Download - August 12, 2020 The Honorable Seema Verma

Kidney Care Partners • 601 13th St NW, 11th Floor • Washington, DC • 20005 • Tel: 202.534.1773

August12,2020TheHonorableSeemaVermaAdministratorCentersforMedicare&MedicaidServices7500SecurityBoulevardBaltimore,MD21244Re:CMS–1732–P:“End-StageRenalDiseaseProspectivePaymentSystem,PaymentforRenalDialysisServicesFurnishedtoIndividualswithAcuteKidneyInjury,andEnd-StageRenalDiseaseQualityIncentiveProgram”DearAdministratorVerma: KidneyCarePartners(KCP)appreciatestheopportunitytoprovidecommentsonthe“End-StageRenalDiseaseProspectivePaymentSystem,PaymentforRenalDialysisServicesFurnishedtoIndividualswithAcuteKidneyInjury,andEnd-StageRenalDiseaseQualityIncentiveProgram”(ProposedRule).ThisletteroutlinesoursupportfortheproposalsrelatedtotheEnd-StageRenalDisease(ESRD)QualityIncentiveProgram(QIP)andhighlightsconcernsaboutthevalidityandreliabilityofsomeofthemeasures,aswellasstructuralproblems,includingtheimpactofthepandemicontheQIP.Ourcommentsontheprospectivepaymentsystemwillbesharedinaseparateletter. KCPisanallianceofmorethan30membersofthekidneycarecommunity,includingpatientadvocates,healthcareprofessionals,providers,andmanufacturersorganizedtoadvancepoliciesthatsupporttheprovisionofhigh-qualitycareforindividualswithchronickidneydisease(CKD),includingthoselivingwithEnd-StageRenalDisease(ESRD). Asdescribedinmoredetailbelow,KCPstronglysupportsthefourproposalsCMSoutlinesintheProposedRulefortheESRDQIP:

• UpdatingthespecificationsusedtocalculatetheUltrafiltrationRateandMedicationReconciliationmeasures;

• ReducingthenumberofrecordsfacilitiesselectedfortheNationalHealthSafetyNetwork(NHSN)validationarerequiredtosubmit;

• ClarifyingthetimelineforfacilitiestomakechangestotheirNHSN

BloodstreamInfection(BSI)clinicalmeasureandNHSNDialysisEventreportingmeasures;and

TheHonorableSeemaVermaAugust12,2020Page2of39

• EstablishingtheperformancestandardsandpaymentreductionsthatwouldapplyforPY2023.

Inaddition,KCPispleasedthatCMShasaffirmedits“plantore-evaluateour

reportingmeasuresforopportunitiestomorecloselyalignthemwithNQFmeasurespecifications.”1Inlightofthiseffort,KCPalsoofferssuggestionswithregardtospecificmeasuresthatwouldallowtheAgencytomeetthisgoal.WealsoencourageCMStoevaluatetheexistingQIPmeasuresconsistentwiththefollowingprinciplesandincludethosemodificationsinthefinalrulethisyear.Aswenotedinour2019commentletterontheESRDQIP,weaskthatCMS:

• UsevalidandreliablemeasuresasestablishedthroughNQFendorsement;• Adoptendorsedmeasureswhentheyareavailableovermeasuresthathavenot

beenendorsed;• NotuseorremovemeasuresthatNQFhasrejectedaspartofitsendorsement

processfromtheESRDQIPorthathavebeenassignedtoreservestatus;• AvoidmodifyingNQF-endorsedmeasureswhenadoptingthemfortheESRD

QIP;• SeekNQFendorsementfornewmeasurespriortoadoptingthemintheESRD

QIPoratleastusethemonlyasreportingmeasureswhileseekingNQF-endorsement;

• Honoritscommitmenttouseratemeasuresinfavorofratiomeasures;• Continuetoworkwithstakeholdersinatransparentprocesstoidentifyand

addressthepotentialcausesthatcouldleadtothepenaltiesincreasingwhenactualperformancehasimproved;

• WorkwiththecommunityandNQFtodevelopabetterapproachtothesmallnumbersproblem;and

• AligntheESRDQIPandESRDDFC/FiveStar.

Inadditiontothecommentsonthespecificmeasures,KCPprovidessuggestionstoaddressthedifferentialhandlingofMedicareAdvantagepatientsinseveralmeasuresintheESRDQIPandhowtoaddressthepandemicinamannerthatensurestheintegrityoftheESRDQIPlong-term.

WecontinuetosupportthetwovascularaccessmeasuresintheESRDQIP.Wealso

supportthedecisionnottoaddanynewmeasurestotheESRDQIPatthistime.Therearenow14ESRDQIPmeasures(notcountingthepooledmeasurefordialysisadequacy),whichdilutestheimpactofanyoneofthesemeasures.Asnotedbelow,weproposereducingthecurrentmeasuresetbyremovingsomeofthemeasures.WelookforwardtoworkingwithCMStomakesurethatthereisaparsimonioussetofmeasuresreflectingthe

1CMS,“MedicareProgram;End-StageRenalDiseaseProspectivePaymentSystem,PaymentforRenalDialysisServicesFurnishedtoIndividualsWithAcuteKidneyInjury,andEnd-StageRenalDiseaseQualityIncentiveProgram”85Fed.Reg.42132(July13,2020).


mostcriticaloutcomesforpatientsandaccuratelyreflectingthecareactuallyprovidedbythefacilities.

I. TheuseofvalidandreliablemeasuresthatalignwithNQF-endorsedmeasures

MeasuresusedintheESRDQIPshouldbeendorsedbyNQFtobeconsistentwith

thestatutorymandate,unlessasthestatutenotes,thereisnoendorsedmeasureinaspecificdomain.Section1890oftheSocialSecurityAct(SSA)requiresCMStocontractwithaconsensus-basedentityfordevelopingmeasuresusedinVBPs.Thesecondstatutorydutylistedfortheconsensus-basedentity,whichiscurrentlyNQF,istoendorsemeasuresforCMS’use.WhentheCongressestablishedtheESRDPPS,itwasevenmorespecificinitsmandatetouseNQFendorsedmeasures.TheStatuterequiresthat“anymeasurespecifiedbytheSecretaryundersubparagraph(A)(iv)musthavebeenendorsedbytheentitywithacontractundersection1890(a).”2Thus,KCPispleasedthatthepreamblestatesthatCMSplanstomorecloselyaligntheQIPmeasureswiththeNQFmeasurespecifications.KCPrecommendsthattoachievethisgoalnotonlyforreportingmeasures,butalsoclinicalmeasures,CMStakethefollowingstepsoutlinedbelow.KCPalsostronglyopposesuseofmeasuresintheQIPthatNQFhasrejectedthroughtheendorsementevaluationprocess.Simplyput,CMSshouldusevalidandreliablemeasuresasestablishedthroughNQFendorsement.

A. KCPsupportsaligningtheQIPUltrafiltrationandMedicationReconciliationDenominatorswiththeNQF-EndorsedSpecifications:CMSshouldavoidmodifyingNQF-endorsedmeasureswhenadoptingthemfortheESRDQIP.

KCPispleasedthatCMShasproposedtoupdatethespecificationsusedforthe

UltrafiltrationRate(UFR;NQF2701)reportingmeasurebystatingthatitwillusethepatient-monthsconstructionthatcomportswiththeNQF-endorsedmeasure.WealsoappreciatetheclarificationthatthisreportingmeasureisbasedontheoneforwhichtheKidneyCareQualityAlliance(KCQA)isthesteward.Similarly,wearepleasedthatthepreamblealsoreaffirmsthatitwillnolongerusethe“facility-months”constructionfortheMedicationReconciliation(NQF2988).Usingthea“patient-months”denominatorconstructionalignsbothofthesemeasureswiththespecificationssubmittedbythemeasuredeveloperandsteward(theKCQA),whichwereendorsedbyNQF.KCPappreciatesandconcurswiththechangetothe“patient-months”constructionforbothmeasures.

2SSA§1881(h)(2)(B)(emphasisadded).


B. KCPsupportstheefforttoreducetheburdenscreatedbytheNHSNvalidationstudy;KCPalsoreiteratesconcernsthattheNHSNBloodstreamInfectionmeasureisnotvalidandneedstobemodifiedtoprovideaccurateinformationtopatientsandactionableinformationtofacilities.

CMSproposestoreducethesubmissionrequirementforfacilitiesselectedto

participateintheNHSNvalidationstudyfrom40to20patientrecordsfromanytwoquartersduringtheapplicablecalendaryear.KCPconcurswiththisreductionandappreciatesthisrevision,whichwillreducefacilityburden.WealsosupporttheclarificationforboththeNHSNDialysisEventandtheNHSNBloodstreamInfectionmeasuresthat“anychangesthatafacilitymakestoitsdataaftertheESRDQIPdeadlinethatappliestothosedatawillnotbeincludedinthequarterlypermanentdatafilethattheCDCgeneratesforpurposesofcreatingtheannualCMSESRDQIPFinalComplianceFile.”3

WhileKCPcontinuestosupporttheNHSNDialysisEventmeasureasareporting

measure,weencourageCMStosubmitthismeasureforNQFreview,consistentwiththestatutorylanguageindicatingthatCMSshouldusemeasuresendorsedbythebodyselectedtoreviewthem,whichinthiscaseistheNQF.Therefore,wealsoaskthatCMSsubmitthemeasuretoNQFforreviewinthenextcycle.Wereiterateourrecommendationthattherecentadditionofasetofsubjectivefactors(e.g.,redness,swelling)tothemeasurebeeliminatedbecausethesefactorsdonotsupportthepurposeofthemeasure.

Consistentwithourpreviousrecommendations,KCPasksCMStoeliminatethe

NHSNBloodStreamInfection(BSI)measurewhileitdetermineshowtorevisethespecificationssothatthevalidityproblemswiththemeasurecanberesolvedandtheNQFhastheopportunitytoreviewthemeasure.CMShasnotidentifieddataindicatingthattheproblemthatasmanyas60-80percentofdialysiseventsmaybeunder-reportedwiththeNHSNBSImeasurehasbeenresolved.Themeasuredoesnotmeetthecriterionofvalidityforendorsement.Thus,patientswhorelyupontheinformationgeneratedbythismeasureare,inmanyinstances,relyingoninaccuratedatathatsuggestthataparticularfacilityhasalownumberofbloodstreaminfectionswhen,infact,thefacilityhasahighernumber.Theimportanceofunderstandinghowafacilitymanagesbloodstreaminfectionsiscriticalforpatientdecision-making.Ameasurethatfailstoaccuratelyrepresentthefacility’sperformancedeprivespatientsoftheirabilitytomakeinformedhealthcaredecisions.Italsounfairlypenalizesfacilitiesthatdiligentlypursueandreportthehospitalinfectiondatanecessaryforafullpictureofinfectionrates.

Thus,wereiterateourrequestthatCMSremovetheNHSNBSIclinicalmeasure

immediatelyandusetheDialysisEventReportingMeasurealone.KCPstronglysupports

3Id.


transparencyandeffortstoreducebloodstreaminfections.Therefore,weaskCMStoworkwiththecommunitytoidentifyspecificmodificationstotheNHSNBSImeasuretoaddressthevalidityconcernsandsubmitthatrevisedmeasuretotheNQFforreview.

C. KCPcontinuestosupporttheconversionoftheStandardizedTransfusionRatio(STrR)measurestoareportingmeasure,becauseofconcernsaboutvalidityarisingfromtheshifttoICD-10coding,buturgesCMStoreplaceitwithamoreappropriateanemiamanagementmeasureandseekendorsementofthenewmeasure.

KCPcontinuestosupportthestatutoryrequirementthatCMSadoptendorsed

measureswhentheyareavailable,butrecognizesthattheremaybetimeswhenchangingcircumstancesresultinanendorsedmeasurenolongerbeingappropriate.Aswenotedduringlastyear’srulemaking,wesupportCMSaddressingtheseproblemsastheyarise.

Forexample,KCPcontinuestosupportthedecisionCMSmadetoconvertthe

StandardizedTransfusionRatio(STrR/NQF2979)toareportingmeasure.BecauseitbecameclearaftertheICD-9toICD-10transitionthatthecodesusedintheSTrRmeasurewerenotaccuratelycapturingbloodtransfusionstoensurevalidityofthemeasure,CMSconvertedthemeasuretoareportingmetricintheCY2019FinalRuletoallowforanexaminationoftheproblem.Goingforward,however,KCPrecommendsshiftingawayfromtheSTrRmeasureandadoptingameasurethatmoredirectlyreflectspatientqualityofcare,ismoreclearlyactionable,andreducesburden.WeagainrecommendthatCMSreplacetheSTrRwithalowhemoglobin(Hgb)measure(e.g.,aHgb<10g/dL).

