CMS greenlights CGMs for coverage

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Tuesday, January 17, 2017

WASHINGTON – CMS classified “therapeutic” continuous glucose monitoring systems as durable medical equipment in a Jan. 12 ruling.

CMS says CGMs are considered therapeutic and meet the definition of DME if:

·      They are approved by the FDA for use in place of a blood glucose monitor for making diabetes treatment decisions (for example, changes in diet and insulin dosage);

·      They are generally not useful to the individual in the absence of an illness or injury;

·      They are appropriate for use in the home; and

·      They include a durable component (a component that CMS determines can withstand repeated use and has an expected lifetime of at least three years) that is capable of displaying the trending of the continuous glucose measurements.

“In all other cases in which a CGM does not replace a blood glucose monitor for making diabetes treatment decisions, a CGM is not considered DME,” the agency states in the ruling.

CMS says it will pay a one-time fee schedule amount of $233 to $277 for CGMs in 2017, plus a bundled monthly payment of $248.38 for the replacement of the sensors, transmitters and all other accessories and supplies. It says the fee schedule amount will be increased in 2018 and subsequent years based on the covered item update factors.

The ruling is effective Jan. 12.