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JDRF, the leading global organization funding type 1 diabetes (T1D) research, is pleased to announce that after more than a decade of advocacy efforts, the Centers for Medicare & Medicaid Services (CMS) has recognized continuous glucose monitoring (CGM) devices approved by the FDA for use in making diabetes treatment decisions as durable medical equipment, a significant step toward making them eligible for coverage under Medicare. JDRF has been the leading advocate for widespread adoption of CGM technologies to manage T1D and for public and private payer coverage of these devices.
“JDRF is encouraged by this decision, which will bring us one step closer to Medicare coverage for continuous glucose monitors,” said Aaron J. Kowalski, PhD, JDRF’s Chief Mission Officer. “We want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible.”
Continuous glucose monitors are small, wearable devices that monitor glucose levels every few minutes, day and night, which helps people with T1D to manage insulin dosing and to see whether their levels are trending high or low before they become dangerous. CGM devices are approved by the U.S. Food and Drug Administration (FDA) and prescribed by physicians, and their use is recommended by national diabetes clinical guidelines and covered by nearly all private health plans. 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). Seniors with T1D 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.
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. People 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—were forced to pay out-of-pocket for CGM or go without.
Today’s CMS decision is a welcome advancement, laying a pathway toward the extension of coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Since Medicare has determined CGM devices are durable medical equipment, the program can now cover them on a case-by-case basis. Medicare beneficiaries should work with their health care professional and CGM provider to obtain coverage.
JDRF wants to thank everyone who made today’s 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. 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.
JDRF has spearheaded the drive to obtain Medicare coverage for CGMs, marshalling research, expert testimony, allied organizations and JDRF advocates from across the nation. JDRF met numerous times with officials at CMS and elsewhere 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 is heartened by today’s decision and will continue to work with officials at the Centers for Medicare & Medicaid Services to ensure robust coverage of CGMs for people with T1D on Medicare.
For Further Information
More on the diabetes device market in the U.S. can be found in a series of reports published by iData Research entitled the US Market Report Suite for Diabetes Monitoring, Treatment and Drug Delivery. The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, inulin pens, insulin syringes and insulin pumps.
The iData report series on diabetes devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Diabetes Monitoring, Treatment and Drug Delivery brochure and synopsis.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.
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