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White Paper: CMS Finalizes Updates to the Stark Law to Reduce Regulatory Burdens and Provide Flexibility to Providers

On 2 December 2020, the Centers for Medicare & Medicaid Services (CMS) published a Notice of Final Rulemaking in the Federal Register (Final Rule), modifying the regulations implementing the federal physician self-referral...more

A Starkly Different Landscape – A Deep Dive Into CMS’ Recently Proposed Amendments to the Stark Law

On October 17, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a Notice of Proposed Rulemaking in the Federal Register (“Proposed Rule”), modifying the regulations implementing the federal physician...more

Increased Scrutiny of Patient Assistance Programs: Enforcement Overview and Considerations

In the midst of ongoing national debates regarding drug pricing [1] and access to innovative therapies, patient assistance programs (“PAPs”) are facing an evolving legal landscape, as well as increased enforcement scrutiny...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

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