CMS Codifies Drug Price Negotiation Program—With Modifications for 2029

Short summary

CMS proposed a rule codifying the Medicare Drug Price Negotiation Program with new policies for 2029 onward. The program expands from 15 to nearly 60 eligible drugs, with clarified rules for fixed-combination drugs, orphan drugs, and temporary small-biotech protections through 2030. Pharmaceutical companies and policy analysts must prepare for these regulatory changes affecting drug pricing and market access.

• •CMS proposed rule codifies Medicare Drug Price Negotiation Program for 2029 and subsequent years
• •Program expands eligibility to nearly 60 drugs from current 15, with new policies for combination drugs and orphan exclusions
• •Introduces temporary floor protections for small biotech drugs through 2030

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