Anti-Kickback Statute Compliance in Healthcare Transactions

Navigating Safe Harbors, Identifying Transactions That Implicate AKS, Limiting Civil Monetary Penalty Exposure

Recording of a 90-minute CLE webinar with Q&A

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Conducted on Thursday, July 14, 2016

Recorded event now available

or call 1-800-926-7926

This CLE course will provide guidance to healthcare counsel on the Anti-Kickback Statute (AKS) provisions and regulatory safe harbors. The panel will provide guidance on how to determine when the AKS is implicated and what counsel can do to identify potential AKS problems. The panel will also offer best practices for structuring arrangements to minimize risk under the AKS.


The federal government continues its focus on reigning in healthcare fraud, including ensuring compliance with the AKS. The AKS provides several safe harbors and exceptions that shield healthcare providers from the prohibitions outlined by the AKS. Unlike the Stark Law exceptions wherein the government will deem a practice per se illegal, if a payment practice does not fully satisfy any of the AKS safe harbors, then the government will analyze the payment practice to determine whether it is compliant with AKS.

AKS violations carry significant penalties, including civil monetary penalties, imprisonment, and exclusion from participating in federal healthcare programs such as Medicare. Healthcare counsel must keep in mind the requirements of the AKS and its safe harbors and exceptions in healthcare contracting and transactions. The scope of the AKS is very broad and counsel must be vigilant in evaluating whether business practices could result in AKS violations.

Listen as our authoritative panel of health law counsel discusses the AKS provisions and safe harbors. The panel will discuss which healthcare transactions may implicate the AKS and examine common pitfalls related to AKS compliance. The panel will also discuss identifying potential AKS problems and offer best practices for responding to them.



  1. Understanding the AKS
    1. Prohibitions
    2. Penalties
    3. The CMP statute
    4. State AKS laws
  2. Safe harbors and exceptions
    1. The difference between statutory exceptions and regulatory safe harbors
    2. Common safe harbor and their requirements
  3. Transactions that might implicate the AKS
    1. Employment agreements
    2. Medical directorships and other personal services arrangements
    3. Investment interests
    4. Management agreements
    5. Marketing agreements
    6. Others
  4. Common pitfalls and reducing risks
  5. Responding to potential AKS problems
    1. Responding to subpoenas
    2. Presenting your case to the OIG
    3. Self-disclosure
    4. Repayment


The panel will review these and other key issues:

  • What are the AKS regulatory challenges facing healthcare providers and their counsel in healthcare contracting and transactions?
  • What is the scope of the AKS safe harbors?
  • How does the AKS relate to managed care arrangements?


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

Waxman, J. Mark
J. Mark Waxman

Retired Partner
Foley & Lardner

Mr. Waxman is former Chair of the firm's Health Care Industry Team. He focused on healthcare issues and handled...  |  Read More

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