A Giant Leap Forward in Value-Based Innovation or an Avalanche of New Administrative Requirements? An Analysis of the Value-Based Aspects of HHS’s AKS and Stark Proposed Rules

Lexology December 11, 2019
K&L Gates

As part of the Department of Health and Human Services’ (“HHS”) “Regulatory Sprint to Coordinated Care,” the following two proposed rules were issued on October 17, 2019, that, if finalized, will markedly change the regulatory fraud and abuse landscape for value-based activities:

i. The HHS Office of the Inspector General (“OIG”) published a Proposed Rule that would introduce new safe harbor protections under the federal Anti-Kickback Statute (“AKS”) [1] 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 Proposed Rule”). [2]

ii. The HHS Centers for Medicare & Medicaid Services (“CMS”) published a Proposed Rule that proposed similar exceptions to the Physician Self-Referral Law...

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