Glucose Monitors Should be Covered by Medicare, Class Action Says

Diabetes patients have filed a class action lawsuit against the U.S. Department of Health and Services Secretary Alex Azar for failing to cover continuous glucose monitors through Medicare.

The patients argue that continuous glucose monitors (CGMs) are medically necessary and lifesaving, challenging Azar’s statement that the devices are “precautionary” or “therapeutic” and therefore should not be covered by Medicare.

Plaintiffs Carol A. Lewis and Douglas B. Sargent have filed the CGM class action lawsuit against Azar in his official capacity as U.S. Department of Health and Services Secretary.

The plaintiffs claim that they and many other diabetes patients have been harmed by Azar’s determination that CGMs should not be covered by Medicare in the cases of many diabetic patients.

Lewis and Sargent seek damages on behalf of themselves and all other similarly affected diabetic Medicare recipients who use continuous glucose monitors.

The plaintiffs say that they both qualify for Medicare on the basis of age or disability based on the standards “previously determined by the Secretary,” and that they are diabetics who use continuous glucose monitors for their health.

Allegedly, they both had their requests for coverage of their CGMs denied by Medicare, because the devices were deemed not medically necessary.

Lewis and Sargent argue that the device is medically necessary, and that it has helped them monitor their glucose levels more effectively than they otherwise would be able to.

Allegedly, for diabetics like Lewis and Sargent whose bodies do not respond as they should to a change in glucose levels, they claim that CGMs enable them to determine if their glucose levels are in a healthy range very quickly and accurately, which enables them to take steps to make sure their glucose levels can return to normal.

The Medicare CGM coverage class action claims that without the information and efficiency offered by the CGMs, diabetics like Lewis and Sargent would more likely to encounter life-threatening situations in which their glucose are at unhealthy levels.

Allegedly, medical devices deemed “precautionary” and “therapeutic” are not disqualified from being covered. Additionally, the plaintiffs claim that “these are terms coined by the Secretary that have no basis in the law and also have no defined meaning.”

Lewis and Sargent go on to say that to justify coverage denial of CGMs, Azar “employs a series of procedural and bureaucratic tactics designed to frustrate an elderly and frequently ill population in their effort to use the program enacted by Congress in the way Congress intended.”

The Medicare diabetes monitor class action states that some patients can get the devices covered, but in many cases the devices are deemed unnecessary and coverage is denied, and the Secretary intentionally attempts to prohibit many patients from having their devices covered by Medicare.

One of these tactics reportedly includes requiring diabetics to re-apply for CGM coverage each month to determine if they should have the CGM covered.

The plaintiffs claim that because Azar deems the device not medically necessary, the burden falls on each CGM user to prove that they require the device in a way that creates an unreasonable barrier to access the device.

Lewis and Sargent are represented by Jeffrey Blumenfeld of Lowenstein Sandler LLP and by James C. Pistorino of Parrish Law Offices.

The Medicare CGM Coverage Class Action Lawsuit is Carol A. Lewis, et al. v. Alex Azar in his capacity as Secretary of the United States Department of Health and Human Services, Case No 1:18-cv-02929, in the U.S. District Court for the District of Columbia.