SENATE BILL No. 1193
March 6, 2002, Introduced by Senators SCHWARZ, SHUGARS, JOHNSON, BYRUM,
EMERSON and NORTH and referred to the Committee on Health Policy.
A bill to amend 1939 PA 280, entitled
"The social welfare act,"
(MCL 400.1 to 400.119b) by adding sections 111k, 111l, 111m,
111n, 111o, 111p, 111q, and 111r.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 SEC. 111K. AS USED IN SECTIONS 111l TO 111R:
2 (A) "BOARD" MEANS THE DRUG UTILIZATION REVIEW BOARD ESTAB-
3 LISHED UNDER SECTION 111M.
4 (B) "COMMITTEE" MEANS THE PHARMACY AND THERAPEUTICS COMMIT-
5 TEE ESTABLISHED UNDER SECTION 111P.
6 (C) "COMPENDIA" MEANS THE "AMERICAN HOSPITAL FORMULARY SERV-
7 ICES DRUG INFORMATION", "U.S. PHARMACOPEIA--DRUG INFORMATION",
8 PEER-REVIEWED MEDICAL LITERATURE, AND CLINICAL INFORMATION
9 SUBMITTED TO THE DEPARTMENT OF COMMUNITY HEALTH BY THE
10 PHARMACEUTICAL RESEARCH COMPANY THAT DEVELOPED THE PRODUCT AND IS
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1 REGISTERED WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION AS
