Value-Based Related Exceptions, Safe Harbors and Other Changes, Part II

January 7, 2021
Bass, Berry & Sims

On November 20, in a coordinated effort, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) released final rules to modernize regulations implementing the federal physician-self referral law (commonly referred to as the “Stark Law” or “Stark”), the federal Anti-Kickback Statute (AKS) and the beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP Law). In addition, the OIG released a final rule addressing pharmaceutical rebates and discounts.

Within these rules, CMS and the OIG create a framework for innovation in the context of value-based payment and coordinated care. Moreover, they promote improvements in technology infrastructure and, perhaps most significantly, take steps to reduce regulatory burdens. Further, the OIG aims to lower drug pricing and create more transparency in drug pricing.

Join Bass, Berry & Sims healthcare attorneys for the second webinar, in our two-part series, breaking down the most significant aspects of the new rules including the following:

  • Value-based framework: definitions, Stark exceptions and AKS safe harbors.
  • Expansion of the AKS personal services, warranties and transportation safe harbors.
  • Exclusion of manufacturer rebates to PBMs and Part D plans from the discount safe harbor.
  • Addition of a new safe harbor for point of sale price reductions for pharmaceutical products.

This webinar will take place from 12:00 – 1:00 PM CT on Thursday, January 7, 2021.

Who Should Attend?

  • In-house legal counsel.
  • Compliance officers.
  • Privacy officers.
  • C-level executives, consultants and principals.


This program is pending approval for General Tennessee CLE credit. Certificate of completion and other necessary application forms provided for use in other jurisdictions.


Submit your questions for presenters upon registration or email questions to Lauren Parkhurst.