftheChurchAmendmentsissmalland,possibly,non‐existent

becauseparagraph(d)oftheChurchAmendmentsdoesnottiefundingtoa

particularappropriationorfinancialstream.225Consequently,thisfinalrulemayadd

65to130newpersonsandentitiestothecoverageof45CFRpart88.226Withthis

incrementalincrease,thisfinalrulecoversanaverageof502,899entities,whichis

themid‐pointofthelow(392,301entities)andhigh‐end(613,497entities).

(A)EstimatedPersonsandEntitiesRequiredtoSignanAssuranceand

CertificationofCompliance

RelativetothepersonsandentitiesshowninTable2,asmallersubsetis

subjectto§88.4,whichrequirescertainrecipientstosubmitanassuranceand

certificationofcomplianceandexemptsothers.TheDepartmentcalculatedthe

subsetofpersonsandentitiessubjectto§88.4by(1)removingestimatedsub‐

recipientsfromthetotalbecause§88.4appliestorecipients,notsub‐recipients,and

(2)removingtheestimatedrecipientsexemptedfrom§88.4,asidentifiedin§

88.4(c)(1)‐(4).InfraatTable3showsthiscalculation.

CalculatingEstimatedSub‐Recipients

225Thetextofparagraph(d)statesthatitsprotectionappliesforhealthserviceprogramandresearchactivities“fundedinwholeorpartunderaprogramadministeredbythe[HHS]Secretary.”226ButseesupraatpartIV.C.2.ii(discussingtheapplicationofparagraph(d)oftheChurchAmendmentstosuchgrantees).


284

TheDepartmentsoughtcommentonthepolicyfor§88.4toapplyto

recipientsbutnotsub‐recipients,notingthattheproposedruletookthisapproach

toreducetheburdenonsmallentities.TheDepartmentdidnotreceivecomments

addressingthisquestion.Onecommenter,however,raisedthequestionthat,ifthe

proposedrule’spolicywastoexemptclinicianswhoarepartofStateMedicaid

programs,thentheproposedruledidnotexcludesuchcliniciansfrom§88.4.

However,clinicianswhoreceivereimbursementthroughaStateMedicaidprogram

aresub‐recipientsoftheDepartment(i.e.,recipientsoftheState,whichisthe

recipientinrelationshiptotheDepartment).UnderaMedicaidfee‐for‐service

model,theStatepaysthecliniciansdirectly,andunderthemanagedcaremodel,a

Statepaysafeetoamanagedcareplan,whichinturnpaystheclinicianforthe

servicesabeneficiarymayrequirethatarewithinthemanagedcareplan’scontract

withtheStatetoserveMedicaidbeneficiaries.227Assub‐recipients,theseclinicians

thatacceptMedicaidarenotsubjectto§88.4,unlesstheybecomerecipientsfrom

HHSFederalfinancialassistanceorotherFederalfundsfromanon‐exemptHHS

program(i.e.,aprogramnotcapturedin§88.4(c)(2)‐(4)).

Intheproposedrule,OCRexplainedthatithadnotfoundareliablewayto

calculatethenumberofsub‐recipientsofthisrule.TheDepartmentassumed

entitiesinsupraatTable2wereallrecipientsexceptforcounties,whichthe

Departmentassumedweresub‐recipientsforthepurposeofthiscalculation.The

227See,e.g.,ProviderPaymentandDeliverySystems,MACPAC,https://www.macpac.gov/medicaid‐101/provider‐payment‐and‐delivery‐systems/(lastvisitedJan.29,2019).


285

Departmentreceivednocommentsregardinginformation,datasources,studies,or

reportsthatcouldassisttheDepartmentinimprovingitsapproach.

Torefinetheestimates,theDepartmentreconsideredtheproposedrule’s

blanketassumptionthatallcountiesaresub‐recipientsforpurposesofthis

calculation.Usingthe“AdvancedSearch”functioninTAGGS,theDepartment

identifiedthetotalnumberofcountyawardeesandde‐duplicatedtheresultsto

obtainonelistofuniquecountyawardeesfromtheDepartmentforFY2017.This

approachidentified625counties(19percent)receivingfundingdirectlyfromHHS

asrecipients.AssumingthatallcountiesareHHSrecipientsorsub‐recipients,the

remainingof2,609counties(81percent)wouldbesub‐recipientsthatarenot

subjectto§88.4’sapplication.Thismethodisamoreaccurateproxyforestimating

thenumberofsub‐recipientcounties.Ifsomeentities(otherthancounties)inTable

2aresub‐recipientsratherthanrecipients,thentheDepartmentoverestimatedthe

scopeofentitiessubjectto§88.4’sapplicationthatarenotexempted.

CalculatingExemptedRecipientsin§88.4(c)(1)‐(4)

TheDepartmentreceivednocommentsregardingthemethodsusedto

estimatethescopeofexemptedrecipientsunder§88.4(c)(1)‐(4).Therefore,the

Departmentmaintainstheproposedrule’smethods.

TheDepartmentassumedthatallphysicians’officeswouldmeetthecriteria

in§88.4(c)(1)andsubtractedout255,684to370,557entities,whichrepresentsthe

lowerandupper‐boundsofallphysicians’offices.228Ifsomephysicians’officesare

228Sumofrows11,12,14‐16,and18ofTable2.


286

recipientsthroughaninstrumentotherthanMedicarePartBreimbursement,then

theDepartmentoverestimatedthenumberofphysicians’officesexempteddueto

§88.4(c)(1).TheDepartmentdoesnothavethenecessarydatatoestimatethe

impactofthefinalrule’snewexemptionforpharmaciesandpharmaciststhat

receiveMedicarePartBbecausetheDepartmentdoesnotknowwhethersuch

pharmaciesorpharmacistsexemptedunder§88.4(c)(1)areDepartmentrecipients

(asopposedtosub‐recipients)ofHHSFederalfinancialassistanceorotherFederal

fundsfromanon‐exemptHHSprogram(i.e.,aprogramnotcapturedin§88.4(c)(2)‐

(4)).

TheDepartmentsubtractedout11,220to44,879personsandentitiesthat

meetthecriteriain§88.4(c)(2)‐(3)regardingtheexemptionforrecipientsofgrant

programsadministeredbytheAdministrationforChildrenandFamiliesorthe

AdministrationforCommunityLiving.229Theexemptionappliesiftheprogram

meetscertainregulatorycriteriaindicatingthatitspurposeisunrelatedtohealth

careandcertaintypesofresearch,doesnotinvolvehealthcareproviders,anddoes

notinvolvereferralfortheprovisionofhealthcare.TheDepartmentreasonably

assumedthatallpersonsandentitiesthatprovidechildandyouthservices(suchas

adoptionandfostercare)wouldfallintothisexemption.TheDepartmentalso

reasonablyassumedthatallentitiesprovidingservicesfortheelderlyandpersons

withdisabilities(byprovidingnonresidentialsocialassistanceservicestoimprove

qualityoflife)wouldfallwithinthisexemption.TheDepartmentdidnotsubtract

229Sumofrows31and33ofTable2.


287

outtheentitiesproviding“OtherIndividualFamilyServices”(e.g.,marriage

counseling,crisisinterventioncenters,suicidecrisiscenters)becausethereisa

significantlikelihoodofreferralfortheprovisionofhealthcareatcrisisintervention

centersandsuicidecrisiscenters.

TheDepartmentsubtractedout230TribesandTribalOrganizationsforthe

exemptionin§88.4(c)(4).ThisnumberrepresentsthetotalTribesandTribal

OrganizationsthatoperatecontractsunderTitleIoftheISDEAAct.230Thisfinalrule

revisestherequirementsforfederallyrecognizedIndiantribes,tribalorganizations,

orurbanIndianorganizationswhoarerecipientsbyvirtueofgrantsorcooperative

agreementsunder42U.S.C.290bb‐36,removingtherequirementthatsuchentities

complywithsection88.4.TheDepartmentdoesnothavethedatanecessaryto

estimatethenumberofsuchentitieswhoarerecipientsoffundsviasuchgrantsor

cooperativeagreementsthatarenotalreadycapturedwithinthescopeofthe

exemptionin§88.4(c)(4).

Table3:EstimatedRangeofRecipientsSubjecttotheAssuranceand

CertificationRequirements(§88.4)

Low‐EndEstimate

Upper‐BoundEstimate

PersonsorEntitiesSubjecttoThisFinalRule 392,301 613,497Sub‐Recipientstowhich§88.4DoesNotApply ‐2,609 ‐2,609RangeofRecipientsExemptedfrom§88.4 ‐267,134 ‐415,666

Total,RecipientsSubjectto§88.4 122,558 195,222

230IndianHealthService,FY2019JustificationofEstimatesforAppropriationsCommitteesCJ‐243(2018),https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.


288

(B)EstimatedNumberofRecipientsIncentivizedtoProvideVoluntarilya

NoticeofRights(§88.5)

Theproposedrulecontainedafreestandingnoticeprovisionwithmandatory

anddiscretionaryelements.Asfinalizedinthisrule,thenoticeprovisionsareno

longermandatory.Section88.5incentivizesrecipientsandtheDepartmentto

providenoticetopersons,entities,andhealthcareentitiesconcerningFederal

conscienceandanti‐discriminationlaws.Theruleintendstoaccomplishthisgoalby

providingthatOCRwillconsiderarecipient’spostingofanoticeasnon‐dispositive

evidenceofcompliancewiththisruleinanyinvestigationorcompliancereview

pursuanttothisrule,totheextentsuchnoticesareprovidedaccordingtothe

provisionsofthissectionandarerelevanttotheparticularinvestigationor

compliancereview.

TheDepartmentexpectsthatsomeregulatedrecipientsandDepartment

componentswillvoluntarilypostthenoticethroughoneofthemethodsspecified.

Becauserecipientsaretheprimaryentitiesresponsibleforcomplianceunderthis

rule,theDepartmentassumesthatsub‐recipientswillnotbeinducedbytheruleto

postanoticeontheirownaccord.

Theproposedruledidnotpermitrecipientstomodifythepre‐writtennotice

inAppendixA.Asdiscussedinthepreamblefor§88.5,supraatpartII.B,public

commentsaskedforflexibilitytomodifythenotice’scontentasappliedto

recipients.Section88.5(c)ofthefinalruleprovidesgreaterflexibilitybystatingthat

therecipientandtheDepartmentshouldconsiderusingthemodeltextprovidedin


289

AppendixAforthenotice,butmaytailorthecontenttoaddressthelawsthatapply

totherecipientorDepartmentundertheruleandtherecipient’sorDepartment’s

particularcircumstances.Accordingly,theDepartmentassumesthatsome

recipientsthatvoluntarilypostnoticeswillmodifythepre‐writtennoticein

AppendixA.Recipientsthatmodifythepre‐writtennoticelikelywilldosoatthe

firmlevel(i.e.,corporatelevel)ratherthantheestablishmentlevel(i.e.,ateach

facility).Forinstance,acompanywithcommonownershipandcontrolover

multiplefacilitieswouldmodifythenoticeatitscorporate(“firm”)levelbutwould

postsubstantiallythesamephysicalnoticesateachfacility(“establishment”)where

noticesarecustomarilypostedtopermitreadyobservationformembersofthe

workforceorforthepublic.

TheDepartmentestimatesthateighteenrecipienttypes,suchasmedical

specialists,eldercareproviders,andentitiesprovidingprimarilysocialservices,are

likelytomodifythepre‐writtennoticeasappliedtothem(inrelationto,for

example,abortion).Thesumofthelow‐endandhigh‐endestimatesoffirms

associatedwiththeseeighteenrecipienttypesis225,751(low‐end)and332,707

(high‐end),providinganaverageof279,229firms.Giventhediscretionarynatureof

thenoticeprovision,theDepartmentadjuststherangeoffirmsdownwardby50

percentforthepurposeofthiscalculationtoderivethevaluesshownininfraat

Table4:112,876firms(low‐end)and166,354firms(high‐end)foramid‐pointof

139,615firmslikelytomodifythepre‐writtennoticeinAppendixA.Totheextent


290

thatrecipienttypesotherthanthoselistedinTable4modifythenotice,the

Departmenthasunderestimatedthescopeofimpact.

Table4:EstimatedNumberofFirmsAssociatedwithEachRecipientType

LikelytoModifytheNoticeofRightsinAppendixA(§88.5)

Type Estimate(Low)

Estimate(High)

1 SkilledNursingFacilities 3,158 4,5772 ResidentialIntellectualandDevelopmentalDisabilityFacilities 2,155 3,1233 ContinuingCareRetirementCommunities 1,302 1,8884 OtherResidentialCareFacilities(e.g.,grouphomes) 1,123 1,6285 EntitiesprovidingHomeHealthCareServices 7,531 10,9156 OfficesofPhysicians,MentalHealthSpecialists 3,662 5,3077 OfficesofMentalHealthPractitioners(exceptPhysicians) 7,170 10,3918 OfficesofDentists 43,437 62,9529 OfficesofChiropractors 13,363 19,36610 OfficesofOptometrists 6,888 9,98211 OfficesofPhysical,OccupationalandSpeechTherapists,and

Audiologists8,811 12,770

12 OfficesofPodiatrists 2,657 3,85113 OfficesofAllOtherMiscellaneousHealthPractitioners 5,751 8,33514 KidneyDialysisCenters 152 22115 OutpatientMentalHealthandSubstanceAbuseCenters 1,888 2,73616 DiagnosticImagingCenters 1,605 2,32617 MedicalLaboratories 1,139 1,65118 EntitiesProvidingChildandYouthServices(e.g.,adoption

agencies,fostercareplacementservices)1,084 4,337

Total,FirmsLikelytoModifyPre‐WrittenNoticeText 112,876 166,354

TheDepartmentassumesthat,forallpostingmethods,recipientswill

executethepostingattheestablishmentlevel.Usingtherangeoffirmssubjectto

thisruleasafoundation,therangeofestablishmentsassociatedwiththose

recipientsisshowninfraatinTable5.Table5employsthemethodologyusedfor

calculatingthenumberofpersonsandentitiesshowninTable2,butusestheU.S.

CensusBureau’sStatisticsofU.S.Businessesdataforestablishmentsratherthan


291

firms.231Thefootnotesdetailtheassumptionsandcalculationsforeachlineand

assume69‐100percentoftheindustryascoveredunlessotherwisenoted,which

parallelstheassumptionsforTable2.

Becausethereisahighdegreeofuncertaintyastotheproportionof

recipientsthatwillvoluntarilypostnoticesthroughoneormoreofthemethods

specifiedin§88.5inthefirstyearoftherule’simplementation,theDepartment

adjuststherangeofestablishmentsassociatedwithcoveredrecipientsdownward

by50percentforthepurposeofthiscalculation.Thevaluesderivedfromthis

calculationappearinfraatinTable5:261,735establishments(low‐end)and

408,918establishments(high‐end)foramid‐pointof335,327establishments.The

Departmentadjustsdownwardtherangeofestablishmentsthatwouldvoluntarily

providenoticesofrightsinyearstwothroughfiveby25percent,relativetoyear

one,toreflectattrition:196,301establishments(low‐end)and306,689

establishments(high‐end)foramid‐pointof251,495establishments.

Table5:NumberofPhysicalEstablishmentsofEachRecipientTypeEstimated

toVoluntarilyProvideNoticeofRightsinYear1(§88.5)

Type

EstablishmentsAssoc.withCovered

Recipients

EstablishmentsAssoc.withCoveredRecipientsThatWouldVoluntarilyPostNoticesinYear1

(Low) (High) (Low) (High) Mid‐PointStateandTerritorialGovernments232 58 58 29 29 29

231https://www.census.gov/data/datasets/2015/econ/susb/2015‐susb.html.TheDepartmentreliedonthedatafiletitled“U.S.&State,NAICS,detailedemploymentsizes(U.S.,6‐digitandstates,NAICSsectors).”Thelatestdataavailableisfrom2015thattheBureaumadeavailableinSeptemberof2017,andthisdatareliedonthe2012NAICScodes.Id.232Assumescoverageofthe50States,D.C.,PuertoRico,6U.S.Territories,andtheIslandAreas.


292

Type


Recipients


(Low) (High) (Low) (High) Mid‐PointFederallyrecognizedTribes233 573 573 287 287 287Counties234 625 625 313 313 313GeneralandMedicalSurgicalHospitals235 3,699 5,361 1,850 2,681 2,265SpecialtyHospitals(e.g.,psychiatric,substanceabuse,rehabilitation,cancer,maternity)236 1,139 1,651 570 826 698SkilledNursingFacilities237 11,789 17,085 5,894 8,543 7,218ResidentialIntellectual&DevelopmentalDisabilityFacilities238 22,611 32,770 11,306 16,385 13,845ContinuingCareRetirementCommunities239 3,668 5,316 1,834 2,658 2,246OtherResidentialCareFacilities(e.g.,grouphomes)240 3,627 5,256 1,813 2,628 2,221EntitiesprovidingHomeHealthCareServices241 21,377 30,981 10,688 15,491 13,089OfficesofPhysicians(exceptMentalHealthSpecialists)242 147,817 214,228

73,909

107,114 90,511

OfficesofPhysicians(MentalHealthSpecialists)243 7,498 10,867 3,749 5,434 4,591OfficesofMentalHealthPractitioners(exceptPhysicians)244 15,022 21,771 7,511 10,886 9,198

233AssumesallfederallyrecognizedTribesgetHHSfunds.IndianHealthService,FY2019,JustificationofEstimatesforAppropriationsCommittees,CJ‐243(2018),https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents/FY2019CongressionalJustification.pdf.234U.S.CensusBureau,2010CensusGeographicEntityTalliesbyStateandType,https://www.census.gov/geo/maps‐data/data/tallies/all_tallies.html(totalcountiesandequivalentareasfortheU.S.,PuertoRico,theU.S.Territories,andtheIslandAreas).Thevaluesestimatethenumberofrecipientcountiesandexcludeestimatedsub‐recipients.235U.S.CensusBureau,StatisticsofU.S.Businesses,2015(releasedSept.2017),https://www.census.gov/data/datasets/2015/econ/susb/2015‐susb.html(nationwidecountoffirmsforNAICSCode622110).236Id.(sumofthenationwidecountoffirmsforNAICSCodes622210and622310).237Id.(nationwidecountoffirmsforNAICSCode623110).238Id.(nationwidecountoffirmsforNAICSCode623210).239Id.(nationwidecountoffirmsforNAICSCode623311).240Id.(nationwidecountoffirmsforNAICSCode623990).241Id.(nationwidecountoffirmsforNAICSCode621610).242Id.(nationwidecountoffirmsforNAICSCode621111).243Id.(nationwidecountoffirmsforNAICSCode621112).244Id.(nationwidecountoffirmsforNAICSCode621330).


293

Type


Recipients


(Low) (High) (Low) (High) Mid‐PointOfficesofDentists245 92,895 134,631 46,448 67,316 56,882OfficesofChiropractors246 26,999 39,129 13,500 19,565 16,532OfficesofOptometrists247 15,101 21,885 7,550 10,943 9,246OfficesofPhysical,Occupational&SpeechTherapists,&Audiologists248 25,213 36,541 12,607 18,271 15,439OfficesofPodiatrists249 5,769 8,361 2,885 4,181 3,533OfficesofAllOtherMisc.HealthPractitioners250 12,731 18,450 6,365 9,225 7,795FamilyPlanningCenters251 1,584 2,295 792 1,148 970FreestandingAmbulatorySurgical&EmergencyCtrs.252 4,609 6,679 2,304 3,340 2,822HMOMedicalCenters253 560 812 280 406 343KidneyDialysisCenters254 5,144 7,455 2,572 3,728 3,150OutpatientMentalHealth&SubstanceAbuseCtrs.255 7,227 10,474 3,614 5,237 4,425DiagnosticImagingCenters256 4,553 6,598 2,276 3,299 2,788MedicalLaboratories257 7,360 10,667 3,680 5,334 4,507AmbulanceServices258 3,271 4,740 1,635 2,370 2,003AllOtherOutpatientCareCenters(e.g.,centers&clinicsforpaintherapy,communityhealth,&sleepdisorders)259 8,054 11,672 4,027 5,836 4,931EntitiesProvidingAllOtherAmbulatoryHealthCareServices(healthscreening,smokingcessation,hearingtesting,bloodbanks)260 3,670 5,319 1,835 2,660 2,247

245Id.(nationwidecountoffirmsforNAICSCode621210).246Id.(nationwidecountoffirmsforNAICSCode621310).247Id.(nationwidecountoffirmsforNAICSCode621320).248Id.(nationwidecountoffirmsforNAICSCode621340).249Id.(nationwidecountoffirmsforNAICSCode621391).250Id.(nationwidecountoffirmsforNAICSCode621399).251Id.(nationwidecountoffirmsforNAICSCode621410).252Id.(nationwidecountoffirmsforNAICSCode621493).253Id.(nationwidecountoffirmsforNAICSCode621491).254Id.(nationwidecountoffirmsforNAICSCode621492).255Id.(nationwidecountoffirmsforNAICSCode621420).256Id.(nationwidecountoffirmsforNAICSCode621512).257Id.(nationwidecountoffirmsforNAICSCode621511).258Id.(nationwidecountoffirmsforNAICSCode621910).259Id.(nationwidecountoffirmsforNAICSCode621498).260Id.(nationwidecountoffirmsforNAICSCode62199).


294

Type


Recipients


(Low) (High) (Low) (High) Mid‐PointDirectHealth&MedicalInsuranceCarriers261 3,712 5,379 1,856 2,690 2,273EntitiesServingtheElderlyandPersonswithDisabilities(provisionofnonresidentialsocialassistanceservicestoimprovequalityoflife)262 10,475 41,899 5,237 20,950 13,093EntitiesprovidingOtherIndividualFamilyServices(e.g.,marriagecounseling,crisisinterventioncenters,suicidecrisiscenters)263 7,184 28,736 3,592 14,368 8,980EntitiesprovidingChild&YouthServices(e.g.,adoptionagencies,fostercareplacementservices)264 2,901 11,604 1,451 5,802 3,626TemporaryShelters(e.g.,short‐termemergencysheltersforvictimsofdomesticviolence,sexualassault,orchildabuse;runawayyouth;andfamiliescaughtinmedicalcrises)265 1,013 4,053 507 2,027 1,267Emergency&OtherReliefServices(e.g.,medicalrelief,resettlement,&counselingtovictimsofdisastersorconflicts)266 309 1,236 155 618 386PharmaciesandDrugStores267 30,450 44,130 15,225 22,065 18,645ResearchandDevelopmentinBiotechnology268 2,505 3,631 1,253 1,816 1,534Colleges,Universities,&ProfessionalSchools269 615 4,788 308 2,394 1,351

261Id.(nationwidecountoffirmsforNAICSCode524114).262Id.(nationwidecountoffirmsforNAICSCode624120).263Id.(nationwidecountoffirmsforNAICSCode624190).264Id.(nationwidecountoffirmsforNAICSCode624110).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.265Id.(nationwidecountoffirmsforNAICSCode624221).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.266Id.(nationwidecountoffirmsforNAICSCode624230).AsdescribedsupraatpartIV.C.2.iii(methodology),forentitieswhoseprincipalpurposeisnothealthcare,theDepartmentassumes25%‐100%ofindustryiscovered.267Id.(nationwidecountoffirmsforNAICSCode44611).268Id.(nationwidecountoffirmsforNAICSCode541711).269Id.(nationwidecountoffirmsforNAICSCode611310).AsdescribedsupraatpartIV.C.2.iii(methodology),theDepartmentassumes13%‐100%ofinstitutionsofhigher‐educationarecovered.


295

Type


Recipients


(Low) (High) (Low) (High) Mid‐PointHHSawardedfundsappropriatedtotheU.S.DepartmentofState&USAID270 65 130 33 65 49

TOTAL 523,470 817,836 261,735 408,918 335,3273. EstimatedBurdens

Therearefivecategoriesofestimatedmonetizedburdensforthisfinalrule

assummarizedinTable6,aswellasburdensthatcannotbefullymonetized.No

commentersprovidedalternatereliablemethodologiesformonetizingtherule’s

burden.Potentialburdensassociatedwithaccesstocareandhealthoutcomesare

discussedinfraatpartIV.C.4.vii.

Severalcommentsarguedthattherulewouldimposecostsonentities

associatedwiththeincreasedriskoflitigationoverincidentsofproviders’exercise

ofconscience,bothbetweenpatientsandprovidersandbetweenindividual

providersandtheiremployers.

Regardinganincreaseinriskforlitigationbetweenindividualprovidersand

theiremployers,theDepartmentagreeswiththepotentialeffectthesecommenters

predict:thatsomeentitieswillchangetheirbehaviortocomeintocompliance,or

improvecompliance,withFederalconscienceandanti‐discriminationlaws.Indeed,

theproposedrule’sRIAandthisRIAestimatetheburdenassociatedwithsuch

voluntarybehaviorchanges.However,whetherentitiestakesuchactionbecauseof

theriskoflitigationistoospeculativeanduncertainforcalculationintheRIA.

270U.S.Dep’tofHealth&HumanServs.,TrackingAccountabilityinGovernmentGrantsSystem(TAGGS)http://taggs.hhs.gov(lastvisitedDec.19,2017).


296

Further,somecourtshaveheldthatthereisnoprivaterightofactionunderthe

Coats‐SnoweandChurchAmendments,excludinglitigationasaviablealternative

forindividuals.271

Regardinganincreaseinriskforlitigationbetweenpatientsandproviders,

theDepartmentagreesthatthisrulewillresultinmoreprovidersexercising

conscientiousobjectionstoparticipatinginservicesrequestedbypatients,andthat

suchobjectionsmaygiverisetolawsuitsbypatients.However,theDepartmentis

unawareofanyreliablebasisforestimatingthefrequencyorcostofsuchlawsuits.

Publiccommentsregardinggeneralburdensareintegratedthroughoutthe

RIA.Publiccommentsregardingtheburden,ifany,thatmayresultfromsecondary

effectsofthisrule,suchasthemonetaryimpactofcertainhealthoutcomesthatmay

arisefromincreasedconscienceprotection,arediscussedintherule’sanalysisof

benefits,infraatIV.C.4.

271See,e.g.,VermontAll.forEthicalHealthcare,Inc.v.Hoser,274F.Supp.3d227,240(D.Vt.2017);Hellwegev.TampaFamilyHealthCenters,103F.Supp.3d1303,1311‐12(M.D.Fla.2015);Orderat4,NationalInstituteofFamilyandLifeAdvocates,etal.v.Rauner,No.3:16‐cv‐50310(N.D.Ill.July19,2017),ECFNo.65.SeealsosupraatpartII.A(describingthelackofprivateremedies).


297

Table6:CostSummaryoftheFinalRule(discounted3%and7%inmillions)272

Year1

Year2

Year3

Year4

Year5

Total(forundiscounted)Annualized

(fordiscount’d.)

Familiarization(undiscounted) $135 $‐ $‐ $‐ $‐ $135Familiarization(3%) $120 $‐ $‐ $‐ $‐ $120Familiarization(7%) $103 $‐ $‐ $‐ $‐ $103 Assurance&Certification(undiscounted) $156 $142 $142 $142 $142 $724Assurance&Certification(3%) $138 $123 $119 $116 $112 $608Assurance&Certification(7%) $119 $101 $95 $89 $83 $486 VoluntaryNotice(undiscounted) $93 $14 $14 $14 $14 $150VoluntaryNotice(3%) $83 $12 $12 $11 $11 $130VoluntaryNotice(7%) $71 $10 $9 $9 $8 $108 VoluntaryRemedialEfforts(undisc.) $7 $7 $7 $7 $7 $36VoluntaryRemedialEfforts(3%) $6 $6 $6 $6 $6 $31VoluntaryRemedialEfforts(7%) $6 $5 $5 $5 $4 $24 OCREnforcementCosts(undisc.) $3 $3 $3 $3 $3 $15OCREnforcementCosts(3%) $3 $3 $2 $2 $2 $12OCREnforcementCosts(7%) $2 $2 $2 $2 $2 $10 TotalCosts(undiscounted) $394 $167 $167 $167 $167 $1,061

TotalCosts(3%) $350 $144 $140 $135 $131 $901TotalCosts(7%) $301 $119 $111 $104 $97 $731Inthisimpactanalysis,theDepartmentcalculateslaborcostsusingthemean

hourlywage(includingbenefitsandoverhead)fora:

272ThetotalsinTable6:CostSummaryoftheFinalRulemaynotappeartoaddcorrectly,butthatisduetorounding.


298

Lawyerat$134.50perhour($67.25perhourx2),273

Executiveat$186.88($93.44perhourx2),274

Administrativeassistantat$38.78perhour($19.39perhourx2),275

Webdeveloperat$69.38perhour($34.69perhourx2),276and

Paralegalat$51.84perhour($25.92perhourX2).277

ThesecalculationsreflecttheDepartment’sstandardpracticeofcalculatingafully

loadedmeanhourlywage(i.e.,wageincludingbenefitsandoverhead)by

multiplyingthehourlypre‐taxwagebytwo.278

(i) FamiliarizationBurden

TheDepartmentestimatesaone‐timeburdenforregulatedpersonsand

entitiestofamiliarizethemselveswiththerule.Theproposedruleestimatedthaton

average,eachpersonandentitywouldspendonehourforfamiliarization.The

Departmentreceivedcommentsarguingthatthisestimatefellshortofthetime

neededtoaccomplishthegoaloffamiliarization.Inlightofthesecomments,the

Departmentincreasedtheestimatefromonehourtotwohours.Thisincrease

273BureauofLaborStatistics,OccupationalandEmploymentStatistics,OccupationalEmploymentandWages,May2016,https://www.bls.gov/oes/current/oes_nat.htm(occupationcode23‐1011).274Id.(occupationcode11‐1011).275Id.(occupationcode43‐6010).276Id.(occupationcode15‐11134).277Id.(occupationcode23‐2011).278“GuidanceforRegulatoryImpactAnalysis,”OfficeoftheAssistantSecretaryforPlanningandEvaluation,U.S.DepartmentofHealthandHumanServices,2016,at28;see,e.g.,81FR31451(2016)(“Wenotethatonecommentersuggestedthatweuseafactorhigherthan100%toadjustwagesforoverheadandbenefits.However,thecommenter’sargumentisbasedonFederaloverheadratesforcontracts,andnotevidenceoftheresourcecostsassociatedwithreallocatingemployeetime.Asaresult,wedonotadoptthecommenter’srecommendation,andwecontinuetousetheDepartment’sstandardof100%foroverheadandfringebenefits.”).


299

reflectspersons’andentities’familiarizationoftherule’srequirementsand

procedures,includingthechangesfromtheproposedrule.

Theburdenisaone‐timeopportunitycostofstafftime(alawyer)toreview

therule.Thelaborcostisapproximately$135.3millioninthefirstyear

($134.50perhourx2hoursx502,899entities(theaverageofthelowandhigh‐end

rangeinTable2))andzerodollarsinyearstwothroughfive.Thisestimatedburden

representstheaverageburden;somepersonsandentitiesmayspendsubstantially

moretimethantwohoursonfamiliarization,andothersmayspendlesstime.

(ii) BurdenAssociatedwithAssurance&Certification(§88.4)

Asaconditionoftheapproval,renewal,orextensionofanyFederalfinancial

assistanceorFederalfundsfromtheDepartment,§88.4requireseveryapplication

forFederalfinancialassistanceorFederalfundsfromtheDepartmenttowhichthe

ruleappliestoprovide,contain,orbeaccompaniedbyanassuranceanda

certificationthattheapplicantorrecipientwillcomplywithapplicableFederal

conscienceandanti‐discriminationlawsandthisrule.

Theburdentorecipientsnotexemptedfrom§88.4istheopportunitycostof

recipientstafftime(1)toreviewtheassuranceandcertificationlanguageandthe

requirementsoftheFederalconscienceandanti‐discriminationlawsreferencedor

incorporated,(2)toreviewrecipient‐widepoliciesandproceduresortakeother

actionstoself‐assesscompliancewithapplicableFederalconscienceandanti‐

discriminationlaws,and(3)toimplementanyactionsnecessarytocomeinto

compliance.InfraatTable7summarizesthesecosts.


300

TheDepartmentestimatesthateachrecipientnotexemptedfrom§88.4will

spendanaverageof4hoursannuallyreviewingtheassuranceandcertification

languageandtheFederalconscienceprotectionandassociatedanti‐discrimination

lawsandtherule.Inthe2008Rule,theDepartmentestimatedthatitwouldtake

30minutestocertifycompliancewiththreelaws:theChurch,Weldon,andCoats‐

SnoweAmendments.279Inthisrule,thereare22additionalstatutoryprovisions

covered.Citationsforeachlawareclearlylistedintherule,thetextsofthestatutes

areeasilyfoundonline.Formanyentities,itwillbeimmediatelyclearwhenalaw

thatthisruleimplementsandenforcesdoesnotapplytothoseentities.280The

Departmentestimateseachrecipientwilltake10minutesperlawonaverage,

yieldinganadditional3.5hoursonaveragetoreviewtheapplicabilityofthe

additionallawsthatthisruleproposestoenforce,foratotalburdenof4hoursper

recipient,peryear,forthefirstfiveyears.Somerecipientsmayspendconsiderably

lesstime;othersmayspendconsiderablymoretime.

Thelaborcostisafunctionofalawyerspending3hoursreviewingthe

assuranceandcertificationandanexecutivespendingonehourtoreviewandsign,

as§88.4(b)(2)requiresasignaturebyanindividualauthorizedtobindthe

recipient.Theweightedmeanhourlywage(includingbenefitsandoverhead)is

27973FR78072,78095(2008Rule).280Forexample,provisionsapplicabletoMedicaidrecipientswouldnotapplytoentitiesthatdonotreceiveMedicaidand,presumably,mostentitiesreadilyknowiftheyreceiveMedicaidreimbursementsasaresultofprovidingcaretoMedicaidbeneficiaries.


301

$147.60perhour.281Thelaborcostis$93.8millioneachyearforthefirstfiveyears

($147.60perhourx4hoursx158,890recipients282).

TheDepartmentestimatesthat79,445recipients,whichishalfofrecipients

requiredtoassureandcertifycompliance(158,890recipients/2),willspend4

hoursreviewingpoliciesandproceduresortakingotheractionstoself‐assess

compliancewithapplicableFederalconscienceandanti‐discriminationlawseach

yearforthefirstfiveyearsafterpublicationoftherule.Someentitieswillspend

moretimeandotherswillspendlesstime.TheDepartmentreasonablyestimates

suchactionbecause§88.4(b)(4)statesthatthesubmissionofanassuranceand

certificationwillnotrelievearecipientoftheobligationtocomeintocompliance

priortooraftersubmissionofsuchassuranceorcertification.Afirststeptosuch

actionsmaybetorevieworganization‐widesafeguards(orbestpractices),suchas

policiesandprocedures,thatmaybe,orshouldbe,inplace.Thelaborcostisa

functionofalawyerspending3hoursandanexecutivespendingonehour,which

producestheaweightedmeanhourlywageof$147.60perhour.Thelaborcostfor

self‐assessingcomplianceisatotalof$46.9millionannuallyforthefirstfiveyears

($147.60perhourx4hoursx79,445entities).