2 THE PRODUCT DISTRIBUTOR.
3 (D) "DUR CRITERIA" MEANS STANDARDS APPROVED BY THE BOARD TO
4 DETERMINE WHETHER USE OF A DRUG IS LIKELY TO BE MEDICALLY APPRO-
5 PRIATE, BE MEDICALLY NECESSARY, AND NOT RESULT IN AN ADVERSE MED-
6 ICAL OUTCOME.
7 (E) "DRUG UTILIZATION REVIEW" OR "DUR" MEANS BOTH RETROSPEC-
8 TIVE AND PROSPECTIVE DRUG UTILIZATION REVIEW. DUR PROGRAMS ARE
9 DESIGNED TO ENSURE THAT DRUG UTILIZATION IS MEDICALLY APPROPRI-
10 ATE, MEDICALLY NECESSARY, AND NOT LIKELY TO HAVE ADVERSE MEDICAL
11 RESULTS.
12 (F) "PRIOR AUTHORIZATION" MEANS A PROCESS REQUIRING THE PRE-
13 SCRIBER OR THE DISPENSER TO VERIFY WITH THE STATE DEPARTMENT OF
14 COMMUNITY HEALTH OR ITS CONTRACTOR THAT PROPOSED MEDICAL USE OF A
15 PARTICULAR MEDICINE FOR A PATIENT MEETS PREDETERMINED CRITERIA
16 FOR COVERAGE BY THE PROGRAM.
17 (G) "PROSPECTIVE DUR" MEANS THAT PART OF THE DRUG UTILIZA-
18 TION REVIEW PROGRAM THAT OCCURS BEFORE A DRUG IS DISPENSED AND
19 THAT USES THE DUR CRITERIA TO SCREEN FOR POTENTIAL DRUG THERAPY
20 PROBLEMS RELATED TO THERAPEUTIC DUPLICATION, DRUG-DISEASE CONTRA-
21 INDICATIONS, DRUG-DRUG INTERACTIONS, INCORRECT DRUG DOSAGE OR
22 DURATION OF DRUG TREATMENT, DRUG-ALLERGY INTERACTIONS, AND CLINI-
23 CAL ABUSE OR MISUSE.
24 (H) "RETROSPECTIVE DUR" MEANS THAT PART OF THE DRUG UTILIZA-
25 TION REVIEW PROGRAM THAT IS A HISTORICAL REVIEW OF DRUG UTILIZA-
26 TION DATA USING DUR CRITERIA TO EXAMINE PHARMACY CLAIMS DATA AND
27 OTHER INFORMATION TO IDENTIFY OVERUTILIZATION, UNDERUTILIZATION,
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1 APPROPRIATE USE OF GENERIC PRODUCTS, THERAPEUTIC DUPLICATION,
2 DRUG-DISEASE CONTRAINDICATIONS, DRUG-DRUG INTERACTIONS, INCORRECT
3 DRUG DOSAGE OR DURATION OF DRUG TREATMENT, AND CLINICAL ABUSE OR
4 MISUSE.
5 SEC. 111l. THE LEGISLATURE RECOGNIZES THAT OUTPATIENT PRE-
6 SCRIPTION DRUGS ARE AN ESSENTIAL COMPONENT OF PATIENT CARE AND,
7 AS A HEALTH BENEFITS PAYER UNDER THE STATE'S MEDICAL ASSISTANCE
8 PROGRAM, THE LEGISLATURE DIRECTS THE DEPARTMENT OF COMMUNITY
9 HEALTH TO ADD A PRIOR AUTHORIZATION COMPONENT TO ITS DRUG UTILI-
10 ZATION REVIEW PROGRAM TO ENSURE THAT BENEFICIARIES HAVE ACCESS TO
11 MEDICALLY NECESSARY MEDICINES IN A CLINICALLY APPROPRIATE AND
12 COST-EFFECTIVE MANNER.
13 SEC. 111M. (1) THE DRUG UTILIZATION REVIEW BOARD IS ESTAB-
14 LISHED WITHIN THE DEPARTMENT OF COMMUNITY HEALTH FOR THE PURPOSE
15 OF IMPLEMENTING A RETROSPECTIVE AND PROSPECTIVE DRUG UTILIZATION
16 REVIEW PROGRAM.
17 (2) THE BOARD SHALL CONSIST OF 11 MEMBERS APPOINTED BY THE
18 DIRECTOR OF THE DEPARTMENT OF COMMUNITY HEALTH TO INCLUDE ALL OF
19 THE FOLLOWING:
20 (A) FOUR PHYSICIANS LICENSED UNDER ARTICLE 15 OF THE PUBLIC
21 HEALTH CODE, 1978 PA 368, MCL 333.16101 TO 333.18838, ACTIVELY
22 ENGAGED IN THE PRACTICE OF MEDICINE, AND CHOSEN FROM A LIST OF
23 NOMINEES PROVIDED BY THE MICHIGAN MEDICAL SOCIETY.
24 (B) FIVE PHARMACISTS LICENSED UNDER ARTICLE 15 OF THE PUBLIC
