Twenty-one Organizations Submit Comments to the Medicare Evidence Development and Coverage Advisory Committee Panel in Advance of December Meeting
Published November 7, 2022
The Alliance for Aging Research and 20 partner organizations submitted comments to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Panel asking them to advise the Centers for Medicare and Medicaid Services (CMS) to revise and improve its Coverage with Evidence Development (CED) study criteria. The letter urges that MEDCAC recommend to CMS that CED-approved studies be clear in their scope, be finite in duration, and be reported on ClinicalTrials.Gov. Under CED, the Medicare program covers FDA-approved medical treatments on an extremely limited basis, and under the condition that beneficiaries must enroll in a clinical trial or patient registry.
Ultimately, the 21 groups believe that CMS should discontinue the use of CED altogether and either: (1) issue final National Coverage Determinations (“NCDs”) that do not utilize the CED process; and (2) issue NCDs that cover all drugs and biologics approved by the U.S. Food and Drug Administration (subject to appropriate conditions such as safety recalls).The letters cites how use of CED is beyond CMS’ authority and has never been authorized by Congress.
Too often, this protocol results in millions of patients not gaining access to treatment they need and further exacerbates health inequities for communities of color and low-income Americans. An April 2022 study published in the American Journal of Managed Care (AJMC) on the CED process notes that of 27 CEDs initiated over the past 15-20 years, less than 20 percent have been concluded, and several never resulted in a study at all. The consequence is that numerous new treatments and technologies continue to be severely limited without ongoing justification.
Organizations on the letter include:
- Alliance for Aging Research
- American Society of Consultant Pharmacists
- Association of Black Cardiologists
- BrightFocus Foundation
- Cancer Support Community
- Caregiver Action Network
- EveryLife Foundation for Rare Diseases
- Global Alzheimer’s Platform Foundation
- Global Coalition on Aging Alliance for Health Innovation
- Infusion Providers Alliance
- Men’s Health Network
- National Alliance for Caregiving
- National Medical Association
- National Minority Quality Forum
- Partnership to Fight Chronic Disease
- The Balm in Gilead
- The Mended Hearts, Inc.
- Voices of Alzheimer’s
Read the letter in full here.