How to Report Medical Device Fraud: The Records Behind the Sale and the Bill

To report medical device fraud, speak with our whistleblower experts about the product, the decisions you witnessed and the government payments involved. You may know why a surgeon received payments, what a sales team told hospital billing staff or what happened to an internal complaint. We work with you to connect that knowledge to a possible False Claims Act case. You can start the conversation with the part you know.

What Evidence Is Needed to Report Fraud?

Evidence to report medical device fraud connects the company’s conduct to a particular device, the people who selected or used it, and the government-funded health care or purchase. Our review starts with your account of what happened, when it happened and how you know.

The Device, the Procedure and the Buyer

The physician choosing an implant, the hospital buying it and the manufacturer selling it can each hold a different part of the transaction. The HHS Office of Inspector General’s physician-owned entities alert explains why implant choice matters so much: physicians may strongly influence both the brand and the type of device used.

Consignment adds another point of connection. A hospital can stock an implant while the manufacturer still owns it, with the sale occurring when the product is used. A representative managing trays and inventory may therefore know which product went into a procedure and when that use became a sale. The device model and unique device identifier help us keep the account tied to the product involved.

For most implants, Medicare pays through the procedure or hospital stay. The hospital claim does not identify the implanted product by its unique device identifier. Product and inventory records can therefore supply detail the bill leaves out. We examine those records alongside the procedure and payment you know. Durable medical equipment can instead appear as a separately billed item. There, we examine how the product supplied compares with the item billed.

Payments and the Work They Were Supposed to Buy

Consulting agreements, royalties and research payments put the same question in different forms: what did the company pay for, and what did it receive? We compare the work performed and payments approved with the physician’s device use.

For a physician-owned distributor, the ownership terms, distribution payments and purchases show how the physician’s financial return connects to the devices selected. For hospitality or practice support, the useful account identifies who received the benefit, who approved it and the business the company expected in return.

Merit Medical’s former chief compliance officer alleged that the company drafted, funded and distributed referral letters to attract business to physicians using its Embosphere devices. The whistleblower’s complaint put the missing disclosure plainly:

The allegation describes a sales campaign presented to referring physicians without disclosing who paid for it. Someone who approved the expenditure or worked on the campaign could explain that connection.

Sales Instructions and the Provider’s Bill

A reimbursement guide, training presentation or sales email can show what a manufacturer told a customer to bill. The procedure record and provider claim show what happened afterward. We examine the instruction, the people who received it, the treatment setting and the billing it produced.

That can involve an inpatient admission, a procedure code or a claim about Medicare coverage. The product’s labeling and the manufacturer’s billing advice belong alongside the clinical and payment records.

A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, published in the Journal of Forensic and Investigative Accounting in 2020, describes healthcare claims for more expensive care than patients received, as well as false statements about compliance with payment conditions. We look at what the provider billed and what the company said to get it paid.

Testing, Complaints and the Company’s Response

Quality and regulatory staff may know the history behind a passing test, a cleared product or a customer complaint. We compare the test conditions with the results the company reported.

In the Advanced Bionics whistleblower complaint, an engineer alleged that passing emissions tests depended on a hand-selected unit, shielding and altered test conditions. That account identifies something a passing report alone would hide: how the result was produced.

An adverse-event file has its own history. The initial complaint and reporting decision show what information reached the company and how it responded. We connect that product history to the sales and payment circumstances. The same approach applies when instructions for single-patient or single-use products differ from the reuse customers were encouraged to adopt.

Credits, Replacement Devices and Federal Contracts

A replacement device can leave records in purchasing, accounts payable and hospital billing. The warranty credit and claim adjustment concern the same transaction even when different departments handle them. Medicare reduces payment for qualifying free or credited replacement devices, so the credit’s path through those departments matters.

We examine the service date and payment setting alongside the credit. The question for an insider may be who received the credit memo, whether billing learned about it and what happened to the government’s payment.

A direct federal purchase follows a different chain. The contract, product origin and representations to the federal buyer become central. In the Medtronic procurement settlement, the government alleged false country-of-origin representations in device sales to the Department of Veterans Affairs and the Department of Defense. A purchasing or distribution insider may know the goods and certifications behind that sale.

How Does Medical Device Fraud Reporting Become a Whistleblower Case?

A medical device whistleblower case connects the conduct to false claims for government money. Under the False Claims Act, a private party can bring a qui tam case on the government’s behalf and share in a recovery. We assess that connection with you and bring in medical device fraud whistleblower lawyers with the relevant experience.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. Any report already made, questions about confidentiality or concerns about your own involvement belong in that conversation with us and your whistleblower counsel.

What the Device Cases Show

Life Spine and Kyphon illustrate why the company’s records and the provider’s records need to be understood together. One concerns payments to the people selecting implants. The other concerns sales activity that changed the setting billed to Medicare.

Life Spine admitted in its civil settlement that management reports compared payments to surgeons with their use of its products, and that sales managers urged increased use when it fell. The government alleged that the resulting procedures generated false Medicare and Medicaid claims. Payment records and the decisions made from them belonged to the same story.

Kyphon’s successor, Medtronic Spine, agreed to a $75 million civil settlement over allegations that Kyphon’s marketing caused hospitals to bill Medicare for inpatient kyphoplasty when less costly outpatient treatment was clinically appropriate. Two former employees brought the whistleblower case.

What Happens After You Contact Us?

We work through how your account fits the device records and the bill. Sales staff may understand the customer instructions, quality staff the testing, and hospital staff the claim. Your account gives the records their context: who made the decision, what information reached them and what followed.

The Decision You Saw May Explain the Bill

If you know who directed the payments, changed the sales instructions or kept a product problem from customers, speak with our whistleblower experts about your medical device fraud case. We bring the evidence, strategy and medical device fraud whistleblower lawyers together around what you know, and remain your partners through the case.