Whileitwillbenecessarytodevelopupdatedspecifications,exclusions,testing,and

businessrules,KCPwouldwelcometheopportunitytoworkwithCMSonsuchameasure;wenotethatCMSdevelopedasimilarmeasureseveralyearsagothatwouldbeanappropriatestartingpoint.WeareawaresuchameasurewasnotendorsedbyNQF,butbelieveNQF’supdatedevidencealgorithmprovidesapathforitsconsiderationanew.AlowHgbmeasurewouldreduceburden,becauseanytransfusionmeasurerequiresdialysisfacilitiestochasepaperworkcreatedbyotherproviders.ItalsoisabettermeasurethantheSTrRbecausefacilitiesandphysicianshaveaccesstopatientHgbdatainthefacility,whereastheydonothaveaccesstotransfusiondata.Moreover,itisactionablebyphysiciansandwillhaveadirectapositiveimpactonanissueofcriticalimporttopatients.Additionally,aswenoteinthefollowingsection,KCPhassignificantconcernsaboutthereliabilityoftheSTrR.


D. WhenNQFhasrejectedameasureormovedameasuretoreservestatus,CMSshouldnotincludeitintheQIPtobeconsistentwiththestatute;thus,KCPasksCMStoremovethePrevalentPatientsWaitlistedmeasureandretiretheHypercalcemiameasurefromtheQIPandreplacetheDialysisAdequacyComprehensiveMeasurewiththeindividualKt/VmeasuresthatNQFhasendorsed.

KCPstronglysupportsthePresident’sinitiativetoincreasethenumberofsuccessful

kidneytransplants.Toachievethegoal,itisimportantthatpatientsareempoweredbyhavingaccurateinformationtoassesswhethertheirprovidersaredoingwhattheycanandshouldbetohelpthemqualifyforatransplant.HavingavalidandreliablemeasureintheESRDQIPthatsupportstransplantsisaworthygoal.

Unfortunately,thePercentageofPrevalentPatientsWaitlisted(PPPW)measure

hasbeendeterminedtolackvaliditybytheNQF.Thus,itshouldnotbeincludedintheQIP,becauseitwillmisleadpatients.WhileCMShasflexibilitytoadoptameasurewhenNQFhasnotendorsedameasureinaparticulardomain,itisacontortedreadingtosuggestthatthisflexibilitymeanstheAgencycanorshoulduseameasurethathasfailedtomeetthescientific,consensus-basedendorsementcriteria.

Ratherthancontinuewiththismeasure,weencourageCMStoworkwithKCPand

othersinthecommunitytoaddresstheproblemsunderlyingthismeasuresothatthereisavalidandreliablemeasurethatwillprovideaccurateinformationrelatedtotransplantationandempowerpatientsintheirdecision-making.

Similarly,theNQFhasconcludedafterextensivereviewthatthe(Kt/V)Dialysis

AdequacyComprehensiveMeasuredoesnotmeettheendorsementcriteria,becauseitfailedonmeasuringaperformancegap,whichisathresholdrequirementforfurtherdiscussiononfactorssuchasvalidityandreliability.KCPisalsoconcernedthatapooledmeasurefailstoprovidethetransparencynecessarytopromotepatientdecision-makingwhenitcomestohomedialysis.ByreportingallKt/Vscores,ithidesfromviewhoweachfacilityperformswhenitcomestoprovidinghomedialysis.GiventheAdministration’semphasisonhomedialysis,weurgeCMStoremovetheDialysisAdequacyComprehensiveMeasurefromtheQIPandreplaceitwiththefollowingmeasuresthathavemeettheendorsementcriteria:

• NQF#0249DeliveredDoseofHDAboveMinimum;• NQF#0318DeliveredDoseofPDAboveMinimum;• NQF#1423MinimumspKt/VforPediatricHDPatients• NQF#2704,MinimumDeliveredPDDose;• NQF#2706,PediatricPDAdequacy—AchievementofTargetKt/V

Thisstepwouldalignwiththestatutorymandateandprovidepatientswiththeabilitytounderstandeachfacility’sactualperformanceonthedifferentdialysismodalities.


KCPalsorecommendsthatCMSworkwithKCPtore-specifyandtestnewindividualPDmeasuressothatfacilitiesthatprovidehomedialysisarenotdisadvantagedbecauseofthedifferencesinthefrequencyoftestinghomedialysispatients.

Finally,CMSshouldretiretheHypercalcemiaMeasurefromuseintheESRDQIP,

becauseitisbasedonNQF#1454,whichtheNQFhasplacedinreservestatusbecauseithas“topped-out”(i.e.,thereislittleroomforadditionalimprovementinthisclinicalarea)andprovidesnosignificantbenefitforpatients.Therefore,CMSshouldretirethemeasure.

Inaddition,KCPreiteratesthatitwouldbeappropriate,forpurposesofhavinga

bonemineralmetabolismmeasure,tousetheNQFserumphosphorusmeasureasareportingmeasureintheQIP.Eventhoughthemeasureisinreservestatus,physiciansrelyupontheserumphosphorusmeasuretomakeclinicaldecisions.Whileworkstillneedstobedonetoidentifytheoptimalphosphorustarget,howtoaddressthetargetforcertainsubpopulations,andwhenphosphorusshouldbeassessed,areportingmeasureemphasizestheneedtomonitorphosphoruslevelswhileallowingtimetoaddresstheseunresolvedissues.

E. KCPencouragesCMStoaddressthereliabilityproblemswiththe

standardizedratiomeasuresandtouserisk-standardizedratemeasuresinstead.

KCPmembersbelievethathospitalizationandreadmissionratesareessential

metricsthatshouldbethecoreofanyvalue-basedpurchasingprogram.However,forsuchmetricstobeeffectivetheymustbereliable–meaningaccurateandreplicableinhowtheymeasurefacilityperformance–andtransparent.Unfortunately,theStandardizedHospitalizationRatio,(SHR/NQF1463)andStandardizedReadmissionRatio(SRR/NQF2496)measures,aswellastheSTrR,donotmeettheserequirements,asCMS’sowndatademonstrate.

CMS’decisiontoprovideonlyaveragereliabilitystatisticsacrossallfacilitysizeslackstransparency.Toimprove,afacilityshouldbeabletoassessthedegreetowhichitsownSHRorSRRscoresrepresentnoiseoractualqualityresults.WhilereliabilitydatastratifiedbysizemaynolongerberequiredbyNQFforendorsement,itiscriticaldataforfacilitiestounderstandtheirperformanceandimproveuponit.KCPstronglyrecommendsthatCMSprovidethesedatainitsNQFsubmissionsormakethempubliclyavailableelsewhere.

InthemostrecentiterationoftheSRR,currentlyunderreviewatNQF,theoverallIURwas0.35—adramaticdeclinefromthe2009NQFsubmissionvalueof0.55.Statistical


literaturetraditionallyinterpretsareliabilitystatistic<0.5as“unacceptable”.4Ameasurewherein65percentofafacility’sscoreisduetorandomnoiseandnotaqualitysignalisinappropriateforuseintheQIP.Moreover,theSRR’sreliabilityof0.35istheaverageacrossallfacilities.Thereliabilityforsmallerfacilitieswillbesignificantlyless,asacknowledgedbyCMS’contractdeveloper.

Likewise,theoverallIURfortheone-yearSHRwas0.53-0.59for2015-2018;a“poor”reliabilitystatisticthatalsorepresentsadeclinefromthe2010-2013IURs(0.7).BasedoncurrentCMSdata,41-47percentofafacility’sSHRscoreisduetorandomnoise,andsmallerfacilitiesagainwillhaveasignificantlygreatercontributionofnoisetotheirscore.

Again,KCPalsonotesthatCMSnowdeclinestoprovidetestingdatastratifiedby

facilitysizeforanymeasuresitsubmitstoNQFbecauseitis“notrequired”byNQF.AsthemostrecentCMSreliabilitydatastratifiedbysizereveal,theIURforsmallfacilities(definedbyCMSatthetimeas<50fortheSHRand<70fortheSRR)forbothmeasureswas0.46in2009(SRR)and2013(SHR)—i.e.,forapproximatelyonethirdofallfacilities(thosemeetingCMS’owndefinitionof“small”),54percentofthescoretheyreceivedontheSRRandSHRcouldbeattributedtorandomnoiseandnotsignal.

AnyscoreassignedtoafacilityfortheSRRhasnoqualitymeaningbasedonCMS

testingresults,andtheSRRshouldberemovedfromtheQIP.TheSHRshouldbedeployedonlyforlargefacilities,asdefinedbyCMS’historicalstratificationresultsinitssubmissionstoNQF.Finally,althoughtheclinicalversionoftheSTrRisnotyetproposed,KCPfeelsitisimportantalsotoemphasizeitspoorreliability,especiallyforsmallfacilities.Inthemostrecentiterationofthemeasure,theoverallIURfortheone-yearSTrRwas0.63-0.68acrosstheyears2014-2017.Datafrom2011-2014,forwhichtherewasasimilaroverallIUR,revealedvaluesaslowas0.30forsmallfacilities—thatis,forapproximatelyonethirdoffacilities,70%ofthescoretheyreceivedontheSTrRcouldbeattributabletorandomnoiseandnotsignal.Whilenewdetailswerenotprovided,CMS’contractmeasuredeveloperacknowledgedthattheSTrRwaslessreliableinsmallerfacilitiesforthe2014-2017dataperiod.

Lastly,althoughnotmentionedperseintheProposedRule,wenotethatCMSnowreliesonanovel,additionalmetricofreliability,referredtoastheprofile-IUR(PIUR).5PerCMS,“ThePIURindicatesthepresenceofoutliersorheaviertailsamongtheproviders,whichisnotcapturedintheIURitself....[When]thereareoutlierproviders,evenmeasureswithalowIURcanhavearelativelyhighPIURandcanbeveryusefulfor

4AdamsJL.TheReliabilityofProviderProfiling:ATutorial.SantaMonica,CA:RANDCorporation.TR-653-NCQA,2009.5HeK,DahlerusC,XiaL,LiY,KalbfleischJD.Theprofileinter-unitreliability.Biometrics.2019Oct23.doi:10.1111/biom.13167.[Epubaheadofprint].


identifyingextremeproviders.”6ThePIURwas0.61fortheSRRand0.75-0.85fortheSHR,whichCMSinterpretsasdemonstratingthemeasuresare“effectiveatdetectingoutlierfacilitiesandstatisticallymeaningfuldifferencesinperformancescoresacrossdialysisfacilities.”7KCPstronglyconcurswiththeNQF’sScientificMethodsPanel(SMP)conclusionthatthePIURisnotanappropriatemeasureofreliabilityforanyQIPmeasure.QIPmeasuresareusedtodistinguishperformancealongacontinuum,inparticularamongprovidersfallinginthemiddleofthecurve,todeterminepenalties;theabilitytoreliablydistinguishoutliersforimplementationofthesemeasuresisnotthepoint.TheIURisandremainstheappropriatemeasureofreliabilityformeasuresproposedfortheQIP.

F. ModifyingICH-CAHPSmeasuretoaddressvalidityproblemsand

makeitmeaningfultopatientsandproviders.

KCPcontinuestosupportpatientsatisfactionmeasures,suchastheICH-CAHPSmeasure.However,thelowresponseratesthreatenthevalidityofICH-CAHPSasanaccountabilitymeasure.Inaddition,thecurrentmeasuredoesnotallowforfeedbackfromhomedialysispatients.WeappreciatetheTechnicalExpertPanelthatCMSconvenedearlierthisyearandsupporttheclosereviewofthemeasure.However,therearesomeimmediatemodificationsCMScouldadoptthatwouldreducetheburdenonpatientsaskedtorespondandaddresssomeoftheresponserateproblems.Specifically,CMScould:

• AdministerICH-CAHPStopatientsonceayear(nottwice)toreduceburdenon

patients;and

• Askindividualpatientstocompleteonlyoneofthethreeindependentlyvalidatedsectionsonthesurvey;thus,whilefacilitiesaresubjecttotheentiresurveyinstrument,noonepatientwillbeaskedtocompletethemorethan60questionsinasingleresponse.

Inaddition,wereiterateouroutstandingrequestthatthesurveyberevisedto

includehomedialysispatientsandthatCMSobtainNQFendorsementofthenewmeasure,whichMedPACandothersinthecommunityalsohaveconsistentlyrequested.ItisalsoimportantthatCMSallowfacilitiesandpatientstousetheICH-CAHPSsurveyresultstoimprovecare.

II. DifferentialHandlingofMedicareAdvantagePatientsinQIPmeasures

threatensthevalidityofseveralQIPmeasures.

TheincreasingnumbersofMApatientsintheESRDprogram—andtheunavailabilityofoutpatientclaimsdataforthesepatients—threatenthevalidityofseveral

6KalbfleischJD,HeK,XiaL,LiY.Doestheinter-unitreliability(IUR)measurereliability?HealthServicesandOutcomesResearchMethodology.2018;18(3):215-225.Doi:10.1007/s10742-018-0185-4.

7Citation:SHRmeasuressubmissionmaterialstoNQF.


