The Centers for Medicare & Medicaid Services (CMS) announced its final National Coverage Determination (NCD) for pre-exposure prophylaxis (PrEP) for HIV prevention, which shifts coverage of these services from Medicare Part D to Part B.
Under the new NCD, PrEP will be treated as a covered preventive service, which will allow patients to receive this care without cost sharing. Although ASHP is supportive of removing financial barriers to PrEP, the NCD may be disruptive to pharmacist-led care models.
Shifting PrEP medication coverage to Part B will disrupt patient access in the 27 states where pharmacists are authorized to provide PrEP, either via independent initiation or through a collaborative practice agreement. Under the new NCD, valid prescriptions written by these pharmacists might not be reimbursed by Medicare Part B because pharmacists cannot enroll in the Provider Enrollment, Chain, and Ownership System as prescribers. Instead, CMS notes in its technical FAQ that services may be billed incident to a physician.
Additionally, the FAQ does not address potential access concerns related to administrative implementation of the NCD. Because some medications used for PrEP under Part B would continue to be covered under Part D for other indications, including post-exposure prophylaxis, plans may require a B versus D coverage determination, which would cause significant delays in care for many patients.
“We are fully supportive of efforts to expand access to these lifesaving medications,” said Tom Kraus, ASHP vice president of government relations. “However, for patients to benefit, it's critical that their access to care not be disrupted. Unfortunately, CMS’s policy will make it harder for many seniors to access HIV care that pharmacists provide to other patients in their community.
ASHP will follow up directly with CMS to reiterate our concerns related to the NCD and opportunities to expand patient access to PrEP. We will closely monitor progress on the NCD implementation and update members on new developments.