Using InfoEd to Enhance Clinical Trial Billing Compliance

Medicare and Medicaid fraud have been in the spotlight lately, with news of the indictment of Dr. Jacques Roy and six others in an alleged scheme that cost taxpayers almost $375 million. Payments to over 75 home healthcare agencies have been suspended pending further investigation.

While fraud is newsworthy, it is also rare. The greatest compliance risk in billing for clinical trial services is simple oversight or error. To reduce this risk, every research protocol should be reviewed for potential billing issues, with service categorizations clearly documented and justified before enrollment begins. It is also important for the research team to alert the central billing office whenever routine care is delivered in a research context that involves a mix of billable and non-billable services.

InfoEd’s Clinical Trials module facilitates billing compliance by:

  • Tracking whether each visit is primarily for routine care vs. research
  • Tracking the purpose of each procedure or activity and how it should be billed
  • Documenting the Medicare coverage determination regarding each procedure/activity associated with a trial
  • Tracking which participants are currently enrolled in clinical trials
  • Facilitating communication between the research team and the central billing office regarding the delivery of clinical services to research participants

Including these functions in the clinical trial record makes them transparent to everyone involved in conducting the trial. It also removes the need for a small team of billing compliance experts to manage all of the institution’s documentation related to service categorization. Instead, they can focus their efforts on reviewing the information entered by research staff, educating them about ongoing compliance initiatives, and performing audits to verify compliance on the back end.

Consistency can become an issue whenever more people get involved in service categorization. InfoEd’s flexible reporting tool can be used to generate reports and alerts that make it possible to evaluate consistency at various levels. InfoEd certifications can be used to manage training initiatives. Institutions can even opt to make completion of required training a prerequisite for access to the Clinical Trials module or its Financials component.

If you would like more information about the Clinical Trials module, please contact Support.

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