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“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 exce...

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...

To embed, copy and paste the code into your website or blog: On Thursday, December 17, 2020, senior representatives of the US Department of Health and Human Services’ Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) delivered a virtual presentation to American Health Law Association members and other health industry stakeholders to explain and elaborate on significant new regulations that become final on January 19, 2021. OIG Senior Counselor for Policy, Vicki Robinson, OIG Industry Guidance Branch Chief, Susan Edwards, and OIG Senior Coun...

To embed, copy and paste the code into your website or blog: On November 20, 2020, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations” (Final Rule). HHS Deputy Secretary Eric Hargan described the new rules as “historic reforms, and come as part of the regulatory sprint to coordinated care …“ The new rules give great flexibility for providers to participate in value-based payment (VBP) and care delivery models, and to provide coordinated care for p...