THD America: Avoiding the Procedure’s T-Code in Reimbursement Advice

In the THD America coding settlement, THD America Inc. and its Italian parent, THD SpA, agreed to pay $700,000 over allegations that they encouraged surgeons to use incorrect codes to increase Medicare and Medicaid reimbursement. The company sold a hemorrhoid removal system and allegedly advised customers how to bill around the procedure’s temporary code when reimbursement was often denied. For someone inside device sales or reimbursement support, the important part is where the advice went next: onto a physician’s claim for government payment.

The Slide One Kit and the Code That Drew Denials

THD America, based in Natick, Massachusetts, sold the Slide One Kit for transanal hemorrhoidal dearterialization. The Justice Department’s account of the procedure describes a surgery involving cauterization of certain blood vessels. The reimbursement allegations concerned what colorectal and general surgeons were encouraged to bill for that work.

The government alleged that, between 2014 and 2017, physicians performing the procedure with the Kit were required to use a temporary code, commonly called a T-Code, assigned to new and emerging services. Reimbursement for this procedure was often denied because it was considered experimental.

According to the Justice Department, THD encouraged surgeons to use the T-Code with an additional CPT code, or to use CPT codes other than the T-Code. The alleged purpose was to avoid denials and increase potential reimbursement.

The payer’s objection to the procedure allegedly became a problem to be solved by changing what the payer was told. The government alleged that taxpayers were asked to pay on that altered description.

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

Yes. A medical device company can face a False Claims Act case over allegations that it knowingly caused providers to submit false claims. The Justice Department announced THD’s settlement on September 6, 2024. It included a qui tam case brought by a former THD America employee over the company’s alleged influence on physicians’ billing.

The manufacturer-to-provider connection is the point. THD sold the Kit and allegedly supplied the coding advice. The surgeon or provider characterized the procedure on the claim. Medicare or a state Medicaid program then received the request for reimbursement. The allegation against the manufacturer concerned its role in shaping that request, even though the physician submitted it.

For an insider, this connects the commercial side of the device business with the billing office. Advice given to a customer can travel beyond a sales conversation and become the description of a service for which taxpayers are asked to pay. We examine that connection: what the manufacturer encouraged, what the customer billed, and how the advice affected the claim.

How Does Reimbursement Work for Medical Devices?

Medical device reimbursement depends on what service or item the code identifies, whether the program covers it, and how the program pays for it. In THD’s case, the government focused on the procedure code physicians used when billing for surgery with the Kit.

In THD’s case, the government alleged that the company encouraged surgeons to change the billing description when the procedure’s own code drew denials.

For device reimbursement insiders, the useful comparison is between the service actually performed and the service described to the payer. The manufacturer’s guidance connects those descriptions when it tells the customer which code to choose.

The Paradigm Spine case also concerned allegations of false coding recommendations by a device manufacturer.

What Evidence Is Needed to Prove Fraud?

Proving manufacturer coding fraud means tying the advice to the claims and what the manufacturer knew. That is the work we do with you, including how a recommendation to add or substitute a code reached the provider and affected the request for payment.

A 2020 paper in the Journal of Forensic and Investigative Accounting puts the billing problem plainly:

That is the connection we examine in a coding case: how the manufacturer’s instruction changed the description on a provider’s bill. Our healthcare fraud experts work with you to trace that connection and understand what the company knew when it gave the advice.

The reason for the recommendation matters too. The government’s THD allegation expressly linked the advice to avoiding denials and increasing potential reimbursement. A person familiar with the advice may know who approved it, which customers received it and what the company understood about the required code. That knowledge gives context to words that might otherwise appear only as a billing suggestion.

Your knowledge may begin with a sales instruction, a reimbursement discussion or a provider’s response. Our work is to connect what you know to the billing decisions and the government money at issue, with medical device whistleblower lawyers who understand manufacturer-caused health care claims.

How Much Is a Whistleblower Claim Worth?

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

We build the case with the insider who understands the device business, connecting the company’s advice to the government claims it affected.

You Know Where the Coding Advice Came From

If you saw a device company steer customers around a procedure’s code, tell our whistleblower experts how the advice reached the billing office. We build your strongest medical device whistleblower case with you, bring in medical device whistleblower lawyers who know reimbursement cases, and stay beside you as the case moves forward.