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in re: NQTICE OF APPROVAL OF REGULATORYDivision of Workers' Compensation ACTION

Regina#ory Action.

Government Code Section 11349.3Title 08, California Code of Regulations

Adopt sections: 9792.27.1, 9792.27.2, OAS Matter Number: 2017-1023-4.19792.27.3, 9792.27.4,9792.27.5, 9792.27.6,9792.27.7, 9792.27.8, OAL Matter Type: Regular {S)9792.27.9, 9792.27.10,9792.27.11, 9792.27.12,9792.27.13, 9792:27.14,9792.27.15, 9792.27.16,9792.27..17, 9792.27.'18,9792.27.19, 9792.27.20,.9792.27.21, 9792.27.22,9792,27.23

Amend sections:Repeal sections:

This action. adopts the .workers' compensation Medical Treatment Utilization Schedule{MTUS} drug... formulary and establishes an advisory Pharmacy end TherapeuticsCommittee.

OAL approves this regulatory action pursuant to section .11349.3 of the GovernmentCode. This regulatory actionbecomes effective an 1/7/2018. ~

Date: December 7, 2017

Original: George Parisotto, ActingAdministrative Director

Copy: Jacqueline Schauer

IYIQIf~ VtVIIII

Senior Attorney

For: Debra M. CornetDirector

r-_ h,STATE OF CALffORNIP.-0FFICE OF ADMINISTRATIVE qtr ~ ~

-' ".. {S'gQ (f1St~UCt1011S Oil~6'~~'~~~ ~~lBLICATION/R~GU~~~1~ ~t~6~~5fs~-~! . ~.:.~ reverse)STD. 400 (REV. O7-2013)

OAL FILE NOTICE FILE NUMBER REG~I4~TOF _n ;, NUMBE EMERGENCY NUMBERNUMeERs Z_2017-0307-01 c 'l..'; ~ ., ~- ~~ ~ "~>, For use by Office ofAdministrative Law. (OAL} only

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For use by Secretary of State only

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NOTICE REGULATIONS

AGENCY WITHRULEMAKINGAUTHORItY ~ AGENCY FILE NUMBERpfany)Department of Industrial Relations -Division of Workers' Compensation

A. PUBLICATION OF NOTICE (Complete for publication in Notice Register)1. SUBJECT OF NOTICE

TITLES) FIRST SECTION AFFECTED 2. REQUESTED PUBLICATION TE

3. NOTICE TYPE - ~ 4. AGENCY CONTACT PERSON ~E~ErnorvE NunnttEtt roc Nunnerttt (Upuonaq{~~ Notice re Proposed

i Ranula}nni 6rtinn ~ Other _OAL VS~ AV ~~VIM VN YKVF'V JtL/ IYV I.1(:t

i rj~710E A~NL~ ~

Approved as ~ Approved as ~ Disapproved/Submitted Modified Withdrawn i ~ -~ ~~~' ,B. SUBMISSION OF REGULATI<3N5 (Complete when submitting regulations}7a. SUBJECT OF REGULATION{S) -

1b. ALl PREVIOUS RELATED OAL REGULATORY ACTION NUMBERS)Workers' Compensation - MTUS -Formulary2. SPECIFY CALIFORNIA CODE OF REGUlAT10N5TIRE(5) ANO SECTION(5) pncluding 8tle 26, if toxin related)

SECTION(5) AFFECTED AooPT

(List all section number(sI Pease see attached (9792.27.1 - 9792.27.23)individually.Attach AME"o

additional sheet if needed.)TITLES) REPEAL

NUMBER I ~ueuc.artor~ oArF

+ 'rb v E' < r r. ~i'y Ea , ~.. ~ ~ ~ ~- s ,, n •` -,_

3. TYPE OF.PILING

RegularRulemaking (Gov..)C ~ Certificate of Compliance: The agency officer named ❑Emergency Readopt (Gov. Changes Without Regulatory

Code §17346) below certifies that this agency complied with the Code, 417346.1(h)) ~ Effect (Cal. Cale Regs., title

O Resubmittal of disapproved or provisions of Gov. Code §§11346.2-113473 either1, §t 00}

withdrawn nonemergency before the emergency regulation was adopted or file &Print Print OnI

filing (Gov. Code §§71344.3, within the time period required by statute. ❑ ❑ Y71349.4)

Emergency (Gov. Code, ~ Resubmittal of disapproved or withdrawn ❑ether (Specify)§p3gg,~~pp emergency filing (Gov. Code, §77346J)a ALL BEGINNING ANO ENDING DATES OF AVAILABILITY OF MODIFIED REGULATIONS AN0/0R MATERIALADDED TO THE RU~EMAKWG FILE (Cal. Code Regs. tiNe t, §44 and Gov.Code §t 7347.7)7/18/17 - 8/2!17; 9/7J17 - 9!22/17S. EFFECTIVE DATE OF CHANGES (Gov. Code, y§ 11343.4, 7134b.i (d); CaL Code Regs, title 1, 4100 )Effective January 1, April 1, July t, or Effective on filing with 4700Changes Without Effective

~anuar ~ 2~~October! (Gov. Code§11343A(a)) ~ Secretary of State ❑ Regulatory Effect ~ ~her(Spxify) y6. CHECK IF THESE REGULATIONS REQUIRE NOTICE TO, OR REVIEW, CONSULTATION, APPROVAL OR CONCURRENCE BY, ANOTHER AGENCY OR ENTITYDepartment of Finance (Form STD.399) (SfiM §6660) ~ Fair Political Practices Commission ~ State Fire Marshal

Other (Spxify)

7. CONTACT PERSON TELEPHONE NUMBER FAX NUMBER {Optlonal) E-MAIL ADDRESS (Optional)Jacqueline Schauer {570) 286- 0563 (510) 286-Q687 jschauer@dir.ca.gov

$• 1 certify that the attached copy of the regulations) is a true and correct copy For use by Office of Administrative Law (OAL} onlyof the regulations) identified on this form, that the information specified on this formis and correct, and that 1 am the head of the agencytaking this action,~ d g~rte~of the head of the agenry, and am authorized to make this certification.

