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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 program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Thursday, August 20, 2020

Recorded event now available

or call 1-800-926-7926

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.


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.



  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?


Heusel, Jonathan
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

Metnick, Carolyn
Carolyn V. Metnick

McDermott Will & Emery

Ms. Metnick concentrates her practice on transactional and business issues affecting healthcare providers. She...  |  Read More

Callaghan, Stacey
Stacey L. Callaghan

McDermott Will & Emery

Ms. Callaghan counsels healthcare entities, healthcare technology companies, data companies, and private equity...  |  Read More

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