CMS Embraces mHealth With Reimbursement for Smartphone CGM Links

Healthcare providers who collaborate with diabetic patients through smartphone-enabled continuous glucose monitors (CGMs) will soon be reimbursed under Medicare.

The Centers for Medicare & Medicaid Services announced the change in coverage this week, bowing to pressure from patients and other stakeholders. When enacted, the new ruling will allow for coverage of CGMs that transmit data to a smartphone; that data can then be shared by the user with care providers and others.

CMS “is taking steps to help Medicare beneficiaries with diabetes to better manage their health,” CMS Administrator Seem Verma tweeted. “Medicare has more than 9 million beneficiaries with diabetes, and improving their care is critical.”

“Medicare beneficiaries & their family members are savvy users of applications that make a huge difference in their ability to manage their health,” she added. “We’re making it easier for patients who want to use technology in their diabetes care.”

The move drew strong support from, among others, the Juvenile Diabetes Research Foundation (JDRF) and The American Association of Diabetes Educators.

In January 2017, CMS waded into the fast-growing mHealth diabetes space by enabling Medicare coverage for therapeutic GCMs, which monitor a user’s blood sugar without the need for drawing blood through regular finger pricks. At that time, CMS indicated it wouldn’t be extending that coverage to smartphones or other devices classified as durable medical equipment (DME).

“Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data,” the agency wrote in its ruling. “If a beneficiary uses a non-DME device (smartphone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare.”

That ruling drew a storm of protest from patients, mHealth vendors and healthcare providers, who said the ban on smart devices prevented patients and their care providers from collaborating on care management.

“There is a straightforward solution to this problem,” James Scott, president of Applied Policy, a health policy and reimbursement consulting company, wrote in The Hill. “If a patient is using data shown on the manufacturer’s receiver, Medicare should cover the system, regardless of whether a smartphone also displays the data. In other words, if the receiver is being used, it should not matter to CMS if the data is also sent to a smartphone for easier access.”

Other critics pointed out that the narrow ruling forced patients with diabetes to choose between Medicare coverage and sharing vital health information with their care providers.

Scott went even further in his criticism of the CMS ruling.

“There is a larger issue here beyond the use of smart phone technology to ease the lives of people with diabetes,” he said. “Congress and the administration need to amend the outdated Medicare statute to accommodate technologies that were not anticipated when President Johnson signed the Medicare program into law in 1965. Medicare officials should not have to strain their interpretation of a benefit designed for reusable medical equipment like walkers, wheelchairs, and hospital beds, to accommodate advanced technologies like continuous glucose monitors. The Medicare program should cover CGM for patients for whom it is medically necessary, without regard to how they use technology to view, store or share their glucose readings with their spouse, caregiver or physician.”

Earlier this year, Congress got into the act.  A bipartisan group of lawmakers sent a letter to CMS in March asking the agency 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.”

Also in March, the U.S. Food and Drug Administration (FDA) approved Dexcom’s interoperable continuous glucose monitoring system, lending federal support to an mHealth platform that connects CGM devices with smartphones.

“Kudos to FDA for making sound digital medical devices available quickly, in this case to diabetic children,” Robert Jarrin, Qualcomm’s senior director of wireless health policy, told Politico at the time. “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.”

With this new ruling, CMS appears to have heeded that advice.  The agency said the ruling will take effect once the Durable Medical Equipment Medicare Administrative Contractors issue a revised policy article.

by Eric Wicklund,