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Stark Law and Anti-Kickback Statute Compliance in Hospital-Physician Transactions

Recording of a 90-minute CLE video 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 Wednesday, November 16, 2022

Recorded event now available

or call 1-800-926-7926

This CLE course will guide healthcare counsel on ensuring compliance with the Stark Law and Anti-Kickback Statute (AKS) in transactions between hospitals and physician groups. The panel will also provide best practices for counsel on structuring arrangements to fit within the AKS safe harbors and Stark exceptions.


When structuring a transaction involving healthcare providers, counsel must beware of, and carefully navigate, the myriad of (often non-intuitive) federal and state statutes that apply to the healthcare industry. Violations may result in significant civil and criminal penalties. To that end, this CLE course will address principal compliance considerations under the federal physician-self referral statute and its implementing regulations (Stark Law) and the federal healthcare program anti-kickback statute (AKS) in transactions and contractual arrangements between hospitals and physicians and their medical practices, including, broadly, joint ventures, services and lease arrangements, and employment agreements. The panel will also provide insights on how counsel may contend with the obstacles and pitfalls presented by these transactions and arrangements, including a discussion of potential exceptions and safe harbors.

Listen as our authoritative panel examines the tension and overlap of the Stark Law and AKS analyses in a hospital-physician transaction. The panel will discuss recurring issues emerging from recent case law and settlements of False Claims Act cases challenging hospital-physician arrangements.



  1. Stark Law
    1. Financial arrangements: ownership vs. compensation
    2. Key considerations
      1. Fair market value
      2. Commercial reasonableness
      3. Prohibition against taking referrals or other business generated into account
    3. Exceptions
      1. Isolated transactions
      2. Bona fide employment relationships
      3. Exceptions for fair market value exchanges (e.g., space and leases, services, etc.)
      4. Indirect compensation arrangements
  2. AKS
    1. Implications
      1. Scienter (state of mind)
      2. Inducement: one-purpose test
        1. The role of “hope” and “expectation” versus inducement
    2. Exceptions and safe harbors
      1. Bona fide employment
      2. Personal services and management contracts
      3. Space and equipment leases
      4. Others
    3. Transactions not covered by an exception/safe harbor
  3. Stark and AKS
    1. Overlap and distinction
  4. Predicates for federal False Claims action


The panel will review these and other key issues:

  • What is the scope of the Stark Law exceptions?
  • What guidance has the OIG provided regarding the application of AKS safe harbors?
  • What steps should counsel take when deal planning to ensure compliance with Stark Law and AKS?


Donald H. Romano
Donald H. Romano

Special Counsel
Foley & Lardner

Mr. Romano has extensive experience counseling hospitals, skilled nursing facilities and academic medical centers and...  |  Read More

Weinreich, Gadi
Gadi Weinreich


Mr. Weinreich is one of the nation’s more experienced and sought-after healthcare fraud and abuse and regulatory...  |  Read More

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