Medicare Coverage – CGMs and Other Devices

One Voice Working to Ensure Medicare Coverage of Continuous Glucose Monitors (CGMs) and Other Devices

Thanks to extensive advocacy by JDRF volunteers and staff, clinician support, and strong bipartisan support from Congress, in early 2017, the Centers for Medicare & Medicaid Services (CMS) determined that continuous glucose monitoring (CGM) devices that are approved for use in treatment decisions are eligible for Medicare coverage. (For more information, please see our JDRF blog and press release.) This decision is a victory for people with type 1 diabetes (T1D) who are on Medicare or will be aging into Medicare. It is also a victory for the entire T1D community as broader coverage creates an incentive for innovation.

CGMs have a medical purpose, and have been recognized as such by Medicare

CGMs are U.S. Food & Drug Administration (FDA)-approved, physician-prescribed devices that detect and display blood-glucose levels continuously—and reveal trends in these levels that often go unnoticed by using finger sticks alone. The Centers for Medicare & Medicaid Services (CMS) had decided previously that CGMs have no “medical purpose” because people use them in addition to blood glucose meters. The broader T1D community disagreed, and spoke up in large numbers—CGMs have a clear medical purpose. CGMs improve diabetes clinical outcomes, according to numerous studies, including a JDRF-funded CGM trial that shows that the rate of severe low blood-sugar (hypoglycemia) events among young adults using a CGM fell by two-thirds over the first year of use. Not surprisingly, CGMs are recommended by national diabetes clinical guidelines — and they’re covered by nearly all private health plans. Moreover, CGMs are already being used to make diabetes treatment decisions, and, as JDRF argued before the FDA in 2016, the CGM indication should be updated to reflect its use.

JDRF worked closely with other interested stakeholders to encourage Medicare to cover CGM devices — and it remained one of our top national advocacy priorities. We are pleased that the agency delivered this good news to people with type 1 who are on Medicare, or will be aging into Medicare, and also set the stage for future innovation in this space due to the broader coverage this decision creates.

Implementation Changes

Medicare’s regulations require that in order to be covered, items of durable medical equipment must last at least three years. For the two CGMs that currently have Medicare coverage, the receiver is the item that confers durable status on the CGM system, because it lasts at least three years. Unfortunately, CMS put out guidance indicating that if a smart device was used in place of a receiver, or even in conjunction with it, Medicare would not cover the CGM. CMS held the position that if a receiver was rendered unnecessary by use of a smart device, then it called into question whether the CGM system should qualify as a covered medical device. This means that for Medicare beneficiaries using such CGMs, they may not use a smart device to share their data with other people, a key safety feature of the CGM system.

JDRF opposes CMS’ policy, which prevents people with diabetes from using a smart device with their CGM. JDRF has shared its concerns about this policy with the agency and is aware that efforts are underway by one of the CGM manufacturers to convince the agency to modify this guidance.

Medicare Coverage for “Patch Pumps”

Medicare has long covered traditional tubed insulin pumps as durable medical equipment. However, patch pumps (such as the Omnipod), have not until recently had a pathway to Medicare coverage. For some time CMS argued that since patch pumps are disposable, they could not qualify for coverage under Medicare’s durable medical equipment benefit. However, the agency recently issued guidance indicating that insulin patch pumps could be covered under a different benefit category, that of outpatient prescription drugs. This decision came after extensive advocacy by the manufacturer, JDRF, and other diabetes provider and patient groups. We are gratified to see this change.