Continuing Progress On National PrEP Coverage

Should Medicare cover HIV pre-exposure prophylaxis and PrEP medication? The federal government is looking for the public’s input. Following the development of a new injectable drug which could mitigate HIV’s spread to high-risk individuals, CMS (Centers for Medicare and Medicaid Services) is considering covering HIV prevention pre-exposure prophylaxis drugs (PrEP) as part of its medical coverage.

Medicare coverage for PrEP is currently varied by state or country. For a service to meet the requirements for national coverage, the U.S. Prevention Task Force (USPSTF) must evaluate the service and give it a qualifying rating (A or B). Last month, the USPSTF rated long-acting injectable PrEP an A. The corresponding oral PrEP received the task force’s approval in 2019.

Under ACA, the Affordable Care Act, approved insurance plans and private insurers are required to cover any preventive services with an A or B rating.

Apretude is a long-acting, injectable medication which can protect those who have been exposed to HIV and are at risk. It is developed by ViiV Healthcare, a subsidiary of GSK. Adults and adolescents who weigh at least 77 pounds have the FDA’s approval to receive Apretude as bi-monthly injections.

“Given that the USPSTF’s current Grade A recommendation, by its terms, broadly applies to all PrEP therapies (even if it was based on clinical evidence supporting daily oral tenofovir disoproxil fumarate-emtricitabine), it is appropriate to apply the USPSTF’s current Grade A recommendation for PrEP to APRETUDE,” writes Andrew Zolopa, head of ViiV North America Medical Affairs, in a letter to CMS. “Finally, provider-administered PrEP is appropriate for individuals enrolled under Medicare Part B. Data show that the Medicare program covers approximately 10% of individuals who could benefit from PrEP, including primarily younger individuals who are eligible for Medicare based on disability.”

Zolopa also says, “We urge CMS to initiate a National Coverage Analysis for provider-administered PrEP as soon as possible.”

In September, federal judges in Texas ruled partially in the flavor of plaintiffs who argued that requiring insurance companies to cover PrEP violates religious grounds. But the government has however indicated an intent to appeal this ruling.

Anyone can keep up with the status of the open discussion surrounding this issue on the CMS.gov website.