Clinical Research Billing Challenges and CMS Mandated Coverage

Clinical Research Billing and Coverage Analyses
CCAF 2014 Meeting
San Diego, CA
April 14, 2014
• City of Hope (COH) is located in close proximity to the Norris
Cancer Center at the University of Southern California and
was aware of USC/Tenet’s settlement related to clinical
research billing
• A process was put in place prior to 2010, but changing
guidelines and an internal reorganization in 2012 provided
the opportunity to identify and implement improvements
• COH commissioned a gap analysis with recommendations and
an updated policy and procedure manual
The Clinical Research Billing Process
The clinical research billing
(CRB) process is complex and
requires coordination and
harmonization between
partnering institutions (the
hospital, the physician practice
plan, and where applicable,
the university).
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Call to Action
COH initiated the following:
• CRB Steering Committee: Executive leadership, faculty and
administrators provide decision-making support to the
Working Group while removing hurdles to progress.
• CRB Working Group: Front-line staff and faculty design,
improve and/or validate business processes critical to
ensuring efficiency, financial accountability, and compliance
within clinical research billing processes.
• Increased frequency of auditing
• Increased focus on a CTMS that would improve the
communication and the workflow
Additional Steps Taken
• Customer satisfaction survey of faculty and focused
discussions on opportunities for improvement
• Comprehensive review of workflow, communication, and
• Revamping of processes in clinical research operations and
the revenue cycle for the physician practice and the hospital
• Reorganization of staff and reporting lines within financial
and operational clinical research programs, e.g., centralized
support of diverse clinical programs with alignment to the
disease teams
• Increased engagement among faculty and administrators
• Increased accountability to the faculty and administrators
• An improved workflow, communication process, and set of
• Clear policies and defined processes based on up-to-date
• Identification and clarification of clinical research billing
• A budget estimator tool for Letters of Intent
• Signs of improvement in the turnaround times for budgets
and contracts
Lessons Learned
• Implementing a clinical research billing process was much
more complicated to discuss and revise than anyone
• Early involvement of leadership from the faculty,
administrators, compliance, and revenue cycle was beneficial
• Small tweaks to the process had ripple effects in the revenue
cycle and had to be addressed more globally
• Technology options are limited, but are critically necessary
Ashley Baker Lee
Senior Vice President, Research Operations
City of Hope
Email: [email protected]
Phone (626) 256-HOPE(4673), ext. 63463
Mobile (310) 938-9524