Regulatory relief coming for Stark and anti-kickback self-referral laws

The federal government has gifted physicians with some regulatory relief from self-referral laws this holiday season.

The Centers for Medicare & Medicaid Services (CMS) and U.S. Department of Health and Human Services Office of Inspector General (OIG) finalized rules related to the Stark and anti-kickback statutes on Nov. 20. Most of the final provisions take effect Jan. 19, 2021, except for new special rules for profit shares and productivity bonuses for group practices — those are effective Jan. 1, 2022. The changes are most applicable to value-based payment arrangements.   

The final rule under the federal Anti-Kickback Statute adds new safe harbor protections for certain coordinated care and value-based arrangements between clinicians, providers, suppliers, and others who meet all safe harbor conditions. These include new safe harbors for care coordination arrangements to improve quality, health outcomes and efficiency, and for value-based arrangements with substantial downside or full financial risk.

The final rule modernizing the physician self-referral regulations (i.e., Stark law) adds several new exceptions for value-based arrangements (e.g., those with meaningful downside financial risk) and cybersecurity donations. It also clarifies key definitions for existing exceptions, removes regulatory requirements identified as burdensome, and updates other exceptions to reflect changes in health care delivery.

For more information you can read the OIG’s final rule and fact sheet online as well as CMS’s final rule and fact sheet. Info on anti-kickback and Stark compliance from a family medicine perspective is also available.

— Kent Moore, Senior Strategist for Physician Payment, American Academy of Family Physicians