CMS proposes modifications to CGM coverage 

WASHINGTON – CMS has published a proposed LCD that modifies the coverage criteria for continuous glucose monitors (CGMs) based on the best available evidence. 

The agency seeks to modify criteria to allow coverage of a CGM for beneficiaries with diabetes mellitus who are insulin treated or have a history of problematic hypoglycemia. Problematic hypoglycemia is defined as: 

• recurrent level 2 hypoglycemic events (<54mg/dL (3.0mmol/L) that persist despite multiple (2 or more) attempts to adjust the medication dosage(s); or the diabetes treatment regime; or 
• history of one level 3 hypoglycemic event (<54mg/dL (3.0mmol/L) requiring the assistance of a third-party for treatment of hypoglycemia. 

Other changes: 

• Removing the requirement for frequent adjustment of the beneficiary’s insulin treatment regimen on the basis of the home blood glucose monitor (BGM) or CGM testing results. 
• Retaining the requirement for a visit with the treating practitioner every six months to assess adherence, although it has clarified language to specifically address the long-standing policy that allows for the use of Medicare-approved telehealth visits.  
• Eliminating the intensive insulin management requirement and the inclusion of telehealth options may also promote health equity for vulnerable rural and non-Asian ethnic minorities, as well as Medicare beneficiaries in areas with health care-professional shortages. 
• Not extending coverage to beneficiaries solely on the basis of having stage 3-5 chronic kidney disease, gestational diabetes mellitus, bariatric surgery or pancreatectomy who do not otherwise meet the outlined coverage criteria. 
• Adding criteria to ensure the CGM is being used in accordance with FDA indications and the beneficiary has received proper training in the use of the device. 
• Continuing to allow CGM supply allowance to be billed monthly, as it is not within the purview of the DME MACs to modify this requirement.