NPC Submits Comments to CMS on Draft Guidance for the Medicare Drug Price Negotiation Program for 2027

NPC submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the notice, “Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027.” We provided several suggestions for CMS to consider that might be helpful in the transparency objective of the Agency as it implements the Medicare Drug Price Negotiation Program under the IRA. Our letter addresses:

1. Improving Transparency in the Implementation Process
2. (Section 40) Requirements for Manufacturers of Selected Drugs
3. (Sections 50 and 60) Negotiation Factors and Process
4. (Section 110) Part D Formulary Inclusion of Selected Drugs
5. General comments regarding orphan drug exemptions and the value of novel formulations