EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0064*
SENATE BILL 64
J2, J5, J4 3lr0314
SB 355/22 – EHE & FIN (PRE–FILED)
By: Senator Lam
Requested: July 6, 2022
Introduced and read first time: January 11, 2023
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
HIV Prevention Drugs – Prescribing and Dispensing by Pharmacists and 2
Insurance Requirements 3
FOR the purpose of authorizing pharmacists to prescribe and dispense postexposure 4
prophylaxis for HIV prevention to patients under certain circumstances; requiring 5
the Maryland Medical Assistance Program to provide drugs that are approved by the 6
U.S. Food and Drug Administration for HIV prevention; prohibiting managed care 7
organizations, insurers, nonprofit health service plans, and health maintenance 8
organizations from requiring prior authorization for preexposure prophylaxis for 9
HIV prevention or step therapy or cost–sharing for preexposure prophylaxis for HIV 10
prevention or postexposure prophylaxis for HIV prevention; and generally relating 11
to HIV prevention drugs. 12
BY adding to 13
Article – Health – General 14
Section 15–102.3(k) and 15–103(a)(2)(xxii) 15
Annotated Code of Maryland 16
(2019 Replacement Volume and 2022 Supplement) 17
BY repealing and reenacting, without amendments, 18
Article – Health – General 19
Section 15–103(a)(1) 20
Annotated Code of Maryland 21
(2019 Replacement Volume and 2022 Supplement) 22
BY repealing and reenacting, with amendments, 23
Article – Health – General 24
Section 15–103(a)(2)(xx) and (xxi) and (b)(32) 25
Annotated Code of Maryland 26
(2019 Replacement Volume and 2022 Supplement) 27 2 SENATE BILL 64
BY repealing and reenacting, with amendments, 1
Article – Health Occupations 2
Section 12–101(x)(1)(xii) and (xiii) 3
Annotated Code of Maryland 4
(2021 Replacement Volume and 2022 Supplement) 5
BY adding to 6
Article – Health Occupations 7
Section 12–101(x)(1)(xiv) and 12–515 8
Annotated Code of Maryland 9
(2021 Replacement Volume and 2022 Supplement) 10
BY repealing and reenacting, with amendments, 11
Article – Insurance 12
Section 15–858 13
Annotated Code of Maryland 14
(2017 Replacement Volume and 2022 Supplement) 15
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 16
That the Laws of Maryland read as follows: 17
Article – Health – General 18
15–103. 19
(a) (1) The Secretary shall administer the Maryland Medical Assistance 20
Program. 21
(2) The Program: 22
(xx) Beginning on July 1, 2023, shall provide, subject to federal 23
approval and limitations of the State budget, community violence prevention services in 24
accordance with § 15–141.3 of this subtitle; [and] 25
(xxi) Beginning on January 1, 2023, shall provide, subject to the 26
limitations of the State budget, and as permitted by federal law, coverage for self–measured 27
blood pressure monitoring for all Program recipients diagnosed with uncontrolled high 28
blood pressure, including: 29
1. The provision of validated home blood pressure monitors; 30
and 31
2. Reimbursement of health care provider and other staff 32
time used for patient training, transmission of blood pressure data, interpretation of blood 33
