An Act To Improve Access to HIV Prevention Medications
Maine Legislature, Session 130, LD 1115
Committee: Health Coverage, Insurance and Financial Services
Sponsors: SANBORN, FECTEAU, CLAXTON, LIBBY
Amends: 22 MRSA §3174-M, 24-A MRSA §4317-D, 32 MRSA §13702-A, 32 MRSA §13786-E

Legislative Document
No. 1115
S.P. 378
In Senate, March 22, 2021
An Act To Improve Access to HIV Prevention Medications
Received by the Secretary of the Senate on March 18, 2021.  Referred to the Committee on 
Health Coverage, Insurance and Financial Services pursuant to Joint Rule 308.2 and ordered 
printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator SANBORN of Cumberland.
Cosponsored by Speaker FECTEAU of Biddeford and
Senators: CLAXTON of Androscoggin, LIBBY of Androscoggin.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  22 MRSA §3174-M, sub-§1-A, ¶B, as enacted by PL 2005, c. 386, Pt. X, 
§1, is amended to read:
B.  Be structured to maintain at least the same therapeutic categories and 
pharmacological classes of drugs provided on the MaineCare preferred drug list in 
effect on July 1, 2005; and
Sec. 2.  22 MRSA §3174-M, sub-§1-A, ¶C, as enacted by PL 2005, c. 386, Pt. X, 
§1, is amended by amending subparagraph (3) to read:
(3)  Conform to national standards for the prescribing of atypical antipsychotic 
drugs.; and
Sec. 3.  22 MRSA §3174-M, sub-§1-A, ¶D is enacted to read:
D.  With respect to HIV prevention drugs as defined in Title 24-A, section 4317-D, 
subsection 1, paragraph B:
(1)  Ensure that preexposure prophylaxis drugs are available; and
(2)  Ensure that post-exposure prophylaxis drugs are available in accordance with 
national standards for the prescribing of post-exposure prophylaxis drugs.
Sec. 4.  24-A MRSA §4317-D is enacted to read:
§4317-D.  Coverage of HIV prevention drugs
1.  Definitions.  As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "CDC guidelines" means guidelines related to the nonoccupational exposure to 
potential HIV infection, or any subsequent guidelines, published by the federal 
Department of Health and Human Services, Centers for Disease Control and 
Prevention.
B.  "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 
prophylaxis drug or other drug approved for the prevention of HIV infection by the 
federal Food and Drug Administration.
C.  "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 
clinical eligibility recommendations provided in CDC guidelines following potential 
exposure to HIV infection.
D.  "Preexposure prophylaxis drug" means a drug or drug combination that meets the 
clinical eligibility recommendations provided in CDC guidelines to prevent HIV 
infection.
2.  Coverage required.  A carrier offering a health plan in this State shall provide 
coverage for an HIV prevention drug that has been prescribed by a provider.  Coverage 
under this section is subject to the following.
A.  If the federal Food and Drug Administration has approved one or more therapeutic 
equivalents of an HIV prevention drug, a carrier is not required to cover all of the 
therapeutically equivalent drugs as long as the carrier covers at least one therapeutically 
equivalent drug at the tier with the lowest cost-sharing requirement on the carrier's 
prescription drug formulary.
B.  A carrier is not required to cover any preexposure prophylaxis drug or post-
exposure prophylaxis drug dispensed by an out-of-network pharmacy provider unless 
the enrollee's health plan provides an out-of-network pharmacy benefit.
C.  A carrier may not prohibit, or permit a pharmacy benefits manager to prohibit, a 
pharmacy provider from dispensing any HIV prevention drugs.
3.  Limits on prior authorization and step therapy requirements.  Notwithstanding 
any requirements in section 4304 or 4320-N to the contrary, a carrier may not subject any 
HIV prevention drug to any prior authorization or step therapy requirement except as 
provided in this subsection.  If the federal Food and Drug Administration has approved one 
or more therapeutic equivalents of an HIV prevention drug, a carrier is not required to cover 
all of the therapeutically equivalent drugs without prior authorization or step therapy 
requirements as long as the carrier covers at least one therapeutically equivalent drug 
without prior authorization or step therapy requirements.
