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). 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.