The federal government proposes that Medicare cover the cost of all forms of pre-exposure prophylaxis, or PrEP, to prevent HIV, including daily pills and long-acting injectables as well as the related doctor visits and screenings, such as tests for HIV and hepatitis.

The Centers for Medicare and Medicaid Services (CMS) posted the proposal July 12 on CMS.gov and is seeking comments on the proposal during the next 30 days (you can submit comments on the website). 

A final decision on CMS’s PrEP coverage is expected in October, according to a related press release from the HIV+Hep Policy Institute.

Medicare is the federal health insurance program for people 65 and older and for younger adults with long-term disabilities. Medicare is the second-largest source of federal funding for HIV care and treatment, according to a recent KFF brief titled “Medicare and People with HIV.” According to KFF (formerly Kaiser Family Foundation), more than a quarter (28%) of people with HIV in the United States were estimated to be covered by Medicare in 2020. What’s more, the number of traditional Medicare beneficiaries with HIV has more than doubled since the 1990s. (For an overview of the brief, see this POZ blog post by HIV.gov.)

The new proposal by CMS “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,” said Carl Schmid, executive director of the HIV+Hep Policy Institute, in the group’s press release.

“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,” Schmid said, adding that if the coverage is finalized, it “would close the gap in the future between FDA [Food and Drug Administration] approval and coverage of new PrEP drugs by Medicare Part B.

“Medicare beneficiaries of all races and ethnicities who should be on PrEP still need to know about its availability and providers must prescribe it,” Schmid said. “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.”

The CMS website explains the proposed coverage in more detail:

“CMS proposes to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the U.S. Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition. 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. In addition, CMS proposes to also cover the administration of injectable PrEP using antiretroviral drugs to prevent HIV infection.

“CMS also proposes to cover up to seven individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence. Counseling must be furnished by a physician or other health care practitioner and individuals must be competent and alert at the time that counseling is provided.

“Additionally, for individuals being assessed for or who are taking PrEP using [antiretroviral medication] to prevent HIV infection, CMS proposes to cover HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV). These screening tests are proposed to be covered with the appropriate FDA-approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations.”

In related news, members of SAGE (Advocacy & Services for LGBTQ+ Elders) urged the Centers for Disease Control and Prevention to recommend HIV testing for people 65 and older (current guidelines recommend everyone ages 13 to 64 be tested for HIV at least once as part of routine health care and that folks with certain risk factors get tested at least annually).

SAGE advocates pointed out that many people 65 and older remain sexually active and in need of HIV testing and prevention. In addition, members of this population group could have contracted the virus years earlier but not be aware of it.

Click #PrEP to find a roundup of related headlines about this HIV prevention. You’ll find numerous reports about the ongoing court battles to ensure that health care insurance covers PrEP and other prevention services.