McGuireWoods is a national leader representing healthcare companies that are subject to government fraud enforcement investigations and actions. Clients rely on our industry-leading regulatory attorneys with their extensive knowledge regarding the laws and regulations impacting healthcare provision as well as the sale and promotion of drugs and medical devices. When problems arise, they know they can turn to McGuireWoods’ nationally recognized litigation and white-collar defense team and its wealth of experience navigating high-risk matters. Time and again, clients have called upon McGuireWoods when confronted with an inquiry, subpoena or complaint from the government or one of its intermediaries.
Our Healthcare Enforcement Team includes members of our Government Investigations and White Collar Litigation Department, recognized twice as a Law360 Group of the Year and comprising a former Deputy Attorney General of the United States, former U.S. Attorneys, more than a dozen federal prosecutors and other former enforcement officials. The team also includes members of the firm’s Healthcare Department, whose lawyers have been recognized by Chambers USA, Best Lawyers in America, Legal Elite and Super Lawyers as among the top legal service providers in the nation. Many of our team members have significant experience working for the enforcement agencies that bring investigations and initiate litigation against our clients, and they maintain strong personal and professional relationships with investigating agencies. This extensive experience and close relationships with prosecutors and regulators enable us to bring credibility to any representation and provide unique insights into the government’s tactics and policy concerns. That insight is critical in helping to persuade prosecutors to decline to file a complaint or intervene in a qui tam (whistleblower) suit, dismiss a qui tam complaint outright, or take other actions that lead to a favorable outcome for a client.
When fraud allegations arise in the administrative, civil or criminal context, our experienced Healthcare Enforcement Team leverages a storied history of helping corporate clients and individuals navigate the complexities of potentially perilous investigations and enforcement actions and attain favorable resolutions with minimal impact on business operations. The multidisciplinary team includes numerous former federal prosecutors with extensive experience prosecuting healthcare fraud cases at the Department of Justice, as well as seasoned trial attorneys who have defended numerous fraud actions in the healthcare sector. Enhancing this representation, the team combines its powerful enforcement and litigation experience with McGuireWoods’ recognized regulatory experience in a broad range of subsectors in the healthcare industry.
The Healthcare Enforcement Team routinely advises clients on regulatory matters that arise during audits, investigations and enforcement proceedings initiated by various federal and state agencies, including the Centers for Medicare and Medicaid Services (CMS) and its intermediaries, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and state health departments, attorneys general and professional licensing boards.
We also advise participants throughout the healthcare and life sciences industries on compliance matters, including the establishment of compliance programs, the adoption of policies and procedures, compliance training, and the resolution of compliance reports and investigations. Our focus on assisting clients with the implementation and operation of effective compliance programs based on applicable law, regulations and guidance enables our clients to identify and resolve regulatory risks before they become significant issues.
How We Help
The healthcare enforcement attorneys at McGuireWoods have the knowledge and experience healthcare providers as well as healthcare companies, investors, manufacturers and insurers need to deftly handle high-risk enforcement investigations and actions and achieve compliance with federal and state-specific regulatory requirements. Our team represents and advises clients with respect to a full range of regulatory areas, including:
- Federal and state criminal fraud and abuse provisions
- False Claims Act (FCA) and state equivalents
- Federal and state anti-kickback laws, including the federal Anti-Kickback Statute
- Federal and state self-referral laws, including the federal Stark law
- Federal and state privacy laws, including HIPAA
- Food and Drug Administration (FDA) regulations
- Corporate practice of medicine restrictions
- Medicare and Medicaid conditions of participation
- Telehealth regulations
- Federal procurement laws and regulations
Beyond responding to investigations and enforcement actions, we also help clients proactively reduce risk by:
- Conducting internal audits and investigations
- Developing and implementing compliance programs
- Facilitating enterprise-wide risk-management solutions
C-suites of Fortune 500 companies, senior executives, boards of directors and high-profile individuals rely on McGuireWoods to handle responses to healthcare fraud investigations from inception to resolution. We focus on minimizing the business and personal interruptions an investigation can cause. By developing strategies to reduce civil, criminal and administrative exposure, we help to navigate a cumbersome, time-consuming process while limiting the consequences of an investigation or action. More specifically, our experienced healthcare enforcement attorneys will:
- Employ close relationship with prosecutors to attempt to glean details about potentially under-seal matters and confidential investigations and limit the scope and breadth of discovery requests
- Confer with McGuireWoods’ premier regulatory experts to quickly master the relevant industry-specific legal regime, program and reimbursement rules, standards and practices
- Formulate and execute a comprehensive internal investigation and defense strategy to quickly and efficiently learn the relevant facts and circumstances to minimize risks and maximize the chances of a quick and favorable outcome for the client
- Navigate ancillary risks and attendant negotiations, such as corporate integrity or monitoring agreements, and potential suspension, exclusion or revocation from federal healthcare programs
We also work closely with our Strategic Risk & Crisis Management Team to address related issues, including board and shareholder relations, media inquiries and other crisis management matters.