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In the Neurosurgical Care P-Stim and eVox settlement, the practice, its neurosurgeon and its practice director agreed to pay $1,017,375 over allegations that they billed non-surgical device applications as surgery and one memory test as multiple tests. The government alleged that a neurosurgeon’s practice charged taxpayers for surgery when a physician assistant applied a device with adhesive and needles. A clinical employee, coder or billing manager could recognize that difference from inside the practice.
The Justice Department announced the civil False Claims Act settlement with Neurosurgical Care LLC on September 21, 2020.
The government alleged that Neurosurgical Care billed Medicare, TRICARE and the Federal Employees Health Benefit Program for implantation of neurostimulators when a physician assistant had applied P-Stim or Stivax without surgery. The billing ran from February 2017 to July 2018, the government said.
P-Stim and Stivax used an adhesive and a limited number of needles. Their application involved no surgery, no anesthesia and no operating room. Surgical implantation, the procedure the government said appeared on the claims, usually requires an operating room and receives federal reimbursement. The claim described an operation that the government said never happened.
The distinction mattered to payment. According to the Justice Department, federal healthcare programs did not reimburse these devices as electro-acupuncture or as implantable neurostimulators.
The Justice Department also identified NeuroStim, AnSiStim, E-Pulse and NSS-2 Bridge as other brand names for the device. The reimbursement issue it described followed the non-surgical application, not just the P-Stim name on the product.
The eVox allegation concerned one diagnostic test billed as multiple different tests. The government said Neurosurgical Care submitted Medicare claims using a combination of six reimbursable codes for a physician assistant’s application of eVox.
Manufactured by Evoke Neuroscience, Inc., the device consisted of a cap with electrodes placed on the patient’s head and connected by wires to a laptop. The announcement described it as purporting to measure biomarkers to assist in treating memory loss. The Justice Department alleged that Medicare did not reimburse eVox as the practice billed it, particularly when one test appeared under multiple codes as several tests.
The alleged eVox scheme worked differently. For P-Stim, the alleged substitution was a surgical procedure for a non-surgical application. For eVox, it was a set of diagnostic tests for a single test. Someone who knows what happened during the appointment has a way to examine either story: does the claim describe the care that actually took place?
The prosecutor blamed the surgeon for taking the sellers’ word on billing. In the announcement, the federal prosecutor said the surgeon should have recognized that P-Stim was not surgery and that an independent review would have shown it could not be billed to federal healthcare programs. The prosecutor described reliance on the reimbursement representations of the people selling the product.
A sales pitch built around a reimbursable code still has to match the care given. Here, the government said the sellers promoted surgical codes for a device applied without surgery. The pitch offered the practice a way to charge federal health care programs for an operation instead of the device application.
The Journal of Forensic and Investigative Accounting’s 2020 paper, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, describes a recurring pattern in healthcare False Claims Act cases: requests for payment for more expensive categories of care than were provided, or services never provided. A reimbursement claim tells the payer what it is buying.
By the time of the settlement announcement, Neurosurgical Care had sued Doc Solutions LLC, the marketers described in the release. The practice that relied on the reimbursement pitch was now suing the people behind it.
The Justice Department also said its investigation extended to other providers and to distributors or marketers that may have devised or carried out the billing scheme.
Azon Medical LLC faced a closely related allegation over AnSiStim. In its September 19, 2024 settlement announcement, the Justice Department alleged that the distributor sold the device as reimbursable under surgically implanted neurostimulator codes even though it used adhesive and needles without surgery.
The useful comparison is the distributor’s role. Neurosurgical Care’s settlement concerned the provider’s billing. The Azon allegations concerned the reimbursement representation used to sell the device. A sales employee may know how a billing instruction reached the practice, while a clinical employee may know exactly what the application involved. Those accounts can connect the promised reimbursement to the service on the claim.
We work with the insider to connect the device application or test to the procedure on the claim and the instructions behind that choice. In this case, that means understanding what the clinician performed, what billing staff submitted and what the practice had been told it could charge.
A separate whistleblower complaint against Medtronic shows how specific that account can be. The whistleblower alleged witnessing a sales representative instruct a physician how to bill the stimulation procedure:
While [the whistleblower] was present, [the sales representative] instructed [the physician] to bill the Sub-Q leads as peripheral nerve lead placements using CPT Code 64555.
United States ex rel. Nickell v. Medtronic Inc., whistleblower complaint, paragraph 26
The allegation identifies an instruction, its recipient and a witness to the conversation. That kind of firsthand account can explain how a device or procedure acquired its billing description.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
If you saw device applications become surgical claims or one test become several on a bill, talk with our whistleblower experts about what you saw. We build your strongest device billing whistleblower case around the care, the coding instructions and the claims. We stay beside you through the case and bring in medical device fraud whistleblower lawyers who understand provider billing.