TheDepartmentestimatesthatapproximately5percentofentities(or16

percentofthosesubjectto§88.4)willtakeanorganization‐wideactiontoimprove

complianceinthefirstyearand0.5percentofentities(1.6percentofthosesubject

281Sumof($134.50x.75)and($186.88x.25).282Thisestimateistheaverageofthelowandhigh‐endestimatesinsupraatTable3.AsexplainedsupraatpartIV.C.2.iv.A,sub‐recipientsarenotsubjecttothisrequirement.


302

to§88.4)willtakeasimilaractionannuallyinyearstwothroughfive.This

percentageequatesto25,145recipientsinyearoneand2,514recipientsannuallyin

yearstwothroughfive.TheDepartmentestimatesthattheserecipientswould

spend4hoursannually,onaverage,totakeremedialefforts.TheDepartment

estimatesthatrecipientswillspendanaverageof4hourstoupdatepoliciesand

procedures,implementstaffingorschedulingpracticesthatrespectanexerciseof

consciencerightsunderFederallaw,ordisseminatetherecipient’spoliciesand

procedures.Thelaborcostisafunctionofalawyerspending3hoursandan

executivespendingonehour,whichproducesaweightedmeanhourlywageof

$147.60perhour.Thelaborcostis$14.8millioninyearone($147.60perhourx4

hoursx25,145entities)andapproximately$1.5millionannuallyforyearstwo

throughfive($147.60perhourx4hoursx2,514entities).

Ifentitieswerealreadyfullytakingstepstobeeducatedon,andcomplywith,

allthelawsthatarethesubjectofthisrule,therewouldlikelynotbeanycosts

withinthefirstfiveyearsofpublicationforremedialeffortsassociatedwitha

recipient’scommitmenttoassureandcertifycompliancein§88.4.However,thefact

thattherewouldbesuchcostsiswhollyconsistentwiththeDepartment’sstated

justificationsfortherule(i.e.,lackofknowledgeof,andcompliancewith,thelaws).

Severalcommentersexpressedconcernwiththepossibleburdenonhealth

careprovidersresultingfromtherequirementstoassureandcertifycompliance

withFederalconscienceandanti‐discriminationlaws.Indraftingtherule,the

Departmentconsideredthepossibleburdenonhealthprovidersandexempted


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certainclassesofrecipientsfrom§88.4.Theimpactoftheexemptionmeansthat,

unlesssuchexemptedpersonsorentitiesarerecipientsofFederalfinancial

assistanceorotherFederalfundsfromtheDepartmentthroughanotherinstrument,

program,ormechanism,approximately70percentofrecipientsdonothaveto

complywiththeassuranceandcertificationrequirement.283Giventhemagnitudeof

theexemption,§88.4doesnotundulyburdenpersonsandentitiessubjecttothe

rule.Wheretheexemptiondoesnotapply,theburdensarisingfromassurancesand

certificationsarefullyjustified,astheyarewitheveryotheranti‐discriminationlaw

thatrequiresasimilarassuranceorcertification.

Moreover,theDepartmentiscommittedtoensuringthatahealthcare

provider’sassuranceandcertificationofcompliancewithFederalconscienceand

anti‐discriminationlawsdoesnotundulyburdensmallhealthcareprovidersin

theirdeliveryofhealthcareservicestothecommunity.Asexplainedinthe

PaperworkReductionActanalysisfor§88.4,theDepartmentisleveragingexisting

grant,contract,andotherDepartmentalformsandgovernment‐widesystems,

consistentwithOMB’sgovernment‐wideefforttoreducerecipientburden.284

283Theaveragebetweenthelower‐bound(267,134)andupper‐bound(415,666)ofrecipientsexemptedis341,400recipients,whichrepresents68percentoftheestimatedtotal500,290recipientsoftherule(whichistheresultof502,899entitiesminustheestimated2,609countiesthatareestimatedforthepurposesofthisruleassub‐recipients).Iffewerrecipientsareimpactedbytheexemptionsin§88.4(c)(1)‐(4)thanestimated,andifsuchrecipientsdonotreceiveHHSFederalfinancialassistanceorotherFederalfundsfromanon‐exemptedHHSprogram,thentheDepartmentoverestimatedthepercentofrecipientsthatdonothavetocomplywiththeassuranceandcertificationrequirement.284Exec.OfficeofthePresident,MemorandumfromMickMulvaney,Dir.,OfficeofManagement&BudgettoHeadsofExecutiveDepartmentsandAgencies,StrategiestoReduceGrantRecipientReportingBurden,at2(Sept.5,2018),https://www.whitehouse.gov/wp‐content/uploads/2018/09/M‐18‐24.pdf.


304

Finally,theDepartmenthasmadeeffortstoreducethefrequencyof

informationcollected.Section88.4(b)(6)allowsanapplicantorrecipientto

incorporatetheassurancesandcertificationbyreferenceinsubsequentapplications

totheDepartmentorDepartmentcomponentifpriorassurancesorcertifications

areinitiallyprovidedinthesameyear.ThisapproachisconsistentwiththeHHS

GrantsPolicyStatement.285Becauserecipientsfileanassuranceofcomplianceform

“fortheorganizationand...not...foreachapplication,”arecipientwithasigned

assuranceonfileassuresthroughitssignatureontheawardapplicationthatithasa

signedForm690onfile.286

Section88.4(b)(1)requiressubmissionmorefrequentlythanthetimeof

applicationiftheapplicantorrecipientfailstomeetarequirementoftherule,or

OCRortherelevantDepartmentcomponenthasreasontosuspectorcauseto

investigatethepossibilityofsuchfailure.Theabilitytorequireassurancesoutside

oftheapplicationprocesspermitsOCRandtheDepartmenttoensurethatthe

FederalfinancialassistanceorotherFederalfundsthattheDepartmentawardsare

usedinamannercompliantwithFederalconscienceandanti‐discriminationlaws

andthefinalrule.Asthisisanewrequirement,OCRhasnotyetgainedthe

experiencetoknowhowmanyrecipients,ifany,wouldberequiredbyOCRora

Departmentcomponenttosignassurancesonanas‐neededbasisoutsideofthe

applicationprocess.

285SeeHHSGrantsPolicyStatement(Jan.2007),https://www.hhs.gov/sites/default/files/grants/grants/policies‐regulations/hhsgps107.pdf.286Id.atI‐31.


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Table7:SummaryofAssuranceandCertificationCosts

CostCategoriesTotalCosts

Year1AnnuallyYears2‐5

ReviewandSign $93.8 $93.8ReviewPolicies&Procedures $46.9 $46.9UpdateorDisseminatePolicies&Procedures $14.8 $1.5

TotalCosts $155.6 $142.2(iii) BurdenAssociatedwithVoluntaryActionstoProvideNoticesofRights

(§88.5)

AsexplainedsupraatinpartIV.C.2.iv.B,theDepartmentassumesthatsome

recipientsandDepartmentcomponentswillvoluntarilypostanddistributeanotice

ofrightsthroughoneofthemethodsspecifiedin§88.5.Theexpectedcostto

recipientsandtheDepartmentis$93.4millioninthefirstyearoftherule’s

implementationand$14.1millionannuallyinyearstwothroughfive.Thecostto

theDepartmentmakesupaminisculeportionofthecost–about0.04percentinthe

firstyearand0.10percentannuallyinyearstwothroughfive.

AsexplainedsupraatpartIV.C.2.iv.B,theDepartmentassumesthatan

estimated139,615recipients(theaverageofthelow‐endandhigh‐endestimates

showninTable4)willlikelymodifythepre‐writtennoticeinAppendixAasapplied

tothem.Becausethescopeofsuchmodificationswouldlikelybelimited,the

Departmentestimatesthatmodifyingthenoticeconstitutesaminimalopportunity

costof20minutesofalawyer’stimefordraftingand10minutesofanexecutive’s

timetoprovidefinalapproval.Forsomerecipients,modifyingthenoticewilltake

moreofthelawyer’sorexecutive’stime;forotherrecipients,itwilltakelesstime.

Theweightedmeanhourlywage(includingbenefitsandoverhead)ofthesetwo


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occupationsis$151.79perhour.287Theone‐timelaborcostis$10.6millioninthe

firstyear($151.79perhourx0.5hoursx139,615recipients).

Thereisuncertaintyregardinghowmanyrecipientswillvoluntarilypost

noticesandwhichmethodormethodsin§88.5theywillemploy.Forthepurposes

ofthiscalculation,theDepartmenterredonthesideofoverestimatingtheburden

andassumesthatrecipientslikelytoprovidenoticewilldoso:

Atphysicallocations,

Ontheirwebsites,and

Intwopublications,suchasapersonnelmanualorother

substantiallysimilardocumentformembersoftherecipient’s

workforce;inanapplicationformembershipintherecipient’s

workforceorforparticipationinaservice,benefitorotherprogram,

includingfortrainingorstudy;orinastudenthandbookorother

substantiallysimilardocumentforstudentsparticipatingina

programfortrainingorstudy,includingforpost‐graduateinterns,

residents,andfellows.

Onecommentersuggestedthatthefinalruleshouldpermitthenotice

requirementtobepostedelectronicallyonly,andnotinpaperform.Becausethe

ruledoesnotrequirerecipientstoprovidenoticesofrights,recipientsarefreeto

providenoticeinelectronicformonlyandhavesuchactionconsideredbyOCRas

non‐dispositiveevidenceofcompliancewiththesubstantiveprovisionsoftherule,

287Sumof($134.50x.67)and($186.88x.33).


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totheextentsuchnoticesareotherwiseprovidedaccordingto§88.5andrelevant

totheparticularOCRinvestigationorcompliancereview.

Forrecipientsthatvoluntarilypostnoticesthroughanyofthemethodsin

§88.5,theDepartmentassumesthattherecipientswillactbytheendofthefirst

yearaftertherule’simplementation.Anentitythatpostsonitswebsiteandina

physicallocationwillincuraone‐timeburden.Arecipientthatincludesaninsertin

apublicationmayincuranannualburdenrepresentedbythecostsoflabor,

materials(paperandinkforhard‐copypublication),andinsomecases,postage.

BurdenforVoluntaryPostinginPhysicalLocations

TheDepartmentestimatesthatitwilltake1/3ofanhourforan

administrativeassistanttoprintnotice(s)andposttheminphysicallocationsofthe

establishmentwherenoticesarecustomarilypostedtopermitreadyobservation.

Forsomeestablishments,itmaytakeanadministrativeassistantlongertoperform

hisorherrespectivefunctions;forotherestablishments,itmaytakelesstime.As

showninTable5,335,327establishmentsistheaverageintherangeofestimated

establishmentsassociatedwithcoveredrecipientsthatwouldvoluntarilypost

noticesinthefirstyearaftertherule’spublication.Theestimatedlaborcostis$4.3

million(1/3hourx$38.78perhourx335,327establishments).

Akeyuncertaintyisthetotalnumberoflocationsperestablishmentwhere

recipientscommonlypostnotices;theper‐establishmenttotalwillvarybasedon

multiplefactors.Thesefactorsincludethetypeofrecipient,floorplansofthe

building,thesquarefootageofthecommonareas,thesquarefootageofthebuilding,


308

thenumberoffloors,thesizeoftheworkforce,andthenumberofultimate

beneficiaries,amongothervariables.TheDepartmentassumesthattheaverage

establishmentwillprintandpostfivenoticesinphysicallocationswherenoticesare

customarilyposted;largerrecipientsmightpostmoreandsmallerrecipientsmight

postfewer.TheDepartmentassumesthatthecostofmaterials(paperandink)is

$0.05perpage.Basedonthisassumption,thefirst‐yearcosttopost5noticesacross

allestablishmentswouldbe$83,832(335,327establishmentsx$.05perpagex

5pages).BecausetheDepartmentassumesthatthiscostisaone‐timecostduring

thefirstyearofthisrule’simplementation,thecostwillnotrecurinyearstwo

throughfive.Thetotallaborandmaterialscostsfor335,327establishmentstopost

noticesinphysicallocationsis$4.4million($4.3millioninlaborcostsand$83,832

formaterials)inyearonewithzerorecurringcosts.

BurdenforWebPosting

Topostthenoticeontheweb,theDepartmentestimatesthatitwilltake

2hoursforawebdevelopertoexecutethedesignandtechnicalelementsfor

posting.Akeyuncertaintyiswhethereachrecipientmaintainsseparatewebsitesfor

eachfacility,andifso,whetherthosewebsitesaremaintainedatthecorporate(i.e.,

firm)levelorfacility(i.e.,establishment)level.Intheproposedrule,theDepartment

erredonthesideofoverestimatingtheburdenandassumedthatrecipients

maintainedseparatewebsitesforeachoftheirfacilitiesattheestablishmentlevel.

Thus,awebdeveloperateachrecipient’sphysicallocationwouldpostthenoticeon

theweb.Forsomeestablishments,itmaytakewebdeveloperslongertoperform


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theirrespectivefunctions;forotherestablishments,itmaytakelesstime.Thislabor

costisapproximately$46.5million(2hoursx$69.38perhourx335,327

establishments).

If,however,recipientsmaintainonewebsiteatthecorporatelevelforallof

theirfacilities,awebdeveloperatthefirm‐level,ratherthanateachestablishment,

wouldbeartheburden.Incontrasttorecipientsbearingthecostacross335,327

facilities,about250,145recipientsatthefirm‐levelwouldeachbearthiscost,which

equals$34.7million(2hoursx$69.38perhourx250,145firms).Thus,ifrecipients

voluntarilypostnoticesontheirwebsites,andiftheydosoattheircorporatelevel

forallsitesincludingfacility‐specificwebsites,recipientswouldsaveonaverage

about25percentoftheirlaborcoststoexecutewebpostinginthismanner.

BurdenforPostinginTwoPublications

TheDepartmentdidnotreceivespecificcommentsestimatingtheannual

costsoflaborormaterialsthatmaybeincurredbyentitiesthatincludenoticesin

relevantpublicationsassetforthintheproposedrule(whichremainvoluntary

underthefinalrule).Giventhekeyuncertaintiesinhowrecipientswilldisseminate

thenoticesofrights,asexplainedinsubsequentparagraphs,theDepartment

assumesthat:(1)establishmentsthatincludenoticesofrightsinpublicationswill

mostoftendosoinonlinepublicationsorinhard‐copypublicationshand‐

distributed,wherethenotice’sinclusionresultsinanadditional100hardcopy

noticesperestablishmentperyear,and(2)halfoftheestablishmentsassociated

withcoveredrecipientsvoluntarilyprovidinghard‐copynotices(i.e.,167,663


310

establishmentsinyearoneand125,747establishmentsannuallyinyearstwo

throughfive)288willdistributethepublicationsviaU.S.mailwheretheweightofthe

noticeincrementallyincreasesthepostagecosts.

TheDepartmentassumesthat,withinthefirstyearaftertherule’s

publication,eachrecipientvoluntarilypostingnoticesinpublicationswouldidentify

thetwopublicationsinwhichtoincludethenotice,revisingthedocumentsortheir

layoutstoincludethenotice,orotherwiseprintinganinserttoincludewithhard

copiesofthepublication.Arecipientthataddsthenoticetoapublication

disseminatedonlyonlinethatisnotdisseminatedinhardcopywillincuraone‐time

laborcostwithzerocostsformaterials.Incontrast,recipientsthataddthenoticeto

apublicationdisseminatedviahardcopymayincurtheannualcostofmaterialsor

incrementalpostage,orboth,aswellastheassociatedlaborcost.Forinstance,a

recipientthatisunabletoaddthenoticetothebackpageofanexistingpublication

mightaddthenoticeasaseparatepagetotheunderlyingpublicationormayprint

noticesannuallytoincludeasinsertswiththehard‐copypublications.Arecipient

thatdoessoanddisseminatesthepublicationviaU.S.mailmightincurincremental

postagecostsiftheincrementalweightofthenoticeplacesthetotalweightofthe

mailinginthenextbracketofpostagecosts.

Theseassumptionsmaydifferfromrecipients’implementationexperiences.

Somerecipientsmaydistributefewerthan100hard‐copynoticeswithrelevant

publicationswhileotherswilldistributemorethan100.Somerecipientsthatmail

288Productof335,327establishmentstimes50percentforyearone.Productof251,495establishmentstimes50percentforyearstwothroughfive.


311

relevantpublicationswithnoticesofrightsmaynotexperienceanyincremental

postagecostsifthetotalweightofthemailingswithnoticesdoesnotplacethe

mailinginthenextpostagebracket.Notwithstandingtheseuncertainties,the

Departmentsetsforththefollowingmonetizationasitsbestestimateoftheburden

basedonitsassumptions.

TheDepartmentassumesanadministrativeassistantwouldspendan

averageoftwohoursinyearoneandonehourannuallyinyearstwothroughfiveto

executetheactivitiesexceptformailing.Theaveragelaborcost,excludingmailing‐

relatedlaborcosts,is$26.0millioninyearone($38.78perhourx2hoursx335,327

establishments)and$9.8millionannuallyinyearstwothroughfive($38.78per

hourx1hourx251,495establishments).289Basedonthemarginalcostofpostage

perounceof$0.15,290anannualnumberofmailingsof100pagesperestablishment,

averageannuallaborcostformailingof$38.78perhour,andanaveragenumberof

laborhourspermailingof0.25hours,thetotalcostsduetothevoluntarymailingof

noticesare$4.1millioninyearone291and$3.1millionannuallyinyearstwo

throughfive.292Finally,theannualcostofprintedmaterialsfornotices(bothmailed

andhanddistributed)is$1.7million(335,327establishmentsx100pagesx$.05

289Underthefinalrule,becauseallthenoticeprovisionsarevoluntary,theDepartmentassumesthat75%ofentitiesthatvoluntarilyprovidenoticesinyearonewillcontinuetodosoinoutyearsandtherewillbelowerattritioncomparedtotheestimateprovidedintheproposedrule.290SeeU.S.PostalServicePostageRates,https://www.stamps.com/usps/current‐postage‐rates/.291Sumofincrementalpostageof$2.5million($0.15permailingx100mailingsx167,663establishments)andincrementallaborof$1.6million($38.78perhourx0.25hoursx167,663establishments).292Sumofincrementalpostageof$1.9million($0.15permailingx100mailingsx125,747establishments)andincrementallaborof$1.2million($38.78perhourx0.25hoursx125,747establishments).


312

perpage)inyearoneand$1.3millionannuallyinyearstwothroughfive(251,495

establishmentsx100pagesx$.05perpage).

Insum,theburdentorecipientsrelatedtothevoluntarypostingand

distributionsofnoticesthat§88.5incentivizesis$93.4millioninthefirstyearand

$14.1millionannuallyinyearstwothroughfive.

BurdentotheFederalGovernment

Federalagenciesareencouragedtoidentifycostsandsavingstogovernment

agencieswheresignificant.293Theburdenof§88.5totheFederalgovernmentisthe

costassociatedwiththeDepartment’scomponentspostingthenoticevoluntarily.

Althoughthisburdenisnotsignificant,theRIAmonetizestheburdenfor

completeness.

TheDepartmentusesaframeworkforestimatingitsburdenthatissimilarto

theframeworkusedtoestimatetheburdentorecipients.Forinstance,the

Departmentassumesthathalfofitscomponentswillpostnoticesofrights

voluntarilyinthefirstyearoftherule’spublication(i.e.,10ofthe20HHSOperating

andStaffDivisionswillpostonline).Becauseofattritionincompliance,75percent

ofthatnumberwillcontinuepostingannuallyincertainpublicationsinyearstwo

throughfive.Asaproxyforthatassumptiontoenablemonetizationofthephysical

posting,theDepartmentassumesthatstaffathalfof533physicallocationsowned

orleasedbytheDepartment294(277physicallocations)wouldpostanaverageof

293OMBCircularA‐4,RegulatoryAnalysis37(2003),https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a‐4.pdf.294ObtainedfromU.S.GeneralServicesAdministrationonOctober30,2018(onfilewithHHSOCR).


313

fivehard‐copynoticesperphysicallocationandwouldpostincertainpublications.

Inyearstwothroughfive,75percentofthe277locations(207locations)would

postincertainpublications.TheDepartmentassumesthatthedurationofthe

anticipatedactivities(e.g.,downloading,printing,andpostingthenotice)would

takeDepartmentstaffthesametimeasitwouldtakerecipientstaff.Similarly,the

DepartmentassumesthathalfofthephysicallocationsassociatedwithHHS

componentsvoluntarilyprovidinghardcopynotices(i.e.,138locationsinyearone

and104locationsannuallyinyearstwothroughfive)295willdistributethe

publicationsviaU.S.mailwheretheweightofthenoticeincrementallyincreasesthe

postagecosts.

Themethodsdivergeinhowthewebpostingisimplemented(byeachHHS

OperatingandStaffDivisionbutnotbyeachfacilityownedorleased)andinthe

averagehourlywagerateused:aGS‐7step5,296which,adjustedupwardforbenefits

andoverhead,equals$47.44perhour($23.72perhourx2).297

Basedontheseassumptions,thetotallaborcostis$5,277inthefirstyear:

($47.44perhourx1/3hourx277locations)+($47.44perhourx2hoursx10

Departmentalcomponents).Costformaterialsforthenoticeis$1,452dollars298in

295Productof277locationstimes50percentforyearone.Productof207locationstimes50percentforyearstwothroughfive.296ThehourlywageratesofstaffarelikelytovaryfromaGS‐3toaGS‐11.TheDepartmentusesthemid‐pointGS‐levelandstepandreliesonhourlywageratesforthelocalitysalaryadjustmentfortheDistrictofColumbiaandsurroundinggeographicarea.297https://www.opm.gov/policy‐data‐oversight/pay‐leave/salaries‐wages/salary‐tables/pdf/2016/DCB_h.pdf.ExecutiveOrder13771requiresagenciestoestimatecostsin2016dollars.298Sumofcostsformaterialstopostinphysicallocations(5pagesx$0.05perpagex277locations)pluscostsformaterialstopostincertainpublications(100pagesx$0.05perpagex277locations).


314

thefirstyearafterpublicationofthefinalruleand$1,037annually299inyearstwo

throughfive.Finally,thecostassociatedwiththeportionofDepartmentlocations

thatmailnoticesofrightswithcertainpublicationsis$3,713inthefirstyear300and

$2,785301annuallyinyearstwothroughfive.Insum,theburdentotheFederal

governmentassociatedwith§88.5is$36,677inthefirstyearand$13,660annually

inyearstwothroughfive.

(iv) Record‐Keeping(§88.6(b))

Paragraph88.6(b)ofthefinalrulerequiresrecipientsandsub‐recipientsto

maintainrecordsevidencingtheircompliancewiththispart.Intheproposedrule,

theDepartmentdidnotidentifyrecord‐keepingasaseparateburdenbecauseit

assumedthatrecipientsandsub‐recipientsalreadymaintainrecordsinthecourse

ofevidencingcompliancewiththetermsandconditionsofaFederalaward,which

wouldincludenotonlyfinancialmanagementrequirementsbutallapplicable

Federallaws,includingFederalconscienceandanti‐discriminationlaws.The

Departmentrequestedcommentonthatassumption.TheDepartmentreceived

numerouscommentsstatingthattherecord‐keepingrequirementsin§88.6(b)

weretoovagueandrequestingclarityonwhatkindsofrecordsmustbemaintained.

However,theDepartmentreceivednocommentscontradictingitsassumptionthat

recipientsandsub‐recipientsalreadyfollowrecord‐keepingpracticesthatsufficeto

299Costsformaterialstopostincertainpublications(100pagesx$0.05perpagex207locations).300Sumofincrementalpostageof$2,074($0.15permailingx100mailingsx138facilities)andincrementallaborof$1,640($47.44perhourx0.25hoursx138facilities).301Sumofincrementalpostageof$1,555($0.15permailingx100mailingsx104facilities)andincrementallaborof$1,230($47.44perhourx0.25hoursx104facilities).


315

documentcompliancewithFederalcivilrightslaws.Therefore,becausethe

Departmentunderstandsthatrecipientsandsub‐recipientsmustdocumentsuch

complianceinthecourseofreceivingaFederalaward,302anypotentialmarginal

increaseinthecostofmaintainingrecordsaccordingtotheclaritysetforthin

88.6(b)wouldbedeminimis.

(v) ReportingaFindingofNoncompliance(§88.6(d))

Paragraph88.6(d)oftheproposedrulewouldhaverequiredrecipientsand

sub‐recipientstoreporttotherelevantDepartmentalfundingcomponentthe

existenceofanOCRcompliancereview,investigation,orcomplaintunder45CFR

part88overafive‐yearperiodassuchincidentsariseandinanyapplicationfor

neworrenewedFederalfinancialassistanceorDepartmentalfunding.The

Departmentreceivednumerouscommentsthatstatedthisrequirementwastoo

burdensome.

Accordingly,theDepartmenthassignificantlyrevised§88.6(d).Recipients

andsub‐recipientswouldnolongerhavetoreportacompliancereview,

investigation,orcomplaintagainstthemasitarises.Moreover,recipientsandsub‐

recipientswouldonlyberequiredtodisclosetheexistenceofadeterminationby

OCRofnoncompliancewiththisruleinanyapplicationforneworrenewedFederal

financialassistanceorDepartmentalfunding(ratherthanreportingcompliance

302See45CFR75.302(regardingthesufficiencyofanHHSawardee’sfinancialmanagementsystem,including“recordsdocumentingcompliancewithFederalstatutes,regulations,andthetermsandconditionsoftheFederalaward”).Seealsoid.section75.361(requiringanHHSawardeetomaintainrecordsforthreeyearsfromthedateofthefinalexpenditurereportorfromthedatetheawardeesubmitsitsquarterlyorannualfinancialreport).


316

reviews,investigations,orcomplaints).Recipientswouldberesponsiblefor

disclosinganyOCRdeterminationsofnon‐compliancemadeagainsttheirsub‐

recipients.Finally,thefinalruleshortensthereportingperiodfromfivetothree

yearsfollowinganOCRdeterminationofnoncompliance.

Giventherevisionsto§88.6(d),theDepartmenthasrevisitedits

methodologyforestimatingthecostsimposedby§88.6(d).TheDepartment

estimatesthattheburdenistheopportunitycostforrecipientsandsub‐recipients

whohavehadOCRdeterminethattheyarenoncompliantwiththisruletoretrieve

informationfromtheirrecordssystemsandenterintheapplicationbasic

identifyinginformationregardingthedetermination.Thecomponentstomonetize

thisburdeninclude:1)thetimespentforastaffmembertoexecutethereporting

functionsandthatperson’sfullyloadedmeanhourlywage,2)thenumberoftimesa

recipientorsub‐recipientappliesforneworrenewedfundingadministeredbythe

Departmentannually,and3)thenumberofrecipientsandsub‐recipientsthatOCR

findsnoncompliantwiththispartannually.

TheDepartmentestimatesitwouldtakearecordscustodianatthe

experiencelevelofaparalegalabout15minutestoretrievetherelevantinformation

(suchasdateoftheOCRdeterminationofnoncomplianceandtheOCR“transaction

number”(i.e.,casenumber))fromtherecipient’sorsub‐recipient’srecordsandan

administrativeassistant15minutestoentertheinformationintheapplicationfor

FederalfinancialassistanceorotherFederalfundsfromtheDepartment.Themean


317

weightedhourlywagefortheparalegalandadministrativeassistantis$45.31.303

TheDepartmentestimatesthatarecipientwouldbearthislaborcostatthefirm

levelforeveryawardactiontherecipientapplied,includingnewfunding

opportunities,supplementalfunding,andnon‐competingcontinuations,among

others.

BecauseOCRhadnopubliclyavailableorreliabledatasourcetoestimate

howmanytotalapplicationsforneworrenewedfundinginafiscalyeararecipient

mightmaketotheDepartmentoritscomponent,actualawarddatafromHHS

TAGGSwasusedasaproxy.TheDepartmentconsideredthenumberofaward

actionstheDepartmentanditscomponentsmadetoStateagenciesandState

universitiesinFY2017toinformtheestimate.AwarddatainHHSTAGGSforFY

2017indicatedthatsomeStateuniversitiesreceivelessthan100awardsperfiscal

yearandothersreceivenearly2,000awards.SomeStateagenciesreceiveoneor

twoawardsperfiscalyearandothersreceive80awardsperfiscalyear.

Consequently,arecipientorsub‐recipientfoundinviolationofthispart,onthe

extremeend,wouldexpend$45,310peryearinlaborcostsatthefirmlevel(2,000

applicationsperyearx$45.31perhourx0.5hours).

Themostsignificantuncertaintyformonetizingtheburdenof§88.6(d)isthe

numberofrecipientsandsub‐recipientsthatOCRwilldetermineasnoncompliant

withthisrule.OCRemploysarangeoffact‐findingmethodsandevaluateseach

complaintbasedontherelevantfacts,circumstances,andlawatissue,whichisan

303Sumof(0.5x$38.78perhour)and(0.5x$51.84perhour).


318

approachthatthisrulecodifiesin§88.7(d).OCRisgainingexperienceinhandling

thecomplexityandvolumeofcomplaintsreceivedallegingviolationsoftheWeldon

Amendment,ChurchAmendment,Coats‐SnoweAmendment,andsection1553of

theAffordableCareAct.Mostofthestatutesthatarethesubjectoftherulehaveno

caselawinterpretingthem.Inaddition,comparedtoOCR’sexperiencehandling

complexcasesforothercivilrightsandhealthinformationprivacymatters,thereis

littleinstitutionalhistoryofOCRenforcementoftheWeldonAmendment,Church

Amendments,Coats‐SnoweAmendment,andsection1553oftheAffordableCare

Act.Indeed,OCRwasreceivingonlyapproximately1.25complaintsperyear

allegingsuchviolationsduringtheeightyearsprecedingthechangein

Administration.However,duringFY2018,themostrecentlycompletedfiscalyear

forwhichdataareavailable,OCRreceived343complaintsallegingconscience

violations.304GiventhisvariablepostureatthisstageoftheDepartment’srenewed

effortsonconscienceandreligiousfreedom,theDepartmentcannotreliablypredict

thenumberofOCRdeterminationsofnoncompliancetomonetizethisburden,but

estimatesthat,forthosetowhomitapplies,therelatedreportingcostisabout

$45,310peryearperentitywiththehighestnumberofapplicationsforHHS

funding.

(vi) VoluntaryRemedialEfforts

TheproposedrulenotedthattheDepartmentanticipatesthatsome

recipientswillinstituteagrievanceorsimilarprocesstohandleinternalcomplaints

304ComplaintdatabasedonOCR’ssystemofrecordsasofDecember20,2018.


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raisedtotherecipient’sorsub‐recipient’sattention.Theruledoesnotrequiresuch

aprocess,butinHHSOCR’senforcementexperience,informalresolutionofmatters

attherecipientorsub‐recipientlevelmayeffectivelyresolveabeneficiary’sor

employee’sconcern.TheDepartmentreceivednocommentsregardingthe

proposedrule’smethodologyforestimatingthesecosts.TheDepartmentanticipates

0.5percentofentities,or2,514entities,305wouldconductsuchinternal

investigationsshouldcomplaintscometotherecipient’sorsub‐recipient’sattention

orwouldundertakeremedialeffortstoresolvecomplaints.

Theburdenistheopportunitycostofstafftimetohandleinternal

investigationsandtakeremedialaction.Uncertaintyexistsastohowmanyhours

annuallyarecipientorsub‐recipientwoulddevotetothiseffort.Onaverage,the

Departmentanticipatesentitiesspending20hoursannually:16hoursofalawyer’s

timeand4hoursofanexecutive’stime.Theweightedmeanhourlywage(including

benefitsandoverhead)is$144.98perhour.306Thelaborcostis$7.3million

($144.98perhourx20hoursx2,514entities).Somerecipientsmayspendmore

than20hoursonvoluntaryremedialefforts,andifthisisthecase,thelaborcostwill

begreater.Otherrecipientsmayspendlessthan20hours,andifthisisthecase,the

laborcostwillbelower.

(vii) OCREnforcementandAssociatedCosts

305Productof0.005x502,899recipients.306Sumof($67.25x.80)+($93.44x.20)andmultipliedbytwotoadjustupwardforoverheadandbenefits.


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TheDepartmentanticipatesatemporaryincreaseininvestigationand

enforcementcoststoOCRoverthefiveyearsimmediatelyfollowingpublicationof

thefinalrule.TheDepartmentexpectsthisincreasefromthesynergisticimpactof

persons’increasedawarenessofrights;increasedconfidenceintheDepartment’s

abilityandwillingnesstoaddressthoserightsthroughtheadministrativecomplaint

process;andanincreaseinthenumberofFederalconscienceandanti‐

discriminationlawsthattheruleproposestoenforce.Indeed,sinceduringFY2018,

themostrecentlycompletedfiscalyearforwhichdataareavailable,OCRreceived

343complaintsallegingconscienceviolations.307

TheimpactoftheruleonOCRistheopportunitycostofabout12FTEsto

performinvestigativeresponsibilitiesandcoordinateenforcementwithHHS

components,assetforthin§88.7,whichisanincreaseof7.5FTEsfromthe

proposedrule’sestimate.Theseresponsibilitiesincludereceivingandhandling

complaints,initiatingcompliancereviews,conductinginvestigations,coordinating

compliancewithintheDepartment,andperformingotherassociatedactivitiesas

partofitsprogramtopromotewidespreadvoluntarycomplianceofFederal

conscienceandanti‐discriminationlaws.TheDepartmentanticipatesthatthe12

FTEsconsistofamemberoftheSeniorExecutiveService,fourGS‐15employees,

threeGS‐14employees,twoGS‐13employees,andtwoGS‐12employees,eachpaid

amid‐levelsalaryfortheD.C.area.308Thefullyloadedlaborcost(includingbenefits

307ComplaintdatabasedonOCR’ssystemofrecordsasofDecember20,2018.308UsingthelocalitysalaryadjustmentfortheDistrictofColumbiaandsurroundinggeographicarea,theannualsalariesadjustedupwardforbenefitsandoverheadareasfollows:$290,324forGS‐15


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andoverhead)forthosetwelveemployeesisestimatedtobe$3millionannually.

