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On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse landscape for “value-based” arrangements:
The HHS Office of the Inspector General (OIG) published a Final Rule that introduces new safe harbor protections under the federal Anti-Kickback Statute (AKS) for certain coordinated care and risk-sharing value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions (AKS Final Rule).
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?
by RAbdelrahmanon February 15, 2021
By Sarah Freymann Fontenot, JD
The beginning of a new administration always brings apprehension and anticipation. How dramatically will the President change the trajectory of the country, if at all? Who will take leadership roles in the Executive Branch, and will Congress enhance or defeat the new President’s priorities?
As I wrote on Jan. 27, President Biden taking on the COVID-19 pandemic is Job #1, protecting and strengthening the Affordable Care Act is a close second priority. The public’s attention will center on those two directives in 2021 what issues off the media grid will be of equal importance to healthcare executives?
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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.
The First 100 Days: President Biden Signs Memo on Tribal Consultation and Strengthening Nation-to-Nation Relationships, February 4, 2021, Tony Franco
Last week, President Biden signed a Memorandum on Tribal Consultation and Strengthening Nation-to-Nation Relationships. In the memorandum, President Biden says “It is a priority of my Administration to make respect for Tribal sovereignty and self-governance, commitment to fulfilling Federal trust and treaty responsibilities to Tribal Nations, and regular, meaningful, and robust consultation with Tribal Nations cornerstones of Federal Indian policy.” The memo also reaffirms Executive Order 13175, which “charges all executive departments and agencies with engaging in regular, meaningful, and robust consultation with Tribal officials in the development of Federal policies that have Tribal implications.” Read more here.