Continuous glucose monitoring (CGM) devices approved by the FDA for use in making diabetes treatment decisions are durable medical equipment, according to a decision on January 12th by the Centers for Medicare & Medicaid Services (CMS). That determination removed a major roadblock to the devices’ coverage under Medicare. Thursday’s decisions mean that CGMs approved by the FDA for use in making diabetes treatment decisions are eligible for reimbursement under Medicare.
Thursday’s decision creates a pathway for Medicare coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Although the significant benefits of CGM use have been known since 2008, CMS had previously refused to consider covering the devices under Medicare, saying they did not meet the statutory definitions of durable medical equipment or any other category the agency could cover. Thursday’s decision removes that impediment.
“JDRF is encouraged by this decision, which will bring us closer to Medicare coverage for continuous glucose monitors,” said Aaron J. Kowalski, PhD, JDRF’s Chief Mission Officer. “I want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible.”
JDRF has been the leading advocate for widespread adoption of CGM technologies to manage T1D and for public and private payer coverage for their purchase and use. JDRF has spearheaded the drive to obtain Medicare coverage for CGM devices, marshalling research, expert testimony, allied organizations, and JDRF advocates from across the nation. JDRF met numerous times with officials at CMS and with others in the executive branch to urge them to provide access to this life-changing technology using the agency’s existing authority. At the same time, JDRF engaged Congress, persuading 50 Senators and 275 Representatives to support legislation to require Medicare to provide CGM coverage.
JDRF wants to thank everyone who made this decision possible, especially the Centers for Medicare & Medicaid Services, Diabetes Caucus co-chairs Senators Susan Collins (R-ME), Senator Jeanne Shaheen (D-NH), Representative Tom Reed (R-NY), and Representative Diana DeGette (D-CO), our Congressional supporters, our allies, and the thousands of JDRF advocates who made their voices heard in Washington, D.C.
Thursday’s decision was more than a decade in the making. In 2006, JDRF launched a multi-center clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with T1D of all ages, including reduced HbA1c levels, increased time in range, and a significant drop in incidents of hypoglycemia. The results from that trial led to national diabetes clinical organizations changing their treatment guidelines for T1D to recommend CGM use and to broad coverage of the technologies by most private insurers. Thursday’s recognition of CGMs as durable medical equipment is just one example of the advances JDRF has been able to achieve for the T1D community because of our unique position as a trusted advisor to lawmakers, government administrators and health care thought leaders.
JDRF is heartened by today’s decision and will continue to work as necessary to ensure robust coverage of CGMs for people with T1D on Medicare. We look forward to working with the incoming Congress and administration to ensure broad and affordable access to exciting new T1D therapies like the artificial pancreas systems and to advance the interests of the T1D community at every level.
Why is it important?
CGMs enable superior blood-glucose management for people with T1D. Because they sense glucose levels every five minutes, night and day, they allow users to see whether their levels are trending high or low before they become dangerous. Extensive clinical evidence shows that CGM use significantly improves diabetes management, enabling users to avoid potentially deadly low blood-sugar crises (hypoglycemia) and the devastating long-term complications associated with chronic high blood-sugar (hyperglycemia). Insulin-dependent seniors in particular are at elevated risk for hypoglycemia, leading not only to bad health outcomes, but increased use of costly emergency room visits and hospitalizations. The government’s refusal to recognize CGMs as durable medical equipment meant they couldn’t be considered for coverage under Medicare, forcing those with T1D who rely on such coverage—even those who had been successfully managing their disease with the devices when they were covered by private insurance—to pay out-of-pocket for CGMs or go without.