25 HEALTH CODE, 1978 PA 368, MCL 333.16101 TO 333.18838, ACTIVELY
26 ENGAGED IN THE PRACTICE OF PHARMACY, AND CHOSEN FROM A LIST OF
27 NOMINEES PROVIDED BY THE MICHIGAN PHARMACY ASSOCIATION.
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1 (C) ONE RESIDENT OF THIS STATE REPRESENTING MEDICAL
2 ASSISTANCE PROGRAM BENEFICIARIES.
3 (D) ONE RESIDENT OF THIS STATE REPRESENTING THE PHARMACEUTI-
4 CAL INDUSTRY CHOSEN FROM A LIST OF NOMINEES PROVIDED BY THE PHAR-
5 MACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA.
6 (3) BOARD MEMBERS SHALL SERVE STAGGERED 3-YEAR TERMS. ONE
7 PHYSICIAN, 1 PHARMACIST, AND THE BENEFICIARY REPRESENTATIVE SHALL
8 EACH BE INITIALLY APPOINTED FOR 2 YEARS, AND 1 PHYSICIAN, 2 PHAR-
9 MACISTS, AND THE INDUSTRY REPRESENTATIVE SHALL EACH BE INITIALLY
10 APPOINTED FOR 1 YEAR. MEMBERS MAY BE REAPPOINTED FOR A PERIOD
11 NOT TO EXCEED 3 THREE-YEAR TERMS. VACANCIES ON THE BOARD SHALL
12 BE FILLED FOR THE BALANCE OF THE UNEXPIRED TERM FROM NOMINEE
13 LISTS FOR THE APPROPRIATE BOARD CATEGORY AS UNDER
14 SUBSECTION (2).
15 (4) BOARD MEMBERS SHALL SELECT A CHAIRPERSON AND A VICE
16 CHAIRPERSON ON AN ANNUAL BASIS FROM THE BOARD MEMBERSHIP.
17 (5) THE BOARD SHALL MEET AT LEAST 6 TIMES EACH YEAR AND MAY
18 MEET AT OTHER TIMES AT THE DISCRETION OF THE CHAIRPERSON. NOTICE
19 OF A MEETING OF THE BOARD SHALL BE PUBLISHED IN THE MICHIGAN BUL-
20 LETIN 30 DAYS BEFORE THE MEETING. BOARD MEETINGS SHALL COMPLY
21 WITH THE OPEN MEETINGS ACT, 1976 PA 267, MCL 15.261 TO 15.275.
22 BOARD MEETINGS ARE SUBJECT TO THE ADMINISTRATIVE PROCEDURES ACT
23 OF 1969, 1969 PA 306, 24.201 TO 24.328.
24 SEC. 111N. THE BOARD SHALL DO ALL OF THE FOLLOWING:
25 (A) ADVISE AND MAKE RECOMMENDATIONS REGARDING RULES PROMUL-
26 GATED BY THE DEPARTMENT OF COMMUNITY HEALTH IMPLEMENTING STATE
27 AND FEDERAL LAW RELATED TO DRUG UTILIZATION REVIEW.
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1 (B) OVERSEE IMPLEMENTATION OF A RETROSPECTIVE AND
2 PROSPECTIVE DUR PROGRAM FOR THE MEDICAL ASSISTANCE PROGRAM,
3 INCLUDING RESPONSIBILITY FOR RECOMMENDING CRITERIA FOR SELECTION
4 OF CONTRACTORS AND REVIEWING CONTRACTS BETWEEN THE MEDICAL
5 ASSISTANCE PROGRAM AND ANY OTHER ENTITY THAT WILL PROCESS AND
6 REVIEW DRUG CLAIMS AND PROFILES FOR THE DUR PROGRAM IN ACCORDANCE
7 WITH SECTIONS 111l TO 111R.
8 (C) DEVELOP AND APPLY THE DUR CRITERIA FOR THE RETROSPECTIVE
9 AND PROSPECTIVE DUR PROGRAMS AND ENSURE THAT THE DUR CRITERIA ARE
10 CONSISTENT WITH THE INDICATIONS SUPPORTED OR REJECTED BY THE COM-
11 PENDIA AND UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVED
12 LABELING FOR THE DRUG. THE BOARD SHALL CONSIDER OUTSIDE INFORMA-
13 TION PROVIDED BY INTERESTED PARTIES, INCLUDING PRESCRIBERS WHO
14 TREAT SIGNIFICANT NUMBERS OF PATIENTS UNDER THE MEDICAL ASSIST-
15 ANCE PROGRAM.
16 (D) ESTABLISH A PROCESS TO REASSESS THE DUR CRITERIA ON A
