The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute.
As we wrote when the proposed rules were released last autumn (see client alerts here and here), the rules reflect HHS’s attempt to create exceptions and safe harbors that refine the Stark Law’s strict-liability-based civil penalties and the Anti-Kickback Statute’s criminal penalties. The goal is to prevent certain non-abusive and beneficial arrangements from finding themselves subject to enforcement activities. As HHS itself notes, the final rules are the result of its effort to address health care industry concerns that these laws, as well as the Civil Monetary Penalty (CMP) Law, function as barriers to the delivery of value-based care that would improve quality of care, health outcomes, and efficiency.
The final rules number over 1,600 pages in current form and incorporate and address over 650 comments industry stakeholders submitted in response to the proposed rules. For our overview and analysis of the final rules, please read our client alert.