10/13/2017

George Parisatto, Administrative Director

Notice Publication/Regulations Submission

STD. 400 (REV. 01-2013}

Attachment Sheet ,,~ -~~~

Notice File Number Z-'0307-01

Department of Industrial Relations, Division of Workers' Compensation

Subject of Regulations: Workers' Compensation Medical Treatment Utilization Schedule (MTUS) —Formulary

Sections Affected (continuation)

Adopt: 9792.27.1, 9792.27.2, 9792.27.3, 9792.27.4, 9792.27.5; 9792.27:6; 9792.27.7, 9792.27.8,9792.27.9, 9792.27.10, 9792.27.11, 9792.27.12, 9792.27.13, 9792.27.14, 9792:27.15, 9792.27.16,9792.27.17, 9792.27.18, 9792.27.19, 9792.27.20, 9792.27.21, 9792.27.22, 9792.27.23

Title 8, California Code of Regulations sections 9792.27.1 — 9792.27.23

Section 9792.27.1. Medical Treatment Utilization Schedule (MTUS) DrugFormulary —Definitions.

For purposes of sections 9792.27.1 through 9792.27.23, the following definitions shallapply:

(a) "Administer" means the direct application of a drug or device to the body of thepatient by injection, inhalation, ingestion, or other means.

(b) "Authorization through prospective review" means authorization for proposedtreatment obtained through the utilization review process set forth in section 9792.6.1 etseq.

(c) "Brand name drug" means a drug that is produced or distributed under an FDAoriginal New Drug Application (NDA) or Biologic License Application (BLA) approved bythe FDA. It also includes a-drug product marketed by any cross-licensed producers ordistributors operating under the same NDA or BLA.

(d) "Combination drug" means a fixed dose combination of two or more active drugingredients into a single dosage form that is FDA-approved for marketing.

(e) "Compounded drug" means any drug subject to:(1) Article 4.5 (commencing with section 1735) or article 7 (commencing with section1751) of division 17 of title 16 of the Califiornia Code of Regulations, or(2) Other regulation adopted by the State Board of Pharmacy to govern the practice ofcompounding, or(3) Federal law governing compounding, including title 21, United State Code, sections353a, 353a-1, 353b.

(f) "Dispense" means: 1) the furnishing of a drug upon a prescription from a physicianor other health care provider acting within the scope of his or her practice, ar 2) thefurnishing of drugs directly to a patient by a physician acting within the scope of his orher practice.

(g) "Executive Medical Director" means the medical director of the Division of Workers'Compensation.

(h) "Exempt drug" means a drug on the MTUS Drug List which is designated as being adrug that does not require authorization through prospective review prior to dispensingthe drug, provided that the drug is prescribed in accordance with the MTUS TreatmentGuidelines. The Exempt status of a drug is designated in the column with the headinglabeled "Exempt / "Exempt /Non-Exempt."

MTUS —Formulary —Title 8, CCR §§9792.27.1— 9792.27.23(To OAL for adoption: October 2017) Page 1 of 15

(i) "Expedited review" means the expedited utilization review conducted prior to thedelivery of the requested medical services, in accordance with Labor Code section 4610and title 8, California Code of Regulations section 9792.6.1 et seq.

(j) "FDA" means the United States Food and Drug Administration within the UnitedStates Department of Health &Human Services.

(k) "FDA-approved drug" means a prescription or nonprescription drug that has beenapproved by the FDA under the federal Food, Drug, and Cosmetic Act, title 21, UnitedStates Cade, section 301 et seq.

(Ij "Generic drug" means a drug that is produced or distributed under an FDAAbbreviated New Drug Application (ANDA) approved by the FDA. A generic drug maybe substituted for a therapeutic equivalent brand name drug pursuant to applicable stateand federal laws and regulations.

(m) "MTUS Drug Formulary" means the MTUS Drug List set forth in section 9792.27.15and the formulary rules set forth in sections 9792.27.1 through 9792.27.23.

{n) "MTUS Drug List" means the drug list and related information in section 9792.27.15,which sets forth the Exempt ar Nan-Exempt status of drugs listed by active drugingredient(s).

(o) Nan-Exempt drug" means a drug on the MTUS Drug List which is designated asrequiring authorization through prospective review prior to dispensing the drug. TheNon-Exempt Drug status of a drug is designated in the column labeled "Exempt / Non-Exempt."

(p) "Nonprescription drug" or "over-the-counter drug" (OTC drug) means a drug whichmay be sold without a prescription and which is labeled for use by the consumer withoutthe supervision of a health care professional.

(q) "Off-label use" means use of a drug for a condition, or in a dosage or method ofadministration, not listed in the drug's FDA-approved labeling for approved use.

(r) "OTC Monograph" means a monograph established by the FDR setting forthacceptable ingredients, doses, formulations, and labeling for a class of OTC drugs.

(s) "Perioperative Fill" means the policy set forth in section 9792.27.13 allowingdispensing of identified Non-Exempt drugs without prospective review where the drug isprescribed within the perioperative period and meets specified criteria.

(t) "P&T Committee" means the Pharmacy and Therapeutics Committee established bythe Administrative Director pursuant to Labor Cade section 5307.29 to review andconsult with the administrative director on available evidence of the relative safety,efficacy, and effectiveness of drugs within a class of drugs in the updating of theevidence-based drug formulary.

MTUS —Formulary —Title 8, CCR §§9792.27.1— 9792.27.23

(To QAl for adoption: October 2017) Page 2 of 15

(u) "Physician": Notwithstanding the definition in Labor Code section 3209.3, forpurposes of the MTUS Drug Formulary, "Physician" means a medical doctor, doctor ofosteopathy, or other health care provider whose scope of practice includes theprescription of drugs. However, for purposes of membership on the P&T Committee,"physician" means a medical doctor or doctor of osteopathy licensed pursuant to theCalifornia Business and Professions Code.

(v} "Prescription drug" means any drug whose labeling states "Caution: Federal lawprohibits dispensing without prescription," "Rx only," or words of similar import.

(w) "Prospective review" means the utilization review conducted prior to the delivery ofthe requested medical services, in accordance with Labor Code, section 4610 and title 8,California Code of Regulations section 9792.6.1 et seq.

(x) "Special Fill" means the policy set forth in section 9792.27.12 allowing dispensing ofidentified Non-Exempt drugs without prospective review where the drug is prescribed ordispensed in accordance with the criteria set forth in subdivision (b) of section..9792.27.12.

(y) A "therapeutic equivalent" is a drug designated by the FDA as equivalent to aReference Listed Drug if the two drugs are pharmaceutical equivalents (contain thesame active ingredient(s), dosage form, route of administration and strength), and arebioequivalent (comparable availability and rate of absorption of the active ingredient(s).)Drugs that the FDA considers to be therapeutically equivalent products are assigned aTherapeutic Equivalence Evaluation Code beginning with the. letter "A" in the FDApublication "Orange Book: Approved Products with Therapeutic EquivalenceEvaluations" which is available on the FDA website and accessible via a link providedan the department's website.