pressure readings and reporting, and the delivery of co –interventions, including 34
educational materials or classes, behavioral change management, and medication 35 SENATE BILL 64 3
management; AND 1
(XXII) SHALL PROVIDE , SUBJECT TO THE LIMIT ATIONS OF 2
THE STATE BUDGET , MEDICALLY APPROPRIAT E DRUGS THAT ARE APP ROVED BY 3
THE U.S. FOOD AND DRUG ADMINISTRATION FOR HIV PREVENTION , INCLUDING: 4
1. PREEXPOSURE PROPHYLAX IS; AND 5
2. POSTEXPOSURE PROPHYLA XIS, AS DEFINED IN § 6
12–515 OF THE HEALTH OCCUPATIONS ARTICLE. 7
(b) (32) A managed care organization may not apply a prior authorization 8
requirement for a prescription drug used as PREEXPOSURE PROPHYLA XIS OR 9
postexposure prophylaxis for the prevention of HIV if the prescription drug is prescribed 10
for use in accordance with Centers for Disease Control and Prevention Guidelines. 11
Article – Health Occupations 12
12–101. 13
(x) (1) “Practice pharmacy” means to engage in any of the following activities: 14
(xii) Prescribing and dispensing contraceptive medications and 15
self–administered contraceptive devices approved by the U.S. Food and Drug 16
Administration; [or] 17
(xiii) Prescribing and dispensing nicotine replacement therapy 18
medications; OR 19
(XIV) PRESCRIBING AND DISPE NSING POSTEXPOSURE 20
PROPHYLAXIS MEDICATI ONS FOR HIV APPROVED BY THE U.S. FOOD AND DRUG 21
ADMINISTRATION . 22
12–515. 23
(A) (1) IN THIS SECTION THE F OLLOWING WO RDS HAVE THE MEANING S 24
INDICATED. 25
(2) “CDC GUIDELINES FOR POSTE XPOSURE PROPHYLAXIS ” MEANS 26
“UPDATED GUIDELINES FOR ANTIRETROVIRAL POSTEXPOSURE PROPHYLAXIS 27
AFTER SEXUAL, INJECTION DRUG USE, OR OTHER NONOCCUPATIONAL EXPOSURE 28
TO HIV – UNITED STATES, 2016” OR ANY SUBSEQUENT GUIDE LINES PUBLISHED BY 29
THE FEDERAL CENTERS FOR DISEASE CONTROL AND PREVENTION. 30
(3) “CDC GUIDELINES FOR PREEX POSURE PROPHYLAXIS ” MEANS 31 4 SENATE BILL 64
“PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE 1
UNITED STATES – 2017 UPDATE: A CLINICAL PRACTICE GUIDELINE” OR ANY 2
SUBSEQUENT GUIDELINE S PUBLISHED BY THE F EDERAL CENTERS FOR DISEASE 3
CONTROL AND PREVENTION. 4
(4) “POSTEXPOSURE PROPHYLA XIS” MEANS ANY DRUG 5
COMBINATION APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION THAT I S: 6
(I) USED TO PREVENT HIV INFECTION FOLLOWING AN 7
EXPOSURE OR POTENTIA L EXPOSURE TO HIV; AND 8
(II) ADMINISTERED IN ACCOR DANCE WITH THE CDC, IN THE 9
CDC GUIDELINES FOR POSTE XPOSURE PROPHYLAXIS . 10
(5) “PREEXPOSURE PROPHYLAX IS” MEANS ANY DRUG COMBI NATION 11
APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION THAT I S: 12
(I) PROVIDED TO AN HIV–NEGATIVE PERSON TO P REVENT 13
HIV INFECTION; AND 14
(II) ADMINISTERED IN ACCOR DANCE WITH THE CDC, IN THE 15
CDC GUIDELINES FOR PREEXP OSURE PROPHYLAXIS . 16
(6) “RYAN WHITE HIV/AIDS PROGRAM” MEANS THE PROGRAM 17
ADMINISTERED BY THE FEDERAL HEALTH RESOURCES AND SERVICES 18
ADMINISTRATION THAT P ROVIDES GRANTS TO PR OVIDE CARE AND TREAT MENT 19
SERVICES TO INDIVIDU ALS WITH HIV TO IMPROVE HEALTH OU TCOMES AND 20
REDUCE HIV TRANSMISSION AMONG H ARD–TO–REACH POPU LATIONS. 21
