Bipartisan Congressional Group Challenges Medicare Drug Pricing Rule on Advanced Therapies

More than 50 members of Congress from both sides of the aisle are calling on federal health authorities to reconsider a proposed Medicare policy that they contend could impede the creation of advanced medical treatments, particularly for cancer patients.

The contentious policy, put forth by the Centers for Medicare & Medicaid Services (CMS) in June, is part of the implementation of the Medicare Drug Price Negotiation Program. This program was established under the Inflation Reduction Act, a legislative package signed into law by President Joe Biden in 2022.

At the heart of the disagreement is how Medicare would determine eligibility for price negotiation for updated versions of existing medications.

Congressional representatives argue that the proposed rule would significantly accelerate the timeline for some enhanced therapies to undergo Medicare price negotiations, often shortly after receiving approval from the Food and Drug Administration (FDA). This, they warn, would diminish incentives for pharmaceutical companies to invest in developing improved iterations of current drugs.

Concerns Over Innovation and Patient Access

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 addressed to CMS.

They specifically referenced breakthroughs in cancer immunotherapy, which now allow some patients to receive quick injections instead of undergoing multi-hour intravenous infusions. These advancements, they noted, streamline treatment, enhance convenience, and improve accessibility, especially for individuals residing in remote 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 congressional letter emphasized regarding the potential negative impact on those fighting serious illnesses.

The lawmakers also pointed out that the FDA already evaluates these therapies as distinct medicines, necessitating separate clinical trials and approval processes. Consequently, they urged CMS to treat these therapies as separate entities within the Medicare drug price negotiation framework.

CMS Justification and Call for Withdrawal

Conversely, CMS has indicated that its proposal is intended to prevent drug manufacturers from circumventing or delaying negotiated Medicare prices by making minimal modifications to existing drugs and then reintroducing them as new products.

However, the lawmakers countered this justification, arguing that CMS actuaries "have not been able to show this policy would produce meaningful savings for taxpayers."

We strongly urge CMS to withdraw the fixed-dose combination proposal from the final rule. The patients we represent need policies that expand access to lifesaving care and reward medical progress and innovation in the treatment of deadly diseases,

the letter concluded with a strong appeal to the agency.

The letter garnered signatures from over 50 lawmakers representing both major political parties. Notable signatories include 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., among others.