With deep and widening racial, ethnic, and gender disparities in uptake, access to PrEP through Medicare is of paramount importance to making sure that Medicare beneficiaries are able to benefit from the widening array of PrEP options without cost-sharing. Medicare beneficiaries (including those dually eligible for Medicaid) comprise 10 percent of the population using PrEP, including both individuals over 65 as well as disabled individuals under 65. We thank CMS for making clear that all FDA-approved forms of PrEP would be available without cost-sharing. This means that Medicare beneficiaries will have unfettered access to future novel forms of PrEP immediately after FDA approval.
Given the importance of medications to the health and well-being of people living with and at risk of HIV, people with hepatitis B & C, and their growing reliance on Medicare for prescription drugs, we are keenly interested in the implementation of the Medicare Drug Price Negotiation Program that CMS is setting up as required by the Inflation Reduction Act (IRA).
64 organizations request expedited Medicare National Coverage Determination for long-acting injectable PrEP
We are pleased that the Centers for Medicare and Medicaid Services (CMS) has accepted a request for a National Coverage Determination (NCD) for cabotegravir, a new long-acting injectable form of pre-exposure prophylaxis (PrEP) to prevent HIV. A National Coverage Determination is the only pathway to coverage under Medicare Part B for a provider-administered drug. We have, however, been disappointed to learn that CMS has given no timeline for action on this National Coverage Determination, which will make this new long-acting PrEP medication out of reach for potential PrEP users. Combined with a USPSTF recommendation, an NCD will also make the drug available to Medicare Part B beneficiaries without cost-sharing, thus eliminating one of the biggest barriers to PrEP uptake.