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CHA Issues Summaries of Finalized Regulations on Stark Law, Anti-Kickback Statute

For CEOs, CFOs, chief legal counsel, government relations staff

CHA has issued summaries, prepared by Health Policy Alternatives, Inc., of the recently finalized rules issued by the Department of Health & Human Services (HHS) on the Stark Law and anti-kickback statute. The regulations are effective Jan. 19, 2021.  

The first summary details the final rule issued by the Centers for Medicare & Medicaid Services (CMS) to modernize and clarify the regulations that interpret the Medicare physician self-referral law, also known as the Stark Law.  In the rule, CMS finalizes exceptions for certain value-based compensation arrangements among physicians, providers of services, and suppliers. It also creates new exceptions for compensation arrangements for limited remuneration for physicians and for donations of cybersecurity technology and related services. CMS also modifies the exception for electronic health record items and services, and it makes a number of clarifications and modifications to existing exceptions and terminology.  

The second summary details the final rule issued by the HHS Office of Inspector General (OIG) that revises safe harbors under the anti-kickback statute, as well as civil monetary penalty rules for beneficiary inducements. In the final rule, OIG creates seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the beneficiary inducements civil monetary penalty.