Stark Law, AKS, and CMP Law Changes: Expanded AKS Safe Harbors, Narrowing Stark Law

Proposed Stark and AKS Protections to Facilitate Value-Based Arrangements and Care Coordination

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

Conducted on Tuesday, February 4, 2020

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar will guide healthcare counsel on the Stark Law, the Anti-Kickback Statute (AKS), and Civil Monetary Penalty Law (CMP) law proposed changes. The panel will discuss the implications of these changes and review the comments provided during the extended comment period.


On October 17, 2019, the U.S. Department of Health and Human Services (HHS) published two proposed rules in the Federal Register that could transform key federal laws restricting healthcare arrangements. The revised rules address barriers to care coordination and value-based care under the Stark Law, the AKS, and the CMP.

With the move to a value-based system, the proposed changes will facilitate the shift by including new protections and flexibilities that represent some of the most significant changes to these laws in the last decade. The proposals—the Stark proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) and the AKS/CMP proposed rule issued by the Department of Health and Human Services, Office of Inspector General (OIG)— intend to lead to greater patient autonomy and an increase in access to various sites of care, including the patient’s home.

Each of the proposed rules employs various methods in an effort to reform the Stark Law, the AKS, and the CMP. The revisions include new exceptions and safe harbors, modify or remove existing outdated regulations, and modernize language and terms within the current regulations.

Notably, CMS proposes new Stark Law exceptions for “value-based arrangements” that will apply broadly to compensation arrangements between physicians and hospitals, other healthcare providers and qualifying payors. OIG proposes several new safe harbors for value-based arrangements, including patient engagement and support safe harbor, and to address innovative partnerships between different providers and other participants in the healthcare industry. The OIG also proposes expanded protections for personal service and management contracts, and a new safe harbor for CMS-sponsored model arrangements and patient incentives.

While the industry awaits the final regulations, stakeholders should consider operational and structural changes, including modification to existing relationships, to harness the flexibility offered by the potential changes.

Listen as our authoritative panel of healthcare attorneys from around the country examines the proposed Stark Law, AKS and CMP law changes and their implications for enforcement actions by HHS-OIG and False Claims Act suits by whistleblowers and the Department of Justice. Our panel will also review comments submitted in response to the CMS and OIG proposed rules.



  1. CMS’s proposed Stark Law changes
  2. OIG’s proposed AKS and CMP law changes
  3. Submitted comments on the proposed regulations
  4. Impact of the proposal on healthcare industry, enforcement actions, and FCA suits


The panel will review these and other important issues:

  • Proposed changes relating to value-based arrangements and patient incentives
  • Proposed AKS safe harbors and Stark Law exceptions
  • Impact of the proposed changes on enterprise risk and enforcement


O’Connell, Scott
Scott O’Connell

Chair, Litigation Department: Trial Practice, Class Action Defense and Health Services Litigation
Nixon Peabody

Mr. O’Connell is a trial attorney and litigation strategist focused on complex commercial disputes involving high...  |  Read More

Simone, Rebecca
Rebecca Simone

Nixon Peabody

Ms. Simone regularly counsels healthcare clients on navigating their practices/businesses within the confines of the...  |  Read More

Tarosky, Adam
Adam R. Tarosky

Nixon Peabody

Mr. Tarosky counsels providers of healthcare products and services, defense contractors, and financial institutions...  |  Read More

Parikh, Harsh
Harsh P. Parikh

Nixon Peabody

Mr. Parikh works with managed care organizations, hospital systems, and other providers on a wide range of regulatory,...  |  Read More

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