Sec. 5.  32 MRSA §13702-A, sub-§28, as amended by PL 2017, c. 185, §1, is 
further amended to read:
28.  Practice of pharmacy.  "Practice of pharmacy" means the interpretation and 
evaluation of prescription drug orders; the compounding, dispensing and labeling of drugs 
and devices, except labeling by a manufacturer, packer or distributor of nonprescription 
drugs and commercially packaged legend drugs and devices; the participation in drug 
selection and drug utilization reviews; the proper and safe storage of drugs and devices and 
the maintenance of proper records for these drugs and devices; the administration of 
vaccines licensed by the United States Food and Drug Administration that are 
recommended by the United States Centers for Disease Control and Prevention Advisory 
Committee on Immunization Practices, or successor organization, for administration to 
adults; the performance of collaborative drug therapy management; the responsibility for 
advising, when necessary or regulated, of therapeutic values, content, hazards and use of 
drugs and devices; the ordering and dispensing of over-the-counter nicotine replacement 
products approved by the United States Food and Drug Administration; the dispensing of 
an HIV prevention drug, as defined in section 13786-E, subsection 1, paragraph B, pursuant 
to a standing order or to protocols developed by the board; and the offering or performing 
of those acts, services, operations or transactions necessary in the conduct, operation, 
management and control of a pharmacy.
Sec. 6.  32 MRSA §13786-E is enacted to read:
§13786-E.  Dispensing HIV prevention drugs
1.  Definitions.  As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "CDC guidelines" means guidelines related to nonoccupational exposure to 
potential HIV infection, or any subsequent guidelines, published by the federal 
Department of Health and Human Services, Centers for Disease Control and 
Prevention.
B.  "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure 
prophylaxis drug or other drug approved for the prevention of HIV infection by the 
federal Food and Drug Administration.
C.  "Post-exposure prophylaxis drug" means a drug or drug combination that meets the 
clinical eligibility recommendations provided in CDC guidelines following potential 
exposure to HIV infection.
D.  "Preexposure prophylaxis drug" means a drug or drug combination that meets the 
clinical eligibility recommendations provided in CDC guidelines to prevent HIV 
infection.
2.  Authorization.  Notwithstanding any provision of law to the contrary and as 
authorized by the board in accordance with rules adopted under subsection 3, a pharmacist 
may dispense HIV prevention drugs pursuant to a standing order or to protocols developed 
by the board in accordance with the requirements in this subsection and may also order 
laboratory testing for HIV infection as necessary.
A.  Before furnishing an HIV prevention drug to a patient, a pharmacist shall complete 
a training program approved by the board on the use of protocols developed by the 
board for dispensing an HIV prevention drug, on the requirements for any laboratory 
testing for HIV infection and on guidelines for prescription adherence and best 
practices to counsel patients prescribed an HIV prevention drug.
B.  A pharmacist shall dispense a preexposure prophylaxis drug in at least a 30-day 
supply, and up to a 60-day supply, as long as all of the following conditions are met:
(1)  The patient tests negative for HIV infection, as documented by a negative HIV 
test result obtained within the previous 7 days.  If the patient does not provide 
evidence of a negative HIV test result in accordance with this subparagraph, the 
pharmacist shall order an HIV test.  If the test results are not transmitted directly 
to the pharmacist, the pharmacist shall verify the test results to the pharmacist's 
satisfaction.  If the patient tests positive for HIV infection, the pharmacist or person 
administering the test shall direct the patient to a primary care provider and provide 
a list of primary care providers and clinics within a reasonable travel distance of 
the patient's residence;
(2)  The patient does not report any signs or symptoms of acute HIV infection on 
a self-reporting checklist of acute HIV infection signs and symptoms;
(3)  The patient does not report taking any contraindicated medications;
(4)  The pharmacist provides counseling to the patient, consistent with CDC 
guidelines, on the ongoing use of a preexposure prophylaxis drug.  The pharmacist 
shall notify the patient that the patient must be seen by a primary care provider to 
receive subsequent prescriptions for a preexposure prophylaxis drug and that a 
pharmacist may not dispense more than a 60-day supply of a preexposure 
prophylaxis drug to a single patient once every 2 years without a prescription;
(5)  The pharmacist documents, to the extent possible, the services provided by the 
pharmacist in the patient's record in the patient profile record system maintained 
by the pharmacy.  The pharmacist shall maintain records of preexposure 
prophylaxis drugs dispensed to each patient;
(6)  The pharmacist does not dispense more than a 60-day supply of preexposure 
prophylaxis to a single patient once every 2 years, unless otherwise directed by a 
practitioner; and
(7)  The pharmacist notifies the patient's primary care provider that the pharmacist 
completed the requirements specified in this paragraph.  If the patient does not have 
a primary care provider, or refuses consent to notify the patient's primary care 
provider, the pharmacist shall provide the patient a list of physicians, clinics or 
other health care providers to contact regarding follow-up care.
