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.
WHY THIS MATTERS
The complaint asserts that HHS's coverage denials have serious consequences for patients' health outcomes and have an impact on healthcare costs at both the individual and national level.
Those who can't afford the cost of a CGM forgo the device and risk acute health complications.
Dramatic changes in glucose levels can mean the difference between just-in-time treatment and serious, even fatal, complications that can result from the delays in care that are all too common with older, more traditional monitoring methods, the complaint states.
Diabetes costs the United States hundreds of billions of dollars each year through direct expenses and lost productivity, the lawsuit said.
The complaint seeks a declaration that federal law requires HHS to reimburse for CGMs; compensation for Medicare beneficiaries' past out-of-pocket costs to purchase these devices in claims previously denied; and a ruling to establish a precedent for all Medicare beneficiaries filing claims for CGMs in the future.
ON THE RECORD
"The Department has continued to deny diabetes patients potentially lifesaving and cost-reducing medical devices and care," said Attorney James Pistorino with the Parrish Law Offices and lead representative for the plaintiffs. "Nonsensically, the department has claimed that CGMs do not serve a medical purpose and are not necessary, despite their being an FDA-approved and verified method for preventing those with diabetes from facing dangerous consequences, such as falling into a diabetic coma or, even worse, death."
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