HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

Posted In Life Sciences

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS did not announce any coverage changes in the fact sheet but is providing advance information to avoid any possible disruptions to beneficiaries should the NCD be issued.

We are closely monitoring this issue and will provide further updates regarding the coverage details and additional guidance in the NCD once it is issued.

Under the proposed NCD, PrEP drugs (which may be covered under Medicare Part D and subject to beneficiary cost-sharing obligations) would be transitioned to Medicare Part B, with no beneficiary cost-sharing obligations. CMS also proposes to cover HIV screening tests and counseling visits under Medicare Part B. This would be consistent with most commercial health insurance and Medicaid plans, which, under the Affordable Care Act, must cover PrEP drugs (oral or injectable), laboratory tests and related clinical visits without cost sharing when prescribed by a healthcare provider.

If the proposed change for PrEP drugs occurs, pharmacies will need to be enrolled in Medicare Part B as either a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier (CMS-855S) or as a Part B pharmacy supplier (CMS-855B). Pharmacies not already enrolled should consider doing so in preparation for the final NCD, as Part B coverage will be effective at the time the final NCD is posted. Pharmacies enrolled in Part B with the provider type “mass immunization” will need to enroll as provider type “pharmacy.” CMS has not provided an expected implementation date for this change if it is finalized.

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.


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. 


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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