September, 2014 Clinical Trial Office: Support

Transcript:September, 2014 Clinical Trial Office: Support:
September, 2014 Clinical Trial Office: Support service for clinical trials performed using BMC clinical infrastructure A new clinical research support service is being launched to provide a central and comprehensive framework of financial and administrative support and oversight for clinical trials performed using BMC clinical infrastructure. The objectives of the service are to: Increase the support for clinical trials through expanded institutional involvement and continued investments in the clinical research infrastructure Improve cost recovery by expanding on our ability to budget and bill industry-sponsored clinical research for professional fees and hospital service costs Enhance clinical research billing processes by educating the clinical research community on national best practices; and implementing policies, procedures and systems The Clinical Trial Office is a major component of this new environment and will be involved with awards for both BU and BMC. This presentation will outline why changes are necessary, what’s new (focus on the Clinical Trial Office), what has been done so far, and next steps. 2 Executive Summary Why is Change Necessary? The National landscape consists of tighter regulations and increased scrutiny of research costs. Noncompliance with federal regulations can lead to stringent corrective action plans and financial implications. A few examples: University of Alabama at Birmingham (2005) $3.4M Unlawfully billed Medicare for clinical research trials that were also billed to the sponsor of research grants (double billing). Rush University Medical Center in Chicago (2005) $1.0M Inappropriate clinical trials charges submitted to Medicare and Medicaid Beth Israel Deaconess Medical Center (2002) $ 3.2M Improper billing of experimental cardiac devices to Medicare The following examples at BMC were identified in the recent past: Clinical Trial participants received bills in error due to incorrect registration Potential misappropriation of clinical trial expenses resulting in return of funds A Clinical Trial requiring Research MRI’s did not follow standard practice and could have resulted in research charges being charged incorrectly An independent assessment of 5 clinical trials in 2012 found that 89% of expected professional charges related to participant study visits were potentially unbilled. 3 4 Membership: Chief Medical Officer (Ravin Davidoff, MD), Chief Financial Officer (Richard Silveria), Vice President, Finance (John Lindstedt), Medical Director, Research (Recruiting), Exec. Director, Research (Michael Collins) Being formed and will include senior faculty across BMC participating in research Membership: A mix of BMC departmental administrators and clinical research coordinators, as well as representation from Patient Financial Services, Revenue Integrity, Investigational Pharmacy, and