In March 2022, Medicare beneficiaries became eligible for coverage for a greater number of CGMs than ever before. Due to a final rule issued on December 21, 2021 by the Centers for Medicare and Medicaid Services (CMS), any CGM that connects with an insulin pump or a standalone receiver will be covered by Medicare for anyone otherwise eligible. This rule took effect at the beginning of this month, so people with Medicare now have access to Dexcom G6, Abbott Freestyle Libre, Senseonics Eversense and Medtronic Guardian, as long as these CGMs are used with an insulin pump or with use of a standalone receiver.
Previously, CMS only covered therapeutic CGMs which are those devices approved by the Food and Drug Administration (FDA) to make insulin dosing decisions. This expansion means that people on Medicare with diabetes will now have access to a broader choice of CGMs similar to what is available to those with commercial insurance.
Under Medicare regulations, CGM remains classified as durable medical equipment, so it must contain a “durable” part, in this case, a receiver, that lasts at least three years. With this rule, CMS has determined that any CGM being used with an insulin pump meets the definition of DME, since the insulin pump itself is an item of durable medical equipment. CMS also cited the clinical benefit of alarms for high or low glucose levels, specifically during sleep, as a justification for expanding coverage to CGMs that are non-therapeutic. The only FDA-approved CGM on the market that is not covered by Medicare is the Medtronic Guardian standalone CGM that uses a mobile phone as its exclusive receiver.
In July 2021, CMS announced that people with diabetes no longer needed to prove that they are testing their blood sugar at least four times per day with a blood glucose meter to get initial Medicare coverage for a CGM device. Additionally, language was clarified to allow individuals using inhaled insulin, not just injected insulin, to access CGM. To read more about this, read our blog post here.
All of these recent changes are long-sought advocacy goals for JDRF and welcome news for members of the T1D community.
The positive impact of CGMs on the health and well-being of those with T1D is clear and JDRF has long advocated for broader coverage and choice of CGMs, resulting in private plan coverage starting over a decade ago, and Medicare coverage on a partial basis in 2017 and expansion this year. CMS’s decision marks an important milestone for Medicare’s coverage of therapies that will improve the lives of those with T1D.
JDRF will continue to work closely with CMS, other Administration officials, and members of Congress to ensure that everyone with T1D, regardless of insurance status, has access to life changing therapies.