The Centers for Medicare & Medicaid Services (CMS) has proposed that PrEP in its oral and injectable forms should be made available to high-risk HIV patients without patients having to cover part of the costs or rely on deductibles.
The agency has recommended that not only should the cost of the antiretroviral drugs (whether oral or injectable) approved by the U.S. Food and Drug Administration (FDA), but also their administration for patients should be without costs.
The use of PrEP on a continuous basis before or after exposure to HIV is highly effective in preventing HIV.
Although new HIV infections in the U.S. alone were down by 32% since 2010, according to data from the U.S. Department of Health and Human Services in 2021, over 38 million people in the world were suffering from HIV.
Currently, PrEP medications are covered under Medicare Part D and may be subject to deductibles or cost sharing. There have traditionally been out-of-pocket costs for patients that the program has not covered.
Under this new proposal by CMS, for certain individuals, both the oral and injectable forms of medication will be covered under the same Part D but as an “additional preventive service”. Patients will, therefore, not have to repay coinsurance or meet deductibles.
Expanded Coverage for HIV Patients
- U.S. Preventive Services Task Force recommendations:
- CMS authorized to add additional preventive services under Medicare Part B if grade A or B designation is earned.
- Expanded coverage proposal for HIV patients includes:
- Coverage for up to seven HIV screenings annually.
- Coverage for up to seven individual counseling visits, addressing reduction, medication adherence, and HIV risk assessment every 12 months.
- Planned coverage for high-risk patients:
- Annual screening for hepatitis B virus (HBV).
“This 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,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.
Schmid further explained that if this proposal is approved, it would mean that the gap between FDA approval and coverage of new PrEP drugs by Medicare Part B will cease to exist in the future.
For individuals who rely on health plans under Medicare, Medicaid, and the Affordable Care Act (ACA), the PrEP Access and Coverage Act also exists, which is meant to remove out-of-pocket costs.
However, in September, this legislation was found unconstitutional by a federal judge ruling that employers are not required to cover PrEP without cost sharing, and the judge also announced that the Act compromised the religious freedom of the employer.
