CMS approves CGMs—what now?

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Friday, January 27, 2017

WASHINGTON – CMS’s recent decision to classify certain continuous glucose monitoring systems as DME is a positive step, but there are a few dominoes that need to fall before they are paid for, say stakeholders.

In a Jan. 12 ruling, CMS said that “therapeutic” CGMs would meet the definition of DME if, among other criteria, they are approved by the FDA for use in place of a blood glucose monitor for making diabetes treatment decisions.

“We’re waiting for directions from the DME MACs and CMS on the effective date and how we get the claims paid,” said Kim Brummett, vice president of regulatory affairs for AAHomecare.

In the ruling, CMS set a one-time fee of $236 to $277 for the CGM receiver, and a monthly allowable of $248.38 for for related accessories.

The question now is, how do providers bill Medicare for CGMs? Because existing HCPCS codes include all CGMs, Brummett thinks the Dexcom G5, the only CGM to currently meet CMS’s definition as “therapeutic,” would need to be billed with a miscellaneous code—like E1399—and would need to be documented somehow in the claim.

Even once all the details are worked out, providers say they will proceed with caution.

“This is a complicated issue that I have not had the time to evaluate fully yet,” said Lisa Feierstein, president of the Raleigh, N.C.-based Active Healthcare.“My major concern is that the cumulative revenue gained from handling CGMs may not be worth the potential audit risk.” 

All agree, however, that this is a step forward in diabetes treatment and, while the Dexcom is the only CGM to currently meet CMS’s definition, the ruling will likely open the door for other devices.

“I suspect that as other devices achieve the same label from the FDA, they would be able to qualify for the same benefit,” said Bennet Dunlap, a patient advocate and founder of the Diabetes Patient Advocacy Coalition.“I think it will be major step toward acceptance of the technology.”