PROVIDING PrEP/PEP IN THE PHARMACY SETTING MAINE EDITION STATE PrEP/PEP PRIMER
WHAT
On June 17, 2021, the governor of Maine signed L.D. 1115, An Act to Improve Access to HIV Prevention Medications 1 This bill aims to expand access to preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) for HIV prevention.1 PrEP is the use of specific combinations of antiretroviral agents to reduce the risk of HIV infection in appropriately identified and evaluated HIV-negative individuals, and PEP uses specific combinations of antiretroviral agents to prevent infection in appropriately identified
and evaluated HIV-negative people who have had a single exposure that presents a substantial risk for HIV acquisition. 2,3
According to L.D. 1115, pharmacists may prescribe, dispense, and administer PrEP and PEP drugs, including ordering HIV tests as needed. They can also make referrals for patients to seek additional services for care and treatment. The act states1:
“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.”
The bill can be found here: https://www.mainelegislature.org/legis/ statutes/32/title32sec13786-E.pdf 1
WHY
Approximately 1.2 million people in the United States are living with HIV today, with 13% of individuals unaware of their positive HIV status.4 Despite efforts to raise awareness about HIV testing and prevention, in 2023, more than 39,000 new HIV diagnoses occurred in the United States, reflecting only a modest decline from previous years.5 Compared with many states, Maine had a relatively low rate (3/100,000 population) of individuals newly diagnosed with HIV. Cumberland was the only county with a reported rate of newly diagnosed individuals in the state, 6/100,000 population, according to 2023 data. However, data are not shown for many counties to protect privacy due to a small population and low numbers of cases.6
PrEP is intended for HIV prevention in HIV-negative individuals; it should be discussed with all sexually active adolescents and adults.2
In contrast, although PEP is also for HIV prevention in HIV-negative individuals, prescribing PEP should be considered an emergency intervention; PEP is not a substitute for appropriate, continuous use of PrEP in conjunction with behavioral risk reduction. Offer PrEP to individuals who continue to be at risk of acquiring HIV after receiving PEP or who have received multiple PEP prescriptions within a short time frame.2,3
HOW
Maine-licensed pharmacists may dispense PrEP and PEP drugs for HIV prevention; however, pharmacy technicians are not authorized to dispense PrEP and PEP in Maine.1
Training
Before independently prescribing, dispensing, or administering HIV prevention drugs, pharmacists must complete a training program by the Accreditation Council for Pharmacy Education (ACPE) or another board-approved provider accredited by an approved accreditation agency, or as part of an equivalent curriculum-based training program completed from a recognized school of pharmacy. The training program should cover:
Although PrEP is highly effective and can reduce the risk of acquiring HIV by 99% when taken as prescribed, it remains underutilized in the United States.2,7 Because 85% to 90% of PrEP prescriptions are filled at community pharmacies, pharmacists have the capability to help end the HIV epidemic by 2030.8,9 In Maine, pharmacists have the legal authority to prescribe and dispense PrEP, and educating Maine pharmacists for this role is vitally important.10
Pharmacists should be aware of the CDC guidelines and recommendations for PrEP implementation, titled Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update: A Clinical Practice Guideline. 2 As scientific research has advanced understanding of best practices for HIV testing and newer PrEP agents have emerged, the International Antiviral Society–USA has issued updated recommendations on PrEP provision.11-13 In addition, the monograph, Pharmacists at the Frontline of HIV Prevention: A Guide to Expanding Access to PEP and PrEP, presents updated information on clinical and logistical tasks necessary to implement PrEP and PEP in day-today practice. Finally, this state primer on Maine PrEP/PEP practice contains state-specific policies and procedures necessary for Maine pharmacists that would not be included in the US-based, comprehensive monograph.
• Screening for HIV and sexually transmitted infections (STIs) and required laboratory testing to determine PrEP/PEP eligibility
• Centers for Disease Control and Prevention (CDC) clinical practice guidelines for PrEP/PEP
• Pharmacology, safety, efficacy, drug–drug interactions, and monitoring requirements for PrEP/PEP medications
• Relevant trauma-informed care
• Best practices for counseling patients using PrEP1
HOW PrEP1
Pharmacists shall dispense or administer a PrEP drug in a supply of at least 30 days and up to 60 days of an oral medication, or in 1 administration of an injectable medication of any duration, if all of the following conditions are met:
• The patient has a negative HIV test result obtained within the previous 7 days.
• The patient does not report any signs or symptoms of acute HIV infection.
• The patient does not report taking any contraindicated medications.
• The pharmacist counsels the patient, in accordance with CDC guidelines, on the ongoing use of a PrEP drug, and notifies the patient that they must be seen by a primary care provider (PCP) to receive subsequent PrEP prescriptions beyond a 60-day supply of an oral PrEP drug or 1 administration of an injectable PrEP drug of any duration to a single patient once every 2 years without a prescription.
• 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 and maintains those records.
• The pharmacist does not dispense or administer beyond a 60-day supply of a PrEP drug or 1 administration of an injectable PrEP drug of any duration to a single patient once every 2 years unless otherwise directed by a practitioner.
• The pharmacist notifies the patient’s PCP that the pharmacist completed the requirements specified above; if the patient does not have a PCP or refuses consent to notify the patient’s PCP, the pharmacist provides a list of providers for follow-up care.
PEP1
A pharmacist shall dispense or administer a complete course of a PEP drug if all of the following conditions are met:
• The pharmacist screens the patient and determines that the potential exposure occurred within the previous 72 hours and that
the patient meets the clinical criteria for a PEP drug under the CDC guidelines.
• The pharmacist provides HIV testing or determines that the patient is willing to undergo HIV testing consistent with CDC guidelines; if the patient is unwilling to undergo testing but is otherwise eligible for PEP, the pharmacist may dispense or administer PEP.