QIPmeasures.DataprovidedbyCMSindicatethatattheendof2017,27percentofdialysispatientshadMAcoverage(presumablyhighernow),andthisvariedwidelyacrossstates—fromabout2percentinWyomingto34percentinRhodeIsland,andmorethan44percentinPuertoRico.SuchgeographicvariationcompromisesthevalidityofthemeasuresifMApatientsarenotaccuratelyaccountedforintheQIPmetrics.Specifically,withoutchangestothecurrentspecifications,theevolvingpatientmixwillintroducesignificantbiasintomeasurecalculationsthatcouldaffectresultsforfacilitieswitheitherveryloworhighMApatientpopulations.Recognizingthis,KCPconcurswiththeneedtochangespecificationsforseveralCMSmeasurestoaccommodatetheincreaseinMApatientsandtoavoiddisparitiesinperformanceduetogeography.KCPstronglybelieves,however,thatgreatertransparencyisrequiredbyCMSasitupdatestherelevantmeasures.

WhiletheapproachtohandlingMApatientsvariesconsiderablyacrossCMS’metrics(Table1,AttachmentB),KCPrecognizesthedifficultyCMSfacesinaddressingthisissueacrossmeasuresofvaryingconstructionandnotesthereappearstobealogicalrationaleformostofthedecisionsmadebecauseofthepropertiesandintendedpurposeofeachmeasure.Nevertheless,KCPstronglyrecommendsthatCMSperformasensitivityanalysisofperformancewithandwithoutMApatientsforeachoftheapplicableQIPmeasuresandmaketheresultspubliclyavailable.SuchdatawillprovideanopportunityforKCPandotherstoofferpotential,evidence-basedmitigationstrategies(e.g.,amodelthataccountsforbothpopulations,useofriskcoefficientsasnecessary).

WealsoaskCMStoperformandprovideananalysisofriskmodelfitunderthepreviousapproachandthenewin-patient-claims-onlyapproach;currentlyweareunabletoassesswhethermodelfitimprovedorworsenedwiththisapproach.KCPisparticularlyconcernedthatlimitingcomorbiditydatatoinpatientclaimsmightskewthemodelstowardsasickerpopulation,andthatsuchaskewmightreflectunfavorablyonfacilitiesthatsuccessfullykeephospitalizationrateslow.Thatis,becausecomorbidityadjustorsdevelopedexclusivelyfromhospitalizationdatawillnecessarilyunderestimatethecomorbidityprofileofpatientsinfacilitieswithlowhospitalizationrates,the“expected”hospitalizationormortalityratescalculatedforsuchfacilitieswillbeerroneouslylow,andthefacilities’scoreswillbeerroneouslyhigh.OnlywithtransparencyinthesematterscanthecommunityassesstheimpactMApatientmixhasontheQIPmeasures.

Finally,KCPnotesthattheSHRandSFR(andStandardizedMortalityRatio(SMR),whichisnotpartoftheQIP)obtainpast-yearcomorbiditydatafrommultiplePartAsources(inpatient,SNFs,homehealth,hospice).Conversely,thepast-yearcomorbiditysourcefortheSRRislimitedtoinpatientclaims.WeaskthatCMSincorporatedatafromthemultiplePartAsourcesusedintheSMR,SHR,andSFRmodels—inpatient,aswellasSNF,homehealth,andhospicedata—tomaketheSRRadjustmentpotentiallymorerobust.Asamatterofmeasureconstruction,italsoisalogicalharmonizationissue.WerecommendCMSperformthisanalysisandmakeitpubliclyavailableorreleaseexistingdataandjustifythecurrentapproach.


III. KCPasksCMStoaddresstheimpactofCOVID-19measureperformance.

TheCOVID-19pandemichaspresentedunprecedentedchallengestopatientswithESRDandthedialysiscommunityandhassignificantlyaffectedpatientcare—andhasthepotentialtoimpacttheQIP.ThepandemicwillimpactperformancebeyondtheobviousoutcomemeasuressuchastheSHRandSRRinareaswithaheavyCOVIDburden,butalso“upstream”processandintermediate-outcomemetrics,eveninrelativelyunaffectedlocales.Forinstance,toavoidorminimizepotentialexposuretothevirus,patientsandprovidershavepostponedelectivefistulaplacementanddelayedroutinelabdraws,andadequacytargetshavenotbeenmetinsomecasesasanxietysometimesmeansanearlyendtoadialysissession.

A. KCPasksCMStoextendthenationwideExtraordinary

CircumstancesExceptionfortheESRDQIPthroughtheendofthepublichealthemergency,plusashortgraceperiod.

KCPappreciatesCMS’proactivegrantingofauniversalExtraordinaryCircumstance

Exception(ECE)fortheESRDQIPinresponsetoCOVID-19.WelikewisethankCMSforallowingfacilitiestheflexibilitytooptoutoftheECE,attheirdiscretion.Wenote,however,thattherecentlywitnessedprogressiveandunpredictableregionalspreadofthevirusnowrendersthecurrentJune20deadlineforthisdecisionobsolete.PreviouslyunaffectedfacilitiesthatchosetooptoutoftheECEpriortoJune20maynowbeinthecenterofanew“hotspot”,nolongerabletomeettherequireddatasubmissionthatpreviouslyseemedfeasible.KCPthusrequeststhatCMSrevisittheJune20deadline,allowingfacilitiesthatpreviouslyoptedoutoftheECEtonowopt-in,withoutpenalty.

WebelievethatCMShastheauthoritytoextendtheflexibilityprovidedinthe

universalECE.CMScreatedtheECEpolicythroughregulation.42C.F.R.§413.178(d)(3)indicatesthatthetimeframeforanECEmaybe“foroneormorecalendardays,whentherearecertainextraordinarycircumstancesbeyondthecontrolofthefacility.”Theregulationsalsoindicatedthat“CMSmaygrantexceptionstofacilitieswithoutarequestifitdeterminesthatoneormoreofthefollowinghasoccurred:(i)Anextraordinarycircumstanceaffectsanentireregionorlocale.”8Thereisnoothertimerestriction.

ThestatutegoverningtheESRDQIPdoesnotprohibitCMSfromextending

exceptionstothereportingrequirements.WhilethestatuterequiresCMStoreducepaymentstoadialysisfacilitythatdoesnotmeetorexceedthetotalperformancescorewithrespecttotheperformancestandards,thisrequirementissubjecttothediscretionoftheSecretaryasevidencedbytheclausetowhichtherequirementissubject“as

842C.F.R.§413.178(d)(6).


determinedappropriatebytheSecretary.”9ThisphrasegivestheSecretarytheauthoritytoestablishtheECE.

Inaddition,CMSindicatedthestatuteclearlyauthorizestheECEthroughthe

discretiontheSecretaryisprovidedtodevelopthemethodologyforsettingthetotalperformancescore.Thereisnotimelimitationonthisauthorityeither.

Section1881(h)(3)(A)(i)oftheActstates,“[T]heSecretaryshalldevelopamethodologyforassessingthetotalperformanceofeachproviderofservicesandrenaldialysisfacilitybasedonperformancestandardswithrespecttothemeasuresselectedunderparagraph(2)foraperformanceperiodestablishedunderparagraph(4)(D).”Giventhepossibilitythatfacilitiescouldbeunfairlypenalizedforcircumstancesthatarebeyondtheircontrol,webelievethebestwaytoimplementanextraordinarycircumstancesexceptionisundertheauthorityofthissection.Wethereforeproposedtointerpretsection1881(h)(3)(A)(i)oftheActtoenableustoconfigurethemethodologyforassessingfacilities’totalperformancesuchthatwewillnotrequireafacilitytosubmit,norpenalizeafacilityforfailingtosubmit,dataonanyESRDQIPqualitymeasuredatafromanymonthinwhichafacilityisgrantedanextraordinarycircumstancesexception.10

ThisauthorityandtherationaleoutlinedwhenCMSfinalizedtheECEpolicy

forCY2015supportsextendingtheECEperiodduringthepublichealthemergency,andweencourageCMStodosoimmediately.WealsoencourageCMStoalsoconsiderextendingtheECEforagraceperiodbeyondoncethepublichealthemergencyhasended(e.g.,30-60days)toprovidetimeforproviderstorampbackup,becauseareas/stateswillbehitunevenly.

B. KCPasksCMStoworkwiththeKCPtoaddresschallengesthe

pandemichascreatedfortheESRDQIP.

AsCMShasrecognizedthroughthenationwideECE,thepandemicisanextraordinarycircumstanceoverwhichwehavenocontrol.Ithasbeendevastatingtoprovidersandpatientsalike.TheimpactoftheoutbreaksintheUnitedStateshasrequiredanunprecedentedresponseandchangesinpracticepatternsthatwillremainwithusthroughoutthedurationofthepublichealthemergencyand,perhaps,evenlonger.

Wenotethat,inadditiontotheshort-termimpactonpatientcareand

outcomes,theCOVID-19pandemicwillhaveeffectsontheQIPforseveralyearsafterthepandemicends.ThisisbecausetheQIPreliesonbenchmarkssetthrough

942U.S.C.§1395rr(h)(1).10CMS,“End-StageRenalDiseaseProspectivePaymentSystem,QualityIncentiveProgram,andDurableMedicalEquipment,Prosthetics,Orthotics,andSupplies”DisplayCopy240(November2014).


previousyears’performance.TotheextentthatdialysisperformanceandmeasurereportingisanomalousduetoCOVID-19,thoseanomalieswillaffectthebenchmarksinsubsequentyears.

KCPaskedDiscernHealthtohelpusunderstandthepotentialimpactofthe

disruptionscreatedbythepandemicandhowthosedisruptionscouldimpacttheaccuracyandreliabilityoftheESRDQIP.DiscernmodeledthreedistinctscenariostoevaluatetheimpactoftheECEonQIPperformance.ItusedtheCY2019QIPperformancedatatomodeleachofthefollowingscenarios.

• Scenario1–BaselineScenario–Thebaselinescenariorepresentsa“normal”QIP

year,assumingnoECEandnoimpactfromCOVID.

• Scenario2–CurrentECEMaintained–ThisscenarioassumesthatthetermsoftheECEexpiringinJunearenotamended.Accordingly,weareassumingsmallermeasuredenominatorsasaresultoftheECE,andpoorerperformancefromJuly2020throughDecember2020.Wealsonotethatsmallerdenominatorsresultinlessreliabilityofthemeasurescores,butsincewecannotestimatetheimpactofpoorreliabilityonthedistribution,themodeldoesnotaccountforthissecond-ordereffect.

• Scenario3–ECEExtended3Months–ThisscenarioassumesthattheECEis

extendedanotherthreemonthsformeasuresreportedthroughCROWNWeborClaims.

Thecomponentsofthemodelwere:

• Measurethresholdeligibility–EachmeasureincludedinQIPhasarequired

denominatortoevaluateafacility.Forexample,theStandardizedHospitalizationRatio(SHR)measureisnotreportediftherearefewerthan5patientyearsatrisk.AnaturalconsequenceoftheECEisareductioninthedenominator,whichwillpushmorefacilitiesbelowthatthreshold.

• Impairedperformance–TheECEwasinitiallyissuedthroughtheendofJune.Ifthe

ECEislefttoexpireinJune(Scenario2)orisonlyextendedanother3months(Scenario3),CY2020willincludedatacollectedduringtheCOVID-19Pandemic.Evenatlowlevelsofcommunityprevalence,thepandemicwilllikelyaffectmeasureperformance.Thisinteractionisdynamicandisitsdirectionandmagnitudearenotknown.Forexample,thepandemichasbeenshowntodiscouragecareseekingbehavior,whichmayreducehospitalizationsmeasuredbytheStandardizedHospitalizationRatio(SHR)11.Ontheotherhand,somedataillustratetherelatively

11https://catalyst.nejm.org/doi/full/10.1056/CAT.20.0193


highrateofhospitalizationforthosewithESRD12.Accordingly,aspecificimpactonperformanceisnotmodeled,butpotentialimplicationsofthisvariabilityareoutlinedasappropriate.

Inaddition,DiscernconsideredhowtheECEwouldaffecttheQIPduringthree

calendaryears,asoutlinedbelow:• PY2022/CY2020–FacilitieswithlowvolumeinCY2020asaresultofECEwill

beineligibleforperformancescores.

• PY2023/CY2021–FacilitieswithlowvolumeinCT2020asaresultofECEwillbeineligibleforimprovementscores.

• PY2024/CY2022–TheECEwillaffectthenationalperformancestandardused

tocalculatetheAchievementScore.