Thedifferencebetweentheproposedrule’sestimateforOCR’senforcementcosts

andthisestimateisprimarilytheresultoftheincreaseinthenumberofFTEs.This

increaseisinformedbyOCR’sexperiencesincepublicationoftheproposedrule,

whichhasdemonstratedthatOCRwillneedtodevotegreaterresourcestothearea

ofconscienceprotectionsthanOCRhadanticipatedatthetimeofpublicationofthe

proposedrule.Thisestimatealsohasbeenadjustedupwardsbasedonthemethod

ofcalculatingthewagesoftheFTEs.Theproposedruleassumedafullyloadedwage

foreachofthe4.5FTEsat$201,000,butthefinalruleestimatesthecostofthe12

FTEsbasedonvariousGSlevelsandthereforereliesuponthefullyloadedwage

usingtheestimatedhourlysalariesofemployeesundertheGSschedule.

OnecommenterstatedthatthecostsassociatedwithOCR’senforcement

effortswoulddoubletotheextentthatbothaproviderandapatientfileacomplaint

overthesamematter.Thecommenterdidnotprovideanexampleofascenario

wheresuch“doublefiling”wouldoccur.TheDepartmentbelievesthatsuch

scenarios,iftheyoccuratall,wouldconstituteademinimisproportionof

complaintsreceivedbyOCRandwouldnotinvolveincreasedordoubledcosts,as

step5(145,162x2);$246,812forGS‐14step5($123,406x2);$208,866forGS‐13step5($104,433x2);and$175,642forGS‐12step5($87,821x2).Seehttps://www.opm.gov/policy‐data‐oversight/pay‐leave/salaries‐wages/salary‐tables/16Tables/html/DCB.aspx.Themid‐levelsalaryadjustedforbenefitsandoverheadforaSeniorExecutiveis$308,275($154,138x2),whichistheaverageoftheminimumandmaximumsalaryforagencieswithacertifiedSESperformanceappraisalsystem.Seehttps://www.opm.gov/policy‐data‐oversight/pay‐leave/salaries‐wages/salary‐tables/16Tables/exec/html/ES.aspx.


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resourcesforresolutionofthetwocomplaintswouldbesharedthrough

investigationofsimilarmatters.

4. EstimatedBenefits

TheDepartmentexpectsthisfinalruletoproduceanetincreaseinaccessto

healthcare,improvethequalityofcarethatpatientsreceive,andsecuresocietal

goodsthatextendbeyondhealthcare.Theseeffectswilloccurprimarilyviafour

mechanisms.

First,thisruleisexpectedtoremovebarrierstotheentryofcertainhealth

professionals,andtodelaytheexitofcertainhealthprofessionalsfromthefield,by

reducingdiscriminationorcoercionthathealthprofessionalsanticipateor

experience.CommentsreceivedbytheDepartmentdemonstratethatalackof

conscienceprotectionsdiminishestheavailabilityofqualifiedhealthcareproviders.

Forexample,inasurveyofprovidersbelongingtofaith‐basedprovider

organizations,overnineinten(91percent)agreedwiththestatement,“Iwould

ratherstoppracticingmedicinealtogetherthanbeforcedtoviolatemy

conscience.”309

Second,insupportingamorediversemedicalfield,therulewillbenefit

patientsbyimprovingdoctor‐patientrelationshipsandqualityofcare.Academic

literaturesupportsthepropositionthatprohibitingtheexerciseofconsciencerights

inmedicinedecreasesthequalityofcarethatpatientsreceive.Asonearticlenoted,

309ChristianMedicalAssociation&Freedom2CaresummaryofpollsconductedApril,2009andMay,2011,availableathttps://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.


323

“[I]fphysiciansdonothaveloyaltyandfidelitytotheirowncoremoralbeliefs,itis

unrealistictoexpectthemtohaveloyaltyandfidelitytotheirprofessional

responsibilities.”310

Third,theruleisexpectedtodecreasetheharmthatproviderssufferwhen

theyareforcedtoviolatetheirconsciences,withattendingimprovementstopatient

health.Scholarshaveobservedthat“[a]bandoningtherighttoconscienceofthe

medicalpractitionernotonlyharmstheindividualpractitionerbutalsothreatens

harmtohispatientsaswell—theharms,howeverparadoxicalitmightseem,are

actuallyinseparablefromoneanother.”311

Fourth,byprovidingforOCRinvestigationandHHSenforcementofFederal

conscienceandanti‐discriminationlaws,thisfinalruleisexpectedtodecrease

unlawfuldiscrimination,therebypermittinggreaterpersonalfreedom.Therulewill

promoteprotectionofreligiousbeliefsandmoralconvictions,whichisasocietal

goodbasedonfundamentalrights.AsJamesMadison,oftenhailedasthe“fatherof

theConstitution,”wrote,

The Religion then of every man must be left to the conviction andconscienceofeveryman;anditistherightofeverymantoexerciseit

310D.WhiteandB.Brody,WouldAccommodatingSomeConscientiousObjectionsbyPhysiciansPromoteQualityinMedicalCare?,305J.Am.Med.Assoc.,May4,2011,at1804‐1805(arguingthatprohibitingconscience‐basedrefusals“maynegativelyinfluencethetypeofpersonswhoentermedicine[,]…maynegativelyinfluencehowpracticingphysiciansattendtoprofessionalobligation[,]…[maycause]higherlevelsofcallousness[byphysicians]towardpatients[,]…[and]mayreciprocallydiminishphysicians’willingnesstobesympathetictoandaccommodatingofpatients’diversemoralbeliefs”).311KevinTheriot&KenConnelly,FreetoDoNoHarm:ConscienceProtectionsforHealthcareProfessionals,49Ariz.St.L.J.549,565(2017);seealsoJ.McCarthy&C.Gastmans(2015).Moraldistress:Areviewoftheargument‐basednursingethicsliterature,NursingEthics,22(1),131–152(findingaconsensusinacademicliteraturethatmoraldistressinvolvessufferingthatispsychological,emotional,andphysiologic).


324

as thesemay dictate…. It is the duty of everyman to render to theCreatorsuchhomage,andsuchonly,ashebelievestobeacceptabletohim.312TheDepartmentreceivedcommentsarguingthattheproposedruledidnot

provideasufficientarticulationofthebenefitsthatthisrulewouldcreateorsecure.

Inadditiontoanalysesprovidedelsewhereinthispreamblewheregermane,the

Department’sanalysisoftherule’sbenefitsrespondstothosecommentsand

reflectsareviewofacademicliteratureonthebenefitsofconscienceprotectionsin

healthcare.Theanalysisdemonstratesthattherulecreatesandsecuressignificant

benefits.

(i) HistoricalSupportforConscienceProtections

ThepeopleoftheUnitedStatesofAmericahavevaluedconscience

protectionssincethecountry’sfoundingera.Madisonsaidthat“[c]onscienceisthe

mostsacredofallproperty;…theexerciseofthat,beinganaturalandunalienable

right.Toguardaman'shouseashiscastle,topaypublicandenforceprivatedebts

withthemostexactfaith,cangivenotitletoinvadeaman’sconsciencewhichis

moresacredthanhiscastle.”313GeorgeWashingtonwrote,“Governmentbeing,

amongotherpurposes,institutedtoprotectthePersonsandConsciencesofmen

fromoppression,itcertainlyisthedutyofRulers,notonlytoabstainfromit

themselves,butaccordingtotheirStations,topreventitinothers,…[and]the

312JamesMadison,“MemorialandRemonstranceAgainstReligiousAssessments”,in2TheWritingsofJamesMadison183,184(G.Hunted.1901)313JamesMadison,“Property”,inTheFounders’Constitution,http://press‐pubs.uchicago.edu/founders/documents/v1ch16s23.html.


325

Consciencious[sic]scruplesofallmenshouldbetreatedwithgreatdelicacy&

tenderness.”314Somescholarshavearguedthattherighttoconsciencewasa

hallmarkofourfoundingandinfact,“[p]rotectionforindividualexerciseofrightsof

consciencewasoneoftheessentialpurposesforthefoundingoftheUnitedStatesof

AmericaandoneofthegreatmotivationsforthedraftingoftheBillofRights.”315

(ii) ExpectedPostiveImpactontheRecruitmentandMaintenanceofHealth

CareProfessionals

Numerousstudiesandcommentsshowthatthefailuretoprotectconscience

isabarriertocareersinthehealthcarefield.

A2009surveyfoundthat82%ofrespondingfaith‐basedhealthcare

providerssaiditwaseither“very”or“somewhat”likelythattheypersonallywould

limitthescopeoftheirpracticeofmedicineifconscienceruleswerenotinplace.

Thiswastrueof81%ofmedicalprofessionalswhopracticeinruralareasand86%

whoworkfull‐timeservingpoorandmedically‐underservedpopulations...91%

agreed,“Iwouldratherstoppracticingmedicinealtogetherthanbeforcedtoviolate

myconscience.”316

314LetterfromGeorgeWashington,toTheSocietyofQuakers(October13,1789),https://founders.archives.gov/documents/Washington/05‐04‐02‐0188.315KevinTheriot&KenConnelly,FreetoDoNoHarm:ConscienceProtectionsforHealthcareProfessionals,49Ariz.St.L.J.549,561(2017)(citingLynnWardle,ProtectionofHealth‐CareProviders’RightsofConscienceinAmericanLaw:Present,Past,andFuture,9AveMariaL.Rev.1,78(2010)).316ChristianMedical&DentalAssociationsummaryofKeyFindingsonConscienceRightsPollingconductedApril,2009,availableathttps://docs.wixstatic.com/ugd/809e70_2f66d15b88a0476e96d3b8e3b3374808.pdf.


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TheDepartmentexpectsthisruletoremovebarrierstoentryintothehealth

careprofessionsandintocertainspecializationswithinthehealthcareprofession317

thatarisefromanticipatedorexperienceddiscriminationagainstsuchpersons’

religiousbeliefsormoralconvictions.TheDepartmentalsoexpectsthisruletodelay

theexitofcertaintypesofhealthprofessionalswhoareconsideringleavingthefield

inordertoavoidsuchcoercionordiscrimination.318Althoughtheruledoesnot

createsubstantiveprotectionsbeyondthoseinexistinglaw,theDepartment

believesthatgreaterawarenessandenforcementofthoselawswillhelppromote

complianceandprovidethesefollow‐oneffects.TheDepartmenthasasignificant

interestinremovingunlawfulbarrierstocareersinthehealthcarefield.

TheAmericanAssociationofPro‐LifeObstetriciansandGynecologists

(AAPLOG),whichrepresents2,500membersandassociates,319wrotein2009,“Like

pro‐lifephysiciansgenerally,AAPLOGmembersoverwhelminglywouldleavethe

medicalprofession–orrelocatetoamoreconscience‐friendlyjurisdiction–before

theywouldacceptcoerciontoparticipateorassistinproceduresthatviolatetheir

consciences.”320AAPLOG’smembersandassociatesrepresent13percentof

OB/GYNsintheUnitedStates.321Yet,asexplainedabove,theDepartmenthas

317Id.(findingthat20%ofrespondingfaith‐basedmedicalstudentschosenottopursueacareerinobstetrics/gynecologybecauseofperceivedcoercionanddiscriminationinthatfield).318Id.319AboutUs,AmericanAssociationofPro‐LifeObstetriciansandGynecologists,http://aaplog.org/about‐us.320LetterfromLawrenceJ.Joseph,onbehalfoftheAmericanAssociationofPro‐LifeObstetricians&Gynecologists,totheOfficeofPublicHealth&Science,Dep’tofHealth&HumanServs.2(Apr.9,2009),http://downloads.frc.org/EF/EF09D50.pdf.321Compareid.,withOccupationalEmploymentStatistics:OccupationalEmploymentandWages,May2017(March30,2018),https://www.bls.gov/oes/current/oes291064.htm(calculationassumesallAAPLOGmembersareOB/GYNs)


327

receivedsignificantanecdotalevidenceofviolationsoftheveryconsciencelawsthat

Congresshasenactedtoprotectsuchproviders.

Becausetheruleisexpectedtoremoveabarriertoentryintothehealthcare

profession,theruleisexpectedtoengendermorepeopletobewillingtoenterthe

healthcareprofession.Sincethereisanunmetneedforhealthcareprovidersinthe

UnitedStates,theDepartmentassumesthatanincreaseinthenumberofpeople

willingtoenterthehealthcareprofession(oracertainspecializationwithinthe

healthcareprofession)willresultinanincreaseinthenumberofproviders.

Similarly,acertainproportionofdecisionsbycurrentlypracticinghealthproviders

toleavetheprofessionaremotivatedbycoercionordiscriminationbasedon

providers’religiousbeliefsormoralconvictions,322sotheDepartmentanticipates

thatthisrule’sprotectionswilldecreasesuchdeparturesfromthefield.Several

commentersagreedanecdotally,statingthatwithouttherule,accesstomedicalcare

willsuffer,becausepro‐lifeandfaith‐basedmedicalproviderswillleavethe

profession.

TheDepartmentanticipatesthatthiseffectwillalsooccuratthemacro‐scale

inthehealthindustry.Forexample,religiously‐operatedhospitalsorhealthcare

systems,beinggrantedgreatersecuritytopracticemedicineconsistentwiththeir

religiousbeliefs,mayfinditworthwhiletohiremoreproviderstoservemore

people,ortoservenewpopulations(geographic,etc.),andwillhavealargerpoolof

322ChristianMedicalAssociation&Freedom2CaresummaryofOnlineSurveyofFaith‐BasedMeidcalProfessionalspollsconductedApril,2009andMay,2011,availableathttps://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.


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medicalprofessionalstochoosefrom.TheDepartmentisnotaware,however,of

dataenablingittoquantifyanyeffecttherulemayhaveonincreasingthenumberof

healthcareprovidersorthepossibleresultofincreasingaccesstocare.The

Departmentinsteadbelievesitisreasonabletoconcludethattherulewillincrease,

oratleastnotdecrease,accesstohealthcareprovidersandservices.

Severalcommentersstatedthatpermittingorhonoringconscientious

objections,especiallyobjectionstoreferringforahealthservice,willexacerbate

currentlackofaccesstohealthcarecausedbytheexistingshortageofhealthcare

providers.Thisargumentappearstonotadequatelytakeintoaccounthowgreater

awarenessandenforcementofconsciencerightswill(1)removeabarriertoentry

forcertainindividualsandinstitutionsintothehealthcarefield,and(2)encourage

individualsandinstitutionswithreligiousbeliefsandmoralconvictionscurrentlyin

thehealthcarefieldthatmaybethinkingaboutleavingthefieldtoremain,thereby

creatingnetbenefits.Asdescribedintheanalysisbelowontheeffectsofthisfinal

ruleonaccesstocare,commenterswhoraisedtheclaimthattherulewould

exacerbatecurrentbarrierstoaccessinghealthcarefailedtoprovidedatathatthe

Departmentbelievesenablesareliablequantificationoftheeffectoftheruleon

accesstoprovidersandtocare.Forthereasonsexplainedinthisanalysis,the

Departmentdisagreeswiththosecommentersandbelievesitismorelikelythat

removingthebarrierstoentrythatmayexistduetoinsufficientenforcementof

consciencelawswillresultinanoverallincreaseinaccesstocare.Again,however,


329

theDepartmentisnotawareofdatathatallowsforanestimateoftheeffectofthis

ruleonaccesstoservices.

(iii) ExpectedPostiveImpactonPatientCarebyReligiousHealthCare

ProfessionalsandOrganizations

Manycommentsdiscussedthesubjectofthemanagementofmiscarriagesin

Catholichospitals,allegingthatCatholichospitals’adherencetotheEthicaland

ReligiousDirectives(ERDs),adocumentthatexpressestheteachingoftheCatholic

Churchonmattersofhealthcare,risksharmtowomenundergoingamiscarriage.

Approximatelyforty‐threepubliccommentsubmissions(eachofwhichmay

representmorethanonecommentpersubmission)citedthearticle“WhenThere’s

aHeartbeat:MiscarriageManagementinCatholic‐OwnedHospitals,”which

describesexperiencesofahandfulofphysiciansacrossthenation’sCatholichealth

carefacilitiesthatadheredtothetheERDs.323Thearticlerelaysanecdotesand

quotesfromsixphysiciansoutofthethirteeninterviewedbytheauthors.The

authorsdonotstatewhythearticleomitsquotesfromtheothersevenproviders,

nordoesithighlightanecdotesfrompositiveorneutralexperienceswithfacilities’

adherencetoERDs.Theauthorsusetheanecdotesandquotesassupportforthe

ideathatadherencetotheERDscreatesactual,potential,orperceiveddeficiencies

inthefacilities’managementofmiscarriagesbyCatholichealthcarefacilities.

AnecdotalaccountsofsuchalimitednaturedonotprovidetheDepartmentwitha

robustbasisforestimatingtherule’simpactonthemanagementofmiscarriages.

323LoriR.Freedman,WhenThere’saHeartbeat:MiscarriageManagementinCatholic‐OwnedHospitals,AM.J.PUB.HEALTH(2008),https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636458/.


330

Twenty‐fourpubliccommentsubmissions(eachofwhichmayrepresent

morethanonecommentpersubmission)discussedthecaseofTameshaMeans,

whowastreatedforamiscarriagebyaCatholichospitalinMichigan,asanexample

oftheharmtopatienthealthcausedbythefaith‐basedpracticesofCatholic

hospitals.Ms.Meanssubsequentlybroughtalawsuitclaimingthatthehospital’s

adherencetotheERDsconstitutednegligence.YettheU.S.CourtofAppealsforthe

SixthCircuitruledthatMs.Meanshadnotallegedanyharmorinjurythatcould

sustainherclaim.Meansv.U.S.Conf.ofCatholicBishops,No.15‐1779(6thCir.2016).

TheruledoesnotincorporateERDs,anditdoesnotenforcethem.Nothingin

therulerequiresanyindividualorinstitutionalprovidertoabidebyanyreligious

belieformoralconvictioninhisorherpracticeofmedicine,andthisruledoesnot

takeapositiononwhetheranyfacilityshouldorshouldnotadheretoERDs.Instead,

theruleprovidesmechanismsfortheenforcementforFederalconsciencelawsand

anti‐discriminationstatutes,whichareverydifferentfromERDsintheirtext,

structure,andlegalsignificance.

Numerouscommentersalsocitedstatisticsdemonstratingthatwomenof

coloraredisproportionatelyservedbyCatholichospitals.Thesecommentersargued

that,becauseERDsprohibitCatholichospitalsfromperformingelectiveabortions,

sterilizations,andotherproceduresthatarecountertoCatholicbeliefs,womenof

colorwouldbedisproportionatelyharmedbyexercisesofreligiousbeliefprotected

bytherule.


331

ThequestionoftheultimateeffectofCatholichospitals’adherencetoERDs

ongeneralaccesstoreproductivehealthcare,oraccessbyanyparticular

population,isoutsidethescopeofthisrule,butappearstobelesssettledthanmany

commentersportrayittobe.Ametastudyin2019foundasurprisingpaucityofdata

ontheissue,statingthat“Althoughmanymayassumethatinstitutionalrestrictions

causeharm,ourcurrentunderstandingdemonstratesthatthelandscapeof

provision[ofreproductivehealthcareservices]iswide‐rangingandcomplexin

nature.”324Onthesubjectofmiscarriagesinparticular,anotherstudyobservedthat

“AnecdotalreportshavesuggestedthatCatholichospitalsareputtingwomenin

dangerduetotherestrictionsonmiscarriagemanagement.Contrarytothese

reports,wefindsomeevidencethatCatholicownershipisinfactassociatedwitha

reductioninmiscarriagesthatinvolveacomplication,suggestingthatanecdotal

accountsmaynotbeindicativeofawidespreadpattern.”325

Additionally,Catholicandotherreligiouslyaffiliatedhealthcareproviders

playamajorroleinthedeliveryofhealthcaretoresidentsoftheUnitedStates,

includingtounderservedorunderprivilegedcommunitiesinparticular,andare

motivatedbytheirbeliefstoservesuchcommunities.326Assomecommenters

324Thorne,etal.,ReproductiveHealthCareinCatholicFacilities:AScopingReview,Obstet.Gynecol.2019;133:105–15,at114.325Hill,etal.,ReproductiveHealthCareinCatholic‐OwnedHospitals,NBERWorkingPaperNo.23768(2017),at4(emphasisadded).326Ascension,RE:DocketHHS‐OCR‐2018‐0002,ProtectingStatutoryConscienceRightsinHealthCare;DelegationsofAuthority(Mar.27,2018)(“Asthelargestnon‐profithealthsystemintheU.S.andtheworld’slargestCatholichealthsystem,Ascensioniscommittedtodeliveringcompassionate,personalizedcaretoall,withspecialattentiontopersonslivinginpovertyandthosemostvulnerable.InFY2017,Ascensionprovidedmorethan$1.8billionincareofpersonslivinginpovertyandothercommunitybenefitprograms.”);CatholicHealthAssociation,REF:RIN0945‐ZA03


332

noted,thatrolemayexplainthedisproportionatelylargeshareofcharitablecare

andservicegivenbyreligiousproviderstounderservedcommunities.Forexample,

Ascension,thenation’slargestreligiouslyaffiliatednon‐profithealthcaresystem,

hadanannualoperatingrevenuein2016thatwasaboutone‐thirdthesizeofthe

annualoperatingrevenueforKaiserPermanente,thenation’slargestnon‐profit

healthcaresystemthatisnotreligiouslyaffiliated.327However,bothorganizations

providedapproximately$2billionincareandotherbenefitprogrammingto

underservedcommunitiesin2017.328

AstheDepartmentdiscussesaboveinresponsetocomments,supraatpart

III.A.,andasobservedintheanalysisbelowontheeffectsofthisfinalruleonaccess

tocare,theDepartmentconcludesthattherelationshipbetweenenforcementof

Federalconscienceandanti‐discriminationlawsthroughthisruleandtheimpacton

accesstocareismorecomplicatedthansuggestedbycommenterswhoclaimthis

rulewilldecreaseaccess.TheDepartmentbelievestheruleisjustas,ormore,likely

toresultinanetincreaseaccesstocarebecausereligiousorotherconscientiously

ProtectingStatutoryConscienceRightsinHealthCare;DelegationsofAuthority:ProposedRule,83Fed.Reg.3880,January26,2018(Mar.27,2018)(“AsaCatholichealthministry,ourmissionandourethicalstandardsinhealthcarearerootedinandinseparablefromtheCatholicChurch'steachingsaboutthedignityofeachandeveryhumanperson,createdintheimageofGod.Accesstohealthcareisessentialtopromoteandprotecttheinherentandinalienableworthanddignityofeveryindividual.ThesevaluesformthebasisforoursteadfastcommitmenttothecompellingmoralimplicationsofourheathcareministryandhavedrivenCHA’slonghistoryofinsistingonandworkingfortherightofeveryonetoaffordable,accessiblehealthcare.”).327CompareKaiserFoundationHealthPlanandHospitalsReport:2017FinancialResults,KaiserPermanente(Feb.9,2018),https://share.kaiserpermanente.org/article/kaiser‐foundation‐health‐plan‐hospitals‐report‐2017‐financial‐results/(lastvisitedDec.3,2018),withOurOneAscensionJourney:YearinReview,Ascension,https://ascension.org/about/community‐and‐investor‐relations/year‐in‐review(lastvisitedDec.3,2018).328FactsandStats,Ascension,https://ascension.org/About/Facts‐and‐Stats(lastvisitedDec.3,2018);Thrive:GiveBack,KaiserPermanente,https://thrive.kaiserpermanente.org/thrive‐together/give‐back(lastvisitedDec.3,2018).


333

objectingprovidersarealreadymorelikelytoserveunderservedcommunities;

imposingviolationsontheirconsciencemayleadtothemlimitingtheirpractices

ratherthanprovidingservicesinviolationoftheirbeliefs;andinsomeunderserved

communitiespatientsmayhaveaproportionatelikelihoodtoagreewithreligious

providersoncontroversialservicessuchasabortion.TheDepartmentbelievesthat,

inpassingFederalconscienceandanti‐discriminationlaws,Congresslikely

intendedtoprotectobjectingproviderspreciselytopreventthemfromlimiting

theirpractices,especiallytounderservedcommunities,soasnottoexacerbate

shortagestothosecommunities.

Inlightofthedemonstratedcommitmentthatreligioushealthcareproviders

havetocaringforthoseforwhomitmaynotalwaysbeprofitabletocare,itlikely

wouldharmunderprivilegedpopulationsiftheDepartmentdidnotprovide

enforcementmechanismsandcertainproceduralandadministrativerequirements,

asthealternativestatusquorisksdrivingsuchentitiesoutofunderserved

communitiesaltogether.Again,however,theDepartmentisnotawareofdataeither

initspossession,fromcommenters,orfromthepublic,thatwouldenablethe

Departmenttoreliablyestimatewhattheimpactofthisrulewouldbeonincreasing,

orallegedlydecreasing,accesstoprovidersorservices.TheDepartment,instead,

concludesthatenforcingFederalconscienceandanti‐discriminationlawsisan

appropriateimplementationofCongressionalintent,andismorelikelyoverallto

leadtonetbenefits,andpossiblytoanincreasein,healthcareproviderandservices

access,thantoleadtoitsreduction.


334

(iv) ExpectedReductionintheMoralDistressthatIndividualProviders

Experience

TheDepartmentanticipatesthatthisfinalrulewillreducetheincidenceof

theharmthatbeingforcedtoviolateone’sconscienceinflictsonproviders.

Substantialacademicliteraturedocumentstheexistenceamonghealthcare

providersof“moraldistress,”whichis“asenseofcomplicityindoingwrong”and“a

deepanguishthatcomesfromthenatureofthosecircumstances[oftheprovider’s

workenvironment]assystemic,persistentlyrecurrent,andpervasivelyproductive

ofcrisesofconscience.”329Moraldistressfunctionsasapressureonprovidersto

leavethehealthcareprofession:“Prolongingtheseconditionscanleadto

exhaustionoftheirresistanceresourcesandcausedissatisfactionwiththe

workplace.Thosewhocontinuetoworkdespitetheseconditionsexperiencestress

andburnoutalongwithdissatisfaction.”330

329ChristyA.Rentmeester,MoralDamagetoHealthCareProfessionalsandTrainees:LegalismandOtherConsequencesforPatientsandColleagues,JournalofMedicineandPhilosophy,33:27–43,2008,p.37(elaboratingthat“[M]oraldistressisasenseofcomplicityindoingwrong.Thissenseofcomplicitydoesnotcomefromuncertaintyaboutwhatisrightbutfromtheexperiencethatone’spowertoresistparticipationindoingwrongisseverelyrestrictedbyone’sworkenvironmentandfromtheexperiencethatresistingparticipationindoingwrongexposesonetoharm.Moraldistressisgeneratedinthehealthcareworkenvironmentwhenapractitionerisawarethatheisactingotherthanhowheismotivatedtoact,buthebelievesthathecannotactasheismotivatedtoactwithoutsufferingsomemorallysignificantharm…Anumberofsituationscangeneratemoraldistress.Broadsystemicchangesintherecentpastinhealthcare—inhowhealthcareinstitutionsareorganized,howhealthcareisfinanced,andhowhealthcareresourcesaremanaged,forexample—havedefactodemandedthatindividualpractitionersadjusttobeingtreatedmorelikelaborersthanautonomousprofessionalsandlessliketrustedfiduciariesthanlikeemployeeswithsuspiciousconflictsofinterest.”)(emphasisadded).330Borhanietal.,Therelationshipbetweenmoraldistress,professionalstress,andintenttostayinthenursingprofession,J.Med.EthicsHist.Med.2014;7:3.


335

Itisdifficulttoquantifytheimpactofthepsychologicaltraumathatresults

frommoraldistress.Thestrengthoftheprovider’smoralobjectionmayvarybased

onthefactsandcircumstancesofeachcase,includingtheserviceinquestion.

(v) ExpectedPatientBenefitsfromthisRule

Totheextenttherulesupportsamorediversemedicalfield,therulewould

createpositiveeffectsforpatients.Therulecouldassistpatientsinseeking

counselorsandotherhealthcareproviderswhosharetheirdeeplyheldconvictions.

Somepatientsappreciatetheabilitytospeakfranklyabouttheirownconvictions

concerningquestionsthattouchuponlifeanddeathandtreatmentoptionsand

preferenceswithadoctorbestsuitedtoprovidesuchtreatment.Apro‐lifewoman

mayseekapro‐lifeOB/GYNtoadviseherondecisionsrelatingtoherfertilityand

reproductivechoices.Opencommunicationinthedoctor‐patientrelationshipwill

fosterbetteroverallcareforpatients.

Thebenefitofopenandhonestcommunicationbetweenapatientandher

doctorisdifficulttoquantify.Onestudyshowedthateven“thequalityof

communication[betweenthephysicianandpatient]affectsoutcomes...[and]

influenceshowoften,andifatall,apatientwillreturntothatsamephysician.”331

Butpoorcommunicationnegativelyaffectscontinuityofcareandunderminesthe

patient’shealthgoals.332Whenconscienceprotectionsarerobust,bothpatientsand

331FallonE.Chipidza,etal.,ImpactoftheDoctor‐PatientRelationship,17(5)ThePrimaryCareCompanionforCNSDisorders(2015),https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308/.332Id.


336

theirphysicianscancommunicateopenlyandhonestlywithoneanotheratthe

outsetoftheirrelationship.

Facilitatingopencommunicationbetweenprovidersandtheirpatientsalso

helpstoeliminatebarrierstocare,particularlyforpeopleoffaith,andespeciallyin

migrantcommunitieswhereculturallycompetentcaremattersgreatly.Because

positionsofconscienceareoftengroundedinreligiousinfluence,“[d]enyingthe

aspectofspiritualityandreligionforsome...patientscanactasabarrier.These

influencescangreatlyaffectthewell‐beingofpeople.Theywerereportedtobean

essentialelementinthelivesofcertainmigrantwomenwhichenabledthemtoface

lifewithasenseofequality.”333Itisimportantforpatientsseekingcaretofeel

assuredthattheirreligiousbeliefsandtheirmoralconvictionswillbehonored.This

willensurethattheyfeeltheyarebeingtreatedfairly.334Andforsome,beingableto

findhealthcareprovidersthatsharethesamemoralconvictionscanbeasourceof

personalhealing.

Asmentionedabove,academicliteraturesupportsthepropositionthat

prohibitingtheexerciseofconsciencerightsinmedicinemaydecreasethequalityof

carethatpatientsreceive.335Commentaryontheconceptofmoraldistressamong

333EmmanuelScheppers,etal.,PotentialBarrierstotheUseofHealthServicesAmongEthnicMinorities:AReview,23FamilyPractice325,343(2006),https://academic.oup.com/fampra/article/23/3/325/475515.334Id.335StephenJ.GenuisandChrisLipp,EthicalDiversityandtheRoleofConscienceinClinicalMedicine,2013Int’l.J.Fam.Med.587541(2013),4‐5(arguingthat“ifsuccessivephysiciansloseindividuallibertyofconscienceandaremorallycompromisedbecauseofauthoritariandictates,theendresult[may]beadiminishingofcollectiveprofessionalismandphysicianmorale,leadingtoinadequatepatientcare.”).


337

providersalsoexpressesconcernoverhowadegradedmoralcultureinhealthcare

canjeopardizepatients’health.336Asonereviewofliteratureonmoraldistressin

nursingfound,“Thereisalsoageneralconsensusamongthereviewsthat[moral

distress]arisesfromanumberofdifferentsources,andthatit(mostly)impacts

negativelyonnurses’personalandprofessionallivesand,ultimately,harms

patients.”337Similarly,allowancefortheexerciseofconsciencerightsmaypromote

ethicalbehaviorbyprovidersmorebroadly,338preserveapreferablemodelof

healthcarepractice,339andimprovethedoctor‐patientrelationship.340

336JoshHyatt,RecognizingMoralDisengagementandItsImpactonPatientSafety,J.ofNursingRegulation,7:4,18(“Perhaps,patientsexperiencethemostsignificantanddangerousconsequencesofmoraldistressandmoraldisengagement…Ashealthcareprovidersreducetheircommunicationswithpatients,patientsmayfeellesssafeandlesssatisfiedwiththeirmedicalexperiences,andtheirclinicalprogressmaybehindered.Further,ifhealthcareprovidersavoidpatientsordistancethemselvesfrompatientsemotionally,theyminimizetheirabilitytoadvocatefortheirpatients’welfare.Providers’emotionaltransitioncanalsomanifestasfrustrationtowardpatients,whichmayimpairthequalityofcare.Ifhealthcareprovidersdonotfulfilltheircommitmentsorperformatamediocrelevel,patientcarecanbecomeinadequateorinappropriate…Lowerqualityofcareleadstoseveralcostsforthepatient.Patientsmayhavetostaylongerinthehospitalormaymisscare.Patientautonomymayalsobethreatened,andpatientscanbemorelikelytobecoercedintopursuingtherapeuticoptionstheywouldotherwisedecideagainst.Carecanthenbecomelesspatientcenteredandmorepaternalistic,astructureassociatedwithworsehealthoutcomes.”(citationsomitted)).337J.McCarthy&C.Gastmans(2015).Moraldistress:Areviewoftheargument‐basednursingethicsliterature,NursingEthics,22(1),150.338WhiteandBrody,supraatnote120;StephenJ.GenuisandChrisLipp,EthicalDiversityandtheRoleofConscienceinClinicalMedicine,2013Int’l.J.Fam.Med.587541(2013),5(“Compromiseofpersonalmoralintegrity,ofanykindornature,willinevitablyleadtoanerosionofethicalbehavior–aprospectnotconducivetotheoptimalprovisionofhealthcare.”)339KevinTheriot&KenConnelly,FreetoDoNoHarm:ConscienceProtectionsforHealthcareProfessionals,49Ariz.St.L.J.549,565‐66(2017)(“[T]he‘publicutility’modelofmedicineisnotonlya‘challenge[to]aconscientiousphysician'sintegrityasaphysician,’italso‘depreciateshisexpertise,reduceshisdiscretionarylatitudeindecisionmaking,andmakeshimatechnicalinstrumentofanotherperson'swishes,’thereby‘subvert[ing]thehealingpurposeforwhichmedicineisintendedinthefirstplace.’Themyopicviewofmedicinethatviewsamedicalpractitionerasamereserviceprovider‘canredoundtothepatient'sharmbyunderminingthephysician'smoralobligationtoprovidesoundadviceandsoundpracticeandtoavoidmedicallyuselessorfutiletreatments.’”(citationsomitted)).340Genuis&Lipp,at5(arguingthat“[freedomofconscience]promotesopen,transparentphysician‐patientrelationshipsandengenderspatientadvocacy…Itisunlikelythatindividualpatientsorsocietywouldsupportasituationinwhichphysicianswerebeingcoercedtohidetheirconvictions,


338

Asnotedabove,theDepartmentassumesthatthisrulewillincreasethe

overallnumberofprovidersbecause(1)itwillreducebarrierstoentryintothe

healthcarefield(andreducepressuretoleavethefield)forindividualsand

organizationswithreligiousbeliefsormoralconvictions,and(2)thereexistsan

unmetdemandformoreproviders.IftheDepartmentisincorrectinassumingthat

therulewillincreasetheoverallnumberofproviders—i.e.,ifhealthcareemployers

andmedicaltrainingprogramsdonotincreasetheirhiringratesandthesizeof

theirprograms,respectively,despiteanincreaseinapplicants—thentherulewill

increasethequalityoftheaverageprovider,becausetheincreaseinthepoolof

availableprofessionalswillresultintheselectionofbetterprovidersoverall.An

increaseinthequalityofproviderswillincreasethequalityofcarethatpatients

receive.TheDepartmentisnot,however,awareofdatathatprovidesabasisfor

quantifyingtheseeffects.