• The pharmacist counsels the patient, consistent with CDC guidelines, on use of the PEP regimen, and informs the patient about the availability of PrEP.
• The pharmacist notifies the patient’s PCP that the pharmacist completed the requirements specified above; if the patient does not have a PCP or refuses consent to notify their PCP, the pharmacist provides a list of providers for follow-up care.
Communication With Patient’s PCP1
A pharmacist shall communicate the services provided under the provisions to the patient and the patient’s PCP, if known. If the patient does not give the name of a PCP, the pharmacist shall give the patient a list of providers or clinics in the area. However, the patient does not need to have a PCP before PrEP and PEP can be prescribed, nor does the pharmacist need to coordinate care with a patient’s PCP.1
Reimbursement and Payment14
Maine’s S.P. 378/L.D. 1115 was enacted with requirements for coverage of HIV prevention drugs. A carrier offering a health plan in Maine must provide coverage for an HIV prevention drug that has been prescribed by a provider. Coverage is subject to the following:
• If the US Food and Drug Administration (FDA) has approved more than 1 HIV prevention drug using the same method of administration, a carrier is not required to cover all approved drugs as long as the carrier covers at least 1 approved drug for each method of administration with no out-of-pocket cost
• Carriers are not required to cover any PrEP or PEP drug dispensed by an out-of-network pharmacy unless the health plan includes an out-of-network pharmacy benefit
• Carriers may not prohibit, or allow a pharmacy benefits manager to prohibit, a pharmacy provider from dispensing or administering any HIV prevention drugs
Prior Authorization and Step–Therapy Requirements14
Carriers may not subject any HIV prevention drug to prior authorization or step-therapy requirements. However, if the FDA has approved 1 or more methods of administering HIV prevention drugs, carriers are not required to cover all of the approved drugs without prior authorization or step-therapy requirements, and if those requirements are met, carriers must cover the drug with no out-of-pocket cost to the patient.
Coverage for Laboratory Testing14
Carriers offering a health plan in Maine must provide coverage with no out-of-pocket cost for laboratory testing recommended by the provider for ongoing monitoring of a patient using an HIV prevention drug.
REFERENCES
1. Maine Revised Statutes. Title 32, §13786-E: Prescribing, dispensing and administering HIV prevention drugs. Updated October 20, 2025. Accessed December 19, 2025. https://www.mainelegislature.org/legis/statutes/32/ title32sec13786-E.pdf
2. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 update: a clinical practice guideline. Updated December 1, 2021. Accessed December 19, 2025. https://stacks.cdc.gov/view/ cdc/112360
3. Tanner MR, O'Shea JG, Byrd KM, et al. Antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV - CDC recommendations, United States, 2025. MMWR Recomm Rep. 2025;74(1):1-56.
4. Centers for Disease Control and Prevention Newsroom. HIV declines among young people and drives overall decrease in new HIV infections. May 23, 2023. Accessed July 4, 2025. https://www.cdc.gov/media/releases/2023/p0523-hiv-declinesamong-young-people.html
5. Centers for Disease Control and Prevention. HIV Surveillance Report: Diagnoses, deaths, and prevalence of HIV in the United States and 6 territories and freely associated states, 2022. May 21, 2024. Accessed December 19, 2025. https:// stacks.cdc.gov/view/cdc/156509
6. AIDSVu.org. Rates of persons newly diagnosed with HIV per 100k, 2023. Accessed December 19, 2025. https://map.aidsvu.org/nd/county/rate/none/none/ cumberland-county-me-maine?
7. Mayer KH, Agwu A, Malebranche D. Barriers to the wider use of pre-exposure prophylaxis in the United States: a narrative review. Adv Ther. 2020;37(5):1778-1811.
Rules for Reimbursement
As of this publication, the rules for reimbursement under the MaineCare program to pharmacists for prescribing, dispensing, and administering HIV prevention drugs have not been provided. The Public Law 2025, chapter 483, of the State of Maine 132nd legislative session requires that the Department of Health and Human Services must provide reimbursement under the MaineCare program no later than January 1, 2027, for PrEP/PEP services including performing testing, providing patient counseling, as well as prescribing and administering.15
8. HIV.gov. What is ending the HIV epidemic in the US? Updated September 18, 2025. Accessed December 19, 2025. https://www.hiv.gov/federal-response/ ending-the-hiv-epidemic/overview
9. Valdiserri RO. Obstacles to HIV elimination: a situational analysis of PrEP uptake and equity. AIDS Educ Prev. 2025;37(5):325-332.
10. Tung EL, Thomas A, Eichner A, Shalit P. Implementation of a community pharmacybased pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care. Sex Health. 2018;15(6):556-561.
11. Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the International Antiviral Society-USA panel. JAMA. 2023;329(1):63-84.
12. Gandhi RT, Landovitz RJ, Sax PE, et al. Antiretroviral drugs for treatment and prevention of HIV in adults: 2024 recommendations of the International Antiviral Society-USA panel. JAMA. 2025;333(7):609-628.
13. Landovitz RJ, Molina JM, Buchbinder SP. Preexposure prophylaxis for HIV: updated recommendations from the 2024 International Antiviral Society-USA panel. JAMA. 2025;334(7):638-639.
14. State of Maine. An act to clarify and increase access to HIV prevention medications. July 1, 2025. Accessed January 16, 2026. https://legislature.maine.gov/legis/bills/ getPDF.asp?paper=HP1122&item=3&snum=132
15. State of Maine. 132nd legislature: first regular and special sessions. Joint Standing Committee on health coverage, insurance and financial services. August 2025. Accessed December 19, 2025. https://legislature.maine.gov/doc/11935