PHILADELPHIA, PA — The United States Attorney for the Eastern District of Pennsylvania, Jacqueline C. Romero, along with David C. Weiss, the United States Attorney for the District of Delaware, announced that PA Green Wellness has agreed to pay $600,000 to settle allegations of improper billing under the False Claims Act. This week’s settlement addresses the alleged misuse of an electro-acupuncture device known as the P-Stim Device.
The P-Stim Device, designed to treat chronic pain, operates by adhering to the patient’s ear and providing electrical pulses through inserted needles. This device is intended for single-use and is battery-powered, designed to be worn for several days until the battery depletes. It is not a surgically implanted device and does not require an operating room or anesthesia. Despite this, PA Green Wellness billed Medicare for the device as if it were a surgically implanted neurostimulator, which is contrary to the guidelines provided by the Centers for Medicare & Medicaid Services (CMS).
From September 2020 to July 2021, PA Green Wellness submitted these improper claims, leading to a suspension of $50,845.99 in Medicare payments. On June 22, 2021, SafeGuard Services LLC, the Northeastern Unified Program Integrity Contractor of Medicare, notified PA Green Wellness that CMS had suspended these payments based on credible allegations of fraud under 42 C.F.R. § 405.371(a)(2). As part of the settlement, the federal government will retain the suspended funds.
“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,” stated U.S. Attorney Jacqueline C. Romero.
David C. Weiss, the U.S. Attorney for the District of Delaware, emphasized the importance of accurate billing practices. “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. 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.”
Maureen R. Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of the Inspector General, added, “Accurately billing for services provided to Medicare beneficiaries is required of all health care providers. 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.”
The investigation was conducted by the U.S. Department of Health and Human Services Office of the Inspector General. The case was handled by District of Delaware Civil Chief Dylan J. Steinberg and Eastern District of Pennsylvania Civil Chief Gregory B. David, along with Auditors Dawn Wiggins and Andrew Schobert.
It is important to note that the settled civil claims remain allegations only, and there has been no determination of civil liability.
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