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EXCLUSIVE: A bipartisan group of more than 50 lawmakers is urging the Trump administration not to finalize a proposed Medicare policy tied to the Biden-era drug price negotiation program, arguing it could discourage development of improved cancer treatments.
In a Sept. 21 letter obtained by Fox News Digital, the lawmakers called on Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz to remove the agency’s proposed fixed-dose combination policy from its final rule implementing Medicare’s Drug Price Negotiation Program.
The Medicare Drug Price Negotiation Program was created under the Inflation Reduction Act, which former President Joe Biden signed into law in 2022. The Trump administration proposed the policy in June as part of implementing that program.
At the center of the dispute is how Medicare would treat newer versions of existing drugs for price negotiation purposes.
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The lawmakers called on CMS Administrator Dr. Mehmet Oz to remove the agency’s proposed fixed-dose combination policy from its final rule implementing Medicare’s Drug Price Negotiation Program. (Aaron Schwartz/CNP/Bloomberg via Getty Images)
The lawmakers argue the proposal would cause some improved treatments to face Medicare price negotiations much sooner after receiving Food and Drug Administration (FDA) approval.
They say that would reduce incentives for drugmakers to develop better versions of existing medicines.
“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 wrote.
CMS, meanwhile, said the proposal is designed to prevent drugmakers from avoiding or delaying negotiated Medicare prices by making only limited changes to existing drugs and introducing them as new products.
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The lawmakers argue that the proposal would subject some newly approved treatment improvements to Medicare price negotiations almost immediately after receiving FDA approval. (Kayla Bartkowski/Getty Images)
The lawmakers pointed to advances in cancer immunotherapy that allow some patients to receive a quick injection instead of spending hours receiving an intravenous infusion.
They said those improvements can make treatment faster, easier and more accessible, particularly for patients in rural areas.
“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 states.
The lawmakers also argued the FDA already evaluates the therapies as separate medicines, requiring separate clinical trials and approvals.
They said CMS should treat those therapies as separate medicines under the Medicare drug price negotiation program.
The lawmakers also argued that CMS actuaries “have not been able to show this policy would produce meaningful savings for taxpayers.”
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The Medicare Drug Price Negotiation Program was created under the Inflation Reduction Act, which former President Joe Biden signed into law in 2022. (Matt Kelley/AP Photo)
“We strongly urge CMS to withdraw the fixed-dose combination proposal from the final rule,” the letter states. “The patients we represent need policies that expand access to lifesaving care and reward medical progress and innovation in the treatment of deadly diseases.”
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The letter was signed by more than 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., and more.
CMS could not immediately be reached by Fox News Digital for comment.