(B) (1) A PHARMACIST MAY PRESC RIBE AND DISPENSE A COMPLETE 22
COURSE OF POSTEXPOSU RE PROPHYLAXIS TO A PATIENT IF THE PHARM ACIST: 23
(I) SCREENS THE PATIENT A ND DETERMINES : 24
1. THE EXPOSURE TO HIV OCCURRED WITHIN THE 25
IMMEDIATELY PRECEDIN G 72 HOURS; AND 26
2. THE PATIENT OTHERWISE MEETS THE CLINICAL 27
CRITERIA FOR POSTEXP OSURE PROPHYLAXIS CO NSISTENT WITH THE CDC 28
GUIDELINES FOR POSTE XPOSURE PROPHYLAXIS ; 29
(II) 1. PROVIDES HIV TESTING THAT IS CLAS SIFIED AS 30
WAIVED UNDER THE FED ERAL CLINICAL LABORATORY IMPROVEMENT 31
AMENDMENTS OF 1988; OR 32 SENATE BILL 64 5
2. EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS 1
SUBSECTION, OBTAINS THE CONSENT OF THE PATIENT TO SU BMIT TO AN HIV TEST 2
CONSISTENT WITH THE CDC GUIDELINES FOR POSTE XPOSURE PROPHYLAXIS ; 3
(III) PROVIDES COUNSE LING TO THE PATIENT ON: 4
1. THE USE OF POSTEXPOSU RE PROPHYLAXIS 5
CONSISTENT WITH THE CDC GUIDELINES FOR POSTE XPOSURE PROPHYLAXIS , 6
INCLUDING EDUCATION REGARDING SIDE EFFEC TS, SAFETY DURING PREGNA NCY 7
AND BREASTFEEDING , ADHERENCE TO RECOMME NDED DOSING , AND THE 8
IMPORTANCE OF TIMELY TESTING AND TREATMEN T, AS APPLICABLE, FOR HIV AND 9
SEXUALLY TRANSMITTED DISEASES; AND 10
2. THE AVAILABILITY OF P REEXPOSURE PROPHYLAX IS 11
FOR INDIVIDUALS WHO ARE AT SUBSTANTIAL R ISK OF CONTRACTING HIV; AND 12
(IV) PROVIDES: 13
1. NOTICE TO THE PATIENT ’S PRIMARY CARE PROVI DER 14
OF THE POSTEXPOSURE PROPHYLAXIS TREATMEN T; OR 15
2. IF THE PATIENT DOES N OT HAVE A PRIMARY CA RE 16
PROVIDER OR REFUSES TO PROVIDE THE NAME OF A HEALTH CARE PRO VIDER, THE 17
PATIENT WITH A LIST OF PHYSICIANS , CLINICS, OR OTHER HEALTH CARE 18
PROVIDERS IN THE ARE A, INCLUDING PROVIDERS THAT RECEIVE FUNDING , EITHER 19
DIRECTLY OR INDIRECT LY, FROM THE RYAN WHITE HIV/AIDS PROGRAM, TO 20
CONTACT REGARDING FO LLOW–UP CARE FOR POSTEXPO SURE PROPHYLAXIS . 21
(2) A PHARMACIST MAY NOT A LLOW A PATIENT TO REF USE OR WAIVE 22
A CONSULTATION REQUI RED UNDER PARAGRAPH (1) OF THIS SUBSECTION . 23
(3) IF THE PATIENT REFUSE S TO CONSENT TO AN HIV TEST UNDER 24
PARAGRAPH (1)(II)2 OF THIS SUBSECTION B UT OTHERWISE MEETS T HE CRITERIA 25
FOR POSTEXPOSURE PROPHYLAXIS UNDER TH IS SUBSECTION, THE PHARMACIST 26
MAY PRESCRIBE AND DI SPENSE POSTEXPOSURE PROPHYLAXIS TO THE P ATIENT. 27
(C) (1) (I) BEFORE PRESCRIBING AN D DISPENSING POSTEXP OSURE 28
PROPHYLAXIS TO A PAT IENT, A PHARMACIST SHALL COM PLETE A TRAINING 29
PROGRAM ON T HE AVAILABILITY OF PREE XPOSURE PROPHYLAXIS AND ON THE USE 30
OF POSTEXPOSURE PROP HYLAXIS THAT IS APPROVED BY THE BOARD. 31
(II) THE TRAINING PROGRAM REQUIRED UNDER 32
SUBPARAGRAPH (I) OF THIS PARAGRAPH SH ALL INCLUDE INFORMAT ION ABOUT 33 6 SENATE BILL 64
FINANCIAL ASSISTANCE PROGRAMS FOR PREEXPOSURE PROPHYLA XIS AND 1
POSTEXPOSURE PROPHYL AXIS. 2
(2) THE BOARD SHALL CONSULT W ITH THE STATE BOARD OF 3
PHYSICIANS, THE STATE BOARD OF NURSING, AND OTHER RELEVANT 4
STAKEHOLDERS , INCLUDING THE MARYLAND CENTER FOR HIV CARE SERVICES, 5
WHEN DEVELOPIN G OR APPROVING TRAIN ING PROGRAMS THAT ME ET THE 6
REQUIREMENTS OF THIS SUBSECTION. 7
(D) THE BOARD, IN CONSULTATION WITH THE STATE BOARD OF 8
