CMS Alerts Pharmacies and Healthcare Providers About Potential Medicare Coverage Change for PrEP

The Centers for Medicare & Medicaid Services (CMS) recently published a fact sheet (PDF, 157KB) on the potential for Medicare Part B coverage of HIV pre-exposure prophylaxis (PrEP) for Medicare beneficiaries. CMS did not announce any coverage changes. However, the fact sheet encourages pharmacies, healthcare providers, and other stakeholders to prepare for a potential National Coverage Determination (NCD) that would result in a change to how people with Medicare would be able to get PrEP, making it available without cost-sharing (i.e., deductibles or co-pays) if the proposed decision would be finalized.

PrEP medications are currently covered under Medicare Part D and typically have cost-sharing and deductibles. In July 2023, CMS issued a proposed NCD to cover PrEP. If finalized, the NCD would expand Medicare Part B coverage to include PrEP drugs and related services without cost-sharing (no deductibles or co-pays for beneficiaries). This would be consistent with most commercial health insurance and Medicaid plans which, under the Affordable Care Act, must cover PrEP drugs (oral or injectable), laboratory tests, and related clinical visits without cost sharing when prescribed by a healthcare provider. The proposed NCD would cover both oral and injectable versions of PrEP, and up to seven individual counseling visits every 12 months, including HIV risk assessments, risk reduction, and medication adherence. Additionally, HIV screenings up to seven times a year and a single screening for hepatitis B virus would be covered.

Some commenters on the proposed NCD expressed concern that a change to Part B coverage might be disruptive for patients who are receiving coverage for PrEP under Part D. This latest step taken by CMS is aimed at allowing providers and others to prepare for the move of PrEP coverage from Medicare Part D to Part B, with the goal of minimizing any possible disruptions in access to the HIV prevention medication for beneficiaries.

In the fact sheet, CMS urges providers and pharmacies to prepare for this possible change since it would involve changes to claims processing as well as to billing and payment codes for drugs and other covered services related to HIV PrEP. For example, to bill for PrEP medications under Medicare Part B, a pharmacy must be enrolled as a Part B pharmacy supplier. Information about enrolling as a Medicare Part B pharmacy can be found on CMS.gov. The fact sheet also encourages providers and pharmacies to be ready to transition coverage to Part B immediately on the date a final NCD is posted to ensure beneficiaries have uninterrupted access to PrEP drugs and HIV treatments.

If you are a Medicare beneficiary using PrEP, you may want to share the CMS fact sheet (PDF, 157KB) with your provider and pharmacist. If you are a healthcare provider or pharmacist serving clients using PrEP who are also Medicare beneficiaries, review the CMS fact sheet and consider what systems may need to be modified to accommodate this change and how you can reach out to affected patients with information about the change. 

This potential NCD for PrEP coverage under Medicare Part B would be an important step in expanding access to HIV prevention measures for older adults. By staying informed and preparing for the potential changes, healthcare providers and pharmacies can help ensure continued access to PrEP for those who need it.