Preparing for PrEP: The Implications of PrEP Medicare Coverage Transition for Pharmacies

The Centers for Medicare and Medicaid Services (CMS) has released pharmacy-specific frequently asked questions regarding the upcoming National Coverage Determination (NCD) for pre-exposure prophylaxis (PrEP) to prevent HIV.¹ Expected to be effective in late September 2024, the NCD aims to shift Medicare coverage for PrEP products from Part D to Part B.² This change is intended to allow patients to receive PrEP either at a physician’s office or a pharmacy, enhancing accessibility and convenience. It will impact how pharmacies administer and bill for these essential products in the fight to end the HIV epidemic.

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PrEP for HIV comes in various forms, including daily oral medications and a long-acting injectable formulation for gluteal intramuscular administration.^3,4 When used as indicated, PrEP is 99% effective at preventing HIV.⁵ Uninterrupted access to PrEP is vital for maintaining its efficacy in preventing HIV infection. Currently, PrEP products are covered for Medicare beneficiaries under Part D, known as the prescription drug benefit.⁶

In 2022, CMS received a formal request to consider an NCD for PrEP.⁷ An NCD is a decision by the CMS to determine how a particular medical service, procedure, or device is covered under Medicare.⁸ After a public comment period, CMS released a proposed decision memo in July 2023, indicating that it would issue the NCD allowing PrEP products to be under Medicare Part A and B. In April 2024, CMS issued a fact sheet explaining that, after the issuance of the NCD, PrEP products will no longer be covered by Part D.⁹ The fact sheet, geared towards physicians, lacked details for pharmacists on how CMS will manage the transition to Part B while ensuring uninterrupted access to PrEP for current patients in a pharmacy setting.

However, CMS recently issued an FAQ document that highlighted important considerations for pharmacies, addressing public feedback requesting more technical information about submitting future Medicare Part B claims for PrEP for HIV. By enabling pharmacies to bill Medicare Part B directly for PrEP, the new NCD ensures that patients have continuous access to these essential preventive medications, thereby supporting ongoing HIV prevention efforts and improving public health outcomes.¹

For pharmacies already enrolled as Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS) suppliers, there is no need for additional enrollment to submit claims for PrEP for HIV. They can continue using their DME Medicare Administrative Contractor (MAC). For those pharmacies not yet enrolled with Medicare, CMS recommends they enroll as Part B pharmacy suppliers due to the lower burden compared to DMEPOS suppliers. Part B pharmacy suppliers face fewer revalidation requirements and simpler enrollment processes, making this pathway more efficient.¹

Interestingly, pharmacies currently enrolled solely for “roster billing” Medicare for vaccinations may not automatically use this pathway to bill for PrEP products under Part B. Such pharmacies must enroll separately as either Part B Pharmacy suppliers or DMEPOS suppliers to bill for PrEP for HIV. It is crucial for pharmacists to understand how the NCD will impact workflow and billing processes within their pharmacies.¹

When it comes to billing Medicare Part B, pharmacies must append valid diagnosis codes to their claims. New billing codes for PrEP for HIV drugs will be available once the NCD is effective. These include general PrEP drug codes and specific codes for oral and injectable PrEP drug combinations.¹

Under the NCD, pharmacies will be able to bill for both oral and injectable PrEP products. CMS also contemplates that some pharmacies may dispense injectable PrEP to a physician or other health care provider for administration. However, CMS does not address how pharmacists will be reimbursed for counseling on or administration of PrEP, even though in some states, pharmacists are authorized to provide long-acting injectable medications, including PrEP.¹

Pharmacists should prepare now for this transition by familiarizing themselves with the new billing codes and ensuring proper enrollment. Staying informed of CMS updates and readiness to implement these changes by late September 2024 will be critical. By staying proactive, pharmacies and pharmacists can ensure seamless integration of PrEP for HIV services into their Medicare Part B billing processes, providing crucial this preventive care to patients effectively and efficiently.

References

1. PrEP for HIV National Coverage Determination. Centers for Medicare and Medicaid Services. Accessed July 18, 2024. https://www.cms.gov/files/document/faq-prep-hiv-06242024.pdf

2. Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. Centers for Medicare and Medicaid Services. January 12, 2023. Accessed July 18, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=310

3. HIV Prevention. HIVinfo.gov. Updated December 11, 2023. Accessed July 18, 2024. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/pre-exposure-prophylaxis-prep#:~:text=Three%20HIV%20medicines%20are%20approved,Truvada%2C%20Descovy%2C%20and%20Apretude.

4. Apretude Prescribing Information. ViiV Healthcare; 2021. Accessed July 18, 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF

5. Pre-Exposure Prophylaxis (PrEP). CDC. Updated July 5, 2022. Accessed July 18, 2024. https://www.cdc.gov/hiv/risk/prep/index.html#:~:text=Pre%2Dexposure%20prophylaxis%20(or%20PrEP,use%20by%20at%20least%2074%25.

6. 2024-04-18-MLNC. Centers for Medicare and Medicaid Services. April 18, 2024. Accessed July 18, 2024. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-04-18-mlnc

7. RE: Formal Request for National Coverage Determination for Provider-Administered Pre-Exposure Prophylaxis (PrEP) for HIV Prevention. ViiV Healthcare. February 1, 2022. Accessed July 18, 2024. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id310.pdf

8. Medicare Coverage Determination Process. Centers for Medicare and Medicaid Services. Updated January 31, 2024. Accessed July 18, 2024. https://www.cms.gov/medicare/coverage/determination-process#:~:text=National%20coverage%20determinations%20(NCDs)%20are,Coverage%20Advisory%20Committee%20(MEDCAC).

9. Fact Sheet: Potential for Medicare Part B Coverage of Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy (oral or injectable) to Prevent Human Immunodeficiency Virus (HIV). Centers for Medicare and Medicaid Services. Accessed July 18, 2024. https://www.cms.gov/files/document/fact-sheet-potential-medicare-part-b-coverage-preexposure-prophylaxis-prep-using-antiretroviral.pdf