EXCLUSIVE: A group of over 50 bipartisan lawmakers is requesting the Trump administration to reconsider a proposed Medicare policy associated with the Biden-era drug price negotiation program, suggesting it might hinder the development of better cancer treatments.
In a letter dated September 21, the lawmakers urged Dr. Mehmet Oz, the Administrator of the Centers for Medicare & Medicaid Services (CMS), to eliminate the proposed fixed-dose combination policy from the final regulations of Medicare’s Drug Price Negotiation Program.
This Drug Price Negotiation Program was established through the Inflation Reduction Act, a law signed by former President Joe Biden in 2022. The Trump administration introduced this policy in June as part of implementing the program.
The main contention involves how Medicare will manage the negotiation of prices for newer versions of existing medications.
The lawmakers contend that the proposal would subject certain improved treatments to price negotiations under Medicare soon after receiving approval from the Food and Drug Administration (FDA), which might discourage drug manufacturers from creating enhanced versions of existing drugs.
“If this is finalized, the proposed policy would subject these advancements to negotiation almost immediately post-FDA approval, negatively affecting patient access and disincentivizing the development of improved therapies,” the lawmakers expressed in their letter.
On the flip side, CMS insists that the proposal seeks to prevent drug manufacturers from avoiding negotiated prices by making only minor modifications to existing drugs and then introducing them as new ones.
The lawmakers highlighted advancements in cancer immunotherapy, which allow some patients to receive a quick injection instead of undergoing lengthy intravenous treatments. They argue that such innovations can make treatment quicker, simpler, and more accessible, especially for those in rural areas.
“Cancer patients deserve access to the latest therapies, and if CMS moves forward with this proposal, these advancements may not reach those who need them the most,” the letter stated.
Moreover, the lawmakers remarked that the FDA evaluates these therapies as distinct medications, necessitating separate clinical trials and approvals. They emphasized that CMS ought to classify those therapies as separate medicines within the Medicare drug price negotiation framework.
Additionally, they argued that CMS actuaries have not proven that this policy would generate significant savings for taxpayers.
In conclusion, the letter firmly urged CMS to retract the fixed-dose combination proposal from the final regulations, stating, “The patients we represent need policies that broaden access to lifesaving care and reward advancements in treating critical illnesses.”
Over 50 lawmakers from both parties, including Representatives John Joyce (R-Pa.), Darin LaHood (R-Ill.), Mike Kennedy (R-Utah), Tim Moore (R-N.C.), Jim Costa (D-Calif.), and Donald Davis (D-N.C.), signed the letter. CMS was not immediately available for comment.