17 PERIODIC BASIS AND MODIFY THE PROSPECTIVE AND RETROSPECTIVE DUR
18 PROGRAMS, AS NECESSARY.
19 (E) PROVIDE A PERIOD FOR PUBLIC COMMENT DURING EACH BOARD
20 MEETING AND FURNISH NOTICE OF PROPOSED CHANGES TO THE DUR CRI-
21 TERIA AND MODIFICATION OF THE PROSPECTIVE AND RETROSPECTIVE DUR
22 PROGRAMS 30 DAYS BEFORE CONSIDERING OR RECOMMENDING A PROPOSED
23 CHANGE TO THE DUR PROGRAMS.
24 SEC. 111o. (1) THE BOARD, IN COOPERATION WITH THE DEPART-
25 MENT OF COMMUNITY HEALTH, SHALL CREATE AND IMPLEMENT A PROSPEC-
26 TIVE AND RETROSPECTIVE DUR PROGRAM FOR OUTPATIENT PRESCRIPTION
27 DRUGS UNDER THE MEDICAL ASSISTANCE PROGRAM, USING DUR CRITERIA TO
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1 ENSURE THAT DRUG UTILIZATION IS MEDICALLY APPROPRIATE, MEDICALLY
2 NECESSARY, AND NOT LIKELY TO RESULT IN ADVERSE MEDICAL OUTCOMES.
3 (2) THE DEPARTMENT OF COMMUNITY HEALTH MAY CONTRACT WITH AN
4 ENTITY TO PROCESS AND REVIEW DRUG CLAIMS AND PROFILES FOR THE DUR
5 PROGRAM. THE DEPARTMENT OF COMMUNITY HEALTH SHALL USE A COMPETI-
6 TIVE BIDDING PROCESS AS REQUIRED UNDER SECTION 261 OF THE MANAGE-
7 MENT AND BUDGET ACT, 1984 PA 431, MCL 18.1261.
8 (3) THE PROSPECTIVE DUR PROGRAM SHALL BE BASED ON DUR CRI-
9 TERIA ESTABLISHED BY THE BOARD AND SHALL PROVIDE THAT, BEFORE A
10 PRESCRIPTION IS FILLED OR DELIVERED, A REVIEW SHALL BE CONDUCTED
11 BY A PHARMACIST AT THE POINT OF SALE TO SCREEN FOR A POTENTIAL
12 DRUG THERAPY PROBLEM. IN CONDUCTING THE PROSPECTIVE DUR REVIEW,
13 A PHARMACIST SHALL NOT ALTER THE PRESCRIBED OUTPATIENT DRUG THER-
14 APY WITHOUT A NEW PRESCRIPTION ORDER BY THE PRESCRIBING PHYSICIAN
15 AND APPROVAL BY THE PATIENT. THE PROSPECTIVE DUR REVIEW SHALL
16 SCREEN FOR ALL OF THE FOLLOWING:
17 (A) THERAPEUTIC DUPLICATION.
18 (B) DRUG-DISEASE CONTRAINDICATIONS.
19 (C) DRUG-DRUG INTERACTIONS.
20 (D) INCORRECT DRUG DOSAGE OR DURATION OF DRUG TREATMENT.
21 (E) DRUG-ALLERGY INTERACTIONS.
22 (F) CLINICAL ABUSE OR MISUSE.
23 (4) THE RETROSPECTIVE DUR PROGRAM SHALL BE BASED ON DUR CRI-
24 TERIA ESTABLISHED BY THE BOARD USING THE DEPARTMENT OF COMMUNITY
25 HEALTH'S MECHANIZED DRUG CLAIMS PROCESSING AND INFORMATION
26 RETRIEVAL SYSTEM TO ANALYZE MEDICAL ASSISTANCE CLAIMS TO DO ALL
27 OF THE FOLLOWING:
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1 (A) IDENTIFY PATTERNS OF FRAUD, ABUSE, GROSS OVERUSE OR
2 UNDERUSE, OR INAPPROPRIATE OR MEDICALLY UNNECESSARY CARE.
3 (B) ASSESS DATA ON DRUG USE BY APPLYING AND REVIEWING CRI-
4 TERIA DEVELOPED FROM THE COMPENDIA OR UNITED STATES FOOD AND DRUG
5 ADMINISTRATION APPROVED LABELING FOR THE PURPOSE OF EVALUATING
6 ALL OF THE FOLLOWING:
7 (i) THERAPEUTIC APPROPRIATENESS.
8 (ii) OVERUTILIZATION OR UNDERUTILIZATION.
9 (iii) APPROPRIATE USE OF GENERIC PRODUCTS.
10 (iv) THERAPEUTIC DUPLICATION.
11 (v) DRUG-DISEASE CONTRAINDICATIONS.
12 (vi) DRUG-DRUG INTERACTIONS.
13 (vii) INCORRECT DRUG DOSAGE OR DURATION OF DRUG TREATMENT.
