The Stark and the Anti-Kickback Final Regulations: Implications for Healthcare Organizations

Navigating the New Value-Based Framework, Changes to the Fair Market Value, Commercial Reasonableness, and Volume or Value Standards

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

Conducted on Tuesday, December 22, 2020

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar will guide healthcare counsel through the Stark Law, the Anti-Kickback Statute (AKS), and the Civil Monetary Penalty Law (CMP) final rules. The panel will discuss how these changes will impact healthcare providers and others in the healthcare industry.


On Nov. 20, 2020, the Department of Health and Human Services published the long-awaited and highly anticipated final rules revising the regulations related to the Stark, AKS, and CMP Laws. The final rules provide a much-needed framework for protecting certain value-based arrangements that incentivize care coordination, quality of care and cost containment. They also propose helpful new exceptions and safe harbors and clarify interpretations of current existing regulations and key definitions, including the “Big 3” fair market value (FMV), commercial reasonableness, and volume or value standards.

These changes should ultimately reduce the compliance burden for providers once the final rules take effect on Jan. 19, 2021, with the exception of group practice profit sharing rules that are effective Jan. 1, 2022. This added flexibility is more important now than it has ever been as the industry continues to navigate the ongoing COVID-19 pandemic. Healthcare organizations will need to move quickly to react and adapt to the interpretations and positions taken by CMS and OIG.

Listen as our authoritative panel of healthcare attorneys examines the new changes to the Stark, Anti-Kickback, and CMP Laws. The panel will discuss what these changes mean for healthcare providers and others in the healthcare industry.



  1. CMS' Stark Law changes
  2. The “Big 3” Standards of FMV, Commercial Reasonableness, and Volume or Value
  3. OIG' AKS and CMP law changes
  4. Impact on and implications for the healthcare industry, enforcement actions, and FCA suits


The panel will review these and other important issues:

  • The changes relating to value-based arrangements and patient incentives
  • The new AKS safe harbors and Stark Law exceptions
  • Impact of the changes on healthcare providers and others in the healthcare industry


James, Alyssa
Alyssa C. James

Hall Render Killian Heath & Lyman

Ms. James works with clients in numerous aspects of health care law. Her work involves counsel regarding...  |  Read More

Schwartz, Katherine
Katherine M. Schwartz

Hall Render Killian Heath & Lyman

Ms. Schwartz assists clients with a broad range of health law matters. Her practice includes hospital/physician...  |  Read More

Wolfe, Joseph
Joseph N. Wolfe

Hall Render Killian Heath & Lyman

Mr. Wolfe provides advice and counsel to many of the nation's largest health systems, hospitals and medical groups...  |  Read More

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