On March 15, the Centers for Medicare and Medicaid Services (CMS) made a series of important announcements regarding implementation of the Inflation Reduction Act (IRA). Most crucially, CMS issued new initial guidance on implementation of the Medicare Drug Price Negotiation Program (Medicare Drug Price Program), with public comments due April 14, 2023.
Notably, CMS did not issue the initial guidance through notice and comment rulemaking. Instead, CMS states that it is “voluntarily soliciting comment on certain topics” in the guidance and asserts that certain aspects of the guidance are “not subject to the notice-and-comment requirement of the Administrative Procedure Act or Medicare statute.” CMS further asserts that “to the extent that this guidance establishes or changes any substantive legal standard, CMS finds that notice and public procedure on this guidance would be impracticable, unnecessary, and contrary to the public interest.” For certain areas of the guidance, CMS states that it intends to issue revised guidance after considering the public comments received in response to this initial guidance.
CMS’s procedures may implicate the Administrative Procedure Act and add to the potential for IRA-related litigation. Stakeholders should comment on the guidance to provide feedback to CMS on implementation, as aspects of the guidance may be revised, and also to raise additional procedural and substantive issues in the event of future IRA litigation.
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