Anti-Kickback Statute and Stark Law revised

shannapearce1@thomsonreuters.com  /  January 4, 2021

The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) recently released their final rules revisions of the Physician Self-Referral Law (the Stark Law) and the Anti-Kickback Statute. Most of the alterations take effect on Jan. 19, 2021.

The changes are intended to modernize law and provide flexibility to providers, though

Here’s a brief overview of the changes.

Stark Law

  • New value-based exceptions permitting compensation arrangements designed to coordinate care and improve care quality while lowering costs.
  • A new cybersecurity technology donation exception was created, while the existing exception for electronic health record systems donations was expanded.
  • A new exception enables physicians to receive remuneration of up to $5,000 per year for items or services rendered by the doctor.
  • A clarification of how a physicians group can distribute profits from Designated Health Services (DHS). “Split-pool” profit-sharing is no longer allowed. Note: this clarification takes effect on Jan. 1 of 2022.
  • The Stark Law Final Rule contains new definitions of the terms “commercially reasonable” and “general market value” and revises “volume or value” and “fair market value.” The changes are intended to clarify and modernize the Stark Law while continuing to protect Medicare from fraud and abuse.

Anti-Kickback Statute

  • Three new safe harbors for remuneration in value-based arrangements.
  • A safe harbor for CMS-sponsored models is intended to create better predictability for participants and to make models more uniform.
  • Modifications to the following safe harbors: Personal Services and Management Contracts, Warranties and Local Transportation. A new safe harbor for Cybersecurity Technology and Services and the statutory provision for Accountable Care Organization Beneficiary Incentive Programs was codified.

The final rules run hundreds of pages. They can be discussed in detail with an attorney experienced in representation in Stark Law and Anti-Kickback Statute compliance matters.