(vi) ExpectedSocietalBenefitsfromthisRule

Therulewillalsoyieldlastingsocietalbenefits.Therulemitigatescurrent

misunderstandingaboutwhatconducttheFederalgovernmentislegallyableto

supportandfund,andeducatesindividualsabouttheirFederalconsciencerights.By

makingdecisionstheyfeltweremorallywrongorunethical,orfailingtoactinwhattheyperceivedtobetheirpatients’bestinterests”);ChristianMedicalAssociation&Freedom2CaresummaryofpollsconductedApril,2009andMay,2011,availableathttps://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf(“77%ofAmericanadultssurveyedsaiditiseither‘very’or‘somewhat’importanttothemthat‘thathealthcareprofessionalsintheU.S.arenotforcedtoparticipateinproceduresorpracticestowhichtheyhavemoralobjections;’”“88%ofAmericanadultssurveyedsaiditiseither‘very’or‘somewhat’importanttothemthattheyshareasimilarsetofmoralsastheirdoctors,nurses,andotherhealthcareproviders”).CommentsreceivedbytheDepartmentsupportedthefindingthatpatientspreferproviderswhosharetheirgeneralbeliefsystem.


339

requiringcertificationsandassurances(withsomeexcemptions),thisruleprovides

amechanismbywhichregulatedentitieswilllearnabout—and,thus,bemorelikely

tocomplywith—Federalconscienceandanti‐discriminationlaws.Therulealso

providesacentralizedofficewithintheDepartmentforindividualsandinstitutions

tofilecomplaintswiththeDepartmentwhensuchindividualsandinstitutions

believethattheirrightshavebeeninfringed.TheDepartmentexpectsthat,asa

resultofthisrule,moreindividuals,havingbeenapprisedofthoserights,willassert

them.Thecombinationofthesemechanismswillcontributetothegeneralpublic’s

knowledgeandappreciationofthefoundationalnatureoftheserights,aswellasthe

protectionsaffordedbyFederallaw.

FosteringrespectfortheexistingFederalconscienceandanti‐discrimination

lawsalsofosterslawfulnessmoregenerally.Asoneauthorstated,

[L]awandconsciencearedeeplyintertwined....Butthephenomenonofconscienceisn’timportantonlytolegalexperts.Justasconsciencehelpsexplainwhypeoplefollowlegalrules,ithelpsexplainwhypeoplefollow other types of rules as well, such as employers’ rules foremployees,parents’ rules for children,andschools’ anduniversities’rules for students. It may also help explain why people adhere todifficult‐to‐enforce ethical rules and to the sorts of cultural rules(“social norms”) thatmake communal life bearable. . . . Twenty‐firstcenturyAmericans still enjoya remarkably cooperative, law‐abidingculture.341Becausefosteringconscienceinindividuals—andcompliancewithFederal

consciencelaws—contributetoamorelawfulandvirtuoussociety,governments

341LynnStout,CultivatingConscience:HowGoodLawsMakeGoodPeople17(2011).


340

andtheirsubdivisionshaveasignificantinterestinencouragingexpressionsof,and

fidelityto,conscience.

Forcingreligiousbelieverstoviolatetheirconsciencesinvolvesharmsthat go beyond these individuals and their communities. When anindividual is forced to act in ways that they view as deeply wrong,indeedasprohibitedbytheultimatepowerresponsibleforeverythingthat exists, moral habits essential for democratic citizenship areundermined.342

Governmentsalsohaveaninterestinensuringtheimplementationandenforcement

ofexistinglaws,aspartofthegreatervirtueoftheruleoflaw.

Itisdifficulttomonetizethebenefitsofrespectforconsciencetothe

individualandsocietyasawhole,buttheyareclearlysignificant.AstheSupreme

Courthassaid:

Bothmoralsandsoundpolicyrequirethatthestateshouldnotviolatetheconscienceoftheindividual.Allourhistorygivesconfirmationtotheviewthatlibertyofconsciencehasamoralandsocialvaluewhichmakesitworthyofpreservationatthehandsofthestate.Sodeepinitssignificanceandvital,indeed,isittotheintegrityofman’smoralandspiritualnaturethatnothingshortoftheself‐preservationofthestateshouldwarrantitsviolation;anditmaywellbequestionedwhetherthestate which preserves its life by a settled policy of violation of theconscienceof the individualwill not in fact ultimately lose it by theprocess.343

Toprotecttherightsofconscienceistoprotectpersonalandinterpersonalgoods

thatpermitpeacefulandfulfillinglives.344

342KathleenA.Brady,TheDisappearanceofReligionfromDebatesaboutReligiousAccommodation,20Lewis&ClarkL.Rev.1093,1110(2017).343UnitedStatesv.Seeger,380U.S.163,169(1965)quotingHarlanFiskStone,TheConscientiousObjector,21Col.Univ.Q.253,269(1919).344ChristopherC.Lund,ReligionIsSpecialEnough,103Va.L.Rev.481,504(2017)(“Freedomofmoralconscience,itturnsout,servesmanyofthesamevaluesservedbyfreedomofreligion–amongotherthings,itcanservetoamelioratepsychologicaldistress,reducecivilstrife,andpreserveindividualidentity.”).


341

(vii) AnalysisofExpectedEffectsofThisFinalRuleonAccesstoCare

TheDepartmentsolicitedinformationoncoststhatmayariseassecondary

effectsofthisrule,suchasthoseassociatedwithchangesinhealthoutcomesarising

fromincreasedprotectionofconscienceforhealthcareproviders,aswellas

informationaboutwhethertheexistenceorexpansionofrightstoexercisereligious

beliefsormoralconvictionsinhealthcareimprovesorworsenspatientoutcomes

andaccesstohealthcare.TheDepartmentalsorequestedcommentontherelated

questionofwhetherthisfinalrulewouldresultinunjustifiedlimitationsonaccess

tohealthcare.

Thequestionsofaccesstocareandofhealthoutcomesarelargely

interdependent;accesstocaremattersbecauseofitseffectsonhealthoutcomes,

andthediscussioninthepubliccommentsonhealthoutcomesinthecontextofthis

ruleweretypicallyframedasaconsequenceofchangesinaccesstocare.Many

commentstheDepartmentreceivedarguedthattherulewoulddecreaseaccessto

careandharmpatienthealthoutcomes,andmostsuchcommentsfocusedonthe

potentialthatproviderswoulddeclinetoperformaparticularserviceforapatient.

Generally,however,insteadofattemptingtoanswerthedifficultquestionof

howthisrulewouldaffectaccesstocareandhealthoutcomes,andhowtoquantify

thoseeffects,suchcommentsarguedthatsignificantdiscriminationagainstsome

segmentsofthepopulationinhealthcareexistsandisperseproofthattherule

wouldresultinharm.Thecommentsmadethisargumentwithoutestablishinga


342

causalrelationshipbetweenthisruleandhowitwouldaffecthealthcareaccess,and

withoutprovidinganydatatheDepartmentbelievesenablesareliable

quantificationoftheeffectoftheruleonaccesstoprovidersandtocare.

Othercommentsfocusedonwhetherhealthdisparitiesexistamong

demographicsthattendtoutilizehealthservicesthatmaybethesubjectof

conscientiousobjectionsprotectedbythisfinalrule,butagainwithoutestablishing

acausallinkbetweentheprovisionsofthisruleandthepredictedorspeculated

effects.

Manycommentsobservedthatvariousdemographicgroups—women,LGBT

people,immigrantsandrefugees,peopleofcolor,peoplelivingwithHIV/AIDS,

peoplewithlanguagebarriers,peoplelivinginpoverty,peoplewithdisabilities,and

peoplelivinginruralareas—alreadyfacebarrierstoaccesstocareandtherefore

wouldbedisproportionatelyharmedbyanyadditionalbarrierstoaccesstocare.

TheDepartmentdoesnotdisputethatpeopleinsuchdemographiccategoriesface

healthcaredisparitiesofvariousforms.TheDepartmentdoesdisagree,however,

withthesecomments’conclusionsthattherulewillcreateanynegativeeffecton

accesstocarethatcannotbeotherwiseaddressed,orthatisnotoutweighedby

gainsinoverallpublichealth,overallaccesstocareduetotheremovalofbarriers

forproviders,orthebenefitsofcompliancewiththelawandrespectforconscience

andreligiousfreedom.Infact,astheDepartmentdiscussessupraatpartIV.C.4.iii

andinfra,theDepartmentexpectstheruletospecificallybenefitunderserved

populations.


343

Acommonsentimentexpressedincommentswasthatconscience

protectionsforprovidersareonlyappropriatetotheextenttheydonotinterfere

with,imposeupon,orinanywayresultinothersfeelingharmed.Thistypeof

objectionisnotacceptedforanyotheranti‐discriminationlaw.Forexample,the

FairHousingActandtheAmericanswithDisabilitiesAct,undercertain

circumstances,requirebuildingandapartmentownerstoincurcoststoensurethat

facilitiesareaccessibletopersonswithdisabilities.Thesestatutesimposecosts,but

CongressandseveralPresidentshavedeemeditimportanttoremovebarriersto

fullparticipationineconomicandsociallifeforpersonswithdisabilities.Similarly,

AmericahassincethefoundingrecognizedthatFreeSpeechresultsinharmand

hurtfeelings(sometimesextraordinarilyso)formanyAmericans,yetitisdeemeda

priceworthpaying.Conscienceprotectionshouldbenotbeaspecialexceptionto

theprinciplethatfundamentalrightsdonotdependontherebeingzeroconflictsor

disagreementsintheirexercise.

Inanyevent,theobjectionsbasedonpotential(oftentemporary)lackof

accesstoparticularproceduresasaresultofenforcementofthelawarereally

objectionstopolicydecisionsmadebythepeople’srepresentativesinCongressin

enactingtheFederalconscienceandanti‐discriminationlawsinthefirstplace,

ratherthantothisrule’smechanismsforimplementingandenforcingthoselaws.

Ananalysisofanychangeinaccesstocarecausedbythisfinalruleisnotthe

sameasananalysisofthetotalimpactoftheexerciseofreligiousbeliefandmoral

convictiononaccesstocare.Norisitthesameasestimatingthetotalimpactof


344

discriminationagainstwomen,LGBTindividuals,orindividualsinanyother

populationdemographiconaccesstocare.Rather,thequestioninvolvesisolating

theimpactoftheexercisesofreligiousbelieformoralconvictionattributabletothis

finalrulespecifically,overandabovewhateverimpactisattributabletothepre‐

existingbaserateofexerciseofreligiousbelieformoralconviction.

Differenttypesofharmcanresultfromdenialofaparticularprocedure

basedonanexerciseofsuchbelieforconviction.First,thepatient’shealthmightbe

harmedifanalternativeisnotreadilyfound,dependingonthecondition.Second,

theremaybesearchcostsforfindinganalternative.Third,thepatientmay

experiencedistressassociatedwithnotreceivingaprocedureheorsheseeks.These

threepotentialharms,however,wouldalsobeapplicablefordenialsofcarebased

on,forexample,inabilitytopaytherequestedamount.Fourth,theremaybeaharm

resultingfromaconscientiousobjectiontoreferringforahealthservice,distinct

fromtheharmoftheinitialobjectiontoperformingtheservice.Fifth,some

commentatorsallegeothersinthecommunitytowhichthepatientbelongsmaybe

lesswillingtoseekmedicalcare.

Ontheotherhand,itisimportantnottoassumethateverypatientwho

wantsaparticularserviceisoffendedbyaprovider’sunwillingnesstoprovidethat

service,orwishesthattheproviderwoulddosoagainsthisorherreligiousbeliefs

ormoralconvictions.Somepersons,outofrespectforthebeliefsofproviders,may

wantaservicebutnottakeanyoffense,nordeemitanyburdenonthemselves,for

theprovidertonotprovidethatservicetothem.Somepatientsmayevenvaluethe


345

healthcareprovider’swillingnesstoobeyhisorherconscience,becausethepatient

feelsthatprovidercanbetrustedtoactwithintegrityinothermattersaswell.The

Departmentdoesnotbelieveitisappropriatetoassumethatallpatientswhowanta

particularservicealsowanttoforceunwillingproviderstoprovideitinviolationof

theirconsciences.

Lastly,numerouscommentsfocusedonthepotentialforapatienttofeel

insultedoremotionallydistressedbecauseofaperceptionthataprovider,in

decliningforreasonsofreligiousbelieformoralconvictiontoperformanobjected‐

toserviceorprocedure,isexpressingdisapprobationofthepatient,especially

regardinghisorherpersonalidentityorpersonalconceptionsofmorality.Although

theDepartmentdoesnotunderstandsuchconscientiousobjectionstobe

necessarilyintendedtoconveysuchdisapprobation,theDepartmentrecognizes

that,insomecircumstances,somepatientsdoexperienceemotionaldistressasa

consequenceofproviders’exerciseofreligiousbeliefsormoralconvictions.

However,Congress,inconsideringthestatutesenforcedbythisrule,didnot

establishbalancingteststhatweighsuchemotionaldistressagainsttherightto

abidebyone’sconscience.

Ontheothersideoftheequation,thosewhosufferdiscriminationonthe

basisoftheirreligiousbeliefsormoralconvictions,orthosecoercedtoviolatethose

convictions,maythemselvesexperienceemotionaldistress,aswellaseconomic

harmssuchasjoblossorrejectionfromadmissionintoatrainingprogram.


346

Thereappearstobenoempiricaldataonhowpreviouslegislativeor

regulatoryactionstoprotectconsciencerightshaveaffectedaccesstocareorhealth

outcomes.Infact,studieshavespecificallyfoundthatthereisinsufficientevidence

toconcludethatconscienceprotectionshavenegativeeffectsonaccesstocare.345

Manycommentersreasonedthat,despitethislackofempiricalevidence,the

rulewouldcauseanincreaseindenialsofcare.Forexample,onecommentcited

variousstatisticsontheratesofdiscriminationagainstLGBTindividuals,butthose

statisticsweregeneralinnatureanddidnotassisttheDepartmentinestimating

whatdegreemaybeattributabletothelawfulexerciseofreligiousbeliefsormoral

convictions.Thecommentalsoidentifiednumeroushealthdisparitiesbetween

LGBTindividualsandnon‐LGBTindividuals,butdidnotexplaintheextenttowhich

suchdisparitiesaretheproductofthelawfulexerciseofreligiousbeliefsormoral

convictions.Thecommentthenconcludedthat“discriminationandrelatedhealth

disparitiesfacingtheLGBTpopulationstandtoworsenifhealthcareprovidersare

authorizedtorefusetoserveLGBTpeople.”

Thesamecommentattachedanamicusbriefthatcitedtwostudiesonhow

statelawsaffecthealthdisparitiesamongLGBTpopulations—onestudyonstates

thateitherdidnotincludesexualorientationasaprotectedcategoryinitshate

345SeeChavkinetal.,Conscientiousobjectionandrefusaltoprovidereproductivehealthcare:AWhitePaperexaminingprevalence,healthconsequences,andpolicyresponses,123Int’lJ.Gynecol.&Obstet.3(2013),S41–S56(“[I]tisdifficulttodisentangletheimpactofconscientiousobjectionwhenitisoneofmanybarrierstoreproductivehealthcare….[C]onscientiousobjectiontoreproductivehealthcarehasyettoberigorouslystudied.”);K.Morrell&W.Chavkin,Conscientiousobjectiontoabortionandreproductivehealthcare:areviewofrecentliteratureandimplicationsforadolescents,27Curr.Opin.Obstet.Gynecol.5(2015),333–338(“[T]hedegreetowhichconscientiousobjectionhascompromisedsexualandreproductivehealthcareforadolescentsisunknown.”).


347

crimesstatuteordidnotprohibitemploymentdiscriminationonthebasisofsexual

orientation,andanotheronstatesthathadconstitutionalamendmentsbanninggay

marriageontheballotin2004and2005.Neitherstudyprovidesareliablebasisfor

inferringananswertothequestionsatissuehere.

Anothercommentcitedtoa2018reportonanecdotalexperiencesof

discriminationamongLGBTindividualsineightstateswherelawshadbeenpassed

toprotectreligiousfreedom.Thereportitselfincludesacitationtoonestudy

findingthatawarenessoflegislationprohibitingdiscriminationonthebasisof

sexualorientationisassociatedwithadecreaseintherateofsuchdiscriminationin

interpersonalemploymentcontexts.Whileanalogous,suchafindingisnotthesame

asafindingthattheawarenessoflegislationprotectingconsciencerightsincreases

theratesofdiscriminatoryconductbypeoplewithreligiousbeliefsormoral

convictions.ThereportprovidesanecdotalaccountsofdiscriminationfromLGBT

residentsofthosestates.However,thereportdoesnotattempttodetermineifthe

lawspassedbythosestatesplayedanycausalroleinthediscriminationexperienced

bytherespondents,e.g.,viacomparisontoLGBTindividuals’experiencesinstates

wherenosuchlawshadbeenpassed.

Multiplecommentsprovidedlistsofvariousincidentsinwhichproviders

declinedtoparticipateinaserviceorproceduretowhichtheyhadareligiousor

moralobjection.Suchlistsoffernosuitabledataforestimatingtheimpactofthis

rule.


348

Nocommentattemptedadetaileddescriptionoftheactualimpactexpected

fromtheruleonaccesstocare,healthoutcomes,andassociatedconcerns.

TheDepartmentattemptedtoquantifytheimpactofthisruleonaccessto

carebutdeterminedthatthereisnotenoughreliabledata,andthattheanalysiswas

subjecttotoomanyconfoundingvariables,fortheDepartmenttoarriveatauseful

estimate.Forinstance,theDepartmentisnotawareofasourcefordataonthe

percentagesofproviderswhohavereligiousbeliefsormoralconvictionsagainst

eachparticularserviceorprocedurethatisthesubjectofthisrule.346

Likewise,theDepartmentisnotawareofdataontheactualrateofproviders’

exerciseofconscientiousobjectionstoperformingsuchservicesorprocedures.

Someproviderswhohaveareligiousormoralobjectiontoperformingaserviceor

proceduremaynonethelessperformitforonereasonoranother,suchasfearof

legalreprisal.Othersmayrespondtopressuretoviolatetheirconsciencesby

limitingtheirpractices,ratherthanprovidingtheservicetowhichtheyobject.

Commenterswhocontendtherulewillreduceaccesstocareseemtoassumeall

providerswithconscientiousobjectionsthatarenotbeinghonoredareproviding

thoseservicesanyway,sothattherulewillreducetheirprovisionofthoseservices.

346Forinstance,eveninthecaseofabortion,forwhichsomedataontheratesofproviders’objectionsactuallyexists,thoseratesvarysignificantlybasedonthefactsandcircumstancesofthescenariopresented,confoundinganattempttoproduceasinglemeasureofproviders’rateofobjectiontoabortioningeneral.SeeHarris,etal.,Obstetrician–Gynecologists’ObjectionstoandWillingnesstoHelpPatientsObtainanAbortion118OBSTETRICS&GYNECOLOGY905(2011)(“Thesedatasuggestthatob‐gynsalsoconsidercontextualfactors,includingriskofphysicalharmtothewomanbycontinuingpregnancy(breastcancer,cardiopulmonarydisease),thecircumstancesofthesexualencounterthatresultedinpregnancy(rape),theimpactabortionmayhaveonpregnancyoutcome(selectivereduction),thepotentialforfetalanomaly(diabetes),andthedurationofpregnancy(secondversusfirsttrimester)…Amongob‐gyns,supportforabortionvarieswidelydependingonthecontextinwhichabortionissoughtandphysiciancharacteristics.”).


349

TheDepartmentdoesnotbelievethatassumptioniscorrect.TheDepartment

consideredmethodsforestimatingtheincreaseintherateofsuchexerciseof

conscientiousobjectionsthatmayoccurasaresultofthisrule,butdeterminedthat

noreliablemethodwasavailable.TheDepartmentlikewiseconsideredwhether

providerswho,forreasonsofreligiousbeliefsormoralconvictions,haveleftthe

practiceofmedicineorlimitedtheirscopeofpracticemayreenterthefieldor

resumetheirpreviousscopeofpractice,giventherule’sexpandedenforcementof

protectionsforreligiousbeliefsormoralconvictions.Ifproviderswholimitedtheir

practicesbecauseofthreatstotheirconsciencesexpandthembecauseofthisrule,

thosewouldnotbeinstancesofareductionintheprovisionofservicestowhich

theyobject,butofanincreaseinotherservices.However,theDepartmentwas

unabletofindreliabledataonthisquestion,andconcludedthatnouseful

quantitativeestimateofthisimpactwasfeasible.

Theimpactonhealthoutcomesfromtheexerciseofconscientiousobjections

toparticularservicesandproceduresalsoresistedausefulquantitativeestimate.

Withoutdata—toinformanestimateofthequantityofsuchobjectionsthatwould

beattributablethisrule,thenumberofthoseobjectionsthatledtoproviders

offeringservicestowhichtheyobjectratherthanlimitingtheirpractices,the

numberofpersonswholeftordidnotentercertainfieldsorpracticesaltogether

becauseconsciencelawswereinsufficientlyenforced,themarketeffectofproviders

expandingormovingintodifferentareasbecauseconsciencelawsareenforced,and

theoverallresultingavailabilityofaccess,bothtoobjected‐toservicesandtoother


350

healthcareoverall—theDepartmentlacksthepredicateforestimatingtheimpact

onhealthoutcomesofanychangeintheavailabilityofservices.Theanalysisonthis

pointisalsogenerallysubjecttothesameconfoundingfactorsdiscussedbelow

regardingtheimpactofconscientiousobjectionstoprovidingreferrals.

TheDepartmentexpectsanydecreasesinaccesstocaretobeoutweighedby

significantoverallincreasesinaccessgeneratedbythisrule.Ifthelawsthatarethe

subjectofthisrulearenotenforced,manyoftheexactsamepeoplewhowouldface

aburdenfromadenialofaccesstoaparticularprocedurefromaparticulardoctor

orproviderwouldfacethepotentialofreceivingnohealthcareatallfromthat

doctororproviderbecausesuchprovidersmaylimit,orleave,theirpracticesif

unabletocomplywiththeirreligiousbeliefsormoralconvictions.Theabsenceor

departureofthoseprovidersfromthehealthfielddoesnotclearlyleadtoany

increaseinotherproviderswhoarewillingtoofferservicesthatarethesubjectof

Federalconscienceandanti‐discriminationlaws,butismorelikelytosimply

diminishtheoverallavailabilityofhealthcareservices.Theburdenofnotbeingable

toreceiveanyhealthcareclearlyoutweighstheburdenofnotbeingabletoreceive

aparticulartreatment.

Forexample,aftertheDepartmentproposedin2009torescindthe2008rule

providingconscienceprotectionsforproviders,asurveyfoundthat81percentof

faith‐basedhealthcareprofessionalsworkinginruralareasand86percentoffaith‐

basedhealthcareprofessionalsworkingfull‐timeinservicetounderserved

communitiessaidthattheywereeither“very”or“somewhat”likelytolimitthe


351

scopeoftheirpracticeifthe2008rulewasrescinded.347Forsuchproviderswhodid

notinfactlimittheirscopeofpractice,thisrulewillhelptopreventfuturesituations

inwhichtheyfeelforcedtodoso.Forthosewhodid,thisruleprovidesprotections

thatmayinducethemtoresumetheirpreviousscopeofpractice.Inthissensethe

Departmentbelievestherulewillbothpreserveandexpandaccesstohealthcare

generally.

Furthermore,asoneacademicarticleobserved,“[P]atientschoosenot

merelyparticularservices,butparticularkindsofprofessionals.”348Asnotedearlier

inthissection,asurveyofpatientsfoundthat88percentwouldpreferthattheir

providerssharetheirmoralbeliefs.349AnothersurveyconductedbyaformerChair

ofBioethicsoftheNationalInstitutesofHealthClinicalCenter“reinforcesthe

existenceofpatientpreferenceforphysicianswithsharedvalues...[finding]that

nearlyone‐fifthof[cancer]patientssurveyed‘thoughttheywouldchange

physiciansiftheirphysiciantoldthemheorshe‘hadprovidedeuthansia[sic]or

347ChristianMedicalAssociation&Freedom2CaresummaryofpollsconductedApril,2009andMay,2011,availableathttps://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf.348M.Bowman&C.Schandevel,TheHarmonybetweenProfessionalConscienceRightsandPatients’RightofAccess,6PhoenixL.Rev.31(2012)at56(“First,apatientwhochoosesapro‐lifephysicianisnotmerelychoosingaphysicianwhodoesnotdosomething.Sheischoosingaphysicianwhoaffirmativelypracticesmedicineaccordingtoprinciplesthatunconditionallyvaluehumanlife,whetherinthecontextofthepreborn,theborn,thedisabled,ortheterminallyill…Second,patientsseekphysiciansnotonlyfordiscreteservices,butevenmoresoforrelationshipsoftrust.”)349ChristianMedicalAssociation&Freedom2CaresummaryofpollsconductedApril,2009andMay,2011,availableathttps://docs.wixstatic.com/ugd/809e70_7ddb46110dde46cb961ef3a678d7e41c.pdf(“88%ofAmericanadultssurveyedsaiditiseither‘very’or‘somewhat’importanttothemthattheyshareasimilarsetofmoralsastheirdoctors,nurses,andotherhealthcareproviders).


352

assistedsuicide’forotherpatients.’’”350TheDepartment,accordingly,expectsthis

rule,throughitsrecognitionofthe“fundamentalnecessityofconscienceprotections

toensuringpatientaccess”for“patientswhowantaccesstophysiciansof

conscience,”toresultinanincreaseinaccesstocare.351

Theeffectoftherule’sprotectionofrefusalstoreferforservices

Aswiththeanalysisintheabovefactors,thereexistssomebaselinerateof

exerciseofconscientiousobjectiontoreferringforaservicetowhichtheprovider

morallyobjects.Asignificantpercentageofprovidersbelievethattheyarenot

obligatedtoreferforaservicetowhichtheymorallyobject.352Itisreasonableto

assumethattheratesofexerciseoftherightnottoreferwillincreaseunderthe

rule,butitisdifficulttodeterminebyhowmuch.Itislikewisedifficulttoestimate

whatpartofthebaselineinstancesofconscientiousobjectionmanifestthemselves

inprovidersprovidingthereferralsinviolationoftheirobjections,insteadof

limitingtheirpracticessoastoavoidtheconflict.

First,itisunclearhowmanyprovidersunderstandtheirexistingrightto

declinetorefer,whethergroundedinethicsorthelaw,tobecoextensivewiththe

freedomthattherulereflects.Forexample,aproviderwhoobjectstoperforming

sterilizationsmayfeelethicallyobligatedtoinformapatientwherevasectomiesare

350Bowman&Schandevel,citingEzekielJ.Emanueletal.,EuthanasiaandPhysician‐AssistedSuicide:AttitudesandExperiencesofOncologyPatients,Oncologists,andthePublic,347Lancet1805,1808(1996).351Id.at36.352Combsetal.,Conscientiousrefusalstorefer:findingsfromanationalphysiciansurvey,J.Med.Ethics2011;37:397‐401,399(“[43%]ofphysiciansinthispresentstudy…didnotagreethatphysiciansareobligatedtomakereferralsthattheybelieveareimmoral.”).


353

locallyavailable—anactthattherulemayallowtheprovidertoabstainfrom—but

maynotfeelobligatedtoprovidethepatientanyfurtherinformationabouthowto

obtainthatprocedure.Researchsuggeststhatprovidersmayoftendrawsucha

distinction.353

Itisalsodifficulttoestimatewhatactualimpacttheincreaseinrefusalsto

referwouldhave.Oneconfoundingfactoristhatthepracticaleffectofaprovider’s

exerciseofconscientiousobjectiontoprovidingareferralmayvarygreatly

dependingontheparticularfactsandcircumstancesofthecase.Publicknowledge

oftheavailabilityofcertainmedicalservicesmaybeextensiveorminimal

dependingontheprocedure.Forinstance,anypregnantwomanisalmostcertainly

awareoftheexistenceandpurposeofabortion,andtheextensiveeffortsofpro‐

choicegroupstofacilitatewomen’saccesstoabortionmakeinformationabouthow

toobtainanabortionrelativelyeasytofind.354Sotheeffectofaprovider’srefusalto

referforanabortionismitigatedbythepatient’sownknowledgeandthe

widespreadavailabilityofinformationaboutabortionaccessontheinternetand

elsewhere.

Thechangeinthenumberofpatientswhodelayorforgohealthcareforfearofbeingdeniedahealthservice

353FarrA.CurlinM.D.,etal.,Religion,Conscience,andControversialClinicalPractices,NEWENG.J.MED.593–600,593(2007)availableathttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC2867473/(findingthatsomeproviderswillinformpatientsofoptionsbutnotreferforsuchoptions)(“Most[providers]alsobelievethatphysiciansareobligatedtopresentalloptions(86%)andtoreferthepatienttoanotherclinicianwhodoesnotobjecttotherequestedprocedure(71%)”).354See,e.g.,https://prochoice.org/think‐youre‐pregnant/find‐a‐provider/(firstresultforGooglesearchofphrase“findabortionclinicnearme”performed10/17/18).


354

Asnumerouspubliccommentsdemonstrate,certainminoritygroupsalready

experiencesignificanthealthcaredisparities.Commentersstatethatnegativehealth

outcomesfromsomedemographicsareduetofearofdiscriminationleadingto

avoidanceofseekinghealthcare.However,theDepartmentisnotawareofanydata

establishingwhat,ifany,partofthisavoidancephenomenonisattributabletothe

exerciseofconscientiousobjectionsprotectedbythisruleorbyimplementationof

theenforcementmechanismsofthisrule.

Othercommentsonaccesstocare

Manyofthecommentsthatclaimedthattherulewouldresultinmore

frequentdenialsofservicetopatientsalsoarguedthattheruleisunnecessary

becausethereisnocurrentproblemwithhealthcareprovidersbeingcoercedinto

violatingtheirconsciences.Theseargumentsarecontradictory.If,underthefinal

rule,aproviderexercisesarightprotectedbytheruletodeclinetoperforma

servicethathehadbeenperformingpriortothisrule,hispreviousperformancesof

theservicewouldlikelyhavebeencontrarytohisconscience.

Manycommentersobservedthat,inruralareas,ifaproviderweretodecline

onreligiousormoralgroundstoprovideaparticularserviceorprocedure,there

maynotbealternativeproviderswithinafeasibledistanceofthepatient.The

Departmentdoesnotdisputethatpatientsinruralareasaremorelikelythan

patientsinurbanareastosufferadversehealthoutcomesasaresultofbeingdenied

care.ThatiswhyenforcementofFederalconscienceandanti‐discriminationlawsto

preventhealthcareprovidersfrombeingunlawfullydrivenoutofbusiness,


355

especiallyinruralareas,isofparamountimportance.Insteadofadecreaseinaccess

toaparticularprocedurefromaparticulardoctororprovider,theresidentsofa

ruralareawouldfacethepotentialofreceivingnohealthcareatallfromthatdoctor

orproviderbecausesuchprovidersmayleavethepracticeifunabletopractice

medicineaccordingtotheirreligiousbeliefsormoralconvictions.Inaddition,as

discussedinresponsetocommentssupraatpartIII.A.,somepollsshowpopulations

inruralcommunitiesmaybemorelikelytoagreewithprovidersinobjectingto

certainproceduresencompassedbyFederalconscienceandanti‐discrimination

laws.Thisimpliesthatthedemandforsuchservicesmaynotexist(orbeasgreat)in

suchcommunities,partiallyoffsettingtheimpactofahighernumberof

conscientiousobjectionsthatmaybeeffectuatedbecauseoftherule.Personsin

urbanareas,incontrast,mayfeellesseffectfromanincreaseinconscientious

objectionsbecauseoftherelativelygreateravailabilityofalternativeprovidersas

comparedtoruralareas.

Onecommenternotedthatindividualswhosehealthinsurancedoesnot

providefinanciallyadequatecoverageforalargeenoughnumberofprovidersmay

similarlyfacealackofalternativeprovidersintheeventoneproviderexercisesa

conscientiousobjectiontoadesiredservice.TheDepartmentregardsitsanalysis

hereinregardingruralareastobeapplicabletosuchsituationsaswell.

Justastheconsequencesofdenialsofcaremayinsomecasesbemagnifiedin

ruralareas,sotoomaybetheconsequencesofforcingaruralhealthcareprovider

toviolateherconscience.First,theprovidermaylimitherpracticeorexitthefield,


356

harminghealthcareaccessinasignificantway.Second,iftheprovidercontinuesto

practice,thestressofhavingtoviolateherconsciencemaydetractfromthequality

ofcaretheproviderdeliverstoherpatientsingeneral,whohavenoalternative

provider.

Additionally,ifaproviderisinanareawherethemajorityofthepopulation

sharestheprovider’sbeliefsystem,andiftheproviderleavestheareadueto

inabilitytoexerciseprotectedbeliefs,manyinthecommunitymaylosetheabilityto

haveaproviderwithvaluestheyshare,thusnegativelyimpactingthedeliveryof

healthcareandthedoctor‐patientrelationship.

5. AnalysisofRegulatoryAlternatives

TheDepartmentcarefullyconsideredalternativestothisfinalrule.The

Departmentdeterminedthatnoalternativecouldachieveappropriatelyrobust

enforcementof,andrespectfor,Federalconscienceandanti‐discriminationlaws

withoutundulyburdeningcoveredpersonsandentitiessubjecttothoselawsand

thisrule.Thefollowingalternativesrepresentthemajorapproachesthe

Departmentconsidered,includinghowburdenreductionwasaconsiderationin

constructingthisrule.

