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A health advisory committee has recommended that Medicare consider metrics such as range time and safety data when making coverage decisions for diabetic devices. At a meeting Tuesday, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) discussed the clinical parameters CMS should request on devices used to manage type 1 diabetes and type 1 diabetes. 2 insulin-dependent in the elderly.
The CMS convened the panel because devices used to monitor and control glucose levels, such as continuous glucose monitors and insulin pumps, have not been studied as much among older people, and insulin-dependent type 2 diabetes is increasing among older people, the agency said in a briefing.
CMS also plans to soon finalize guidance on how it will consider evidence when making national coverage decisions.
Steven Farmer, the agency's director of strategy for coverage, said device makers will be better positioned if they anticipate both FDA and CMS expectations.
The advisory committee voted on the importance of four types of evidence in diabetes device studies: surrogate markers, safety, health outcomes and quality of life.
Seven of the nine panelists found surrogate markers – such as time in range, number of hypoglycemic episodes or impact on HbA1c – to be “extremely important”.
“I think that's actually the most important because that's what you're asking: Does the device do what it claims to be trying to do?” said Alexander Fanaroff, assistant professor of medicine at the Perelman Center for Advanced Medicine at the University of Pennsylvania.
Most panelists also found device security “very important.” The metric was defined as hypoglycemia-related emergency department visits, harms such as tissue damage, device discontinuation rates, and patient preferences.
Panelists said safety is essential, but expressed concerns about turning off the devices as a safety measure. For example, perhaps a patient doesn't have transportation to get to the pharmacy or clinic to pick up the support or supplies they need, said Brian Isetts, a professor in the College of Pharmacy from the University of Minnesota.
Votes on health outcomes and quality of life metrics were less decisive.
“I am concerned that adopting strict measures requiring consideration of diabetes complications, including kidney disease and major cardiovascular events, for CMS to cover these devices would be prohibitively expensive…and would then so that the devices are not available for health insurance. population,” said Joy Lewis, professor of internal medicine and public health at AT Still University.
Lewis voted that quality of life measures were “very important” because a person might be able to have better hypoglycemic awareness, eat what they want and exercise without fear.
In contrast, Melissa Garrido, a research professor of health law, policy and management at the Boston University School of Public Health, voted that it was “not important.”
“I think quality of life measures are important and should continue to be studied, but I don't think they should be considered in a CMS coverage decision,” Garrido said.
Industry supports measuring time spent in range
Diabetes businesses and nonprofit leaders also used the meeting to share their thoughts with CMS advisors.
Executives from Dexcom and Tandem Diabetes Care have both advocated time in range as an important metric.
“In a population like this, there is no consensus on what a blood sugar goal should be due to the high risk of hypoglycemia and other heterogeneous factors,” said Laurel Messer, senior director of business. Tandem medical services. “It is therefore very important to take into account the individual needs of older people with diabetes. »
Aaron Turner-Phifer, health policy director at the diabetes nonprofit JDRF, drew attention to time spent in Level 1 hypoglycemia and Level 1 hypoglycemia as important metrics for people with type 1 diabetes.
JDRF and Leaders of the American Diabetes Association welcomed CMS's recent decision to expand CGM coverage to all people with diabetes who take insulin or have a history of hypoglycemia and urged the agency not to limit access to the devices.
“We also caution against any suggestion, as suggested in the papers prepared for this meeting, that there is a lack of clear evidence regarding the impact of diabetes on older people living with (type 1 diabetes),” Turner-Phifer said. “We don't think there is a fundamental difference in the physiology of older people that warrants separate data from younger people.”