Long-acting injectable PrEP is now to be covered without cost-sharing under Affordable Care Act rules, the Biden administration announced October 21. The news comes just weeks after it was announced that all forms of PrEP will be covered without cost-sharing for Medicare patients under Medicare Part B.
"With low uptake of PrEP among the communities most impacted by HIV, this insurance coverage requirement with zero cost-sharing will help jumpstart the use of more effective forms of PrEP and lead to fewer HIV transmissions," Carl Schmid, a gay man who is executive director of the Washington, D.C.-based HIV+Hepatitis Policy Institute, stated about the Biden administration's announcement.
"We are grateful to the Biden-Harris administration for responding to our request to issue this guidance," Schmid added. "Without it, we feel some insurers would continue to only cover daily oral PrEP, and not provide PrEP users with the choice they need. With up to a third of privately insured PrEP users still being charged cost-sharing, we must ensure that both federal and state regulators vigorously enforce PrEP coverage requirements."
PrEP, or pre-exposure prophylaxis, refers to the use of antiviral drugs to prevent people exposed to HIV from becoming infected with the virus. The pill Truvada was first approved for PrEP use in 2012 by the U.S. Food and Drug Administration; since then the FDA has also approved the pill Descovy for some groups, and ViiV Healthcare's drug Apretude as an injectable treatment.
The determination to cover injectable PrEP without cost-sharing was made under the Patient Protection and Affordable Care Act, also known as Obamacare, which mandates coverage of preventative care as recommended by the United States Preventive Services Task Force.
Regarding the Medicare changes, in September, the Centers for Medicare and Medicaid Services, or CMS, announced that there'd be no cost sharing for PrEP under Medicare, which covers Americans 65 and older. Schmid said that PrEP had been under Medicare Part D in the past but that as of September 30 it was now covered under Part B.
"This is really great and beneficial for PrEP users who have Medicare," Schmid said in a phone interview with the Bay Area Reporter last week. "This is all forms of PrEP — we asked for this because of long-acting PrEP. Part D is mostly oral drugs."
Dr. Daniel O'Neill, chief medical officer of the San Francisco Community Health Center, stated to the B.A.R. October 21 that the Medicare announcement is "an encouraging development in the HIV prevention landscape."
"All too often seniors have been relatively ignored when it comes to HIV prevention efforts, with the wrong assumption that they are just not at risk — not having as much sex or using drugs as their younger counterparts," he stated. "This announcement both reminds providers to consider risk individually and to discuss PrEP with folks 65 and older. It also empowers those same patients to take a more proactive role in their sexual health."
O'Neill continued that "real and perceived logistical barriers must be overcome to make this improved coverage successful."
"Providers need to know about the change and also to ensure that PrEP medications are sent to a Medicare Part B-enrolled pharmacy," he stated. "Payment for up to eight episodes [of] STD counseling sessions and associated testing is another bonus of this new National Coverage Determination for PrEP coverage."
Schmid was worried pharmacies may not have been ready to immediately switch to putting PrEP pills in Part B instead of in Part D.
"We didn't know they were going to move all of PrEP to Part B, and so you ask what the impact may be, and it's that we estimate 45,000 people in Medicare on oral PrEP today in Part D, paying cost sharing, getting their drug with no problem, they no longer can get it through Part D anymore, now they need to go through Part B," Schmid explained. "What we've been working on for years with CMS is a lot of pharmacies don't bill for Part B. It's a difficult process to get reimbursed, it's a lot more complicated."
Schmid said that "we thought they could keep oral [PrEP] in [Part] D, but they said they don't have the authority to do that, so there's no transition period."
Schmid asked the B.A.R. to reach out to pharmacies to ask if they could bill for PrEP in Medicare Part B. The B.A.R. reached out to Walgreens, Rite Aid, and CVS, but only heard back from one as of press time October 21.
CVS spokesperson Amy Thibault stated to the B.A.R. that, yes, "our pharmacies can bill Medicare Part B for eligible medications, including those outlined within the September 30, 2024 Medicare National Coverage Determination (NCD) notice. Medications prescribed for PrEP are covered under Medicare Part B with no out-of-pocket costs to beneficiaries (no copayments, coinsurance, or deductibles)."
Thibault continued that "Medicare Part D continues to cover HIV drugs utilized for non-PrEP purposes, such as HIV treatment and Post-Exposure Prophylaxis (PEP)."
PEP, or post-exposure prophylaxis, is another prevention tool that involves taking a monthlong course of antiretrovirals after sex or other types of exposure. Although the two-drug combination pills used for PrEP can prevent HIV from taking hold in the body, PEP — which is essentially very early treatment — uses a stronger three-drug regimen taken for 28 days.
LGBTQ Agenda is an online column that appears weekly. Got a tip on queer news? Contact John Ferrannini at [email protected]
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