TheDepartmentconsideredpreservingthestatusquobymaintaining45CFR

part88withoutchangefromthe2011Rule.Underthisapproach,theDepartment

wouldlargelydefertotheStatestoenforcetheirrespectiveconsciencelawsorto

enactnewlawstofillgapsinthelandscapeofFederalandStateconscience

protectionandassociatedanti‐discriminationrightsandtheirenforcement,


357

continuewiththecurrentinadequateenforcementscheme,andprovideno

meaningfulenforcementoftheconscienceandassociatedanti‐discriminationlaws

thatwerenotpartofthe2011Rule.TheDepartmentreceivedcommentsadvocating

thisapproachsince,incommenters’views,Statelaw,inconjunctionwithFederal

law,alreadyprovidesadequateaccommodationofreligiousbeliefs.Furthermore,

somecommentersstatedthatthestringentprotectionsforconscienceestablished

bythestatutesimplementedbythisruleareintensionwithStatenondiscrimination

laws,Statepharmaceuticaldispensinglaws,andStateimmunizationlawsthatoffer

employersgreaterleewayinhandlingsituationsinwhichanemployeeassertsa

conscientiousobjection.355Asstatedelsewhereinresponsetosimilarcomments,

theDepartmentdisagreeswiththesearguments.Asdescribedaboveandfurtherin

therule’sFederalismanalysis,toeliminateorreduceanytensionbetweenthisrule’s

applicationofFederalstatutesandStatelaw,thefinalrulenarrowsthescopeofthe

definitionsof“discrimination”and“referral”in§88.2.

TheDepartmentalsodisagreesthatmaintainingthestatusquoispreferable

tothisrule.DeferencetoStateswouldperpetuatethecurrentcircumstances

necessitatingFederalregulation,whichinclude(1)inadequatetonon‐existent

FederalgovernmentframeworkstoenforceFederalconscienceandanti‐

discriminationlawsand(2)inadequateinformationandunderstandingaboutthe

obligationsofregulatedpersonsandentitiesandtherightsofpersons,entities,and

healthcareentitiesundertheFederalconscienceandanti‐discriminationlaws.State

355Thesecommentsparalleledtheconcerns,describedsupraatpartIII.B,raisedbycommenterswhoarguedthatthisruleconflictswithotherFederalstatuteslikeTitleVIIoftheCivilRightsActof1964.


358

actioncannotcorrectthesedeficienciesattheFederallevel.Furthermore,the

Departmentcouldnot,ingoodfaith,choosetorelyonStatestopromoteconscience

protectionpolicies,knowingthatsomeStateshaveadoptedlawsthatare

inconsistentwith,orhaveotherwiseexpressedindifferencetowards,therights

protectedbythelawsthatpart88(aswritteninthe2011Rule)implements—the

Weldon,Church,andCoats‐SnoweAmendments.356

Additionally,asnotedmoreextensivelyinthepreamble’ssummaryof

regulatoryhistory,supraatpartI,manycommentershavepointedoutthemutually

reinforcinginadequatecircumstancesofthestatusquocontributetothecritical

needforthisfinalrule,includingaconspicuouslyminimalisticregulatoryscheme

(comparedtoregulationsimplementingothercivilrightslawsOCRenforces);alack

ofrecognitionbycourtsofaprivaterightofactionundercertainFederalconscience

andanti‐discriminationlaws;357andhostilitytoconscienceprotectionsinsome

portionofthepopulationandincertainStateandlocalgovernments.Maintaining

thestatusquoleavesagapwhereHHShasaresponsibilitytocoordinatecompliance

with,andenforcementof,Federalconscienceprotectionandanti‐discrimination

lawsbutdoesnothavetheregulatoryschemetoaccomplishthatgoal.The

Departmentconsequentlypromulgatesthisfinalruletoeliminatethatgap.

TheDepartmentconsideredmaintainingthestatusquo,butdramatically

increasingitsoutreach.Numerouscommentersassertedthestrongneedfor

356SeesupraatpartII.A(discussinglawsandpoliciesthatsomeStateshaveadopted).357See,e.g.,Cenzon‐DeCarlov.MountSinaiHospital,626F.3d695(2dCir.2010);Hellwegev.TampaFamilyHealthCenters,103F.Supp.3d1303(M.D.Fla.2015);NationalInstituteofFamilyandLifeAdvocates,etal.v.Rauner,No.3:16‐cv‐50310,at4(N.D.Ill.July19,2017).


359

outreachtocombatbiasandanimusinthehealthcaresectoragainstindividuals

withreligiousbeliefsormoralconvictions,toraiseawarenessoftheconscience

rightsofindividuals,entities,andhealthcareentities,andtoclarifythelegal

obligationsofregulatedpersonsandentities.Commenterssuggestedarangeof

ideas,includingthattheDepartmentpublisheducationalmaterialsforacademic

medicalinstitutionstoeducatestudentsabouttheirprotectedconsciencerightsand

theobligationofregulatedentitiestocomplywithFederalconscienceandanti‐

discriminationlaws;thatHHSpartnerwithStateinstitutionsregulatinghealth

professions;andthatHHScreateanadvisoryteamwithdiversememberstodevelop

aplanforextensiveoutreachtocombatignoranceaboutFederalconscienceand

anti‐discriminationlaws.

TheDepartmentremainscommittedtorobustoutreach.Outreachhas

tremendousbenefitstoclarifylegalobligations,raiseawarenessofOCR,andelevate

awarenessoftheimportanceofconscienceprotectionsgenerally.TheDepartment,

however,agreeswithonecommenterwhonotedthat,althoughoutreachis

important,itisinsufficientwithoutanenforceableruletoupholdthesubstantive

protectionsunderFederallaw.Aswitheveryothercivilrightslaw,outreachwithout

adequateenforcementmechanismsisnotenoughtoensureappropriatecompliance.

TheDepartmentconsideredaregulatoryschemethatwasmoreprescriptive

thanthisrulebyrequiringallrecipientsandsub‐recipientstoestablishpoliciesand

proceduresforaccommodatingworkforcememberswhoobjectedtocertain

servicesbasedonmoralconvictionsorreligiousbeliefs;toaddresscertain


360

substantiveelementsintheirpoliciesandprocedures;andtorequirethe

disseminationofinformationtoworkforcemembersaboutFederalconscienceand

anti‐discriminationlaws,thisrule,ortherecipient’sandsub‐recipient’spoliciesand

procedures.Theburdenunderthisoptionacross502,899entities(themid‐pointof

therangeshowninsupraatTable2)isthelaborofalawyer’stime(3hours)andan

executive’stime(1hour).Usingthemeanhourlywagesfortheseoccupations

adjustedupwardforbenefitsandoverhead,theannualaverageburdenwouldbe

$297million.358

TheDepartmentrejectedthisalternative,butestimatessupraatpartIV.C.3.ii

thatfivepercentofentitiesinyearoneand0.5percentofentitiesannuallyinyears

twothroughfivewouldvoluntarilyupdatepoliciesandproceduresordisseminate

themtostaffasaby‐productofassuringandcertifyingcompliancewithFederal

conscienceandanti‐discriminationlawsandthisrule.

Asdiscussedabove,theDepartmentconsideredrequiringrecipientstopost

noticesofnondiscriminationinvariousphysicallocationsandonline,buthas

chosentomakethenoticeprovisionsvoluntary,inparttoreduceburden.Thefinal

ruleallowsrecipientsandsub‐recipientsflexibilitytodecidewhatmeasureswill

bestensurecompliancewithFederalconscienceandanti‐discriminationlawsand

thisrule,whileprovidingforvigorousenforcementincasesofviolation.Recipients

andsub‐recipientsarebetterpositionedtodecidewhetherorganization‐wide

actionisnecessary,andifso,whatextent,content,andmannerofthatactionis

358Productofweightedmeanhourlywageof$147.60perhourx4hoursx502,899entities.


361

appropriatetoensurecompliance.Thisapproachallowsrecipientsandsub‐

recipientstotailorappropriateorganization‐wideactionbasedontheirtype,the

populationstheyserve,theirsize,thescopeoftheirworkforcememberslikelyto

exerciseprotectedrightsundertheFederalconscienceandanti‐discriminationlaws

andthisrule,andotherrelevantconsiderations.Thisrule,therefore,permits

recipientemployerstoestablishtheirownpoliciesandproceduresforhowtheywill

handleindividuals’objectionstocertainprocedures,suchasabortion,sterilization,

orassistedsuicide,andrecognizestheavailabilityofappropriateaccommodation

procedures.Inaddition,thisrulepermitsrecipientemployerswhodohave

institution‐wideobjectionstoperformingcertainprocedures,suchassterilization,

butthatdonotobjecttoreferringforsuchprocedures,toestablishreferralsystems

withnearbyinstitutionsthatdonothaveobjectionstosuchprocedurestofacilitate

thedeliveryoftheservicesorprograms.

D. ExecutiveOrder13771

ExecutiveOrder13771(January30,2017)requiresthatthecostsassociated

withsignificantnewregulations“totheextentpermittedbylaw,beoffsetbythe

eliminationofexistingcostsassociatedwithatleasttwopriorregulations.”The

Departmentbelievesthatthisfinalruleisasignificantregulatoryactionasdefined

bysection3(f)ofExecutiveOrder12866.Thisruleisalsoconsideredaregulatory

actionunderExecutiveOrder13771.Excludinganynegativeexternalitiesattributed

tothisruleintheformofhealthoutcomesorothereffectsnotcompensatedby

positivehealthorotherexternalitiesfromprotectingconsciencerights,the


362

Departmentestimatesthatthisrulewillgenerate$148.2millioninannualizedcosts

ata7percentdiscountrate,discountedrelativetoyear2016,overaperpetualtime

horizon.

OnecommenterarguedthatthefinalruleviolatesExecutiveOrder13771

becauseitimposescostsbutdoesnotidentifywhatotherburdensimposedbyother

regulationsarebeingeliminated.Althougheachagencymustidentifyoffsetting

deregulatoryactionsforeachnewregulatoryburden,OMBdoesnotinterpret

ExecutiveOrder13771torequireeachregulationthatimposescoststocitethe

particularderegulatoryactionsthatoffsetthatparticularburden.359

E. RegulatoryFlexibilityAct

HHShasexaminedtheeconomicimplicationsofthisfinalruleasrequiredby

theRegulatoryFlexibilityAct(RFA)(5U.S.C.601‐612).TheRFArequiresanagency

todescribetheimpactofarulemakingonsmallentitiesbyprovidinganinitial

regulatoryflexibilityanalysisunlesstheagencyexpectsthattherulewillnothavea

significantimpactonasubstantialnumberofsmallentities,providesafactualbasis

forthisdetermination,andtocertifythestatement.5U.S.C.603(a),605(b).Ifan

agencymustprovideaninitialregulatoryflexibilityanalysis,thisanalysismust

addresstheconsiderationofregulatoryoptionsthatwouldlessentheeconomic

effectoftheruleonsmallentities.ForpurposesoftheRFA,smallentitiesinclude

359OfficeofManagement&Budget,GuidanceImplementingExecutiveOrder13771,TitledReducingRegulationandControllingRegulatoryCosts,at16(Apr.5,2017),https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M‐17‐21‐OMB.pdf(statingintheanswertoquestion37that“[w]hileeachFederalRegisternoticeshouldidentifywhethertheregulationisanEO13771regulatoryaction,thereisnoneedtodiscussspecificoffsettingEO13771deregulatoryactionswithinthesameFederalRegisterentry.”).


363

smallbusinesses,nonprofitorganizations,andsmallgovernmentaljurisdictions.

HHSconsidersaruletohaveasignificantimpactonasubstantialnumberofsmall

entitiesifithasatleastathreepercentimpactofrevenueonatleastfivepercentof

smallentities.

Basedonitsexamination,theDepartmenthasconcludedthatthisruledoes

nothaveasignificanteconomicimpactonasubstantialnumberofsmallentities.

Theentitiesthatwouldbeaffectedbythisfinalrule,inindustriesdescribedindetail

intheRIA,areconsideredsmallbyvirtueofeithernonprofitstatusorhaving

revenuesoflessthanbetween$7.5millionand$38.5millioninaverageannual

revenue,withthethresholdvaryingbyindustry.360PersonsandStatesarenot

includedinthedefinitionofasmallentity.TheDepartmentassumesthatmostofthe

entitiesaffectedmeetthethresholdofasmallentity.

Althoughthisfinalrulewillapplytoand,thus,affectsmallentities,thisrule’s

per‐entityeffectsarerelativelysmall.TheDepartmentestimatesthatthisrule

wouldimposeanaveragecostof$778perentityinthefirstyearofcompliance361

andabout$325.30peryearinyearstwothroughfive.362Furthermore,thesecosts

wouldgenerallybeproportionaltothesizeofanentity,sothatthesmallestaffected

entitieswillfaceloweraveragecosts.Giventhethresholdsdiscussedinthe

360U.S.SmallBusinessAdministration,TableofSmallBusinessSizeStandardsMarchedtoNorthAmericanIndustryClassificationSystemCodes(Oct.1,2017),https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf(identifyingthesizestandardsbyNAICScodeforthehealthcareandsocialserviceindustries).361Resultof$391.5millioninfirstyearcoststonon‐HHSentitiesdividedby502,899entities.362Resultof$163.6millionannuallytonon‐HHSentitiesinyearstwothroughfivedividedby502,899entities.


364

precedingparagraphs,theaveragecostsarebelowthoserequiredtohavea

significantimpactonasubstantialnumberofsmallentities,withinthemeaningof

theRFA.

Furthermore,theruleattemptstominimizecostsimposedonsmallentities.

Forexample,theassuranceandcertificationrequirementsin§88.4contain

exceptionstorelievemanysmallentitiesoftherequirementtosubmitanassurance

andcertification.Approximately70percentofrecipientsareexemptedfromthe

assuranceandcertificationrequirement,assumingthatthoseexempteddonot

receiveHHSfundingthroughanon‐exemptprogram.363Giventhemagnitudeand

typeofentitiesgrantedtheexception,§88.4shouldnotbeunderstoodasunduly

burdeningsmallentitiessubjecttotherule.

TheDepartmenthasfurthercommittedtoleveragingexistinggrant,contract,

andotherDepartmentalformswherepossibletoimplement§88.4,ratherthan

createadditional,separateformsforrecipientstosign.Similarly,§88.5nolonger

requiresrecipientstoprovidenoticesofconsciencerights,butincentivizes

recipientstovoluntarilyprovidesuchnotices.Inlightofthisdetermination,the

Secretarycertifiesthatthisrulewillnotresultinasignificantimpactona

substantialnumberofsmallentities.

F. UnfundedMandatesReformAct

363Theaveragebetweenthelower‐bound(267,134)andupper‐bound(415,666)ofrecipientsexemptedis341,400recipients,whichrepresents68percentoftheestimatedtotal500,290recipientsoftherule(excludingtheestimated2,609countiesthatforthepurposeofthisruleareestimatedtobesub‐recipients).


365

TheDepartmentsimilarlyconcludesthattherequirementsoftheUnfunded

MandatesReformActof1995arenottriggeredbythisfinalrule.Section202(a)of

thatActrequirestheDepartmenttoprepareawrittenstatement,includingan

assessmentofanticipatedcostsandbenefits,beforeissuing“anyrulethatincludes

anyFederalmandatethatmayresultintheexpenditurebyState,local,andtribal

governments,intheaggregate,orbytheprivatesector,of$100,000,000ormore

(adjustedannuallyforinflation)inanyoneyear.”Thecurrentthresholdafter

adjustmentforinflationis$150million,usingthemostcurrent(2016)ImplicitPrice

DeflatorfortheGrossDomesticProduct.AsdiscussedinthisRIA,thisrulewillnot

resultinanexpenditureinanyyearthatmeetsorexceedsthatamountwithregard

toState,local,ortribalgovernments,butwillexceedthatamountwithregardtothe

privatesector.Anin‐depthanalysisoftherulewithrespecttoStateandlocal

governmentsspecificallyappearsinthefollowingsectionofthisRIAregarding

ExecutiveOrder13132(Federalism).

G. ExecutiveOrder13132—Federalism;ExecutiveOrder13175—

ImpactonTribalEntities

Federalism

TheSecretaryhasdeterminedthatthisfinalrulecomportswithExecutive

Order13132.364ExecutiveOrder13132aimsto“guaranteethedivisionof

governmentalresponsibilitiesbetweenthenationalgovernmentandtheStatesthat

wasintendedbytheFramersoftheConstitution...[and]ensurethattheprinciples

364E.O.13132,64FR43255(Aug.4,1999).


366

offederalism...guidetheexecutivedepartmentsandagenciesintheformulation

andimplementationofpolicies.”365SomeoftheFederallawsthatthisrule

implementsandenforces,suchastheWeldonandCoats‐SnoweAmendments,

directlyregulateStatesandlocalgovernmentsthatreceiveFederalfundingby

conditioningthereceiptofsuchfundingonthegovernments’commitmentsto

refrainfromdiscriminationoncertainbasesorbyimposingcertainrequirements

onStatesandlocalgovernmentsthatreceiveFederalfunding.Thisimpact,however,

isaresultofthestatutoryprohibitionsandrequirementsthemselves,andarenot

duetothemechanismsprovidedbythisrule.

UndertheSupremacyandSpendingClausesoftheConstitution,Statesand

theirpoliticalsubdivisionsaresubjecttoActsofCongress,366andFederal

conscienceandanti‐discriminationlawsarenoexception.ThisruleholdsStatesand

localgovernmentsaccountableforcompliancewiththeselawsbysettingforth

mechanismsforOCRinvestigationandHHSenforcementrelatedtothose

requirements.Theruledoesnotchangethesubstantiveconscienceprotectionsor

anti‐discriminationrequirementsofthesestatutes.

TheDepartmentreceivedcommentsarguingthattheenforcementofthis

rulethrough§88.7couldinfringeonStatesovereignty,inviolationofthelimitsof

theSpendingClausepoweraffordedbytheU.S.ConstitutiontoCongress.The

FederalgovernmentpresumestheconstitutionalityofstatutesthatCongressenacts.

CongresshasexercisedthebroadauthorityaffordedtoitundertheSpendingClause

365Id.366Id.section2(d).


367

toattachclearconditionsonFederalfundstosecureconscienceprotectionand

associatedanti‐discriminationrights.IncasesofviolationoftheFederalconscience

andanti‐discriminationlaws,theDepartmentintendstointerpretandapplythe

remediesthat§88.7setsforthinamannerconsistentwiththeparticularFederal

law(s)atissueandtheU.S.Constitution,and,asdiscussedinresponsetoearlier

comments,willcomplywithrelevantSupremeCourtprecedentsconcerning

federalism.367

Somecommentersarguedthattheruleimplicatestherequirementsof

ExecutiveOrder13132andunconstitutionallyimpedestheabilityofStatesto

exercisepowerinareastraditionallyreservedtothem,suchashealth,safety,and

welfare.CommentersalsoraisedconcernsthattherulemayinhibitStatesfrom

implementingtheirownconscienceprotections.TheDepartmentdisagreeswith

theseconcerns.TheDepartmentpromulgatesthisruleunderlongstandingFederal

lawsthatleaveampleroomforStateactivity.Statesarefreetoenacttheirown

conscienceprotectionandanti‐discriminationlawsthatconsidertheirown

respectiveneeds,populations,andprerogatives.Indeed,allfiftyStateshavesome

protectionsinplaceforconscientiousobjectorstocertainhealthormedicalservices

andseveralprovisionsofthisruleexplicitlyapplytoreinforceandrespectstate

conscienceprotections.368Statesarefreetoexperimentwithvariousapproachesto

promoterespectof,andtolerancefor,theexerciseofconsciencerights,andthisfinal

367SeesupraatpartIII.B(section‐by‐sectionanalysisfor§88.7)andpartI.B(thisregulation’shistory)forfurtherdiscussionofthismatter.368SeeKevinTheriot&KenConnelly,FreetoDoNoHarm:ConscienceProtectionsforHealthcareProfessionals,49Ariz.St.L.J.549,575‐76,587‐600(2017)(summarizingStatelaws).


368

rulerespectsthatprerogative.StatesarealsofreetorejectFederalfundingifthey

objecttoconditionsrequiredbyanyofthelawsthatarethesubjectofthisrule.

Section88.8oftherulemakesclearthattheruleisnotintendedtointerfere

withtheoperationofStatelaw.ForStatelawsequallyormoreprotectiveof

religiousfreedomandmoralconvictionsthanthisrule,§88.8ofthisrulestatesthat

nothingintherule“shallbeconstruedtopreempt”suchStateorlocallaw.Section

88.8alsodeclaresthatnothingintherule“shallbeconstruedtonarrowthe

meaningorapplicationofanyState...lawprotectingfreeexerciseofreligious

beliefsormoralconvictions.”

Somestatuesthattheruleimplements,suchas42U.S.C.1396s(c)(2)(B)(ii),

requireproviderstocomply“withapplicableStatelaw,includinganylawrelatingto

anyreligiousorotherexemption”asaconditionofparticipationintheprogramthat

thestatuteauthorizes(inthisexample,theFederalpediatricvaccineprogram).

Otherlawsthatthisruleimplements,suchas42U.S.C.280g‐1(d),clarifythat

Federalassistancefornewbornandinfanthearingscreeningprogramsdonot

preemptorprohibitanyStatelawprotectionsforparentstoassertreligious

objectionstosuchscreenings.Similarly,42U.S.C.1396fclarifiesthatnothing

requiresaStatetocompelapersontoundergomedicalscreenings,examination,

diagnosis,treatment,healthcareorservicesifapersonobjectsonreligiousgrounds,

withlimitedexceptions.

Thisrule’srequirementsandprohibitionsdonotimposesubstantialdirect

effectsonStatesandtheirpoliticalsubdivisions,modifytherelationshipbetween


369

theFederalgovernmentandtheStates,oralterthedistributionofpowerand

responsibilitiesamongthevariouslevelsofgovernment.369

Somecommentersarguedthatthisrule,orthestatutesthattherule

implements,conflictwithStateandlocallawsregardingstudentandhealthprovider

immunizations,mandatedprovisionofabortioncoverage,employerprotections,

counselingrelatedtoassistedsuicide,oremployersbeingabletoaccommodate

objectorswithalternativearrangements.Thesecommentsparalleledtheconcerns

alreadyaddressedabove.Inshort,theDepartmentfinalizestheruletorecognize

formsofaccommodationandtoeliminateorreducesuchtensionbetween

applicablestatutesorbetweenthisfinalruleandStatelaws.Accordingly,thefinal

rulenarrowsthescopeofthedefinitionsof“discrimination”and“referral”in§88.2.

Theimpactof§88.4isminimalintermsoftheaddedlaborcostsforState

andlocalgovernmentstafftoassureandcertifycompliance.370Additionally,therule

reliesonenforcementmechanismsalreadyavailabletoHHSforgrantsandother

formsoffinancialassistance.

Inlightoftheabove,therulecannotbeproperlyunderstoodtoimpose

substantialdirecteffectsonStatesortheirpoliticalsubdivisions,theirrelationship

withtheFederalgovernment,orthedistributionofpoweramongthevariouslevels

ofgovernment.

369E.O.13132,section1(a).ExecutiveOrder13132requiresanagencytomeetcertainrequirementswhenitpromulgatesarulewith“policiesthathavefederalismimplications.”Id.sections2‐3,6(b)‐(c)(identifyingfederalismprinciples,policymakingcriteria,andconsultationrequirements).370SeesupraatpartIV.C.2.viofthisRIAestimatingtherule’sburden.


370

Onecommentnotedthatit“doesnotthreatenprinciplesoffederalism[to]

requir[e]respectforconstitutionally‐protectedconsciencerightsasaconditionof

receivingfederalfunds.”TheDepartmentagrees.TheDepartmenthasnotidentified

anyFederallawsorjurisprudencethatindicatesthatmerelyimplementingand

enforcingFederallawsaswrittenviolatesconstitutionalprinciplesoffederalism.

ImpactonTribalEntities

OnecommentstatedthattheDepartmentwouldberequiredtoengagein

tribalconsultationregardingtheruleasrequiredunderExecutiveOrder13175.

However,becausethefinalruleremovestherequirementintheproposed§

88.3(p)(1)(iii)thatcertainfederallyrecognizedIndiantribesortribalorganizations

andurbanIndianorganizationscomplywithsections88.4and88.6oftherule,the

Departmentbelievesthattheruledoesnothavetribalimplicationsasdefinedin

ExecutiveOrder13175,andthattribalconsultationregardingtherulewas,

therefore,notnecessary.

H. CongressionalReviewAct

TheCongressionalReviewActdefinesa“majorrule”as“anyrulethatthe

AdministratoroftheOfficeofInformationandRegulatoryAffairs(OIRA)ofthe

OfficeofManagementandBudgetfindshasresultedinorislikelytoresultin—(A)

anannualeffectontheeconomyof$100,000,000ormore;(B)amajorincreasein

costsorpricesforconsumers,individualindustries,Federal,State,orlocal

governmentagencies,orgeographicregions;or(C)significantadverseeffectson

competition,employment,investment,productivity,innovation,orontheabilityof


371

UnitedStates‐basedenterprisestocompetewithforeign‐basedenterprisesin

domesticandexportmarkets.”5U.S.C.804(2).Basedontheanalysisofthisfinal

ruleunderExecutiveOrder12866,theOfficeofManagementandBudgethas

determinedthatthisruleisamajorruleforpurposesoftheCongressionalReview

Act.

I. AssessmentofFederalRegulationandPoliciesonFamilies

Intheproposedrule,theDepartmentincludedadiscussionofsection654of

theTreasuryandGeneralGovernmentAppropriationsActof1999,Pub.L.105‐277,

section654,112Stat.2681(1998)asamendedbyPub.L.108‐271,section 654,118

Stat.814(2004),whichrequiredFederaldepartmentsandagenciestodetermine

whetherapolicyorregulationcouldaffectfamilywell‐being.Theseprovisionsare

codifiedasa“note”to5U.S.C.601.BecauseCongressdidnotrenewthese

requirementsinthemostrecentappropriationsactapplicabletotheDepartment,371

theDepartmentbelievesitisnotobligatedtoconductananalysisofpotential

impactonfamilywell‐beingbeforefinalizingregulations.Additionally,OMBCircular

A‐4doesnotrequiresuchananalysis.Nevertheless,outofanabundanceofcaution,

theDepartmentconductssuchananalysisbelow.

Section601(note)of5U.S.C.requiredagenciestoassesswhethera

regulatoryaction(1)impactsthestabilityorsafetyofthefamily,particularlyin

termsofmaritalcommitment;(2)impactstheauthorityofparentsintheeducation,

nurture,andsupervisionoftheirchildren;(3)helpsthefamilyperformits

371DepartmentofDefenseandLabor,HealthandHumanServices,andEducationAppropriationsAct,2019andContinuingAppropriationsAct,2019,Pub.L.No.115‐245,132Stat.2981(2018).


372

functions;(4)affectsdisposableincomeorpovertyoffamiliesandchildren;(5)if

theregulatoryactionwhichfinanciallyimpactsfamilies,isjustified;(6)maybe

carriedoutbyStateorlocalgovernmentorbythefamily;and(7)establishesa

policyconcerningtherelationshipbetweenthebehaviorandpersonalresponsibility

ofyouthandthenormsofsociety.

TheDepartmentreceivedcommentsstatingthatitdidnotadequatelyassess

theimpactonfamiliesintheproposedruleandreachedanincorrectconclusionin

determiningthatitisunlikelythatthisrulewillnegativelyimpactfactors(1)‐(4),

withrespecttothestabilityofthefamily,parentalauthority,orthedisposable

incomeorpovertyoffamiliesandchildren.Othercommentsreferencedconcerns

abouthowdelaysorrefusalsintreatmentorinthetransmissionofinformation

couldaffectfactor(5):theemotionalandfinancialwell‐beingoffamilies.The

Departmentdidnotreceivecommentsaddressingfactors(6)or(7).Inresponseto

thesecomments,theDepartmentnotesthattheseconcernsdonotconstitutean

impactonthewell‐beingofthefamilywithinthemeaningof5U.S.C.601(note)and

that,inanyevent,theobjectionsaretotheunderlyingstatutesthatarethesubject

oftherule,notthemechanismsprovidedbytheruleitself.Withregardtofactor(5),

theprospectofapersonlosingtheirjob,thusaffectingtheemotionalandfinancial

well‐beingoftheirfamily,isgreaterifconsciencelawsarenotenforcedaspeopleof

faithandmoralconvictionriskbeingdrivenoutofthehealthcarefieldasdiscussed

above.Furtherdiscussionontheimpactofthisruleonpatientsandindividualscan

befoundinpartIV.C.4(EstimatedBenefits).


373

AstheDepartmentnotedintheproposedrule,theactiontakeninthisrule

cannotbecarriedoutbyStateorlocalgovernmentsorbythefamilyontheirown

(factor(6))becausetherulepertainstoenforcementofcertainFederallaws.

Additionally,byprotectingparents’abilitytoassertconsciencerightsonbehalfof

theirchildren,theruleclearlyenhancesparentalauthorityunderfactor(2).Noneof

therule’sprovisionsimpactfactors(1),(3)‐(5),or(7)tothedegreecontemplated

by5U.S.C.601(note).Accordingly,thisrulewillnotnegativelyaffectfamilywell‐

beingwithinthemeaningof5U.S.C.601(note)intheeventsuchprovisionsapply.

J. PaperworkReductionAct

ThisfinalrulerequiresnewcollectionsofinformationunderthePaperwork

ReductionActof1995(44U.S.C.3501‐3520).CongressenactedthePaperwork

ReductionActof1995to“maximizethepracticalutilityandpublicbenefitofthe

informationcreated,collected,disclosed,maintained,used,sharedand

disseminatedbyorfortheFederalgovernment”andtominimizetheburdenofthis

collection.44U.S.C.3501(2).Asdefinedin5CFR1320.3(c),“collectionof

information”comprisesreporting,record‐keeping,monitoring,posting,labeling,

andothersimilaractions.TheDepartmentsoughtcommentsregardingtheburden

estimatesandtheinformationcollectionsgenerally.Somecommentsarediscussed

supraatpartIV.C.3.ii‐viandothersdiscussedinthefollowingsections.The

collectionsofinformationrequiredbythisfinalrulerelateto§88.4(Assuranceand

Certification),§88.5(VoluntaryPostingofNoticeofRights),and§88.6(d)

(ComplianceRequirements).


374

1. InformationCollectionfor§88.4(AssuranceandCertification)

(i) SummaryoftheCollectionofInformation

Thisfinalrulerequireseachrecipient(orapplicanttobecomearecipient),

withlimitedexceptions,toassureandcertifycompliancewithFederalconscience

andanti‐discriminationlaws.Specifically,§88.4(a)(1)‐(2)requireseachrecipientor

applicanttoincludeinitsapplicationforFederalfunds,oraccompanyitsapplication

with,anassuranceandacertificationthatitwilloperateapplicableprojectsor

programsincompliancewithapplicableFederalconscienceandanti‐discrimination

lawsandthisrule.

OperationalizingtheAssuranceofComplianceRequirement

Tooperationalizetherequirementin§88.4(a)(1)forarecipientorapplicant

tosignanassuranceofcompliance,theDepartmentisseekingclearanceunderthe

PRAtoupdatetheHHS‐690form,whichisentitled“AssuranceofCompliance”372

andisdescribedinthesection‐by‐sectionanalysisofthepreamblefor§88.4.The

newlanguagethattheDepartmentisaddingtotheHHS‐690formidentifiesthe

majorFederalconscienceandanti‐discriminationlawsbytheirpopulartitlesand

theirU.S.Codeprovisions(ifcodified)anddirectsthereadertoOCR’sConscience

andReligiousFreedomwebpageforafulllistingofthelaws.

OperationalizingtheCertificationofComplianceRequirement

InresponsetopubliccommentsthatencouragedtheDepartmenttouse

existingforms,theDepartmentexploredoperationalizingthecertificationof

372U.S.Dep’tofHealth&HumanServs.,AssuranceofCompliance,HHS690,https://www.hhs.gov/sites/default/files/hhs‐690.pdf.


375

compliancerequirementin§88.4(a)(2)byupdatingtheHHSform5161‐1,butthis

formisonlyusedbytwoHHScomponentsratherthanbyallormostHHSoperating

orstaffdivisions.TheDepartmentalsoexploredupdatingtheAssurancesforNon‐

ConstructionPrograms(SF‐424B),which,despiteitsname,enablestheauthorized

representativeoftheapplicanttocertifyuptonineteenparagraphsofagencyand

program‐specificlawsandregulations,suchashousing,environmental,andlabor

lawsandregulations.373PursuanttoanOMBdirective,“[e]ffectiveJanuary1,2019,

theSF‐424Bwillbecomeoptionalandagenciesshallmakeplanstophaseoutusein

FundingOpportunityAnnouncements.”374Giventhisdirective,theDepartmentdid

notfurtherexploreupdatingtheSF‐424B.

TheDepartmentisseekingPRAclearancetooperationalizethecertification

ofcompliancerequirementduringcalendaryear2019throughtheexisting

signatureblockofthegovernment‐wideApplicationforFederalAssistance(SF‐

424)375or,forresearchorrelatedgrants,throughtheApplicationforFederal

AssistanceforResearchandRelated(R&R)Series(SF‐424R&R)376.Thesignature

blockforbothapplicationscontainsthefollowingstatement:

Bysigningthisapplication,Icertify(1)tothestatementscontainedinthelistofcertifications**and(2)thatthestatementshereinaretrue,

373AssurancesforNon‐ConstructionPrograms,SF‐424B,(OMB#4040‐0007)https://apply07.grants.gov/apply/forms/sample/SF424B‐V1.1.pdf(lastvisitedApr.11,2019).374Exec.OfficeofthePresident,MemorandumfromMickMulvaney,Dir.,OfficeofManagement&BudgettoHeadsofExecutiveDepartmentsandAgencies,StrategiestoReduceGrantRecipientReportingBurden,at2(Sept.5,2018),https://www.whitehouse.gov/wp‐content/uploads/2018/09/M‐18‐24.pdf.375ApplicationforFinancialAssistance,SF‐424,(OMB#4040‐0004),https://apply07.grants.gov/apply/forms/sample/SF424_2_1‐V2.1.pdf(lastvisitedApr.11,2019).376ApplicationforFinancialAssistance,SF‐424(R&R),(OMB#4040‐0001),https://apply07.grants.gov/apply/forms/sample/RR_SF424_2_0‐V2.0.pdf(lastvisitedApr.11,2019).


