DOJ SETTLES KICKBACK ALLEGATIONS CASE WITH MEDICAL DEVICE COMPANY AND SURGEON FOR $2.6 MILLION

FROM:  U.S. JUSTICE DEPARTMENT 

Friday, August 29, 2014

Manufacturer of Spinal Devices and Surgeon to Pay United States $2.6 Million to Settle Alleged Kickback Scheme Omni Surgical L.P., doing business as Spine 360, a manufacturer of devices used in spinal surgery, and Dr. Jamie Gottlieb, an Indiana spinal surgeon, have agreed to pay $2.6 million to the United States to settle allegations that Spine 360 paid illegal kickbacks to Gottlieb to induce him to use the company’s products.  Spine 360 is based in Austin, Texas.

“The Department of Justice has longstanding concerns about improper financial relationships between health care providers and their referral sources, because such relationships can alter a physician’s judgment about the patient's true health care needs and drive up health care costs for everybody,” said Assistant Attorney General Stuart F. Delery for the Justice Department’s Civil Division.   “In addition to yielding a recovery for taxpayers, this settlement should deter similar conduct in the future and help make health care more affordable.”

The Anti-Kickback Statute restricts the financial relationships that medical device manufacturers may have with doctors who use or prescribe their products.  It is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based upon the best interests of the patient.

The settlement announced today involved payments that Spine 360 made between 2007 and 2009 to an entity controlled by Gottlieb.  Although the payments were purportedly made pursuant to a series of intellectual property agreements, the United States contended that those agreements were shams, and that the payments were intended to compensate Gottlieb for using Spine 360 products in his surgeries.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $22.4 billion through False Claims Act cases, with more than $14.2 billion of that amount recovered in cases involving fraud against federal health care programs.

The case was handled by the Commercial Litigation Branch of the department’s Civil Division , the U.S. Attorney’s Office for the Northern District of Indiana and the U.S. Department of Health and Human Services-Office of Inspector General.  The claims settled by this agreement are allegations only, and there has been no determination of liability.

$30 MILLION PAID TO SETTLE FALSE CLAIMS ACT ALLEGATIONS BY MEDICAL COMPANY

Photo From U.S. Department Of Defense.

FROM: U.S. DEPARTMENT OF JUSTICE

Friday, November 2, 2012
Orthofix Subsidiary, Blackstone Medical, Pays U.S. $30 Million to Settle False Claims Act Allegations
Allegedly Paid Kickbacks to Doctors to Induce Use of Company’s Products

Orthofix International NV, has agreed to pay the United States $30 million to settle allegations that an Orthofix subsidiary, Blackstone Medical Inc., paid illegal kickbacks to physicians in order to induce use of the company’s products, the Justice Department announced today. Orthofix, which manufactures spinal implants and other spinal surgery products, is a publicly traded company headquartered in Curacao.

The civil settlement resolves allegations that Blackstone paid kickbacks to spinal surgeons. These alleged kickbacks took a number of forms, including sham consulting agreements, sham royalty arrangements, sham research grants, travel and entertainment.

"Kickbacks to physicians are incompatible with a properly functioning health care system," said Stuart F. Delery, the Acting Assistant Attorney General for the Department’s Civil Division. "They can corrupt physicians’ medical judgment and cause misallocation of vital health care resources. Today’s settlement reflects the progress we are making in the ongoing fight against abusive and illegal practices in the healthcare industry."

"This settlement demonstrates the government’s continued resolve to ensure that patients receive, and the government pays for, health care that is based solely on sound medical judgment, not compromised by kickbacks," said Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts. "We believe that this is a just and meaningful resolution that is in the best interests of the citizens of the Commonwealth and taxpayers across the nation."

"To those contemplating taking advantage of Medicare for their own gain, today’s settlement sends a loud, clear message," said Susan Waddell, Special Agent in Charge of the U.S. Department of Health and Human Services Office of Inspector General New England region. "Law enforcement will work aggressively to eliminate efforts to abuse vital taxpayer-funded health care programs."

"Our men and women in uniform and their beneficiaries rely on their healthcare providers to perform their jobs without bias and make decisions in the best interest of their patients," said Kathryn Feeney, Resident Agent in Charge for the Defense Criminal Investigative Service, New Haven Resident Agency. "Kickbacks, like those alleged here, undermine the TRICARE Military Health System . A settlement like this helps maintain the integrity of an important program our armed services depend on."

"Blackstone Medical, Inc. now knows the FBI and our law enforcement partners are committed to investigating and uncovering healthcare fraud in all its forms, particularly schemes like the kickbacks Blackstone perpetrated to obtain profits at the expense of taxpayers," said Richard DesLauriers, Special Agent in Charge of the Federal Bureau of Investigation Boston Field Division.

As part of the settlement, Orthofix also agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services, which provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that alleged in this matter.

The allegations resolved by today’s settlement were initially alleged in a whistleblower suit filed under the False Claims Act, which authorizes private citizens to bring suit on behalf of the government for false claims for government funds, and share in any recovery. The whistleblower in this case, Susan Hutcheson, will receive $8 million as her share of the settlement amount.

This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover $9.5 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $13.2 billion.

The case was handled by the Justice Department’s Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, Office of Inspector General of the Department of Health and Human Services, the FBI and the Defense Criminal Investigative Service of the Department of Defense. The claims settled by this agreement are allegations only, and there has been no determination of liability.