U.S. Attorney Announces Additional Enforcement Action as Part of National Effort to Combat Electrical Stimulation Fraud Scheme and Recover Millions

PHILADELPHIA - United States Attorney David Metcalf announced the filing of a complaint under the False Claims Act in the Eastern District of Pennsylvania. This is the latest action in the national investigation into the scheme of improper billing using the RST-Sanexas neoGEN-series electric stimulation device. Federal healthcare programs do not reimburse for electrical nerve stimulation treatments furnished in outpatient clinics to treat pain, nor do they cover vitamin injections used in conjunction with such treatments. As detailed below, this District and others have pursued and settled various False Claims Act cases against electrical stimulation providers, recovering millions.

The complaint is against Drs. Michael Glickert and Joseph Novof of St. Louis, Missouri, as well as their integrated chiropractic clinic, The Vanguard Clinic LLC, and Sanexas device distributorship, Fleur de Lis, LLC, alleging violations of the False Claims Act. As alleged in the complaint, Glickert is a chiropractor who helped develop the scheme for billing Sanexas treatment and vitamin injections to insurance and promoted that scheme nationwide. Novof is an emergency room physician who served as Medical Director for Vanguard, as well as two other Sanexas clinics, and distributed Sanexas devices nationwide.

Beginning in late 2018, Glickert promoted Sanexas treatment and vitamin injections as reimbursable by Medicare and provided coding instructions. But the United States alleges that Glickert knew that billing Medicare could be considered fraudulent. And despite later admitting in a federal complaint that their billing of Sanexas treatment and vitamin injections was not covered by Medicare, Glickert continued to bill Medicare. Meanwhile, Novof falsely certified that vitamin injections were medically necessary, despite not even knowing the ingredients in those injections.

"Our office continues to lead the national charge to hold alleged fraudsters accountable for improper Sanexas billing," said U.S. Attorney Metcalf. "We will continue working closely with our partners at CMS's Center for Program Integrity, the Department of Health and Human Services Office of Inspector General, the Justice Department's Civil Division, and sister U.S. Attorney's Offices around the country to pursue any other providers who inappropriately billed for these devices and caused false claims to be submitted."

The ongoing national effort to identify and combat electrical stimulation billing fraud is a collaboration between this District, the Justice Department's Civil Division, Commercial Litigation Branch, Fraud Section, the Centers for Medicare & Medicaid Services' ("CMS") Center for Program Integrity, the Department of Health and Human Services Office of Inspector General ("HHS-OIG"), other federal healthcare programs, state partners, and sister U.S. Attorney's Offices around the country.

The cases in this District have been investigated by the U.S. Department of Health and Human Services Office of Inspector General. They have been handled by Assistant U.S. Attorneys Eric S. Wolfish and Civil Chief Gregory B. David.

Prior DOJ press releases related to the Sanexas national initiative include:

• https://www.justice.gov/usao-edpa/pr/two-doctors-and-their-medical-practice-pay-more-181000-resolve-false-claims-act
• https://www.justice.gov/usao-edpa/pr/us-attorney-announces-two-additional-civil-settlements-part-national-effort-combat
• https://www.justice.gov/usao-edpa/pr/us-attorney-announces-additional-civil-settlement-chiropractor-and-his-practice-part
• https://www.justice.gov/usao-edpa/pr/rst-sanexas-inc-and-its-owners-agree-pay-15-million-resolve-allegations-they-caused

The investigation and pursuit of this matter illustrate the government's emphasis on combating healthcare fraud, including in the healthcare technology arena. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The claims above are allegations only and there has been no determination of liability.