Healthcare & Life Sciences: Drug Pricing Digest - July 2021 #2

Latham & Watkins LLP

CMS Releases Proposed Physician Fee Schedule for 2022: On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released the proposed Physician Fee Schedule (PFS) for 2022 (link). Among other issues, the PFS addresses Medicare reimbursement for drugs approved under the 505(b)(2) pathway, after CMS withdrew a related proposal during last year’s rulemaking cycle. CMS again discusses price and utilization differences between 505(b)(2) drugs and “corresponding” multiple source drugs. As CMS considers potential future policymaking, the agency published a potential framework through which it would determine if a 505(b)(2) drug could be assigned to an existing multiple source (generic) drug code rather than receive its own billing code.

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