Industry asks CMS to drop cost-plus approach to IRA

CMS has a great deal of discretion about how it implements the Inflation Reduction Act. Decisions it will make over the next year could have profound effects on the kinds of medicines that are developed and made available to patients.

CMS’s choices in the coming months could also determine if the Medicare drug price negotiation program will be launched on time, or if it will be delayed and modified as a result of litigation, including lawsuits challenging the agency’s decision to rely on guidance rather than formal notice-and-comment rulemaking. ...