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Non-Diabetes Advocacy Groups: Let Clinicians Help Medicare Beneficiaries to Determine Interventions, Not Barriers

Published May 21, 2024

A young set of hands using a device to test the blood of an older person's finger.

Today, in a letter to the Centers for Medicare and Medicaid Services (CMS), 28 non-diabetes advocacy organizations voiced opposition to any efforts by CMS to restrict beneficiary access to FDA-approved devices for self-management of Type 1 and insulin-dependent Type 2 diabetes.

The organizations are increasingly disturbed by the CMS Coverage and Analysis Group’s leveraging or creation of research debates to justify utilization management of Part B items and services.

Today’s process of positioning the agency’s Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to re-evaluate clinical outcomes for an entire class of medical products—that the FDA already legitimately determined to be safe and efficacious—takes valuable time and resources away from diabetes researchers, clinicians, and patient advocates to serve people living with diabetes.

The letter details that no external organizations requested this evidence review of end points for trials of diabetes devices. Nor was the federal health agency charged with CMS evidence reviews—the Agency for Healthcare Research and Quality—consulted.

The letter states that the standards of care established by the American Diabetes Association and American Association of Clinical Endocrinology unequivocally endorse the use of continuous glucose monitors and insulin pumps by people who are insulin dependent. These endorsements rest on a foundation of voluminous clinical data, with scores of studies affirming the medical necessity of these technologies. The use of these devices is established science and there is no basis whatsoever for calling that into question. 

It makes sense that the federal statute authorizing Medicare starts with a non-interference clause that prohibits CMS from “supervision or control over the practice of medicine or the manner in which medical services are provided.” Clinicians should be able to help Medicare patients decide which interventions are best for them, without complicated coverage barriers dictating care.

An excerpt: CMS is a payer; it is not a biomedical expert agency like the FDA or anyone’s family doctor. The actions being taken by CMS on diabetes self-care devices are an overreach of agency authority and undermining of public trust in the FDA and more broadly in biomedical science itself. Ultimately, the agency and this advisory committee should not be staging research debates to vindicate itself from what’s really happening here—a set-up to the rationing of patient care.

Read the full letter.

The letter was signed by the following:

  • Alliance for Aging Research
  • Alliance for Women’s Health and Prevention
  • American Cochlear Implant Alliance
  • American Kidney Fund
  • American Society of Consultant Pharmacists
  • Association of Black Cardiologists
  • Caregiver Action Network
  • Global Alzheimer’s Platform Foundation
  • Global Coalition on Aging Alliance for Health Innovation
  • Healthy Men Inc.
  • HealthyWomen
  • Let My Doctors Decide
  • Lupus and Allied Diseases Association, Inc.
  • Melanoma Research Alliance
  • National Association of Nutrition and Aging Services Programs
  • National Caucus and Center on Black Aging
  • National Consumers League
  • National Grange
  • National Hispanic Council on Aging
  • National Medical Association
  • National Minority Quality Forum
  • Nevada Chronic Care Collaborative
  • Partnership to Fight Chronic Disease
  • Prevent Blindness
  • RetireSafe
  • The Balm In Gilead, Inc
  • UsAgainstAlzheimer’s
  • Voices of Alzheimer’s

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