As of September 30, 2024, Medicare covers these services without cost-sharing (for example, deductibles or copayments under Part B) to decrease an individual's risk of acquiring HIV:

• FDA-approved Pre-exposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV in individuals at increased risk of acquiring HIV 
• Administration of injectable PrEP using antiretroviral drugs to prevent HIV
• Supplying or dispensing the drug regardless of the route of administration (oral and injectable)
• Individual counseling (up to 8 visits every 12 months), including:
  • HIV risk assessment (initial or continued assessment of risk)
  • HIV risk reduction
  • Medication adherence 
• HIV screenings (up to 8 times every 12 months using FDA-approved laboratory tests and point-of-care tests)
• Hepatitis B virus screening (1 time only)

CMS covers HIV prevention services, including PrEP, for people with Medicare at increased risk of acquiring HIV. Physicians and health care practitioners assessing the individual’s history determine if an individual is at increased risk for HIV. To be eligible for counseling, individuals must be competent and alert during counseling.

People with Medicare don’t pay deductibles, copayments, or coinsurance.

Some people with Medicare may have previously gotten PrEP for HIV drug coverage through Part D and paid a deductible and coinsurance or copayments. As of September 30, 2024, Part B covers these drugs.

If an individual currently has HIV and uses antiretroviral drugs to treat HIV, Part D will continue to cover these drugs, even though these may be the same drugs that are used for HIV PrEP.

Help make sure people with Medicare have critical, uninterrupted access to HIV PrEP drugs:

• Inform and educate people with Medicare about the new Part B covered services
• Encourage them to talk to their pharmacy
• Prepare your office staff to communicate information to the pharmacy so they have what they need to submit Part B claims
• Show patients this fact sheet

Pharmacies can bill for PrEP for HIV drugs if they're enrolled as one of the following:

• DMEPOS supplier (CMS-855S)
• Part B pharmacy supplier (CMS-855B)

Check to see if you’re enrolled by entering the pharmacy’s NPI in the search bar. Even if you provide vaccines, you’re not necessarily enrolled in Part B.

• If a physician or health care practitioner buys an injectable PrEP drug, submit claims to the A/B MACs.
• If you’re enrolled as a DMEPOS supplier, submit claims for PrEP drugs and for supplying those drugs to your DME MAC. They’ll now process claims for PrEP drugs and the supplying of those drugs.
• If you’re a Part B pharmacy supplier, submit claims for PrEP drugs and for supplying those drugs to your A/B MAC.
• For the date of service on the claim, use the date the patient picks up the drug from the pharmacy or, if a mail-order pharmacy, the date you mail the drug. Don’t include span dates on the claim.   
• You may not need a claim for a supplying fee. If you do, use the same claim as the Medicare claim for the covered drug.   
• Include the name and NPI of the ordering or referring provider on the Part B claim.
• See MLN Matters Article National Coverage Determination: 210.15: Pre-Exposure Prophylaxis for HIV Prevention for billing and payment requirements.

Counseling

• Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) practitioners can bill for individual counseling when they perform these services in RHCs and FHQCs.
• For claims with dates of service on or after September 30, 2024, bill HIV PrEP counseling as a stand-alone visit if it’s the only medical service provided on that day with an RHC or FQHC practitioner. If it’s furnished on the same day as another medical visit, it’s not a separately billable visit and will be packaged in the RHC AIR or FQHC PPS payment:
  • Use code G0011 when a physician or another qualified health professional provides the counseling.
  • For FQHCs, bill with G0466 or G0467. For RHCs, add the CG modifier if this is the only service.
• When auxiliary personnel provide counseling, use code G0013. This service is packaged in the RHC AIR and FQHC PPS payment.

PrEP

• PrEP refills don’t require visits.
• RHCs and FQHCs don’t have to enroll as a “Part B pharmacy.”
• For claims with dates of service from September 30-December 31, 2024, RHCs and FQHCs should include costs for PrEP for HIV drugs, and any supply and administration fees, on their cost reports.
• Starting January 1, 2025, we’ll pay FQHCs 100% of the Medicare payment amount for PrEP for HIV drugs, and any supply and administration fee, on a claim-by-claim basis.
  • For more information on payment amounts and coding, see “How Do I Bill Starting January 1, 2025?” below.
  • To bill for PrEP on or after January 1, 2025, RHCs and FQHCs can use an institutional claim form to bill Medicare like you bill for other medical services. RHC and FQHC pharmacies should coordinate with their medical billing areas for this purpose.
  • Since these services can be billed and paid separately from the FQHC PPS and RHC AIR, a claim for PrEP for HIV won’t cause any same-day billing denials.
  • RHCs and FQHCs can bill PrEP alone or in addition to other services.

There are multiple diagnosis codes that may be appropriate to use for HIV prevention services:

ICD-10 Codes :

• Z29.81: Encounter for HIV pre-exposure prophylaxis
• Z11.4: Encounter for screening for human immunodeficiency virus [HIV]
• Increased risk factors reported: Z11.3, Z11.4, Z11.59, Z20.2, Z20.5, Z20.6, Z29.81, Z72.51, Z72.52, Z72.53
   

Expanded ICD-10 Codes (codes accepted on claims submitted on or after December 24, 2024):

