. Clinical . Trial . Office:. S. upport . service for clinical trials . performed . using BMC clinical infrastructure. A . new . clinical research support service is being launched to . provide a central . ID: 240319
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service for clinical trials
using BMC clinical infrastructureSlide2
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 costsEnhance clinical research billing processes by educating the clinical research community on national best practices; and implementing policies, procedures and systemsThe 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.
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) $3.4MUnlawfully 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) $1.0MInappropriate clinical trials charges submitted to Medicare and Medicaid Beth Israel Deaconess Medical Center (2002) $ 3.2MImproper billing of experimental cardiac devices to MedicareThe following examples at BMC were identified in the recent past:Clinical Trial participants received bills in error due to incorrect registrationPotential misappropriation of clinical trial expenses resulting in return of fundsA Clinical Trial requiring Research MRI’s did not follow standard practice and could have resulted in research charges being charged incorrectlyAn independent assessment of 5 clinical trials in 2012 found that 89% of expected professional charges related to participant study visits were potentially unbilled.
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 Radiology
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
Hired to bring management to the various Research Operation Functions
Supports clinical research by managing the financial, legal and administrative components of clinical trials in conjunction with Principal Investigators and Study Teams
Institutional Commitment to Clinical Research:
Creating a Clinical Research IdentitySlide5
BU Charles River Campus
Boston Medical Center
Human Research Protection Program (IRB
Office of Research
Intellectual Property and Commercial Ventures: CRC
Clinical and Translational Science
Office: BMCEffective: 2014
Laboratory for Animal Science
BU Medical Campus
Note: Excludes research operations
A New Value Added
MANAGE | USESlide6
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 InitiationMedicare Coverage Analysis (MCA)Budget Development (comprehensive negotiation support)Negotiation of Contract Terms and Conditions Financial and Billing Management Reporting and AuditingAccount 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.
Benefits of CTO Support Service
One office for BMC research to support contract management, research-related and patient-related billing, and closeout
Development and negotiation with sponsors for each protocol and study by a Clinical Trial Financial Analyst (CTFA)
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
senior faculty in setting research identity
Clinical Research Administrative
study coordinators and departmental administration in changes to policies, processes and practices for clinical trial managementSlide8
PI Engagement is Important for Success!
FunctionDetailsMedicare Coverage AnalysisRequirement for all clinical trials and involves PI effortBilling GridsRequirement for all clinical trials and involves study team effortStudy Participant ChargesGreater scrutiny to ensure patient charges are reconciled and meet Medicare billing standards PI AttestationInvestigator attestation that study funding will be administered in good faith (study initiation) and charges have been properly submitted (close out).
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.Slide9
Director, Clinical Trial Office:
Formerly Administrative Director of Cancer Center, Tufts Medical Center
Senior Clinical Trial Financial Analyst:
Clinical Trial Financial
Analyst, Massachusetts General Hospital (CCPO)
Senior Clinical Trial Financial Analyst:
Formerly Senior Research Administrator
, Beth Israel Deaconess Medical
Clinical Research Attorney:
Formerly Senior Agreement Associate, Partners HealthcareSlide10
Boston Medical Center has made a capital investment ($600K+) to implement a
fully functional clinical trial management
will assist with:
articipant recruitment and accrual
for all clinical
implementation will be staged in three main
involve stakeholders with various cross-functioning subject matter expertise, and external
support and is expected to
be complete May, 2015 .
setup, configuration and onboarding new
: Additional interfaces created and integrated over next three years
Michael Collins: Executive Director, Research
Garo Stone-DerHagopian: Associate Director, Research Business IntelligenceSlide11
Clinical Trial Finance Lifecycle
Policies and Procedures (Ernst & Young Engagement)
35 policies and
procedures (some in draft).
Minimal or no edits were suggested for 27 policies with proposed edits
drafted an additional 20 policies to support research operations.Slide14
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 and Educational Opportunities
Training SessionPI requirementStudy team requirementClinical Research BillingMedicare Coverage AnalysisBudget DevelopmentCharge 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.Slide15Slide16
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