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

Lowenstein Sandler and Parrish Law Offices filed a class action in the U.S. District Court for the District of Columbia today 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.

Jointly filed by the Parrish Law Offices and 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. For many who suffer from diabetes, 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.

“Health and Human Services has a duty to live up to its name and provide coverage to the distressed populations it claims to assist,” said Jeffrey Blumenfeld, partner at Lowenstein Sandler. “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.”

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 Jeffrey Blumenfeld and Gavin J. Rooney of Lowenstein Sandler.