APPROVED CHAPTER
JUNE 17, 2021 265
BY GOVERNOR PUBLIC LAW
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND TWENTY-ONE
_____
S.P. 378 - L.D. 1115
An Act To Improve Access to HIV Prevention Medications
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.
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 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 HIV
prevention drugs that use the same method of administration, a carrier is not required
to cover all approved drugs as long as the carrier covers at least one approved drug for
each method of administration with no out-of-pocket cost.
B. A carrier is not required to cover any preexposure prophylaxis drug or post-
exposure prophylaxis drug dispensed or administered 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 or administering 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 methods of administering HIV prevention drugs, a carrier is not required to cover
all of the approved drugs without prior authorization or step therapy requirements as long
as the carrier covers at least one approved drug for each method of administration without
prior authorization or step therapy requirements. If prior authorization or step therapy
requirements are met for a particular enrollee with regard to a particular HIV prevention
drug, the carrier is required to cover that drug with no out-of-pocket cost to the enrollee.
4. Coverage for laboratory testing related to HIV prevention drugs. A carrier
offering a health plan in this State shall provide coverage with no out-of-pocket cost for
laboratory testing recommended by a provider related to the ongoing monitoring of an
enrollee who is taking an HIV prevention drug covered by this section.
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
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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 prescribing,
dispensing and administering of an HIV prevention drug, as defined in section 13786-E,
subsection 1, paragraph B, pursuant to a standing order or collaborative practice agreement
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. Prescribing, dispensing and administering 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 prescribe, dispense and administer HIV prevention drugs pursuant to a standing order
or collaborative practice agreement or to protocols developed by the board for when there
is no prescription drug order, standing order or collaborative practice agreement 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 prescribing, dispensing and administering 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 or administer 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:
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 (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 or administer 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 or administered to each patient;
(6) The pharmacist does not dispense or administer more than a 60-day supply of
a preexposure prophylaxis drug 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 or administer 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 or administer
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
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 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
or administering 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 prescribe, dispense and administer HIV prevention drugs in accordance with
subsection 2, including adequate training requirements and protocols for when there is no
prescription drug order, standing order or collaborative practice agreement. 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.
Sec. 9. Appropriations and allocations. The following appropriations and
allocations are made.
PROFESSIONAL AND FINANCIAL REGULATION, DEPARTMENT OF
Administrative Services - Professional and Financial Regulation 0094
Initiative: Allocates funds for technology-related costs associated with establishing one
half-time Regulatory Health Compliance position to manage the anticipated increase in
workload associated with the regulation of pharmacists' authority to dispense HIV
prevention drugs.
OTHER SPECIAL REVENUE FUNDS 2021-22 2022-23
All Other $2,729 $3,347
__________ __________
OTHER SPECIAL REVENUE FUNDS TOTAL $2,729 $3,347
Licensing and Enforcement 0352
Initiative: Allocates funds for one half-time Regulatory Health Compliance position to
manage the anticipated increase in workload associated with the regulation of pharmacists'
authority to dispense HIV prevention drugs.
OTHER SPECIAL REVENUE FUNDS 2021-22 2022-23
POSITIONS - LEGISLATIVE COUNT 0.500 0.500
Personal Services $35,328 $49,424
All Other $5,782 $2,904
__________ __________
OTHER SPECIAL REVENUE FUNDS TOTAL $41,110 $52,328
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PROFESSIONAL AND FINANCIAL
REGULATION, DEPARTMENT OF
DEPARTMENT TOTALS 2021-22 2022-23
OTHER SPECIAL REVENUE FUNDS $43,839 $55,675
__________ __________
DEPARTMENT TOTAL - ALL FUNDS $43,839 $55,675
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Statutes affected:
Bill Text LD 1115, SP 378: 22.3174, 32.13702
Bill Text ACTPUB , Chapter 265: 22.3174, 32.13702