14 (viii) CLINICAL ABUSE OR MISUSE.
15 (C) PROPOSE REMEDIAL STRATEGIES TO IMPROVE THE QUALITY OF
16 CARE AND PROMOTE EFFECTIVE USE OF MEDICAL ASSISTANCE PROGRAM
17 FUNDS OR BENEFICIARY EXPENDITURES.
18 SEC. 111P. (1) NOTWITHSTANDING ANY OTHER PROVISION OF LAW,
19 THE DEPARTMENT OF COMMUNITY HEALTH MAY IMPLEMENT A PRIOR AUTHORI-
20 ZATION PROGRAM FOR OUTPATIENT PRESCRIPTION DRUGS UNDER THE MEDI-
21 CAL ASSISTANCE PROGRAM ONLY AS PROVIDED IN SECTIONS 111l TO
22 111R.
23 (2) THE PHARMACY AND THERAPEUTICS COMMITTEE IS ESTABLISHED
24 WITHIN THE DEPARTMENT OF COMMUNITY HEALTH FOR THE PURPOSES OF
25 IMPLEMENTING PRIOR AUTHORIZATION FOR OUTPATIENT PRESCRIPTION
26 DRUGS UNDER THE MEDICAL ASSISTANCE PROGRAM.
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1 (3) THE COMMITTEE SHALL CONSIST OF 11 MEMBERS APPOINTED BY
2 THE DIRECTOR OF THE DEPARTMENT OF COMMUNITY HEALTH TO INCLUDE ALL
3 OF THE FOLLOWING:
4 (A) FIVE PHYSICIANS LICENSED UNDER ARTICLE 15 OF THE PUBLIC
5 HEALTH CODE, 1978 PA 368, MCL 333.16101 TO 333.18838, ACTIVELY
6 ENGAGED IN THE PRACTICE OF MEDICINE, AND CHOSEN FROM A LIST OF
7 NOMINEES PROVIDED BY THE MICHIGAN MEDICAL SOCIETY.
8 (B) FOUR PHARMACISTS LICENSED UNDER ARTICLE 15 OF THE PUBLIC
9 HEALTH CODE, 1978 PA 368, MCL 333.16101 TO 333.18838, ACTIVELY
10 ENGAGED IN THE PRACTICE OF PHARMACY, AND CHOSEN FROM A LIST OF
11 NOMINEES PROVIDED BY THE MICHIGAN PHARMACY ASSOCIATION.
12 (C) ONE RESIDENT OF THIS STATE REPRESENTING MEDICAL ASSIST-
13 ANCE PROGRAM BENEFICIARIES.
14 (D) ONE RESIDENT OF THIS STATE REPRESENTING THE PHARMACEUTI-
15 CAL INDUSTRY CHOSEN FROM A LIST OF NOMINEES PROVIDED BY THE PHAR-
16 MACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA.
17 (4) COMMITTEE MEMBERS SHALL SERVE STAGGERED 3-YEAR TERMS.
