​The purpose of this memo is to inform Pre-Exposure Prophylaxis Assistance Program (PrEP-AP) Enrollment Workers (EW) about policy updates regarding PrEP coverage for Medicare clients. The Centers for Medicare & Medicaid Services (CMS) have issued a final National Coverage Determination (NCD) for PrEP on September 30, 2024, directing Medicare to cover all forms of PrEP (oral and injectable) through Medicare Part A or Part B. Medicare Part A or Part B beneficiaries are now able to access PrEP with zero cost-sharing. This also applies to Medicare Part C (Advantage Plan) beneficiaries.

Medicare Beneficiary PrEP Access

This change may effect how Medicare beneficiaries can access PrEP. Previously, Medicare covered PrEP through Medicare Part D, Medicare’s prescription drug program. Since the NCD was issued, coverage for PrEP has been removed from Medicare Part D and added to Medicare Part A and Part B. Clients may experience problems accessing PrEP prescriptions if their current pharmacy is not set-up to bill Medicare Part B. Medicare clients who have Part B coverage will need to access their prescription at a pharmacy that is able to bill Medicare Part B. Clients can call
1-800-MEDICARE to find a pharmacy. Clients using Medicare Part A to access PrEP will work with their inpatient facility to access PrEP.

The released NCD also includes coverage of the following additional preventative services required for PrEP with zero cost-sharing:

• Up to eight individual counseling visits every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. Counseling must be furnished by a physician or other health care practitioner. Individuals must be competent and alert at the time that counseling is provided.
• HIV screening up to eight times annually
• A single screening for hepatitis B virus (HBV)

PrEP-AP Medicare Clients

Medicare Part A Only

Medicare beneficiaries with Part A only, which covers inpatient care, should enroll in PrEP-AP as uninsured. Medicare Part A now covers PrEP while receiving in-patient care. Medicare Part A clients with no Part B and with Part D will need to co-enroll in a Pharmaceutical Assistance Program for PrEP medication coverage. PrEP-AP will provide coverage for PrEP-related services if accessed at a PrEP-AP Clinical Provider. Prescriptions for medications other than PrEP that are on the PrEP-AP Formulary (PDF) can be filled at a pharmacy in the PrEP-AP Pharmacy Network.

Medicare Part B/C (Advantage)

Medicare Part B beneficiaries (including those enrolled in Part C Advantage plans) should enroll as PrEP-AP with Medicare. These clients no longer need to co-enroll in a Pharmaceutical Assistance Program (PAP) as Medicare Part B now covers PrEP. PrEP-AP will provide wrap-around coverage for PrEP-related services not fully covered by Medicare Part B. These clients must find a participating pharmacy that can bill Medicare Part B (call 1-800-MEDICARE for assistance with finding a pharmacy). Prescriptions for medications other than PrEP that are on the PrEP-AP Formulary (PDF) can be filled at a pharmacy in the PrEP-AP Pharmacy Network.

The following matrix describes PrEP coverage and PrEP-AP client type for Medicare beneficiaries enrolled in different Medicare plans after the NCD is issued:

*Note: For government insured individuals who have coverage for their prescribed Gilead medication but are not able to afford the out-of-pocket cost, there may be situations where those individuals qualify for free medication through PAP through a hardship policy. For those individuals enrolled in PAP through hardship now, they will stay on PAP through end of year.

Medicare Part B Pharmacy Enrollment

Pharmacies that dispense PrEP should ensure that they are enrolled in Medicare as either: 1) a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier (CMS-855S), or 2) a Part B Pharmacy supplier (CMS-855B). A pharmacy that is enrolled in Part B solely as a “mass immunization” pharmacy will need to enroll as a Part B Pharmacy supplier. For more information, view CMS’s Fact Sheet (PDF) and Technical FAQ for Pharmacies (PDF). To enroll as a Part B Pharmacy supplier, pharmacies can visit the Medicare Provider Enrollment website.

CMS’s Fact Sheet (PDF) also includes anticipated drug and billing and payment codes that pharmacies will use to bill Medicare Part B for PrEP. It will be important for pharmacies to ensure that they are using the correct billing codes in order to avoid patients being charged copayments.

If you have any questions regarding the information provided in this memo, please contact your PrEP-AP Advisor.

You can read this NDC One Pager for more information (PDF). The full NDC can be found here: NCA - Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection (CAG-00464N) - Decision Memo (cms.gov)

Thank you,

 ​​

Joseph Lagrama

ADAP Branch Chief

California Department of Public Health

Resources:

Fact Sheet: Medicare Part B Coverage of Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention (cms.gov) (PDF)

 PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies (cms.gov) (PDF)