376

completeandaccuratetothebestofmyknowledge.Ialsoprovidetherequiredassurances**andagreetocomplywithanyresultingtermsifIacceptanaward.Iamawarethatanyfalse, fictitious,or fraudulentstatements or claims may subject me to criminal, civil, oradministrativepenalties.(U.S.Code,Title18,Section1001).**Thelistofcertificationsandassurances,oranInternetsitewhereyoumay obtain this list, is contained in the announcement or agencyspecificinstructions.Incalendaryear2020andtheoutyears,theDepartmentisseekingPRA

clearancetooperationalizethecertificationofcompliancerequirementthroughthe

government‐wideSystemforAwardManagement(SAM)377becausethissystem,

pursuanttoanOMBdirective,“willbecomethecentralrepositoryforcommon

government‐widecertificationsandrepresentationsrequiredofFederalgrants

recipients.”378ThecertificationsandrepresentationsthroughSAMreplacethe

government‐wideassurancescontainedintheAssurancesforNon‐Construction

Programs(SF‐424B).379

InsubmittingthegeneralcertificationsandrepresentationsthroughSAM,380

theauthorizedrepresentativecertifiestoseveralstatements,twoofwhichthe

377U.S.Gen.Servs.Admin.,SystemforAwardManagement,Home,https://www.sam.gov/SAM/pages/public/index.jsf(lastvisitedApr.11,2019).378Exec.OfficeofthePresident,MemorandumfromMickMulvaney,Dir.,OfficeofManagement&BudgettoHeadsofExecutiveDepartmentsandAgencies,StrategiestoReduceGrantRecipientReportingBurden,at2(Sept.5,2018),https://www.whitehouse.gov/wp‐content/uploads/2018/09/M‐18‐24.pdf.379Seeid.(“[R]egistrationinSAMisrequiredforeligibilityforaFederalawardandregistrationmustbeupdatedannually....FederalagencieswilluseSAMinformationtocomplywithawardrequirementsandavoidincreasedburdenandcostsofseparaterequestsforsuchinformation,unlesstherecipientfailstomeetaFederalawardrequirement,orthereisaneedtomakeupdatestotheirSAMregistrationforotherpurposes.”).380U.S.Gen.Servs.Admin.,SystemforAwardManagement,SAMReleaseNotesBuild2019‐02‐01,at3(Feb.2,2019),https://www.sam.gov/SAM/transcript/SAM_Release_Notes_2019_02_01.pdf(describingunder“enhancements”thatSAMhas“anewgovernment‐wideFinancialAssistanceRepresentationsandCertificationsmodulewithintheSAMentitymanagementregistration”and


377

Departmentinterpretsasoperationalizing§88.4(b).381First,theauthorized

representativecertifiesthatit“[w]illcomplywithU.S.statutoryandpublicpolicy

requirementswhichprohibitdiscrimination,includingbutnotlimitedto[]”certain

Federalcivilrightsstatutes.382TheFederalconscienceandanti‐discriminationlaws

arenotlistedbecausethegeneralcertificationsandrepresentationsidentifiedin

SAMaregovernment‐wide,ratherthanagencyormulti‐agencyspecific.However,

theDepartmentconstruesthenon‐exhaustivelistasincorporatingtheFederal

conscienceandanti‐discriminationlaws,asapplicable,thatthefinalrule

implements.

Anotherstatementconveysthattheauthorizedrepresentativecertifiesthat

it“[w]illcomplywithallapplicablerequirementsofallotherFederallaws,executive

orders,regulations,andpoliciesgovernmentfinancialassistanceawardsandany

financialassistanceprojectcoveredbythiscertificationdocument.”383The

Departmentconstruesthiscatch‐allstatementasincorporatingtheFederal

conscienceandanti‐discriminationlaws,asapplicable,andthefinalrule.

(ii) NeedforInformation

Requiringcertainrecipientsandapplicantstoassureandcertifycompliance

servestwopurposes.First,throughtheactofreadingandreviewingthestatutory

“[a]llnon‐federalregistrantsinSAMwillberequiredtocertifytothenewFinancialAssistanceReps&Certsaspartoftheirregistration”).381Thecertificationsandrepresentationsarenotpubliclyavailableuntilanindividualcreatesanaccount.ThelistofcertificationsandrepresentationswereobtainedfromstaffatGrants.govonMarch19,2019,andareonfilewithOCR.382FinancialAssistanceGeneralCertificationsandRepresentations,at2,para.9(onfilewithOCR).383FinancialAssistanceGeneralCertificationsandRepresentations,at1,para.7(onfilewithOCR).


378

requirementstowhichrecipientsorapplicantsassureandcertifycompliance,

recipientswouldbeapprisedoftheirobligationsundertheapplicableFederal

conscienceandanti‐discriminationlawsandthisrule.Second,arecipient’sor

applicant’sawarenessofitsobligationswouldincreasethelikelihoodthatitwould

complywithsuchlawsand,consequently,affordentitiesandindividualsprotection

oftheirconsciencerightsandprotectionfromcoercionordiscrimination.

Intheproposedrule,theDepartmentrequestedcommentonwhetherthe

collectionofinformationisnecessaryfortheproperperformanceofthe

Department’sfunctionstoenforceFederallawsonwhichFederalfundingis

conditioned.AtleastonecommenterencouragedtheDepartmenttoaddthe

assuranceandcertificationrequirementsin§88.4becauseofthe“surgein

harassmentandcoercionofmedicalprovidersoffaith.”Othercommentersstated

thatassuranceandcertificationwasunnecessarybecauserecipientsalreadymust

certifycompliancewithFederallawuponthereceiptofFederalfunds.

ThiscollectionofinformationfacilitatestheDepartment’sobligationto

ensurethattheFederalfinancialassistanceorotherFederalfundsthatthe

DepartmentawardsareusedinamannercompliantwithFederalconscienceand

anti‐discriminationlawsandthefinalrule.TheDepartment’sadministrationofa

requirementforanentityatthetimeofapplicationorreapplicationtoassureand

certifycompliancewithFederalconscienceandanti‐discriminationlawsandthe

finalruledemonstratesthatthepersonorentitywasawareofitsobligationsunder

thoselawsandtherule.


379

Inaddition,HHShastheauthoritytoplacetermsandconditionsconsistent

withthosestatutesinanyinstrumentHHSissuesortowhichitisaparty(e.g.,

grants,contractsorotherHHSinstruments).ADepartmentcomponentextendingan

awardmustcommunicateandincorporatestatutoryandpublicpolicyrequirements

andobligatetherecipienttocomplywithFederalstatuesand“publicpolicy

requirements,including...those...prohibitingdiscrimination.”384More

specifically,theDepartmentcomponent“mustcommunicate...allrelevantpublic

policyrequirements,includingthoseingeneralappropriationsprovisions,and

incorporatethemeitherdirectlyorbyreferenceinthetermsandconditionsofthe

Federalaward.”385TheDepartmentalcomponentmayrequirearecipient“tosubmit

certificationsandrepresentationsrequiredbyFederalstatutes,orregulations...

.”386

(iii) UseofInformation

TheDepartmentanditscomponentsawardingFederalfundsandOCRwill

usethesignedassuranceandcertificationasdocumentationof(1)arecipient’sor

applicant’sawarenessofitsobligationsundertheFederalconscienceandanti‐

discriminationlawsandthisrule,and(2)arecipient’sorapplicant’sbinding

agreementtoabidebysuchobligations.Thisusewouldmostlikelyoccurduringan

OCRinvestigationoftherecipient’scompliancewithFederalconscienceandanti‐

38445CFR75.300(a).385Id.386Id.section75.208.


380

discriminationlawsandthisrule,andaspartofanentity’srecordkeeping

obligationsunderthisrule.

(iv)DescriptionoftheRespondents

TherespondentsareapplicantsorrecipientsforFederalfinancialassistance

orFederalfundsfromtheDepartmentassetforthin§88.3,whichidentifiesthe

applicabilityofthisruleforeachoftheunderlyingstatutesthatwouldbe

implementedandenforced.Respondentsincludehospitals,researchinstitutions,

healthprofessionstrainingprograms,qualifiedhealthplanissuers,Health

InsuranceMarketplaces,homehealthagencies,communitymentalhealthcenters,

andskillednursingfacilities.

(v) NumberofRespondents

TheDepartmentestimatesthenumberofrespondentsat158,890personsor

entities,whichistheaveragebetweenthelow(122,558)andhigh(195,222)

estimatesofentitiesrequiredtosignanassuranceoracertification.Thesefigures

appearsupraatTable3,partIV.C.2.iv.A.Respondentsareasubsetoftherecipients

because§88.4(c)(1)through(4)excludescertaincategoriesofrecipients.Therule

excludesphysicians,asdefinedin42U.S.C.1395x(r),physicianoffices,otherhealth

carepractitionersorpharmacistswhoarerecipientsintheformofreimbursements

forservicesprovidedtobeneficiariesunderMedicarePartB.See§88.4(c)(1).The

rulealsoexemptsrecipientsofcertaingrantprogramsadministeredbythe

AdministrationforChildrenandFamiliesortheAdministrationforCommunity

Livingwhentheprogram’spurposeisunrelatedtohealthcareandcertaintypesof


381

research,doesnotinvolvehealthcareproviders,anddoesnotinvolveany

significantlikelihoodofreferralfortheprovisionofhealthcare.See§88.4(c)(2)and

(3).Finally,thisfinalruleexcludesIndianTribesandTribalOrganizationswhen

contractingwiththeIndianHealthServiceundertheIndianSelf‐Determinationand

EducationAssistanceAct.See§88.4(c)(4).

(vi)BurdenofResponse

ThePaperworkReductionActburdenistheopportunitycostofrecipient

stafftimetoreviewtheassuranceandcertificationlanguageaswellasthe

requirementsoftheunderlyingFederalconscienceandanti‐discriminationlaws

referencedorincorporated.ThemethodsthattheDepartmentusesareoutlined

supraatpartIV.C.3.ii,andthemeanhourlywageisadjusteddownwardtoexclude

benefitsandoverhead.

Thelaborcostisafunctionofalawyerspending3hoursreviewingthe

assuranceandcertificationandanexecutivespendingonehourtoreviewandsign,

as§88.4(b)(2)requiresasignaturebyanindividualauthorizedtobindthe

recipient.Theweightedmeanhourlywage(notincludingbenefitsandoverhead)of

thesetwooccupationsis$73.80perhour.387Thelaborcostis$46.9millioneach

year($73.80perhourx4hoursx158,890entities).388

387Sumof($67.25x.75)and($93.44x.25).388ThistotaldiffersfromtheburdenintheRIAbecauseafully‐loadedwagethatisadjustedupwardsforbenefitsandoverheadmustbeusedintheRIA.


382

TheDepartmentaskedforpubliccommentontheinformationcollection

under§88.4.SeveralspecificquestionsthattheDepartmentposedreceivedno

comments:

•WhethertheexceptionforIndianTribesandtribalOrganizationsin

proposed45CFR88.4(c)(vi)avoids“tribalimplications”anddoesnot“impose

substantialdirectcompliancecostsonIndianTribalgovernments”asstatedin

ExecutiveOrder13175,ConsultationandCoordinationwithIndianTribal

Governments,sec.5(b)(Nov.9,2000);

•WhetherassuringcompliancewiththeFederalconscienceprotectionand

associatedanti‐discriminationstatuteswouldconstituteaburdenexemptfromthe

PaperworkReductionActasausualandcustomarybusinesspracticeincurredby

recipientsduringtheordinarycourseofbusiness;

•Howthequality,utility,andclarityoftheinformationtobecollectedmay

beenhanced;and

•Howthemannerofcompliancewiththeassuranceandcertification

requirementscouldbeimproved,includingthroughuseofautomatedcollection

techniquesorotherformsofinformationtechnology.

TheDepartmentreceivedpubliccommentsexpressingconcernwiththe

possibleburdenonhealthcareprovidersresultingfrom§88.4,whichisdiscussed

supraatpartIV.C.3.ii.Inaddition,asexplainedinthesummaryofthisPaperwork

ReductionActanalysis,theDepartmentisleveragingexistinggrant,contract,and


383

otherDepartmentalformsandgovernment‐widesystems,consistentwithOMB’s

government‐wideefforttoreducerecipientburden.389

2. InformationCollectionfor§88.5(Notice)


Underthisruleasfinalized,§88.5doesnotmandatetheprovisionofnotice,

butratherincentivizesrecipientsandDepartmentcomponentstoprovidenotice

concerningFederalconscienceandanti‐discriminationlaws.Theruleintendsto

accomplishthisgoalbyconsideringarecipient’soraDepartmentcomponent’s

postingofthenoticeasnon‐dispositiveevidenceofcompliancewiththerulewhen

OCRinvestigatesorinitiatesacompliancereviewofarecipientorDepartment

component.Ifrecipientsvoluntarilyprovidenoticetoimplement§88.5,recipients

areencouragedtousethepre‐writtennoticeinAppendixA.Therecipientis

otherwisefreetodraftitsownnoticestailoredtoitsspecificcircumstancesand

applicablelawsundertherule.


TheDepartmentincentivizesrecipientsandDepartmentcomponentsto

providenoticeofrightsbecausenoticeservesthreeprimarypurposes.First,

individualsbecomeapprisedoftheirrightsunderapplicableFederalconscienceand

anti‐discriminationlaws,includingtherighttofileacomplaintwithHHSOCR.

Second,anindividual’sawarenessofhisorherrightsincreasesthelikelihoodthat

389Exec.OfficeofthePresident,MemorandumfromMickMulvaney,Dir.,OfficeofManagement&BudgettoHeadsofExecutiveDepartmentsandAgencies,StrategiestoReduceGrantRecipientReportingBurden,at2(Sept.5,2018),https://www.whitehouse.gov/wp‐content/uploads/2018/09/M‐18‐24.pdf.


384

theindividualwillexercisethoserights.Third,recipientsandtheirmanagersand

employeeswillbemorelikelytobereminded,andbemadeaware,oftheirown

obligationsundertheselaws.


Individuals,entities,andhealthcareentitieswillusetheinformationto

increasetheirawarenessoftheirrightsandfilecomplaintswithOCRiftheybelieve

theirrightshavebeenviolated.Entitiesrequiredtocomplywillhaveanincreased

likelihoodofunderstandingtheirobligationstothusactaccordinglytofulfillthem.

DuringOCRinvestigationorcompliancereviewofarecipient,OCRwillconsideras

non‐dispositiveevidenceofcompliancewhetherandhowtherecipientposteda

noticeaccordingto§88.5.

(iv) DescriptionoftheRespondents

Therespondentsarerecipientsasdefinedinthisruleat§88.2.Respondents

include,butarenotlimitedto,States,hospitals,researchinstitutions,andskilled

nursingfacilities.


Thenumberofrespondentsisestimatedat335,327recipientsatthe

establishment‐levelinyearoneand75percentofthatamountinyearstwothrough

five(i.e.,251,495establishments).Thisestimaterepresentstheaveragebetween

thelowerandupper‐boundestimatesofhowmanyrecipientestablishmentswill

voluntarilypostnoticesthroughoneofmoreofthemethodsin§88.5inyearsone


385

andannuallyinyearstwothroughfive.Asubsetofrespondents,about139,615

recipientsatthefirmlevel,willlikelymodifythepre‐writtennoticeinAppendixA.

(vi) BurdenofResponse

Eventhoughthenoticeprovisionofthefinalruleisentirelyvoluntary,the

DepartmentexpectsthatsomesegmentoftherecipientsandDepartment

componentsthatthisruleregulateswillchoosetopostthenoticethroughoneofthe

methodsspecified.Theburdenismixoflabor,materials,andinsomecases,postage

costs.ThemethodsandassumptionsthattheDepartmentusesareoutlinedsupraat

partIV.C.3.iii,andthemeanhourlywageisadjusteddownwardtoexcludebenefits

andoverhead.UnliketheburdenestimatedintheRIAoftherule,thePRAburden

associatedwith§88.5excludesthecostsofpostingthenoticeforthoseentitiesthat

postitverbatimbecausetheDepartmentissupplyingthelanguageforthenoticefor

thepurposeofdisclosuretothepublic,under5CFR1320.3(c)(2).

Assumingthat139,615recipientsatthefirmlevelalterthetextofthenotice

inAppendixA,theserecipientswill,onaverage,bearaminimalopportunitycostof

1/3hourofalawyer’stimefordraftingandtenminutesofanexecutive’stimeto

providefinalsign‐off.Theweightedmeanhourlywage(excludingbenefitsand

overhead)ofthesetwooccupationsis$75.89perhour.Theone‐timelaborcostis

$5.3millioninthefirstyear($75.89perhourx0.5hoursx139,615recipients).

Theassumptionsregardingthetimingofprovidingnoticesofrightsandthe

variousuncertaintiesinherentintheimplementationof§88.5describedindetailin

theRIAsupraatpartIV.C.3.iiiapplytothisanalysis,too,suchasthenumberof


386

locationswherenoticesarecustomarilyposted,andthelengthoftimeitmaytake

anadministrativeassistantorwebdevelopertoperformtheirrespectivefunctions.

(vii) BurdenforVoluntaryPostinginPhysicalLocations

TheDepartmentestimatesthatitwilltake1/3ofanhourforan

administrativeassistanttoprintnotice(s)andposttheminphysicallocationsofthe

establishmentwherenoticesarecustomarilyposted.The139,615recipientsatthe

firmlevelestimatedtoalterthenoticeareassociatedwith180,331establishments.

Assumingthatabout180,331facilitiesattheestablishmentlevelchoosevoluntarily

topostnoticesinphysicallocations,theestimatedlaborcostis$1.2million(1/3

hourx$19.39perhourx180,331establishments).390Thecosttopost5notices

acrossallestablishmentswouldbe$45,083(180,331establishmentsx$.05per

page(paperandink)x5pages).Thetotallaborandmaterialscostsassociatedwith

voluntarypostinginphysicallocationsby180,331establishmentsis$1.2million

($1.2millioninlaborcostsand$45,083formaterials)inthefirstyearof

implementationwithzerorecurringcosts.

Onecommenterraisedconcernswiththenoticerequirementbeingoverly

broadbecauseitwouldrequireamulti‐statehealthcareentitytopostnoticesat

everylocationwhereworkforcenoticesarecustomarilypostedtopermitready

observation,eveniftheparticularlocationhadnoconnectiontothefundingor

activitygivingrisetotheobligationtopostthenotice.Thefinalrule’smodification

390ThistotaldiffersfromtheburdenintheRIAbecauseafullyloadedwagethatisadjustedupwardsforbenefitsandoverheadmustbeused.


387

ofthenoticefrommandatorytovoluntaryshouldresolvethisconcern.Additionally,

theruleprovidesforpostinginlocationsas“applicableandappropriate.”

OnecommenterexpressedconcernthattheDepartment’sestimateoftime

thatanadministrativeassistantwouldspendtopostthenoticedidnottakeinto

accountthemultiplefacilitiesownedbyacorporateentity.Theestimatesforthe

PaperworkReductionActandintheRIA,however,dotakethisintoaccountbecause

theDepartmentmultipliedtheperfacilitylaborandmaterialscostsbythenumber

offacilities(i.e.,establishments)overwhichacorporateentity(i.e.,firm)exercises

commonownershipandcontrol.

(viii) BurdenforVoluntaryWebPosting

Topostthenoticeontheweb,theDepartmentestimatesthatitwilltake

2hoursforawebdeveloperateachrecipient’sphysicallocationtoexecutethe

designandtechnicalelementsforposting.Thislaborcostisapproximately

$12.5million(2hoursx$34.69perhourx180,337establishments)inthefirstyear

ofimplementationwithzerorecurringcosts.391

(ix) BurdenforVoluntaryPostinginTwoPublications

TheDepartmentassumesthat,withinthefirstyearaftertherule’s

publication,eachrecipientvoluntarilypostingnoticesinpublicationswouldidentify

twopublicationsinwhichtoincludethenotice,revisingthedocumentoritslayout

toincludethenotice,orotherwiseprintinganinserttoincludewithhardcopiesof

391ThistotaldiffersfromtheestimateoftheburdenintheRIAbecausetheRIAusesafullyloadedwagerate(i.e.,includingbenefitsandoverhead)notemployedhere.


388

thepublication.392AcknowledgingtheuncertaintiesoutlinedsupraatpartIV.C.3.iii,

theDepartmentestimatestheannualcostsoflabor,material,andpostageaccording

tothefollowingassumptions.TheDepartmentassumesthat(1)establishmentsthat

includenoticesofrightsinpublicationswillmostoftendosoinonlinepublications

orinhard‐copypublicationshand‐distributed,wherethenotice’sinclusionresults

inanadditional100hardcopynoticesperestablishmentperyear,and(2)halfof

theestablishmentsassociatedwithcoveredrecipientsvoluntarilyprovidinghard

copynotices(i.e.,90,166establishmentsinyearoneand67,624establishments

annuallyinyearstwothroughfive)393willmailthepublicationsforwhichthe

weightofthenoticeincrementallyincreasesthepostagecosts.Theseassumptions

maydifferfromtheactualexperienceofrecipients’implementation,asdescribed

supraatpartIV.C.3.iii.

Usingthemodel,hourlyestimates,andotherassumptionsdescribedsupraat

partIV.C.3.iii,theaveragelaborcost,excludingmailing‐relatedlaborcosts,resulting

fromincludingnoticesinrelevantpublicationsis$7.0millioninyearone($19.39

perhourx2hoursx180,331establishments)and$2.6millionannuallyinyearstwo

throughfive($19.39perhourx1hourx135,249establishments).394Basedonthe

marginalcostofpostageperounceof$0.15,395anannualnumberofmailingsof100

392Underthefinalrule,becauseallthenoticeprovisionsarevoluntary,theDepartmentassumesthat75%ofentitiesthatvoluntarilyprovidenoticesinyearonewillcontinuetodosoinoutyearsandtherewillbelowerattritioncomparedtotheestimateprovidedintheproposedrule.393Productof180,331establishmentstimes50percentforyearone.Productof135,249establishmentstimes50percentforyearstwothroughfive.394ThesetotalsdifferfromtheestimateoftheburdenintheRIAbecausetheRIAusesafullyloadedwagerate(i.e.,includingbenefitsandoverhead)notemployedhere.395SeeU.S.PostalServicePostageRates,https://www.stamps.com/usps/current‐postage‐rates/.


389

pagesperestablishment,averageannuallaborcostformailingof$19.39perhour,

andanaveragenumberoflaborhourspermailingof0.25hours,thetotalcostsdue

tothevoluntarymailingofnoticesis$1.8million396inyearoneand$1.3million397

annuallyinyearstwothroughfive.398Finally,theannualcostofprintedmaterials

fornotices(bothmailedandhanddistributed)is$0.9million(180,331

establishmentsx100pagesx$.05perpage)inyearoneand$676,243annuallyin

yearstwothroughfive(135,249establishmentsx100pagesx$.05perpage).

Insum,thetotalexpectedcostofactivitiesrelatedtothevoluntaryposting

anddistributionsofnoticesthat§88.5incentivizesis$28.7millioninthefirstyear

and$4.6millionannuallyinyearstwothroughfive.

(x) BurdentotheFederalGovernment

UnliketheburdenestimatedintheRIAoftherule,thePRAburdentothe

Departmentassociatedwith§88.5excludesthecostsofpostingthenoticeforthose

HHScomponentsthatpostitverbatimbecausetheDepartmentissupplyingthe

languageofthenoticeforthepurposeofdisclosuretothepublic,under5CFR

1320.3(c)(2).BecausetheDepartmentcomponentswilllikelypostthenoticefrom

AppendixAverbatim,allcoststotheDepartmentunderthePRAfor§88.5are

excluded.

396Sumofincrementalpostageof$1.4million($0.15permailingx100mailingsx90,166establishments)andincrementallaborof$437,078($19.39perhourx0.25hoursx90,166establishments).397Sumofincrementalpostageof$1.0million($0.15permailingx100mailingsx67,624establishments)andincrementallaborof$327,809($19.39perhourx0.25hoursx67,624establishments).398ThistotaldiffersfromtheestimateoftheburdenintheRIAbecausetheRIAusesafullyloadedwagerate(i.e.,includingbenefitsandoverhead)notemployedhere.


390

Theremainingissueraisedbycommentersiswhethertherulerequires

translationofthenoticeintonon‐Englishlanguages.Undertheconscience

protectionandassociatedanti‐discriminationlawsandthisrule,translationor

postingoftranslatednoticesisnotindependentlyrequired.However,recipients

subjecttothisrulemayalsohaveindependentobligationstoprovidelanguage

assistanceservicesandmeaningfulaccesstoindividualswithlimitedEnglish

proficiencywhenabidingbytheprohibitionofnationalorigindiscriminationin

FederalcivilrightslawsthatOCRenforces.399

TheDepartmentaskedforpubliccommentonthefollowingissuesand

receivednocomments:

•Whethertheproposedcollectionofinformationisnecessaryfortheproper

performanceoftheDepartment’sfunctionstoenforceFederallawsonwhich

Federalfundingisconditioned,includingwhethertheinformationwillhave

practicalutility;

•Whetherthepublichadfeedbackontheassumptionsthatformedthebasis

ofthecostestimatesforthenoticeprovision;and

•Howthemannerofcompliancewiththenoticeprovisioncouldbe

improved,includingthroughtheuseofautomatedcollectiontechniquesorother

formsofinformationtechnology.

3. ComplianceProcedures(§88.6(d))

399E.g.,42U.S.C.2000d(TitleVIoftheCivilRightsActof1964);45CFRpart80(HHSimplementingregulations);GuidancetoFederalFinancialAssistanceRecipientsRegardingTitleVIProhibitionAgainstNationalOriginDiscriminationAffectingLimitedEnglishProficientPersons,68FR47311,47313(Aug.8,2003).


391


Paragraph88.6(d)requiresanyrecipientorsub‐recipientthatissubjecttoa

determinationbyOCRofnoncompliancewiththispartconcerningFederal

conscienceandanti‐discriminationlawstoreportthisfactinanyapplicationfor

neworrenewedFederalfinancialassistanceorDepartmentalfundinginthethree

yearsfollowingthedeterminationofnoncompliance.Thisincludesarequirement

thatrecipientsdiscloseanyOCRdeterminationsmadeagainsttheirsub‐recipients.


TheinformationalertsapplicableDepartmentalcomponentsofOCR’s

determinationofnoncomplianceonthepartoftherecipientorsub‐recipient,to

ensureappropriatecoordinationwithintheDepartmentduringOCR’senforcement

ofFederalconscienceandanti‐discriminationlaws,andtoinformfundingdecision‐

making.


ThisrequirementputstheDepartmentalcomponentonnoticeofOCR’s

determinationofnoncompliancetoinformacomponent’sdecisionwhetherto

approve,renew,ormodifyFederalfundingtotherecipient.Thisrequirementalso

facilitatescoordinationbetweenthecomponentandOCRonthestatusofthe

recipientorsub‐recipient’scompliancestatus.

(iv) DescriptionoftheRespondents

Therespondentsarerecipientsandsub‐recipientsthatHHSOCRhasfound

noncompliantwiththisfinalrule.


392


Asexplained,supraatpartIV.C.3.v,theDepartmentcannotpredictthe

numberofentitiesthatOCRwillfindnoncompliantwiththerule.

(vi) BurdenofResponse

TheDepartmentestimatesitwouldtakearecordscustodianatthe

experiencelevelofaparalegalabout15minutestoretrievetherelevantinformation

(suchasdateoftheviolationfindingandtheOCR“transactionnumber”(e.g.,case

number))fromtherecipient’sorsub‐recipient’srecordsandanadministrative

assistant15minutestoentertheinformationontheapplication.Basedonthe

methodsandassumptionssupraatpartIV.C.3.v,theDepartmentassumesthata

recipient,atthehighestend,wouldsubmit2,000applicationseachyearfornew

fundingopportunities,supplementalfunding,andnon‐competingcontinuations,

amongothers.Themeanweightedhourlywagefortheparalegalandadministrative

assistantis$22.66,whichexcludesbenefitsandoverhead.Eachrecipientorsub‐

recipientfoundinviolationoftherulewouldexpendonthehighestend,$22,655

peryearinlaborcostsatthefirmlevel($22.66perhourX2000applicationsX0.5

hours).400

Commentersstatedthattheversionofthisrequirementintheproposedrule

wasredundantandduplicative.TheDepartmentagrees.Thefinalruleandthis

informationcollectionhasbeenmodifiedsubstantiallytorequirerecipientsand

sub‐recipientstonotifytheDepartmentalcomponentsfromwhichtherecipientor

400ThistotaldiffersfromtheburdenintheRIAbecauseafullyloadedwagethatisadjustedupwardsforbenefitsandoverheadmustbeused.


393

sub‐recipientreceivesFederalfundsinthethreeyearsfollowingadeterminationof

noncompliancewithFederalconscienceandanti‐discriminationlawsandthisfinal

rulebyOCR.

LISTOFSUBJECTS

Abortion,Adulteducation,Advanceddirectives,Assistedsuicide,Authority

delegations,Childbirth,Civilrights,Coercion,Collegesanduniversities,Community

facilities,Contracts,Educationalfacilities,Employment,Euthanasia,Family

planning,Federal‐Staterelations,Governmentcontracts,Governmentemployees,

Grantprograms‐health,Grantsadministration,Healthcare,Healthfacilities,Health

insurance,Healthprofessions,Hospitals,Immunization,IndianTribes,Insurance,

Insurancecompanies,Laboratories,Manpowertrainingprograms,Maternaland

childhealth,Medicaid,Medicalanddentalschools,Medicalresearch,Medicare,

Mentalhealthprograms,Mercykilling,Moralconvictions,Nondiscrimination,

Nursinghomes,Nursingschools,Occupationalsafetyandhealth,Occupational

training,Physicians,Prescriptiondrugs,Publicassistanceprograms,Public

awareness,Publichealth,Religiousdiscrimination,Religiousbeliefs,Religious

liberties,Religiousnonmedicalhealthcareinstitutions;Reportingand

recordkeepingrequirements,Rightsofconscience,Scholarshipsandfellowships,

Schools,Scientists,Stateandlocalgovernments,Sterilization,Students,Technical

assistance,TribalOrganizations.

Forthereasonssetforthinthepreamble,theDepartmentofHealthand

HumanServicesrevises45CFRpart88toreadasfollows:


394

PART88— PROTECTINGSTATUTORYCONSCIENCERIGHTSINHEALTHCARE;

DELEGATIONSOFAUTHORITY

Sec.88.1Purpose.88.2Definitions.88.3Applicablerequirementsandprohibitions.88.4Assuranceandcertificationofcompliancerequirements.88.5NoticeofrightsunderFederalconscienceandanti‐discriminationlaws.88.6Compliancerequirements.88.7Enforcementauthority.88.8Relationshiptootherlaws.88.9Ruleofconstruction.88.10Severability.AppendixAtoPart88—NoticeofRightsUnderFederalConscienceandAnti‐DiscriminationLawsAuthority:42U.S.C.300a–7(theChurchAmendments);42U.S.C.238n

(Coats‐SnoweAmendment);theWeldonAmendment(e.g.,Pub.L.115‐245,Div.B,

sec.507(d));42U.S.C.18113(Section1553oftheAffordableCareAct);Medicare

Advantage(e.g.,Pub.L.115‐245,Div.B,sec.209);theHelms,Biden,1978,and1985

Amendments,22U.S.C.2151b(f)(e.g.,Pub.L.116‐6,Div.F,sec.7018);22U.S.C.

7631(d);29U.S.C.669(a)(5);42U.S.C.300gg‐92;42U.S.C.1302(a);42U.S.C.

18041(a)(Section1321oftheAffordableCareAct);42U.S.C.18081(Section1411

oftheAffordableCareAct);42U.S.C.18023(Section1303oftheAffordableCare

Act);26U.S.C.5000A(d)(2);42U.S.C.18031;42U.S.C.280g‐1(d);42U.S.C.290bb‐

36(f);42U.S.C.1315;42U.S.C.1315a;42U.S.C.1320a–1;42U.S.C.1320c‐11;42

U.S.C.1395cc(f);42U.S.C.1395i‐3;42U.S.C.1395i‐5;42U.S.C.1395w‐22(j)(3)(B);

42U.S.C.1395w–26;42U.S.C.1395w–27;42U.S.C.1395x;42U.S.C.1396a;42U.S.C.


395

1396a(w)(3);42U.S.C.1396f;42U.S.C.1396r;42U.S.C.1396s(c)(2)(B)(ii);42U.S.C.

1396u‐2(b)(3)(B);42U.S.C.1397j‐1(b);42U.S.C.5106i(a);42U.S.C.14406;5U.S.C.

301;40U.S.C.121(c);42U.S.C.263a(f)(1)(E);45CFRparts75and96;48CFR

Chapter1;48CFRparts300thru370;2CFRpart376.

§88.1Purpose.

Thepurposeofthispartistoprovidefortheimplementationand

enforcementoftheFederalconscienceandanti‐discriminationlawslistedin§88.3.

Suchlaws,forexample,protecttherightsofindividuals,entities,andhealthcare

entitiestorefusetoperform,assistintheperformanceof,orundergocertainhealth

careservicesorresearchactivitiestowhichtheymayobjectforreligious,moral,

ethical,orotherreasons.Suchlawsalsoprotectpatientsfrombeingsubjectedto

certainhealthcareorservicesovertheirconscientiousobjection.Consistentwith

theirobjectivetoprotecttheconscienceandassociatedanti‐discriminationrightsof

individuals,entities,andhealthcareentities,thestatutoryprovisionsandthe

regulatoryprovisionscontainedinthispartaretobeinterpretedandimplemented

broadlytoeffectuatetheirprotectivepurposes.

§88.2Definitions.

Forthepurposesofthispart:

AssistinthePerformancemeanstotakeanactionthathasaspecific,

reasonable,andarticulableconnectiontofurtheringaprocedureorapartofa

healthserviceprogramorresearchactivityundertakenbyorwithanotherperson

orentity.Thismayincludecounseling,referral,training,orotherwisemaking


396

arrangementsfortheprocedureorapartofahealthserviceprogramorresearch

activity,dependingonwhetheraidisprovidedbysuchactions.

DepartmentmeanstheDepartmentofHealthandHumanServicesandany

componentthereof.

