Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention

CMS National Coverage Determination | ncd_id=377 | manual_section=210.15 | coverage_level_code=1 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications Effective for claims with dates of service on or after September 30, 2024, CMS covers PrEP using antiretroviral drugs approved by the U.S. Food and Drug Administration (FDA) to prevent HIV in individuals at increased risk of HIV acquisition. The determination of whether an individual is at increased risk for HIV is made by the physician or health care practitioner who assesses the individual’s history. CMS also 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: a) Up to eight individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. Counseling must be furnished by a physician or other health care practitioner. Individuals must be competent and alert at the time that counseling is provided. b) Up to eight HIV screening tests every 12 months. c) A single screening for hepatitis B virus (HBV). These screening tests are covered when the appropriate FDA-approved laboratory tests and point of care tests are used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. C. Nationally Non-Covered Indications Preventive services are non-covered by Medicare unless specifically covered in this NCD, any other NCD, in statute, or regulations. D. Other Medicare Part B coinsurance and deductible are waived for this preventive service.