NPC submitted comments to the Centers for Medicare & Medicaid Services in response to the CMS–10847 Information Collection Request for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act (ICR or the ICR). The comments encourage CMS to use discretion in designing the Negotiation Data Elements information collection in a way that neither inappropriately burdens manufacturers nor constrains the ability of stakeholders to fully communicate relevant information in the context of a transparent drug evaluation process. NPC recommends that CMS:
- Increase Transparency and Flexibility around CMS’s Process.
- Reduce Manufacturer Burden While Removing Inappropriate Constraints.
- Clarify and Expand Patient-Centered Data Elements on the Value of Treatments