CMS Issues Final National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention

  • On September 30, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Decision Memo titled “Final National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention” (Decision Memo). 
  • In the Decision Memo, CMS determined that PrEP using antiretroviral drugs to prevent HIV is covered as an additional preventive service for individuals at increased risk of HIV acquisition. CMS found that PrEP using antiretroviral drugs to prevent HIV is: o reasonable and necessary for the prevention of an illness or disability; o recommended with a grade of A by the United States Preventive Services Task Force (USPSTF); and o appropriate for individuals entitled to Medicare benefits under Part A or enrolled under Part B.
  • The physician or other health care practitioner who assesses the individual’s history will also make the determination of whether the individual is at increased risk for HIV. CMS covers furnishing HIV PrEP using antiretroviral drugs, including the supplying or dispensing of these drugs and the administration of injectable PrEP.
  • For individuals being assessed for or using PrEP to prevent HIV, CMS covers all the following as an additional preventive service: o Up to eight individual counseling visits with a physician or other health care practitioner every 12 months, which include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. 
    • Up to eight HIV screening tests every 12 months.
    • A single screening for hepatitis B virus (HBV). 
    • Medicare Advantage plans must follow this National Coverage Determination, including providing PrEP drugs for HIV with no cost sharing at in-network providers beginning on September 30, 2024. 

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