Medicare Part B Coverage of HIV PrEP

stay informed about these changes. CMS released two helpful guidance documents: the PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies and the Fact Sheet: Medicare Part B Coverage of Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention. Below is a summary of the guidance provided in these two CMS documents.

First, the pharmacy must be enrolled as a Part B pharmacy supplier or as a DMEPOS supplier to bill Medicare Part B for HIV PrEP medications. If your pharmacy is not currently enrolled as a supplier, but you wish to take the steps to become enrolled, CMS recommends enrolling as a Part B pharmacy supplier since there is a “lower burden of enrollment” and revalidation does not occur as frequently for a Part B pharmacy supplier compared to a DMEPOS supplier. More information about enrollment can be found by going to the PrEP for HIV & Related Preventative Services CMS webpage and clicking on “How Do I Enroll”.

Second, pharmacies must submit a valid diagnosis code (ICD-10) on the HIV PrEP claim. Below is a table of diagnosis codes that may be appropriate.

Third, the following are expectations of the dispensing pharmacy:

1. Have and maintain the order from the ordering physician or non-physician practitioner.
2. Obtain the diagnosis code from the ordering practitioner.
3. Have and maintain proof of delivery (i.e., a signed receipt or some other indication the item was dispensed to the beneficiary).
4. The date the claim is billed should match the date of dispensing, defined as the date the drug is picked up from the pharmacy or date drug is mailed.
5. Bill either a 30, 60, or 90 days’ supply and bill the appropriate corresponding HCPCS code.
6. No modifiers are required on the HIV PrEP claims (see PAAS Tips for 340B claims).

Fourth, “the supply fee must be billed on the same claim as the PrEP for HIV drug”. This means, the pharmacy will bill the drug fee as well as the supply (“dispensing”) fee; both claims should be billed with the same date of service, diagnosis code, place of service, etcetera. If your pharmacy utilizes a Medicare Part B billing intermediary, the dispensing fee claim will likely be taken care of by the intermediary on behalf of the pharmacy. If the PrEP drug (e.g., cabotegravir) is being delivered to a medical practice for administration, the date of service billed should match the date of service delivered to the medical office. The medical office would then bill Medicare separately for the administration fee once they administer the medication to the patient. The date of service on the administration fee claim from the medical practice does not have to match the date of service on the pharmacy’s drug and supply fee claims.

Fifth, Medicare Part B claims must be submitted with the name and NPI number of the enrolled ordering/referring practitioner and the name and NPI of that practitioner must appear in the CMS Order and Referring dataset. Since pharmacists do not currently appear in this dataset, they are not eligible for ordering PrEP drugs for payment under Medicare Part B. Therefore, “if a pharmacist, under state scope of practice laws, furnishes counseling, injects a PrEP drug or orders PrEP, those series cannot be paid directly to the pharmacy and the drugs cannot be paid by Medicare Part B. Pharmacists may provide, when all conditions are met, service as auxiliary personnel “incident to” a physician’s or other practitioner’s service in certain settings. The incident to regulations require supervision by a physician or other practitioner, and such services would be billed by the supervising physician or practitioner.” Additional information about “incident to” services can be found under 42 CFR §§410.26 and 410.227 or visit the Incident To Services & Supplies CMS webpage.

PAAS Tips:

• Ensure these HIV PrEP medications are returned with a $0 copay from in-network pharmacies as of September 30, 2024
• Pharmacies not enrolled as a DMEPOS supplier or Medicare Part B Pharmacy supplier can refer individuals to 1-800-MEDICARE (1-800-633-4227) and they can assist the individual with finding another pharmacy where they can receive their PrEP
  • Mail order pharmacies may be available
  • Teletypewriter (TTY) users can call 1-877-486-2048
• Pharmacies enrolled with Medicare Part B solely with a “mass immunization” provider type will need to enroll as a provider type “pharmacy” before they can bill Medicare Part B for HIV PrEP
• These same antiretroviral drugs may also be used for the treatment of HIV and (when using for treatment, not prevention) should continue to be billed to Medicare Part D
• For a patient with a Medicare Advantage plan, bill their Advantage plan (not their original Medicare Part B red/white/blue card) and watch the returned patient co-pay; if it is not $0, the pharmacy may not be contracted with the Advantage plan for medical billing (even if the pharmacy is contracted for pharmacy billing)
• PrEP claims which are 340B eligible do require a modifier on the claim, either “JG” (drug or biological acquired with 340B drug pricing discount, reported for information purposes) or “TB” (drug or biological acquired with 340B drug pricing discount, reported for information purposes for select entities); for more information on 340B modifiers, refer to the March 2023 Medicare Learning Network bullet