• Z29.81: Encounter for HIV pre-exposure prophylaxis
• Z11.4: Encounter for screening for human immunodeficiency virus [HIV]
• Increased risk factors reported: A51.31, A51.32, A51.39, A51.41, A51.42, A51.43, A51.44, A51.45, A51.46, A51.49, A52.01, A52.02, A52.03, A52.04, A52.05, A52.06, A52.09, A52.11, A52.12, A52.13, A52.14, A52.15, A52.16, A52.17, A52.19, A52.2, A52.71, A52.72, A52.73, A52.74, A52.75, A52.76, A52.77, A52.78, A52.79, A53.0, A54.00, A54.01, A54.02, A54.03, A54.09, A54.1, A54.21, A54.22, A54.23, A54.24, A54.29, A54.31, A54.32, A54.33, A54.39, A54.41, A54.42, A54.43, A54.49, A54.5, A54.6, A54.81, A54.82, A54.83, A54.84, A54.85, A54.86, A54.89, A56.01, A56.02, A56.09, A63.8, A64, F11.10, F11.20, F11.21, F11.90, Z11.3, Z11.59, Z13.29, Z20.2, Z20.5, Z20.6, Z20.828, Z20.89, Z20.9, Z29.81, Z32.00, Z32.01, Z32.02, Z72.51, Z72.52, Z72.53, Z72.89, Z79.899, Z86.59, and Z87.898

Original Medicare (Fee-for-Service) claims pharmacies submit must be processed by the DME MAC or the A/B MAC, depending on whether the pharmacy is enrolled as a DMEPOS supplier or a Part B supplier pharmacy. This includes claims for the oral or injectable HIV PrEP drugs and the pharmacy supplying fee. The MACs are pricing these codes through December 31, 2024. Note: Use the codes below through December 31, 2024. For codes starting January 1, 2025, see “How Do I Bill Starting January 1, 2025?” for more information.

Billing Codes for Pharmacy Suppliers

Billing Codes for Providers

If a pharmacy provides an injectable drug directly to the practitioner, the practitioner bills Part B for the PrEP for HIV drug (such as J0739 in a typical “buy and bill” approach). The pharmacy isn’t able to bill for the drug and, therefore, not able to bill a supply fee. We understand in such arrangements that the pharmacy may invoice the practitioner.

Starting January 1, 2025, Medicare pays for PrEP for HIV drugs according to the DCAPS (Drugs Covered as Additional Preventive Services) fee schedule. Original Medicare (Fee-for-Service) claims pharmacies submit must be processed by the DME MAC or the A/B MAC, depending on whether the pharmacy is enrolled as a DMEPOS supplier or a Part B supplier pharmacy. This includes claims for the oral or injectable HIV PrEP drugs and the pharmacy supplying fee.

Billing Codes for Pharmacy Suppliers

More information on using Q0521 to furnish PrEP:

Billing Codes for Providers

* Codes G0011 and G0013 relate to counseling and aren’t on the DCAPS fee schedule. They’re included here for reference.

If a pharmacy provides an injectable drug directly to the practitioner, the practitioner bills Part B for the PrEP for HIV drug (such as J0739 in a typical “buy and bill” approach). The pharmacy isn’t able to bill for the drug and, therefore, not able to bill a supply fee. We understand in such arrangements that the pharmacy may invoice the practitioner.

If you want to bill for PrEP for HIV drugs, if you’re enrolled in Part B with the provider type “mass immunization,” you must still enroll as provider type “pharmacy” to bill for PrEP for HIV drugs.

RHCs and FQHCs don’t have to enroll as a “pharmacy” to bill for PrEP for HIV drugs. 

For information on pharmacy enrollment, listen to this webinar or view the transcript.

1. Pre-Enrollment

•  Get an NPI (PDF) if you or your organization doesn't already have it.
• Become a PECOS registered user. PECOS advantages are:
  • Faster enrollment
  • A tailored application process where you only give information relevant to your application
  • More control over your enrollment information and reassignments
  • Easier access to check and update your information
  • Less staff time and administrative costs to complete and submit enrollment to Medicare
• Identify your Medicare Administrative Contractors (MACs). MACs process enrollment applications and Medicare Fee-for-Service (FFS) claims. MACs also:
  • Pay providers for Medicare FFS claims 
  • Answer providers’ questions
  • Educate providers about Medicare FFS billing requirements

2. Submit Your Provider Enrollment Application(s) to Your MAC(s)

• Choose and complete an electronic or paper application
  • Electronic: Apply online through PECOS. For more information on PECOS (like technical help and FAQs), see Medicare Provider Enrollment, or view the PECOS Enrollment Tutorial video. 
  • Paper: Use CMS-855B (PDF) for clinics, group practices, and certain other suppliers.

3. What to Expect After Submitting Your Enrollment Application

• MACs take approximately 45 days or less to review submitted applications, but it may take longer if you use the paper application.
• Respond quickly to any requests for additional information or documents.
• If approved, your billing effective date is the later of these:
  • The date the MAC got your application
  • The date you begin providing services
• Update changes in your enrollment information in a timely manner.  You must submit most changes within 30 days of the date of the change.

• Fact Sheet: Potential for Medicare Part B Coverage of Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy (oral or injectable) to Prevent Human Immunodeficiency Virus (HIV) 
• PrEP for HIV National Coverage Determination Technical Frequently Asked Questions for Pharmacies
• Fact Sheet for Medicare Patients: Medicare Now Covers Pre-exposure Prophylaxis (PrEP) for HIV Prevention
• CY2025 Physician Fee Schedule Final Rule: Fee Schedule for Drugs Covered as Additional Preventive Services (DCAPS)
• MLN Matters Article: National Coverage Determination 210.15: Pre-Exposure Prophylaxis for HIV Prevention
• Health Plan Management System (HPMS) memo on the Proposed NCD on PrEP for HIV Prevention
• National Coverage Analysis Tracking Sheet
• CDC Guidelines: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States
• PECOS Enrollment Tutorial Video
• U. S. Preventive Services Task Force (USPSTF) Recommendation for Prevention of Acquisition of HIV: Preexposure Prophylaxis
• National Coverage Decision for PrEP