Full article reprinted from 'The Gray Sheet" - July 20, 2009
Medtronic, Boston Scientific, St. Jude Medical and AtriCure are targeted in an ongoing Justice Department probe into alleged off-label promotion of cardiac ablation devices for atrial fibrillation. Find out more...
Full article reprinted from 'The Gray Sheet" - July 20, 2009
Medtronic, Boston Scientific, St. Jude Medical and AtriCure are targeted in an ongoing Justice Department probe into alleged off-label promotion of cardiac ablation devices for atrial fibrillation.
A fifth company, Endoscopic Technologies, has already reached a 1 settlement with the government, DoJ announced July 14.
Endoscopic Technologies agreed to pay $1.4 million to resolve civil allegations of Medicare fraud related to its Cobra ablation products. The whistleblower allegations first appeared in an August 2007 False Claims Act lawsuit.
Endoscopic Technologies denies the allegations and says it agreed to settle the case "to avoid continued litigation and associated risks."
The San Ramon, Calif.-based firm also is negotiating a corporate integrity agreement with the HHS Office of Inspector General to resolve the government's administrative claims.
The 2007 whistleblower 2 lawsuit was filed in the U.S. District Court for the Southern District of Texas by an unnamed former Boston Scientific sales rep.
Four related lawsuits were brought against Medtronic, Boston Scientific/Guidant, St. Jude Medical/Epicor and AtriCure between 2007 and 2008.
The five cases were unsealed July 10, but the whistleblower's identity will be kept confidential until the investigations are concluded, as the rep's spouse is also employed in the medical device industry, court documents explain. The qui tam provisions of the False Claims Act allow the whistleblower to receive $210,000 of the $1.4 million Endoscopic Technologies settlement, plus $100,000 for attorneys' fees.
Coordinated Off-Label Promotion Campaigns?
According to the whistleblower, the ablation device makers caused false or fraudulent Medicare reimbursement claims to be submitted to the government by illegally promoting their products for treatment of atrial fibrillation, an unapproved, off-label application.
Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational are currently the only cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation, although other devices with approved general cardiac ablation claims are often used off-label for atrial fibrillation, and several firms are pursuing the indication for their devices (3 'The Gray Sheet' Feb. 9, 2009).
The former device sales rep claims the five device firms targeted by DoJ have conducted a "coordinated nationwide sales campaign" to "entice physicians and hospitals to use their products for off-label purposes."
Firms Encourage Over-Reimbursement, Suits Say
The lawsuits also accuse the firms of promoting more expensive, open-heart surgical procedures with their devices, or encouraging hospitals to bill for minimally-invasive procedures under the higher-paying open-heart code.
Ablation devices such as Endoscopic Technologies' Cobra can be used either in conjunction with open heart surgery or in a stand-alone minimally invasive procedure. On average, open-heart procedures cost more than $30,000, while minimally-invasive procedures cost only $10,650.
The whistleblower further alleges that the companies provided kickbacks to physicians to encourage them to purchase their ablation devices.
For example, companies "routinely" offered free products, such as generators, scopes and trays, free use of equipment or free advertising, and referral services, the suits allege.
"Although these free gifts are often described in the contracts and invoices as simply 'discounted' items, they do not comply with the Medicare anti-kickback safe harbor for legitimate discounts," the complaints maintain.
- Jessica Bylander
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