(z) "Unlisted drug" means a drug that does not appear on the MTUS Drug List andwhich is one of the following: an FDA-approved or a nonprescription drug that ismarketed pursuant to an FDA OTC Monograph. An "unlisted drug" does not include acompounded drug but does include a combination drug.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Gode.

Section 9792.27.2. MTUS Drug Formulary; MTUS Drug List; Scope of Coverage;Effective -Date.

(a) Drugs prescribed or dispensed to treat a work related injury or illness fall withinLabor Code section 4600's definition of "medical treatment" and are subject to therelevant provisions of the MTUS, including the MTUS Treatment Guidelines, provisionsrelating to the presumption of correctness, and the methods for rebutting thepresumption and for substantiating medical necessity where the MTUS TreatmentGuidelines do not address the condition or injury.

MTUS —Formulary —Title 8, CCR ~~9792.27.1— 9792.27.23{To OAL far adoption: October 2017) Page 3 of 15

(b) Except for continuing drug treatment subject to section 9792.27.3, subdivision (b), adrug dispensed on or after January 1, 2Q18 for outpatient use shall be subject to theMTUS Drug Formulary, regardless of the date of injury.

(1) A drug is for "outpatient use" if it is dispensed to be taken, applied, or self-administered by the patient at home or outside of a clinical setting, including "takehome" drugs dispensed at the time of discharge from a facility. "Home" includes aninstitutional setting in which the injured worker resides, including but not limited to, anassisted living facility..

(2) The MTUS Drug Formulary does not apply to drugs administered to the patient by aphysician. However, the physician administered drug treatment. is subject to relevantprovisions of the MTUS, including the MTUS Treatment Guidelines.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Cade.

Section 9792.27.3. MTUS Drug Formulary Transition.

(a) Except as provided in subdivision (b), the MTUS Drug -Formulary applies to-drugs -dispensed an or after January 1, 2018, regardless of the date of injury.

(b} {1) For injuries occurring prior to January 1, 2018, the MTUS Drug Formularyshould be phased in to ensure that injured workers who are receiving ongoing drugtreatment are not harmed by an abrupt change to the course of treatment. Thephysician is responsible for requesting a medically appropriate and safe course oftreatment for the injured worker in accordance with the MTUS, which may include use ofa Non-Exempt.drug or unlisted drug, where that is necessary for the injured worker's-conditian or necessary for safe weaning, tapering, or transition to a different drug.

(2) If the. injured .worker with a date of injury prior to January 1, 2018 is receiving acourse of treatment that includes allon-Exempt drug, an unlisted drug, ar acompounded drug, the physician shall submit a progress report issued pursuant tosection 9785 and a Request for Authorization that shall address the injured worker'songoing drug treatment plan..The report shall either:

(A) Include a treatment plan setting forth a medically appropriate weaning, tapering, ortransitioning of the worker to a drug pursuant to the MTUS, or

(B) Provrde supporting documentation, as appropriate, to substantiate the medicalnecessity af, and to obtain authorization for, the Non-Exempt drug, unlisted drug, orcompounded drug, pursuant to the MTUS (via guidelines, Medical Evidence SearchSequence, andlor Methodology far Evaluating Medical Evidence.)

(3} The progress report, including the treatment plan and Request for Authorizationprovided under this subdivision, shall be submitted at the time the next progress reportis due under section 9785, subdivision (f)(8), however, if that is not feasible, no laterthan April 1, 2018.

MTUS —Formulary —Title 8, CCR }§9792.27.1— 9792.27.23

(To OAL for adoption: October 2017) Page 4 of 15

(4) Previously approved drug treatment shall not be terminated or denied except asmay be allowed by the MTUS and in accordance with applicable utilization review andindependent medical review regulations.

(5) The claims administrator shall process the progress report, treatment plan andRequest for Authorization in accordance with the standard procedures and timeframesset forth in section 9792.6.1. et seq.

Authority: Sections 133, 4603,5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.4. MTUS Drug Formulary —Pharmacy Networks; PharmacyBenefit Manager Contracts.

Where an employer or insurer contracts pursuant to Labor Code section 4600.2 with apharmacy, a pharmacy benefit manager, or pharmacy network for the provision of drugs#or #h~ treatment of injured workers, the drugs available to the injured worker must beconsistent with the MTUS Treatment Guidelines and MTUS Drug Formulary for thecondition or injury being treated, and may not be restricted pursuant to the contract.

Authority: Sections 133, 4603.5, 5307.3 and 53Q7.27, ~abar Code.Reference; Sections 460Q, 4600.2; 4604.5 and 5307.27., Labor. Code.

Section 9792.27.5. MTUS Drug Formaalary —Off-Label Use.

(a) Off-label use of a drug shall be in accordance with the MTUS Treatment Guidelinesand rules and the MTUS Drug Formulary.

(b) Authorization through prospective review is not required to dispense an Exemptdrug for an off-label use if the MTUS Treatment Guideline recommends the off-label useof the drug to treat the condition.

(c) Authorization through prospective review is required prior to dispensing thefollowing drugs for an off-label .use:(1) Non-Exempt drug, or(2) Unlis#ed .drug, or(3) Exempt drug lacking recommendation in the MTUS Treatment Guideline far theintended off-label use.

(d) When a physician believes it is medically necessary to prescribe a drug for an off-label use not recommended by the MTUS Treatment Guidelines or not addressed bythe MTUS Treatment Guidelines, the permissibility of the treatment outside of theguidelines is governed by section 9792.21 subdivision (d} (condition not addressed byMTUS or seeking to rebut the MTUS), section 9792.21.1 (medical evidence search

MTUS —Formulary —Title 8, CCR §~~'9792.27.1— 9792.27.23(To OAL for adoption: October 2017) Page 5 of 15

sequence), section 9792.25 (quality and strength of evidence definitions) and section9792.25.1 (MTUS methodology for Evaluating _Medical Evidence).

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.6. MTUS Drug Formulary —Access to Drugs Not Listed as anExempt Drug on the MTU•S Drug List.

