Medicare Spells Out CGM Coverage for Diabetes

Miriam E. Tucker

March 24, 2017

The Dexcom Mobile G5 Continuous Glucose Monitoring (CGM) System will now be covered as durable medical equipment under Medicare Part B for beneficiaries with type 1 or type 2 diabetes who receive intensive insulin therapy.

The March 24 announcement of the details for the coverage follows the US Centers for Medicare & Medicaid Services' (CMS's) determination in January that CGMs qualify as therapeutic devices provided they are used "nonadjunctively," meaning that the devices' readings can replace finger-stick blood glucose measurements for making decisions about insulin dosing.

The Dexcom G5 Mobile was granted that indication by the US Food and Drug Administration in December 2016 and is currently the only CGM device that this indication applies to, so for now, it is the only one covered under Medicare.

The Endocrine Society has applauded the move: "For many years, the Society has advocated to expand coverage for CGMs to the Medicare population. The Society is pleased with the new coverage criteria and looks forward to continuing work with CMS to ensure patients have access to these lifesaving tools," it said in a statement.

In September 2016, the Endocrine Society's clinical practice guideline on diabetes technology recommended CGMs as the gold standard of care for adults with type 1 diabetes and also stated that CGMs may be helpful for those with type 2 diabetes who are at risk for severe hypoglycemia.

According to CMS, therapeutic CGMs may be covered by Medicare when the beneficiary patient meets the following criteria:

  •   Has diabetes.

  •   Has been using a home blood glucose monitor and has been performing at least four finger-stick glucose tests per day.

  •   Is treated with insulin via multiple daily injections or an insulin pump.

  •   Is receiving an insulin treatment regimen that requires frequent adjustment on the basis of therapeutic test results.

Coverage is effective for claims with dates of service on or after January 12, 2017. An article describing coding and coverage is available online.

Medtronic, which manufacturers both a stand-alone CGM and a "hybrid closed-loop" CGM-insulin pump system (the 670G), told Medscape Medical News in a statement, "The [CMS] ruling on continuous glucose monitoring is a decision that has positive implications for Medicare-eligible patients and the broader diabetes community. Reimbursement coverage to a broad range of CGM technologies that can simplify and improve diabetes management while positively impacting clinical outcomes and quality of life is important for America's seniors. In assessing the CMS decision as well as the applicability to MiniMed 670G system, Medtronic will be pursuing nonadjunctive labeling for the Guardian Sensor 3. We believe this will enable reimbursement for Medicare patients under the recent CMS ruling."

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