Understanding the New System: Final Rule on Fraud Prevention in Medicaid, Medicare and CHIP

Carolyn McNiven, a former federal prosecutor, handles white collar criminal defense and related administrative, regulatory and compliance matters for individuals and companies and has particular expertise in the areas of health care, food and drug, and FCPA compliance counseling, risk assessment and litigation.

After graduating from U.C. Berkeley’s Boalt Hall Law School, where she served as editor on the law review, Ms. McNiven clerked for a federal district court judge and practiced law at a prominent Chicago firm and the US Department of Justice before joining DLA Piper in 2010 as a partner.

Although Ms. McNiven is an active trial attorney, having personally tried numerous cases in both federal and state courts, she has also been successful in less public arenas where she has obtained favorable results for clients in negotiations with government attorneys in the context of criminal, civil and regulatory actions. Ms. McNiven understands from first-hand experience what government decision-makers, judges and juries find persuasive, and uses those skills to counsel and defend clients facing high-stakes investigations and litigation.

She has experience handling fraud, antitrust, Foreign Corrupt Practices Act (FCPA), public corruption, tax, Dodd-Frank whistleblower investigations and securities matters and providing compliance counseling to public and private entities. For health care sector clients, she provides anti-kickback and Stark Act advice, risk assessments, False Claims Act (FCA) defense and loss computations, fraud and FCA due diligence, qui tam defense, and defense of misbranding and other food and drug offenses. She also has extensive experience in provider-side health care fraud enforcement and serves as DLA Piper’s point person on food safety issues.

Craig Smith rejoined the firm in 2008 after serving as General Counsel for Florida’s Agency for Health Care Administration. Craig is Board Certified in Health Law by the Florida Bar, and he represents health care industry clients on a wide range of regulatory, transactional, and litigation matters.

As General Counsel of the agency with a budget of over $17 billion that regulates more than 32,000 health care facilities, Craig supervised over 40 in-house lawyers in four different offices across Florida and was a member of the agency’s Senior Management Team. Craig oversaw significant class action and other complex litigation against the agency at the trial court and appellate court levels, and he addressed many critical health care issues, including statewide Medicaid managed care reform and the appropriate expansion of electronic health information.

While serving as the chief legal officer of one of the nation’s largest Medicaid programs, Craig coordinated frequently with federal officials at the Centers for Medicare and Medicaid Services and the Department of Justice. He was a member of the South Florida Health Care Fraud Task Force, and he represented the agency in its recovery of Medicaid overpayments, including one of the largest Medicaid overpayment recoveries in history. Craig also worked closely with Governor Crist’s administration on legislative initiatives and to create innovative health care programs such as Cover Florida and Florida’s Prescription Drug Discount Card Program.

GEORGE B. BREEN is a Shareholder of Epstein Becker & Green, P.C and a member of its Health Care and Life Sciences and Litigation practices. A litigator for over twenty years, Mr. Breen focuses his practice on the representation of health care and life sciences clients, both corporations and individuals, in government investigations and complex litigation.

Mr. Breen:

• Defends clients undergoing investigation for health care fraud by the Department of Justice, the Department of Health and Human Services Office of the Inspector General, and other state and federal governmental authorities
• Serves as defense counsel in connection with False Claims Act cases (including qui tam litigation)
• Conducts internal investigations and advises clients on compliance issues
• Represents MCOs, HMOs, nursing homes, home health agencies, health care providers, manufacturers and suppliers before courts and administrative tribunals at the federal and state level, including challenges to regulatory actions and disputes under government contracts
• Defends individuals and organizations against claims of malpractice and professional liability

He is a Vice Chair of the American Health Lawyers Association’s Healthcare Liability and Litigation Practice Group and a Past President and Board member of the District of Columbia Defense Lawyers Association. Mr. Breen is also a frequent lecturer and author on fraud and abuse issues and health care litigation

Mr. Breen has been Peer Review rated “AV” by the Martindale-Hubbell Law Directory and was named an “Outstanding Healthcare Litigator” by Nightingale’s Healthcare News in January 2010, one of only 10 lawyers across the country selected for this honor.