Healthcare Government Investigations and Audits

Holland & Knight's Healthcare Government Investigations and Audits Team blends the skills of former federal and state prosecutors and regulators with lawyers who have decades of healthcare regulatory and litigation experience to provide comprehensive counsel to healthcare clients. We assist clients in navigating the complex healthcare regulatory landscape and the vast resources and power of the government in order to address investigations, audits and compliance issues and achieve the best possible outcomes.

Healthcare providers and other industry stakeholders benefit from our ability to conduct thorough and timely internal investigations in times of crisis, including in response to – and in anticipation of – government investigations. We provide effective representation of clients facing federal and state False Claims Act (FCA) investigations, criminal healthcare fraud proceedings, U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) investigations, as well as multimillion-dollar Medicare and Medicaid audits and extrapolated overpayments. Our attorneys also litigate FCA cases in federal courts nationwide.

Clients rely on our Healthcare Government Investigations and Audits Team for assistance with a wide range of issues, including:

• Investigations. We defend healthcare clients facing civil and criminal government investigations in a broad range of matters involving the FCA, the Anti-Kickback Statute (AKS), federal healthcare fraud statutes, the Controlled Substances Act, the Stark Law, Civil Monetary Penalties and Patient Inducement statutes, the Health Insurance Portability and Accountability Act (HIPAA), and other federal and state healthcare regulations.
• Audits. We assist clients in responding to Medicare and Medicaid audits, including UPIC and SMRC audits, and other regulatory reviews. Our attorneys have extensive experience successfully appealing multimillion-dollar extrapolated overpayments resulting from these audits through the Medicare and Medicaid administrative appeals process.
• Litigation. Our team regularly litigates False Claims Act qui tam cases in federal courts across the country. We have extensive litigation experience both in cases where the government has intervened as well as declined cases pursued by whistleblowers. We also represent healthcare companies, executives and providers in criminal healthcare fraud cases. Our lawyers bring the combination of deep healthcare regulatory knowledge and trial experience to help achieve the best possible outcomes for healthcare clients in courts across the country.
• Internal Investigations and Compliance. We have a deep bench of experienced healthcare lawyers able to conduct rapid and thorough internal investigations to get to the bottom of any suspected billing or compliance issues that may arise. Our team also works with healthcare clients to develop and implement comprehensive compliance programs to prevent and detect violations of healthcare laws and regulations. We assist clients in negotiating and maintaining compliance with corporate integrity agreements instituted by the HHS Office of Inspector General (OIG). Our attorneys also provide training, education and ongoing monitoring to help ensure adherence to industry standards.
• Regulatory Advice. We offer strategic advice on a wide range of healthcare regulatory matters, including reimbursement, billing and coding issues. Our team stays current on the latest industry trends and regulatory developments to provide informed guidance to our clients.
• Self-Reporting. Our lawyers have extensive experience assisting healthcare clients who have discovered fraud or other compliance lapses with evaluating a company's exposure to monetary penalties and the applicable voluntary self-disclosure (VSD) policies, guiding clients through all aspects of the VSD process and helping to ensure that they receive maximum credit from the government as they negotiate a resolution.

Extensive Experience and Capabilities

Our Healthcare Government Investigations and Audits Team includes former federal prosecutors who handled an array of healthcare fraud prosecutions and FCA investigations during their time with the government, as well as experienced healthcare litigators who have tried healthcare fraud cases across the country. Our healthcare lawyers have deep experience in white collar criminal and civil litigation from both sides of the courtroom, and they know many of the decision-makers at the U.S. Department of Justice (DOJ), HHS OIG and other enforcement agencies.

Our attorneys have built an impressive track record defending clients' FCA matters across the United States, including cases where the government has intervened. We have been similarly successful in appealing costly and potentially crippling Medicare and Medicaid audits, reducing multimillion-dollar overpayments to four- or five-figure overpayments through the Medicare and Medicaid appeals process and convincing the Centers for Medicare & Medicaid Services (CMS) to lift potentially devastating payment suspensions on behalf of providers.

Our team includes:

• a former U.S. attorney who led the office to national prominence in healthcare fraud prosecutions
• a former assistant U.S. attorney who oversaw a regional DOJ Medicare Fraud Strike Force
• the former deputy chief of a regional DOJ Health Care Fraud Unit that obtained billions of dollars in criminal fines and civil settlements
• a former associate deputy attorney general with responsibility for financial crimes who tried dozens of cases to verdict, advised the Senate Judiciary Committee on drafting criminal legislation and later presided over more than 400 trials as a judge

We complement that litigation acumen with attorneys who have a deep understanding of the regulatory and operations side of healthcare. Our team members who have worked in-house at major pharmaceutical, hospital and medical device companies and the agencies that regulate them bring an industry insider's perspective to client matters.

