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Government Investigations – Health Care

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Baker Donelson has developed a nationally recognized practice defending providers in government investigations from the very outset of an investigation through settlement, trial and, if necessary, appeal.

Featured Videos

Government Investigations: How to Respond to a Search Warrant - 10 Practical Steps [Ober|Kaler] January 1, 2016
How to Implement a Document Preservation Notice While Under Government Investigation - Ten Practical Steps [Ober|Kaler] August 1, 2014
Responding to a Government Subpoena or Other Document Demand - Six Helpful Hints [Ober|Kaler] December 1, 2013
How to Respond to a Search Warrant - Ten Practical Steps [Ober|Kaler] December 1, 2013
Conducting an Internal Investigation: Managing Messages, Risks and Outcomes [Ober|Kaler] November 13, 2013

Featured Experience

Defended a large physician-owned Medicare Advantage HMO in parallel criminal and civil investigations in which the United States alleged a significant failure to provide care to Medicare members. After a three year investigation, the criminal and civil matters against the client were closed without action.

Serves as the Independent Review Organization for North Broward Hospital District (the work requires the recommendation of the hospital system and approval of the government), which is the ninth largest public health system in the country, following its entering into the largest non-litigated Stark Law settlement in history and the associated Corporate integrity Agreement (CIA). The hospital system includes four hospitals with over 1,500 beds, over 9,000 employees, nearly 1,900 credentialed physicians, and numerous ancillary and community health service lines. The work has included an Arrangements Systems Review, which has included the Governor-appointed Board of Commissioners, every member of corporate and hospital level senior management, and every department involved in the focus arrangement process, significant compliance testing, remuneration tracking, and other work as well as an Arrangements Transactions Review to ensure compliance with federal laws, regulations, and the CIA.  

Represented clients in OIG enforcement efforts, including under Operation Restore Trust and Operation Lab Scam. Oversaw self-disclosures, negotiated settlements and corporate integrity agreements (IAs) and supervised annual reporting under the CIA.

Practice Overview

Overview

No health care provider expects to become the target of a government investigation. Yet it happens, even to established, ethical businesses with strong compliance programs. Data mining, for example, can draw unwarranted attention; so can legitimate differences of opinion about medical necessity.

Once underway, investigations of health care providers can lead to complex parallel civil, criminal and administrative proceedings under the False Claims Act, the Stark law on self-referrals, the federal Anti-Kickback Statute and myriad state laws. Baker Donelson's Health Care Government Investigations Group was formed specifically to handle such complicated cases, combining the experience of regulatory lawyers from our Health Law Department with the litigation and trial advocacy experience of the former federal and state prosecutors, former judges and agents, and white-collar defense attorneys in our Government Investigation and Litigation Group. We have developed a nationally recognized practice defending providers in government investigations from the very outset of an investigation through settlement, trial and, if necessary, appeal.

Baker Donelson's attorneys understand federal and state health care laws and know how to respond to subpoenas and search warrants (including document retention notifications). We have experience advising clients how to control the scope of an investigation and can help them understand agents' and prosecutors' goals, because our attorneys have not only defended health care fraud allegations but have also prosecuted health care providers.  Beyond issues of liability, we have extensive experience negotiating corporate integrity agreements with the HHS Office of Inspector General. We also advise clients how to satisfy the compliance and reporting requirements under such agreements.

The attorneys in our Health Care Government Investigations Group understand the nuances and requirements faced by the Department of Justice and its agencies, including the U.S. Attorney's office; the Federal Bureau of Investigation; the Department of Health and Human Services Office of Inspector General, including the Office of Counsel to the Inspector General; the Centers for Medicare and Medicaid Services and its contractors; and state attorneys general and their Medicaid Fraud Control Units.

Understanding clearly what agents and prosecutors are trying to accomplish is essential to defending health care fraud allegations. Our team of health care regulatory lawyers and ex-government attorneys understand how investigations work: the different types of subpoenas used and why; the reasons for executing a search warrant; when to cooperate and when to prepare for trial; the complexity of parallel investigations; the legal requirements that arise with a grand jury; how to use public policy arguments effectively; and how to develop a beneficial relationship with agents and prosecutors. All are imperative to the successful defense of health care fraud investigations cases. At Baker Donelson, we have years of proven experience and success doing just that.

Representative Matters
  • Defended a large physician-owned Medicare Advantage HMO in parallel criminal and civil investigations in which the United States alleged a significant failure to provide care to Medicare members. After a three year investigation, the criminal and civil matters against the client were closed without action.

  • Serves as the Independent Review Organization for North Broward Hospital District (the work requires the recommendation of the hospital system and approval of the government), which is the ninth largest public health system in the country, following its entering into the largest non-litigated Stark Law settlement in history and the associated Corporate integrity Agreement (CIA). The hospital system includes four hospitals with over 1,500 beds, over 9,000 employees, nearly 1,900 credentialed physicians, and numerous ancillary and community health service lines. The work has included an Arrangements Systems Review, which has included the Governor-appointed Board of Commissioners, every member of corporate and hospital level senior management, and every department involved in the focus arrangement process, significant compliance testing, remuneration tracking, and other work as well as an Arrangements Transactions Review to ensure compliance with federal laws, regulations, and the CIA.  

  • Represented providers in national OIG initiatives.

  • Represented suppliers and providers in implementing compliance programs, responding to civil investigative demands and negotiating corporate integrity agreements.

  • Represented clients in OIG enforcement efforts, including under Operation Restore Trust and Operation Lab Scam. Oversaw self-disclosures, negotiated settlements and corporate integrity agreements (IAs) and supervised annual reporting under the CIA.

  • Obtained favorable OIG Advisory Opinions for privately-financed ventures.

  • Represented a health care provider in a criminal investigation by the state attorney general and obtained a civil resolution with the criminal charges avoided.

  • Helped conduct and respond to document requests during an investigation of pharmacies by the U.S. Attorney Office in the Southern District of Florida.

  • Assisted in negotiating a Corporate Integrity Agreement with the OIG on behalf of a hospital client.

  • Advised a health care provider on OIG self-disclosure.

  • Successfully represented a physician in a government investigation involving federal anti-kickback and false claims law.

  • Represented a hospital in a psychiatric and outpatient partial hospitalization program civil and criminal investigation.

  • Represented a health maintenance organization in qui tam and governmental investigations alleging a pharmaceutical company switch program.

  • Represented a hospital in a civil and criminal false claim investigation regarding cardiac interventional procedures.

  • Represented a generic pharmaceutical company in a pay-for-delay investigation by the Mississippi Attorney General as part of a multi-state task force concerning restraints on generic competition for branded drugs caused by settlement of patent litigation and related contracts for supply and distribution arrangements granted by the branded pharma companies to the client company, with the result that after a confidentiality agreement was negotiated and some documents produced, the Attorney General's office decided to close the investigation.

  • Represented a health care facility during a multi-year investigation by the United States Department of Justice.

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