Effective Jan. 19, 2021, two final rules promulgated by the U.S. Health & Human Services (HHS) take effect and will represent the most significant leg in the “regulatory sprint to coordinated care” that HHS has been leading over the past few years. The rules promulgated by the HHS Office of Inspector General (OIG) include revisions to the safe harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules regarding beneficiary inducements. The rules promulgated by the Centers for Medicare and Medicaid Services (CMS) modify the physician self-referral “Stark Law” rules. The rules cover a fairly broad array of topics, but central to both sets of rules are new and revised provisions that create greater flexibility for health care providers and suppliers to (1) enter into and implement arrangements to jointly coordinate and manage patient care and (2) enter into and implement value-based arrangements under which one or more parties assume varying degrees of financial risk for the delivery of patient care items and services. In addition, the new CMS rule includes new definitions and guidance regarding key Stark Law terms that have given stakeholders fits over the years, including new and revised definitions of “commercially reasonable” and “fair market value,” and including new special rules detailing the conditions under which (1) an arrangement “takes into account” the volume or value of a physician’s referrals or other business generated by a physician and (2) compensation is “set in advance.”

See the links below for detailed summaries of the following major elements of the final rules:

• Value-Based Care Stark Law Exceptions and Anti-Kickback Safe Harbors
• New Definitions for Key Stark Law Terms
• Cybersecurity Technology and Services Stark Law Exceptions and Anti-Kickback Safe Harbors; Updates to EHR Donation Rules
• Anti-Kickback Safe Harbor for Patient Engagement and Support
• Modifications to Anti-Kickback Law Personal Services and Management Contracts Safe Harbor
• Modifications to Stark Law Rules for Ancillary Income Distribution Within Physician Group Practice

As noted above, the effective date for most of these new rules is Jan. 19, 2021 — the principal exception being the Stark Law changes regarding group practices, which take effect Jan. 1, 2022. Please contact any member of our Health Care and Life Sciences group with questions you may have about these new rules and how they may affect your organization.