PHILADELPHIA – United States Attorney Jennifer Arbittier Williams announced that Adam Teichman, DPM, Thomas Rocchio, DPM, R T Equity Holdings LLC (“R T Equity”), and PA Foot & Ankle Associates LLC (collectively, “PA Foot”) have agreed to pay $181,758 to resolve liability under the False Claims Act for the alleged improper billing of “Sanexas” devices.
Drs. Teichman and Rocchio are podiatrists and co-owners of PA Foot & Ankle Associates LLC, with office locations in Allentown, Easton, Northampton, and Lansford, Pennsylvania. From approximately September 2019 through March 2021, PA Foot submitted over 7,000 claims for payment to Medicare involving application of an RST Sanexas neoGEN-Series device (“Sanexas”), often billed with accompanying vitamin injections under various procedure codes (97012, 97016, 97032, 97112, G0283, and 99072) and injection codes (96372, J1955, J3411, J3415, J3420, and J3490).
Sanexas is an electric stimulation device marketed by RST Sanexas, Inc. (“RST”) to treat various forms of pain and other medical conditions. It consists of a large central unit and electrical leads that are temporarily affixed to the area being treated.
PA Foot principally used Sanexas treatment for patients suffering from diabetic neuropathy. Patients at PA Foot received treatment on an outpatient basis and typically received two treatments per week for twelve weeks, for a total of 24 treatments. Treatment times generally lasted approximately 30 to 40 minutes. In conjunction with Sanexas treatment, PA Foot injected patients with a vitamin blend. The United States contends that Medicare did not permit reimbursement of Sanexas or vitamin injections used in conjunction with Sanexas in the way in which PA Foot administered them. In particular, National Coverage Determination 160.7.1 states: “Electrical nerve stimulation treatments furnished by a physician in his/her office, by a physical therapist or outpatient clinic are excluded from coverage by § 1862(a)(1) of the Act.” Similarly, Local Coverage Determination (“LCD”) L35456 reinforces that “[t]he use of electrostimulation alone for the treatment of multiple neuropathies or peripheral neuropathies caused by underlying systemic diseases is not medically reasonable and necessary.” Other LCDs contain the same or similar statements, such as L35457, L37642, L35222, and L36850.
The United States Food and Drug Administration cleared Sanexas as substantially equivalent to a transcutaneous electrical nerve stimulator (“TENS”) in January 2003. Sanexas treatment was not FDA cleared for use in combination with vitamin injections, the vitamin blend was not FDA approved, and the vitamin blend was produced in bulk, rather than prescribed for individual patients.
The United States contends that vitamin injections used in conjunction with Sanexas treatment as PA Foot administered them do not fall under the limited coverage available for prescription drugs under Medicare Part B. Several LCDs reinforce that vitamin injections that act as nerve blocks are not medically reasonable and necessary, such as L35456, L35457, L37642, L35222, and L36850.
“Providers cannot blindly rely on a marketer’s advice or a medical billing service, especially when a healthcare billing scheme sounds too good to be true,” said U.S. Attorney Williams. “We would encourage anyone who may have been involved in similar billing to come forward voluntarily and self-disclose the misconduct.”
Williams continued, “we appreciate Drs. Teichman and Rocchio’s willingness to promptly negotiate a resolution in this matter, and we will continue working closely with our partners at CMS’s Center for Program Integrity, the Department of Health and Human Services Office of the Inspector General, and U.S. Attorney’s Offices around the country to hold accountable those responsible for causing similar false claims to be submitted.”
“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,” said Chiquita Brooks-LaSure, Administrator of the Centers for Medicare and Medicaid Services. “Patient care and safety are top priorities for us, and every dollar saved is critical to the sustainability of our Medicare program and the needs of our beneficiaries.”
“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 Sanexas and similar devices.”
The settled civil claims are allegations only. There has been no determination of civil liability. This matter was investigated by the U.S. Department of Health and Human Services Office of the Inspector General. The investigation and settlement were handled by Special Assistant U.S. Attorney Eric S. Wolfish, Assistant U.S. Attorney and Civil Division Chief Gregory B. David, and Auditors Dawn Wiggins and Andrew Schobert.