Active Integrated: The Sanexas Settlement That Needed Enforcing

Active Integrated’s $1.9 million Sanexas settlement covered alleged improper billing for treatment, TM Flow testing and epidermal nerve fiber density testing, after more than 67,000 Medicare claims involving Sanexas. Enforcement followed when the government sued, saying the practice and its chiropractor co-owners had refused to make the required payments. Behind that payment dispute were questions a clinic insider would recognize: what treatment patients received, whether testing changed their care, and what the bills told federal health programs.

What Active Integrated Billed

Active Integrated Medical Centers, PC operated offices in Downingtown and Hershey, Pennsylvania. The government’s June 14, 2024 announcement described a joint settlement with the practice and its two chiropractor co-owners. The allegations covered the treatment and the testing surrounding it.

Sanexas is an electrical stimulation device with a central unit and leads temporarily attached to the area being treated. The clinics described in the announcement principally used it for patients with diabetic neuropathy. Patients generally received outpatient treatment twice a week for twelve weeks, approximately 24 treatments in all. Sessions typically lasted 30 to 40 minutes, with vitamin injections accompanying the treatment.

The Sanexas claims covered approximately February 5, 2020, through April 14, 2022, often with accompanying vitamin injections. Active Integrated’s billing also reached TRICARE, the federal health care program for military service members and their families, with approximately 2,500 claims for Sanexas treatment and TM Flow testing during the period.

Why Medicare Coverage and Billing Codes Mattered

The government alleged that Medicare did not cover Sanexas treatment and vitamin injections as Active Integrated administered them. It also challenged the codes used to describe those services.

In the device business, clearance and payment answer different questions. FDA authorization concerns whether a device may be marketed. Medicare coverage concerns whether the service qualifies for payment, and a billing code describes what the provider says it furnished. In this case, the FDA had cleared Sanexas as similar to a TENS unit. The government’s announcement said that clearance did not include the combination with vitamin injections. It also described the vitamin blend as unapproved and produced in bulk, rather than prescribed for individual patients.

For the Medicare claims, the government pointed to a national coverage determination excluding electrical nerve stimulation furnished in a physician’s office, by a physical therapist or by an outpatient clinic. It also cited local coverage limitations on electrostimulation alone for certain neuropathies and on vitamin injections used as nerve blocks.

The announcement’s account of the billing codes makes the mismatch concrete. Code 97012 requires mechanical traction and patient supervision. Code 97016 applies to lymphedema treatment and requires supervision. Codes 97032 and 97112 require one-on-one patient contact. Those descriptions tell Medicare something specific about the care. A person who saw how treatment sessions ran may know whether the bill describes what happened in the room.

TM Flow Screening That Did Not Change Treatment

The government alleged that Active Integrated offered Sanexas treatment regardless of the results of TM Flow testing. According to the government, the clinic used the test at initial visits to screen patients for diseases that could purportedly support the need for electrical stimulation.

TM Flow performs autonomic nervous system and vascular function assessments. The coverage limitations cited in the announcement addressed screening without signs or symptoms of autonomic dysfunction, results unused in clinical decisions, and testing without the necessary specialist competence. The government alleged that Active Integrated used the tests for screening, did not let the results determine whether Sanexas was offered, and lacked the training needed to perform and interpret the autonomic testing.

Active Integrated submitted approximately 1,500 Medicare claims for TM Flow testing during the period. The alleged sequence is the point: patients were tested to support a treatment decision, but the treatment was offered either way.

ENFD Biopsies Before and After Sanexas

Epidermal nerve fiber density testing involves a punch biopsy to assess nerve damage. The government described clinics using ENFD testing before Sanexas treatment to evaluate damage and afterward to look for improved nerve health. It challenged those additional tests because the treatment, as administered, was not covered and the device was not cleared to heal or regrow nerves. Active Integrated submitted nearly 70 Medicare claims for ENFD testing.

The government said patients experienced pain during the punch biopsies. Patients bore that pain while Medicare was billed for tests the government said were unnecessary.

The Settlement Needed Enforcing

The Department of Justice based the settlement on its own inability-to-pay policy. The practice and both co-owners agreed to the resolution, but the government then said they refused to make the required payments.

The same announcement that described the settlement also reported that the United States had filed a complaint to enforce it. The government had already taken ability to pay into account. It still had to go to court over the promise to pay.

In a December 16, 2025 announcement, the Justice Department reported that the district court had entered a consent judgment resolving the enforcement case over the breached payment obligations.

The Manufacturer’s Part in the Claims

RST-Sanexas, the device’s manufacturer, separately settled allegations that it caused provider customers to submit false Medicare claims.

What Kind of Proof Is Needed to Be a Whistleblower?

For allegations like these, useful evidence connects the treatment delivered, the reason for testing, the billing instructions and the claim submitted to Medicare or TRICARE. We examine how those records fit together: whether results informed care, whether the service matched its code, and what the people directing billing knew about coverage.

A 2020 forensic accounting paper explains why the claim matters. Published in the Journal of Forensic and Investigative Accounting, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud examines what makes a request for payment false. Its analysis distinguishes a request that misstates the services delivered from one that falsely claims compliance with a payment requirement. That distinction helps make sense of this case’s separate coverage and coding allegations: we connect what happened at the clinic to what the government was asked to pay for.

A clinical employee may know when test results became available and whether they changed treatment. A billing employee may know which codes were selected and whose instructions drove those choices. Our whistleblower experts work with that firsthand knowledge to build the account behind the claims.

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

You Saw the Treatment Behind the Bill

If you know how Sanexas treatments were delivered, why tests were ordered or who supplied the billing instructions, bring that knowledge to our whistleblower experts. We develop the medical-device fraud case with you and bring in medical device whistleblower lawyers who understand provider billing and manufacturer promotion. You have a partner from the first account of what happened in the clinic through the pursuit of a recovery.