Alliance Statement to MEDCAC on Devices for Self-management of Type 1 and Insulin-Dependent Type 2 Diabetes

The following statement was made today by Alliance President & CEO Sue Peschin, MHS, during the public comment portion of the Centers for Medicare & Medicaid Services (CMS) virtual meeting of its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on devices for self-management of Type 1 and insulin-dependent Type 2 diabetes:

The Alliance for Aging Research is the leading nonprofit organization dedicated to changing the narrative to achieve healthy aging and equitable access to care. The Alliance receives unrestricted support from industry and others for our mission.

The Alliance is locking arms today with 27 other non-diabetes organizations, to oppose any efforts by the CMS to restrict beneficiary access to FDA-approved devices for self-management of Type 1 and insulin-dependent Type 2 diabetes.

We have sent a letter signed by 28 non-diabetes organizations to Administrator Brooks-LaSure and to this MEDCAC, along with key Congressional staff. The letter is publicly available on the Alliance’s website at agingresearch.org, and it was emailed to all of you. I’ll read just a few of the groups here:

• American Kidney Fund
• Melanoma Research Alliance
• National Grange
• National Hispanic Council on Aging
• National Medical Association
• Prevent Blindness
• Voices of Alzheimer’s

In part, the letter states:

We are increasingly disturbed by the CMS Coverage and Analysis Group’s creation and leveraging of research debates to justify utilization management of Part B items and services. This process of positioning this advisory committee 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 researchers, clinicians, and patient advocates serving people living with diabetes.

No external organizations requested this evidence review of end points for trials of diabetes devices. Nor was the Agency for Healthcare Research and Quality consulted, and that is the HHS agency charged with conducting CMS evidence reviews. CMS instead convened a MEDCAC subgroup on its own in February 2024 that was not publicly announced until about a month after it occurred. This subgroup reviewed a report, written by an outside contractor, on devices for diabetes self-management, and enlisted one guest endocrinologist to provide responses to CMS’s questions. It raises questions about the agency’s judgment when it pursues this topic, without reasonable justification, in light of its struggles to manage resources.

To be clear—no one in the diabetes community asked for this.

Here’s where CMS’ interests lie—diabetes is the most expensive chronic disease in the United States. That makes medical devices for diabetes self-management a rich target for Medicare Part B coverage restrictions. This should not be done. 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.

This exercise is similar to one CMS staged in 2021, when mundane academic debate on targeting amyloid was leveraged to squash coverage for the entire class of FDA-approved disease-modifying therapies for the treatment of early Alzheimer’s in April 2022.

The effectiveness of CMS’ cost-cutting strategy in Alzheimer’s lies in the small number of Medicare-related claims paid for Leqembi, the second FDA-approved therapy in the class. Since July 2023, based on claims data, only a scant 4,000-5,000 patients have started on Leqembi, with approximately 2,000-2,500 patients currently on treatment. This is a fraction of potentially eligible patients.

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.

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. Thank you.