An Act To Improve Access to HN Prevention Medications
Maine Legislature, Session 130, LD 1115
Committee Amendment CA_A_S239 (Senate)
Amends: 32 MRSA §13702-A

COMMITTEE AMENDMENT" fr" to S.P. 378, L.D. 1115, "An Act To Improve 
Access to HN Prevention Medications" 
Amend the bill in section 4 in §4317-D by striking out all of subsection 2 (page 1, lines 
to 39 and page 2, lines 1 to 7 in L.D.) and inserting the following: 
'2. Coverage required. A carrier offering a health plan in this State shall provide 
coverage for an HN 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 can-ier 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 pe1mit a pharmacy benefits manager to prohibit, a 
pharmacy provider from dispensing or administering any HN prevention drugs.' 
Amend the bill in section 4 in §4317-D by striking out all of subsection 3 (page 2, lines 
to 15 in L.D.) and inse1iing the following: 
'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 
HN 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 HN 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 HN prevention 
drug, the carrier is required to cover that drug with no out-of-pocket cost to the enrollee.' 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT" fl-" to S.P. 378, L.D.1115 (S-25'1) 
Amend the bill in section 4 in §4317-D by inserting after subsection 3 the following: 
'4. Coverage for laboratory testing related to HIV prevention drugs. A canier 
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.' 
Amend the bill by striking out all of section 5 and inse1ting the following: 
'Sec. 5. 32 MRSA §13702-A, sub-§28, as amended by PL 2017, c. I 85, § 1, is 
fmther 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 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.' 
Amend the bill in section 6 in §13786-E in the first line (page 2, line 36 in L.D.) by 
striking out the following: "Dispensing" and inserting the following: 'Prescribing, 
dispensing and administering' 
Amend the bill in section 6 in §13786-E by striking out all of subsection 2 (page 3, 
lines 10 to 43 and page 4, lines 1 to 27 in L.D.) and inserting the following: 
'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 HN 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 HN 
prevention drug. 
COMMITTEE AMENDMENT 
coMMJTTEE AMENDMENT "/4 " '° s.P. '"· L.D. , JJ5 Cs- z3 l 
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: 
(1) The patient tests negative for HlV 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 prima1y care providers and clinics within a reasonable tr~vel distance of 
the patient's residence; 
(2) The patient does not report any signs or symptoms of acute HlV infection on 
a self-reporting checklist of acute HlV 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 primmy 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 m·e 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 HlV 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; 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT" ft-" to S.P, 378, L.D, 1115 ( ::'.>· L 31\ 
(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 
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.' 
Amend the bill in section 6 in § 13786-E by striking out all of subsection 3 (page 4, 
lines 28 to 32 in L.D.) and inserting the following: 
'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.' 
Amend the bill by inserting after section 8 the following: 
'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 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
Licensing and Enforcement 0352 
2021-22 
$2,729 
$2,729 
2022-23 
$3,347 
$3,347 
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 
POSITIONS - LEGISLATIVE COUNT 
Personal Services 
All Other 
OTHER SPECIAL REVENUE FUNDS TOT AL 
2021-22 
0.500 
$35,328 
$5,782 
$41,110 
COMMITTEE AMENDMENT 
2022-23 
0.500 
$49,424 
$2,904 
$52,328 
COMMITTEE AMENDMENT" /4" to S.P. 378, L.D. 1115 ( $-23~ 
PROFESSIONAL AND FINANCIAL 
REGULATION, DEPARTMENT OF 
DEPARTMENT TOTALS 
2021-22 
OTHER SPECIAL REVENUE FUNDS 
$43,839 
DEPARTMENT TOTAL - ALL FUNDS 
$43,839 
2022-23 
$55,675 
$55,675 
Amend the bill by relettering or renumbering any nonconsecutive Part letter or section 
number to read consecutively. 
SUMMARY 
This amendment is the majority report of the committee. The amendment clarifies that 
health insurance carriers are not required to cover all of the drugs approved by the federal 
Food and Drug Administration for HIV prevention as long as the carrier covers at least one 
approved drug for each method of administration with no out-of-pocket cost to the enrollee. 
The amendment also clarifies that a carrier is required to cover at least one approved drug 
for each method of administration without prior authorization or step therapy requirements. 
The amendment also makes changes to the bill's provisions authorizing a phannacist 
to dispense HIV prevention drugs under certain conditions pursuant to a standing order or 
to protocols developed by the Maine Board of Pharmacy by authorizing a pharmacist to 
prescribe, dispense and administer HIV prevention drugs pursuant to a standing order or 
collaborative practice agreement or when there is no prescription drug order from a health 
care provider, subject to rules and protocols adopted by the board. The amendment also 
adds an appropriations and allocations section. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/04/21 frac. 
LD 1115 
LR 1215(02) 
An Act To Improve Access to HIV Prevention Medications 
Fiscal Note for Bill as Amended by Committee Amendment ";t(S-1.....~, 
Committee: Health Coverage, Insurance and Financial Services 
Appropriations/ Allocations 
Other Special Revenue Funds 
Transfers 
Other Special Revenue Funds 
Fiscal Detail and Notes 
Fiscal Note Required: Yes 
Fiscal Note 
FY 2021-22 
FY 2022-23 
$43,839 
$55,675 
$0 
$0 
Projections 
FY 2023-24 
$58,640 
$0 
Projections 
FY2024-25 
$61,783 
$0 
The bill includes Other Special Revenue Funds allocations to the Department of Professional and Financial 
Regulation of $43,839 in fiscal year 2021-22 and $55,675 in fiscal year 2022-23 to implement the requirements of 
· this legislation within the Office of Professional and Occupational Licensing, Maine Board of Pharmacy. 
Of this amount, the bill includes Other Special Revenue Funds allocations to the Licensing and Enforcement program 
of $41,110 in fiscal year 2021-22 and $52,328 in fiscal year 2022-23 to establish one half-time Regulatory Health 
Compliance position and related All Other costs to manage the anticipated increase in workload associated with the 
regulation of phannacists authority to dispense HN prevention drugs. Additionally, the bill includes Other Special 
Revenue Funds allocations to the Administrative Services Division of $2,729 in fiscal year 2021-22 and $3,347 in 
fiscal year 2022-23 for technology-related costs associated with establishing the Regulatory Health Compliance 
position. The Office of Professional and Occupational Licensing will transfer funds from its Licensing and 
Enforcement program (which includes funds for the Maine Board of Pharmacy) to the Administrative Services 
Division to fund the allocations. 
The Maine Board of Phannacy within the Office of Professional and Occupational Licensing has sufficient resources 
available to support the cost of this legislation without raising fees through the 2022-2023 biennium. However, fees 
may need to be increased in future biennia if the current fee structure does not generate sufficient revenue to cover 
the cost of this legislation.