Response to CMS Proposed Guidance for the Next Round of Drug Price Negotiation
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CLS submitted comments in response to CMS’ proposed guidance on how they plan to implement the Medicare Drug Price Negotiation Program. In the next round of the negotiation program, CMS will select 15 drugs with their CMS negotiated prices going into effect in 2027. Among other topics, CLS emphasized ways for the agency to improve manufacturer and stakeholder engagement during the negotiation process, expressed concerns with the current scope of the Orphan Drug Exemption and provided considerations for the Small Business Exemption. We expect the guidance to be finalized this fall.
Read comments here.