AtriCure: The 2024 Dismissal and the Missing Government Claim

Whistleblower Justice Network

The AtriCure dismissal ended a former sales manager’s federal False Claims Act case over alleged device kickbacks because the complaint did not identify an actual government claim with enough detail. It described procedures, patient birthdates, device lot numbers and prices. The missing connection was to the bill submitted for payment, a distinction that matters to anyone who sees the device sale but not the hospital’s billing.

On September 12, 2024, the Southern District of Ohio ended the federal claims. The state and local claims could still be brought in the appropriate courts.

AtriCure makes equipment used to treat atrial fibrillation. The former sales manager brought the case against the manufacturer, St. Helena Hospital and Adventist Health, which operated the hospital. The United States declined to join the case.

Consulting Fees, Grants and Free Equipment

The whistleblower’s complaint alleged that AtriCure used payments and free services to increase device purchases and procedures, generating false claims to government health care programs. The allegations covered conduct from at least 2011 onward. Its account reached from the surgeon’s consulting agreement to the hospital’s equipment costs, with taxpayers allegedly paying for the resulting claims.

Surgeons and electrophysiologists allegedly received hourly or event-based consulting fees to promote AtriCure products at conferences, training sessions and patient outreach events. The complaint described promotion of both on-label and off-label uses, along with payments intended to induce off-label procedures and expand the surgical patient population.

The educational-grant allegation put the sales incentive plainly:

For example, upon identifying such a hospital, the AtriCure sales representative would tell the hospital that it could receive an AtriCure “grant” for patient education once the hospital started doing off-label procedures, to assist the hospital in increasing off-label case volume.

United States ex rel. Stevens v. AtriCure, Fourth Amended Complaint, paragraph 154

In that account, starting the procedures unlocked the grant, and the grant helped grow the procedure business. The complaint alleged that sales representatives guided hospitals through applications and that grants could also come directly from sales and marketing budgets.

Other alleged benefits covered work that the customer would otherwise have to pay for: reimbursement assistance, professional credentialing, placement on a patient-referral website and radio ads. The complaint also described free generators and other capital equipment offered in exchange for purchases of disposable products, disguised as loan agreements. Free disposables allegedly came with commitments to buy a targeted volume or give AtriCure products preferred status.

A 2020 analysis in the Journal of Forensic and Investigative Accounting, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, describes kickback arrangements as economic relationships that can be more complex than a payment for services. That perspective fits the allegation here: the claimed inducement included taking costs off a customer’s books, as well as putting cash into a physician’s hands.

How Does Reimbursement Work for Medical Devices?

Medicare usually pays the hospital one amount for the procedure or stay, with the device inside that payment. The court emphasized that reimbursement follows the procedure, not the device’s price. A list of the manufacturer’s products and prices did not identify the hospital’s government claim. The device sale was one transaction. The request for public money was another.

The complaint used that payment structure to explain the alleged equipment incentive. It said free products reduced the hospital’s costs while its procedure payment stayed fixed. A free generator could also support future purchases of the disposables used with it. The alleged benefit reached both the hospital’s margin and the manufacturer’s future business.

A separate case involving Endoscopic Technologies shows why coding advice belongs in this account. Its whistleblower complaint alleged that the company instructed hospitals to code closed-chest ablation as open-heart surgery and tied free equipment to purchasing commitments. The Justice Department announced a $1.4 million civil settlement in July 2009 covering allegations of atrial-fibrillation promotion, unnecessary invasive procedures, upcoding advice and kickbacks. That case illustrates the alleged route from a manufacturer’s sales support into the hospital’s bill.

Why the Court Dismissed the AtriCure Claims

The court found that the complaint’s detailed account of the alleged sales scheme still did not identify a specific false claim submitted to the government. Its analysis focused on that missing connection.

The former sales manager pointed to procedure dates, hospitals, patient birthdates, Medicare coverage, specific parts, lot numbers and the prices AtriCure charged. He also cited a spreadsheet allegedly prepared by AtriCure explaining how Medicare would reimburse use of its devices. These were details about the treatment and its expected payment. The court wanted details connecting them to an actual submitted claim.

Scheduled operations, patient ages and device part numbers described anticipated or reported care, but did not identify the bill sent to the government. A part number could identify what the surgeon used without identifying what the hospital billed.

The court also found that the former sales manager had not alleged personal knowledge of the defendants’ billing practices. It contrasted his account with reports in other cases showing claims actually submitted to the government.

The hospital allegations had the same missing connection. The complaint described training events, an atrial-fibrillation program and educational grants, but the court found no specific account of the hospitals participating in or knowing about fraudulent government submissions.

AtriCure Had Already Settled Promotion and Kickback Allegations

AtriCure’s earlier Medicare fraud settlement was a separate case. The Justice Department announced a $3.76 million settlement in February 2010 over allegations involving atrial-fibrillation promotion, unnecessary invasive surgery, upcoding advice and kickbacks. A former insider later alleged a similar mix of promotion and kickbacks.

Where the Sale Meets the Hospital’s Bill

Our work with device insiders connects the sales arrangement, the treatment decision and the claim for payment. A sales employee may understand why a grant was offered or equipment was free. A hospital billing employee may understand how the procedure reached Medicare. We work with insiders to connect those views and assess what their knowledge can establish.

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

You Know the Sale Behind the Procedure

If you saw grants tied to case volume, free equipment tied to purchases or reimbursement support shaping hospital claims, speak to our whistleblower experts about how those sales reached Medicare. We connect your knowledge of the device business to the payment evidence and bring in medical device fraud whistleblower lawyers who understand manufacturer and hospital cases. We work with you to build your strongest medical device whistleblower case and stay with you through the pursuit of a recovery.

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