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Proactive clinical research revenue cycle compliance

M.A. Hall (mhall@dugganbertsch.com) is the Healthcare Practice Co-Lead at Duggan Bertsch LLC in Chicago.

Erika Stevens (erika@recherchetransformationrapide.com) is a Principal at Recherche Transformation Rapide in Lumberton, NJ.

Mary Veazie (mlveazie@mdanderson.org) is the Executive Director of Clinical Research Finance at The University of Texas MD Anderson Cancer Center in Houston.

The field of clinical research is no different than any other in the healthcare industry, in that there are federal and state regulations and laws that affect its revenue cycle. Institutions conducting research on humans must comply with all applicable laws and regulations throughout the clinical research cycle in order to continue to provide care for patients, bill for services, and maintain funding. Regulatory requirements and laws impact each phase of the clinical research revenue cycle (CRRC):

  • Institutional review board (IRB)

  • Pre-award, study start-up

  • Post-award

  • Close-out

For this article, we will discuss the compliance risks associated with the regulatory requirements within the pre-award, post-award, and close-out phases of the CRRC and how noncompliance with regulatory requirements across the revenue cycle can affect a clinical research department’s fiscal bottom line. In FY 2017, the federal government recovered $2.4 billion from healthcare fraud actions, which is a return on investment of $6.10 for each dollar spent.[1] For clinical research, understanding compliance risks is essential for everyone, including executive management (C-suite), to avoid significant penalties from federal and state governments. We will discuss and identify the benefits of introducing the concept of proactive compliance to a CRRC program as the most advantageous way of addressing regulatory matters for an institution.

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