Jennifer E. Michael
The fraud and abuse laws touch virtually every arrangement in the healthcare sector. Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA). She also leads internal investigations for healthcare companies to identify and quantify potential overpayments from federal healthcare programs; advises on fraud risks of existing and proposed arrangements in connection with pending and proposed transactions; and designs, implements, and evaluates compliance programs.
Memberships
American Health Law Association (AHLA)
Representative Experience
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Representation of Advanced Dermatology & Cosmetic Surgery (ADCS), the largest team of dermatology experts nationwide, in its acquisition of Maragh Dermatology, Surgery and Vein Institute, a comprehensive dermatology centers specializing in medical, cosmetic, laser and surgical dermatology. Terms of the transaction were not disclosed.
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Publications
Past Events
Media Mentions & Firm News
Additional News & Insights
Publications
- “Are We There Yet? OIG and CMS Issue Long-Awaited Final Rules Aimed at Promoting Innovative Value-Based Care Models and Arrangements,” (co-author) Journal of Health Care Compliance (January–February 2021)
- “Legal and Compliance Considerations When Bringing Cellular Therapies to Market,” (co-author) Journal of Commercial Biotechnology (2020, 25(4), 74–7. doi: 10.5912/jcb958)
Media Mentions
- “IG Approval of Free Kymriah Might Be Model for Other CAR T Makers,” Inside Health Policy (March 26, 2021)
- “Medical Device Makers Get More Flexibility with Value-Based Care in Stark, Anti-Kickback Final Rules,” MedTech Dive (November 24, 2020)
- “U.S. Officials Will Let Novartis Pay Expenses for Some Kymriah Patients Who Must Travel for Treatment,” STAT News (January 30, 2020)
Presentations
- “Charitable Patient Assistance Programs: Ensuring Compliance. Establishing and Maintaining Arrangements With PAPs, Monitoring and Auditing PAPs,” Strafford Webinar (February 2, 2021)
- “Healthcare Providers and Voluntary Disclosures: Evaluating If, When, and How to Report to CMS, DOJ, or OIG,” Strafford Webinar (October 13, 2020)
- “Rapid Evolution: Fair Market Value in the COVID Era and Beyond,” AHLA 2020 Virtual Fraud and Compliance Forum (September 2020)
Accolades
Partnership for Public Service Citizen Impact Award (2017)
Excellence in Government Fellows Program (2016)
Inspector General’s Exceptional Achievement Award (2012, 2014, 2015, 2016)
