Health Care Fraud & Abuse – CLE Event

Co-sponsored by Mitchell Hamline’s Health Care Compliance Program and the MSBA Health Law Section.

Event Agenda

• 8:30am: Barbara Colombo, Professor of Law and Director, Health Law Institute – Welcome
• 8:35-9:20am: Strategy #1: Gain a greater understanding of the federal fraud and abuse regulations (False Claims Act, Anti-Kickback Statute, Physicians Self-Referral).
  • Speaker: Mara Sanders
• 9:30-10:15am: Strategy #2: Recognize how emerging regulatory guidance and trends, as well as recent case law will influence health care organizations.
  • Speakers: Gabriel Imperato
• 10:30-11:30am: Strategy #3: Roundtable discussion-Learn from experts in the field of health law about best practices to maintain compliance and reduce risk.
  • Speakers: Ross D’Emanuele, Elizabeth Smith, Gabriel Imperato, and Seth Whitelaw

Speaker Biographies

• Ross D’Emanuele is a Partner at Dorsey & Whitney LLP and works in the healthcare provider, payor, and drug and medical device segments of the healthcare industry. His areas of expertise include healthcare fraud and abuse, Stark and anti-kickback laws, pharmaceutical and medical device licensing, co-development, and supply arrangements, HIPAA and other privacy and security laws, reimbursement rules and appeals, clinical trial agreements and regulation, FDA regulation, open payments and state “Sunshine Act” laws, accountable care organizations, value-based reimbursement, and telemedicine.
• Gabriel L. Imperato is the managing partner of the Fort Lauderdale office of Nelson Mullins and the Team Leader of the Firm’s Health Care Criminal and Civil Enforcement, Litigation and Compliance Practice. His personal practice includes representing individuals and organizations accused of healthcare fraud and assisting and advising healthcare organizations on corporate governance and compliance matters.  He is Board Certified as a specialist in health law by the Florida Bar and is also certified in Health Care Compliance (CHC) by the Health Care Compliance Association.  Imperato is also a past president, interim CEO and a longtime member of the board of directors of the Society of Corporate Compliance and Ethics and the Health Care Compliance Association (“SCCE/HCCA”).
• Mara Sanders is an associate in the Health Transactions and Regulatory Group of Dorsey & Whitney LLP, located in Minneapolis. Mara provides regulatory, enforcement, and transactional advice to clients in the health care and life sciences industries. Mara regularly advises clients on matters of state and federal regulatory compliance, investigations, and enforcement, including with respect to health care fraud and abuse laws, such as the Stark Law and Anti-Kickback Statute, clinical research compliance and ethics, and liability under the False Claims Act. Mara also advises clients on matters related to the Medicare and Medicaid programs, state and federal privacy & security laws, scope of practice and licensure, and federal grant funding.
• Elizabeth Truesdell Smith, JD, MPH, is Senior Vice President, General Counsel & Corporate Secretary for Allina Health and is a member of the Executive Leadership Team. As the chief legal counsel for the Board of Directors and organization, she serves an integrated delivery system that includes 29,000 employees, 1400 physicians, 10 hospitals, 90+ clinics, 15 retail pharmacies and many specialty care centers and specialty medical services, home care, and emergency medical transportation services. In addition to her leadership in the Legal Department, her current role also includes senior executive oversight of the Risk & Insurance Programs for the integrated delivery system and oversight of the Office of Contract Management, a corporate shared service.  Truesdell Smith has served as in-house counsel and as a leader for Allina Health since December 2000.  During her tenure at Allina Health, Ms. Truesdell Smith has served as lead counsel representing the organization’s system level Board of Directors as well as its subsidiary and regional hospital Advisory Boards, primary care and specialty providers of all types, hospitals and clinics, business and physician leaders in all aspects of patient care and corporate health law, including corporate governance, patient safety and clinical risk management, medical staff matters, strategic and operational matters, enterprise risk management, all types of litigation and government investigations, strategic transactions and regulatory matters.  She also served as Interim Chief Compliance Officer in 2015.  Before joining Allina Health, Ms. Truesdell Smith practiced as a trial lawyer for eight years with a focus on hospital and health law, medical professional liability and medical products liability litigation defense.
• Seth Whitelaw has 30 years of industry experience in the life sciences and healthcare sectors as an attorney, compliance officer (C.R. Bard, Inc., GlaxoSmithKline, and Misonix, Inc.) and industry consultant (Deloitte, Whitelaw Compliance Group LLC.). He also served as a compliance expert in the Opioid MDL litigation. In addition to being a Food and Drug Law Institute (FDLI) fellow and having worked for the FDA’s Office of Chief Counsel, he has a J.D. from Washington & Lee School of Law, an LL.M. from George Washington University Law School, and a doctorate in Health Law from Widener University School of Law. Dr. Whitelaw is the Editor of the Policy & Medicine Compliance Update and teaches corporate governance and compliance at Mitchell Hamline School of Law, where he is the Senior Fellow & Adjunct Professor, Life Sciences Compliance.