Comments on Proposed Rule, “Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program”

The commenters provide input on several provisions of the proposed rule codifying Medicare drug price negotiation, including CMS’s approach to aggregating reformulated products, assessing bona fide generic and biosimilar competition, and determining the relevant approval date for drugs later deemed biologics. They encourage CMS to be more transparent about how the various exclusions, such as those for orphan drugs and plasma-derived products, affect drug selection, as well as how the agency weighs the evidence considered during negotiations to reach a final maximum fair price.