National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00464N

Issue

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 (https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/prevention-human-immunodeficiency-virus-hiv-infection-prep). [link broken, final USPSTF recommendation and link below]). 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
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/12/2023
Expected NCA Completion Date
10/10/2023
Public Comment Period
01/12/2023 - 02/11/2023
Proposed Decision Memo Due Date
Proposed Decision Memo Released
07/12/2023
Proposed Decision Memo Public Comment Period
07/12/2023 - 08/11/2023
Decision Memo Released
09/30/2024
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Rachel Katonak
Rachel.katonak@cms.hhs.gov
410-786-8564
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: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

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 https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis. * 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.

April 15, 2024

The Centers for Medicare & Medicaid Services (CMS) released a Fact Sheet for the potential National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV. CMS is sharing this information to encourage pharmacies and other interested parties to prepare for a potential National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV. The fact sheet is available at https://www.cms.gov/files/document/fact-sheet-potential-medicare-part-b-coverage-preexposure-prophylaxis-prep-using-antiretroviral.pdf.

CMS did not announce any coverage changes; however, many interested parties commented on the proposed NCD last year. Some commenters were concerned that a change to Part B coverage might be disruptive for patients who had been receiving coverage under Part D. CMS is sharing as much information as possible before issuing a NCD to avoid any possible disruptions for beneficiaries.

June 25, 2024

The Centers for Medicare & Medicaid Services (CMS) released a Technical Frequently Asked Questions for Pharmacies. CMS received public feedback asking that more technical information for submitting future Medicare Part B claims for PrEP for HIV be released in advance of the final National Coverage Determination. This FAQ provides more technical detail following the previous posting of the fact sheet and is available at https://www.cms.gov/files/document/faq-prep-hiv-06242024.pdf.

CMS did not announce any coverage changes under this FAQ. CMS is sharing as much information as possible before issuing the final NCD to avoid disruptions for beneficiaries.

September 30, 2024