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Plan Ahead for Changes to Physician Group Practice Profit Sharing | Bradley Arant Boult Cummings LLP

Plan Ahead for Changes to Physician Group Practice Profit Sharing | Bradley Arant Boult Cummings LLP
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The New Stark Law Value-Based Exceptions Seek to Advance the Shift from Volume to Value in the Delivery of Health Care in the United States | Butler Snow LLP

Value-based arrangement
means an arrangement for the provision of at least one value-based activity for a target patient population to which the only parties are (1) the value-based enterprise and one or more of its VBE participants; or (2) VBE participants in the same value-based enterprise.”
As previously noted, only “compensation arrangements” (and
not ownership or investment arrangements) qualify as “value-based arrangements” for purposes of the new value-based exceptions. Further, only those compensation arrangements between a physician (or an immediate family member of a physician) and an entity to which the physician makes referral for DHS (and
not compensation arrangements between a payor and a physician) qualify as “value-based arrangements”. Of note, qualifying “value-based arrangements” must ultimately relate to a target patient population, but are ....

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White Paper: Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law | K&L Gates LLP

“Full Financial Risk”
A. Overview of Key Safe Harbors and Exceptions
An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. Stakeholders must navigate the requirements under both regulatory regimes for arrangements that potentially implicate each law. Although a number of commenters sought a unified set of requirements between Stark Law and AKS requirements, CMS and OIG rejected this approach, noting the different purposes of each law. In general, CMS provides more flexibility for Stark Law exceptions, given its strict liability standard. In contrast, OIG felt it was appropriate for the AKS which is an intent-based law to serve as “backstop” protection for arrangements that implicate both laws. The six safe harbors and exceptions set forth by OIG and CMS are as follows: ....

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Anti-Kickback Statute, Stark Law Value-Based Safe Harbors

Tuesday, February 2, 2021
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:
(i) 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).
(ii) The HHS Centers for Medicare & Medicaid Services (CMS) published a Final Rule that finalizes similar exceptions to the Physician Self-Referral Law (Stark Law) for certain value-based compensation arrangements between or among physicians, providers, and suppliers (Stark Final Rule, and together with t ....

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The Tortoise and the Hare? HIPAA Joins the Regulatory Sprint to Coordinated Care | K&L Gates LLP

Introduction
On 10 December 2020, the Office of Civil Rights (OCR) for the federal Department of Health and Human Services (the Department) issued Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement (the Proposed Rule).
1 The Proposed Rule comes nearly two years after OCR issued a Request for Information from stakeholders regarding the ways that HIPAA could be modernized to support coordinated, value-based care.
2 OCR includes numerous proposed changes to the HIPAA Privacy Rule intended to eliminate regulatory barriers for purposes of fostering care coordination and the shift to value-based care models, including clarifying the scope of care coordination for disclosures of protected health information (PHI) under the health care operations and treatment exceptions, and creating an exception to the minimum necessary standard for disclosures related to care coordination and case management. ....

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