(a) Drug treatment that is in conformity with the MTUS Treatment Guidelines ispresumed correct on the issue of extent and scope of medical treatment pursuant tosection 9792.21, subdivision (c), and Labor Code section 4604.5. Although the MTUSDrug List identifies Exempt drugs that do nat require prospective review whendispensed in accordance with the MTUS Treatment Guidelines, other medicallynecessary drugs are available to the injured worker when authorized throughprospective review.

{b) Any medically necessary FDA-approved drug, or nonprescription drug that ismarketed pursuant to an FDA OTC Monograph, may be authorized through prospectivereview and dispensed to an injured worker if it is shown in accordance with the MTUSregulations that the drug is required to cure or relieve the injured worker from the effectsof the injury. Determination of the medical necessity of treatment based onrecommendations found outside of the MTUS Treatment Guidelines is governed bysection 9792.21 subdivision (d} (condition nat addressed by MTUS ar seeking to rebutthe. MTUS), section 9792.21.1 (medical evidence search sequence), section 9792.25(quality and strength of evidence definitions) and section 9792.25.1 (MTUSmethodology far evaluating medical evidence).

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.7. MTUS Drug Formulary —Brand Narne Drugs; Generic Drugs.

If a physician prescribes a brand name drug when a less costly therapeuticallyequivalent generic drug exists, and writes "Da Not Substitute" or "Dispense as Written"on the prescription in conformity with Business and Professions Code section 4073, thephysician must document the medical necessity for prescribing the brand name drug inthe patient's medical chart and in the Doctor's First Report of Injury (Form 5021) orProgress Report {PR-2.) The documentation must include the patient-specific factorsthat support the physician's determination that the brand name drug is medicallynecessary. The physician must submit a Request far Authorization and obtainauthorization through prospective review before the brand name drug is dispensed.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor CodeReference: Sections 4600, 46Q4.5 and 5307.27, Labor Code.

Section 9792.27.8. Physician-Dispensed Drugs.

MTUS —Formulary —Title 8, CCR y~'y~'9792.27.1— 9792.27.23(To OAL for adoption: October 2017} Page 6 of 15

{a) Drugs dispensed by a physician must be authorized through prospective reviewprior to being dispensed, except as provided in subdivision (b), section 9792.27.12{"Special Fill"), and section 9792.27.13 ("Perioperative Fill"}.

(b} A physician may dispense up to a seven-day supply of one or more drugs that aredesignated as "Exempt" in the MTUS Drug List without obtaining authorization throughprospective review, if the drug treatment is in accordance with the MTUS TreatmentGuidelines and the up-to-seven-day supply is dispensed at the time of an initial visit thatoccurs within 7 days of the date of injury.

(c) Nothing in this Article shall invalidate a provision in a Medical Provider Networkagreement which restricts physician dispensing by medical providers within the network.

(d) Nothing in this Article shall permit physician dispensing where otherwise prohibitedby a pharmacy benefit contract pursuant to subdivision (a) of Labor Code section4600.2..

.Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.9. Compounded Drugs.

(a) Compounded drugs must be authorized through prospective review prior to beingdispensed. When it is necessary for medical reasons to prescribe or dispense acompounded drug instead of an FDA-approved drug orover-the-counter drug thatcomplies with an OTC Monograph, the physician must document the medical necessityin the patient's medical chart, and in the Doctor's First Report of Injury {Form 5029 } orProgress Report {PR-2) and must submit a Request far Authorization. Thedocumentation must include the patient-specific factors that support the physician'sdetermination that a compounded drug is medically necessary.

(b) Nothing in this Article shall invalidate a provision in a Medical Provider Network.agreement which restricts physician dispensing of compounded drugs by medicalproviders within the network.

(c) Nothing in this Article shall permit physician dispensing of compounded drugs whereotherwise prohibited by a pharmacy benefit contract pursuant to subdivision (a) of LaborCode section 4600.2.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 46Q4.5 and 5307.27, Labor Code.

Section 9792.27.10. MTUS Drug List; Exempt Drugs, Non-Exempt Drugs, UnlistedDrugs, Prospective Review.

MTUS —Formulary —Title 8, CCR §9792.27.1-9792.27.23(To OAL for adoption: October 2017) Page 7 of 15

{a) The MTUS Drug List is set forth by active drug ingredient(s).

(b) A drug that is identified as "Exempt" may be dispensed to the injured worker withoutobtaining authorization through prospective review if the drug treatment is inaccordance with the MTUS Treatment Guidelines, except:(1) Brand name drugs are subject to section 9792.27.7;(2) Physician-dispensed drugs are subject to section 9792.27.8.(3) Compounded drugs are subject to section 9792.27.9 even if one or more of theingredients is listed as "Exempt" on the MTUS Drug List.

(c) For a drug that is identified as "Non-Exempt," authorization through prospectivereview must be obtained prior to the time. the drug is dispensed. Expedited reviewshould be conducted where it is warranted by the injured worker's condition.

(d) For a drug that is identified as eligible for "Special. Fill" or "Perioperative Fill", theusual requirement to obtain authorization through prospective review prior to dispensingthe drug is altered for the specified circumstances set forth in sections 9792.27.12 and9792.27.13. If the requirements set forth in section 9792.27.12 or section 9792.27.13are not met, then the drug is considered "Non-Exempt" .and is subject to the provisionsset forth under subdivision (c).

(e) For an unlisted drug, authorization through prospective review must be obtainedprior to the time the drug is dispensed. A combination drug that is not on the MTUSDrug List is an unlisted drug even if the individual active ingredients are on the MTUSDrug List.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4604, 4604.5 and 5307.27, Labor ode.

Section 9792.27.11. Vliaiver of Prospective Review.

Nothing in the MTUS Drug Formulary shall prohibit waiver of the prospective reviewrequirement for allon-Exempt or unlisted drug if the drug falls within a utilization reviewplan's provision of prior authorization without necessity of a request for authorization,where that provision is adopted pursuant to section 9792.7, subdivision (a)(5).

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.12. MTUS Drug List —Special Fill.

(a) The MTUS Drug List identifies drugs that are subject to the Special Fill policy.Under this policy, a drug that usually requires prospective review because it is "Non-Exempt" will be allowed without prospective review as specified in subdivision (b).

