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Clinical Research Billing and the Law: Tips for Compliance

In the article: Clinical research billing and the law: Tips for compliance, authors Douglas Schoeneman and Tara Krieg discuss three key statutory regulations implicated in clinical research include: The False Claims Act, Stark Law, and The Anti-Kickback Statute.


  • NCD 310.1 provides guidance on Medicare coverage of research services. For any items or services to be potentially billable to Medicare, a study must meet Centers for Medicare & Medicaid Services qualifying criteria.
  • Medicare will pay for certain “routine costs” in a qualifying clinical trial.
  • Key statutory regulations implicated in clinical research are the False Claims Act, Stark Law, and the Anti-Kickback Statute.
  • When in doubt about compliance with the Anti-Kickback Statute, a party can request that the Office of Inspector General write an advisory opinion.
  • Proactively review areas at risk for noncompliance to ensure research protocols are being conducted in compliance with federal laws and regulations.

Read the full article:

Even in the face of a nationwide pandemic, the department’s dedicated employees continued to investigate and litigate cases involving fraud against the government and to ensure that citizens’ tax dollars are protected from abuse and are used for their intended purposes,’ said Acting Assistant Attorney General Clark. ‘The continued success of the department’s False Claims Act enforcement efforts are a testament to the dedication of the civil servants who pursue these important cases as well as to the fortitude of whistleblowers who report fraud.


healthcare compliance, compliance & ethics, risk & compliance, risk management, article, healthcare & life sciences

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