When we release the final NCD, Medicare is expected to cover these services without cost-sharing (for example, deductibles or co-pays under Part B) to decrease an individual's risk of acquiring HIV:

• FDA-approved PrEP using antiretroviral drugs (oral or injectable) to prevent HIV in individuals at high risk of HIV acquisition
• Administration of injectable PrEP using antiretroviral drugs to prevent HIV
• Supplying the drug regardless of the route of administration (oral and injectable)
• Individual counseling (up to 7 visits every 12 months), including:
  • HIV risk assessment (initial or continued assessment of risk)
  • HIV risk reduction
  • Medication adherence 
• HIV screenings (up to 7 times every 12 months using FDA-approved laboratory tests and point-of-care tests)
• Hepatitis B virus screening (1 time only)

We’ll cover HIV prevention services, including PrEP, for people with Medicare at high risk of acquiring HIV. Physicians and health care practitioners assessing the individual’s history determine if an individual is at high risk for HIV. To be eligible for counseling, individuals must be competent and alert at the time you provide the counseling.

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

Some people with Medicare currently get PrEP for HIV drug coverage through Part D and may pay a deductible and coinsurance or copayments. These drugs are expected to be covered by Part B when the final NCD is posted and effective in late September 2024. Pharmacies should prepare now to get ready for this transition.

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 uninterrupted access to HIV PrEP drugs:

• Inform and educate people with Medicare about the soon-to-be covered services under Part B
• 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

It may take some time to adjust systems to reflect Part B payment for these drugs when used as prevention. We encourage Part D sponsors, pharmacies, claims clearinghouses, Part D pharmacy claims processors, and pharmacy benefit managers to prepare for the final NCD, as payment under Part B would be effective at the time the final NCD is posted. 

Medicare Advantage (Part C) and cost plan (Part C) organizations and parties involved in processing Part C claims should also work with their contracted pharmacies to prepare for this potential transition to ensure enrollees have access to HIV PrEP drugs without cost-sharing (for example, deductibles or co-pays) when we finalize the proposed decision.

To bill for PrEP for HIV drugs, a pharmacy must be enrolled in Medicare as either:

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

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.

• If a physician or health care practitioner buys an injectable PrEP drug, you’ll submit claims to the A/B MACs.
• If you’re already enrolled as a DMEPOS supplier, submit future claims for PrEP drugs and for supplying those drugs to your DME MAC. DMEPOS supplier pharmacies currently send claims to the DME MACs. They’ll begin processing claims for PrEP drugs and the supplying of those drugs.
• If you’re a Part B pharmacy, submit claims for PrEP drugs and for supplying those drugs to your A/B MAC.
• For the date of service on the claim, you’ll 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.

Original Medicare (fee-for-service) claims submitted by pharmacies 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 pharmacy. This would include claims for the oral or injectable HIV PrEP drugs and the pharmacy supplying fee. We expect Medicare-enrolled providers and pharmacy suppliers would bill these drug and billing and payment codes:

• 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
• 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