Medicare proposes coverage of all forms of PrEP

National Coverage Determination Would Lead to No Beneficiary Cost-Sharing

Washington DC…  In response to CMS’ draft National Coverage Determination (NCD) issued today that would require all Medicare plans to cover, without beneficiary cost-sharing, all forms of PrEP to prevent HIV, including long-acting PrEP, Carl Schmid, executive director of the HIV+Hepatitis Policy Institute issued the following statement:

“Today’s announcement marks a huge step in ensuring Medicare beneficiaries who want to protect themselves against HIV by using either daily oral or long-acting PrEP can do so without cost-sharing. As people are living longer and remain sexually active, it is important that anyone who has a reason to be on PrEP can access it.

“Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D and face out-of-pocket costs, and long-acting injectable PrEP has not generally been covered.

“In addition to covering the drugs without cost-sharing, we are pleased that CMS heeded our suggestion that the coverage determination encompass PrEP ancillary services, including periodic medical and counseling visits along with HIV and hepatitis B testing. The proposed decision memo also ensures that future long-acting forms of PrEP will be covered.

“While this coverage determination, if finalized, would close the gap in the future between FDA approval and coverage of new PrEP drugs by Medicare Part B, it still takes too long for private insurers and others to cover new PrEP drugs. Recently, Sen. Tina Smith and Rep. Adam Schiff introduced legislation (S. 2188/H.R. 4932) which would require all payers to cover all PrEP drugs without cost-sharing immediately after FDA approval.

“Medicare beneficiaries of all races and ethnicities who should be on PrEP still need to know about its availability and providers must prescribe it. However, today’s announcement by the Biden administration removes some of the largest barriers and brings us closer to ending HIV in the United States.”

While oral PrEP was first approved by the FDA a decade ago, the first and only provider-administered medication for PrEP (Apretude) was approved by the FDA in December 2021 after clinical trials demonstrating superiority to daily oral PrEP. In August 2022, the HIV+Hepatitis Policy Institute led a letter to CMS that was signed by 64 organizations requesting a timely and efficient National Coverage Determination. CMS initiated the NCD process in January 2023, and the HIV+Hepatitis Policy Institute submitted comments in support of the NCD.

Today’s proposal initiates a final 30-day public comment period, after which CMS’ final decision is expected to take effect in October 2023. 

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.