The U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. 17:49:25
“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Kevin Sayer, President and Chief Executive Officer, Dexcom. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”
According to CMS, therapeutic CGM may be covered by Medicare when all of the following criteria are met:
The beneficiary has diabetes mellitus; and,
The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
The patient’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.
In order to be included in this category, the system must be defined as therapeutic CGM, meaning you can make treatment decisions using the device. Dexcom G5 Mobile is the only system approved by the FDA to meet that criteria.
The nonprofit organization T1D Exchange, that works to improve outcomes for people with type 1 diabetes, played a significant role in providing patient-driven evidence to support this ruling, including:
The REPLACE BG study: A trial comparing continuous glucose monitoring (CGM) with and without routine blood glucose monitoring (BGM) in adults with type 1 diabetes. The results of this study support the use of CGMs for treatment decisions.
The FDA also received data from two T1D Exchange studies that analyzed hypoglycemia in older adults. These analyses found that 21% of people over the age of 65 who had type 1 diabetes for more than 40 years reported seizures or loss of consciousness due to a severe hypoglycemic episode. This percentage was far greater than what was previously believed.
See the Medicare Administrative Contractor (MAC) website for instructions for individual claim adjudication. Coverage is effective for claims with dates of service on or after January 12, 2017. A link to the article on coding and coverage can be found at: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors .