On August 24, 2020, CMS released a notice extending its timeline to publish its final rule with significant changes to the Stark regulations that was proposed in October 2019. Previously, CMS had indicated that it intended to finalize the rule in August 2020. However, the agency notice explains that CMS is “still working through the complexity of the issues raised by comments received on the proposed rule,” and therefore is not able to meet the target publication date. Now CMS’s timeline for finalizing the rule is extended for an additional year to August 31, 2021, although the agency could publish the rule earlier.

As previously reported CMS’s proposed rule included significant and highly anticipated changes to the regulations implementing the Stark Law, including changes to address value-based arrangements and major changes to other key Stark Law concepts and definitions. On the same day, OIG also released its own proposed rule as part of the Regulatory Sprint to Coordinated Care initiative that included changes to the safe harbors under the Anti-Kickback Statute and the beneficiary inducements provision in the civil monetary penalties law.

The Office of Management and Budget (OMB) website indicates that both OIG and CMS’s final rules were received by OMB for review on July 21, 2020 and that both have final action dates scheduled for August 2020. OIG has not issued a public statement about the status of publication of modifications to the Anti-Kickback Statute safe harbors and the beneficiary inducements rules.

CMS’s notice that was published in the Federal Register on August 27, 2020 is available here.