Predictions in the current antitrust, regulatory and legislative environments are hard – there is just too much happening. The better insights might be reached by thinking through what the bigger questions might be for example, some things to think about as we approach 2021 and contemplate where a new administration in Washington and evolving antitrust enforcement regimes and priorities will take the health care industry. Will the FTC continue to pursue health system and hospital mergers and affiliations aggressively, as it did in 2020? Will its loss in the Eastern District of Pennsylvania, regarding the Jefferson-Einstein merger, be upheld on appeal? Or will the “market realities” aspect of market definition cause the FTC to refocus its efforts and analysis?
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HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology Monday, February 8, 2021
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others.