Advanced Bionics LLC, a Valencia, California-based manufacturer of cochlear implant system devices, has agreed to pay more than $12 million to settle allegations that it misled federal health care programs regarding radio-frequency (RF) emissions generated by some of its cochlears. Implant applications.
“The United States expects device manufacturers to provide accurate information when their devices meet certain tests or standards,” Principal Deputy Assistant Attorney General Brian M. said Boynton, head of the Justice Department’s Civil Division. “The integrity of our health care system depends on the government trusting the information manufacturers provide when they apply for approval to market their devices.”
“The FDA’s approval process requires companies to demonstrate the effectiveness of their products,” said Jacqueline C., U.S. Attorney for the Eastern District of Pennsylvania. Romero said. “The settlement of this case demonstrates our commitment to holding accountable any medical device manufacturer that ignores these rules. Consumers who use these devices and federal programs that pay for many of them are better off.
The tests at issue are the extent to which cochlear implant systems generate RF emissions that may interfere with other devices using the RF spectrum. Other such devices may include telephones, alarm and security systems, televisions and radios.
The settlement resolves allegations that Advanced Bionics made false claims about the results of its RF emission tests in submitting premarket approval applications to the Food and Drug Administration (FDA) for the Neptune and Naida cochlear implant processors. Advanced Bionics claimed that its processors satisfied an internationally recognized emission standard when, in fact, Advanced Bionics did not comply with that standard. More specifically, Advanced Bionics allegedly failed to respect the standard’s requirements for testing processors using “bad” configurations, and improperly protecting certain emission-producing computer components during emissions testing. Advanced Bionics reportedly sought reimbursement from Medicare, Medicaid and other federally funded health programs for these devices.
“Patients deserve access to medical devices that comply with all federal standards,” said Maureen R. Dixon said. “Manufacturers must be truthful in submitting claims for payment to Medicaid and Medicaid programs. HHS-OIG will continue to work with the Department of Justice and our law enforcement partners to protect the integrity of Medicaid funds.
“The Department of Defense Office of the Inspector General’s Defense Criminal Investigative Service (DCIS) is committed to working with its law enforcement partners, including the Department of Justice, to combat health care fraud,” said Special Agent in Charge Patrick J. Hegarty said. DCIS Northeast Field Office. “TRICARE, the health care program for active duty military personnel, retirees and dependents, relies on medical providers to provide complete and truthful information about the effectiveness of their products and services. Today’s settlement demonstrates DCIS’ tireless commitment to investigating the submission of false claims and reports to TRICARE.
“We expect that the medical supplies provided to federal employees and their families meet the standards promised by the manufacturer,” said Special Agent in Charge Amy K. Parker said. “We credit today’s settlement with the hard work of our law enforcement partners and colleagues in the judiciary.”
“The Office of Veterans Affairs (VA-OIG) is dedicated to ensuring that veterans receive the quality health care products they are promised,” said Christopher Algieri, Special Agent in Charge of the VA-OIG Northeast Field Office. Exposes malpractice that affects facilities and improperly uses VA dollars for their benefit.”
In addition to the civil settlement, Advanced Bionics entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG. The CIA requires an independent review of the activities and processes related to the preparation or submission of premarket approval applications (PMAs) to the FDA and the performance standards associated with those PMAs. Advanced Bionics must implement a robust compliance program that includes, among other things, a risk assessment program and compliance certifications of key managers and board of directors.
The settlement provides that Advanced Bionics will pay approximately $11.36 million to the United States, and that Advanced Bionics will pay approximately $1.24 million to participating medical states, pursuant to the terms of Advanced Bionics’ separate settlement agreements. Those states.
The settlement resolves a lawsuit originally brought by David Nyberg, a former advanced bionics engineer. qui tam or whistleblower provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Mr. Nyberg will receive approximately $1.87 million in federal settlement money.
The settlement is the result of a coordinated effort by the Justice Department’s Civil Division’s Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, with assistance from the Department of Health and Human Services, Office of Counsel to the Inspector General and Office of Investigation; Defense Criminal Investigation Service; Defense Health Agency Office of the General Counsel; Office of Personnel Management, Office of the Inspector General; Department of Veterans Affairs, Office of the Inspector General; and the National Association of Medical Fraud Control Units.
The investigation and resolution of this matter illustrates the government’s importance in combating healthcare fraud. One of the most powerful tools in this endeavor is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement may be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
Daniel Spiro, senior trial counsel for the Civil Division’s Commercial Litigation Section, Fraud Section, and Lauren DeBruker, Assistant U.S. Attorney for the Eastern District of Pennsylvania, prosecuted the case.
The case resolved by this settlement is the subject United States, et al., ex rel. Nyberg v. Advanced Bionics Corp., Case no. 2:19-cv-3439 (EDPA.). Claims resolved by settlement are allegations only, and there is no determination of liability.