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Michael R. Manthei

Partner
Boston
t: 617-305-2160

Michael Manthei is a partner in the Boston office of Holland & Knight LLP. He represents clients exclusively in the Health Care and Life Sciences industries. Mr. Manthei represents clients primarily in health care fraud, abuse and compliance matters, in privacy matters, and in other health care regulatory matters. He routinely represents clients before state and federal regulatory and law enforcement authorities including the Department of Justice, United States Attorneys offices, State Attorneys General offices, the Center For Medicare and Medicaid Services and the Office of Inspector General for the Department of Health and Human Services. He is a frequent speaker and is a co-author of the PLI Corporate Compliance Help Book that was published in fall '08.

Mr. Manthei has extensive experience advising clients on matters involving enforcement of federal and state anti-kickback statutes, Stark and the Federal False Claims Act. In addition, Mr. Manthei works with clients to develop and to implement comprehensive corporate compliance programs and to conduct internal investigations. In the event that an internal investigation reveals possible wrongdoing, Mr. Manthei helps the client determine the appropriate remedial steps, up to and including, strategic voluntary disclosures to law enforcement authorities.

Outside of the fraud, abuse and compliance arena, Mr. Manthei advises clients on a wide range of managed care contracting, transactional and regulatory issues relating to reimbursement, privacy, concierge medicine, disease management, health information technology, clinical trials and technology transfer. His experience includes the formation of integrated delivery systems, the formation of nationwide disease management networks, securing reimbursement for new technologies and the negotiation of a wide variety of joint venture, administrative services and provider agreements.

After law school, Mr. Manthei served as a law clerk to the Hon. C. Roger Vinson, U.S. district judge, Northern District of Florida. Within the firm, Mr. Manthei is the Co-Chair of the Firm's GLBT Initiative and is a member of the firm's Diversity Committee and of the Boston recruiting committee.

Memberships

  • American Bar Association
  • American Health Lawyers Association
  • Cambridge Community Art Center, President, Board of Directors
  • Gay, Lesbian, Straight Education Network (GLSEN), National Leadership Council

Court Admissions

  • All State Courts in Massachusetts
  • All Federal Courts in Massachusetts
  • All State Courts in Florida
  • All Federal Courts in Florida

Speaking Engagements

  • Speaker, Navigating Regulatory Issues of Social Media in Health Care Webinar, November 19, 2009
  • Control Off-Label Promotion Liability Risks and Examine Revised Guidance Impact on Industry, CBI's 5th Annual Medical Device and Diagnostic Marketing Compliance Congress, June 15 - 16, 2009
  • Panelist, The New Massachusetts Drug and Medical Device Marketing Code of Conduct and Public Reporting System, BBA Continuing Legal Education, May 6, 2009
  • Panelist, Fighting Healthcare Fraud Through Medical Community Outreach, SFHHA Healthcare Summit, May 9, 2008
  • Panelist, Trends in Health Care Fraud Enforcement, Boston Bar Association's Health Care Fraud Conference, April 3, 2008
  • Medical Device Fraud: The Next Target of Prosecutors, Boston Bar Association's BBA Week, November 29, 2007
  • Compliance Minefields in Health Industry Sales and Marketing: How to Protect Your Company, StarCite Executive Forum for the Life Sciences Industry, August 2, 2007
  • Criminal Liabilities Under HIPAA, Lorman Educational Services, May 14, 2007
  • Health Care Fraud, the New Wave of Fraud Enforcement, Boston Bar Association, April 19, 2007
  • Pharmacy Fraud and Abuse Law, National Association of Chain Drug Stores, Developments in Pharmacy Law XVII, November 10, 2006
  • Civil Monetary Penalties and Enforcement Under HIPAA, 4th National WEDI SNIP Summit, Beyond HIPAA Compliance: Our Journey Continues, November 17, 2003
  • Advanced Disease Management Problem Solving Workshop, Third National Disease Management Summit, May 13, 2003
  • Disease Management Legal Clinic: A Practical Check-Up for Your DM Program, Disease Management Association of America 4th Annual Disease Management Leadership Forum, October 23, 2002
  • Fraud and Abuse Implications and Compliance Solutions, Medical Device Manufacturers Association 2002 Coverage and Reimbursement Conference, October 17, 2002

Published Articles & Books