The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing.
In addition, CMS is proposing to cover the administration of injectable PrEP and up to seven individual counseling visits every 12 months that include HIV risk assessment, reduction and medication adherence. The agency is also pitching coverage for HIV screening up to seven times annually and a single screening for hepatitis B virus, according to a press release.
Under Medicare Part B, CMS may add “additional preventive services” if recommended with a grade of A or B by the U.S. Preventive Services Task Force, among other criteria. PrEP earned a designation of A.
Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D, facing out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Injectable PrEP has not been covered traditionally.
Schmid praised the proposal’s details July 12 in a statement to Fierce Healthcare.
“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,” he said. “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. 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.
"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,” Schmid added. “Recently, Sen. Tina Smith and Rep. Adam Schiff introduced legislation, which would require all payers to cover all PrEP drugs without cost-sharing immediately after FDA approval.”
The PrEP Access and Coverage Act is drafted to eliminate out-of-pocket costs for PrEP for individuals with health plans under Medicare, Medicaid, the Affordable Care Act (ACA) and more.
In September, a federal judge ruled that employers are not required to cover PrEP without cost sharing, finding a major part of the ACA’s preventive service clause unconstitutional. The judge said it violated employers’ religious freedom.
Data from the U.S. Department of Health and Human Services show that approximately 38.4 million people in the world had HIV in 2021. New HIV infections were down 32% from 2010, and nearly half of the people diagnosed in the U.S. with HIV are aged 50 and older.
The decision follows a recommendation from December for prescribing PrEP with antiretroviral therapy to people with an increased risk of getting HIV.
CMS is now soliciting public comments for 30 days and looking for scientific feedback. The agency began national coverage analysis in January.
HIV is known to disproportionately affect certain racial and ethnic groups. At the end of 2019, 40% of diagnosed or undiagnosed HIV infections were Black or African American, with the prevalence rate being seven times greater than white individuals. One in 4 people with diagnosed or undiagnosed HIV were Hispanic or Latino.
"Medicare beneficiaries of all races and ethnicities who should be on PrEP still need to know about its availability and providers must prescribe it,” explained Schmid. “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 draft proposal cites research noting there is a lack of awareness of PrEP “particularly among primary care providers.”