The Centers for Medicare & Medicaid Services (CMS) is expected to weigh recommendations from the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in establishing guidelines for clinical evidence for devices for the self-management of diabetes for Medicare beneficiaries. Meanwhile, a group of 28 non-diabetes organizations has questioned CMS’s reasons for convening the May meeting at which MEDCAC considered the devices.
MEDCAC’s role and authority
Established in 1998 and originally named the Medicare Coverage Advisory Committee (MCAC), MEDCAC’s primary purpose is to provide CMS independent guidance and expert advice on specific clinical topics. It supports the evidence-based determination process for Medicare’s coverage policies, helping CMS decide which medical items and services meet the standard of being reasonable and necessary for coverage under Medicare.
Importantly, MEDCAC does not make coverage decisions. Its charter emphasizes the committee’s role in supplementing CMS’s internal expertise by enabling an unbiased and contemporary deliberation of “state-of-the-art” technology and science.
A former director of the Coverage and Analysis Group in CMS’s Centers for Clinical Standards and Quality once observed that MEDCAC meetings are crucial not only when there is disagreement about a treatment option but also when there is a large body of evidence to review regarding a non-controversial treatment option. This wide-ranging utility can invite speculation about the purpose of any individual meeting.
Questioning CMS’s purpose for convening MEDCAC
In announcing that MEDCAC would meet on May 21, CMS stated that the committee was being called to “examine what clinical endpoints should be of interest to CMS in studies of new devices for self-management of type 1 and insulin-dependent type 2 diabetes in older adults.” Those questioning the purpose for the— including the Alliance for Aging Research, the National Hispanic Council, and Voices in Alzheimer’s— contend that MEDCAC was convened as a step towards restricting Medicare beneficiaries’ access to devices approved by the Food and Drug Administration (FDA).
In a letter to CMS Administrator Chiquita Brooks-LaSure, the coalition argued that CMS had opted to “leverage research debates to justify utilization management.” They also faulted CMS for not publicizing the February meeting of a MEDCAC subgroup on self-management devices until after the group had met. Stating that CMS had not consulted the Agency for Healthcare Research and Quality (AHRQ), the groups argued, “No external organizations requested this evidence review of end points for trials of diabetes devices.”
According to CMS, the May review was necessary because many of the studies submitted to the FDA for its approval of continuous glucose monitors, insulin pumps, and automated insulin delivery systems for people with Type 1 and Type 2 insulin-treated diabetes had not been specific enough to the elderly population covered under Medicare.
MEDCAC member Brian Isetts, RPh PhD, BS-Pharm, expressly rejected the argument that the meeting was “a set-up to the rationing of patient care.” He said that MEDCAC acted as “stewards of the Medicare Trust Fund” and expressed his hope for a collaborative discussion.
MEDCAC Chair Joseph Ross, M.D. echoed Isetts’ characterization of MEDCAC’s role and the purpose of the meeting. He commented that MEDCAC does not “discuss the authorization or payment for any specific technology” but advises CMS on “what they should be looking for in the body of evidence.”
In his remarks to the committee, Aaron Turner-Phifer, Director of Health Policy at Breakthrough T1D (formerly JDRF), which was not a party to the letter, stated that he had seen “real-world evidence that the impact of these devices is a positive one across population demographics.” He said, “With respect to the underlying data about the impact of the devices, I think that we would consider it to be positive across the board.”
Ensuring patient access to innovative technologies remains a critical challenge for CMS and the broader healthcare system. The forthcoming guidance document and subsequent policy decisions will have significant implications for the availability of advanced diabetes devices and the overall quality of care for older adults with diabetes, especially as the number of people with diabetes continues to grow in our country.
CMS stated it will publish draft guidelines for clinical evidence threshold for Medicare beneficiaries with diabetes that manufacturers and investigators of diabetes technology can use when developing evidence for coverage. The public will have an opportunity to comment on the draft guidelines before they are finalized. CMS did not provide a timeline for when the draft will be published.