Late this afternoon, the Centers for Medicare & Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released long-awaited and highly anticipated Stark and Anti-Kickback Statute final rules (“Final Rules”) aimed at modernizing and streamlining key fraud and abuse regulations under the federal Stark, Anti-Kickback and Civil Monetary Penalties Laws. As anticipated, the Final Rules include some major changes to the fraud and abuse regulations and will impact many financial arrangements in health care. The Final Rules both have effective dates of January 19, 2021.

The Final Rules are a key part of the Department of Health and Human Services’ (“HHS”) recently launched “Regulatory Sprint to Coordinated Care” and are intended to accelerate the transition from volume to value. The Final Rules provide a much-needed framework for protecting certain value-based arrangements that incentivize care coordination, quality of care and cost containment. The Final Rules also clarify CMS and OIG interpretations of current existing regulations and propose helpful new exceptions and safe harbors. These changes should ultimately reduce the compliance burden for providers once the Final Rules go into effect. This added flexibility is more important now than it has ever been as the industry continues to navigate the ongoing COVID-19 pandemic.

It has taken a heavy lift by HHS, CMS and OIG over the last few years to get here. On June 20, 2018, CMS published a Request for Information that sought input on how to address regulatory barriers posed by the fraud and abuse laws. CMS and OIG then issued proposed rules (“Proposed Rules”) on October 9, 2019 and allowed industry stakeholders to provide comments until December 31, 2019. Many key components of the Final Rules are similar to what was included in the Proposed Rules, so we encourage you to review our prior alerts on our Fraud and Abuse Reform landing page. As your efforts are focused on the pandemic, we are committed to developing new and practical content that will address relevant aspects of the Proposed Rules and potential opportunities for your health care organization.

Upcoming Hall Render Fraud and Abuse Service Line Webinar

The Final Rules show that HHS, CMS and OIG have delivered on their promise to work on modernizing and streamlining the fraud and abuse regulations. It is important to note that the changes in the Final Rules are effective on January 19, 2021, provided that an addition to Stark group practice compensation distribution provisions is not effective until January 1, 2022. Health care organizations will need to move quickly to react and adapt to the interpretations and positions taken by CMS and OIG.

As a next step, please register here for a Hall Render webinar roundtable discussion on the Proposed Rules scheduled for December 1, 2020 at 1:00 PM EST and watch for our future content on the Final Rules.