C.  A pharmacist shall dispense a complete course of a post-exposure prophylaxis drug 
as long as all of the following conditions are met:
(1)  The pharmacist screens the patient and determines that the exposure occurred 
within the previous 72 hours and the patient otherwise meets the clinical criteria 
for a post-exposure prophylaxis drug under CDC guidelines;
(2)  The pharmacist provides HIV testing to the patient or determines that the 
patient is willing to undergo HIV testing consistent with CDC guidelines.  If the 
patient refuses to undergo HIV testing but is otherwise eligible for a post-exposure 
prophylaxis drug under this subsection, the pharmacist may dispense a post-
exposure prophylaxis drug;
(3)  The pharmacist provides counseling to the patient, consistent with CDC 
guidelines, on the use of a post-exposure prophylaxis drug.  The pharmacist shall 
also inform the patient of the availability of a preexposure prophylaxis drug for 
persons who are at substantial risk of acquiring HIV; and
(4)  The pharmacist notifies the patient's primary care provider of the dispensing 
of the post-exposure prophylaxis drug.  If the patient does not have a primary care 
provider, or refuses consent to notify the patient's primary care provider, the 
pharmacist shall provide the patient a list of physicians, clinics or other health care 
providers to contact regarding follow-up care.
3.  Rules; protocols.  The board by rule shall establish standards for authorizing 
pharmacists to dispense HIV prevention drugs in accordance with subsection 2, including 
adequate training requirements and protocols for dispensing HIV prevention drugs.  Rules 
adopted under this subsection are routine technical rules as defined in Title 5, chapter 375, 
subchapter 2-A.
Sec. 7.  Exemption from review.  Notwithstanding the Maine Revised Statutes, 
Title 24-A, section 2752, this Act is enacted without review and evaluation by the 
Department of Professional and Financial Regulation, Bureau of Insurance.
Sec. 8.  Application.  The requirements of this Act apply to all individual and group 
health plans, as defined in the Maine Revised Statutes, Title 24-A, section 4301-A, 
subsection 7, executed, delivered, issued for delivery, continued or renewed in this State 
on or after January 1, 2022.  For purposes of this Act, all contracts are deemed to be 
renewed no later than the next yearly anniversary of the contract date.
SUMMARY
This bill makes the following changes to improve access to HIV prevention drugs.
The bill requires that any drug formulary used in the MaineCare program must ensure 
that HIV prevention drugs are available to members covered by MaineCare.
The bill requires health insurance carriers to provide coverage for an enrollee for HIV 
prevention drugs that have been determined to be medically necessary by a health care 
provider.  A carrier is not required to cover a preexposure prophylaxis drug, also known as 
PrEP, in excess of a 60-day supply to a single enrollee every 2 years.  If the federal Food 
and Drug Administration has approved one or more therapeutic equivalents of an HIV 
prevention drug, a carrier is not required to cover all of the therapeutically equivalent drugs 
as long as the carrier covers at least one therapeutically equivalent drug at the tier with the 
lowest cost-sharing requirement on the carrier's prescription drug formulary.  The bill also 
prohibits a carrier from imposing prior authorization or step therapy requirements on any 
HIV prevention drug, except that, if the federal Food and Drug Administration has 
approved one or more therapeutic equivalents of an HIV prevention drug, a carrier is 
required to cover at least one therapeutically equivalent drug without prior authorization or 
step therapy requirements.  The bill's requirements with regard to health insurance carriers 
apply to health plans issued or renewed on or after January 1, 2022.
The bill also authorizes a pharmacist to dispense HIV prevention drugs under certain 
conditions without a prescription subject to rules for dispensing and protocols adopted by 
the Maine Board of Pharmacy.