Biden Administration Calls for Medicare to Cover HIV Drug, PrEP

The Biden administration is recommending that Medicare cover the oral and injectable HIV-fighting medications known as pre-exposure prophylaxis, or “PrEP,” at no cost for persons at high risk for HIV infection.

“The determination of whether an individual is at high risk for HIV infection is made by the physician or health care practitioner who assesses the individual’s history,” said the National Coverage Determination from the Centers for Medicare and Medicaid Services.

“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,” said a statement from Carl Schmid, executive director of the HIV + Hepatitis Policy Institute.

“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,” Schmid’s statement added. “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.”

Gilead Sciences Inc.’s Truvada and Descovy for PrEP are oral versions of the medication, while Apretude by ViiV Healthcare is an injectable version.

The CMS is also calling for Medicare coverage of up to seven individual counseling visits, every 12 months, to cover HIV risk assessment, risk reduction, and medication adherence. For those being assessed for, or taking PrEP using antiretroviral therapy to prevent HIV infection, the CMS is also recommending coverage of HIV screening up to seven times a year, and a single screening for hepatitis B virus.

“These screening tests are proposed to be covered with the appropriate FDA approved laboratory tests and point of care tests,” the summary decision said.

The proposal triggers a 30-day comment period before a final coverage decision is made.

HIV is acquired through contact with the blood, semen, pre-seminal fluid, rectal fluids, vaginal fluids, or breast milk of a person with HIV. In 2021, an estimated 1.2 million people aged 13 and older had HIV in the US and an estimated 87% know their HIV status, according to the Centers for Disease Control & Prevention.