18 TWO PHYSICIANS, 1 PHARMACIST, AND THE MEDICAL ASSISTANCE BENEFI-
19 CIARY REPRESENTATIVE SHALL EACH BE INITIALLY APPOINTED FOR 2-YEAR
20 TERMS, AND 1 PHYSICIAN, 1 PHARMACIST, AND THE INDUSTRY REPRESEN-
21 TATIVE SHALL EACH BE INITIALLY APPOINTED FOR 1-YEAR TERMS.
22 MEMBERS MAY BE REAPPOINTED FOR A PERIOD NOT TO EXCEED 3
23 THREE-YEAR TERMS. VACANCIES ON THE COMMITTEE SHALL BE FILLED FOR
24 THE BALANCE OF THE UNEXPIRED TERM FROM NOMINEE LISTS FOR THE
25 APPROPRIATE COMMITTEE CATEGORY AS UNDER SUBSECTION (3).
26 (5) COMMITTEE MEMBERS SHALL SELECT A CHAIRPERSON AND A VICE
27 CHAIRPERSON ON AN ANNUAL BASIS FROM THE COMMITTEE MEMBERSHIP.
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1 (6) THE COMMITTEE SHALL MEET AT LEAST 6 TIMES EACH YEAR AND
2 MAY MEET AT OTHER TIMES AT THE DISCRETION OF THE CHAIRPERSON.
3 NOTICE OF A MEETING OF THE COMMITTEE SHALL BE PUBLISHED IN THE
4 MICHIGAN BULLETIN 30 DAYS BEFORE THE MEETING. COMMITTEE MEETINGS
5 SHALL COMPLY WITH THE PROVISIONS OF THE OPEN MEETINGS ACT, 1976
6 PA 267, MCL 15.261 TO 15.275. COMMITTEE MEETINGS ARE SUBJECT TO
7 THE PROVISIONS OF THE ADMINISTRATIVE PROCEDURES ACT OF 1969, 1969
8 PA 306, MCL 24.201 TO 24.328.
9 SEC. 111Q. THE COMMITTEE SHALL DO ALL OF THE FOLLOWING:
10 (A) ADVISE AND MAKE RECOMMENDATIONS REGARDING RULES PROMUL-
11 GATED BY THE DEPARTMENT REGARDING OUTPATIENT PRESCRIPTION DRUG
12 PRIOR AUTHORIZATION.
13 (B) OVERSEE THE IMPLEMENTATION OF A DRUG PRIOR AUTHORIZATION
14 PROGRAM FOR THE MEDICAL ASSISTANCE PROGRAM.
15 (C) ESTABLISH THE DRUG PRIOR AUTHORIZATION REVIEW PROCESS IN
16 COMPLIANCE WITH SECTION 111R.
17 (D) MAKE FORMAL RECOMMENDATIONS TO THE DEPARTMENT REGARDING
18 ANY OUTPATIENT PRESCRIPTION DRUG COVERED BY THE MEDICAL ASSIST-
19 ANCE PROGRAM REQUIRING PRIOR AUTHORIZATION.
20 (E) REVIEW ON A SEMIANNUAL BASIS WHETHER DRUGS PLACED ON
21 PRIOR AUTHORIZATION ARE TO REMAIN ON PRIOR AUTHORIZATION.
22 (F) IF NECESSARY, MODIFY THE PRIOR AUTHORIZATION REVIEW PRO-
23 CESS TO ACHIEVE THE OBJECTIVES OF THIS ACT.
24 SEC. 111R. (1) A DRUG PRIOR AUTHORIZATION PROGRAM SHALL
25 MEET ALL OF THE FOLLOWING CONDITIONS:
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1 (A) THE PROGRAM SHALL PROVIDE TELEPHONE, FACSIMILE, OR OTHER
2 ELECTRONICALLY TRANSMITTED APPROVAL OR DENIAL WITHIN 24 HOURS
3 AFTER RECEIPT OF THE PRIOR AUTHORIZATION REQUEST.
4 (B) IN AN EMERGENCY SITUATION, INCLUDING A SITUATION IN
5 WHICH A RESPONSE TO A PRIOR AUTHORIZATION REQUEST IS UNAVAILABLE,
6 A 72-HOUR SUPPLY OF THE PRESCRIBED DRUG SHALL BE DISPENSED AND
7 PAID FOR BY THE MEDICAL ASSISTANCE PROGRAM OR, AT THE DISCRETION
8 OF THE COMMITTEE, A SUPPLY GREATER THAN 72 HOURS THAT WILL ASSURE
