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: https://bit.ly/3JSPBRs