Sonas Medical Sues over Statistical Analysis of Medical Equipment Necessity

On Friday, a case was filed in the Eastern District of Texas by Sonas Medical Supply, Inc. against Xavier Becerra in his office as the Secretary of the United States Dept. of Health and Human Services. The case alleges regulatory and constitutional violations in the determination of payment rates and in the processing of appeals by the contractors for Medicare under the aegis of the Department of Health and Human Services.

Sonas, the complaint said, provides durable medical equipment such as prosthetics, orthotics and other equipment to Medicare patients. Durable medical goods suppliers are required to provide a certificate of medical necessity from a doctor prior to billing the purchases to Medicare, as well as being required to maintain that documentation for Medicare review purposes, the plaintiff explained.

As a part of preventing overpayment by Medicare on these goods, statistical sampling is used and extrapolated to detect possible fraudulent billing patterns for not medically necessary goods. The plaintiff contended that the statistical sampling used by Medicare to determine possible overpayment was not selected according to sound statistical methodology, and was thus arbitrary and capricious.

The plaintiffs noted that the agency has violated due process rights in the extreme delay in exhausting the administrative appeals process, noting that the first notice of overpayment was issued in 2016, and the process was only exhausted in 2021. Also, the plaintiffs noted that review of this type, which substitutes the agency’s determination as to the medical necessity of the device usurps the role of the doctor in determining medical necessity, especially when the determination is made on a statistical basis instead of review of the actual documentation supporting individual purchases.

The plaintiffs are represented by the firm Kennedy Attorneys & Counselors at Law.