DiscriminateorDiscriminationincludes,asapplicableto,andtotheextent

permittedby,theapplicablestatute:

(1)Towithhold,reduce,excludefrom,terminate,restrict,ormake

unavailableordenyanygrant,contract,subcontract,cooperativeagreement,loan,

license,certification,accreditation,employment,title,orothersimilarinstrument,

position,orstatus;

(2)Towithhold,reduce,excludefrom,terminate,restrict,ormake

unavailableordenyanybenefitorprivilegeorimposeanypenalty;or

(3)Toutilizeanycriterion,methodofadministration,orsiteselection,

includingtheenactment,application,orenforcementoflaws,regulations,policies,

orproceduresdirectlyorthroughcontractualorotherarrangements,thatsubjects

individualsorentitiesprotectedunderthisparttoanyadversetreatmentwith

respecttoindividuals,entities,orconductprotectedunderthispartongrounds

prohibitedunderanapplicablestatuteencompassedbythispart.

(4)Notwithstandingsubparagraphs(1)through(3)ofthisdefinition,an

entitysubjecttoanyprohibitioninthispartshallnotberegardedashavingengaged

indiscriminationagainstaprotectedentitywheretheentityoffersandthe

protectedentityvoluntarilyacceptsaneffectiveaccommodationfortheexerciseof


397

suchprotectedentity’sprotectedconduct,religiousbeliefs,ormoralconvictions.In

determiningwhetheranyentityhasengagedindiscriminatoryactionwithrespect

toanycomplaintorcompliancereviewunderthispart,OCRwilltakeintoaccount

thedegreetowhichanentityhadimplementedpoliciestoprovideeffective

accommodationsfortheexerciseofprotectedconduct,religiousbeliefs,ormoral

convictionsunderthispartandwhetherornottheentitytookanyadverseaction

againstaprotectedentityonthebasisofprotectedconduct,beliefs,orconvictions

beforetheprovisionofanyaccommodation.

(5)Notwithstandingsubparagraphs(1)through(3)ofthisdefinition,an

entitysubjecttoanyprohibitioninthispartmayrequireaprotectedentityto

informitofobjectionstoperforming,referringfor,participatingin,orassistingin

theperformanceofspecificprocedures,programs,research,counseling,or

treatments,butonlytotheextentthatthereisareasonablelikelihoodthatthe

protectedentitymaybeaskedingoodfaithtoperform,referfor,participatein,or

assistintheperformanceof,anyactorconductjustdescribed.Suchinquirymay

onlyoccurafterthehiringof,contractingwith,orawardingofagrantorbenefittoa

protectedentity,andoncepercalendaryearthereafter,unlesssupportedbya

persuasivejustification.

(6)Thetakingofstepsbyanentitysubjecttoprohibitionsinthisparttouse

alternatestafformethodstoprovideorfurtheranyobjected‐toconductidentified

insubparagraph(5)ofthisdefinitionwouldnot,byitself,constitutediscrimination

oraprohibitedreferral,ifsuchentitydoesnotrequireanyadditionalactionby,or


398

doesnottakeanyadverseactionagainst,theobjectingprotectedentity(including

individualsorhealthcareentities),andifsuchmethodsdonotexcludeprotected

entitiesfromfieldsofpracticeonthebasisoftheirprotectedobjections.Entities

subjecttoprohibitionsinthispartmayalsoinformthepublicoftheavailabilityof

alternatestafformethodstoprovideorfurthertheobjected‐toconduct,butsuch

entitymaynotdosoinamannerthatconstitutesadverseorretaliatoryaction

againstanobjectingentity.

Entitymeansa“person”asdefinedin1U.S.C.1;theDepartment;aState,


subdivisionthereof;anypublicagency,publicinstitution,publicorganization,or

otherpublicentityinanyStateorpoliticalsubdivisionofanyState;or,asapplicable,

aforeigngovernment,foreignnongovernmentalorganization,orintergovernmental

organization(suchastheUnitedNationsoritsaffiliatedagencies).

Federalfinancialassistanceincludes:

(1)GrantsandloansofFederalfunds;

(2)ThegrantorloanofFederalpropertyandinterestsinproperty;

(3)ThedetailofFederalpersonnel;

(4)Thesaleorleaseof,andthepermissiontouse(onotherthanacasualor

transientbasis),Federalpropertyoranyinterestinsuchpropertywithout

considerationoratanominalconsideration,orataconsiderationwhichisreduced

forthepurposeofassistingtherecipientorinrecognitionofthepublicinterestto

beservedbysuchsaleorleasetotherecipient;and


399

(5)AnyagreementorothercontractbetweentheFederalgovernmentanda

recipientthathasasoneofitspurposestheprovisionofasubsidytotherecipient.

Healthcareentityincludes(1)forpurposesoftheCoats‐SnoweAmendment

(42U.S.C.238n)andthesubsectionsofthispartimplementingthatlaw(§88.3(b)),

anindividualphysicianorotherhealthcareprofessional,includingapharmacist;

healthcarepersonnel;aparticipantinaprogramoftraininginthehealth

professions;anapplicantfortrainingorstudyinthehealthprofessions;apost‐

graduatephysiciantrainingprogram;ahospital;amedicallaboratory;anentity

engaginginbiomedicalorbehavioralresearch;apharmacy;oranyotherhealthcare

providerorhealthcarefacility.Asapplicable,componentsofStateorlocal

governmentsmaybehealthcareentitiesundertheCoats‐SnoweAmendment;and,

(2)forpurposesoftheWeldonAmendment(e.g.,DepartmentofDefenseandLabor,

HealthandHumanServices,andEducationAppropriationsAct,2019,and

ContinuingAppropriationsAct,2019,Pub.L.No.115‐245,Div.B.,sec.507(d),132

Stat.2981,3118(Sept.28,2018)),PatientProtectionandAffordableCareAct

section1553(42U.S.C.18113),andtosectionsofthispartimplementingthoselaws

(§88.3(c),(e)),anindividualphysicianorotherhealthcareprofessional,includinga

pharmacist;healthcarepersonnel;aparticipantinaprogramoftraininginthe

healthprofessions;anapplicantfortrainingorstudyinthehealthprofessions;a

post‐graduatephysiciantrainingprogram;ahospital;amedicallaboratory;an

entityengaginginbiomedicalorbehavioralresearch;apharmacy;aprovider‐

sponsoredorganization;ahealthmaintenanceorganization;ahealthinsurance


400

issuer;ahealthinsuranceplan(includinggrouporindividualplans);aplansponsor

orthird‐partyadministrator;oranyotherkindofhealthcareorganization,facility,

orplan.Asapplicable,componentsofStateorlocalgovernmentsmaybehealthcare

entitiesundertheWeldonAmendmentandPatientProtectionandAffordableCare

Actsection1553.

Healthserviceprogramincludestheprovisionoradministrationofanyhealth

orhealth‐relatedservicesorresearchactivities,healthbenefits,healthorhealth‐

relatedinsurancecoverage,healthstudies,oranyotherservicerelatedtohealthor

wellness,whetherdirectly;throughpayments,grants,contracts,orother

instruments;throughinsurance;orotherwise.

InstrumentisthemeansbywhichFederalfundsareconveyedtoarecipient

andincludesgrants,cooperativeagreements,contracts,grantsunderacontract,

memorandaofunderstanding,loans,loanguarantees,stipends,andanyother

fundingoremploymentinstrumentorcontract.

OCRmeanstheOfficeforCivilRightsoftheDepartmentofHealthandHuman

Services.

RecipientmeansanyState,politicalsubdivisionofanyState,instrumentality

ofanyStateorpoliticalsubdivisionthereof,andanypersonoranypublicorprivate

agency,institution,organization,orotherentityinanyState,includingany

successor,assign,ortransfereethereof,towhomFederalfinancialassistanceis

extendeddirectlyfromtheDepartmentoracomponentoftheDepartment,orwho

otherwisereceivesFederalfundsdirectlyfromtheDepartmentoracomponentof


401

theDepartment,butsuchtermdoesnotincludeanyultimatebeneficiary.Theterm

mayincludeaforeigngovernment,foreignnongovernmentalorganization,or

intergovernmentalorganization(suchastheUnitedNationsoritsaffiliated

agencies).

Referralorreferforincludestheprovisionofinformationinoral,written,or

electronicform(includingnames,addresses,phonenumbers,emailorweb

addresses,directions,instructions,descriptions,orotherinformationresources),

wherethepurposeorreasonablyforeseeableoutcomeofprovisionofthe

informationistoassistapersoninreceivingfundingorfinancingfor,trainingin,

obtaining,orperformingaparticularhealthcareservice,program,activity,or

procedure.

Stateincludes,inadditiontotheseveralStates,theDistrictofColumbia.For

thoseprovisionsrelatedtoorrelyinguponthePublicHealthServiceAct,theterm

“State”includestheseveralStates,theDistrictofColumbia,theCommonwealthof

PuertoRico,Guam,theNorthernMarianaIslands,theU.S.VirginIslands,American

Samoa,andtheTrustTerritoryofthePacificIslands.Forthoseprovisionsrelatedto

orrelyingupontheSocialSecurityAct,suchasMedicaidortheChildren’sHealth

InsuranceProgram,theterm“State”shallbedefinedinaccordancewiththe

definitionof“State”foundat42U.S.C.1301.

Sub‐recipientmeansanyState,politicalsubdivisionofanyState,

instrumentalityofanyStateorpoliticalsubdivisionthereof,oranypersonorany

publicorprivateagency,institution,organization,orotherentityinanyState,


402

includinganysuccessor,assign,ortransfereethereof,towhomthereisapass‐

throughofFederalfinancialassistanceorFederalfundsfromtheDepartment

througharecipientoranothersub‐recipient,butsuchtermdoesnotincludeany

ultimatebeneficiary.Thetermmayincludeaforeigngovernment,foreign


UnitedNationsoritsaffiliatedagencies).

Workforcemeansemployees,volunteers,trainees,contractors,andother

personswhoseconduct,intheperformanceofworkforanentityorhealthcare

entity,isunderthedirectcontrolofsuchentityorhealthcareentity,whetherornot

theyarepaidbytheentityorhealthcareentity,aswellashealthcareproviders

holdingprivilegeswiththeentityorhealthcareentity.

§88.3Applicablerequirementsandprohibitions.

(a)TheChurchAmendments,42U.S.C.300a–7.

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraphs(a)(2)(i)

through(vii)ofthissectionand§88.6ofthispart.

(ii)AnyStateorlocalgovernmentorsubdivisionthereofandanyother

publicentityisrequiredtocomplywithsubparagraphs(a)(2)(i)through(iii)ofthis

section.

(iii)Anyentitythatreceivesagrant,contract,loan,orloanguaranteeunder

thePublicHealthServiceAct[42U.S.C.201etseq.]afterJune18,1973,isrequired


403

tocomplywithsubparagraph(a)(2)(iv)ofthissectionand§§88.4and88.6ofthis

part.

(iv)Anyentitythatreceivesagrantorcontractforbiomedicalorbehavioral

researchunderanyprogramadministeredbytheSecretaryofHealthandHuman

ServicesafterJuly12,1974,isrequiredtocomplywithsubparagraph(a)(2)(v)of

thissectionand§§88.4and88.6ofthispart.

(v)TheDepartmentandanyentitythatreceivesfundsforanyhealthservice

programorresearchactivityunderanyprogramadministeredbytheSecretaryof

HealthandHumanServicesisrequiredtocomplywithsubparagraph(a)(2)(vi)of


(vi)Anyentitythatreceives,afterSeptember29,1979,anygrant,contract,

loan,loanguarantee,orinterestsubsidyunderthePublicHealthServiceActorthe

DevelopmentalDisabilitiesAssistanceandBillofRightsActof2000[42U.S.C.15001

etseq.]isrequiredtocomplywithsubparagraph(a)(2)(vii)ofthissectionand§§

88.4and88.6ofthispart.

(2)Requirementsandprohibitions.

(i)Pursuantto42U.S.C.300a–7(b)(1),thereceiptofagrant,contract,loan,

orloanguaranteeunderthePublicHealthServiceActbyanyindividualdoesnot

authorizeentitiestowhichthissubparagraph(a)(2)(i)appliestorequiresuch

individualtoperformorassistintheperformanceofanysterilizationprocedureor

abortionifhisperformanceorassistanceintheperformanceofsuchprocedureor

abortionwouldbecontrarytohisreligiousbeliefsormoralconvictions.


404

(ii)Pursuantto42U.S.C.300a–7(b)(2)(A),thereceiptofagrant,contract,

loan,orloanguaranteeunderthePublicHealthServiceActbyanyrecipientdoes

notauthorizeentitiestowhichthissubparagraph(a)(2)(ii)appliestorequiresuch

recipienttomakeitsfacilitiesavailablefortheperformanceofanysterilization

procedureorabortioniftheperformanceofsuchprocedureorabortioninsuch

facilitiesisprohibitedbytherecipientonthebasisofreligiousbeliefsormoral

convictions.

(iii)Pursuantto42U.S.C.300a–7(b)(2)(B),thereceiptofagrant,contract,

loan,orloanguaranteeunderthePublicHealthServiceActbyanyrecipientdoes

notauthorizeentitiestowhichthissubparagraph(a)(2)(iii)appliestorequiresuch

recipienttoprovidepersonnelfortheperformanceorassistanceintheperformance

ofanysterilizationprocedureorabortioniftheperformanceorassistanceinthe

performanceofsuchprocedureorabortionbysuchpersonnelwouldbecontraryto

thereligiousbeliefsormoralconvictionsofsuchpersonnel.

(iv)Pursuantto42U.S.C.300a–7(c)(1),entitiestowhichthissubparagraph

(a)(2)(iv)appliesshallnotdiscriminateagainstanyphysicianorotherhealthcare

personnelinemployment,promotion,terminationofemployment,orextensionof

stafforotherprivilegesbecausesuchphysicianorotherhealthcarepersonnel

performedorassistedintheperformanceofalawfulsterilizationprocedureor

abortion,becauseherefusedtoperformorassistintheperformanceofalawful

sterilizationprocedureorabortiononthegroundsthathisperformanceor

assistanceintheperformanceofsuchprocedureorabortionwouldbecontraryto


405

hisreligiousbeliefsormoralconvictions,orbecauseofhisreligiousbeliefsormoral

convictionsrespectingsterilizationproceduresorabortions.

(v)Pursuantto42U.S.C.300a–7(c)(2),entitiestowhichthissubparagraph

(a)(2)(v)appliesshallnotdiscriminateagainstanyphysicianorotherhealthcare

personnelinemployment,promotion,terminationofemployment,orextensionof

stafforotherprivilegesbecausesuchphysicianorotherhealthcarepersonnel

performedorassistedintheperformanceofanylawfulhealthserviceorresearch

activity,becauseherefusedtoperformorassistintheperformanceofanysuch

serviceoractivityonthegroundsthathisperformanceorassistanceinthe

performanceofsuchserviceoractivitywouldbecontrarytohisreligiousbeliefsor

moralconvictions,orbecauseofhisreligiousbeliefsormoralconvictionsrespecting

anysuchserviceoractivity.

(vi)Pursuantto42U.S.C.300a–7(d),entitiestowhichthissubparagraph

(a)(2)(vi)appliesshallnotrequireanyindividualtoperformorassistinthe

performanceofanypartofahealthserviceprogramorresearchactivityfundedin

wholeorinpartunderaprogramadministeredbytheSecretaryofHealthand

HumanServicesiftheindividual’sperformanceorassistanceintheperformanceof

suchpartofsuchprogramoractivitywouldbecontrarytohisreligiousbeliefsor

moralconvictions.

(vii)Pursuantto42U.S.C.300a–7(e),entitiestowhichthissubparagraph

(a)(2)(vii)appliesshallnotdenyadmissiontoorotherwisediscriminateagainstany

applicant(includingapplicantsforinternshipsandresidencies)fortrainingorstudy


406

becauseoftheapplicant’sreluctanceorwillingnesstocounsel,suggest,recommend,

assist,orinanywayparticipateintheperformanceofabortionsorsterilizations

contraryto,orconsistentwith,theapplicant'sreligiousbeliefsormoralconvictions.

(b)TheCoats‐SnoweAmendment(Section245ofthePublicHealthService

Act),42U.S.C.238n.

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraphs(b)(2)(i)

through(ii)ofthissectionand§88.6ofthispart.

(ii)AnyStateorlocalgovernmentorsubdivisionthereofthatreceives

Federalfinancialassistance,includingFederalpaymentsprovidedas

reimbursementforcarryingouthealth‐relatedactivities,isrequiredtocomplywith

subparagraphs(b)(2)(i)through(ii)ofthissectionand§§88.4and88.6ofthispart.


(i)Pursuantto42U.S.C.238n(a)(1),(2),and(3),entitiestowhichthis

subparagraph(b)(2)(i)appliesshallnotsubjectanyhealthcareentityto

discriminationonthebasisthatthehealthcareentity—

(A)Refusestoundergotrainingintheperformanceofinducedabortions,to

requireorprovidesuchtraining,toperformsuchabortions,ortoprovidereferrals

forsuchtrainingorsuchabortions;

(B)Refusestomakearrangementsforanyoftheactivitiesspecifiedin

(b)(2)(i)(A);or


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(C)Attendsorattendedapost‐graduatephysiciantrainingprogramorany

otherprogramoftraininginthehealthprofessionsthatdoesnotordidnotperform

inducedabortionsorrequire,provide,orreferfortrainingintheperformanceof

inducedabortions,ormakearrangementsfortheprovisionofsuchtraining.

(ii)Pursuantto42U.S.C.238n(b),entitiestowhichthissubparagraph

(b)(2)(ii)appliesshallnot,forthepurposesofgrantingalegalstatustoahealthcare

entity(includingalicenseorcertificate),orprovidingsuchentitywithfinancial

assistance,services,orbenefits,failtodeemaccreditedanypostgraduatephysician

trainingprogramthatwouldbeaccreditedbutfortheaccreditingagency'sreliance

uponaccreditationstandardsthatrequireanentitytoperformaninducedabortion

orthatrequireanentitytorequire,provide,orreferfortrainingintheperformance

ofinducedabortionsormakearrangementsforsuchtraining,regardlessofwhether

suchstandardsprovideexceptionsorexemptions.Entitiestowhichthis

subparagraph(b)(2)(ii)appliesandwhichareinvolvedinsuchmattersshall

formulatesuchregulationsorothermechanisms,orenterintosuchagreements

withaccreditingagencies,asarenecessarytocomplywiththissubparagraph.

(c)WeldonAmendment(See,e.g.,Pub.L.115‐245,Div.B,sec.507(d)).

(1)Applicability.

(i)TheDepartmentanditsprograms,whileoperatingunderan

appropriationsactthatcontainstheWeldonAmendment,arerequiredtocomply

withsubparagraph(c)(2)ofthissectionand§88.6ofthispart.


408

(ii)AnyStateorlocalgovernmentthatreceivesfundsunderan

appropriationsactfortheDepartmentthatcontainstheWeldonAmendmentis

requiredtocomplywithsubparagraph(c)(2)ofthissectionand§§88.4and88.6of

thispart.

(2)Prohibition.Theentitiestowhichthissubparagraph(c)(2)appliesshall

notsubjectanyinstitutionalorindividualhealthcareentitytodiscriminationonthe

basisthatthehealthcareentitydoesnotprovide,payfor,providecoverageof,or

referfor,abortion.

(d)MedicareAdvantage(See,e.g.,Pub.L.115‐245,Div.B,sec.209).

(1)Applicability.TheDepartment,whileoperatingunderanappropriations

actthatcontainsaprovisionwithrespecttotheMedicareAdvantageprogramasset

forthbyPub.L.115‐245,Div.B,sec.209,isrequiredtocomplywithsubparagraph

(d)(2)ofthissectionand§88.6ofthispart.

(2)Prohibition.Theentitiestowhichthissubparagraph(d)(2)appliesshall

notdenyparticipationintheMedicareAdvantageprogramtoanotherwiseeligible

entity(includingaProviderSponsoredOrganization)becausethatentityinforms

theSecretarythatitwillnotprovide,payfor,providecoverageof,orprovide

referralsforabortions.

(e)Section1553oftheAffordableCareAct,42U.S.C.18113.

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(e)(2)ofthis

sectionand§88.6ofthispart.


409

(ii)AnyStateorlocalgovernmentthatreceivesFederalfinancialassistance

underthePatientProtectionandAffordableCareAct(orunderanamendment

madebythePatientProtectionandAffordableCareAct)isrequiredtocomplywith

subparagraph(e)(2)ofthissectionand§§88.4and88.6ofthispart.

(iii)AnyhealthcareproviderthatreceivesFederalfinancialassistanceunder

thePatientProtectionandAffordableCareAct(orunderanamendmentmadeby

thePatientProtectionandAffordableCareAct)isrequiredtocomplywith

subparagraph(e)(2)ofthissectionand§§88.4and88.6ofthispart.

(iv)AnyhealthplancreatedunderthePatientProtectionandAffordableCare

Act(orunderanamendmentmadebythePatientProtectionandAffordableCare

Act)isrequiredtocomplywithsubparagraph(e)(2)ofthissectionand§§88.4and

88.6ofthispart.

(2)Prohibition.Theentitiestowhichthissubparagraph(e)(2)appliesshall

notsubjectanindividualorinstitutionalhealthcareentitytodiscriminationonthe

basisthattheentitydoesnotprovideanyhealthcareitemorservicefurnishedfor

thepurposeofcausing,orforthepurposeofassistingincausing,thedeathofany

individual,suchasbyassistedsuicide,euthanasia,ormercykilling.Nothinginthis

subparagraphshallbeconstruedtoapplyto,ortoaffect,anylimitationrelatingto:

(i)Thewithholdingorwithdrawingofmedicaltreatmentormedicalcare;

(ii)Thewithholdingorwithdrawingofnutritionorhydration;

(iii)Abortion;or


410

(iv)Theuseofanitem,good,benefit,orservicefurnishedforthepurposeof

alleviatingpainordiscomfort,evenifsuchusemayincreasetheriskofdeath,so

longassuchitem,good,benefit,orserviceisnotalsofurnishedforthepurposeof

causing,orthepurposeofassistingincausing,death,foranyreason.

(f)Section1303oftheAffordableCareAct,42U.S.C.18023.

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(f)(2)(i)ofthis


(ii)Qualifiedhealthplans,asdefinedunder42U.S.C.18021,offeredthrough

anyExchangecreatedunderthePatientProtectionandAffordableCareAct,are

requiredtocomplywithsubparagraphs(f)(2)(i)and(ii)ofthissectionand§§88.4

and88.6ofthispart.


(i)Pursuantto42U.S.C.18023(b)(1)(A)(i),entitiestowhichthis

subparagraph(f)(2)(i)appliesshallnotconstrueanythinginTitleIofthePatient

ProtectionandAffordableCareAct(oranyamendmentmadebyTitleIofthe

PatientProtectionandAffordableCareAct)torequireaqualifiedhealthplanto

providecoverageofabortionorabortion‐relatedservicesasdescribedin42U.S.C.

18023(b)(1)(B)(i)or(B)(ii)aspartofitsessentialhealthbenefitsforanyplanyear.

(ii)Pursuantto42U.S.C.18023(b)(4),entitiestowhichthissubparagraph

(f)(2)(ii)appliesshallnotdiscriminateagainstanyindividualhealthcareprovider


411

orhealthcarefacilitybecauseofitsunwillingnesstoprovide,payfor,provide

coverageof,orreferforabortions.

(g)Section1411oftheAffordableCareAct,42U.S.C.18081.

(1)Applicability.TheDepartmentshallcomplywithsubparagraph(g)(2)of

thissectionand§88.6ofthispart.

(2)Requirement.TheDepartmentshallprovideacertificationdocumentinga

religiousexemptionfromtheindividualresponsibilityrequirementandpenalty

underthePatientProtectionandAffordableCareActandshallcoordinatewithState

HealthBenefitExchangesintheimplementingofthecertificationrequirements

of42U.S.C.18031(d)(4)(H)(ii)whereapplicableto:

(i)Anyapplicantforsuchacertificateforanymonthwhoprovides

informationdemonstratingthattheapplicant:

(A)isanadherentofreligioustenetsorteachingsbyreasonofwhichheis

conscientiouslyopposedtoacceptanceofthebenefitsofanyprivateorpublic

insurancewhichmakespaymentsintheeventofdeath,disability,old‐age,or

retirementormakespaymentstowardthecostof,orprovidesservicesfor,medical

care(includingthebenefitsofanyinsurancesystemestablishedbytheSocial

SecurityAct),or

(B)isanadherentofreligioustenetsorteachingsthatarenotdescribedin

(i)(A),whoreliessolelyonareligiousmethodofhealing,andforwhomthe

acceptanceofmedicalhealthserviceswouldbeinconsistentwiththereligious

beliefsoftheindividual,andtheapplicationforthecertificateincludesan


412

attestationthattheindividualhasnotreceivedmedicalhealthservicesduringthe

precedingtaxableyear.

(1)Forpurposesofsubparagraph(i)(B),“medicalhealthservices”doesnot

includeroutinedental,visionandhearingservices,midwiferyservices,vaccinations,

necessarymedicalservicesprovidedtochildren,servicesrequiredbylaworbya

thirdparty,andsuchotherservicesastheSecretarymayprovideinimplementing

section1311(d)(4)(H)ofthePatientProtectionandAffordableCareAct;

and

(ii)Anyapplicantforsuchacertificateforanymonthwhoprovides

informationdemonstratingthattheapplicantisamemberofa“healthcaresharing

ministry,”asdefinedin26U.S.C.5000A(d)(2)(B)(ii),forthemonth.

(h)Counselingandreferralprovisionsof42U.S.C.1395w‐22(j)(3)(B)and

1396u‐2(b)(3)(B)).

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraphs(h)(2)(i)

through(ii)ofthissectionand§88.6ofthispart.

(ii)AnyStateagencythatadministersaMedicaidprogramisrequiredto

complywithsubparagraph(h)(2)(ii)ofthissectionand§§88.4and88.6ofthispart.


(i)Pursuantto42U.S.C.1395w‐22(j)(3)(B),entitiestowhichthis

subparagraph(h)(2)(i)appliesshallnotconstrue42U.S.C.1395w‐22(j)(3)(A)or42

CFR422.206(a)torequireaMedicareAdvantageorganizationtoprovide,reimburse


413

for,orprovidecoverageof,acounselingorreferralserviceiftheorganization

offeringtheplan:

(A)objectstotheprovisionofsuchserviceonmoralorreligiousgrounds,

and

(B)inthemannerandthroughthewritteninstrumentalitiessuch

organizationdeemsappropriate,makesavailableinformationonitspolicies

regardingsuchservicetoprospectiveenrolleesbeforeorduringenrollmentandto

enrolleeswithin90daysafterthedatethattheorganizationadoptsachangein

policyregardingsuchacounselingorreferralservice.

(ii)Pursuantto42U.S.C.1396u‐2(b)(3)(B),entitiestowhichthis

subparagraph(h)(2)(ii)appliesshallnotconstrue42U.S.C.1396u‐2(b)(3)(A)or42

CFR438.102(a)(1)torequireaMedicaidmanagedcareorganizationtoprovide,

reimbursefor,orprovidecoverageof,acounselingorreferralserviceifthe

organization:

(A)objectstotheprovisionofsuchserviceonmoralorreligiousgrounds,

and

(B)inthemannerandthroughthewritteninstrumentalitiessuch

organizationdeemsappropriate,makesavailableinformationonitspolicies

regardingsuchservicetoprospectiveenrolleesbeforeorduringenrollmentandto

enrolleeswithin90daysafterthedatethattheorganizationadoptsachangein

policyregardingsuchacounselingorreferralservice.

(i)AdvanceDirectives,42U.S.C.1395cc(f),1396a(w)(3),and14406.


414

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(i)(2)ofthis

sectionand§88.6ofthispartwithrespecttotheMedicareandMedicaidprograms.

(ii)AnyStateagencythatadministersaMedicaidprogramisrequiredto

complywithsubparagraph(i)(2)ofthissectionand§§88.4and88.6ofthispart

withrespecttoitsMedicaidprogram.

(2)Prohibitions.Theentitiestowhichthissubparagraph(i)(2)appliesshall

not:

(i)Construe42U.S.C.1395cc(f)or1396a(w)(3)torequireanyprovideror

organization,oranyemployeeofsuchaproviderororganization,toinformor

counselanyindividualregardinganyrighttoobtainanitemorservicefurnishedfor

thepurposeofcausing,orthepurposeofassistingincausing,thedeathofthe

individual,suchasbyassistedsuicide,euthanasia,ormercykilling;ortoapplytoor

affectanyrequirementwithrespecttoaportionofanadvancedirectivethatdirects

thepurposefulcausingof,orthepurposefulassistingincausing,thedeathofany

individual,suchasbyassistedsuicide,euthanasia,ormercykilling;or

(ii)Construe42U.S.C.1396atoprohibittheapplicationofaStatelawwhich

allowsforanobjectiononthebasisofconscienceforanyhealthcareprovideror

anyagentofsuchproviderwhichasamatterofconsciencecannotimplementan

advancedirective.

(j)GlobalHealthPrograms,22U.S.C.7631(d).

(1)Applicability.


415

(i)TheDepartmentisrequiredtocomplywithsubparagraph(j)(2)ofthis


(ii)Anyentitythatisauthorizedbystatute,regulation,oragreementto

obligateFederalfinancialassistanceundersection104AoftheForeignAssistance

Actof1961(22U.S.C.2151b–2),underChapter83ofTitle22oftheU.S.Codeor

undertheTomLantosandHenryJ.HydeUnitedStatesGlobalLeadershipAgainst

HIV/AIDS,Tuberculosis,andMalariaReauthorizationActof2008,totheextentsuch

FederalfinancialassistanceisadministeredbytheSecretary,isrequiredtocomply

withsubparagraph(j)(2)ofthissectionand§§88.4and88.6ofthispart.

(2)Prohibitions.Theentitiestowhichthissubparagraph(j)(2)appliesshall

not:

(i)Requireanorganization,includingafaith‐basedorganization,thatis

otherwiseeligibletoreceiveassistanceundersection104AoftheForeign

AssistanceActof1961(22U.S.C.2151b–2),underChapter83ofTitle22oftheU.S.

Code,orundertheTomLantosandHenryJ.HydeUnitedStatesGlobalLeadership

AgainstHIV/AIDS,Tuberculosis,andMalariaReauthorizationActof2008,tothe

extentsuchassistanceisadministeredbytheSecretary,forHIV/AIDSprevention,

treatment,orcareto,asaconditionofsuchassistance:

(A)Endorseorutilizeamultisectoralorcomprehensiveapproachto

combatingHIV/AIDS;or


416

(B)Endorse,utilize,makeareferralto,becomeintegratedwith,orotherwise

participateinanyprogramoractivitytowhichtheorganizationhasareligiousor

moralobjection.

(ii)Discriminateagainstanorganization,includingafaith‐based

organization,thatisotherwiseeligibletoreceiveassistanceundersection104Aof

theForeignAssistanceActof1961(22U.S.C.2151b–2),underChapter83ofTitle22

oftheU.S.Code,orundertheTomLantosandHenryJ.HydeUnitedStatesGlobal


2008,totheextentsuchassistanceisadministeredbytheSecretary,forHIV/AIDS

prevention,treatment,orcare,inthesolicitationorissuanceofgrants,contracts,or

cooperativeagreementsundersuchprovisionsoflawforrefusingtomeetany

requirementdescribedinsubparagraph(j)(2)(i).

(k)TheHelms,Biden,1978,and1985Amendments,22U.S.C.2151b(f);see,e.g.,

ConsolidatedAppropriationsAct,2019,Pub.L.116‐6,Div.F,sec.7018.

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(k)(2)(i)ofthis


(ii)Anyentitythatisauthorizedbystatute,regulation,oragreementto

obligateorexpendFederalfinancialassistanceunderpartIoftheForeign

AssistanceActof1961,asamended(22U.S.C.2151b–2),totheextentadministered

bytheSecretary,isrequiredtocomplywithsubparagraph(k)(2)(i)ofthissection

and§§88.4and88.6ofthispart.


417

(iii)AnyentitythatreceivesFederalfinancialassistanceunderpartIofthe

ForeignAssistanceActof1961,asamended(22U.S.C.2151b–2),totheextent

administeredbytheSecretary,isrequiredtocomplywithsubparagraph(k)(2)(ii)of


(2)Prohibitions.

(i)Theentitiestowhichthissubparagraph(k)(2)(i)appliesshallnot:

(A)PermitFederalfinancialassistanceidentifiedin(k)(1)(ii)tobeusedina

mannerthatwouldviolateprovisionsinsubparagraphs(k)(2)(ii)(A)(1)through(5)

ofthissectionrelatedtoabortionsandinvoluntarysterilizations.

(B)ObligateorexpendFederalfinancialassistanceunderanappropriations

actthatcontainsthe1985Amendmentandidentifiedin(k)(1)(ii)foranycountryor

organizationifthePresidentcertifiesthattheuseofthesefundsbyanysuch

countryororganizationwouldviolateprovisionsinsubparagraphs(k)(2)(ii)(A)(1)

through(5)ofthissectionrelatedtoabortionsandinvoluntarysterilizations.

(ii)Theentitiestowhichthissubparagraph(k)(2)(ii)appliesshallnot:

(A)UsesuchFederalfinancialassistanceidentifiedin(k)(1)(iii)to:

(1)Payfortheperformanceofabortionsasamethodoffamilyplanning;

(2)Motivateorcoerceanypersontopracticeabortions;

(3)Payfortheperformanceofinvoluntarysterilizationsasamethodof

familyplanning;

(4)Coerceorprovideanyfinancialincentivetoanypersontoundergo

sterilizations;or


418

(5)Payforanybiomedicalresearchthatrelatesinwholeorinpart,to

methodsof,ortheperformanceof,abortionsorinvoluntarysterilizationasameans

offamilyplanning.

(B)ObligateorexpendFederalfinancialassistanceunderanappropriations

actthatcontainsthe1985Amendmentandidentifiedin(k)(1)(iii)foranycountry

ororganizationifthePresidentcertifiesthattheuseofthesefundsbyanysuch

countryororganizationwouldviolateprovisionsinsubparagraphs(k)(2)(ii)(A)(1)

through(5)ofthissectionrelatedtoabortionsandinvoluntarysterilizations.

(l)NewbornandInfantHearingLossScreening,42U.S.C.280g‐1(d).

(1)Applicability.TheDepartmentisrequiredtocomplywithsubparagraph

(l)(2)ofthissectionand§88.6ofthispart.

(2)Requirement.TheDepartmentshallnotconstrue42U.S.C.280g‐1to

preemptorprohibitanyStatelawthatdoesnotrequirethescreeningforhearing

lossofchildrenofparentswhoobjecttothescreeningonthegroundsthatit

conflictswiththeparents’religiousbeliefs.