(b) The drug identified as a Special Fill drug may be dispensed to the injured workerwithout seeking prospective review if all of the following conditions are met:MTUS —Formulary —Title 8, CCR §§9792.27.1— 9792.27.23(To OAL for adoption: October 2017) Page 8 of 15

(1 }The drug is prescribed at the single initial treatment visit following a workplace injury,provided that the initial visit is within 7 days of the date of injury; and

(2}The prescription is for a supply of the drug not to exceed the limit set forth in theMTUS Drug List; and

(3) The prescription for the Special Fill —eligible drug is for:

(A) An FDA-approved generic drug or single source brand name drug, or,

(B) A brand name drug where the physician documents and substantiates the medicalneed for the brand name drug rather than the FDA-approved generic drug, and

(4) The drug is prescribed in accordance with the MTUS Treatment Guidelines.

(c}When calculating the 7-day period in subdivision (b}(1 }, the day after the date ofinjury is "day one."

(d) An employer or insurer that has a contract with a pharmacy, pharmacy network,pharmacy benefit manager, or a medical provider network (MPN) that includes apharmacy ar pharmacies within the MPN, may provide for a longer Special Fill period ormay cover. additional drugs under the Special Fill policy pursuant to a pharmacy benefitcontract or MPN contract.

(e) After the Special Fill provision has been in effect for one year, the AdministrativeDirector shall evaluate the impact of the provision on the use of opioids by injuredworkers. -As part of the evaluation process, the Administrative Director shall solicitfeedback from the workers' compensation system participants.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Cade.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.13. MTUS Drug List — Perioperative Fill.

(a) The MTUS Drug List identifies drugs that are subject to the Perioperative Fill policy.Under this policy, the Non-Exempt drug identified as a Perioperative Fill drug may bedispensed to the injured worker without seeking prospective review if all of the followingconditions are met:

(1) The drug is prescribed during the perioperative period; and

(2}The prescription is for a supply of the drug not to exceed the limit set forth in theMTUS Drug List; and

(3) The prescription for the Perioperative Fill -eligible drug is for:

MTUS —Formulary —Title 8, CCR ~~9792.27.1— 9792.27.23(To OAl for adoption: October 2017)

Pdge 9 of 15

(A} An FDA-approved generic drug or single source brand name drug, or,

{B} A brand name drug where the physician documents and substantiates the medicalneed for the brand name drug rather than the FDA-approved generic drug, and

(4) The drug is prescribed in accordance with the MTUS Treatment Guidelines.

(b} For purposes of this section, the perioperative .period is defined as the period from 4days prior to surgery to 4 days after surgery, with the day of surgery as "day zero".

(c) An employer or insurer that has a contract with a pharmacy, pharmacy network,pharmacy benefit manager, or a medical provider network that includes a pharmacy orpharmacies within the MPN, may provide for a longer Perioperative .Fill period or maycover additional drugs under the Perioperative Fill policy pursuant to a pharmacy benefitcontract or MPN contract.

Authority: Sections 133, 4603.5, 53Q7.3 and 5307.27, Labor Code.Reference; Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.14. Treatment Provided Under Applicable Health .and SafetyRegulations.

The MTUS Drug Formulary and associated regulations do not relieve an employer ofany responsibilities pursuant to applicable health and safety regulations such as therequirements of the California occupational Bloadborne Pathogens standard at title 8,.California Code of Regulations, section 5193, including the responsibility to provideurgent post-exposure prophylaxis as needed to protect the health of the employee.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.15. MTUS Qrug List.

[Excel Document: MTUS DRUG LIST ($ CCR §9792.27.15)]

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

Section 9792.27.16. National Drug Codes, Unique Pharmaceutical Identifier -MTUS Drug List.

(a) The Administrative Director may maintain and post on the DWC website a listing byNational Drug Code, RxCUI (clinical drug concept unique identifier maintained by theNational Library of Medicine}, or other unique pharmaceutical identifier, of drug products

MTUS —Formulary —Title 8, CCR ~§9792.27.1— 9792.27.23(Ta OAL for adoption: October 2017)

Page 10 of 15

that are embodied in the MTUS Drug List. If posted, the listing. will be regularly updatedto account for revisions to the MTUS Drug List and for changes in drug products thatare marketed for outpatient use.

(b) For each active ingredient on the MTUS Drug List, the product listing shall includebrand name and therapeutically equivalent generic versions of outpatient prescriptiondrugs and non-prescription drug products. The listing shall include only drug productsthat can be self-administered by the patient. Injectable drug products must bepackaged and identified for patient self-administration.

(c) The listing shall include combination drugs with multiple active ingredients only if thecombination of active. ingredients is listed on the MTUS Drug List.

(d) The ..listing may include, but is not limited to, the following data elements(1 } National Drug. Code, RxCU), or other pharmaceutical identifier;(2) .Drug ingredient(s);(3) Therapeutic class;.(4) Strength;(5) Dosage form;(6} Exempt or Non-Exempt status, as applicable;{7) Any applicable Special Fill or Perioperative Fill policies.

Authority: Sections 133, 4603,5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307,29, .Labor Code.

Section 9792.27.1.7. Formulary —Dispute Resolution.

(a) .Medical Necessity Disputes.Disputes over the medical, necessity of pharmaceutical treatment covered by the MTUSDrug Formulary are governed by the utilization review and independent medical reviewprovisions of Labor Cody sections 4610, 4610.5, and regulations at section 9792.6.1 etseq, and section 9792.10.1 et seq.

(b) Formulary Rule Medical Treatment Disputes Qther than Medical NecessityDisputes.Disputes over failure to fallow formulary rules, other than medical necessity disputescovered by subdivision (a), shall be resolved through the procedure for non-IMRIIBRdisputesset forth in WCAB rules, title 8, California Code of Regulations, section10451.2, Determination of Medical Treatment Disputes.

Authority: Sections 133, 4603.5, 5307.3, 5307.1 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.1, 5307.27 and 5307.29, labor Cade.

Section 9792.27.18. Pharmacy and Therapeutics Committee —Composition;Application for Appointment; Term of Service.MTUS —Formulary —Title 8, GCR ~~9792.27.1— 9792.27.23(To OAl for adoption: October 2017)

Page 11 of 15

(a) The Administrative Director shall create an independent Pharmacy and TherapeuticsCommittee (P&T Committee) to review and consult with the Administrative Director onavailable evidence of the relative safety, efficacy, and effectiveness of drugs within aclass of drugs, for purposes of updating the MTUS Drug List.

(b) The P&T Committee shall consist of the Executive Medical Director, and sixmembers appointed by the Administrative Director.

(1) The Executive Medical Director, or his or her designee, shall serve as chairperson ofthe P&T Committee. If the Executive Medical Director position becomes vacant, theAdministrative Director shall .appoint a competent person to temporarily assume theauthority and duties of the Executive Medical Director on the P&T Committee, until suchtime that the Executive Medical Director position is filled.

