Corporate Compliance

Tip: Audit clinical research billing to identify and reduce risk areas

Healthcare Auditing Weekly, March 10, 2009

Not all clinical trials/research studies are created equal. Clinical research studies can very by duration, complexity, number of arms, and use of certain hospital departments and ancillary services.
Additionally, not all institutions are equal in their ability to comply with the complexities of clinical trials billing. Therefore, certain clinical departments may have different challenges than other areas based on the type of trial, underlying registration and billing systems, and personnel, all of which may increase or lessen billing risk. To this end, a targeted sampling approach may work best if there is a need to favor protocols in one clinical area versus another.
Other ways to target/select the sample include but are not limited to:
  • By patient enrollment: Select for studies by the enrollment per protocol or by department
  • By third-party payer: Select for studies that likely enroll a high proportion of patients with Medicare or other governmental payer as their health insurer
  • By device vs. drug vs. surgical vs. observation studies: Select for a higher proportion of device studies, then drug studies, etc.
  • By study sponsor: Select for studies based on the type of sponsor—that is:
    • Internally-funded
    • Investigator-initiated
    • National Institutes of Health (NIH)-funded clinical trials
    • Industry-sponsored
    • Cooperative group
This tip was adapted from The Healthcare Compliance Professional’s Guide to Clinical Trials. For more information about the book or to order your copy, visit the HCMarketplace.

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