National Coverage Analysis (NCA) Tracking Sheet

Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection



Per Section 1861(ddd) of the Social Security Act and implementing regulations at 42 CFR 410.64, CMS may cover "additional preventive services," if it determines through the national coverage determination (NCD) process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the United States Preventive Services Task Force (USPSTF) and that it also meets certain other requirements.

The USPSTF recently published (December 13, 2022) 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 ( This draft is an update to their 2019 recommendation.

CMS received a complete, formal request to consider an NCD for coverage of PrEP using antiretrovirals for persons at high risk of HIV acquisition.

CMS is soliciting public comment relevant to the consideration. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

National Coverage Determinations

Benefit Category

Additional Preventive Services

Requestor Information

Requestor Name Requestor Letter
ViiV Healthcare View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
01/12/2023 - 02/11/2023
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
07/12/2023 - 08/11/2023
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Rachel Katonak
Lead Medical Officers
Carl Li, M.D.

Medicare Benefit Category Determination Date

Actions Taken

January 12, 2023

CMS initiates this national coverage analysis for Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.

July 12, 2023

August 28, 2023

On August 22, 2023, the USPTSF Issued their Final Recommendation titled “Prevention of Acquisition of HIV: Preexposure Prophylaxis.” The recommendation is available at * The link above in the Issues section and in the bibliography for the proposed decision memo is no longer active.

October 10, 2023

CMS will not be issuing a final National Coverage Determination on PrEP Using Antiretroviral Drugs to Prevent HIV today, but a decision is forthcoming.