On November 20, 2020, the U.S. Department of Health and Human Services unveiled its highly anticipated Regulatory Sprint to Coordinated Care final rules to modernize the regulations that implement the Stark Law and Anti-Kickback Statute. The final rules represent major steps toward removing barriers to care coordination and transforming the U.S. healthcare system into one that pays for value. The final rules apply broadly and took effect on January 19, 2021.
The centerpiece of the Regulatory Sprint rules is a set of safe harbors and exceptions available to protect remuneration exchanged among healthcare providers and other participants within a Value-Based Enterprise as part of a Value-Based Arrangement, as well as remuneration furnished to support and engage patients, all to advance Value-Based Purposes of the Value-Based Arrangement.
While the Value-Based Enterprise construct holds great potential for providing regulatory flexibility to healthcare industry participants in their efforts to move to value-based care reimbursement and care delivery models, the Regulatory Sprint rules include numerous requirements that must be incorporated into the overall structure of a transaction and documented in the definitive agreements.
This presentation will focus on practical considerations for translating the Value-Based Enterprise concept into a deal structure and documents that can be used to satisfy the new value-based safe harbors and exceptions.
Chris Lim, Vice President and Associate General Counsel, Fresenius Medical Care North America
For more information on this webinar, visit the AHLA Transactions Conference 2021 event page.