Last night, the Centers for Medicare and Medicaid Services (CMS) released a Ruling which, for the first time, classified certain continuous glucose monitoring (CGM) systems as durable medical equipment (DME) under the Medicare Part B benefit. This Ruling, which is binding on all CMS and HHS components including contractors, is a critical step in securing coverage and payment for patients with diabetes.

Continuous glucose monitoring systems continuously measure glucose levels and report them directly to patients, allowing them to make immediate treatment decisions (such as how much insulin to use) as well as to make longer-term decisions with their physician. Until yesterday, Medicare had declined to cover the devices as they were viewed as complementary to, and not a replacement for, traditional fingerstick blood glucose measurement. However, last month the Food and Drug Administration (FDA) approved for the first time one such system, the Dexcom G5 Mobile, for use as a replacement for test meters and strips for making diabetes treatment decisions. CMS refers to CGMs approved for this use as “therapeutic” CGMs, and in this Ruling states that they meet the regulatory definition of durable medical equipment, which:

• Can withstand repeated use;
• Has an expected life of at least 3 years;
• Is primarily and customarily used to serve a medical purpose;
• Is generally not useful in the absence of an illness or injury; and
• Is appropriate for use in the home.

The Ruling imposes a fee schedule for payment for the CGM device and accessories, but does not address the specifics of coverage (e.g. Type 1 vs. Type 2 diabetes), leaving those determinations to the regional Medicare Appeals Contractors. Nevertheless, stakeholders including the Juvenile Diabetes Research Foundation have praised the Ruling and will continue to engage CMS in coverage discussions.

If you have questions about durable medical equipment coverage, payment, or any other health policy issues, Applied Policy is eager to help improve the lives of patients. Please contact us at gpugh@appliedpolicy.com or 202-558-5272.