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  • videocam On-Demand
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  • schedule 90 minutes

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

$297.00

This course is $0 with these passes:

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Description

Healthcare providers are increasingly focused on precision or personalized medicine. The availability of genetic information has advanced the diagnosis and treatment of disease. Treatment can now be tailored to the needs of individuals based on their genetic makeup.

Collaborations in the delivery of personalized medicine among providers such as hospitals, health systems, and laboratories are increasingly common. Yet these arrangements present complex regulatory issues that require careful attention. Providers considering a precision medicine collaboration must evaluate and consider numerous healthcare fraud and abuse laws, including the federal Anti-Kickback Statute, the Stark Law, the Medicare Beneficiary Inducement Statute, and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), as well as state law equivalents. Federal and state privacy and anti-mark-up laws also require evaluation.

Listen as our authoritative panel of healthcare attorneys discusses the pitfalls of precision medicine collaborations and examines the regulatory issues that typically present. The panel will also examine fraud and abuse trends and recent enforcement action in the space and provide practical guidance for providers exploring these arrangements.

Presented By

Stacey L. Callaghan
Attorney
McDermott Will & Emery, LLP

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.

Jonathan W. Heusel
Professor, Pathology & Immunology
University Of Washington

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.

Carolyn V. Metnick
Partner
Sheppard Mullin Richter & Hampton Llp - San Diego

Ms. Metnick is a partner in the Corporate Practice Group in the firm's Chicago office and a member of the Healthcare and Privacy & Cybersecurity Teams. She represents a range of healthcare industry clients, including hospitals and health systems, physician organizations and digital health companies. Ms. Metnick advises on healthcare regulatory and transactional matters with a focus on health information privacy and security. She is the founder and leader of Sheppard Mullin Healthy AI, which is an initiative focused on legal issues relates to the use of AI in healthcare. Ms. Metnick counsels healthcare clients on issues relating to AI, including governance, contractual matters, and data related issues. She advises clients on a range of privacy and security laws, including HIPAA and other federal and state privacy laws. Ms. Metnick also counsels businesses in data breach investigations and compliance with federal and state breach notification laws. She is a Certified Information Privacy Professional/United States (CIPP/ US) and a Certified Information Privacy Professional/Europe (CIPP/E).

Credit Information
  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

Date + Time

  • event

    Thursday, August 20, 2020

  • schedule

    1:00 p.m. ET./10:00 a.m. PT

  1. Introduction and overview of collaborative arrangements
  2. Fraud and abuse considerations
    1. AKS
    2. EKRA
    3. Stark Law
    4. Medicare Beneficiary Inducement Statute
    5. State law equivalents
  3. Other healthcare regulatory considerations
    1. Federal and state privacy and security laws
    2. Anti-markup laws
  4. Practical guidance and take-aways

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?