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A Holiday Gift for the Health Care Industry? Value-Based Care and Related Final Rules for Stark, Anti-Kickback, and Civil Monetary Penalties Regulations

Introduction. On November 20, 2020, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) released their long-awaited final rules describing changes to the “safe harbor” regulations implementing the federal anti-kickback statute (the “AKS”), the beneficiary inducement provisions of the civil monetary penalty law (the “CMPL”), and the physician anti-self-referral law (“Stark”) and its exceptions. OIG’s final rulemaking (the “OIG Final Rule”) and the final rulemaking from CMS (the “CMS Final Rule”) each include three new provisions for value-based care arrangements presenting different financial risk profiles.

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District Court Rejects Fraud-on-the-FDA Theory of False Claims Act Liability

Practices: Health Care, Life Sciences, Government Enforcement / White Collar Criminal Defense

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