ResultsforPY2022/CY2020MeasureEligibility:DiscernestimatedthedenominatorsforeightmeasuresbasedonCY2018ESRDperformanceQIPdataandtheCOVID-19ECEFAQ.TheseeightmeasureswereselectedbasedonavailabilityofdataanddenominatorsintheCY2018QIPdataset.Below,thenumberoffacilitieseligibleforeachmeasure(Facilities),andthepercentofallfacilities(%Ttl)theyrepresentareshown:

Figure3.ESRDFacilitiesEligibleforEachMeasure

Scenario1 Scenario2 Scenario3

Facilities %Ttl Facilities %Ttl Facilities %TtlLongTermCatheter 6,475 87% 5,673 76% 3,598 48%SFR 6,442 87% 5,579 75% 3,341 45%Kt/V 7,055 95% 6,620 89% 5,403 73%Hypercalcemia 6,981 94% 6,582 89% 5,389 73%ICHCAHPSMeasures 2,957 40% 566 8% 566 8%SRR 6,859 92% 6,572 89% 6,030 81%STrR 6,292 85% 5,694 77% 4,431 60%SHR 6,895 93% 6,734 91% 6,403 86%

Fromthistable,6,895facilitieshavesufficientvolumetobeeligiblefortheSHRinScenario1;6,734inScenario2;and6,403inScenario3.Fromthisanalysis,SRRandSHRmeasuresretainfairlyhighcoverage;Kt/V,Hypercalcemia,STrR,LongTermCatheter,andSFRhavemodestcoverage;andtheICHCAHPSmeasurehaspoorcoverage.

12https://www.cms.gov/blog/medicare-covid-19-data-release-blog


Discernalsoconsideredthenumberofmeasuresforwhicheachfacilitywouldbeeligible.Asignificantnumberoffacilitiesarestilleligibleforsevenoreightoftheeightanalyzedmeasures.InScenario2,thisis72percentoffacilities,and44percentoffacilitiesinScenario3,ascomparedto82percentinScenario1.Conversely,thenumberoffacilitieseligiblefornomeasures,risesfrom3.7percentinScenario2,to7.2percentinScenario2,to12.0percentinScenario3.

Figure4.EstimatedNumberofEligibleMeasuresbyESRDFacility

Inadditiontoreducedeligibility,smallerdenominatorswillincreasetheweightgiventothenationalaveragethroughreliabilityadjustment.

ResultsforPY2023/CY2021:InPY2023,datafromCY2020willserveasthebaselinefortheimprovementscore.Technicalguidancespecifiesthat“Ifafacilitydoesnothavesufficientdatatocalculateameasureimprovementrate…thenthefacilityscoreforthatmeasureisbasedsolelyonachievement,”13.Weareassumingthatthesamethresholdformeasureeligibilityisusedforimprovementscoreeligibility.

BecauseofthedataexceptedbytheECE,morefacilitiesthanusualwillbeineligiblefortheimprovementscore.Thisisonlyanissueforfacilitiesthatwouldhaveotherwisereceivedanimprovementscore.ThetablebelowestimateshowmanyfacilitieswouldhavereceivedanimprovementscoreifnotfortheECE.

13https://www.cms.gov/files/document/esrd-measures-manual-v52.pdf

0

1000

2000

3000

4000

5000

0 1 2 3 4 5 6 7 8

ESRD

Fac

ilitie

s

# Measures Eligible

Measure Eligibility by ESRD Facility

Scenario 1 Scenario 2 Scenario 3


Figure5.NumberofESRDFacilitiesReceivingLowerScoreDuetoIneligibilityfor

ImprovementScoreScenario2

Scenario3

VATCatheterMeasure 78 199VATFistulaMeasure 73 170Kt/VComprehensiveMeasure 93 191HypercalcemiaMeasure 50 155ICHCAHPSNephCommandCaringMeasure 98 98ICHCAHPSQualityofDialysisCareandOpsMeasure

71 71

ICHCAHPSProvidingInfotoPatientsMeasure 88 88ICHCAHPSOverallRatingofNephMeasure 133 133ICHCAHPSOverallRatingofDialysisStaffMeasure

108 108

ICHCAHPSOverallRatingofDialysisFacilityMeasure

86 86

SRRMeasure 20 51STrRMeasure 58 206SHRMeasure 20 64

Forexample,underScenario3,199facilitieswillbeineligibleforanimprovementscoreontheVATCatheterMeasureinPY2023,andwillreceivealowerscoreundertheAchievementScore.

ResultsforPY2024/CY2022:InPY2024/CY2022,datafromCY2020willserveasthenationalperformancestandardusedtocalculatetheAchievementScore.Giventhatthesetargetsaresetnationally,evenwithapartialyearofresults,smallnumberproblemsareunlikelyformostmeasures.However,iftheECEcontinuesthroughtheendof2020,theICHCAHPSmeasureswillhavenodatafor2020.

WhilethedirectionandmagnitudeofCOVID-19’sinfluenceonmeasureperformanceisnotknown,theimpactonthePY2024nationalperformancestandardwouldcounterbalancetheeffectonthePY2022performancescore.Forexample,ifCOVID-19isanetharmtofacilityperformance,morefacilitieswouldreceivepenaltiesinPY2022,buttheAchievementtargetswouldbelowerinPY2024.Whiletheseimpactscounterbalanceeachother,theirneteffectisunclear.

AstheDiscerndatashow,thereareseveralshort-andlong-termexpectedresultsoftheECEontheQIPandareasofuncertainty.GiventhesignificantfinancialeffectoftheQIPanduncertaintyaroundCOVID-19’seffectontheQIP,weaskthatCMS:


• Performanevidence-basedimpactassessmenttodeterminethelong-termeffectofCOVID-19onmeasuresusedforQIP.Long-termconsequencesofCOVID-19arestillbeingunderstoodbythescientificcommunity,andpreliminaryresearchsuggestseffectsonmultiplebodysystems.14OtherevidencesuggeststhatCOVID-19leadstokidneydamage,with15percentofthosehospitalizedrequiringdialysisafterdischarge.TheAmericathatemergesfromthePHEwillbedifferentfromtheonethatentersit.

• BaseImprovementandAchievementbenchmarksuponthelastfullyearofpre-COVID-19performance,CY2019.Basedupontheimpactassessment,modificationofthesescalendaryearbenchmarksmaybeneeded.

COVID-19presentsauniquechallengeforwhichthereislittleprecedent,andtherearelikelynosimplesolutions(especiallywhenwedonotyetknowthefullimpact).WebelievetheserecommendationswillstabilizetheQIPintothefuture,andpromotequalityoutcomes.

IV. KCPsupportsmaintainingthestructuralaspectsoftheESRDQIP

forPY2024,butencouragesCMStoconsiderchangesthatwillmakepaymentreductionsundertheprogrammorepredictable.

Aswehaveindicatedinpreviouscommentletters,weappreciatethatCMS

recognizestheimportanceofmaintainingthestructuralaspectsoftheESRDQIPyear-to-yearthatallowformulti-yearcomparisonsofproviders.Thisconsistencyisappropriateandhelpful.Thus,KCPtheproposalsforPY2024thatmaintaintheperformanceperiod,performancestandards,andscoringaspectsoftheprogram.WecontinuetourgeCMStoweightcertainmeasures,suchasthereductionincathetermeasure,moreheavilythanothers.

A. Addressingunintendedpaymentreductions.

Wealsoreiterateourconcernsthatinpastrulemakingsthepaymentreductionscale

hasresultedinasubstantialincreaseinthenumberoffacilitiesbeingpenalizedundertheESRDQIP,eventhoughtheactualperformanceofthefacilitieswasimproving.WealsoreiterateourconcernsthatinpastrulemakingsthepaymentreductionscalehasresultedinunpredictablepercentagesoffacilitiesbeingpenalizedundertheESRDQIP,eventhoughtheactualperformanceofthefacilitieswasimproving.

14https://www.advisory.com/daily-briefing/2020/06/02/covid-health-effects


AnalysisbyDiscernhasshownthatanyunderlyingchangesinperformancedistributioncouldhavelargeeffectsonthissystem.Figure6showstheyearlychangesinminimumTPSandpaymentreductionscales:15

Figure6.PaymentReductionScalePY2020-2023

Reduction%

PY2020 PY2021 PY2022 PY2023(estimated)

0.0% 100-61 100-56 100-54 100-570.5% 60-51 55-46 53-44 56-471.0% 50-41 45-36 43-34 46-371.5% 40-31 35-26 33-24 36-272.0% 30-0 25-0 23-0 26-0

IntheProposedRule,CMSprojectsthatthenumberoffacilitiesthatfallundereachpaymentreductionleveleachyearasshowninFigure7.MorefacilitiesareprojectedtoreceivepaymentreductionsinPY2021,butthendecreasethereafter.Discernhasperformedpreviousanalysesthatsuggestthisisnotanintentionalpolicydecision,butratheraresultofchangesinthedistributionoffacilityperformance.Thisyear’sprojectionsappeartofollowthattrend.

Figure7.ActualandEstimatedDistributionsofPaymentsReductions

PY2018–PY2023

15https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/Downloads/ESRD-QIP-Summary-Payment-Years-2019-2024.pdf16https://data.medicare.gov/data/dialysis-facility-compare17https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/Downloads/ESRD-Final-Rule-2019.pdf18https://www.govinfo.gov/content/pkg/FR-2019-11-08/pdf/2019-24063.pdf19https://www.govinfo.gov/content/pkg/FR-2020-07-13/pdf/2020-14671.pdf

PaymentReduction

PY2020Actual16

PY2021Projected17

PY2022Projected18

PY2023Projected19

Count % Count % Count % Count %0.0% 4481 60.4% 3,802 56.0% 5,293 73.9% 5,490 76.8%0.5% 1669 22.5% 1,532 22.6% 1,339 18.7% 1,215 17.0%1.0% 849 11.4% 896 13.2% 432 6.0% 336 4.7%1.5% 294 4.0% 359 5.3% 81 1.1% 65 0.9%2.0% 127 1.7% 188 2.8% 19 0.3% 41 0.6%WeightedAveragePaymentPenalty

0.32% 0.38% 0.18% 0.16%


Giventhatpaymentreductionsshiftbasedonunderlyingprogramperformancetrends,KCPhaspreviouslyurgedCMStoconsidersettingpaymentpenaltiesatspecificdistributionpoints.ThiswouldcreateamorepredictablemodelforfacilitiesandCMS,whilestillincentivizingfacilitiestomaximizetheirQIPperformance.

KCPcontinuestobelievethatqualityisnotrelativeandthatanyprogramthat

requirespublicreportingandpenalizesprovidersshouldreflecttheactualqualityofcarebeingprovided.Tothatend,KCPreiteratesthatwewouldprefertheTotalPerformanceScore(TPS)cutpointsandthebenchmarksandthresholdsforattainmentandimprovementtobebasedobjectivegoals.WeremainconcernedthatsettingafixednumberoffacilitiesinanyofthefiveTPScategoriesdistortsqualityandeliminatestransparency.Itresultsinapre-determinednumberoffacilitiesbeinglabeledasprovidingpoorquality,wheninrealitytheremayactuallyagreaterorlessernumberoffacilitiesthatshouldfallintothelowestquintilebasedontheiractualperformance.Ifthisapproachweretaken,theresultsprojectedbyearlierrulemakingsshouldnothaveoccurred.WewouldliketomeetwithCMStodiscussspecificproposalsforresolvingthisproblem.

B. KCPcontinuestoencourageCMStoworkwiththecommunityand

NQFtodevelopabetterapproachtothesmallnumbersproblem.

AnotherissuethatweaskCMStoaddressrelatestothesmallnumberproblem.Thedecisiontoincludefacilitieswith11ormorecasesasthebasisformeasureapplicabilityinsteadofthemorewidelyaccepted25ormorecasesthatcommercialinsurersandotherprivatequalityprogramstypicallyapplyunderminesthestatisticalreliabilityofthemeasureresults.WeappreciatetheworkCMShasdoneonthesmallfacilityadjuster,butasDiscernHealthanalyseshaverepeatedlyshown(whichwehaveprovidedinseveralofthepreviousKCPcommentletters),thecurrentpolicyunfortunatelydoesnoteliminatetherandomresultsassociatedwithsmallnumbers.WeencourageCMStoreviewtheworkthattheNQFhascompletedinrelationtoruralareasthatidentifieswaystodevelopedmeasuresthatcanbeusedwithoutsmallnumbersnegativelyimpactingtheoutcomesreported,aswell.20

V. AlignmentofESRDQualityPrograms

Asafinalissue,KCPwouldliketoreiterateourcommitmenttoworkwithCMStoeliminatetheinconsistenciesandconflictsthathavearisenamongthevariousMedicareESRDqualityprograms.Inpreviouscommentletters,KCPhassuggestedawaytoaligntheprograms,bothintermsofmeasuresandstructuralscoringissues.WeaskagainthatCMSreviewtheserecommendationsandworkwithKCPtostrengthenbothprogramstoDialysisFacilityCompare(DFC)andtheQIPtoachievetheindependentgoalsCMShasidentifiedforeachandthatwouldpreservetheCongressionalintentfortheESRDQIP.

20Id.at6.


