Healthcare White Collar Defense and Investigations

Holland & Knight's Healthcare White Collar Defense and Investigations Team is largely composed of lawyers who have spent much of their careers investigating and prosecuting executives and companies accused of violating federal laws in medical reimbursement, government contracts and securities. 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), Department of Health and Human Services (HHS), Offices of Inspector General (OIG) and other enforcement agencies.

Located in offices in every region of the U.S., our healthcare attorneys use their knowledge of the enforcement agencies and their processes to shape defense and settlement strategies for clients who face federal or state inquiries or litigation. They are familiar with the intricacies of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the False Claims Act (FCA), Medicare, Medicaid, TRICARE, securities law, the Anti-Kickback Statute (AKS), Stark Law, tax reporting, and other areas of government criminal and civil enforcement.

In any type of case a client brings to us, we have a partner who once was on the government side of such an action.

A Practice Built on Litigation Experience

Examples of our Healthcare White Collar Defense and Investigations Team's experience include:

• 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
• the lead attorney in Holland & Knight's successful defense of a former governor's public corruption trial and appeal, where all charges ultimately were dismissed

Regulatory and In-House Experience

The DOJ is just one side of our portfolio of experience. We complement our litigation acumen with attorneys who have a deep understanding of the regulatory and operations side of healthcare. Lawyers who 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. They understand CMS reimbursement regulations because they once had positions where they oversaw the processes of reimbursement operations and compliance. These attorneys appreciate the complexities of interacting with patients, physicians, sales representatives, regulatory agencies and boards of directors because that was once part of their jobs. They support our litigators with their wealth of healthcare subject matter knowledge.

Internal Investigations for Healthcare Companies

Internal investigations, often conducted for boards of directors, pinpoint problems and assign responsibility, enabling companies to take remedial action, or to fix inadequate processes before they result in problems. When there are problems, a company's proactive, good-faith investigation often curtails a government inquiry and leads to a more favorable settlement. Our Healthcare White Collar Defense and Investigations Team has conducted dozens of internal investigations for major healthcare companies, as well as businesses in financial services and other areas. Our team of lawyers moves quickly and quietly to audit records and interview employees, so that boards and senior management have the information they need to make decisions that may affect the lifeblood of the business. When public companies are involved or the investigation otherwise must be disclosed or appears in news media, we work with our internal media strategy consultants to advise clients on their public posture.

Healthcare Law Compliance and Training

Our healthcare attorneys help clients write, implement and monitor policies that reduce risks. Our experience in reviewing hundreds of cases both as defense lawyers and prosecutors has shown us that companies often get into trouble because employees and managers are not trained properly and are inappropriately incentivized. Healthcare law also is complex and constantly evolving through the imposition of new regulations and case law, making it difficult for operations executives to keep up. Our Healthcare White Collar Defense and Investigations Team can tailor education to line employees, senior managers and boards that helps them make decisions that support operations while avoiding entanglements with enforcement agencies.

Representative Engagements

• 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 Corporate Integrity Agreement
• Represented a drug manufacturer in an investigation by HHS and the OIG into allegations the company inaccurately reported average sales pricing (ASP) to the U.S. Department of Veterans Affairs (VA) and HHS, 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
• Conducted an internal investigation regarding sales and marketing practices for a major pharmaceutical company
• Conducted an internal investigation of pharmaceutical sales and marketing practices for a Fortune 100 company subject to criminal and civil investigations involving multiple regional DOJ offices and investigative agencies, implicating the FCA, AKS and off-label issues
• Successfully represented a pharmacy distributor in a U.S. Drug Enforcement Administration (DEA) investigation
• Represented for more than a decade 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
• Conducted an internal corporate investigation regarding allegations by the DEA of unlawful manufacturing of controlled substances
• 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
• Led an internal investigation related to potential violations of the FCA by a global healthcare company
• 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, HHS and 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 a related state attorney general investigation and advised on public relations because the state case has attracted media attention
• Conducted an internal investigation regarding the FCA and AKS for a medical device and diagnostics company
• 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