Medicare coverage for PrEP (pre-exposure prophylaxis) and associated preventive services
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Medicare coverage of FDA‑approved antiretroviral medications and injectable PrEP for individuals determined by a clinician to be at high risk for HIV; includes counseling, testing, and hepatitis B testing services. Applies to GlobalHealth plan administration of the CMS NCD.
CMS determined to cover pre-exposure prevention (PrEP) of HIV using FDA‑approved antiretroviral medications, including supply/dispensing and injectable PrEP, as a medically necessary preventive service.
Coverage includes up to eight counseling visits and up to eight HIV tests every 12 months, plus a single hepatitis B detection test when indicated by FDA or lab regulations.
Coverage Criteria for PrEP and Associated Services
Initial PrEP coverage and associated services
Covered when ALL of the following are met
PrEP coverage criteria
- Counseling: Up to eight counseling visits every 12 months covering HIV risk assessment (initial or ongoing), risk reduction, and medication adherence; counseling by a doctor or other health professional; individual must be competent and alert at time of counseling.<=8/year
- HIV testing: Up to eight HIV tests every 12 months.<=8/year
- Hepatitis B testing: A single test for the detection of hepatitis B covered when indicated as established by the FDA and in accordance with applicable laboratory regulations.single test
No specific programmatic exclusions are listed in this determination. Coverage is defined to apply to individuals who have been determined by a physician to be at high risk of acquiring HIV; beyond that physician risk determination, the document does not identify additional exclusions.
The policy does not enumerate explicit "not medically necessary" conditions. Services provided outside the scope described—such as to persons who are not documented by a physician as being at high risk—would not meet the coverage determination and therefore are not covered under this NCD.
Coding, Quantities, and Testing Limits
Provider Determinations, Documentation, and Process
Physician determination of high risk required
Coverage is available only when a physician determines the individual is at high risk of acquiring HIV; the determination of high risk is the physician's responsibility based on evaluation of the individual's history. The policy does not specify any prior authorization codes or separate prior authorization process.
No step therapy required
No step therapy or prior medication-failure requirements are specified in this update; CMS coverage applies without any stated step therapy sequence for PrEP.
Document physician clinical risk assessment
Maintain documentation of the physician's evaluation and clinical judgment that the individual is at high risk for acquiring HIV to support coverage of PrEP medications and associated services.
- Retain records of the patient's history and the physician's risk assessment.
- Include documentation of counseling, HIV testing, and hepatitis B testing when performed per coverage limits.
Denial risk if no physician risk determination documented
Services may be denied if the individual has not been evaluated and documented by a physician as being at high risk for acquiring HIV; ensure the physician's risk determination is present in the medical record before billing or providing covered PrEP services.
Definitions
Background
Pre-exposure prophylaxis (PrEP) uses FDA‑approved antiretroviral medications to prevent acquisition of HIV in individuals identified as high risk. Coverage includes supply/dispensing of oral agents and administration of injectable PrEP, and also covers related preventive services: up to 8 counseling visits every 12 months (for HIV risk assessment, risk reduction, and medication adherence), up to 8 HIV tests every 12 months, and a single hepatitis B detection test when indicated by the FDA and applicable laboratory regulations.
Revision History and Policy Changes
CMS determined on September 30, 2024 to cover HIV pre-exposure prophylaxis (PrEP) using FDA‑approved antiretroviral medications, including supply/dispensing and injectable PrEP, as a medically necessary preventive service for individuals at high risk; coverage was implemented into plan policy.
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