New report analyzes the patient impact of growing coverage restrictions for FDA accelerated approval treatments.

WASHINGTON — Patients Rising, a non-profit organization that champions patients with chronic and rare diseases, today released a special report titled CMS vs FDA: How Medicare and Medicaid Coverage Decisions Limit Access to FDA-Approved Treatments, which analyzes the impact of growing coverage restrictions on new accelerated approval drugs. 

The report comes on the heels of several unprecedented decisions from the Centers for Medicare and Medicaid Services (CMS), most notably its restrictions on coverage for an entire class of Alzheimer’s drugs granted accelerated approval by the Food and Drug Administration (FDA). With the first of those drugs, lecanemab, receiving full traditional approval this month, CMS has restricted coverage to individuals participating in patient registries.

The report will be discussed in full at a Hill Briefing on Monday, July 24, at noon ET. The list of speakers, including Mel Mann, the longest-living Gleevec patient, is available here. 

The report is informed by policy experts, physicians, and patients who have benefitted from accelerated approval drugs, and assesses the impact of the new CMS precedent on future drugs that receive accelerated approval. Many drugs that receive accelerated approval are treatments for cancer, which remains the second-leading cause of death for American adults. 

“The reason that the accelerated approval pathway exists is to give patients quick access to safe and effective new treatments,” said Terry Wilcox, CEO of Patients Rising. “These coverage restrictions from CMS undermine the FDA’s authority and the mission of this pathway, because what good is a treatment if patients can’t get coverage for it? It’s incredibly concerning for patients who do not have a single approved treatment and are desperately waiting for one to arrive.” 

CMS vs FDA: How Medicare and Medicaid Coverage Decisions Limit Access to FDA-Approved Treatments includes a comprehensive timeline of the accelerated approval pathway and provides a detailed accounting of CMS’s response to newly approved drugs over the past 30 years. Also included is an assessment of other areas of restrictions on accelerated approval drugs, such as state Medicaid programs, where several states have denied coverage for these treatments.

“Recent scientific advances have vastly increased our understanding of diseases and the long-term value of new and innovative therapies,” said MacKay Jimeson, Executive Director at Patients Rising’s Patient Access & Affordability Project. “This progress has allowed for the development of medications and treatments with the potential to significantly improve quality of life for patients across a broad spectrum of diseases and populations. Policymakers should focus on encouraging this type of progress instead of burdening innovators with inappropriate restrictions and placing barriers between patients and the latest treatments.”

The report is a product of the Patient Access and Affordability Project, a program of Patients Rising. It is available on

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