Figure8belowoutlinesthesuggestionsofthemembersofKCPforfocusingDFConmeaningfulmeasuresthatarenotusedintheESRDQIPandprovidingpatientswiththedataabouteachmeasureonitswebsiteinawaythatallowspatientstoprioritizethemeasureresultstheywanttosee.TheESRDQIPwouldbeasmallersetofmeaningfulmeasuresthatensurethateachmeasurehassubstantialweighttoavoidanyonemeasurebeingdilutedbytheothers.BecausetheCongressmandatedthattheQIPbeapublicreportingprogram,wesuggestedthatCMSshiftthestarratingstotheQIPTPSscores.Figure8:KCPRecommendationsforDistributingMeasuresAcrosstheQIPandDFCESRDQIPMeasures ESRDDFCMeasures

Standardizedhospitalizationratemeasure(currentratiomeasuremodifiedtoatruerisk-standardizedrate)

KCQAUFRMeasure

Standardizedreadmissionsratemeasure(currentratiomeasuremodifiedtoatruerisk-standardizedrate)

KCQAMedicationReconciliation(MedRec)Measure

Catheter>90DaysClinicalMeasure NHSNHealthcarePersonnelInfluenzaVaccinationReportingMeasure

Bloodstreaminfectionmeasure(notthecurrentmeasures,butonethatisvalidandreliableandmeetsotherNQFcriteria)

Kt/VDialysisAdequacyComprehensiveClinicalMeasure(modifiedtoreturntoindividualdialysisadequacymeasures)

PatientExperienceofCare:In-CenterHemodialysisConsumerAssessmentofHealthcareProvidersandSystems(ICHCAHPS)SurveyClinicalMeasure(modifiedperhistoricrecommendations)

Fistulameasures(CurrentAVmeasure;futurestandardizedfistularate)

Hgb<10g/dL ClinicalDepressionScreeningandFollow-UpReportingMeasure

Serumphosphorous StandardizedMortalityRatemeasure(currentratiomeasuremodifiedtoatruerisk-standardizedrate)

Transplantreferralmeasure,includingassistancewithfirstvisit

PatientReportedOutcomeMeasure(whendevelopedandendorsed)

WealsowouldaskthateachofthesemeasuresberefinedbasedonKCPrecommendationsforthespecificmeasures.WehavealsosuggestedthatCMScouldalignthetwoprogramsbyensuringthattheDFCandQIPmeasureshavethesamespecificationsandthesamescoringmechanism.

WeencourageCMStocarefullyreviewtheseproposalsandwouldwelcomethe

opportunitytoidentifywaysofbetteraligningtheESRDQIPandDFCsothatpatientscould


usebothprogramsfordecision-making,buteachonewouldbesupportiveoftheotherratherthanconflictingastheyaretoday.

V. ConclusionKCPappreciatestheopportunitytoprovidecommentsontheProposedRule.Kathy

Lester,ourcounselinWashington,willbeintouchtoscheduleameeting.However,pleasefeelfreetocontactheratanytimeifyouhavequestionsaboutourcommentsorwouldliketodiscussanyoftheminfurtherdetails.Shecanbereachedatklester@lesterhealthlaw.comor202-534-1773.Thankyouagainforconsideringourrecommendations.

Sincerely,

JohnButler

Chairman


AppendixA:KCPMembers

AkebiaTherapeuticsAmericanKidneyFund

AmericanNephrologyNurses’AssociationAmericanRenalAssociates,Inc.

AmericanSocietyofPediatricNephrologyAmgenArdelyx

AmericanSocietyofNephrologyAstraZeneca

AtlanticDialysisBaxterBBraun

CaraTherapeuticsCentersforDialysisCare

DaVitaDialyzeDirect

DialysisPatientCitizensFreseniusMedicalCareNorthAmerica

FreseniusMedicalCareRenalTherapiesGroupGreenfieldHealthSystems

KidneyCareCouncilNephrologyNursingCertificationCommissionNationalRenalAdministratorsAssociation

RenalPhysiciansAssociationRenalSupportNetworkRockwellMedicalRogosinInstituteSatelliteHealthcareU.S.RenalCare

VertexViforPharma

AppendixB:Table1:KCPMeasureSummaryandRecommendationsAnalysis

NQFNUMBER

MEASURETITLE/DESCRIPTION

KCPCONCERNSANDRECOMMENDATION

1 0258 In-CenterHemodialysisConsumerAssessmentofHealthcareProvidersandSystems(ICHCAHPS)SurveyAdministration(clinicalmeasure):Measureassessespatients’self-reportedexperienceofcarethroughpercentageofpatientresponsestomultipletestingtools.

MeasureValidityCMS’owndatashowthattheICH-CAHPSresponserateislowandcontinuestodrop,andthattheincreasinglylowerresponseratesthreatenthevalidityofICH-CAHPSasanaccountabilitymeasure.ThePatient-ReportedOutcomesTEPsuggestedthatthelowresponserateisduetopatientfatigue;themannerinwhichthemeasureisfieldedexhaustspatientsanddiscouragesthemfromcompletingthesurvey.Understandingthepatient’sperspectiveandincorporatingitintohealthcaredecision-makingiscritical.

Recommendation:KCPsuggestmaintainingthemeasureasareportingmeasureuntiltheresponserateisimproved.Inpreviousletters,KCPhasofferedsuggestionsastohowtoaddresstheproblemoffatiguebydividingthesurveyintothethreevalidatedsectionandfieldingeachone.Then,whileafacilityissurveyedonthecompletetool,anyonepatienthastocompleteonlyathirdofthequestions.HomeDialysisPatientsDespiterequestsfromMedPACandothersinthecommunity,thesurveydoesnotincludehomedialysispatients.GiventheAdministration’sstrongdesiretoincentivizehomedialysis,havinganin-centeronlytoolseemstocontradictthatposition.

Recommendation:Thesurveyshouldberevisedtoincludehomedialysispatients;NQFendorsementofthenewmeasureshouldbesought.HomelessPatientsThesurveydoesnotexcludethehomeless.Becausefacilitiesarenotallowedtoprovidethesurveydirectlytopatients,distributiontohomelesspatientsisnotpossible.

Recommendation:CMSshouldexcludethehomelesstowhomthesurveycannotbedistributedgiventhatfacilitiesarenotallowedtoprovideitdirectlytopatients.BurdenReductionTwiceyearlyfieldingofthesurveyimposessubstantialadministrativeburdenonfacilitiesandcontributestopatient“survey-fatigue.”

Recommendation:CMSshouldfieldthesurveyonceayearandnottwicetoreduceburdenonfacilitiesandpatients.PatientEmpowermentFacilitiesdonotseeandsocannotusesurveyresultstoimprovecare.Thefactthatfacilitiesneverseethesurveyresultsandcannotcommunicatewithpatientsabouttheresultsleavespatientsfeelingunheard.

NQFNUMBER



Recommendation:CMSshouldallowfacilitiestoseetheresultsofthesurveyssotheycanrespondtothespecificpatientconcerns.PatientmembersoftheTEPshaverecommendedthisstep.KCPhasconsistentlyrecommendedextendingthesurveytoincludequestionsrelatedtohomedialysispatients.GiventheAdministration’sAdvancingKidneyCareInitiative,CMSshouldprioritizeaddingthesequestionstothesurveyandseekingNQFendorsementofthenewmeasure.

2 2496 StandardizedReadmissionRatio(SRR)(clinicalmeasure):Ratioofthenumberofobservedunplanned30-dayhospitalreadmissionstothenumberofexpectedunplanned30-dayreadmissions.

OverallReliabilityCMSdatahaveshowntheSRRisnotreliable.InthemostrecentiterationofthemeasurecurrentlyunderreviewatNQF,theoverallIURwas0.35.Statisticalliteraturetraditionallyinterpretsareliabilitystatisticof0.5-0.6as“unacceptable”.21

Recommendation:WeagainrecommendCMSimplementthemeasureand/oradjustmenttoyieldareliabilitystatistic>=0.70,consistentwithhowNQFbasesitsevaluationofmeasuresandmoregenerousthantheliterature.22Thisand/oranupdatetotheSFArangesisnecessarytopreventsmallfacilitiesfromhavingscoreshighlysubjecttorandomvariability.ReliabilityNotStratifiedbyFacilitySizeTestingdatastratifiedbyfacilitysizewerenotprovidedforthemeasureiterationcurrentlyunderreviewbyNQFbecauseit“isnotrequired.”CMSdatafrom2009revealedanIURof0.46forsmallfacilities—i.e.,forapproximatelyone-thirdofallfacilities,54percentofthescoretheyreceiveonthe2009SRRcouldbeattributabletorandomnoiseandnotsignal.

Recommendation:KCPbelievespenalizingfacilitiesforperformanceduetorandomchanceisnotappropriateandthatitisimperativethatCMSprovidethemostrecentreliabilityresultsstratifiedbyfacilitysize.Absentthatinformation,wesubmitthatthedemonstrablyunreliableSRR,ascurrentlyspecified,isparticularlyunreliableandunsuitableforuseinsmallfacilities.KCPmaintainsthatuntilitisreliableforallfacilities,theSRRshouldnotbeusedintheESRDQIP.PIURisNotanAppropriateMeasureofReliabilityCMS/UM-KECCcraftedanadditionalmetricofreliabilitytermedtheprofile-IUR(PIUR)23to“indicatethepresenceofoutliersorheaviertailsamongtheproviders,whichisnotcapturedintheIURitself....[When]thereareoutlierproviders,evenmeasureswithalowIURcanhavearelativelyhighPIURandcan

21AdamsJL.TheReliabilityofProviderProfiling:ATutorial.SantaMonica,California:RANDCorporation.TR-653-NCQA,2009.22Kline,P.(2000).Thehandbookofpsychologicaltesting(2nded.).London:Routledge,p.13;DeVellis,RF.(2012).Scaledevelopment:Theoryandapplications.LosAngeles:Sage.pp.109–110;Adams,JL.(2009).Thereliabilityofproviderprofiling.RANDHealth.

23HeK,DahlerusC,XiaL,LiY,KalbfleischJD.Theprofileinter-unitreliability.Biometrics.2019Oct23.doi:10.1111/biom.13167.[Epubaheadofprint.]

NQFNUMBER



beveryusefulforidentifyingextremeproviders.”24ThePIURfortheSRRwasPIURis0.61,whichCMSinterpretsasdemonstratingthat“theSRRiseffectiveatdetectingoutlierfacilitiesandstatisticallymeaningfuldifferencesinperformancescoresacrossdialysisfacilities.”25Initsreviewofthismeasure,however,NQF’sScientificMethodsPanel(SMP),noneofwhomwerefamiliarwiththePIUR,disagreedthatitisanappropriatemeasureofreliabilityforanyQIPmeasure,whichareusedtodistinguishperformancebetweenprovidersfallinginthemiddleofthecurvetodeterminepenalties.TheSMPconcludedthattheIURisandremainstheappropriatemeasureofreliabilityforthispurpose.

Recommendation:KCPstronglyconcurswiththeNQF’sScientificMethodsPanel(SMP)conclusionthatthePIURisnotanappropriatemeasureofreliabilityforanyQIPmeasure.QIPmeasuresareusedtodistinguishperformancealongacontinuum,inparticularamongprovidersfallinginthemiddleofthecurvetodeterminepenalties;theabilitytoreliablydistinguishoutliersforimplementationofthesemeasuresisnotthepoint.TheIURisandremainstheappropriatemeasureofreliabilityformeasuresproposedfortheQIP.DoublePenaltiesThereisunnecessaryoverlapwiththeSRRandtheStandardizedHospitalizationRatiomeasure(SHR,NQF1463),whichresultsinafacilitybeingtwicepenalizedforareadmissionoccurringwithin30daysoftheindexdischarge.InresponsetostakeholdersexpressingthisconcernduringNQF’scurrentreviewofthemostrecentiterationofthemeasures,CMSacknowledgedthatthesamehospitalizationeventmayindeedbecountedtwice,butbelieves“thisisappropriatebecauseitplacesadditionalemphasisontheimportanceofavoidinghospitalizationsandre-hospitalizationfordialysispatients...[andcan]helpreducethismajorcostdriver.”Recommendation:WhileKCPagreesreductionofhospitalizationsandreadmissionsisparamount,wedonotbelieveinflictingspeciouspenaltiesondialysisfacilitiesisanappropriateorethicalsolutionandmayultimatelylimitaccesstocare.Toavoidthis“doublepenalty”,weagainaskthatCMSincludeanexclusionintheSHRforhospitalizationsthatoccurwithin29daysoftheindexdischarge.IncorporatingthisexclusionwillavoidreadmissionsbeingcapturedasahospitalizationbytheSHR,butitwillbecapturedasareadmissionbytheSRR.Thischangepreventsafacilityfrombeingpenalizedtwiceforeachsuchreadmission.Ratesvs.Ratios

24KalbfleischJD,HeK,XiaL,LiY.Doestheinter-unitreliability(IUR)measurereliability?HealthServicesandOutcomesResearchMethodology.2018;18(3):215-225.Doi:10.1007/s10742-018-0185-4.


