Tehachapi Physician IUD Fraud: Internet-Purchased IUDs Billed as the Authorized Product

Whistleblower Justice Network

The Tehachapi physician IUD fraud case concerned a gynecologist who bought unapproved devices online and billed patients and insurers for approved IUDs, according to the Justice Department’s account of his guilty plea. The doctor knew the products differed, continued using them after a Food and Drug Administration warning, and kept patients in the dark. For someone inside a medical practice, the case connects decisions that can look separate in daily work: where a device is bought, what a patient receives, and what the practice says it supplied when it asks to be paid.

What Happened With the IUDs?

The physician implanted unapproved intrauterine devices without telling patients about the substitution or obtaining their consent. The Justice Department described that conduct when it announced his guilty plea to mail fraud on August 24, 2015.

He practiced obstetrics and gynecology in Tehachapi, California, providing birth control among his services. The government’s account identified ParaGard T-380A as the only IUD approved by the Food and Drug Administration using copper as its active ingredient at that time. It said the approved product was sold only by its manufacturer and was unavailable through third-party websites. The doctor bought the devices at issue from online retailers between April 2008 and June 2012.

That purchase channel mattered because the products were different. According to the court documents described in the plea announcement, the doctor had been warned that the online products were not identical to ParaGard and had not been approved by the Food and Drug Administration as safe and effective. He nevertheless used them and charged patients and insurers the higher cost of approved IUDs.

The FDA Warning Came Before More Implantations

The criminal case included repeated warnings followed by continued use. The physician received multiple bulletins and newsletters warning against unapproved IUDs, including the warning that online products differed from the approved copper device.

In August 2010, Food and Drug Administration agents confronted him about his history of implanting unapproved IUDs. He agreed to stop. When agents searched his office in 2012, they learned that he had continued implanting them.

Patients Complained and the Devices Stayed

The guilty-plea announcement describes patients who complained about complications and struggled to have the IUDs removed. It also says unapproved copper IUDs carried an increased risk of pelvic inflammatory disease, ectopic pregnancy and hysterectomy. The patients had not been told about those risks.

According to the plea agreement as described by the Justice Department, many patients complained to the physician and other doctors about medical complications they associated with the insertions. In multiple instances, he responded by re-inserting the IUD rather than removing it. Some patients ultimately changed doctors to have the device removed.

How the Product Identity Reached the Claim

The 2020 Journal of Forensic and Investigative Accounting paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud explains why the description of the product matters in a civil False Claims Act inquiry:

A factually false claim involves a reimbursement request containing an improper listing of services rendered or goods provided.

A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, Journal of Forensic and Investigative Accounting, 2020

The bill named one product. The patient got another. The paper’s definition of a factually false claim fits that mismatch exactly. That is where a purchasing employee’s knowledge of the actual product can matter to a billing review.

The Same Brand-Name Substitution in an Orthopedic Practice

A separate whistleblower complaint against Tennessee Orthopaedic Clinics alleged a similar mismatch between purchasing and billing. The whistleblower alleged that the clinic bought an unapproved Synvisc-like substance from distributors outside the United States at a substantially lower price than the manufacturer’s product, then supplied it to patients as Synvisc.

The complaint alleged that the clinic billed federal health programs as though the products had been legitimately purchased and regulated. It also described how the substitution could disappear inside the patient file:

Defendants create fraudulent records to support their false claims by noting in the patient files that the patients are being treated with Synvisc, or other brand name agents, and not re-imported viscosupplementation agents.

Whistleblower’s allegation in United States ex rel. Estey v. Tennessee Orthopaedic Clinics P.C., Appalachian Orthopaedic Associates P.C. and Appalachian Orthopaedic Partners LLC, complaint, paragraph 59

Tennessee Orthopaedic Clinics agreed to pay $1.3 million in a civil settlement announced in January 2014 over allegations of billing Medicare for reimported products with foreign-market labeling.

The parallel is the way the product was described as it moved from purchase to treatment to billing. The complaint alleged that the familiar brand name carried through the patient file even though the source of the product had changed. For an employee reading that file, the brand name could conceal the very purchasing decision that made the claim worth examining.

What Evidence Is Needed to Prove Fraud?

We work with insiders to connect the product purchased, the treatment patients received and the bills sent for payment. In a suspected medical device substitution, we examine those records together with what the people making the decisions knew.

Someone working in purchasing may understand the source of the product. Someone in clinical care may know what patients received and what they were told. A billing employee may see the description sent to the insurer. We work with that inside knowledge to understand how the decisions fit together and where the supporting records show the same transaction.

The warning history matters to that work. In the Tehachapi criminal account, the doctor had been told specifically how the online products differed from the approved device. In the orthopedic complaint, the alleged concealment reached into patient files. We bring the product knowledge and the payment records together, so a familiar brand name on a bill does not end the inquiry.

For a potential civil whistleblower case, our work connects that evidence to claims involving government money. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know What the Practice Actually Bought

If your practice’s purchases tell a different story from its patient records or bills, speak with our whistleblower experts about the substitution. We turn your knowledge of the product and the decisions behind it into a focused case, bring in medical device fraud whistleblower lawyers, and stay beside you as the case moves forward.

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