Representative Experience

• Won summary judgment on behalf of a national pharmacy benefits manager in Texas federal court (affirmed by the U.S. Court of Appeals for the Fifth Circuit), resulting in a landmark defense ruling on the issue of falsity in one of the largest FCA cases in the country
• Secured dismissal of an FCA case against a lab company based on failure to plead specific false claims, affirmed by the U.S. Court of Appeals for the Sixth Circuit only one year after the case was first unsealed
• Secured voluntary dismissal of an FCA case against a rural hospital in Texas in exchange for an agreement not to seek attorneys' fees against a physician whistleblower
• Won summary judgment on all counts on behalf of a behavioral healthcare company, resulting in complete dismissal of an FCA case in Arkansas federal court
• Secured dismissal of an FCA case against a behavioral healthcare company in California federal court and obtained attorneys' fees award against a whistleblower
• Represented a national home health company in an FCA case in Tennessee federal court; won motion to dismiss at the pleading stage, before any discovery commenced
• Defended a leading medical device manufacturer in an FCA case in Tennessee federal court, in which the U.S. intervened; helped negotiate a favorable settlement with the government
• Represented a large retina practice in an FCA investigation by the DOJ; successfully negotiated a settlement of $200,000, far below the multimillion-dollar demand the government made at the beginning of the investigation, and convinced the government not to require a corporate integrity agreement (CIA) and not to issue a news release, both of which are typical in FCA cases
• Represented a national chain of infusion centers in an FCA investigation in Missouri; secured a favorable settlement with the government for a fraction of single damages and without imposition of a CIA
• Represented a reference laboratory in an FCA investigation in Kentucky; secured a favorable settlement with the government for a small fraction of single damages, convinced HHS OIG to not impose a CIA and obtained the lift of a payment suspension by CMS
• Represented a nationwide physical therapy provider in an FCA investigation in Minnesota; negotiated a favorable settlement with the government and without imposition of a CIA
• Represented a nonprofit nursing home in an FCA investigation in Tennessee; secured a favorable settlement with the DOJ based on single damages and without imposition of a CIA
• Represented a specialty pharmacy in an FCA investigation in Tennessee; convinced DOJ to forego criminal proceedings against the owner and negotiated a favorable civil settlement on behalf of the company
• Represented a national behavioral healthcare provider in an FCA investigation in West Virginia and negotiated a favorable civil settlement on behalf of the company
• Represented an ophthalmology practice in an FCA investigation in Tennessee involving dilution of injections; case resulted in conviction of a rogue physician without any civil or criminal charges being filed against the practice
• Defended a generic drug manufacturer in qui tam litigation and related DOJ and state Medicaid investigations stemming from the company's self-disclosed, accidental misclassification of an innovator drug under the Medicaid Drug Rebate Program, and negotiated a settlement equal to the amount of underpayment, plus interest, with no penalties and no imposition of a CIA
• Represented a drug manufacturer in an investigation by HHS OIG into allegations with potential penalties of $80 million, ultimately negotiating a settlement that required the company to pay only a minor fine
• Served as white collar and civil litigation counsel to an international pharmaceutical company involving multijurisdictional litigation, receivership proceedings in various countries, and alleged civil Racketeer Influenced and Corrupt Organizations Act (RICO) violations
• Represented an executive of a major pharmaceutical company in an 11-defendant, three-month jury trial in which the DOJ alleged illegal kickbacks
• Investigated best price reporting issues and pharmaceutical sales and marketing practices for a NASDAQ-listed company under both criminal and civil investigations
• Successfully represented a pharmacy distributor in a U.S. Drug Enforcement Administration (DEA) investigation
• Represented the nation's largest publisher of pharmaceutical drug pricing information in dozens of federal and state government investigations and private payer lawsuits involving allegations of fraud and false claims
• Represented the nation's second-largest drugstore chain in response to subpoenas and investigations concerning its use of average wholesale price (AWP) and reimbursement policies
• Served as independent counsel to the audit committee of a publicly traded healthcare company to investigate potential overbillings of government agencies and related FCA liabilities
• Served as lead counsel for a group of physicians' offices in a federal criminal investigation involving identity theft and income tax fraud
• Represented a chain of nursing home and rehabilitation centers in an FCA mediation with DOJ and HHS OIG
• Represented a medical device company in an FCA case and won dismissal of a repeat qui tam relator's case because of the FCA government action rule
• Conducted an internal investigation regarding the FCA and pricing practices for a newly acquired medical device company
• Represented a medical device company in defending an FCA and parallel criminal AKS and related fraud investigation into sales and marketing activities, as well as relationships with physicians and medical facilities
• Defended a medical device company in state attorney general investigation and advised on public relations because the state case attracted significant media attention
• Led an internal investigation of a large medical services provider concerning allegations of improper Medicare billing and conducted most employee interviews in Spanish
• Represented a client in DOJ-ordered anti-corruption training and submitted annual reviews to the government
• Represented leading academic medical center in internal investigation and FCA litigation