Medicare Coverage of HIV Pre-exposure Prophylaxis (PrEP) - Information for Patients, Providers, and Pharmacists - Coverage Transition to Part B

Sep 27, 2026

Federal CMS issues a final National Coverage Determination directing Medicare to cover all forms of HIV pre-exposure prophylaxis (PrEP)—oral and injectable—under Medicare Part B for outpatient treatment. The change shifts coverage from the prior Part D oral PrEP pathway, removing patient cost sharing such as deductibles, copayments, and coinsurance for eligible services. The NCD outlines covered counseling visits, HIV screening frequency, and hepatitis B screening, while clarifying that other laboratory needs follow existing Medicare rules and may not be included, and provides guidance for pharmacy enrollment and correct billing codes to prevent copay charges.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

AccessFree to download

Coverage of PrEP in Medicare

Transition to Part B coverage

Covered ancillary services under the NCD

Counseling visits and HIV screening

Hepatitis B screening

Services not addressed in the NCD

STI screening and hepatitis C coverage

Kidney function, lipid screening, pregnancy testing

Pharmacy actions for Part B fulfillment

Enrollment requirements (DMEPOS or Part B pharmacy supplier)

Start enrollment and use correct billing codes

Medicare Coverage of HIV Pre-exposure Prophylaxis (PrEP): Information for Patients, Providers, and Pharmacists Coverage of PrEP in Medicare: Transition to Coverage in Part B The federal Centers for Medicare and Medicaid Services (CMS) have issued a ﬁnal National Coverage Determination (NCD) for PrEP directing Medicare to cover all forms of PrEP (oral and injectable) through Medicare Part B, the portion of Medicare that covers outpatient treatment. This allows Medicare members at increased risk of HIV acquisition to get PrEP under Medicare Part B with no deductibles, copayments, or coinsurance. This is a change from the way that Medicare previously covered oral PrEP, which was through Medicare Part D, the Medicare prescription drug program. Medicare Part D is administered by private health insurance plans that Medicare beneﬁciaries can enroll in. (Some Medicare beneﬁciaries receive their prescription drug coverage bundled in Medicare Advantage or Part C plans. ) Since federal regulations require all antiretroviral drugs, including PrEP, to be included in a Part D plan’s formulary without prior authorization or step therapy rules, there could be no prior authorization or step therapy requirements for PrEP under Medicare Part D. 1 However, Medicare Part D plans could require deductible, coinsurance, or copayments for PrEP. The transition to Part B coverage eliminates these cost sharing requirements for patients. CMS has been urging pharmacies for several months to prepare for this transition. More information is provided below, and further details are available in a PrEP for HIV National Coverage Determination: Technical Frequently Asked Questions for Pharmacies, which CMS released in June 2024. What ancillary services related to PrEP will Medicare cover? The NCD includes coverage of the following clinical and laboratory services required for PrEP: • 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”; • HIV screening up to eight times annually; and • A single screening for hepatitis B virus (HBV) .2 Like the medications for PrEP, these services would be covered under Medicare Part B with no costsharing. In addition to the Technical FAQ for Pharmacies, CMS has published a Fact Sheet on future Part 1 See 42 C. F. R. § 423 . 120(b)(2)(vi)(C); 84 Fed. Reg. 23,832 (May 23, 2019) . 2 Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeﬁciency Virus (HIV) Infection, National Coverage Analysis, Decision Memo (September 30, 2024), [https://www.cms.gov/medicare-coverage](https://www.cms.gov/medicare-coverage)database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=310 (“Decision Memo”) . B coverage of PrEP that includes suggested billing codes for the above ancillary services, as well as a new diagnosis code (Z29 .81: Encounter for HIV pre-exposure prophylaxis) that can be used for PrEP visits. More information for health care providers on how to bill Medicare for PrEP is also available here. Other clinical or laboratory services needed for patients on PrEP, however, are not addressed in the NCD and are subject to preexisting Medicare rules regarding coverage. So, for example, PrEP patients with Medicare can access sexually transmitted infection (STI) screening, with no coinsurance or deductible, for chlamydia, gonorrhea, and syphilis, if they are members of certain groups at increased risk; however, the groups eligible for these screenings and the frequency of screenings do not align completely with the CDC recommendations for STI screenings for PrEP.3 In addition, the NCD does not discuss Medicare coverage of hepatitis C screening, so this service is also subject to existing Medicare coverage rules. In general, Medicare covers a single hepatitis C screening for adults born from 1945 through 1965, and annual screening for people at “high risk,” with

FAQs

What should pharmacies do to fill PrEP prescriptions under Medicare Part B?

Pharmacies should ensure they enroll as a DMEPOS supplier (CMS-855S) or as a Part B Pharmacy supplier (CMS-855B), avoid relying on “mass immunization” enrollment alone, and use the correct Part B billing codes to prevent patient copay charges.

Sep 27, 2026

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