After a down year in 2020, healthcare M&A in 2021 had surpassed already 2020 totals before the start of the fourth quarter. Counsel should anticipate 2022 will be another big year for healthcare deals.
In November 2020, the Department of Health and Human Services published the long-awaited and highly anticipated Final Rules revising the regulations related to the Stark Law and the AKS. In large part, these Final Rules have been recognized as providing a framework for protecting specific value-based arrangements that incentivize care coordination, quality of care, and cost containment. Yet, they also set forth new Stark exceptions and AKS safe harbors and modified existing exceptions and safe harbors that affect transactions outside of the value-based arena. For example, the Final Rules clarify interpretations of current existing regulations and key definitions, including the "Big 3" fair market value, commercial reasonableness, and volume or value standards.
Counsel to parties doing healthcare deals must ensure compliance, as the penalties for violation of these fraud and abuse rules can be severe. Providers must ensure arrangements with physicians are appropriate. Counsel to healthcare M&A deals will need to review regulatory considerations, including compliance with the Stark Law and AKS and state law equivalents, among other things.
Listen as our authoritative panel of healthcare attorneys examines the impact and application of the Final Rules on healthcare transactions and M&A.
