Category: KB

Source: Federal Bureau of Investigation (FBI) State Crime Alerts (b)

DETROIT – United States Attorney Dawn N. Ison announced today a series of three civil settlements, totaling over $8 million, related to, among other allegations, kickbacks that medical device company Ra Medical Systems, Inc. (Ra Medical), paid to various physicians across the country related to Ra Medical’s DABRA laser.

Ison was joined in the announcement by Special Agent in Charge Mario M. Pinto of the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG), Chicago Regional Office, Cheyvoryea Gibson, Special Agent-in-Charge of the Detroit Field Office of the Federal Bureau of Investigation, and Special Agent in Charge Patrick J. Hegarty, Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS), Northeast Field Office. 

Ra Medical was a medical device company that was formerly headquartered in Carlsbad, California.  From 2017-2019, Ra Medical manufactured and sold a device known as the DABRA Laser.  The settlement with Ra Medical resolves the following alleged violations of the False Claims Act:

• Ra Medical marketed the DABRA Laser for use in atherectomies, a procedure whereby plaque is mechanically removed from occluded blood vessels in patients suffering from peripheral artery disease. The U.S. Food and Drug Administration, however, had not approved the DABRA Laser for use in atherectomy procedures.
• Additionally, Ra Medical knowingly marketed the DABRA Laser despite product performance issues causing frequent calibration and overheating problems, which posed a risk to physicians and patients, and prompted a recall in August 2019.
• Ra Medical also knowingly offered and paid illegal remuneration to certain physicians to induce them to use the DABRA Laser in violation of the Federal Anti-Kickback Statute. The United States contends that the illegal remuneration consisted of cash payments and fees paid in connection with purported training events and consulting services. The United States further contends that RMS tracked utilization of its high-volume physician customers using an internal document titled “Who Deserve[] Love,” which was used to identify physicians that RMS should target with offers of improper remuneration. Two of the recipients of the alleged kickback payments were Elias Kassab, M.D. (Kassab), of Dearborn, Michigan, and David Allie, M.D. (Allie), of Lafayette, Louisiana.

The Federal Anti-Kickback Statute prohibits offering or paying anything of value to induce referrals of items or services covered by Medicare and other federally funded programs.  The statute is intended to ensure that a medical provider’s judgment is not compromised by improper financial incentives.

Under the terms of the agreement with Ra Medical, which was entered into pursuant to DOJ’s inability to pay settlement guidelines and was executed in December 2020, Ra Medical paid $2.5 million up front and would pay up to $28 million more if future financial contingencies were met.  In January 2023, Ra Medical paid an additional $5 million, after its reverse merger with Catheter Precision, Inc., triggered one of the contingencies.

The settlement with Ra Medical remained under seal while the United States continued its investigation into Kassab and Allie, among others, who were alleged to have received improper kickbacks.  In a separate settlement, Kassab and two of his companies agreed to pay $450,000 to resolve the allegations against them.  In the third settlement, Allie and his consulting company agreed to pay $250,000 to resolve the allegations against them.

“The United States will not allow doctors to hold out their hands expecting to be paid to use and promote a device,” said U.S. Attorney Ison. “The millions of people who depend on our federal healthcare programs deserve and expect medical decisions untainted by kickbacks, and this settlement reflects our commitment to pursuing not just the companies that pay illegal kickbacks, but also the physicians who willingly extract and accept them.”

“The payment of kickbacks to induce referrals can undermine the trust in our nation’s providers and result in costly reductions to our federal health care programs,” said Special Agent in Charge Mario M. Pinto of the U.S. Department of Health and Human Services Office of Inspector General. “We will continue to work diligently with our law enforcement partners to ensure the appropriate use of taxpayer dollars.”

“Healthcare services are being unlawfully influenced by medical providers engaging in criminal kickback schemes, significantly impacting programs such as Medicare and Medicaid,” said Cheyvoryea Gibson, Special Agent in Charge of the FBI in Michigan. “Our office is fully committed to investigating and holding accountable those individuals and organizations involved in illegal profit-driven practices that harm our medical system.”

“Protecting TRICARE, the healthcare system for military members and their dependents, is a top priority for the Defense Criminal Investigative Service (DCIS), the law enforcement arm of the Department of Defense Office of Inspector General,” stated Special Agent-in-Charge Patrick J. Hegarty, DCIS Northeast Field Office.  “The settlement agreement announced today demonstrates our ongoing commitment to work with our law enforcement partners and the Department of Justice to investigate allegations of healthcare fraud.”

The civil settlements resolve the claims brought by Robert Gruber, under the qui tam or whistleblower provisions of the False Claims Act.  Under these provisions, a private party may file an action on behalf of the United States and receive a portion of any recovery.  The qui tam case is captioned United States ex rel. Gruber v. Ra Medical Systems, Inc., et al., No. 19-12044 (E.D. Mich.).  The whistleblower will receive a combined $1,722,000 from the three settlements.  The claims resolved by the settlements are allegations only; there has been no determination or admission of liability.

The matter was investigated by Assistant U.S. Attorney Jonny Zajac of the U.S. Attorney’s Office for the Eastern District of Michigan, with assistance from HHS-OIG, the FBI, and the Defense Criminal Investigative Service.

