Provider to Pay $600,000 to Resolve False Claims Act Liability Arising from Billing of Electro-Acupuncture Device

PHILADELPHIA - United States Attorney for the Eastern District of Pennsylvania Jacqueline C. Romero and United States Attorney for the District of Delaware David C. Weiss announced that PA Green Wellness ("PA Green"), a business located within King of Prussia and Harrisburg, Pa., and Greenville and Lewes, Del., agreed to pay $600,000 to resolve liability under the False Claims Act for the alleged improper billing of an electro-acupuncture device.

From September 2020 through July 2021, PA Green billed Medicare for the application of a percutaneous electrical nerve pulse stimulation device (the "P-Stim Device") in an office setting.

The P-Stim Device is a device for treatment of chronic pain that, pursuant to manufacturer's instructions, is affixed behind a patient's ear using an adhesive. Needles are inserted into the patient's ear and affixed using another adhesive. Once activated, the device then provides intermittent stimulation by electrical pulses. It is a single-use, battery-powered device designed to be worn for several days until its battery runs out, at which time the device is thrown away. Other brand names for this device include Stivax, NeuroStim, ANSiStim, E-Pulse, and NSS-2 Bridge.

PA Green applied the P-Stim Device simply using an adhesive and insertion of a limited number of needles. The procedure did not involve any surgery, anesthesia, or take place in an operating room (or even at a facility with such capabilities) but was billed to Medicare as a surgically implanted neurostimulator, contrary to repeated guidance from the Centers for Medicare & Medicaid Services ("CMS").

On June 22, 2021, SafeGuard Services LLC, the Northeastern Unified Program Integrity Contractor of Medicare, provided notice to PA Green Wellness that CMS had suspended $50,845.99 of Medicare payments to PA Green Wellness pursuant to 42 C.F.R. § 405.371(a)(2) based on credible allegations of fraud. As part of the settlement, PA Green has agreed that the United States will retain the suspended payments.

"Along with other U.S. Attorneys around the country, CMS, and the Department of Health and Human Services Office of Inspector General, we have held distributors and providers accountable for inappropriate acupuncture device billing. It may not be billed as surgically implanted neurostimulators," said U.S. Attorney Romero.

"The decisions made by CMS about what procedures are reimbursable and how they may be billed are designed to ensure that all beneficiaries receive safe and effective treatment at an appropriate cost," said U.S. Attorney Weiss. "Providers who seek to enrich themselves by inaccurate billing increase the costs for everyone. My office will continue to work with our partners at the Department of Justice and the Department of Health and Human Services to hold those providers accountable."

"Accurately billing for services provided to Medicare beneficiaries is required of all health care providers," said Maureen R. Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of the Inspector General. "HHS-OIG, CMS's Center for Program Integrity, and the U.S. Attorney's Office will continue to evaluate and pursue inaccurate billings of P-Stim and similar devices."

This case was investigated by the U.S. Department of Health and Human Services Office of the Inspector General. It was handled by District of Delaware Civil Chief Dylan J. Steinberg and Eastern District of Pennsylvania Civil Chief Gregory B. David and Auditors Dawn Wiggins and Andrew Schobert.

The settled civil claims are allegations only. There has been no determination of civil liability.