NQFNUMBER



TheQIPshoulduseatruerisk-standardizedratemeasure;theratiomeasurehasrelativelywideconfidenceintervalsthatcanleadtofacilitiesbeingmisclassifiedandtheiractualperformancenotbeingreported.Aratiothatisthenmultipliedbyanationalmedianisnotatruerisk-standardizedrate.

Recommendations:CMScouldusetheunderlyingreadmissionrateandappropriatelyriskadjustitusingrace/ethnicity(asisdonewiththestandardizedmortalityratio).ItshouldalsobuildoffofitscontractedworkwithNQFanddevelopsocio-demographicadjusters,consistentwithKCP’s2018commentletterrecommendations.WhileCMSsubmitsthenewmeasuretotheNQFforendorsement,itcouldusethisimprovedreadmissionsratemeasureintheQIP.

CMShasacknowledgedinpreviousrulemakingthatratemeasuresaremoretransparentandeasierforpatientsandcaregiverstounderstand.CMSshouldactquicklytoestablishameaningfulreadmissionsmeasurefortheQIP.SDSFactorsCMScouldusetheunderlyingreadmissionrateandappropriatelyriskadjustitusingrace/ethnicity(asisdonewiththeSMR).ItshouldalsobuildoffofitscontractedworkwithNQFanddevelopsocio-demographicadjusters,consistentwithKCP’s2018commentletterrecommendations.WhileCMSsubmitsthenewmeasuretotheNQFforendorsement,itcouldusethisimprovedtransfusionratemeasureasareportingmeasureintheQIP.

Recommendation:CMSshouldappropriatelyadjusttheunderlyingtransfusionrateusingrace/ethnicity.BurdenReductionIncorporationofameasurewithscoresknowntobehighlysubjecttorandomvariabilityanddoublepenalizesprovidersimposesanunnecessaryburdenonfacilities,aswellaspatientswhoareinterestedinunderstandingtheactualperformanceoffacilitiesandcannot.

Recommendation:Asabove,KCPbelievesensuringthatperformancemeasuresaddressingthiscriticalclinicaltopicarefairandreliableisvitalandnecessarytoreducefacilityandpatientburdenandconfusion.PatientEmpowermentReadmissionsisanimportantfactorinmakinghealthcaredecisionsforpatients.

Recommendation:Asabove,KCPbelievesensuringthatperformancemeasuresaddressingthiscriticalclinicaltopicarereliableandavalidrepresentationofperformanceforallfacilitiesisvitalandnecessarytoinformpatientsinmakingtheseweightydecisions.

3 BasedonNQF2979

StandardizedTransfusionRatio(STrR)(areportingmeasure):Dialysisfacility

MeasureValidity

NQFNUMBER



reportingofdataonMedicareclaimsandinCROWNWebthatareusedtodeterminethenumberofeligiblepatientyearsatriskforcalculatingtheriskadjustedfacilityleveltransfusionratio(STrR)foradultMedicaredialysispatients.

TheSTrRmeasurelacksvalidity;KCPispleasedthatCMShasacknowledgedthisconcernandsupportsitsdecisiontochangethemeasuretoareportingmetricwhilereviewingtheproblem.

InsufficientReliabilityforSmallFacilitiesTheSTrRclinicalmeasurehasnotbeendemonstratedreliableforsmallfacilities.Inthemostrecentiterationofthemeasure,currentlyunderreviewatNQF,theoverallIURfortheone-yearSTrRwas0.63-0.68acrosstheyears2014-2017.CMSdidnotprovidetestingdatastratifiedbyfacilitysizetoNQFbecauseit“isnotrequired”.Yetdatafrom2011-2014forwhichtherewasasimilaroverallIURrevealedvaluesaslowas0.30forsmallfacilities—thatis,forapproximatelyonethirdoffacilities,70percentofthescoretheyreceivedontheSTrRcouldbeattributabletorandomnoiseandnotsignal.Absentthisinformationforthenewclinicalmeasureiteration(currentlyunderreviewatNQF),wesubmitthattheSTrRclinicalmeasureremainsunreliableandunsuitableforuseinsmallfacilities,andthatuntilitisreliableforallfacilitiesthemeasureshouldnotbeusedintheESRDQIP.

Recommendation:KCPdoesnotbelievethatpenalizingfacilitiesforperformanceduetorandomchanceisappropriateandthatitisimperativethatCMSprovidethemostrecentreliabilityresultsstratifiedbyfacilitysize.WeagainrecommendthatCMSimplementthemeasureand/oradjustmenttoyieldareliableresult(reliabilitystatistic>=0.70),whichisconsistentwithhowtheNQFbasesitsevaluationofmeasuresandmoregenerousthantheliterature.26Thisstepisnecessarytopreventsmallfacilitiesfromhavingscoresthatarehighlysubjecttorandomvariabilityand/ortoupdatetheSFAranges.Untilitisreliableforallfacilities,theclinicalmeasureshouldnotbeusedintheESRDQIP.

TheSTrRisNotanAppropriateMeasureofAnemiaManagementGiventhatphysiciansandhospitals,notdialysisfacilities,controlwhetherornotapatientreceivesatransfusion,KCPagainrecommendsshiftingawayfromtheSTrRtoassessanemiamanagementtoamoreappropriatemeasurethatmoredirectlyreflectspatientqualityofcare,ismoreclearlyactionable,andreducesburden.TheSTrRshouldbereplacedwithlowhemoglobin(Hgb)measure(e.g.,aHgb<10g/dL).Whileitwillbenecessarytodevelopupdatedspecifications,exclusions,testing,andbusinessrules,KCPwouldwelcometheopportunitytoworkwithCMSonsuchameasure;wenotethatCMSdevelopedasimilarmeasureseveralyearsagothatwouldbeanappropriatestartingpoint.AlowHgbmeasurewouldreduceburden,becauseanytransfusionmeasurerequiresdialysisfacilitiestochasepaperworkcreatedbyotherproviders.ItalsoisabettermeasurethantheSTrRbecausefacilitiesandphysicianshaveaccesstopatienthemoglobindatainthefacility,whereastheydonothaveaccesstoSTrRdata.Moreover,itisactionablebyphysiciansandwillhaveadirectapositiveimpactonanissueofcriticalimporttopatients.

26Kline,P.(2000).Thehandbookofpsychologicaltesting(2nded.).London:Routledge,p.13;DeVellis,RF.(2012).Scaledevelopment:Theoryandapplications.LosAngeles:Sage.pp.109–110;Adams,JL.(2009).Thereliabilityofproviderprofiling.RANDHealth.

NQFNUMBER



Recommendation:KCPagainurgesCMStoadoptamoreappropriateanemiamanagementmeasure,suchastheHgb<10g/dL.WeareawarethatsuchameasureisnotcurrentlyendorsedbyNQF,butbelieveNQF’supdatedevidencealgorithmwouldprovideapathforitsconsiderationanew,andthattheHgb<10measure,stewardedbyCMS,representsaframeworktowhichupdatedspecifications,exclusions,andbusinessrulescouldbeapplied.KCPvolunteerstoworkwithCMStodevelopsuchameasure.Onceanappropriatemeasureisdeveloped,KCPasksthatCMSsubmitittoNQFforendorsement.Ratesvs.RatiosTheQIPshouldusetruerisk-standardizedratemeasures,becauseratiomeasureshaverelativelywideconfidenceintervalsthatcanleadtofacilitiesbeingmisclassifiedandtheiractualperformancenotbeingreported.Aratiothatisthenmultipliedbyanationalmedianisnotatruerisk-standardizedrate.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasures.SDSFactorsCMScouldusetheunderlyingtransfusionrateandappropriatelyriskadjustitusingrace/ethnicity(asisdonewiththeSMR).ItshouldalsobuildoffofitscontractedworkwithNQFanddevelopsocio-demographicadjusters,consistentwithKCP’s2018commentletterrecommendations.WhileCMSsubmitsthenewmeasuretotheNQFforendorsement,itcouldusethisimprovedtransfusionratemeasureasareportingmeasureintheQIP.

Recommendation:CMSshouldappropriatelyadjusttheunderlyingtransfusionrateusingrace/ethnicity.BurdenReductionShiftingtoamoreappropriateanemiamanagementmeasurefordialysisfacilitieswouldreduceburden,becauseanytransfusionmeasure(includingaratemeasure)requiresdialysisfacilitiestochasepaperworkcreatedbyotherproviderswhoalsoexperiencetheburdenonhavingtoprovidethedata/documentationofprovidingthetransfusion.

Recommendation:Asabove,KCPagainurgesCMStoadoptamoreappropriateanemiamanagementmeasure,suchastheHgb<10g/dL,tominimizefacilityburden.PatientEmpowermentAnemiamanagementisanimportantfactorinmakinghealthcaredecisionsfordialysispatients.Transfusionsalsoplacepatientsatriskofbecomingineligiblefortransplant.CMShasacknowledgedinpreviousrulemakingthatratemeasuresaremoretransparentandeasierforpatientsandcaregiverstounderstand.CMSshouldactquicklytoestablishameaningfultransfusionratemeasurefortheQIP.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasurestomakethemetricsmoremeaningfultopatients.

NQFNUMBER



4 NQFendorsed

differentmeasureandhasrejectedthepooledmeasure

(Kt/V)DialysisAdequacyComprehensive(clinicalmeasure):AmeasureofdialysisadequacywhereKisdialyzerclearance,itisdialysistime,andVistotalbodywatervolume.Percentageofallpatientmonthsforpatientswhosedelivereddoseofdialysis(eitherhemodialysisorperitonealdialysis)metthespecifiedthresholdduringthereportingperiod.

LackofNQFEndorsementCMSshouldremovemeasuresthatNQFhasrejectedaspartofitsendorsementprocess.AlthoughNQFhadendorsedadistinctcompositedialysisadequacymeasure,theNQFRenalStandingCommitteehassincereviewedthe(Kt/V)DialysisAdequacyComprehensivemeasureandrecommendedagainstendorsement.

Recommendation:CMSshouldadoptendorsedmeasureswhentheyareavailableovermeasuresthathavenotbeenendorsed.NQFhasendorsedothermeasuresinthedomainofdialysisadequacy:NQF#0249DeliveredDoseofHDAboveMinimum;NQF#0318DeliveredDoseofPDAboveMinimum;NQF#1423MinimumspKt/VforPediatricHDPatients;NQF#2704,MinimumDeliveredPDDose;NQF#2706,PediatricPDAdequacy—AchievementofTargetKt/V.PooledMeasureUsingapooledmeasureapproachresultsinallpatientsfromthefourdialysispopulations(adultandpediatric/peritonealandhemodialysis)tobepooledintoasingledenominatorandinscoresbeingcalculatedaswouldbedoneforasinglemeasure.Thisapproacheliminatestheabilitytodetermineperformanceonanyspecificpatientpopulationordialysismodality.

Thepooledmeasurealsodisincentivizeshomedialysis.Homefacilitieswillhaveloweradequacyscoresunderthepooledmeasure,whichwillmakethemmorelikelytobepenalized.

Recommendation:Topromotetransparencyindialysisperformanceandtheadoptionofhomedialysisbypatientsintheirfacilities,KCPsuggestsusingthedistinctadultHDandPDadequacyadultandpediatricmeasuresendorsedbytheNQF.KCPvolunteerstoworkwithCMStoaddressthesmallnumbersproblemforpediatricfacilitiesandsuggestsbuildingonthelessonslearnedfromtheNQF’sruralhealthprojectinwhichsmallnumberswereaddressedthroughothermeansthanpoolingmeasures.BurdenReductionTheconfusioncreatedbypoolingtheadequacymeasurescreatesanunnecessaryburdenonfacilities,aswellasonpatientswhoareinterestedinunderstandingtheactualperformanceoffacilitiesandcannot.

Recommendation:Toreducebothfacilityandpatientburden,KCPagainurgesCMStoreplacethepooledKt/VComprehensiveMeasurewiththeindividualNQF-endorsedadequacymeasures,asabove.PatientEmpowermentTomakeinformeddecisionsaboutmodalitychoice,patientsneedtounderstandafacility’sactualperformanceonthedifferentmodalitytypes.Thepooledmeasurehidesthisinformationfrompatients.

NQFNUMBER



Recommendation:Tofacilitatetheconveyanceofactionable,meaningfulinformationtopatients,KCPagainurgesCMStoreplacethepooledKt/VComprehensiveMeasurewiththeindividualNQF-endorsedadequacymeasures,asabove.

5 2977 HemodialysisVascularAccess:StandardizedFistulaRate(clinicalmeasure):MeasurestheuseofanAVfistulaasthesolemeansofvascularaccessasofthelasthemodialysistreatmentsessionofthemonth.

Ratesvs.RatiosTheQIPshouldusetruerisk-standardizedratesbecausetheratiomeasureshaverelativelywideconfidenceintervalsthatcanleadtofacilitiesbeingmisclassifiedandtheiractualperformancenotbeingreported.Aratiothatisthenmultipliedbyanationalmedianisnotatruerisk-standardizedrate.

