Clinical Trial Office:
Support service for clinical trials performed
using BMC clinical infrastructure
September, 2014
Executive Summary
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:
1. Increase the support for clinical trials through expanded institutional involvement and
continued investments in the clinical research infrastructure
2. Improve cost recovery by expanding on our ability to budget and bill industry-sponsored
clinical research for professional fees and hospital service costs
3. 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.
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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.
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Institutional Commitment to Clinical Research:
Creating a Clinical Research Identity
Being recruited to support the
strategic direction of clinical
research at BMC and provide
clinical and scientific support to
Principal Investigators and the
central service functions that
support clinical research
Research
Leadership
Council
Medical
Director,
Research
Executive
Director,
Research
Hired to bring
management to the
various Research
Operation Functions
BMC
Clinical
Research
Being formed and will
include senior faculty across
BMC participating in
research
BMC
Clinical Trial
Office
Research
Committee
Membership: A mix of BMC departmental
administrators and clinical research
coordinators, as well as representation from
Patient Financial Services, Revenue Integrity,
Investigational Pharmacy, and Radiology
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)
Clinical
Research
Admin. Task
Force
Supports clinical research by managing
the financial, legal and administrative
components of clinical trials in
conjunction with Principal Investigators
and Study Teams
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A New Value Added Service for Research
MANAGE | USE
BU Charles River Campus
Human Research
Protection Program
(IRB): BUMC
BU Medical Campus
Boston Medical Center
Clinical and
Translational
Science Award:
BUMC
Intellectual
Property and
Commercial
Ventures: CRC
Note: Excludes research operations
managed separately
Office of Research
Compliance: CRC
Research
Laboratory for Animal
Science Center: BUMC
Clinical Trial Office: BMC
Effective: 2014
Investigational
Pharmacy
Service: BMC
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Clinical Trial Office Support Services
The Clinical Trial Office (CTO) will support clinical research by managing the financial, legal
and administrative components of clinical trials in conjunction with Principal Investigators
(PIs) and Study Teams.
The CTO is involved in the following functions:
 Study Initiation
 Medicare Coverage Analysis (MCA)
 Budget Development (comprehensive negotiation support)
 Negotiation of Contract Terms and Conditions
 Financial and Billing Management
 Reporting and Auditing
 Account Reconciliation and Closeout
The new program leverages best practices from peer institutions, including Partners
Healthcare, Beth Israel Deaconess Medical Center, Tufts Medical Center, and Children’s
Hospital. In addition to the local peer review; Jim Moran, Executive Director, Healthcare
Advisory Services at Ernst & Young (formerly of Washington University) and Erika Stevens,
Senior Manager (formerly of Dartmouth Hitchcock Medical Center and Columbia University
Medical Center) are contributing insight to ensure that the CTO is consistent with standard
practices.
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Benefits of CTO Support Service
Function
Details
Centralized Support
One office for BMC research to support contract
management, research-related and patient-related billing,
and closeout
Budgets
Development and negotiation with sponsors for each
protocol and study by a Clinical Trial Financial Analyst
(CTFA)
Professional Fees
Partnership between CTFA and professional groups to
correctly budget and bill the sponsors to more accurately
reflect physician time spent on clinical trials and increase
revenue recovery
Research Committee
Involvement of senior faculty in setting research identity
Clinical Research Administrative
Task Force
Involvement of study coordinators and departmental
administration in changes to policies, processes and
practices for clinical trial management
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PI Engagement is Important for Success!
Although the CTO will strive to minimize additional administrative burdens on Principal
Investigators, increased participation is needed to ensure the continued success of the
institution’s clinical research program.
Function
Details
Medicare Coverage Analysis
Requirement for all clinical trials and involves PI effort
Billing Grids
Requirement for all clinical trials and involves study
team effort
Study Participant Charges
Greater scrutiny to ensure patient charges are
reconciled and meet Medicare billing standards
PI Attestation
Investigator attestation that study funding will be
administered in good faith (study initiation) and
charges have been properly submitted (close out).
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CTO Recruitment
Director, Clinical Trial Office: Selvin Ohene
• Formerly Administrative Director of Cancer Center, Tufts Medical Center
Senior Clinical Trial Financial Analyst: Dean Robinson
• Formerly Clinical Trial Financial Analyst, Massachusetts General Hospital (CCPO)
Senior Clinical Trial Financial Analyst: Allisson Dugan
• Formerly Senior Research Administrator, Beth Israel Deaconess Medical Center
Clinical Research Attorney: Meghan Garland
• Formerly Senior Agreement Associate, Partners Healthcare
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VelosCT
Boston Medical Center has made a capital investment ($600K+) to implement a fully functional
clinical trial management system (Velos eResearch) that will assist with:
•
•
•
•
Participant recruitment and accrual
Scheduling, follow-up, retention and management
Financial management
Reporting for all clinical trials
The implementation will be staged in three main phases, involve stakeholders with various crossfunctioning subject matter expertise, and external support and is expected to be complete May,
2015 .
Phase I: System setup, configuration and onboarding new trials
Phase II: Data migration of selected existing studies
Phase III: Additional interfaces created and integrated over next three years
Executive Sponsor: Michael Collins: Executive Director, Research
Project Manager: Garo Stone-DerHagopian: Associate Director, Research Business Intelligence
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Appendix
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Clinical Trial Finance Lifecycle
CTO INVOLVEMENT
PATIENT
VISIT
RESEARCH
vs. SOC
CHARGE
CAPTURE
BILLING
&
CODING
CLAIMS
EDITING
Study
Start
Up
PATIENT
REGISTRATION
INVOICING
Post
Award
COLLECTIONS
PATIENT
CONSENT
PreAward
COVERAGE
ANALYSIS
Close
Out
POST TO
CORRECT
RESEARCH
ACCT.
RECONCILIATION
IRB
BUDGETS
REPORTING
CONTRACT
MGMT
IRB APPROVAL
ACCOUNT
CLOSEOUT
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Policies and Procedures (Ernst & Young Engagement)
Study Initiation
Post-Award
• A total of 14 study initiation policies and procedures
developed by Executive Director, Research were
reviewed by EY with minimal revision. An additional
7 new policies and procedures were created by EY
to enhance BMC pre-award processes.
• A total of 21 existing post-award policies and
procedures were reviewed by E&Y with minimal
revision. An additional 13 new policies and
procedures were created by EY to enhance BMC
post-award processes.
E&Y Advisory Services reviewed 35 policies and procedures (some in draft). Minimal or no edits were
suggested for 27 policies with proposed edits to 8 policies. E&Y drafted an additional 20 policies to
support research operations.
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Training and Educational Opportunities
The CTO will work in collaboration with the Associate Director, Research Operations to provide the
clinical research community with opportunities for training and education.
There will be multiple channels available to PIs and their study teams to receive training:
• Live group training sessions (available in Fall, 2014)
• Targeted online training (via Healthstream) (TBA)
• Seminar series (TBA)
The following training sessions will be required for Investigators/study teams involved in clinical
research:
Training Session
PI requirement
Study team
requirement
Clinical Research Billing
• Medicare Coverage Analysis
• Budget Development
• Charge Capture (SOC vs. Research vs.
Blended study visits)
Clinical Trial Management System (VelosCT)
optional
Time commitment is expected to be 1 hour per topic area.
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