On Sept. 30, the Centers for Medicare and Medicaid Services (CMS) announced that, going forward, Medicare would fully cover all forms of pre-exposure prophylaxis (PrEP) to prevent HIV. Full coverage means the cost of the medications, HIV testing, hepatitis B testing, and prevention counseling, as well as patient copays and cost-sharing. But it doesn’t stop there. Rather than mandate that people use the relatively cheap generic daily oral PrEP option, this decision also covers the more expensive branded Truvada (FTC/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) daily oral options, the far more expensive once-every-other-month injectable version Apretude (cabotegravir), and all future forms of PrEP, regardless of delivery method or price.

CMS’ announcement comes off of the U.S. Preventive Services Task Force decision in 2023 to give PrEP a Grade A rating, deeming it a safe and highly effective tool to prevent getting HIV.

Maintaining Access to PrEP Under the New Rule

Importantly, the announcement indicates that whereas PrEP has previously been covered by Medicare Part D, the program’s pharmacy benefit, Medicare will now fully cover all FDA-approved PrEP options, as well as related provider visits and key screenings, under the program’s Part B. This means that pharmacies offering PrEP will now need to be part of the Medicare Part B network.

Medicare Advantage plans will also be required to fully cover PrEP and the above-mentioned related services. These plans are offered through private insurers approved by Medicare and serve about half of all people with Medicare.

As for the roughly 45,000 people who currently get their PrEP through Medicare, to maintain access to care, they will need to contact their pharmacy to make sure the pharmacy can bill for Part B drugs. That’s according to HIV services coverage expert Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Schmid says that certain large pharmacy chains like CVS and Walgreens are already in that network.

If the pharmacy can’t bill for Part B drugs, Schmid recommends that people talk to their health care provider about finding a pharmacy that can. And he says that if an Advantage plan refuses to fully cover PrEP and its related services despite the government ruling, one should call the plan to tell them of the ruling—or contact Medicare directly at 1-800-MEDICARE or submit a complaint online.

Marketplace Plans Must Cover PrEP Too

It should also be noted that in late October, CMS issued a “Frequently Asked Questions” (FAQ) document clarifying that most workplace-linked and Obamacare/marketplace insurance plans must also fully cover—without copays or cost-sharing—all forms of PrEP to protect against HIV.

With that FAQ, “They’re clarifying for the first time that long-acting injectables for PrEP must be fully covered by most work-linked and Obamacare marketplace plans,” Schmid told TheBody. “This levels the playing field between long-acting and daily oral PrEP options. A lot of people find it difficult to take a daily oral pill when you’re not sick.”

However, many consumers may be unaware that private plans have a long history of avoiding honoring such mandates or of the government failing to hold them accountable. Given this history, Schmid says it is likely that many plans’ first response to covering an expensive Apretude prescription will be to refuse the request. Schmid says that anyone who wants their health plan to cover Apretude may well have to fight for it by calling their insurance company, alerting them to the new mandate, and threatening to report the plan to their state health insurance department.

If that does not work, Schmid suggests that consumers file their complaint. It may not change things immediately, but with enough filings, the government will intercede. Schmid also urges people whose plans reject their Apretude coverage to email him at cschmid@hivhep.org so that his organization can track coverage refusals.

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Tim Murphy, Contributing Editor: