On January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect. These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes to the Stark Law and AKS in a decade. Primary aspects of the changes include:
- New exceptions and safe harbors for value-based arrangements that are intended to remove regulatory barriers to entering into care coordination arrangements.
- Clarifications to fundamental terminology and requirements.
- Added flexibility for non-abusive practices that may alleviate some of the traditional burdens of complying with the Stark Law, in particular.
- For physician practices, changes to the Stark Law’s “group practice” definition that go into effect on January 1, 2022, which may necessitate modifications to common physician compensation methodologies within group practices.
However, the core requirements and prohibitions of the Stark Law and AKS have not changed, nor have the penalties for violating these laws. As a result, the final rules create new complications from added regulations, changed definitions, and a fresh overlay of agency interpretation of existing rules. This means added risks for organizations in understanding the regulatory changes and ensuring compliance with them.
Join us for an overview explaining what you need to know about these final rules, including a breakdown of the changes under each of the regulations and examples illustrating how they will impact healthcare organizations and how to address related new compliance challenges.
Ross C. D’Emanuele, Partner, Dorsey & Whitney LLP
Laura B. Morgan, Partner, Dorsey & Whitney LLP
Alissa Smith, Partner, Dorsey & Whitney LLP
Materials (includes white papers)
Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group maintains The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources here and has published two white papers, which are available at the following links:
- White Paper: Understanding the Final Rules to Revise the Stark Law Regulations
- White Paper: Understanding the Final Rules to Revise the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations
These white papers provide an in-depth summary of the changes to these regulations, including key provisions from CMS and OIG preamble guidance. Please contact the authors or your regular Dorsey attorney if you would like assistance with understanding how the final rules impact your organization.
**NOTE: Watching this recording does not allow the user to obtain CLE, CPD, CPE or HR credits.