(2) The Administrative Director shall appoint 3 pharmacists and 3 physicians (medicaldoctors ar doctors of osteopathy) to serve on the P&T Committee. At least one of thephysicians appointed shall be actively engaged in the treatment of injured workers. Atleast one of the pharmacists appointed shall be an actively practicing pharmacist.

(3) The members of the P&T Committee shall. be appointed to serve atwo-year term,but shall remain in the position until a successor is appointed. A member may apply tobe reappointed when his or her twa-year term ends. The Administrative Director maycancel the appointment of a committee member if a substantial conflict of interestarises, or for other reason constituting good cause.

(c} A person interested in serving on the P&T Committee shall submit an application onthe #orm prescribed by the Administrative Director and a completed Confilict of InterestDisclosure Form. The applicant for P&T Committee appointment shall demonstrate thathe or she has. knowledge or expertise in one or more of the following:

(1) Clinically appropriate prescribing of covered drugs;

(2) Clinically appropriate dispensing and monitoring of covered drugs;

(3} Drug use review;

(4} Evidence-based medicine.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Code.

Section 9792.27.19. Pharmacy and Therapeutics Committee —Application forAppointment to Committee Form.

jFORM: DWC MTUS PT-App {New 7/17)]

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.MTUS —Formulary —Title 8, CCR §9792.27.1— 9792.27.23(To OAL for adoption: October 2017} Page 12 of 15

Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Code.

Section 9792.27.20. Pharmacy and Therapeutics Committee —Conflict of Interest.

(a) The conflict of interest. standards are intended to ensure that the members of theP&T Committee are free from financial interests or other relationships that couldcompromise the objectivity of the members of the committee as they perform theirduties to consult with the Administrative Director on formulary updates based upon theprinciples of evidence-based medicine. Appointed members of the P&T Committeemust impartially perform formulary update review activities, and must be free of conflictsof interest.

(b) Persons applying to be appointed to the P&T Committee shall not be employed by apharmaceutical manufacturer, a pharmacy benefits management company, or acompany engaged in the development of a pharmaceutical formulary for commercialsale, and shall not have been so employed for 12 months prior to the appointment. AP&T Committee member who undertakes such employment during the term ofappointment shall not be eligible to continue to serve on the committee.

(c) Members of the P&T-Committee-shall not-have a substantial financial conflict of -interest in relation to a pharmaceutical entity.

(1) "Pharmaceutical entity" means a pharmaceutical manufacturer, pharmaceuticalrepackager; pharmaceutical relabeler, compounding pharmacy, pharmacy benefitsmanagement company, biotechnology company, or any other business. entity that isinvolved in manufacturing, packaging, selling or distribution of prescription or non-prescription drugs, drug delivery systems, ar biological agents.

(2) For purposes of this section, "substantial financial conflict of interest" means that theapplicant or committee .member, or his ar her immediate family member, has a direct orindirect financial interest in a pharmaceutical entity, including:

(A) Receipt of income within the previous 12 months, amounting to a total of $500 armore from the pharmaceutical entity, including but not limited to salary, wages,speaking fees, consultant fees, expert witness fees, honoraria, gifts, loans, and travelpayments;

(B} Receipt of grants or research funding from the pharmaceutical entity within theprevious 24 months;

(C} Has had ownership interest in the pharmaceutical entity at any time during theprevious 12 months, including but not limited to, a sole proprietorship, partnership,limited liability company, or stack ownership in a corporation that is not publicly traded;

(D) Investment interest worth $2,000 or more in apublicly-traded pharmaceutical entity,not including an investment held through a diversified mutual fund;

MTUS —Formulary —Title $, CCR §~~'9792.27.1— 9792.27.23{To OAL for adoption: October 2017) Page 13 of 15

(3) "Immediate family member" means spouse, domestic partner, child, son-in-law,daughter-in-law, parent, mother-in-law, father-in-law, brother or sister;

(4) (A} "Direct financial interest" means an interest held by the applicant or committeemember.(B) "Indirect financial interest" means an interest held by the applicant or committeemember's immediate family member, or held by a business entity or trust in which theapplicant or committee member owns directly or indirectly, or beneficially, a 10-percentinterest or greater.

(d) The members of the P&T Committee shall submit an updated Conflict of InterestDisclosure Form annually, and more frequently if there have been changes incircumstances relating to employment by, or financial interests in, a pharmaceuticalentity.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Code.

Section 9792.27.21. Pharmacy and Therapeutics Committee —Conflict of InterestDisclosure Form.

[FORM: DWC MTUS PT-COI (New 7/17)]

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Code.

Section 9792.27.22. Pharmacy and Therapeutics Committee —Meetings.

(a} The P&T Committee shall meet when deemed necessary by the Executive MedicalDirector, buff na less frequently than quarterly.

(b) P&T Committee meetings shall be conducted in accordance with the Bagley-KeeneOpen Meeting Act, California Government Cade sections 11120 through 11132.

(c) Notice of the regularly scheduled meetings shall be given at least ten days inadvance of the meeting as follows:

(1) Ta persons who have requested notice of the meetings;

(2) To persons on the Administrative Director's mailing list; and

(3) By posting notice on the division's website.

(d) The Executive Medical Director shall include a period to receive public commentduring the P&T Committee meetings, in a manner consistent with the orderly andefficient conduct of the business of the committee. Members of the public addressingthe P&T Committee shall be limited to three minutes per speaker.

MTUS — Formulary —Title 8, CCR ~~~'9792.27.1— 9792.27.23

(To OAL for adoption: October 2017) Page 14 of 15

(e) The Executive Medical Director shall maintain a written summary of the meetingsand the recommendations made to the Administrative Director in a format determinedby the Administrative Director. The written summary shall be posted on the Division'swebsite. It shall include a description of any action taken and the vote or abstention ofeach P&T Committee member present.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 11120 — 11132, Government Code, 4600, 4604.5, 5307.27 and5307.29, Labor Code.

Section 9792.27.23. MTUS Drug List Updates.

(a) The Administrative Director shall consult with the P&T Committee as needed onupdates to the MTUS Drug List, which may be adopted by the Administrative Directoron a quarterly or more frequent basis in order to allow provision for all appropriatemedications.

