RST-Sanexas: Noncovered Treatment and Referral Commissions

In the RST Sanexas settlement, the manufacturer and its owners jointly agreed to pay $1.5 million to resolve allegations that they caused false Medicare claims for noncovered treatment, unnecessary nerve testing and services tied to referral kickbacks. The government’s account follows the device beyond the sale, into the treatment room, the biopsy order and the bill. Clinic employees and sales representatives see different parts of that treatment package.

The Department of Justice announced the settlement on December 16, 2025. The government based the amount on what the settling defendants could pay. RST-Sanexas, based in Las Vegas, manufactures and markets electrical stimulation devices.

How the Sales Pitch Became a Medicare Claim

The government alleged that Sanexas marketed a broader treatment than its device’s clearance allowed, then caused providers to bill Medicare for the resulting services. The alleged promotion ran from September 2017 through May 2022.

The Justice Department described the RST Sanexas neoGEN-Series as having limited Food and Drug Administration clearance for electrical nerve stimulation. According to the Justice Department, the company and its owners promoted it for acute pain, improved nerve health, nerve regrowth and use together with vitamin injections. The government alleged that those promoted uses fell outside the clearance and were not medically reasonable or necessary.

The device had clearance for sale, but the government alleged that providers billed Medicare for treatments it did not cover.

The government’s coverage allegation concerned electrical nerve stimulation furnished in a physician’s office, by a physical therapist or in an outpatient clinic. The settlement announcement cited a national Medicare coverage exclusion for those treatments. It also cited local policies treating vitamin injections used to perform a nerve block as not medically reasonable or necessary. The allegation reached the services providers billed after buying the device.

Nerve Testing After the Treatment Decision

Sanexas allegedly encouraged providers to use epidermal nerve fiber density testing to measure improvement following treatment. This testing, commonly called ENFD, involves a punch biopsy to evaluate nerve damage. The government’s allegation was that providers billed Medicare for additional testing to assess supposed healing or regrowth, even though the device lacked clearance for those purposes and those procedures were not covered.

A separate government complaint against The Vanguard Clinic and Fleur de Lis describes what that could look like inside a practice. In its account, the test result had no say in whether the patient received treatment:

The complaint alleges that patients underwent biopsies whose results the clinic did not wait for, while providers billed Medicare for that testing. Patients went through the procedures, and taxpayers faced the bill. For the employee handling appointments, biopsy results or claims, the dates tell a story that the treatment brochure cannot.

Referral Commissions on Both Sides of the Device Sale

The Justice Department alleged that Sanexas and its owners both paid and received referral commissions. The paying side involved distributorships owned and operated by medical providers who used Sanexas devices in their practices. The government alleged that those distributors received volume-based discounts and commissions tied directly to the value of business they generated for Sanexas.

That alleged arrangement put health care providers on the selling side as well as in the treatment room. The provider uses the product with patients and can earn money by generating business for its manufacturer.

The receiving side ran through a diagnostic laboratory. The government alleged that the settling defendants received commissions for referring medical providers to perform nerve biopsies in conjunction with Sanexas treatment. In that account, an order for a nerve biopsy could produce a laboratory referral and a payment back to the device business.

A 2020 review in the Journal of Forensic and Investigative Accounting, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, examines laboratory schemes in which processing and handling fees rewarded physicians for more referrals and more blood tests. That comparison makes the financial question concrete here: which patient orders generated a commission, who received it, and how did the payment change with the business sent to the laboratory?

The laboratory connection also appears in the Advanced Pathology Solutions resolution announced June 17, 2026. The government alleged volume-based commissions to a Sanexas owner for nerve biopsy referrals from Sanexas users. Compared with the manufacturer’s ability-to-pay settlement, the laboratory’s larger $30 million combined resolution covered broader allegations of laboratory kickbacks and unnecessary pathology testing.

The Provider Cases Followed the Services Billed

Separate Sanexas provider settlements show the same treatment and testing allegations at the point where claims reached Medicare. The PA Foot & Ankle Associates settlement, announced in June 2022, concerned alleged noncovered outpatient Sanexas stimulation and accompanying vitamin injections.

In June 2024, the Justice Department reported settlements involving Active Integrated Medical Centers and Nova Integrated Health. Active Integrated’s allegations concerned Sanexas, TM Flow and epidermal nerve fiber density testing. Nova’s concerned noncovered Sanexas treatment and nerve testing. The Healing Place Medical settlement, announced in October 2024, concerned alleged noncovered Sanexas stimulation, vitamin injections and related diagnostic tests.

The provider cases show why the manufacturer’s promotion and the clinic’s claims belong in the same inquiry: the device sale was followed by decisions about treatment, injections and tests charged to Medicare.

What Evidence Is Needed to Prove Fraud?

For these allegations, the useful evidence connects the sales representations, treatment decisions, test results and referral payments to the claims Medicare received. We examine those connections with the healthcare insider who knows how the work actually happened.

The separate Vanguard complaint alleges that providers billed Medicare for Sanexas treatments requiring direct one-on-one contact without providing that contact.

Distributor agreements and commission calculations answer another question: what business triggered the payment? For nerve testing, orders, results and treatment dates reveal whether the test informed care. For the manufacturer’s promotion, the relevant comparison is between the uses it encouraged and the services its customers billed. Those are the connections our whistleblower experts build into a medical device fraud case.

Can a Whistleblower Take Legal Action Against a Medical Device Company?

Yes. The RST-Sanexas settlement resolved allegations in whistleblower cases filed under the False Claims Act. The government alleged that the manufacturer and its owners caused false claims through provider customers. The Justice Department said the whistleblowers would receive awards from the recovery.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know How the Treatment Was Sold and Billed

If you worked with Sanexas sales, clinic billing, biopsies or referral payments, talk with our whistleblower experts about what you saw. We connect your account to the manufacturer’s decisions and the Medicare claims, and bring in medical device whistleblower lawyers who understand provider billing and referral commissions. We work beside you throughout the case, from the first conversation about the treatment pitch to the pursuit of a recovery.