9 A MINIMUM EFFECTIVE DURATION OF THERAPY FOR AN ACUTE
10 INTERVENTION.
11 (C) AUTHORIZATION SHALL BE GRANTED IF THE DRUG IS PRESCRIBED
12 FOR A MEDICALLY ACCEPTED USE SUPPORTED BY EITHER THE COMPENDIA,
13 APPROVED PRODUCT LABELING, OR PEER-REVIEWED LITERATURE UNLESS
14 THERE IS A THERAPEUTICALLY EQUIVALENT GENERIC DRUG THAT IS AVAIL-
15 ABLE WITHOUT PRIOR AUTHORIZATION.
16 (D) THE DRUG UTILIZATION REVIEW PROGRAM ADMINISTRATORS SHALL
17 CONSULT WITH PRESCRIBERS TO DEVELOP A STREAMLINED PROCESS FOR THE
18 PRESCRIBER TO FURNISH ANY DOCUMENTATION REQUIRED TO SUPPORT A
19 PRIOR AUTHORIZATION REQUEST, INCLUDING, BUT NOT LIMITED TO, NAME,
20 TITLE, ADDRESS, AND TELEPHONE NUMBER OF THE PRESCRIBER MAKING THE
21 REQUEST, DATE OF THE REQUEST, THE PRODUCT NAME OF THE REQUESTED
22 DRUG, A DESCRIPTION OF THE CIRCUMSTANCES AND BASIS FOR THE
23 REQUEST, AND WHETHER THE REQUEST IS AN EMERGENCY. THE PROCESS
24 SHALL FLOW DIRECTLY FROM THE PATIENT CARE INTERACTION. THE
25 DEPARTMENT OF COMMUNITY HEALTH SHALL NOT REQUIRE A SEPARATE SET
26 OF TASKS OF THE PRESCRIBER.
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1 (2) THE COMMITTEE SHALL NOT RECOMMEND A DRUG FOR PRIOR
2 AUTHORIZATION, AND THE DEPARTMENT OF COMMUNITY HEALTH SHALL NOT
3 PLACE A DRUG ON PRIOR AUTHORIZATION, UNLESS ALL OF THE FOLLOWING
4 CONDITIONS ARE MET:
5 (A) THE COMMITTEE ANALYZES THE RETROSPECTIVE DUR DATA USING
6 THE DUR CRITERIA TO IDENTIFY A DRUG, USE OF WHICH IS LIKELY NOT
7 TO BE MEDICALLY APPROPRIATE OR MEDICALLY NECESSARY OR IS LIKELY
8 TO RESULT IN AN ADVERSE MEDICAL OUTCOME.
9 (B) THE COMMITTEE CONSIDERS THE POTENTIAL IMPACT ON PATIENT
10 CARE AND THE POTENTIAL FISCAL IMPACT THAT MAY RESULT FROM A DRUG
11 ON PRIOR AUTHORIZATION.
12 (C) ANY CONSIDERATION OF THE COST OF THE DRUG BY THE COMMIT-
13 TEE SHALL REFLECT THE TOTAL COST OF TREATING THE CONDITIONS FOR
14 WHICH THE DRUG IS PRESCRIBED, INCLUDING NONPHARMACEUTICAL COSTS
15 AND COSTS INCURRED BY OTHER SECTORS OF THE STATE HEALTH CARE PRO-
16 GRAM THAT MAY BE AFFECTED BY THE DRUG'S AVAILABILITY FOR USE IN
17 TREATING MEDICAL ASSISTANCE PROGRAM BENEFICIARIES.
18 (D) THE COMMITTEE PROVIDES 30 DAYS' PUBLIC NOTICE PRIOR TO
19 EACH MEETING DEVELOPING RECOMMENDATIONS CONCERNING WHETHER A DRUG
20 SHOULD BE PLACED ON PRIOR AUTHORIZATION. ANY INTERESTED PARTY
21 MAY REQUEST AN OPPORTUNITY TO MAKE AN ORAL PRESENTATION TO THE
22 COMMITTEE RELATED TO THE PRIOR AUTHORIZATION OF THE DRUG. THE
23 COMMITTEE SHALL ALSO CONSIDER ANY INFORMATION PROVIDED BY ANY
24 INTERESTED PARTY, INCLUDING, BUT NOT LIMITED TO, PHYSICIANS,
25 PHARMACISTS, BENEFICIARIES, AND MANUFACTURERS OR DISTRIBUTORS OF
