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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Slide1
September, 2014
Clinical
Trial
Office:
S
upport
service for clinical trials
performed
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.
2Executive SummarySlide3
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 funds
A 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.
3Slide4
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 researchMembership: 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
):
BUMC
Office of Research
Compliance:
CRC
Intellectual Property and Commercial
Ventures:
CRC
Clinical and Translational Science
Award:
BUMC
Clinical Trial
Office:
BMC
Effective: 2014
Investigational Pharmacy
Service:
BMC
Laboratory for Animal Science
Center:
BUMC
BU Medical Campus
Note: Excludes research operations
managed separately
A New Value Added
Service
for Research
5
MANAGE | USESlide6
Clinical Trial Office Support ServicesThe 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 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.
6 Slide7
7
Benefits of CTO Support Service
Function
DetailsCentralized SupportOne office for BMC research to support contract management, research-related and patient-related billing, and closeoutBudgetsDevelopment and negotiation with sponsors for each protocol and study by a Clinical Trial Financial Analyst (CTFA)
Professional FeesPartnership 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 recoveryResearch Committee Involvement of senior faculty in setting research identityClinical Research Administrative
Task ForceInvolvement of study coordinators and departmental administration in changes to policies, processes and practices for clinical trial managementSlide8
8
PI Engagement is Important for Success!
Function
DetailsMedicare 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
9
CTO Recruitment
Director, Clinical Trial Office:
Selvin OheneFormerly Administrative Director of Cancer Center, Tufts Medical CenterSenior Clinical Trial Financial Analyst: Dean RobinsonFormerly Clinical Trial Financial Analyst, Massachusetts General Hospital (CCPO)Senior Clinical Trial Financial Analyst: Allisson DuganFormerly Senior Research Administrator, Beth Israel Deaconess Medical CenterClinical Research Attorney: Meghan GarlandFormerly Senior Agreement Associate, Partners HealthcareSlide10
VelosCT10
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 accrualScheduling, follow-up, retention and management Financial management Reporting for all clinical trialsThe implementation will be staged in three main phases, involve stakeholders with various cross-functioning subject matter expertise, and external support and is expected to be complete May, 2015 .
Phase I: System setup, configuration and onboarding new trialsPhase II: Data migration of selected existing studies Phase III: Additional interfaces created and integrated over next three yearsExecutive Sponsor: Michael Collins: Executive Director, Research Project Manager
: Garo Stone-DerHagopian: Associate Director, Research Business IntelligenceSlide11
Appendix
11Slide12
RESEARCH
vs. SOC
CHARGE
CAPTUREPATIENTVISIT
PATIENTREGISTRATION
PATIENT
CONSENT
COLLECTIONS
BILLING
&
CODING
INVOICING
CLAIMS
EDITING
IRB APPROVAL
COVERAGE
ANALYSIS
POST TO
CORRECT
RESEARCH
ACCT.
Clinical Trial Finance Lifecycle
BUDGETS
CONTRACT
MGMT
12
RECONCILIATION
ACCOUNT CLOSEOUT
REPORTING
CTO INVOLVEMENTSlide13
13
Policies and Procedures (Ernst & Young Engagement)
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.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:
14
Training and Educational OpportunitiesTraining SessionPI requirementStudy team requirement
Clinical Research BillingMedicare Coverage AnalysisBudget DevelopmentCharge Capture (SOC vs. Research vs. Blended study visits)Clinical Trial Management System (VelosCT)optionalTime commitment is expected to be 1 hour per topic area.