The Biden administration is directing insurance companies to offer PrEP without copays or deductibles.
PrEP, or pre-exposure prophylaxis, refers to two antiviral medications — under the brand names of Truvada, which was approved by the federal Food and Drug Administration in 2012, and Descovy, which was approved in 2019 — that are taken by HIV-negative people to prevent HIV infection.
According to guidance released July 19 jointly by the U.S. Departments of Labor, Health and Human Services, and the Treasury, the Patient Protection and Affordable Care Act requires insurance companies to provide evidence-based services with an "A" or "B" rating from the U.S. Preventive Services Task Force without cost-sharing requirements in most situations.
As PrEP received an "A" grade from the task force in 2019 as "effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition," according to the guidance, companies must now not charge copays or deductibles for the medicine itself, labs, and associated office visits.
The Bay Area Reporter reported at the time that this "A" grade would lead to an access mandate "expected to be fully implemented in 2021."
Companies will have 60 days to enter into compliance, the guidelines state, and state governments are invited to help with enforcement.
The cost of PrEP has created barriers to getting it to the communities that need it most. Brand-name Truvada typically sells for around $1,600 to $1,800 per month. A long-awaited generic version of Truvada went on the market in late 2019. But the wholesale cost of the new pill from Teva Pharmaceuticals was about $1,455 for a 30-day supply.
As the B.A.R. reported in 2019, California Insurance Commissioner Ricardo Lara, a gay man, warned insurance providers that under state guidelines they could not refuse coverage to PrEP users.
A report from the state's insurance department found that several companies had denied or limited coverage, restricted products available through accelerated underwriting, placed conditions on coverage, or charged higher rates to PrEP users, though the names of the particular companies were not disclosed by the state.
A law that went into effect in California last year, authored by gay state Senator Scott Wiener (D-San Francisco) and gay then-Assemblyman Todd Gloria (D-San Diego) allows Californians to obtain a two-month supply of PrEP from a local pharmacy without a prescription. The law also prohibits insurance companies from requiring patients to obtain prior authorization before using their insurance benefits to obtain PrEP or PEP from a pharmacy. (PEP refers to post-exposure prophylaxis and is a different medication.)
Wiener, who uses PrEP himself, told the B.A.R. that the new guidance is "a big deal for HIV prevention."
"PrEP has the potential to end new HIV infections but only if we dramatically increase access," stated Wiener. "Eliminating cost-sharing for PrEP will be a big help in that effort."
Aaron Fox, the director of government relations for the Los Angeles LGBT Center, said that the guidance will help PrEP distribution become more equitable.
"We commend the Centers for Medicare and Medicaid Services for their guidance to ensure PrEP is more accessible and affordable for everyone who needs it," Fox stated to the B.A.R. July 22. "By dismantling the existing regional and community disparities which prevent access to the life-saving daily medication, we will be another step further in ending the HIV epidemic."
The HIV + Hepatitis Policy Institute, a nonprofit advocating for those living with or at risk for HIV and hepatitis, among other health conditions, issued a statement in support.
"We are pleased that the federal government has issued this long-awaited guidance to insurers that will reduce barriers to PrEP and help prevent further HIV infections while advancing efforts to end HIV in the United States," stated Carl Schmid, the executive director of the institute. "It seems that insurers responded to our earlier analysis. However, now we must ensure all are fully complying with their legal requirements, including those spelled out in the new guidance, and federal and state regulators enforce them."
Schmid called on both insurance companies and regulators to "do more to ensure people with private insurance can obtain PrEP without cost-sharing.
"Additionally, transparency in how insurers display coverage of preventive medications such as PrEP needs further attention," Schmid added. "We look forward to conducting additional plan reviews and holding all parties accountable for providing clear, transparent information to make it as easy as possible for people with insurance who need PrEP to access it."
Reina Hernandez, the associate director of HIV and PrEP Navigation at the San Francisco AIDS Foundation, stated to the B.A.R. that "it's about time that the federal government mandates that insurance companies abide by their legal obligation to fully cover PrEP in accordance with the Grade A recommendation set forth by the United States Preventive Services Task Force and the Affordable Care Act."
"Black, Latinx, and other people of color, who are disproportionately impacted by HIV, have experienced the brunt of inaccessibility when it comes to PrEP," Hernandez stated. "This legal mandate to insurance companies will hopefully alleviate some of the financial barriers that have contributed to low utilization rates by these communities that need it the most."
Updated, 7/22/21: This article has been updated with comment from the LA LGBT Center.
Updated, 7/27/21: This article has been updated with comment from SFAF.
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