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Alliance, 34 Organizations Outline Detrimental and Unethical Issues with CED Policy

Published August 22, 2023

The Alliance for Aging Research, alongside 34 other organizations, on August 21, submitted a letter to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare program’s recent Proposed Guidance on Coverage with Evidence Development (CED).

The letter highlights the concerns of patient advocates, caregivers, and healthcare providers that the proposed CED criteria will lead to detrimental patient access issues, will put beneficiaries in unfair and unethical situations, and would constitute a significant overstep of CMS’ duties as assigned by Congress. For example, anyone who doesn’t have access to a major research hospital won’t have access. Also addressed is that patients might need to pay for a placebo if they’re forced to participate in a trial.

Additionally, the letter outlines the inherent need for CMS criteria to align with U.S. Food and Drug Administration (FDA) standards and congressional intent, underscoring the fact that Medicare’s core mission is to cover treatments that are both safe and effective and that the FDA’s Accelerated Approval Pathway is an important tool in bringing products to market for the most vulnerable and high-need patient populations. Our community is also concerned that the updated CED clinical study criteria outlined in this proposed guidance are overly broad with vague endpoints, which will likely lead to significant uncertainty for both beneficiaries and manufacturers about how and why CED will be implemented.

Overall, the letter strongly rebukes CMS’s failure to address stakeholders’ concerns, and advocates for broader access, inclusive data collection methods, and a decoupling of data collection from coverage requirements. It is imperative that CMS makes significant changes to this guidance in order to safeguard patient autonomy, ethical healthcare practices, and equitable access to essential and life-saving therapies.

Read the full letter here, signed by the following organizations:

  • Alliance for Aging Research
  • Alliance for Health Innovation
  • Alliance for Patient Access
  • Alzheimer’s Los Angeles
  • Alzheimer’s New Jersey
  • Alzheimer’s San Diego
  • Alzheimer’s San Diego
  • Arthritis Foundation
  • Association of Black Cardiologists
  • Autoimmune Association
  • Caregiver Action Network
  • Chronic Care Policy Alliance
  • EveryLife Foundation for Rare Diseases
  • Family Caregiver Alliance
  • Global Coalition on Aging Alliance for Health Innovation
  • HealthyWomen
  • Infusion Access Foundation
  • Infusion Providers Alliance
  • LuMind
  • LUNGevity
  • Lupus and Allied Diseases Association, Inc.
  • Melanoma Research Alliance
  • National Consumers League
  • National Minority Quality Forum
  • National Task Group on Intellectual Disabilities and Dementia Practices
  • Nevada Chronic Care Collaborative
  • NTM Info & Research
  • Parent Project Muscular Dystrophy
  • Partnership to Fight Chronic Disease
  • Society for Women’s Health Research
  • The Global CEO Initiative on Alzheimer’s Disease
  • The Mended Hearts, Inc.
  • UsAgainstAlzheimer’s
  • Voices of Alzheimer’s

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