26 THE DRUG.
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1 (E) THE COMMITTEE MAKES A FORMAL WRITTEN RECOMMENDATION TO
2 THE DEPARTMENT OF COMMUNITY HEALTH THAT A DRUG BE PLACED ON PRIOR
3 AUTHORIZATION THAT IS SUPPORTED BY AN ANALYSIS OF PROSPECTIVE AND
4 RETROSPECTIVE DUR DATA DEMONSTRATING ALL OF THE FOLLOWING:
5 (i) THE EXPECTED IMPACT OF A DECISION ON THE CLINICAL CARE
6 LIKELY TO BE RECEIVED BY BENEFICIARIES FOR WHOM THE DRUG IS MEDI-
7 CALLY NECESSARY.
8 (ii) THE EXPECTED IMPACT ON PHYSICIANS WHOSE PATIENTS
9 REQUIRE THE DRUG.
10 (iii) THE EXPECTED FISCAL IMPACT ON THE MEDICAL ASSISTANCE
11 PROGRAM.
12 (F) THE DEPARTMENT OF COMMUNITY HEALTH ACCEPTS OR REJECTS
13 THE RECOMMENDATION OF THE COMMITTEE AND, IN A WRITTEN DECISION,
14 DETERMINES WHETHER A DRUG SHALL BE PLACED ON PRIOR
15 AUTHORIZATION. THE DEPARTMENT OF COMMUNITY HEALTH MAY CONSIDER
16 ANY ADDITIONAL AND CLARIFYING INFORMATION PROVIDED BY ANY INTER-
17 ESTED BEFORE PARTY RENDERING ITS DECISION.
18 (G) THE DEPARTMENT OF COMMUNITY HEALTH'S DECISION SHALL BE
19 PUBLISHED FOR PUBLIC COMMENT FOR A PERIOD OF NOT LESS THAN 30
20 DAYS. THE EFFECTIVE DATE OF THE DECISION SHALL NOT BE PRIOR TO
21 THE CLOSE OF THE COMMENT PERIOD AND EFFECTIVE NOTICE OF THE
22 DECISION'S FINALITY IS AVAILABLE TO PRESCRIBERS.
23 (3) NOTWITHSTANDING ANY OTHER PROVISION OF SECTIONS 111l TO
24 111R, UNLESS A DRUG HAS BEEN APPROVED OR HAD ANY OF ITS PARTICU-
25 LAR USES APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRA-
26 TION UNDER A PRIORITY REVIEW CLASSIFICATION, THAT DRUG SHALL NOT
27 BE RECOMMENDED TO REQUIRE PRIOR AUTHORIZATION BY THE COMMITTEE
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1 AND PLACED ON PRIOR AUTHORIZATION BY THE DEPARTMENT OF COMMUNITY
2 HEALTH.
3 (4) THE COMMITTEE SHALL DEVELOP A GRIEVANCE MECHANISM FOR
4 INTERESTED PARTIES TO APPEAL THE DEPARTMENT OF COMMUNITY HEALTH'S
5 DECISION TO PLACE A DRUG ON PRIOR AUTHORIZATION. AFTER PARTICI-
6 PATING IN THE GRIEVANCE MECHANISM DEVELOPED BY THE COMMITTEE, ANY
7 INTERESTED PARTY AGGRIEVED BY THE PLACEMENT OF A DRUG ON PRIOR
8 AUTHORIZATION IS ENTITLED TO AN ADMINISTRATIVE HEARING BEFORE THE
9 DEPARTMENT OF COMMUNITY HEALTH ACCORDING TO THE PROVISIONS OF THE
10 ADMINISTRATIVE PROCEDURES ACT OF 1969, 1969 PA 306, MCL 24.201 TO
11 24.328.
12 (5) THE COMMITTEE SHALL REVIEW THE PRIOR AUTHORIZATION
13 STATUS OF A DRUG EVERY 6 MONTHS.
14 (6) THE COMMITTEE SHALL PROVIDE 30 DAYS' PUBLIC NOTICE PRIOR
15 TO EACH MEETING DETERMINING IF CHANGES SHOULD BE MADE TO THE DRUG
16 PRIOR AUTHORIZATION REVIEW PROCESS.
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