(b) The-P&T Committee-is-responsible for reviewing and consulting with theAdministrative Director an available evidence of the relative safety, efficacy, andeffectiveness of drugs within a class of drugs. In carrying out these duties the P&TCommittee may provide consultation on a variety of relevant issues, including but notlimited to the following:

(1 } Recommendations on prospective review requirements for drugs;

(2) Recommendations on Special FiII and Perioperative Fill designation and policies;

(3) Review of drug treatment changes adopted into the MTUS Treatment Guidelines toidentify needed additions or deletions of drugs from the MTUS Drug List;

(4} Recommendations on establishing a therapeutic interchange program in order topromote safe and appropriate cost effective care.

(c) The P&T Committee serves in an advisory role only. P&T Committeerecommendations are not binding on the Administrative Director.

(d) Updates to the MTUS Drug List will be adopted by issuance of an AdministrativeDirector's order specifying the changes and the effective date, and shall be posted anthe division's website pursuant to Labor Code section 5307.29.

Authority: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code.Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labac Code.

MTUS —Formulary —Title 8, CCR §~~'9792.27.1— 9792.27.23(To OAL for adoption: October 2017) Page 15 of 15

MTUS Drug lis4 (8 CCR § 97

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Tp OALfor adoption: October 20ll

20 of 20

APPLICATION FOR APPOINTMENT TO THE PHARMACY AND THERAPEUTICS COMMITTEE

State of California~~,, Department of Industrial Relations

`?l~;' ~ Division of Workers' CompensationAdministrative Director

P.O. Box 70823Oakland, CA 94612

SECTION L IDENTIF[CATIO~; AND CONTACT INFORMATION (PtE,~sE rrPE ox Piuy'TtEGistY)I am applying for appointment to serve on the Pharmacy and Therapeutics Committee: as a Physician[ as a Pharmacist0,

Last Name First NameMI ~ JR/SR

Mailing Address City State Zip Code

E-mail Address Phone Number Fay Number

National Provider IdentiTier California Professiona(License Number License Expiration Date (MMJDD/YYYY)

SECTION 2: EDUCATION

htedieal School t Osteopaihic School !School of Pharmacy Degree Date of Degree (_LLbGYYYYJ

City State Country

SECTION; 3: QliALIFY'I~YG ItiVOWLEDGE OR EXPERTISEApplicants for the Pharmacy and Therapeutics Committee must possess knowledge or expertise in one or more of the subject areas listedbelow. Provide information to demonstrate your qualifications; attach additional sheets if needed.

I have knowledge or expertise as follows:Cllnicalty appropriate prescribing of covered arugs YesLj NoU Please exptam your experience below:

Clinically appropriate dispensing and monitoring of covered drugs Yes[] No~ Please explain your experience below:

DWC MTtJS PT-APP (New 11/l7}"8 CCR §9792.27.19 (To OAL for Adoption October 2017)

Page l Of 3

Dn,, use review Yes[ No[] Please explain your experience below:

Evidence Based Medicine Yes No~ Please explain your experience below:

SECTION 4: I~1FORI~IATION REGARDING CURRENT PROFESSIONAL STATUS

The Pharmacy and Therapeutics Committee will include at least one physician actively engaged in the treatment of injured workers and atleast one actively practicing pharmacist.. Provide. the requested information regarding your current professional status:For Physician Applicants: I am a physician (M.D. or D.O.) actively engaged in the treatment of injured workers. Yes[ No~For Pharmacist Applicants:. I am an actively practicing pharmacist. YesC) NoC]

SECTION 5: ADDITIONAL INFORMATION REGARDING QUALIFICATIONSA) You must attach your Curriculum Vitae.B) You must. attach a completed Conflict of Interest Disclosure Form.C) You may attach other relevant material in support of your application (e.g. Board Certification; scientific or medical journal article youauthored.)

SECTIOiV 6; AFFIR~IAT10~'S (Initialing each box affirms that you have read and agree to each of the j~17~I~LSstatements. Do not initial if your statement is untrue. Attach an explanation on a separate piece of paper)

A. I am not employed by a pharmaceutical manufacturer, a pharmacy benefits management company, or a company engaged in the development ofa pharmaceutical formulary for commercial sale, and I have not been so employed tivithin the last 12 months.B. License Status. I certify that no disciplinary action has ever been Taken against my California license Co practice as a physician, or my license topractice as a pharmacist, and that my license is active and neither restricted nor encumbered by suspension. interim suspension or probation. I agreeto promptly notify the DWC Administrative Director of any future disciplinary action taken against me by my licensin; agency. (Do not initial ifanvpart of the stntentent is unb~z~e. Attach an e_r~lavration on a sepai~crte piece of paper.)C. Convictions, I certify that I have never been convicted of a misdemeanor or felony related to my practice, or for a crime of moral turpitude.I agree to promptly notify the DWC Adminstrative Director of any. future practice-related conviction, or cam-fiction for a crime of moral turpitude.(Do not initinl if anv part of the statement is untrue. Attach an explanation on a separate piece of paler. )

SECTION 7: .VERIFICATION

I have used ail reasonable diligence in preparing and completing this application. I have reviewed this completed application and to the bestof my knowledge the informafron contained herein and in the attached supporting documentation is true, correct and complete.F declare under penalty of perjury under the taws of the State of California that the foregoing is true and correct.

Executed on: at pity ,State

Applicant's Signature

DWC MTUS P7'-APP (New i lli~) ~ Page 2 of 38 CCR §4792.27.14 (To OAL for Adoption October 2017)

A PUBLIC DOCUMENT

PRIVACY NOTICE -The Information Practices Act of 1977 andYthe Federal Privacy Act Require the Administrative Director of the Divisionof Vl~orkers' Compensation within the Department of Industrial Relations, to provide the following notice to individuals who are asked by agovernmental entity to supply information for appointment as a member of the Pharmacy and Therapeutics Committee.

The California Labor Code section 530729 provides for licensed physicians and pharmacists to participate in the workers' compensationsystem by serving on the Administrative Director's Pharmacy and Therapeutics Committee. The Division of Workers' Compensation hasadopted implementing regulations which require applicants under this program to provide: name; business address, professional education,license number, national provider identification number, conflicts of interest disclosure, and documents deemed necessary by theAdministrative Director of the Division of Workers' Compensation to determine qualifications relevant to selection of members for thecommittee. It is mandatory to furnish all the relevant information requested by the Administrative Director as part of the application. Failureto provide all of the requested information may result in disqualification from further consideration of the application. The principal purposefor requesting information from physicians and pharmacists is to evaluate the applicant's qualifications to serve on the committee in order toadminister the pharmaceutical portion of the Medical Treatment Utilization Schedule program within the California workers' compensationsystem. Additional information may be requested.

