The lawsuit seeks Medicare coverage for all continuous glucose monitors and retroactive payment for out-of-pocket costs.
Diabetic patients on Medicare have filed a class action lawsuit against Health and Human Services Secretary Alex Azar for allegedly denying them coverage for continuous glucose monitors.
The suit was filed December 13 by plaintiffs Carol A. Lewis and Douglas B. Sargent on behalf of themselves and others in the U.S. District Court for the District of Columbia, after their complaint was denied by the Medicare Appeals Council.
CGM devices continuously test a diabetic’s blood to monitor for glucose levels and transmit that information to patients and caregivers. The devices reduce the need to finger prick for blood, the method of testing prior to the early 2000s when CGMs were developed.
In January 2017, the Centers for Medicare and Medicaid Services did deem CGMs as durable medical equipment covered under Medicare, but only for certain devices that were “primarily and customarily used to serve a medical purpose,” according to the lawsuit.
CMS denies coverage if the CGM does not completely replace the finger prick test strips, according to the lawsuit.
Therapeutic CGM systems that aid in treatment decisions are covered but nontherapeutic CGMs are not. CMS said that without the treatment decisions, patients are not led to change their diet or insulin dosage based on the readings.
The lawsuit said that more than 98 percent of private insurers cover CGMs.
CGMs cost about $300 to $350 a month for the purchase of a receiver, transmitter, disposable sensors and test strip supplies. They are available by prescription only.
The plaintiffs want retroactive payments for patients who have spent about $3,500 a year out-of-pocket replacing sensors and transmitters, according to attorneys.