Editor’s Note: Since the original publication date of this article, CMS has updated its guidelines to cover PrEP under Part B. See full details here.
By Lauren Means
Last year, the Centers for Medicare and Medicaid Services (CMS) unveiled a new proposal aimed at expanding Medicare Part B coverage to include medications that prevent HIV, at no cost to beneficiaries. If finalized, this decision would ensure that people at high risk of acquiring HIV could access life-saving medications without needing to pay for deductibles or copays.
On July 12, 2023, CMS proposed a groundbreaking step of covering pre-exposure prophylaxis (PrEP) through antiretroviral drugs — either oral or injectable — approved by the U.S. Food and Drug Administration (FDA) to prevent HIV. PrEP is a critical tool in reducing HIV transmission in individuals considered to be at high risk. Whether a person qualifies for this preventive treatment would be determined by their doctor or healthcare practitioner based on their medical history.
Beyond medication coverage, CMS also proposed to include up to seven counseling visits per year, focusing on HIV risk assessment, risk reduction strategies, and ensuring medication adherence. These counseling sessions would also be provided without cost-sharing, ensuring that beneficiaries have the support they need to stay on track with their preventative care.
In addition to PrEP and counseling, the proposal outlines Medicare coverage for HIV screenings up to seven times a year, as well as a one-time hepatitis B screening for individuals.
The potential changes would shift coverage of HIV PrEP drugs from Medicare Part D, which covers prescription drugs, to Medicare Part B, which primarily covers medical services. This move has sparked concern among some public commenters who worry that transitioning from Part D to Part B could lead to disruptions in access to these preventative drugs. Specifically, beneficiaries currently using Part D for PrEP might miss critical doses during the transition.
However, CMS has assured that they are taking steps to minimize any disruption. By releasing details ahead of the final decision, CMS aims to facilitate a smooth transition for those who may be affected. CMS expects the final National Coverage Determination decision to be posted and effective in late September 2024.
If the proposal is finalized, it would fall under Medicare’s “additional preventive services” benefit, which means beneficiaries would not be financially responsible for these services. This significant change could enhance access to preventive HIV care for Medicare beneficiaries at high risk, potentially leading to a further decline in new HIV cases nationwide.
As the final decision nears, CMS remains focused on ensuring an effective implementation process, which will preserve access to preventive HIV medications for all beneficiaries without delay or disruption.
This proposed expansion of coverage comes as a major advancement in public health efforts to curb HIV transmission and ensure equitable access to preventive care for Medicare beneficiaries.