Medicare should permit its beneficiaries who use continuous glucose monitoring to view the readings on their smartphone
© Greg Nash

Millions of Americans are using technology to improve their health. On our phone or on our wrist, we can track how many steps we are taking, how fast our heart is beating, and how our food intake measures up on any given day. Most of us rightfully take for granted our discrete access to this straightforward, personal and valuable information. But for many people with Type 1 diabetes or Insulin Dependent Type 2 diabetes, one critical number that could help them conveniently manage their health decisions using everyday technology is just out of reach because of outdated Medicare regulations. Fixing the problem would, of course, help these people control their diabetes. It would also be a sign that Medicare is willing to deliver on its promise to embrace new technology.

THE BACKGROUND:

Just over a year ago, Medicare added coverage for CGM, or continuous glucose monitoring system as a replacement for finger-stick monitoring, a major step forward in diabetes management for our nation’s seniors and people with disabilities. The first system covered under this new Medicare benefit not only replaces the cumbersome “finger-stick” method of glucose monitoring almost entirely, it also updates glucose readings every five minutes, as well as information on their rate of change, up to 288 times a day. The system uses a small sensor that measures glucose levels just underneath the skin, as well as a transmitter that fits onto the sensor to send data wirelessly to a receiver or compatible smart device in real time. Currently, experts estimate that few individuals with Type 1 diabetes take fingerstick readings more often than the ADA-recommended six times a day, many times administering insulin without any specific glucose information at all. Studies have shown that frequent monitoring of CGM systems may help a diabetes patient reduce A1C levels as well as the risk for hypoglycemia.

The CGM represents a quantum leap in helping to make daily diabetes decisions and is unique to the point that the FDA created a new “non-adjunctive” indication for the system. This non-adjunctive labeling means that the system can be used independently to make decisions on insulin doses. Patients would still need to calibrate their CGM using fingersticks, but only twice a day. This new “non-adjunctive” indication is a first step toward enabling people 65 and older with Medicare to access CGM, as non-adjunctive labeling is a requirement for Medicare coverage.

With Medicare coverage for CGM assured, patients who had come to rely on its almost real-time data thought they could look forward to a future of greater ease and less hassle in managing their diabetes. Users of the CGM could use the manufacturer’s receiver for monitoring or, they expected, their smart phone – a device that has become a ubiquitously used part of the landscape in meetings, restaurants, and at social events. A smartphone also offers the additional benefits of being able to share the data with a spouse or caregiver, and triggering an alarm day or night if readings supplied by the CGM move above or below safe parameters.

But there is a hurdle. Medicare needed to find a statutory benefit category that CGM could fit into and the one Medicare officials identified was the durable medical equipment (DME) category, which is designed to cover equipment like wheelchairs, walkers and hospital beds. Medicare determined that the CGM receiver met Medicare’s DME requirement. Because of this classification, Medicare will also pay for the sensors, transmitters and other disposable supplies necessary to view the glucose readings on the receiver. Medicare then went further than was necessary, specifically saying that, “If a beneficiary uses a non-DME device (smart phone, 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.” This means that patients would have to use the manufacturer’s receiver, and only the manufactuer’s receiver, to access data from the system, even though the FDA cleared the smartphone app as part of the CGM system.

Simply put: accessing the data generated by the CGM on the manufacturer’s receiver means that the cost of the entire system, and related materials, are covered subject to Medicare’s usual cost-sharing requirements. Accessing data generated by the system on a smart phone, in addition to or instead of the receiver, means that none of the costs are covered.

One very important clarification: no one is asking Medicare to buy smart phones for people with diabetes. But people with diabetes are asking Medicare to cover the cost of their CGM system and related materials if they choose to access their health data on their smart phone.

THE SOLUTION:

There is a straightforward solution to this problem. 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 smart phone for easier access. 

But there is a larger issue here beyond the use of smart phone technology to ease the lives of people with diabetes. 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. 

Congress and the administration can send an important message that it is willing to support and embrace innovative technologies that could help improve patients’ lives. Conversely, by not making such a simple change to allow the use of a beneficial technology like CGM, Medicare sets a disturbing precedent that it intends to cling to decades-old standards in medical care within its benefit package which will discourage future innovation that could improve the lives of seniors and people with disabilities.

James Scott is President of Applied Policy, a health policy and reimbursement consulting company.