(m)MedicalScreening,Examination,Diagnosis,Treatment,orOtherHealth

CareorServices,42U.S.C.1396f.

(1)Applicability.TheDepartmentisrequiredtocomplywithsubparagraph

(m)(2)ofthissectionand§88.6ofthispart.

(2)Requirementsandprohibitions.TheDepartmentshallnotconstrue

anythingin42U.S.C.1396etseq.torequireaStateagencythatadministersaState

MedicaidPlantocompelanypersontoundergoanymedicalscreening,examination,


419

diagnosis,ortreatmentortoacceptanyotherhealthcareorservicesprovided

undersuchplanforanypurpose(otherthanforthepurposeofdiscoveringand

preventingthespreadofinfectionorcontagiousdiseaseorforthepurposeof

protectingenvironmentalhealth),ifsuchpersonobjects(or,incasesuchpersonisa

child,hisparentorguardianobjects)theretoonreligiousgrounds.

(n)OccupationalIllnessExaminationsandTests,29U.S.C.669(a)(5).

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(n)(2)ofthis


(ii)Anyrecipientofgrantsorcontractsunder29U.S.C.669,totheextent

administeredbytheSecretary,isrequiredtocomplywithsubparagraph(n)(2)of


(2)Requirements.Entitiestowhichthissubparagraph(n)(2)appliesshallnot

deemanyprovisionof29U.S.C.651etseq.toauthorizeorrequiremedical

examination,immunization,ortreatment,asprovidedunder29U.S.C.669,forthose

whoobjecttheretoonreligiousgrounds,exceptwheresuchisnecessaryforthe

protectionofthehealthorsafetyofothers.

(o)Vaccination,42U.S.C.1396s(c)(2)(B)(ii).

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraph(o)(2)ofthis



420

(ii)AnyStateagencythatadministersapediatricvaccinedistribution

programunder42U.S.C.1396sisrequiredtocomplywithsubparagraph(o)(2)of


(2)Requirement.Theentitiestowhichthissubparagraph(o)(2)appliesshall

ensurethat,underanyState‐administeredpediatricvaccinedistributionprogram

under42U.S.C.1396s,theprovideragreementexecutedbyanyprogram‐registered

provider,asdefinedunder42U.S.C.1396s(c)(1),includestherequirementthatthe

program‐registeredproviderwillprovidepediatricvaccinesincompliancewithall

applicableStatelawrelatingtoanyreligiousorotherexemption.SuchStatelawmay

includeStatestatutory,regulatory,orconstitutionalprotectionsforconscienceand

religiousfreedom,whereapplicable.

(p)SpecificAssessment,PreventionandTreatmentServices,42U.S.C.290bb‐

36(f),5106i(a).

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraphs(p)(2)(i)

through(iii)ofthissectionand§88.6ofthispart.

(ii)AnyState,politicalsubdivision,publicorganization,privatenonprofit

organization,institutionofhighereducation,ortribalorganizationactivelyinvolved

withtheState‐sponsoredstatewideortribalyouthsuicideearlyinterventionand

preventionstrategy,designatedbyaStatetodevelopordirecttheState‐sponsored

Statewideyouthsuicideearlyinterventionandpreventionstrategyunder42U.S.C.

290bb–36andthatreceivesagrantorcooperativeagreementthereunder,is


421

requiredtocomplywithsubparagraph(p)(2)(iii)ofthissectionand§§88.4and

88.6ofthispart.

(iii)AnyfederallyrecognizedIndiantribeortribalorganization(asdefined

intheIndianSelf‐DeterminationandEducationAssistanceAct[25U.S.C.5301et

seq.])oranurbanIndianorganization(asdefinedintheIndianHealthCare

ImprovementAct[25U.S.C.1601etseq.])thatisactivelyinvolvedinthe

developmentandcontinuationofatribalyouthsuicideearlyinterventionand

preventionstrategyunder42U.S.C.290bb–36andthatreceivesagrantor

cooperativeagreementthereunderisrequiredtocomplywithsubparagraph

(p)(2)(iii)ofthissection.

(iv)Anyentitythatreceivesfundsunder42U.S.C.Chapter67,SubchaptersI

orIIIisrequiredtocomplywithsubparagraphs(p)(2)(i)and(ii)ofthissectionand

§§88.4and88.6ofthispart.

(2)Requirementsandprohibitions.(i)Entitiestowhichthissubparagraph

(p)(2)(i)appliesshallnotconstruethereceiptoffundsunderoranythingin42

U.S.C.Chapter67,SubchaptersIorIIIasestablishinganyFederalrequirementthata

parentorlegalguardianprovideachildanymedicalserviceortreatmentagainst

thereligiousbeliefsoftheparentorlegalguardian.

(ii)Entitiestowhichthissubparagraph(p)(2)(ii)appliesshallnotconstrue

thereceiptoffundsunderoranythingin42U.S.C.Chapter67,SubchaptersIorIIIas

requiringaStatetofind,orprohibitingaStatefromfinding,childabuseorneglectin

casesinwhichaparentorlegalguardianreliessolelyorpartiallyuponspiritual


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meansratherthanmedicaltreatment,inaccordancewiththereligiousbeliefsofthe

parentorlegalguardian.

(iii)Entitiestowhichthissubparagraph(p)(2)(iii)appliesshallnotconstrue

anythingin42U.S.C.290bb‐36torequiresuicideassessment,earlyintervention,or

treatmentservicesforyouthwhoseparentsorlegalguardiansobjectbasedonthe

parents’orlegalguardians’religiousbeliefsormoralobjections.

(q)Religiousnonmedicalhealthcare,42U.S.C.1320a–1(h),1320c‐11,1395i‐5,

1395x(e),1395x(y)(1),1396a(a),and1397j‐1(b).

(1)Applicability.

(i)TheDepartmentisrequiredtocomplywithsubparagraphs(q)(2)(i),(ii),

(iii)and(iv)ofthissectionand§88.6ofthispart.

(ii)AnyStateagencythatmakesanagreementwiththeSecretarypursuant

to42U.S.C.1320a‐1(b)isrequiredtocomplywithsubparagraph(q)(2)(i)ofthis

sectionand§§88.4and88.6ofthispart.

(iii)AnyentityreceivingFederalfinancialassistancefromparticipatingin

Medicareisrequiredtocomplywithsubparagraphs(q)(2)(ii)ofthissectionand§§

88.4and88.6ofthispart.

(iv)Anyentity,includingaState,receivingFederalfinancialassistancefrom

participatinginMedicaid,includinganyentityreceivingFederalfinancialassistance

throughCHIPthatisusedtoexpandMedicaid,isrequiredtocomplywith

subparagraphs(q)(2)(iii)ofthissectionand§§88.4and88.6ofthispart.


423

(v)Anyentity,includingaStateorlocalgovernmentorsubdivisionthereof,

receivingFederalfinancialassistanceundersubtitleBofTitleXXoftheSocial

SecurityAct(42U.S.C.1397j‐1397m‐5)isrequiredtocomplywithsubparagraph

(q)(2)(iv)ofthissectionand§§88.4and88.6ofthispart.


(i)Theentitiestowhichthissubparagraph(q)(2)(i)appliesshallnotapply

theprovisionsof42U.S.C.1320a‐1toareligiousnonmedicalhealthcareinstitution

asdefinedin42U.S.C.1395x(ss)(1).

(ii)Withrespecttoareligiousnonmedicalhealthcareinstitutionasdefined

in42U.S.C.1395x(ss)(1),theentitiestowhichthissubparagraph(q)(2)(ii)applies

shallnot:

(A)FailorrefusetomakeapaymentunderpartAofsubchapterXVIIIof

chapter7ofTitle42oftheU.S.Codeforinpatienthospitalservices,post‐hospital

extendedcareservices,orhomehealthservicesfurnishedtoanindividualbya

religiousnonmedicalhealthcareinstitutionthatisahospitalasdefinedin42U.S.C.

1395x(e),askillednursingfacilityasdefinedin42U.S.C.1395x(y),orahomehealth

agencyasdefinedin42U.S.C.1395x(aaa),respectively,iftheconditionunder42

U.S.C.1395i‐5(a)(2)issatisfiedandanindividualmakesanelectionpursuantto

1395i‐5(b)that:

(1)Suchindividualisconscientiouslyopposedtoacceptanceofmedicalcare

ortreatmentotherthanmedicalcareortreatment(includingmedicalandother

healthservices)thatis:


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(i)Receivedinvoluntarily,or

(ii)RequiredunderFederalorStatelaworlawofapoliticalsubdivisionofa

State;and

(2)Acceptanceofsuchmedicaltreatmentwouldbeinconsistentwithsuch

individual’ssincerereligiousbeliefs,or

(B)Inadministering42USC1395i‐5or1395x(ss)(1):

(1)Requireanypatientofareligiousnonmedicalhealthcareinstitutionto

undergomedicalscreening,examination,diagnosis,prognosis,ortreatmentorto

acceptanyothermedicalhealthcareservice,ifsuchpatient(orlegalrepresentative

ofthepatient)objectstosuchserviceonreligiousgrounds,or

(2)Subjectareligiousnonmedicalhealthcareinstitutionoritspersonnelto

anymedicalsupervision,regulation,orcontrol,insofarassuchsupervision,

regulation,orcontrolwouldbecontrarytothereligiousbeliefsobservedbythe

institutionorsuchpersonnel,or

(C)Subjectreligiousnonmedicalhealthcareinstitutiontotheprovisionsof

partBofsubchapterXIofChapter7ofTitle42oftheU.S.Code.

(iii)Pursuantto42U.S.C.1396a(a),theentitiestowhichthissubparagraph

(q)(2)(iii)appliesshallnotfailorrefusetoexemptareligiousnonmedicalhealth

careinstitutionfromtheMedicaidrequirementsto:

(A)MeetStatestandardsdescribedin42U.S.C.1396a(a)(9)(A);

(B)Beevaluatedunder42U.S.C.1396a(a)(33),ontheappropriatenessand

qualityofcareandservices;


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(C)Undergoaregularprogram,under42U.S.C.1396(a)(31),ofindependent

professionalreview,includingmedicalevaluation,ofservicesinanintermediate

carefacilityforpersonswithmentaldisabilities;and

(D)Meettherequirementsof42U.S.C.1396(b)(i)(4)toestablishautilization

reviewplanconsistentwith,orsuperiorto,theutilizationreviewplancriteriaunder

42U.S.C.1395x(k)forMedicare.

(iv)Pursuantto42U.S.C.1397j‐1(b),theentitiestowhichthissubparagraph

(q)(2)(iv)appliesshallnotconstruesubtitleBofTitleXXoftheSocialSecurityAct

(42U.S.C.1397j‐1397m‐5)tointerferewithorabridgeanelder'srighttopractice

hisorherreligionthroughrelianceonprayeraloneforhealingwhenthischoice:

(A)Iscontemporaneouslyexpressed,eitherorallyorinwriting,withrespect

toaspecificillnessorinjurywhichtheelderhasatthetimeofthedecisionbyan

elderwhoiscompetentatthetimeofthedecision;

(B)Ispreviouslysetforthinalivingwill,healthcareproxy,orotheradvance

directivedocumentthatisvalidlyexecutedandappliedunderStatelaw; or

(C)Maybeunambiguouslydeducedfromtheelder'slifehistory.

§88.4Assuranceandcertificationofcompliancerequirements.

(a)Ingeneral.

(1)Assurance.Exceptforanapplicationorrecipienttowhichparagraph(c)

ofthissectionapplies,everyapplicationforFederalfinancialassistanceorFederal

fundsfromtheDepartmenttowhich§88.3ofthispartappliesshall,asacondition

oftheapproval,renewal,orextensionofanyFederalfinancialassistanceorFederal


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fundsfromtheDepartmentpursuanttotheapplication,provide,contain,orbe

accompaniedbyanassurancethattheapplicantorrecipientwillcomplywith

applicableFederalconscienceandanti‐discriminationlawsandthispart.

(2)Certification.Exceptforanapplicationorrecipienttowhichparagraph

(c)ofthissectionapplies,everyapplicationforFederalfinancialassistanceor

FederalfundsfromtheDepartmenttowhich§88.3ofthispartapplies,shall,asa

conditionoftheapproval,renewal,orextensionofanyFederalfinancialassistance

orFederalfundsfromtheDepartmentpursuanttotheapplication,provide,contain,

orbeaccompaniedby,acertificationthattheapplicantorrecipientwillcomplywith

applicableFederalconscienceandanti‐discriminationlawsandthispart.

(b)Specificrequirements.

(1)Timing.Entitieswhoarealreadyrecipientsasoftheeffectivedateofthis

partoranyapplicantsshallsubmittheassurancerequiredinsubparagraph(a)(1)of

thissectionandthecertificationrequiredinsubparagraph(a)(2)ofthissectionasa

conditionofanyapplicationorreapplicationforfundstowhichthispartapplies,

throughanyinstrumentorasaconditionofanamendmentormodificationofthe

instrumentthatextendsthetermofsuchinstrumentoraddsadditionalfundstoit.

Submissionmayberequiredmorefrequentlyif:

(i)Theapplicantorrecipientfailstomeetarequirementofthispart,or

(ii)OCRortherelevantDepartmentcomponenthasreasontosuspector

causetoinvestigatethepossibilityofsuchfailure.


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(2)Formandmanner.Applicantsorrecipientsshallsubmittheassurance

requiredinsubparagraph(a)(1)ofthissectionandthecertificationrequiredin

subparagraph(a)(2)ofthissectionintheformandmannerthatOCR,in

coordinationwiththerelevantDepartmentcomponent,specifies,orshallsubmit

theminaseparatewritingsignedbytheapplicant’sorrecipient'sofficerorother

personauthorizedtobindtheapplicantorrecipient.

(3)Durationofobligation.Theassurancerequiredinsubparagraph(a)(1)of

thissectionandthecertificationrequiredinsubparagraph(a)(2)ofthissectionwill

obligatetherecipientfortheperiodduringwhichtheDepartmentextendsFederal

financialassistanceorFederalfundsfromtheDepartmenttoarecipient.

(4)Compliancerequirement.Submissionofanassuranceorcertification

requiredunderthissectionwillnotrelievearecipientoftheobligationtotakeand

completeanyactionnecessarytocomeintocompliancewithFederalconscienceand

anti‐discriminationlawsandthispartpriorto,atthetimeof,orsubsequentto,the

submissionofsuchassuranceorcertification.

(5)Conditionofcontinuedreceipt.Provisionofacompliantassuranceand

certificationshallconstituteaconditionofcontinuedreceiptofFederalfinancial

assistanceorFederalfundsfromtheDepartmentandisbindingupontheapplicant

orrecipient,itssuccessors,assigns,ortransfereesfortheperiodduringwhichsuch

FederalfinancialassistanceorFederalfundsfromtheDepartmentareprovided.

(6)Assurancesandcertificationsinapplications.Anapplicantorrecipient

mayincorporatetheassurancesandcertificationsbyreferenceinsubsequent


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applicationstotheDepartmentorDepartmentcomponentifpriorassurancesor

certificationsareinitiallyprovidedinthesamefiscalorcalendaryear,asapplicable.

(7)Enforcementofassurancesandcertifications.TheDepartment,

Departmentcomponents,andOCRshallhavetherighttoseekenforcementofthe

assurancesandcertificationsrequiredinthissection.

(8)Remediesforfailuretomakeassurancesandcertifications.Ifanapplicant

orrecipientfailsorrefusestofurnishanassuranceorcertificationrequiredunder

thissection,OCR,incoordinationwiththerelevantDepartmentcomponent,may

effectcompliancebyanyofthemechanismsprovidedin§88.7.

(c)Exceptions.Thefollowingpersonsorentitiesshallnotberequiredto

complywithsubparagraphs(a)(1)and(2)ofthissection,providedthatsuch

personsorentitiesarenotrecipientsofFederalfinancialassistanceorotherFederal

fundsfromtheDepartmentthroughanotherinstrument,program,ormechanism,

otherthanthosesetforthinsubparagraphs(c)(1)through(4)ofthissection:

(1)Aphysician,asdefinedin42U.S.C.1395x(r),physicianoffice,pharmacist,

pharmacy,orotherhealthcarepractitionerparticipatinginPartBoftheMedicare

program;

(2)ArecipientofFederalfinancialassistanceorotherFederalfundsfromthe

Departmentawardedundercertaingrantprogramscurrentlyadministeredbythe

AdministrationforChildrenandFamilies,thepurposeofwhichiseithersolely

financialassistanceunrelatedtohealthcareorwhichisotherwiseunrelatedto

healthcareprovision,andwhich,inaddition,doesnotinvolve—


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(i)Medicalorbehavioralresearch;

(ii)Healthcareproviders;or

(iii)Anysignificantlikelihoodofreferralfortheprovisionofhealthcare;

(3)ArecipientofFederalfinancialassistanceorotherFederalfundsfromthe

Departmentawardedundercertaingrantprogramscurrentlyadministeredbythe

AdministrationonCommunityLiving,thepurposeofwhichiseithersolelyfinancial

assistanceunrelatedtohealthcareorwhichisotherwiseunrelatedtohealthcare

provision,andwhich,inaddition,doesnotinvolve—

(i)Medicalorbehavioralresearch;

(ii)Healthcareproviders;or

(iii)Anysignificantlikelihoodofreferralfortheprovisionofhealthcare.

(4)IndianTribesandTribalOrganizationswhencontractingwiththeIndian

HealthServiceundertheIndianSelf‐DeterminationandEducationAssistanceAct.

§88.5NoticeofrightsunderFederalconscienceandanti‐discriminationlaws.

(a)Ingeneral.Ininvestigatingacomplaintorconductingacompliance

review,OCRwillconsideranentity’svoluntarypostingofanoticeof

nondiscriminationasnon‐dispositiveevidenceofcompliancewiththeapplicable

substantiveprovisionsofthispart,totheextentsuchnoticesareprovidedaccording

totheprovisionsofthissectionandarerelevanttotheparticularinvestigationor

compliancereview.

(b)Placementofthenoticetext.InevaluatingtheDepartment’sora

recipient’scompliancewiththispart,OCRwilltakeintoaccountwhether,as


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applicableandappropriate,theDepartmentorrecipienthasprovidedthenotice

underthissection:

(1)OntheDepartmentorrecipient’swebsite(s);

(2)InaprominentandconspicuousphysicallocationinDepartmentor

recipientestablishmentswherenoticestothepublicandnoticestoitsworkforce

arecustomarilypostedtopermitreadyobservation;

(3)Inapersonnelmanualorothersubstantiallysimilardocumentfor

membersoftheDepartmentorrecipient’sworkforce;

(4)InapplicationstotheDepartmentorrecipientforinclusioninthe

workforceorforparticipationinaservice,benefit,orotherprogram,includingfor

trainingorstudy;and

(5)Inanystudenthandbookorothersubstantiallysimilardocumentfor

studentsparticipatinginaprogramoftrainingorstudy,includingforpost‐graduate

interns,residents,andfellows.

(6)Suchthatthetextofthenoticeislargeandconspicuousenoughtobe

readeasilyandispresentedinaformat,location,ormannerthatimpedesor

preventsthenoticebeingaltered,defaced,removed,orcoveredbyothermaterial.

(c)Contentofthenoticetext.TherecipientandtheDepartmentshould

considerusingthemodeltextprovidedinAppendixAforthenotice,butmaytailor

itsnoticetoaddressitsparticularcircumstancesandtomorespecificallyaddress

thelawsthatapplytoitunderthisrule.


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(d)Combinednondiscriminationnotices.TheDepartmentandeachrecipient

maypostthenoticetextprovidedinAppendixAofthispart,oranoticeitdrafts

itself,alongwiththecontentofothernotices(suchasothernon‐discrimination

notices).

§88.6Compliancerequirements.

(a)Ingeneral.TheDepartmentandeachrecipienthasprimaryresponsibility

toensurethatitisincompliancewithFederalconscienceandanti‐discrimination

lawsandthispart,andshalltakestepstoeliminateanyviolationsoftheFederal

conscienceandanti‐discriminationlawsandthispart.Ifasub‐recipientisfoundto

haveviolatedtheFederalconscienceandanti‐discriminationlaws,therecipient

fromwhomthesub‐recipientreceivedfundsmaybesubjecttotheimpositionof

fundingrestrictionsoranyappropriateremediesavailableunderthispart,

dependingonthefactsandcircumstances.

(b)Recordsandinformation.TheDepartment,eachrecipient,andeachsub‐

recipientshallmaintaincompleteandaccuraterecordsevidencingcompliancewith

Federalconscienceandanti‐discriminationlawsandthispart,andaffordOCR,upon

request,reasonableaccesstosuchrecordsandinformationinatimelymannerand

totheextentOCRfindsnecessarytodeterminecompliancewiththeFederal

conscienceandanti‐discriminationlawsandthispart.Suchrecords:

(1)Shallbemaintainedforaperiodofthreeyearsfromthedatetherecord

wascreatedorobtainedbytherecipientorsub‐recipient;


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(2)Shallcontainanyinformationmaintainedbytherecipientorsub‐

recipientthatpertainstodiscriminationonthebasisofreligiousbelieformoral

conviction,including,withoutlimitation,anycomplaints;statements,policies,or

noticesconcerningdiscriminationonthebasisofreligiousbelieformoral

conviction;proceduresforaccommodatingemployees’orotherprotected

individuals’religiousbeliefsormoralconvictions;andrecordsofrequestsforsuch

religiousormoralaccommodationandtherecipientorsub‐recipient’sresponseto

suchrequests;and

(3)MaybemaintainedinanyformandmannerthataffordsOCRwith

reasonableaccesstotheminatimelymanner.

(c)Cooperation.TheDepartment,eachrecipient,andeachsub‐recipientshall

cooperatewithanycompliancereview,investigation,interview,orotherpartof

OCR’senforcementprocess,whichmayincludeproductionofdocuments,

participationininterviews,responsetodatarequests,andmakingavailableof

premisesforinspectionwhererelevant.FailuretocooperatemayresultinanOCR

referraltotheDepartmentofJustice,incoordinationwiththeDepartment’sOfficeof

theGeneralCounsel,forfurtherenforcementinFederalcourtorotherwise.Each

recipientorsub‐recipientshallpermitaccessbyOCRduringnormalbusinesshours

tosuchofitsbooks,records,accounts,andothersourcesofinformation,aswellas

itsfacilities,asmaybepertinenttoascertaincompliancewiththispart.Asserted

considerationsofprivacyorconfidentialitymaynotoperatetobarOCRfrom

evaluatingorseekingtoenforcecompliancewiththispart.Informationofa


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confidentialnatureobtainedinconnectionwithcompliancereviews,investigations,

orotherenforcementactivitiesshallnotbedisclosedexceptasrequiredinformal

enforcementproceedingsorasotherwiserequiredbylaw.

(d)Reportingrequirement.Ifarecipientorsub‐recipientissubjecttoa

determinationbyOCRofnoncompliancewiththispart,therecipientorsub‐

recipientmust,inanyapplicationforneworrenewedFederalfinancialassistance

orDepartmentalfundinginthethreeyearsfollowingsuchdetermination,disclose

theexistenceofthedeterminationofnoncompliance.Thisincludesarequirement

thatrecipientsdiscloseanyOCRdeterminationsmadeagainsttheirsub‐recipients.

(e)Intimidatingorretaliatoryactsprohibited.NeithertheDepartmentnor

anyrecipientorsub‐recipientshallintimidate,threaten,coerce,ordiscriminate

againstanyentityforthepurposeofinterferingwithanyrightorprivilegeunder

theFederalconscienceandanti‐discriminationlawsorthispart,orbecausesuch

entityhasmadeacomplaintorparticipatedinanymannerinaninvestigationor

reviewundertheFederalconscienceandanti‐discriminationlawsorthispart.

§88.7Enforcementauthority.

(a)Ingeneral.OCRhasbeendelegatedtheauthoritytofacilitateand

coordinatetheDepartment’senforcementoftheFederalconscienceandanti‐

discriminationlaws,whichincludestheauthorityto:

(1)Receiveandhandlecomplaints;

(2)Initiatecompliancereviews;

(3)Conductinvestigations;


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(4)CoordinatecompliancewithintheDepartment;

(5)Seekvoluntaryresolutionsofcomplaints;

(6)Incoordinationwiththerelevantcomponentorcomponentsofthe

DepartmentandtheOfficeoftheGeneralCounsel,makeenforcementreferralsto

theDepartmentofJustice;

(7)IncoordinationwiththerelevantDepartmentalfundingcomponent,

utilizeexistingregulationsforinvoluntaryenforcement,suchasthosethatapplyto

grants,contracts,orCMSprograms;and

(8)Incoordinationwiththerelevantcomponentorcomponentsofthe

Department,coordinateotherappropriateremedialactionastheDepartment

deemsnecessaryandasallowedbylawandapplicableregulation.

(b)Complaints.Anyentity,whetherindividually,asamemberofaclass,on

behalfofothers,oronbehalfofanentity,mayfileacomplaintwithOCRallegingany

potentialviolationofFederalconscienceandanti‐discriminationlawsorthispart.

OCRshallcoordinatehandlingofcomplaintswiththerelevantDepartment

component(s).Thecomplaintfilerisnotrequiredtobetheentitywhoserights

undertheFederalconscienceandanti‐discriminationlawsorthisparthavebeen

potentiallyviolated.

(c)Compliancereviews.OCRmayconductcompliancereviewsoruseother

similarproceduresasnecessarytopermitOCRtoinvestigateandreviewthe

practicesoftheDepartment,Departmentcomponents,recipients,andsub‐

recipientstodeterminewhethertheyarecomplyingwithFederalconscienceand


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anti‐discriminationlawsandthispart.OCRmayinitiateacompliancereviewofan

entitysubjecttothispartbasedoninformationfromacomplaintorothersource

thatcausesOCRtosuspectnon‐compliancebysuchentitywiththispartorthelaws

implementedbythispart.

(d)Investigations.OCRshallmakeapromptinvestigation,whenevera

compliancereview,report,complaint,oranyotherinformationfoundbyOCR

indicatesathreatened,potential,oractualfailuretocomplywithFederalconscience

andanti‐discriminationlawsorthispart.Theinvestigationshouldinclude,where

appropriate,areviewofthepertinentpractices,policies,communications,

documents,compliancehistory,circumstancesunderwhichthepossible

noncomplianceoccurred,andotherfactorsrelevanttodeterminingwhetherthe

Department,Departmentcomponent,recipient,orsub‐recipienthasfailedto

comply.OCRshallusefact‐findingmethodsincludingsitevisits;interviewswiththe

complainants,Departmentcomponent,recipients,sub‐recipients,orthird‐parties;

andwrittendataordiscoveryrequests.OCRmayseektheassistanceofanyState

agency.

(e)Failuretorespond.Absentgoodcause,thefailureofanentitythatis

subjecttothisparttorespondtoarequestforinformationortoadataordocument

requestwithin45daysofOCR’srequestshallconstituteaviolationofthispart.

(f)Relatedadministrativeorjudicialproceeding.Consistentwithother

applicableFederallaws,testimonyandotherevidenceobtainedinaninvestigation

orcompliancereviewconductedunderthispartmaybeusedbytheDepartmentfor,


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andofferedintoevidencein,anyadministrativeorjudicialproceedingrelatedto

thispart.

(g)Supervisionandcoordination.Ifasaresultofaninvestigation,compliance

review,orotherenforcementactivity,OCRdeterminesthataDepartment

componentappearstobeinnoncompliancewithitsresponsibilitiesunderFederal

conscienceandanti‐discriminationlawsorthispart,OCRwillundertake

appropriateactionwiththecomponenttoassurecompliance.IntheeventthatOCR

andtheDepartmentcomponentareunabletoagreeonaresolutionofanyparticular

matter,themattershallbesubmittedtotheSecretaryforresolution.OCRmayfrom

timetotimerequesttheassistanceofofficialsoftheDepartmentincarryingout

responsibilitiesinconnectionwiththeenforcementofFederalconscienceandanti‐

discriminationlawsandthispart,includingtheachievementofeffective

coordinationandmaximumuniformitywithintheDepartment.

(h)ReferraltotheDepartmentofJustice.Ifasaresultofaninvestigation,

compliancereview,orotherenforcementactivity,OCRdeterminesthatarecipient

orsub‐recipientisnotincompliancewiththeFederalconscienceandanti‐

discriminationlawsorthispart,OCRmay,incoordinationwiththerelevant

DepartmentcomponentandtheOfficeoftheGeneralCounsel,makereferralstothe

DepartmentofJustice,forfurtherenforcementinFederalcourtorotherwise.OCR

mayalsomakereferralstotheDepartmentofJustice,incoordinationwiththeOffice

oftheGeneralCounsel,concerningpotentialviolationsof18U.S.C.1001or42U.S.C.

300a–8forenforcementorotherappropriateaction.


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(i)Resolutionofmatters.

(1)Ifaninvestigationorcompliancereviewrevealsthatnoactionis

warranted,OCRwillsoinformanypartywhohasbeennotifiedoftheexistenceof

theinvestigationorcompliancereview,ifany,inwriting.

(2)Ifaninvestigationorcompliancereviewindicatesafailuretocomply

withFederalconscienceandanti‐discriminationlawsorthispart,OCRwillso

informtherelevantpartiesandthematterwillberesolvedbyinformalmeans

wheneverpossible.AttemptstoresolvemattersinformallyshallnotprecludeOCR

fromsimultaneouslypursuinganyactiondescribedin§88.7(a)(5)‐(7).

(3)IfOCRdeterminesthatthereisafailuretocomplywithFederal

conscienceandanti‐discriminationlawsorthispart,compliancewiththeselaws

andthispartmaybeeffectedbythefollowingactions,takenincoordinationwith

therelevantDepartmentcomponent,andpursuanttostatutesandregulations

whichgoverntheadministrationofcontracts(e.g.,FederalAcquisitionRegulation),

grants(e.g.,45CFRpart75)andCMSfundingarrangements(e.g.,theSocialSecurity

Act):

(i)TemporarilywithholdingFederalfinancialassistanceorotherFederal

funds,inwholeorinpart,pendingcorrectionofthedeficiency;

(ii)DenyinguseofFederalfinancialassistanceorotherFederalfundsfrom

theDepartment,includinganyapplicablematchingcredit,inwholeorinpart;

(iii)Whollyorpartlysuspendingawardactivities;


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(iv)TerminatingFederalfinancialassistanceorotherFederalfundsfromthe

Department,inwholeorinpart;

(v)Denyingorwithholding,inwholeorinpart,newFederalfinancial

assistanceorotherFederalfundsfromtheDepartmentadministeredbyorthrough

theSecretaryforwhichanapplicationorapprovalisrequired,includingrenewalor

continuationofexistingprogramsoractivitiesorauthorizationofnewactivities;

(vi)IncoordinationwiththeOfficeoftheGeneralCounsel,referringthe

mattertotheAttorneyGeneralforproceedingstoenforceanyrightsoftheUnited

States,orobligationsoftherecipientorsub‐recipient,underFederallaworthis

part;and

(vii)Takinganyotherremediesthatmaybelegallyavailable.

(j)Noncompliancewith§88.4.IfarecipientofFederalfinancialassistanceor

applicantthereforfailsorrefusestofurnishanassuranceorcertificationrequired

under§88.4orotherwisefailsorrefusestocomplywitharequirementimposedby

orpursuanttothatsection,OCR,incoordinationwiththerelevantDepartment

component,mayeffectcompliancebyanyoftheremediesprovidedinparagraph

88.7(i).TheDepartmentshallnotberequiredtoprovideassistanceinsuchacase

duringthependencyoftheadministrativeproceedingsbroughtundersuch

paragraph.

§88.8Relationshiptootherlaws.

NothinginthispartshallbeconstruedtopreemptanyFederal,State,orlocal

lawthatisequallyormoreprotectiveofreligiousfreedomandmoralconvictions.


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Nothinginthispartshallbeconstruedtonarrowthemeaningorapplicationofany

StateorFederallawprotectingfreeexerciseofreligiousbeliefsormoral

convictions.

§88.9Ruleofconstruction.

Thispartshallbeconstruedinfavorofabroadprotectionofthefreeexercise

ofreligiousbeliefsandmoralconvictions,tothemaximumextentpermittedbythe

ConstitutionandthetermsoftheFederalconscienceandanti‐discriminationlaws.

§88.10Severability.

Anyprovisionofthispartheldtobeinvalidorunenforceableeitherbyits

termsorasappliedtoanyentityorcircumstanceshallbeconstruedsoasto

continuetogivethemaximumeffecttotheprovisionpermittedbylaw,unlesssuch

holdingshallbeoneofutterinvalidityorunenforceability,inwhicheventsuch

provisionshallbeseverablefromthispart,whichshallremaininfullforceand

effecttothemaximumextentpermittedbylaw.Aseveredprovisionshallnotaffect

theremainderofthispartortheapplicationoftheprovisiontootherpersonsor

entitiesnotsimilarlysituatedortoother,dissimilarcircumstances.

AppendixAtoPart88—ModelText:NoticeofRightsunderFederalConscience

andAnti‐DiscriminationLaws

[Nameofrecipient,theDepartment,orDepartmentcomponent]complies

withapplicableFederalconscienceandanti‐discriminationlawsprohibiting

exclusion,adversetreatment,coercion,orotherdiscriminationagainstindividuals

orentitiesonthebasisoftheirreligiousbeliefsormoralconvictions.Youmayhave


440

therightunderFederallawtodeclinetoperform,assistintheperformanceof,refer

for,undergo,orpayforcertainhealthcare‐relatedtreatments,research,orservices

(suchasabortionorassistedsuicide,amongothers)thatviolateyourconscience,

religiousbeliefs,ormoralconvictions.

Ifyoubelievethat[Nameofrecipient,theDepartment,orDepartment

component]hasfailedtoaccommodateyourconscientious,religious,ormoral

objection,orhasdiscriminatedagainstyouonthosegrounds,youcanfilea

conscienceandreligiousfreedomcomplaintwiththeU.S.DepartmentofHealthand

HumanServices,OfficeforCivilRights,electronicallythroughtheOfficeforCivil

RightsComplaintPortal,availableathttps://ocrportal.hhs.gov/ocr/portal/lobby.jsf

orbymailorphoneat:U.S.DepartmentofHealthandHumanServices,200

IndependenceAvenue,SWRoom509F,HHHBuildingWashington,D.C.20201,1‐

800‐368‐1019,800‐537‐7697(TDD).Complaintformsandmoreinformationabout

Federalconscienceandanti‐discriminationlawsareavailableat

http://www.hhs.gov/conscience.

Dated:__________,2019.

—————————————————

AlexM.AzarII

Secretary

DepartmentofHealthandHumanServices.

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