Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.

Gregory E. Fosheim
Gregory (Greg) E. Fosheim provides counsel on a wide array of corporate, transactional and regulatory compliance matters across the healthcare and life sciences industry. Drawing on his extensive laboratory and public health background, he regularly advises on clinical and diagnostic laboratory matters, anatomic pathology and fertility laboratory compliance. Greg represents hospitals, health systems and physician practice management companies in all aspects of transactional and operational matters, particularly those with regulatory, licensing, accreditation and policy considerations. He has also negotiated several acquisitions and sales of proton therapy centers. Read Gregory's full bio. 

Monica Wallace
Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice. Read Monica's full bio. 

Emily Jane Cook
Emily Cook is a practice area leader for McDermott's Healthcare Regulatory & Compliance practice. She is a national authority on the 340B drug pricing program, and also helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Learn more about Emily's practice here.

Jae Hyun Lee
Jae Hyun Lee is a member of the Healthcare Practice Group. He focuses his practice on healthcare mergers and acquisitions as well as regulatory and compliance matters. Read Jae's full bio here.




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