Precision Medicine: Structuring Collaborations and Avoiding Fraud and Abuse Pitfalls
Navigating Healthcare Regulatory Issues Common in Precision Medicine Arrangements Among Hospitals, Health Systems, and Clinical Laboratories
Recording of a 90-minute CLE webinar with Q&A
This CLE course will offer guidance to healthcare counsel on precision medicine and the associated collaborations. The panel will examine the fair market value (FMV) requirements as well as the fraud and abuse risks. The panel will offer guidance on how to ensure compliance and avoid the challenges of precision medicine.
Outline
- Introduction and overview of collaborative arrangements
- Fraud and abuse considerations
- AKS
- EKRA
- Stark Law
- Medicare Beneficiary Inducement Statute
- State law equivalents
- Other healthcare regulatory considerations
- Federal and state privacy and security laws
- Anti-markup laws
- Practical guidance and take-aways
Benefits
The panel will review these and other key issues:
- What are the risks for Medicare compliance with precision medicine collaborations?
- What other legal issues should counsel evaluate when structuring precision medicine collaborations?
Faculty
Jonathan W. Heusel, MD, PhD
Professor, Pathology & Immunology
Washington University
Dr. Heusel is a Professor of Pathology, and of Genetics at Washington University School of Medicine and currently... | Read More
Dr. Heusel is a Professor of Pathology, and of Genetics at Washington University School of Medicine and currently directs Clinical and Translational Genomics for the Department of Pathology & Immunology. He also represents the medical school as one of two directors for the recently established Cordell Institute for Policy in Medicine & Law at Washington University, which combines expertise and scholarship across biomedical science, health and privacy law, digital technologies and ethics in order to facilitate the emergence of a fair, transparent and healthy digital future.
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Carolyn V. Metnick
Partner
McDermott Will & Emery
Ms. Metnick concentrates her practice on transactional and business issues affecting healthcare providers. She... | Read More
Ms. Metnick concentrates her practice on transactional and business issues affecting healthcare providers. She routinely guides her healthcare clients through various transactions including joint ventures, M&As and reorganizations. Ms. Metnick counsels her clients on governance matters, regulatory issues, and federal fraud and abuse laws. She also counsels her clients on HIPAA compliance, healthcare technology (mData), and disputes and litigation with an emphasis in contract law, covenants not to compete, and business torts.
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Stacey L. Callaghan
Attorney
McDermott Will & Emery
Ms. Callaghan counsels healthcare entities, healthcare technology companies, data companies, and private equity... | Read More
Ms. Callaghan counsels healthcare entities, healthcare technology companies, data companies, and private equity entities as they navigate transactional, regulatory, and compliance issues. She focuses on assisting clients on matters including data privacy and protection requirements under HIPAA and other privacy laws, data breach investigations and compliance, and data sharing, licensing, and de-identification arrangements. Ms. Callaghan also assists clients in developing telemedicine strategies and documenting agreements given the evolving digital health regulatory landscape.
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