CMS finalized enforcement provisions in the 2026 OPPS Final Rule implementing the regulatory requirement that Part B drug coverage is contingent on an active National Drug Rebate Agreement (NDRA). Effective April 1, 2026 Medicare Part B began denying payment for drugs from manufacturers that do not have a NDRA in place. Affected drugs will be assigned HCPCS status indicator E1 (not paid by Medicare on outpatient claims).
Practices can reference the quarterly CMS ASP pricing files for a list of “Drugs Not Payable Under Part B”. Because the files are updated quarterly, payment denials will begin in the quarter in which a drug appears on the applicable ASP file as non-payable and will generally continue until the manufacturer’s NDRA status is restored and reflected in a subsequent quarterly ASP file update.
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