The Centers for Medicare and Medicaid Services (CMS) held a comment period after releasing their initial guidance memo on how they plan to implement the Inflation Reduction Act (IRA). Patients Rising Now’s comments focused on two aspects of the memo. Firstly, the memo details a definition for unmet medical need and how that will factor into the negotiation process. However, the definition offered was very narrow in scope and in direct contrast with more comprehensive definitions from the FDA and the IRA bill text itself. This is a problem because it could potentially exclude disease areas from being included in this process in the future. Patients Rising Now recommended that the definition of unmet medical need be more in line with better, existing definitions to prevent this from happening.
Secondly, in the memo, CMS reaffirmed its commitment to seeking public comment on its implementation of the IRA going forward. But, CMS stated that its decision on the drug negotiation program, arguably the most important provision of the law, was finalized and not subject to a comment period. This is a concerning trend as CMS progresses forward with implementing the biggest overhaul to the Medicare program in nearly 20 years. Stakeholder input is an integral part of Federal Rulemaking as it helps Agencies make informed decisions before laws take effect. Patients Rising Now strongly urged CMS to continue soliciting comments as they proceed with implementing the IRA.