CMS’ Final Guidance on Medicare Drug Price Negotiation Program Offers Some Clarity, But Misses Opportunity to Address the Small Molecule Penalty

Executive Director of Incubate, John Stanford, issued the following statement regarding the release of the Centers for Medicare and Medicaid Services’ (CMS) final guidance on the Medicare Drug Price Negotiation Program.

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07.06.2023

Washington, DC – Executive Director of Incubate, John Stanford, issued the following statement regarding the release of the Centers for Medicare and Medicaid Services’ (CMS) final guidance on the Medicare Drug Price Negotiation Program – the agency’s roadmap for how it will implement the prescription drug price controls included in legislation passed by Congress last year:

“We appreciate the improvements offered by CMS in final guidance, however, the final guidance fails to meaningfully address the majority of the concerns raised in our April comment letter to CMS’ draft guidance. Most importantly, the guidance reinforces the perverse incentives created in the price control program that favor certain types of drugs over others, fails to meaningfully engage stakeholders, and undermines incentives for the development of treatments for rare diseases. We hope CMS will consider alternative approaches within the statute that will not exacerbate the growing trend of investment dollars away from small molecule medicines. The guidance also underscores the urgency for Congress to address the small molecule pill penalty.”