- As federal regulators approve more mHealth devices for diabetes care management and coordination, some in Congress are lobbying for better Medicare coverage of digital health.
A bipartisan group of lawmakers this week asked the Centers for Medicare and Medicaid Services (CMS) to provide coverage for “clinically appropriate treatment” for people living with diabetes, including mobile health devices that measure a user’s blood glucose levels and transmit that data to smartphones and other care management devices – and, eventually, to caregivers.
“Effective management of diabetes is crucial to holding down healthcare costs and helping seniors manage their diabetes successfully to allow them to continue to live healthy and productive lives,” Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) wrote in a letter to CMS Administrator Seema Verma. “We urge your careful review of Medicare coverage policies for patch pumps and other life-saving therapies for diabetes, in accordance with applicable laws and regulations, and to review the procedures at CMS that have resulted in these disparities in coverage.”
The letter, which was also reportedly endorsed by U.S. Reps. Diana DeGette (D-Colo.) and Tom Reed (R-N.Y.), co-chairs of the House Diabetes Caucus, takes Medicare to task for not covering innovative mHealth technology that has been approved by the U.S. Food and Drug Administration to help those with diabetes.
“In today’s ever-changing environment, we are optimistic that scientists are discovering better disease management tools and treatments every day, and believe CMS should closely follow these changes through their approval process,” the letter states. “For instance, patch pumps that provide continuous insulin delivery from a patch without the need for tubes, such as the Omnipod Insulin Management System, which the [FDA] first approved in 2005, are covered by many private insurers, yet CMS has not included these devices for coverage under Medicare. Consequently, individuals with diabetes may lose coverage for the physician-prescribed therapies they have been successfully using to manage their diabetes when they age into Medicare.”
CMS has a long history of reticence in covering mHealth and telehealth, and has been the subject of many Congressional bills seeking relaxed regulations or increased reimbursements. While only a few of the many bills proposed last year made it to law, the two-year budget deal signed by President Donald Trump in February did contain several provisions designed to improve Medicare and Medicaid coverage for telemedicine and telehealth.
Still, the going isn’t easy. CMS is rolling out a new National Diabetes Prevention Program (NDPP) this April, but certain digital health coaching models are being left out of Medicare coverage because the agency has said they haven’t proved their value.
That’s not the case with mHealth technology for diabetes care management, say Collins and Shaheen.
Ironically, their letter comes at the same time as FDA approval of a new continuous glucose monitoring (CGM) platform, the second such mHealth device to gain FDA approval this month.
The FDA this week announced approval of the Dexcom G6 integrated CGM system, billed as the first device to be able to integrate with other compatible medical devices, including blood glucose meters, insulin pumps and other diabetes management devices.
The Dexcom G6 is a coin-sized patch that attaches to the abdomen. A small sensor in the device continuously measures blood glucose levels and transmits readings every five minutes to a smartphone app or similar mHealth platform. When paired with an insulin dosing device such as a pump, the G6 could automatically trigger insulin injections when its sensors detect high blood glucose levels.
The Dexcom G6 was also reclassified from a Class III (highest risk) device to a Class II (moderate risk, with special controls to ensure acceptable performance) device, paving the way for faster federal approval for future devices operating with the same technology.
“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a release. “In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
The news drew praise from several mHealth advocates. Bradley Merrill Thompson, an attorney with Epstein, Becker and Green who closely follows FDA regulation in digital health, told Politico the FDA “appears to be getting comfortable with what it takes to make an interoperable claim.”
Robert Jarrin, Senior Director of Wireless Health Policy for Qualcomm, also praised the announcement – while making note of CMS’ reluctance to reimburse providers for using the technology.
"Kudos to FDA for making sound digital medical devices available quickly, in this case to diabetic children," he told Politico. "Now let's hope that someday soon CMS will return the favor and designate digital medical [devices] as [durable medical equipment] and reimburse for these technologies in Medicare."
Roughly two weeks ago, the FDA approved Medtronic’s Guardian Connect CGM platform, which reports blood sugar readings every five minutes and can detect a user’s trending blood sugar levels up to an hour in advance and send a smartphone alert. Those alerts are generated by a smartphone app developed with IBM’s Watson Health, which uses AI tools to detect trending health concerns before they happen.