As authorized by law, information furnished on this form may be given to: you, upon request; the public, pursuant to the PublicRecords Act; a governmental entity, when required by state of federal law; to any person, pursuant to a subpoena or court order orpursuant to any other exception in Civil Code § 1798.24,

An individual has a right of access to records containing his/her personal information that are maintained by the AdministrativeDirector. An individual may also amend, correct, or dispute information in such personal records. (Civil Code ~y 1798.25, 1798.3,1798.35.}

Requests should be sent to:

.Division of Workers' Compensation -Medical UnitP.O. Box 70823Oakland, CA 9461?

Or to the Department of Industrial Relations Privacy Officer:

Privac„Xcr D(R.ca.~rov

Copies of all records are ten cents ($0.10) per page, payable in advance. (Civil. Code.§ 1798.33.)

DWC MTUS PT-APP {New 11117)8 CCR §9742.27.19 (To OAL for Adoption October 2017}

Page 3 Of 3

g.

State of GaliforniaDepartment of Industrial Relations

t ~ Division of Workers' CompensationPHARMACY AND THERAPEUTICS COMMITTEE

Conflict of Interest Disclosure FormCalifornia Code of Regulations, title 8, section 9792.27.21

Plaaca tuna nr mint in ink

Name:

Address:

Telephone Number: E-Mail Address:

1. Employment

A. Are you currently employed by a pharmaceutical manufacturer, a pharmacy benefits management company, or acompany engaged in the development of a pharmaceutical formulary for commercial sale?

~'" Yes ~" No

B. Were you employed by a pharmaceutical manufacturer, a pharmacy benefits management company, or a companyengaged in the development of a pharmaceutical formulary for commercial sale during the past 12 months?

~" Yes ~`~° No

If you have answered "Yes" to either of the above questions please explain on a separate sheet.

2. P8~T Committee Member arApplicant Information

For the purpose of this section, "pharmaceutical entity" means a pharmaceutical manufacturer, pharmaceutical repackager,pharmaceutical relabeler, compounding pharmacy; pharmacy benefits management company; biotechnology company, arany other business entity that is involved. in manufacturing, .packaging, selling or dis#ribution of prescription or non-prescription drugs, drug delivery systems, or biological agents. "Immediate family member" means spouse, domesticpartner, child, son-in-law, daughter-in-law, parent, mother-in-law, father-in-law, and brother or sister.

a. Did you, or an immediate family member, receive income within the previous 12 months amounting to a total of $500 ormore from a pharmaceutical entity, including but not limited to salary, wages, speaking fees, consultant fees, expertwitness fees, honoraria, gifts, loans, and travel payments?

~°' Yes ° No

B. Did you, or an immediate family member, receive within the previous 24 months grants or research funding from apharmaceutical entity?

~"' Yes ~" No

C. Do you, or an immediate family member, have at any time during the previous 12 months an ownership interest in apharmaceutical entity; including but not limited to, a sole proprietorship, partnership, limited liability company,. stockownership in a corporation that is not publicly traded?

~`` Yes ~`` No

D. Do you, or an immediate family member, have an investment inkerest worth $2,000 or more in apublicly-traded

DWC MTUS PT-COI (New 11117) (TO OAL for Adoption October 2017) Page 1

pharmaceutical entity, not including an investment held through a diversified mutual fund?

~" Yes Na

If you have answered "Yes" to any of the above questions please explain an a separate sheet.

have reviewed California Code of Regulations, title 8, section 9792.27.18 and do not have a substantial financial conflict ofinterest in relation to a pharmaceutical entity, nor do I have an employment conflict of interest. I understand that it is myobligation to fully disclose all potential conflicts of interest. If my conflicts. of interests change, or if I become aware of anyadditional .potential conflicts, I understand .that is my responsibility to submit an updated disclosure form to theAdministrative Director, of the Division of Workers' Compensation. 1 have used all reasonable diligence in preparing andcompleting this disclosure. I have reviewed this document and to the best of my knowledge the information containedherein and in any attached supporting documentation is true, correct and complete.

declare under penalty of perjury under the laws of the State of California that the foregoing is true and correct.

Date:Signature: Executed at (city and state

A PUBLIC. DOCUMENT

PRIVACY NOTICE —The Information Practices Act of 1977 and the Federal Privacy Act Require the AdministrativeDirector of the Division of Workers' Compensation within the Department of Industrial Relations,. to provide the followingnotice to individuals who are asked by a governmental entity to supply information for appointment as a member of thePharmacy and Therapeutics Committee.

The. California Labor Code section 5307.29 provides for licensed physicians and pharmacists to participate in the workers'compensation system by serving on the Administrative Director's Pharmacy and Therapeutics Committee. The Division ofWorkers' Compensation has adopted implementing regulations which require applicants under this program to provide:name; business address, professional education, license number., national provider identification number, conflicts ofinterest disclosure, and documents deemed necessary by thsAdministrative Director of the Division of Workers'Compensation to determine qualifications relevant to selection of members for the committee. It is mandatory to furnish ailthe relevant information. requested by the Administrative Director as part of the application. Failure to-provide aA of-therequested information may resulf in disqualification from further consideration of the application. The .principal .purpose for.requesting information from physicians and pharmacists is to evaluate the applicant's quaPifications to serve on thecommittee in order to administer the pharmaceutical .portion of the Medical Treatment Utilization Schedule program withinthe California workers'..compensation system. Additional information may be requested.

As authorized bylaw, information furnished on this form may be given to: you, upon request; the public, pursuant to thePublic Records Act; a governmental .entity, when required by state of federal law; to any person, pursuant to a subpoena orcourt order or pursuant to any other exception in Civil Code § 1798.24.

An individual .has a right of access to records containing his/her personal. information that are maintained by theAdministrative Director. An individual may also amend, correct, or dispute information in such personal records. (Civil Code§§ 179$.25, 179$.34, 1798.35.)

Requests should be sent to:

Division of Workers' Compensation —Medical UnitP.O. Box 70823Oakland,. CA 94612

Or to the Department of .Industrial Relations Privacy Officer: Privacv(a~7DIR.ca.gov

Cagies of all records are ten cents ($0.10) per page, payable in advance. (Civil Code ~ 1798.33.

DWC MTUS PT-COI (New 11117) (TO OAL for Adoption October 2017) Page 2