Lawsuit Challenges ‘Nonsensical’ Denial of Medicare Coverage for Continuous Glucose Monitors

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A proposed class action filed against U.S. Department of Health and Human Services Secretary Alex Azar, in his official capacity, claims he has “nonsensically” denied Medicare coverage for continuous glucose monitors (CGMs) for diabetes patients.

The lawsuit explains that CGMs are life-saving devices that allow diabetics to manage their disease by monitoring blood glucose levels around the clock. The devices can prevent potentially fatal consequences when an individual’s blood sugar drops too low, the suit continues, and allows the user to avoid “expensive complications” that require medical attention.

Azar’s allegedly “arbitrary and capricious” denials of diabetics’ claims for CGM coverage under their Medicare plans are at the center of the 36-page lawsuit. Moreover, the secretary’s claim that CGMs are “precautionary” and “therapeutic” has no basis in law, the lawsuit says, as the terms are reportedly never mentioned in statutes related to Medicare coverage.

To the contrary, the lawsuit argues that CGMs qualify as “durable medical equipment” that should be covered under the Medicare program but are refused coverage without explanation or substantial justification.

“Though these devices meet the requirements to be covered as durable medical equipment, the Secretary generally has refused to acknowledge this obvious conclusion,” the complaint reads. “Instead, nonsensically, the Secretary contends that the FDA approved, life-saving devices are ‘nonmedical in nature’ or ‘not used to serve a medical purpose’ and therefore refuses to provide coverage as dictated by Congress.”

The case points out that the defendant’s position has been challenged at least three times in district court and each time was considered to be “without merit.”

“Unfazed,” the case says, “the secretary continues to issue the same denials.”

The lawsuit seeks to cover a proposed class of individuals who submitted claims for CGM coverage that were denied (and not reversed on appeal) since December 13, 2012, as well as two proposed subclasses that identify specific CGM brands.