United States Attorney's Office for the Eastern District of Pennsylvania

09/21/2020 | Press release | Distributed by Public on 09/21/2020 13:30

Neurosurgeon Medical Practice Director to Pay Over $1 Million to Resolve False Claims Act Liability Arising from Billing of P-Stim Devices

PHILADELPHIA - First Assistant United States Attorney Jennifer Arbittier Williams announced that neurosurgeon Sagi M. Kuznits, practice director Pnina Kuznits, and Neurosurgical Care LLC (collectively, 'Kuznits'), have agreed to pay $1,017,375.03 to resolve liability under the False Claims Act for the alleged improper billing of electro-acupuncture devices called Stivax and/or P-Stim and a memory-loss device called eVox.

From February 2017 through July 2018, Kuznits billed Medicare, TRICARE, and the Federal Employees Health Benefit Program for the implantation of neuro-stimulators - a surgical procedure which usually requires an operating room and which is reimbursed by federal healthcare programs - when in fact the only procedures performed had been the non-surgical application of P-Stim and Stivax by a physician assistant. P-Stim and Stivax are applied with an adhesive and insertion of a limited number of needles, and they do not involve surgery, anesthesia, or take place in an operating room. Federal healthcare programs do not reimburse for devices such as P-Stim or Stivax, whether they are characterized as an electro-acupuncture device or as an implantable neuro-stimulator. Other brand names for this device include NeuroStim, ANSiStim, E-Pulse, and NSS-2 Bridge.

In addition, Kuznits billed Medicare for a physician assistant's application of an 'eVox' device. Manufactured by Evoke Neuroscience, Inc., eVox consists of a cap with electrodes that are placed on the head and connected to a laptop by wires, purporting to measure certain 'biomarkers' to assist in treatment of memory loss. Kuznits submitted claims to Medicare for payment using a combination of six reimbursable codes apparently in an effort to maximize reimbursement. The United States alleges that Medicare does not reimburse for eVox at all, and especially not when one diagnostic test is mis-billed under multiple codes as if it were multiple different tests.

'Dr. Kuznits, as a surgeon, should have known better. P-Stim is clearly not surgery and should not be billed using the surgical codes improperly pushed by marketers,' said First Assistant U.S. Attorney Williams. 'Dr. Kuznits failed to do his own independent due diligence which would have shown that he could not bill federal healthcare programs for P-Stim. Instead, he chose to take the money based on the self-serving representations of those selling the product that Medicare would pay for it.'

Now, in addition to this settlement, Dr. Kuznits is suing those marketers. See Neurosurgical Care, LLC v. Doc Solutions LLC, Civil Case No. 19-5751 (E.D. Pa.). 'As this settlement shows,' continued First Assistant U.S. Attorney Williams, 'if a marketer pushes a healthcare scheme like P-Stim or eVox that sounds too good to be true, it likely is - and you shouldn't do it.'

This is the third electro-acupuncture device settlement announced in this District as part of an ongoing investigation. In recent months, other jurisdictions including the Southern District of Texas and the Middle District of Tennessee have also taken action to hold providers accountable. See https://www.justice.gov/usao-sdtx/pr/pain-doctor-pays-settle-allegations-deceptive-medicare-billing; https://www.justice.gov/usao-sdtx/pr/pain-doctor-pays-settle-allegations-deceptive-medicare-billing);https://www.justice.gov/usao-mdtn/pr/united-states-and-tennessee-file-suit-against-comprehensive-pain-specialists-and); https://www.tn.gov/attorneygeneral/news/2020/6/10/pr20-27.html#:~:text=Nashville%2D%20Tennessee%20Attorney%20General%20Herbert,Tennessee%20Medicaid%20False%20Claims%20Act.

'We continue to work closely with our partners at CMS's Center for Program Integrity, the Department of Health and Human Services Office of Inspector General, other federal healthcare programs, state partners, and sister U.S. Attorney's Offices around the country to hold accountable any other providers who inappropriately billed this device and any product distributors or marketers who may have devised or carried out such a billing scheme,' stated First Assistant U.S. Attorney Williams.

'Every dollar saved is critical to the sustainability of our Medicare program and the needs of our beneficiaries,' said Centers for Medicare and Medicaid Services Administrator Seema Verma. 'We thank our partners at the Department of Justice and Department of Health and Human Services Office of Inspector General for working hard with us to identify, investigate, and eliminate waste, fraud and abuse in our federal healthcare programs.'

'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.'

The settled civil claims are allegations only. There has been no determination of civil liability. This case was investigated by the U.S. Department of Health and Human Services Office of the Inspector General. It was handled by Assistant U.S. Attorney Matthew E. K. Howatt, Civil Chief Gregory B. David, and Auditor Dawn Wiggins.