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An update on risk adjustment, utilization management, and third-party marketing and brokerage commissions and administrative payments, and inquiries into all the above by CMS, OIG and Capitol Hill.

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An update on risk adjustment, utilization management, and third-party marketing and brokerage commissions and administrative payments, and inquiries into all the above by CMS, OIG and Capitol Hill.

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The Food and Drug Administration has long taken the position that while an off-label use of pharmaceuticals and medical devices is legal, off-label marketing or promotion is not legal.  However, recent jurisprudence calls into question whether merely marketing a product for an off-label use is sufficient to satisfy the requirement of making a “false statement” under the False Claims Act (FCA).  In this presentation, we will outline the elements of the FCA and the Anti-Kickback Statute (AKS), and discuss case law and agency guidance regarding whether off-label marketing or promotion truly puts healthcare companies at risk of violating the FCA and AKS.

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This Legal Update will offer tips, tricks, and other things to consider when drafting and/or negotiating a contract in the healthcare ‘space.

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The Federal Government and a number of prominent state governments have enacted, or proposed, legislation and other regulations aimed at regulating or curbing private equity investment in healthcare provider entities. Investors and providers should understand current and proposed limits on their ability to transact.

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