In public comments to the President’s Advisory Council on HIV/AIDS, the HIV+Hepatitis Policy Institute suggests ways that the federal government can improve PrEP uptake: 1) having CMS ensure that private insurers comply with ACA $0 cost-sharing requirements, 2) having the CDC’s Division of HIV Prevention dedicate more funding for PrEP, and 3) having HRSA ensure that the community health centers PrEP program works effectively.
We are concerned that without further Division of Insurance action, PrEP users in Massachusetts will continue to be charged cost-sharing in violation of the ACA mandate, and that those who cannot afford these copays will be in danger of PrEP discontinuation and seroconversion. We believe that the cases we have described are but the tip of the iceberg: only people with time, information, resources, and persistence come forward to pursue lengthy complaint processes with insurance regulators. We should also note that insurance regulators have occasionally wrongly denied complaints, as in one of the cases highlighted by the Boston Globe.
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).
On behalf of the HIV+Hepatitis Policy Institute, an organization dedicated to promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions, we thank you for this opportunity to comment on a National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) on the use of provider-administered pre-exposure prophylaxis (PrEP). The first provider-administered medication for HIV pre-exposure prophylaxis (Apretude or cabotegravir as PrEP) was approved by the Food and Drug Administration in January 2022. In August 2022, we wrote to you on behalf of 64 organizations to request that CMS quickly and efficiently evaluate provider-administered PrEP for a National Coverage Determination, which is the only pathway to coverage under Medicare Part B. We commend CMS on moving forward with the NCD process and urge CMS to approve the NCD for provider-administered PrEP.