MIL Security OSI –

Source: Federal Bureau of Investigation (FBI) State Crime Alerts (b)

DETROIT – United States Attorney Dawn N. Ison announced today a series of three civil settlements, totaling over $8 million, related to, among other allegations, kickbacks that medical device company Ra Medical Systems, Inc. (Ra Medical), paid to various physicians across the country related to Ra Medical’s DABRA laser.

Ison was joined in the announcement by Special Agent in Charge Mario M. Pinto of the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG), Chicago Regional Office, Cheyvoryea Gibson, Special Agent-in-Charge of the Detroit Field Office of the Federal Bureau of Investigation, and Special Agent in Charge Patrick J. Hegarty, Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS), Northeast Field Office. 

Ra Medical was a medical device company that was formerly headquartered in Carlsbad, California.  From 2017-2019, Ra Medical manufactured and sold a device known as the DABRA Laser.  The settlement with Ra Medical resolves the following alleged violations of the False Claims Act:

• Ra Medical marketed the DABRA Laser for use in atherectomies, a procedure whereby plaque is mechanically removed from occluded blood vessels in patients suffering from peripheral artery disease. The U.S. Food and Drug Administration, however, had not approved the DABRA Laser for use in atherectomy procedures.
• Additionally, Ra Medical knowingly marketed the DABRA Laser despite product performance issues causing frequent calibration and overheating problems, which posed a risk to physicians and patients, and prompted a recall in August 2019.
• Ra Medical also knowingly offered and paid illegal remuneration to certain physicians to induce them to use the DABRA Laser in violation of the Federal Anti-Kickback Statute. The United States contends that the illegal remuneration consisted of cash payments and fees paid in connection with purported training events and consulting services. The United States further contends that RMS tracked utilization of its high-volume physician customers using an internal document titled “Who Deserve[] Love,” which was used to identify physicians that RMS should target with offers of improper remuneration. Two of the recipients of the alleged kickback payments were Elias Kassab, M.D. (Kassab), of Dearborn, Michigan, and David Allie, M.D. (Allie), of Lafayette, Louisiana.

The Federal Anti-Kickback Statute prohibits offering or paying anything of value to induce referrals of items or services covered by Medicare and other federally funded programs.  The statute is intended to ensure that a medical provider’s judgment is not compromised by improper financial incentives.

Under the terms of the agreement with Ra Medical, which was entered into pursuant to DOJ’s inability to pay settlement guidelines and was executed in December 2020, Ra Medical paid $2.5 million up front and would pay up to $28 million more if future financial contingencies were met.  In January 2023, Ra Medical paid an additional $5 million, after its reverse merger with Catheter Precision, Inc., triggered one of the contingencies.

The settlement with Ra Medical remained under seal while the United States continued its investigation into Kassab and Allie, among others, who were alleged to have received improper kickbacks.  In a separate settlement, Kassab and two of his companies agreed to pay $450,000 to resolve the allegations against them.  In the third settlement, Allie and his consulting company agreed to pay $250,000 to resolve the allegations against them.

“The United States will not allow doctors to hold out their hands expecting to be paid to use and promote a device,” said U.S. Attorney Ison. “The millions of people who depend on our federal healthcare programs deserve and expect medical decisions untainted by kickbacks, and this settlement reflects our commitment to pursuing not just the companies that pay illegal kickbacks, but also the physicians who willingly extract and accept them.”

“The payment of kickbacks to induce referrals can undermine the trust in our nation’s providers and result in costly reductions to our federal health care programs,” said Special Agent in Charge Mario M. Pinto of the U.S. Department of Health and Human Services Office of Inspector General. “We will continue to work diligently with our law enforcement partners to ensure the appropriate use of taxpayer dollars.”

“Healthcare services are being unlawfully influenced by medical providers engaging in criminal kickback schemes, significantly impacting programs such as Medicare and Medicaid,” said Cheyvoryea Gibson, Special Agent in Charge of the FBI in Michigan. “Our office is fully committed to investigating and holding accountable those individuals and organizations involved in illegal profit-driven practices that harm our medical system.”

“Protecting TRICARE, the healthcare system for military members and their dependents, is a top priority for the Defense Criminal Investigative Service (DCIS), the law enforcement arm of the Department of Defense Office of Inspector General,” stated Special Agent-in-Charge Patrick J. Hegarty, DCIS Northeast Field Office.  “The settlement agreement announced today demonstrates our ongoing commitment to work with our law enforcement partners and the Department of Justice to investigate allegations of healthcare fraud.”

The civil settlements resolve the claims brought by Robert Gruber, under the qui tam or whistleblower provisions of the False Claims Act.  Under these provisions, a private party may file an action on behalf of the United States and receive a portion of any recovery.  The qui tam case is captioned United States ex rel. Gruber v. Ra Medical Systems, Inc., et al., No. 19-12044 (E.D. Mich.).  The whistleblower will receive a combined $1,722,000 from the three settlements.  The claims resolved by the settlements are allegations only; there has been no determination or admission of liability.

The matter was investigated by Assistant U.S. Attorney Jonny Zajac of the U.S. Attorney’s Office for the Eastern District of Michigan, with assistance from HHS-OIG, the FBI, and the Defense Criminal Investigative Service.

MIL Security OSI –