Medicare Invites Public Comment as it Considers National Coverage Determination for HIV PrEP

The Centers for Medicare and Medicaid Services (CMS) announced on January 12, 2023, that it has initiated a national coverage analysis for Medicare coverage of HIV pre-exposure prophylaxis (PrEP). The analysis, which involves a review of the evidence and consideration of public comments, will inform a National Coverage Determination (NCD) by the agency. The public comment period closes on February 11, 2023. Instructions on submitting comments can be found on this page of the CMS website.

Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). NCDs are national policy granting, limiting, or excluding Medicare coverage for a specific medical item or service. Medicare contractors in all states and jurisdictions are required to follow NCDs published by CMS.

CMS may cover "additional preventive services," if it determines through the NCD process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the U. S. Preventive Services Task Force (USPSTF) and that it also meets certain other requirements. The USPSTF recently published a draft recommendation with a grade A for prescribing PrEP with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.

Public comments can be submitted online until the 30-day public comment period ends on February 11, 2023. CMS considers all public comments and is particularly interested in clinical studies and other scientific information relevant to the topic under review. After reviewing instructions on submitting comments, to submit a comment click the blue "Comment" button at the top of this page, then enter comments directly into the “Submit A Public Comment” webpage that opens.

CMS anticipates issuing a proposed decision on HIV PrEP this summer. You can track progress of the analysis on this page of CMS’ website.

Medicare is a health insurance program for people age 65 or older, people under age 65 with certain disabilities, and people of all ages with End-Stage Renal Disease (permanent kidney failure requiring dialysis or a kidney transplant). The Centers for Medicare and Medicaid Services (CMS), part of the U.S. Department of Health and Human Services, administers Medicare.