Recommendation:CMScouldusetheunderlyingfistularatemeasure.WhileCMSsubmitsthenewmeasuretotheNQFforendorsement,itcouldusethecurrentmeasureintheQIP.

InsuranceStatusKCPnotesCMSmaywishtoworkwiththecommunitytodetermineifinsurancestatuspriortoreceivingdialysisshouldbeariskadjusterforthismeasure.

Recommendation:CMSshouldconsiderworkingwiththecommunitytodetermineifinsurancestatuspriortoreceivingdialysisshouldbeariskadjusterforthismeasure.PatientEmpowermentVascularaccessmaybethemostimportantmeasureforpatientsmakingdecisionsaboutdialysisfacilitiesintheESRDQIP,withcatheterreductionbeingthemostimportantofthetwoaccessmeasures.CMShasacknowledgedinpreviousrulemakingthatratemeasuresaremoretransparentandeasierforpatientsandcaregiverstounderstand.CMSshouldactquicklytomakethisaratemeasure.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasurestomakethemetricsmoremeaningfultopatients.BurdenReductionTheconfusionaroundtheratiomeasureandmisclassificationoffacilitiescreateanunnecessaryburdenonfacilities,aswellaspatientswhoareinterestedinunderstandingtheactualperformanceoffacilitiesandcannot.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasurestoreducefacilityandpatientburdenandconfusion.

NQFNUMBER



6 2978 HemodialysisVascularAccess:Long-TermCatheterRate(clinicalmeasure):Measurestheuseofacathetercontinuouslyfor3monthsorlongerasofthelasthemodialysistreatmentsessionofthemonth.

InsuranceStatusGenerally,KCPsupportsthismeasure,butnotesCMSmaywishtoworkwiththecommunitytodetermineifinsurancestatuspriortoreceivingdialysisshouldbeariskadjusterforthismeasure.

Recommendation:CMSshouldconsiderworkingwiththecommunitytodetermineifinsurancestatuspriortoreceivingdialysisshouldbeariskadjusterforthismeasure.

PatientEmpowermentVascularaccessmaybethemostimportantmeasureforpatientsmakingdecisionsaboutdialysisfacilitiesintheESRDQIP,withcatheterreductionbeingthemostimportantofthetwoaccessmeasures.

7 Basedon1454,(NQFreservestatus);theMeasureApplicationsPartnership(MAP)didnotsupportthemeasureinits2016report

Hypercalcemia(clinicalmeasure):Proportionofpatient-monthswith3-monthrollingaverageoftotaluncorrectedserumorplasmacalciumgreaterthan10.2mg/dL.

TheMeasureis“ToppedOut”Themeasureisnotusedtomakeclinicaldecisionsandistoppedout.

Recommendation:CMSshouldretirethemeasure.BurdenReductionReportingameasurethathasprovidesneitherclinicalvaluenordifferentiatesamongfacilitiesimposesaburdenwithoutprovidingbenefit.

Recommendation:CMSshouldretiretheHypercalcemiameasure.PatientEmpowermentGiventhetopped-outnatureofthismeasure,thereisnosignificantbenefitforpatients.

Recommendation:CMSshouldretiretheHypercalcemiameasure.

8 1463 StandardizedHospitalizationRatio(SHR)(clinicalmeasure):Risk-adjustedSHRofthenumberofobservedhospitalizationstothenumberofexpectedhospitalizations.

OverallReliabilityCMSdatahaveshownthattheSHRmeasureisnotreliable.InthemostrecentiterationofthemeasurecurrentlyunderreviewatNQF,theoverallIURfortheone-yearSHRwas0.53-0.59for2015-2018.Wenotethatthisvaluerepresentsadeclinefromthe2010-2013IURs(0.7),andthatstatisticalliteraturetraditionallyinterpretsareliabilitystatisticof0.50-0.60as“poor”.27

Recommendation:WeagainrecommendedthatCMSimplementthemeasureand/oradjustmenttoyieldareliableresult(reliabilitystatistic>=0.70),whichisconsistentwithhowtheNQFbasesitsevaluationof

27AdamsJL.TheReliabilityofProviderProfiling:ATutorial.SantaMonica,California:RANDCorporation.TR-653-NCQA,2009.

NQFNUMBER



measuresandmoregenerousthantheliterature.28Thisstepisnecessarytopreventsmallfacilitiesfromhavingscoresthatarehighlysubjecttorandomvariabilityand/ortoupdatetheSFAranges.

ReliabilityNotStratifiedbyFacilitySizeWhiletestingdatastratifiedbyfacilitysizewerenotprovidedforthemeasureiterationcurrentlyunderreviewbyNQFbecauseit“isnotrequired”,2010-2013datarevealedanIURaslowas0.46forsmallfacilities—thatis,forapproximatelyone-thirdoffacilities,54percentofthescoretheyreceivedontheSHRcouldbeattributabletorandomnoiseandnotsignal.Webelieveit'sdisingenuous,atbest,nottoprovidereliabilitybasedonfacilitysizemerelybecauseNQF"doesnotrequire"it.

Recommendation:KCPbelievespenalizingfacilitiesforperformanceduetorandomchanceisnotappropriateandthatitisimperativethatCMSprovidethemostrecentreliabilityresultsstratifiedbyfacilitysize.Absentthatinformation,wesubmitthatthedemonstrablyunreliableSHR,ascurrentlyspecified,isparticularlyunreliableandunsuitableforuseinsmallfacilities.Untilitisreliableforallfacilities,themeasureshouldnotbeusedintheESRDQIP.PIURisNotanAppropriateMeasureofReliabilityToassessmoredirectlythevalueofSHRinidentifyingfacilitieswithextremeoutcomes,CMSandUM-KECCcraftedanadditionalmetricofreliabilitytermedtheprofile-IUR(PIUR).29PerCMS,“ThePIURindicatesthepresenceofoutliersorheaviertailsamongtheproviders,whichisnotcapturedintheIURitself....[When]thereareoutlierproviders,evenmeasureswithalowIURcanhavearelativelyhighPIURandcanbeveryusefulforidentifyingextremeproviders.”30ThePIURfortheSHRwasPIURis0.75-0.85for2015-2018,whichCMSinterpretsasdemonstratingthat“theSHRiseffectiveatdetectingoutlierfacilitiesandstatisticallymeaningfuldifferencesinperformancescoresacrossdialysisfacilities.”31Wenotethatinitsreviewofthismeasure,however,NQF’sScientificMethodsPanel(SMP),noneofwhomwerefamiliarwiththePIUR,disagreedthatitisanappropriatemeasureofreliabilityforanyQIPmeasure,whichareusedtodistinguishperformancebetweenprovidersfallinginthemiddleofthecurvetodeterminepenalties.TheSMPconcludedthattheIURisandremainstheappropriatemeasureofreliabilityforthispurpose.

Recommendation:KCPstronglyconcurswiththeNQF’sScientificMethodsPanel(SMP)conclusionthatthePIURisnotanappropriatemeasureofreliabilityforanyQIPmeasure.QIPmeasuresareusedtodistinguish

28Kline,P.(2000).Thehandbookofpsychologicaltesting(2nded.).London:Routledge,p.13;DeVellis,RF.(2012).Scaledevelopment:Theoryandapplications.LosAngeles:Sage.pp.109–110;Adams,JL.(2009).Thereliabilityofproviderprofiling.RANDHealth.

29HeK,DahlerusC,XiaL,LiY,KalbfleischJD.Theprofileinter-unitreliability.Biometrics.2019Oct23.doi:10.1111/biom.13167.[Epubaheadofprint]30KalbfleischJD,HeK,XiaL,LiY.Doestheinter-unitreliability(IUR)measurereliability?HealthServicesandOutcomesResearchMethodology.2018;18(3):215-225.Doi:10.1007/s10742-018-0185-4.


NQFNUMBER



performancealongacontinuum,inparticularamongprovidersfallinginthemiddleofthecurvetodeterminepenalties;theabilitytoreliablydistinguishoutliersforimplementationofthesemeasuresisnotthepoint.TheIURisandremainstheappropriatemeasureofreliabilityformeasuresproposedfortheQIP.Ratesvs.RatiosTheQIPshouldusetruerisk-standardizedratesbecausetheratiomeasureshaverelativelywideconfidenceintervalsthatcanleadtofacilitiesbeingmisclassifiedandtheiractualperformancenotbeingreported.Aratiothatisthenmultipliedbyanationalmedianisnotatruerisk-standardizedrate.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasures.SDSFactorsCMScouldusetheunderlyinghospitalizationrateandappropriatelyriskadjustitusingrace/ethnicity(asisdonewiththeSMR).ItshouldalsobuildoffofitscontractedworkwithNQFanddevelopsocio-demographicadjusters,consistentwithKCP’s2018commentletterrecommendations.WhileCMSsubmitsthenewmeasuretotheNQFforendorsement,itcouldusethisimprovedhospitalizationratemeasureintheQIP.

Recommendation:CMSshouldappropriatelyadjusttheunderlyinghospitalizationrateusingrace/ethnicity.BurdenReductionTheconfusionaroundtheratiomeasureandmisclassificationoffacilitiescreateanunnecessaryburdenonfacilities,aswellaspatientswhoareinterestedinunderstandingtheactualperformanceoffacilitiesandcannot.

Recommendation:TheQIPshouldusetruerisk-standardizedratemeasurestoreducefacilityandpatientburdenandconfusion.PatientEmpowermentHospitalizationratesarecriticalindicatorsofqualityperformanceforbothpatientsandproviders.ThelackofreliabilityfortheSHRmeansthatthemeasureisnotaccuratelyreflectingtheperformanceofsmallfacilitiesandprovidesinaccurateinformationuponwhichpatientsarethenaskedtomakehealthcaredecisions.Recommendation:TheQIPshouldusetruerisk-standardizedratemeasurestomakethemetricsmoremeaningfultopatients.

9 BasedonNQF#0418

ClinicalDepressionScreeningandFollow-Up(reportingmeasure):FacilityreportsinCROWNWeboneofsixconditionsforeach

CMSShouldImplementMeasuresasEndorsedbyNQFCMShaschangedthespecificationsmakingthemeasuredifferentthantheonethatNQFendorsed.ThesechangesmeanthattheQIPmeasurehasnotbeenreviewedorendorsedbyNQF.

NQFNUMBER



qualifyingpatienttreatedduringperformanceperiod.

Recommendation:IfitweretoremainintheQIP,KCPcontinuesrecommendingthatCMSuseitasareportingmeasurebutencouragesCMStoworkwiththekidneycarecommunitytoestablishastandardizedESRD-specifictool.BurdenReductionWhenCMSchangesthespecificationsofanNQF-endorsedmeasure,itcreatesaburdenonfacilitiesbecausetheyarereportingameasurethatmayormaynotmeetmeasuredevelopmentcriteria,andifitdoesnot,reportingtheinformationdoesnotprovideanyvalue.Patientsareburdenedbyhavingtofigureoutontheirownwhetherornotthemeasureisaccuratelyreportingonafacility’sperformance.

Recommendation:Toreducebothfacilityandpatientburden,KCPagainurgesCMStoimplementonlyNQF-endorsedmeasurespecificationsintheQIP.PatientEmpowerment:ClinicalDepressionisanimportantcomponentinmanagingpatientslivingwithkidneyfailure.However,thismeasureisbettersuitedfortheDialysisFacilityCompareprogramsothatafacility’sperformanceonthemeasureisnotdilutedbyothermeasures,makingitdifficultforpatientstouseittomakedecisions.CMShasindicatedthatthepurposeofDFCisspecifictothistask.

Recommendation:Tofacilitatepatientusability,theClinicalDepressionScreeningandFollow-UpmeasureshouldbelimitedtouseintheDialysisFacilityCompareprogram.

10

BasedonNQF2701:AvoidanceofUtilizationofHighUltrafiltrationRate(>13ml/kg/hour)

UltrafiltrationRate(reportingmeasure):Numberofmonthsforwhichafacilityreportselementsrequiredforultrafiltrationratesforeachqualifyingpatient.

Patient-MonthsConstructionKCPappreciatesthatCMSnowconcurswithourlongstandingpositionthattheNQF-endorsedUFRmeasurespecificationsshouldbeusedandhasrevisedthespecificationstothepatient-monthsconstruction.Aswehavepreviouslynoted,KCPstronglyobjectedtothechangeto“facility-months”;thepatient-monthsmeasureconstructionwascarefullyanddeliberatelyselectedbyKCQAwhendevelopingthemeasuresothatpatientsreceivingcareatagivenfacilityforfewerthan12monthswouldstillbecapturedandcountedinmeasurecalculationsandwouldcontributetothefacilityscoreinaccordancewiththenumberofmonthstheyreceivedcarethere.Thisspecific—andintended—constructionwassupportedbytheNQFRenalStandingCommitteewhenitendorsedthemeasurein2017.Thecalculationusingthepatient-monthsconstructionnowcomportswiththeNQF-endorsedmeasureandshouldbeused.