PHYSICIANS AND THE STATE BOARD OF NURSING, SHALL ADOPT REGULATI ONS 9
ESTABLISHING PROCEDU RES FOR CREATING AND DISSEMINATING A LIST OF 10
ENTITIES THAT RECEIV E FUNDING, EITHER DIRECTLY OR I NDIRECTLY, FROM THE 11
RYAN WHITE HIV/AIDS PROGRAM. 12
SECTION 2. AND BE IT FURTHER ENACTED, That the Laws of Maryland read 13
as follows: 14
Article – Health – General 15
15–102.3. 16
(K) THE PROVISIONS OF § 15–858 OF THE INSURANCE ARTICLE APPLY TO 17
MANAGED CARE ORGANIZ ATIONS IN THE SAME M ANNER AS THEY APPLY TO 18
CARRIERS. 19
Article – Insurance 20
15–858. 21
(a) (1) [This] EXCEPT AS PROVIDED IN PARAGRAPH (3) OF THIS 22
SUBSECTION, THIS section applies to: 23
(i) insurers and nonprofit health service plans that provide coverage 24
for prescription drugs under individual, group, or blanket health insurance policies or 25
contracts that are issued or delivered in the State; and 26
(ii) health maintenance organizations that provide coverage for 27
prescription drugs under individual or group contracts that are issued or delivered in the 28
State. 29
(2) An insurer, a nonprofit health service plan, or a health maintenance 30
organization that provides coverage for prescription drugs through a pharmacy benefits 31
manager is subject to the requirements of this section. 32
SENATE BILL 64 7
(3) THIS SECTION DOES NOT APPLY TO A GRANDFATH ERED PLAN, AS 1
DEFINED IN § 1251 OF THE AFFORDABLE CARE ACT. 2
(b) An entity subject to this section may not apply a prior authorization 3
requirement OR STEP THERAPY OR I MPOSE ANY COST –SHARING REQUIREMENTS , 4
INCLUDING COPAYMENTS , COINSURANCE , OR DEDUCTIBLES , for a prescription drug 5
used as PREEXPOSURE PROPHYLA XIS OR postexposure prophylaxis for the prevention of 6
HIV if the prescription drug is prescribed for use in accordance with Centers for Disease 7
Control and Prevention guidelines. 8
(C) AN ENTITY SUBJECT TO THIS SECTION MAY NOT IMPOSE ANY 9
COST–SHARING REQUIREMENTS , INCLUDING COPAYMENTS , COINSURANCE , OR 10
DEDUCTIBLES , FOR MEDICALLY NECESS ARY AND APPROPRIATE SERVICES RELATED 11
TO THE USE OF PREEXPOSURE PROPHYLA XIS OR POSTEXPOSURE PROPHYL AXIS, 12
INCLUDING: 13
(1) HIV TESTING; 14
(2) KIDNEY FUNCTION TESTING; 15
(3) ONGOING FOLLOW –UP AND MONITORING EV ERY 3 MONTHS; 16
(4) PREGNANCY TESTING ; 17
(5) PROVIDER OFFICE AND TELEHEALTH VISITS FO R PRESCRIBING 18
AND MEDICATION MANAG EMENT; 19
(6) SEROLOGIC LABORATORY TESTING FOR HEPATITI S B AND 20
HEPATITIS C VIRUSES; 21
(7) TESTING FOR OTHER SE XUALLY TRANSMITTED I NFECTIONS, 22
INCLUDING THREE –SITE TESTING FOR GON ORRHEA AND CHLAMYDIA ; AND 23
(8) VACCINATIONS FOR HEP ATITIS B. 24
SECTION 3. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall 25
apply to all policies, contracts, and health benefit plans that are not grandfathered plans 26
as defined in § 1251 of the Affordable Care Act issued, delivered, or renewed in the State 27
on or after January 1, 2024. 28
SECTION 4. AND BE IT FURTHER ENACTED, That Section 2 of this Act shall take 29
effect January 1, 2024. 30
SECTION 5. AND BE IT FURTHER ENACTED, That, except as provided in Section 31
4 of this Act, this Act shall take effect October 1, 2023. 32