The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two highly-anticipated and significant final rules (scheduled to be published today, December 2, 2020) that seek to modernize and clarify the Anti-Kickback Statute (AKS) and Physician Self-Referral Statute (Stark). These final rules are part of the HHS Regulatory Sprint to Coordinated Care Initiative which aims to remove certain regulatory barriers and administrative burdens that hindered the shift to a value-based health care system and the development by providers of innovative arrangements to improve the coordination of patient care. Both OIG and CMS emphasized that the final rules offer health care providers greater flexibility to coordinate and improve care while maintaining important safeguards against overutilization and inappropriate incentives. The final rules will go into effect on January 19, 2021.
The OIG and CMS worked together to develop these final rules. Although overall the two final rules are consistent, OIG and CMS did not completely align the AKS safe harbors and Stark exceptions set out in the final rules. Outlined below is a brief overview of the major provisions in the final rules.