Medicare Coverage Class Action Filed Against Health and Human Services Secretary on Behalf of Diabetes Patients

The Parrish Law Offices filed a class action in the U.S. District Court for the District of Columbia against Alex Azar in his capacity as Secretary of the U.S. Department of Health and Human Services (HHS) on behalf of diabetic Medicare recipients denied reimbursement coverage for use of medically prescribed continuous glucose monitors (CGMs). 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, the claims for which HHS improperly denied; and a ruling to establish a precedent for all Medicare beneficiaries filing claims for CGMs in the future.

This action asserts that HHS has routinely ignored past court and administrative law decisions and improperly denied CGM users’ Medicare reimbursement requests on the contention that CGMs do not qualify as durable medical equipment (DME) that is primarily or customarily used to serve a medical purpose. As the plaintiffs detail in their complaint, HHS’s decisions violate several federal statutes and are arbitrary and capricious, disregard Congressional intent, and ignore the fact that these devices meet Medicare coverage requirements. Plaintiffs ask the court to reverse HHS’s erroneous past decisions and issue an order finding that a CGM and its related supplies do, in fact, serve an essential medical purpose.

Filed by the Parrish Law Offices with assistance from Lowenstein Sandler, the class action complaint asserts that HHS’s coverage denials have serious consequences for patients’ health outcomes and have an impact on health care costs at both the individual and national level. Diabetes costs the United States hundreds of billions of dollars each year through direct expenses and lost productivity. For many who suffer from this incurable disease, the only way to adequately and consistently monitor their glucose levels is through a CGM, which continually tests those levels and transmits detailed data to patients and caregivers. Such data, especially in instances of 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 Department has continued to deny diabetes patients potentially lifesaving and cost-reducing medical devices and care,” said James Pistorino, a lawyer with the Parrish Law Offices and lead representative for the plaintiff class. “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.”

More than 98 percent of private insurance companies cover CGMs, which are FDA-approved, lifesaving devices providing a proven, 24/7 way to test glucose levels and prevent complications and, potentially, death from diabetes. Nevertheless, in too many instances, Medicare will not cover CGM use, which means that patients must pay for this costly equipment on their own. Those who simply cannot afford the cost must forgo the device completely and risk acute health complications. That translates into higher medical costs (e.g., due to more hospitalizations and treatments), which only contributes to the nation’s already skyrocketing national health care expenditures.

“Health and Human Services has a duty to live up to its name and provide coverage to the distressed populations it claims to assist,” Pistorino added. “Providing adequate medical coverage to those in need makes common and ethical sense and, in the case of CGMs, is also exactly what Congress intended. By improving and saving lives and boosting positive health care outcomes, CGMs also save the general public, the government, and the economy in terms of short- and long-term costs.” 

“It is truly unfortunate that CMS forces Medicare beneficiaries to bring suit to secure access to FDA-approved technology which is globally accepted as the standard of care,” stated George Grunberger, MD, FACP, FACE, Chairman, Grunberger Diabetes Institute; Clinical Professor, Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine; Professor, Internal Medicine, Oakland University William Beaumont School of Medicine; and Past President, American Association of Clinical Endocrinologists. 

Plaintiffs Carol A. Lewis and Douglas B. Sargent are both filing the suit after being denied coverage from the Medicare Appeals Council and are represented by James Pistorino and Debra Parrish of the Parrish Law Offices, in conjunction with Lowenstein Sandler.

For information about the class action, contact the Parrish Law Offices at admin@dparrishlaw.com.