BasedonNQF2701KCPalsoappreciatesCMS’explicitnotationinthisProposedRulethattheUFRReportingMeasureisbasedontheKidneyCareQualityAlliance’sNQF-endorsedAvoidanceofUtilizationofHighUFR,NQF#2701.PatientEmpowerment

NQFNUMBER



KCPcontinuestobelievethatfluidmanagementisanimportantqualityarea,whichiswhyitfundedtheKidneyCareQualityAlliance(KCQA)toundertakesuchmeasuredevelopment.KCPmembersidentifiedaddressingfluidmanagementasthehighestpriorityinKCP’sStrategicBlueprintforKidneyCareQuality.

11

BasedonNQF1460

NHSNBloodstreamInfection(BSI)inHemodialysisPatients(clinicalmeasure):TheStandardizedInfectionRatio(SIR)ofBSIswillbecalculatedamongpatientsreceivinghemodialysisatoutpatienthemodialysiscenters.

NHSNValidationStudyKCPappreciatesCMS’proposaltoreducethesubmissionrequirementforfacilitiesselectedtoparticipateintheNHSNvalidationstudyfrom40to20patientrecordsfromanytwoquartersduringtheyearfortheapplicablecalendaryear.Weconcurthatthisrevisedapproachwillreducefacilityburdenwhilemaintaininganadequatesamplesizeforthemeasurevalidationanalysis.

TheMeasureisNotReliableorValidThemeasureisnotmeetingtherigorouscriteriaofreliabilityandvalidity;asaresult,themeasureisnotreportingaccuratedatatopatientsorproviders.ResearchconductedbytheCDC(themeasure’sdeveloper)andothers,includingCMS,showthatthemeasureisnotvalidorreliable.CMSdatashowsthatasmanyas60-80percentofdialysiseventsmaybeunder-reportedwiththeNHSNBSImeasure.32Inafollow-upTEP,CMSandotherHHSagencyofficialsindicatedthatthepercentagewasslightlylower,butTEPmembersraisedconcernsthatthepercentageremainsunacceptablyhigh.Inlightofthesedata,itisclearthatthemeasuredoesnotmeetthecriterionofvalidityforendorsement.Thismeansthatthemeasureinmanyinstancesmayincorrectlyreportthatafacilityhasalownumberofbloodstreaminfectionswhen,infact,thefacilityhasahighernumber.Giventheunderstandableimportancethatpatientsplaceonafacility’sabilitytomanagebloodstreaminfections,ameasurethatfailstoaccuratelyrepresentthefacility’sperformancedeprivespatientsoftheirabilitytomakeinformedhealthcaredecisions.Italsounfairlypenalizesfacilitiesthatdiligentlypursueandreportthehospitalinfectiondatanecessaryforafullpictureofinfectionrates.

Recommendation:Intheshort-term,removingtheclinicalmeasureandusingtheDialysisEventReportingMeasurealonewouldletpatientsknowwhetherafacilityisreportingsuchinfectionswhileallowingCMSandthecommunitytofixtheproblems.Inpreviouscomments,KCPhassuggestedthatCMSconverttheNHSNBSImeasuretoareportingmeasurewhileitconvenesaTEPtoidentifytheproblemwiththemeasureandproposesolutions.Onceanewmeasureisspecified,CMSshouldsubmitittoNQFforendorsementbeforeadoptingitasaclinicalmeasurefortheESRDQIP.CMSShouldImplementMeasuresasEndorsedbyNQFCMSshouldavoidmodifyingNQF-endorsedmeasureswhenadoptingthemfortheESRDQIP;theNHSNBloodstreamInfection(BSI)inHemodialysisPatientsisnotedtobe“basedon”NQF1460butdoesnotfullycomportwiththeendorsedspecifications.

322018ProposedRuleDisplayCopy90.

NQFNUMBER



Recommendation:Asdescribedabove,CMSshouldeliminatetheNHSNBSImeasureandrelyupontheNHSNdialysiseventreportingmeasurewhileCMSconvenesaTEPtoidentifytheproblemswiththeBSImeasure.Onceithasrevisedthemeasure,CMSshouldsubmittherevisedmeasure[toNQF],whichwouldmeetthevalidityrequirementsofendorsements,totheNQF.

BurdenReductionResearchsuggeststhattheunderreportingidentifiedwiththismeasuremaybeduetothefactthathospitals,notdialysisfacilities,havetherequisitedata.Itisaburdenonhospitalstoprovidethedatatofacilitiesandonfacilitiestochasehospitalsforthedata.Addressingthisproblemthroughavalidmeasurewouldreduceunnecessaryburdenonthehospitalsandfacilities.

Recommendation:Tominimizefacilityburdens,KCPagainurgesCMStoeliminatetheNHSNBSImeasureandrelyupontheNHSNdialysiseventreportingmeasurewhileCMSexploresandidentifiestheproblemswiththeBSImeasure.PatientEmpowermentThismeasuretopicareaiscriticallyimportanttopatients.AmeasurethatincorrectlyreportsafacilityashavingalownumberofBSIwheninfactitdoesnotdistortsthecarebeingprovidedandmisleadspatientsinawaythatdisruptstheirabilitytomakeaninformedhealthcaredecision.

Recommendation:KCPagainurgesCMStoeliminatetheNHSNBSImeasureandrelyupontheNHSNdialysiseventreportingmeasurewhileCMSexploresandidentifiestheproblemswiththeBSImeasure.

12

NeversubmittedforNQFendorsement

NHSNDialysisEvent(reportingmeasure):NumberofmonthsforwhichfacilityreportsNHSNDialysisEventdatatoCDC.

CMSHasNotSubmittedthisMeasuretoNQFforEndorsementThisisinconsistentwiththeintentoftheCongressforCMStouseNQFendorsedmeasuresintheQIP(seeSSA§1881(h)(2)(B)).Withouttherigorofendorsement,thereliabilityandvalidityofthemeasureremainuncertainandthespecificationhavebeenallowedtomorphsothattherearenowseveralsubjectivelyinterpretedsignsofinfection(e.g.,swelling,redness)included.

Recommendation:CMSshouldremovethesubjectivefactorsandseekNQFendorsementofthemeasure.BurdenReductionTheexpansionofthereportingprotocoltobehighlysubjectiveisextremelyburdensomeanddoesnotcontributetothemeasure’sunderlyingpremise—toidentifyBSIsverifiedbypositivebloodcultures.Eliminatingthesubjectivefactorswouldhelpreducetheburdenofthismeasure.

Recommendation:CMSshouldremovethesubjectivefactorsspecifiedinthemeasure.PatientEmpowerment

NQFNUMBER



ItisimportanttopatientsandKCPthatfacilitiesareappropriatelymonitoringBSI.However,theinformationreportedshouldbeobjectiveandservethepurposeofidentifyingpatientsatriskforBSIsotheycanreceiveappropriatetreatment.Thesubjectivefactorsaddedtothemeasurespecificationslastyeardonotachievethisgoal.

Recommendation:CMSshouldremovethesubjectivefactorsspecifiedinthemeasure.

13

RejectedbyNQF

PercentageofPrevalentPatientsWaitlisted(PPPW)(clinicalmeasure):Percentageofpatientsateachdialysisfacilitywhowereonthekidneyorkidney-pancreastransplantwaitlistaveragedacrosspatientsprevalentonthelastdayofeachmonthduringtheperformanceperiod.

CMSShouldRemoveMeasuresNQFhasRejectedfromtheQIPNQFhasrejectedthePPPWmeasureaslackingvalidity.

Recommendation:CMSshouldremovethePPPWfromtheQIP.KCPstandsreadytodevelopanappropriatetransplant-relatedmeasurewithCMSandothersinthekidneycarecommunitythatmeetstheendorsementcriteriaofNQFandtheintentoftheCongress.KCPDoesNotSupportAttributiontoDialysisFacilitiesofSuccessful/UnsuccessfulWaitlistingKCPbelievesthatwhileareferraltoatransplantcenter,initiationofthewaitlistevaluationprocess,orcompletionofthewaitlistevaluationprocessmaybeappropriatefacility-levelmeasuresthatcouldbeusedinESRDqualityprograms,thePPPWisnot.Waitlistingperseisadecisionmadebythetransplantcenterandisbeyondadialysisfacility’slocusofcontrol.Inreviewingthesemeasures,weofferthefollowingcomments.

Recommendation:CMSshouldremovethePPPWfromtheQIP.KCPstandsreadytodevelopanappropriatetransplant-relatedmeasurewithCMSandothersinthekidneycarecommunitythatmeetstheendorsementcriteriaofNQFandtheintentoftheCongress.

StratificationofReliabilityResultsbyFacilitySizeCMShasprovidednostratificationofreliabilityscoresbyfacilitysizeforeithermeasure;wearethusunabletodiscernhowwidelyreliabilityvariesacrossthespectrumoffacilitysizes.WeareconcernedthatthereliabilityforsmallfacilitiesmightbesubstantiallylowerthantheoverallIURs,ashasbeenthecase,forinstance,withotherCMSstandardizedratiomeasures.

Recommendation:KCPbelievesitisincumbentonCMStodemonstratereliabilityforallfacilitiesbyprovidingdatabyfacilitysize.BurdenReductionCollectingandsubmittingdataonthePPPWmeasurewhenitdoesnotprovideanaccurateviewofdialysisfacilityqualityisaburdenwithoutbenefit.

NQFNUMBER



Recommendation:CMSshouldremovethePPPWfromtheQIP.KCPstandsreadytodevelopanappropriatetransplant-relatedmeasurewithCMSandothersinthekidneycarecommunitythatmeetstheendorsementcriteriaofNQFandtheintentoftheCongress.PatientEmpowermentMakingsurethatfacilitiesaredoingeverythingwithintheirscopetopromotetransplants(e.g.,educatingpatientsabouttransplantoptions,protectingpatientsfrominfection,referringpatientstotransplantcenters,etc.)isimportanttopatients,thecommunity,andtheAdministration.However,usingameasurethatisnotaccuratelyreportingonfacilityactionmisleadspatientsandforcesthemtomakehealthcaredecisionsbasedonfalsedata.

Recommendation:CMSshouldremovethePPPWfromtheQIP.KCPstandsreadytodevelopanappropriatetransplant-relatedmeasurewithCMSandothersinthekidneycarecommunitythatmeetstheendorsementcriteriaofNQFandtheintentoftheCongress.

14

BasedonNQF2988

MedicationReconciliationforPatientsReceivingCareatDialysisFacilities(MedRec)(reportingmeasure):Percentageofpatient-monthsforwhichmedicationreconciliationwasperformanceanddocumentedbyaneligibleprofessional.

Patient-MonthsConstructionKCPappreciatesthatCMSnowconcurswithourlongstandingpositionthattheNQF-endorsedMedicationReconciliationmeasurespecificationsshouldbeusedandhasrevertedtothepatient-monthsconstruction.Aswehavepreviouslynoted,KCPstronglyobjectedtothechangeto“facility-months”;themeasurewasdeliberatelyconstructedandendorsedusingpatient-monthstoaddressthefactthatpatientsmaycontributevaryingamountsoftimetotheannualdenominatorpopulation.Thecalculationusingthepatient-monthsconstructionnowcomportswiththeNQF-endorsedmeasureandshouldbeused.DiscrepanciesBetweenthePublishedandtheEndorsedSpecificationsRemainCMShaschangedthespecificationsfromthosethatNQFendorsed.Specifically,theQIPrevisionsdeletespecificitemsthatmustbeaddressedinthemedicationreconciliation(e.g.,medicationname,dosage,etc.).ThesechangesmeanthatNQFhasnotreviewedorendorsedthenewmeasure.Recommendation:KCPsupportsusingtheMedicationReconciliationmeasureintheQIPandasksthatCMSusesthespecificationsasendorsedbytheNQF.BurdenReductionWhenCMSchangesthespecificationofanNQF-endorsedmeasure,itcreatesaburdenonfacilitiesbecausetheyarereportingameasurethatmayormaynotmeetmeasuredevelopmentcriteriaand,ifitdoesnot,reportinginformationthathasquestionablevalue.Patientsareburdenedbyhavingtofigureoutontheirownwhetherornotthemeasureisaccuratelyreportingafacility’sperformance.

Recommendation:KCPsupportsusingtheMedicationReconciliationmeasureintheQIPandasksthatCMSusesthespecificationsasendorsedbytheNQF.

NQFNUMBER



PatientEmpowermentTEPshaveconsistentlyendorsedtheadoptionofamedicationreconciliationmeasure.TobeconsistentwithCMS’ownprinciplesandthoseofexpertslikeNQF,themeasureusedshouldbereliableandvalidsothatpatientscanusetheinformationtomakeinformeddecisions.Changingthespecificationscallsthenew,revisedmeasure’svalidityandreliabilityintoquestion.

Recommendation:KCPsupportsusingtheMedicationReconciliationmeasureintheQIPandasksthatCMSusesthespecificationsasendorsedbytheNQF.