Bipartisan Lawmakers Urge CMS to Reconsider Medicare Proposal Linked to Drug Pricing Law

<p>A bipartisan group of more than 50 lawmakers is urging the Trump administration not to finalize a proposed Medicare policy related to the Biden-era drug price negotiation program, citing concerns it could hinder the development of improved cancer treatments.</p><p>In a letter dated September 21, the lawmakers called on Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz to remove the proposed fixed-dose combination policy from the final rule implementing Medicare's Drug Price Negotiation Program.</p><p>The Medicare Drug Price Negotiation Program was established under the Inflation Reduction Act, which was signed into law by former President Joe Biden in 2022. The Trump administration introduced the policy in June as part of the program's implementation.</p><p>The central issue involves how Medicare would handle newer versions of existing drugs during price negotiations.</p><p>The lawmakers contend that the proposal would subject improved treatments to Medicare price negotiations shortly after receiving Food and Drug Administration (FDA) approval, which they argue would diminish incentives for drug manufacturers to develop better versions of existing medications.</p><p>“If finalized, the proposed fixed-dose combination policy would subject these advancements to negotiation almost immediately after FDA approval, harming patient access as well as incentives to develop these improved therapies,” the lawmakers stated in their letter.</p><p>CMS has indicated that the proposal aims to prevent drug manufacturers from circumventing negotiated Medicare prices by making only minor modifications to existing drugs and marketing them as new products.</p><p>The lawmakers highlighted advancements in cancer immunotherapy that enable some patients to receive a quick injection rather than spending hours on intravenous infusions, making treatment more efficient and accessible, especially for those in rural areas.</p><p>“Patients fighting cancer deserve access to the most advanced new therapies, and if CMS finalizes this proposal, those advances are less likely to reach those who need it the most,” the letter asserts.</p><p>They also noted that the FDA evaluates these therapies as distinct medicines, requiring separate clinical trials and approvals, and argued that CMS should treat them as separate entities under the Medicare drug price negotiation program.</p><p>Furthermore, the lawmakers claimed that CMS actuaries have not demonstrated that this policy would yield significant savings for taxpayers.</p><p>“We strongly urge CMS to withdraw the fixed-dose combination proposal from the final rule,” the letter concludes. “The patients we represent need policies that expand access to lifesaving care and reward medical progress and innovation in the treatment of deadly diseases.”</p><p>The letter was signed by over 50 lawmakers from both parties, including Reps. John Joyce, R-Pa., Darin LaHood, R-Ill., Mike Kennedy, R-Utah, Tim Moore, R-N.C., Jim Costa, D-Calif., Donald Davis, D-N.C., among others.</p><p>CMS could not be reached for comment at the time of publication.</p>