University of Michigan Medical School
Calendar Review & Analysis Office
(CRAO)
Gina Vuocolo-Branch, Director
November 1, 2011
Brief History of
• June 2000, President Clinton issued an executive
memorandum; Medicare will pay for routine care services
provided during clinical trials
– UMHS Leadership recognizes the need for a Clinical
Research compliance office to ensure consistency and
compliance to billing regulations
• Clinical Research Billing Unit (CRBU) established; now
known as CRAO
• Hard stop in IRB approval process-Ancillary Committee
status
• Billing Calendar mandatory
– Study activities cannot begin without CRAO approval
Clinical Research Billing (CRB)
Compliance
Billing calendar completion and timely
submission of subject enrollment to the
Revenue Cycle Research Billing (RCRB)
staff is essential to routing charges to the
correct payor
Billing Calendar
Subject Enrollment
Billing Compliance
What Happens When You Don’t Get It Right?
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Northwestern University
John Hopkins
Hospital Settlement
TJU
Univ of Louisville
Beth Israel Deaconess
Medical College of Georgia
Univ of CA at San Diego
Mayo
University of Alabama
Dr LaHaye
Yale University
Rush University
$5.5 million settlement
$2.6 million settlement
$5.4 million cardiac device settlement
$2.6 million settlement
Mandated to review 1,151 open studies
$920,000 settlement
$6.1 million settlement
$4.7 million settlement
$6.5 million
$3.4 million
$1.1 million settlement
194,000
More than $ 1 million
* Exclusion from government contracting, subcontracting or involvement in procurement
programs can also be imposed
CRB Issues Statistics
Clinical Research Billing Issues Reporting
2011
140
125
116
120
109
100
Jul-11
78
80
Aug-11
Sep-11
60
38
40
27
20
15
2
1
0
1
1
0
3
5
1
0
1
0
CRB Issues Received Incorrectly charged Incorrectly charged
to patient account to study account
Other
Avg Days to Close
Categories
Cost Discrepancy
Special Request for account review
Open CRB Issues
Products and Services
• Medicare Coverage Analysis (MCA)
• Billing Calendar Review
• Review the study protocol, informed consent,
billing calendar, budgets, and contract for
harmony including removing MSP Conditional
Language and follow the UMHS Position
Statement for Subject injury payment
• Clinical Research Billing Issue resolution
• Audit study exempt status
• Various education sessions
Interfacing Departments
 Internal Customers
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IRBMED
Study Team Members
Grants Office
UMHS Revenue Cycle
DRDA
CCC CTO
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UMHS Compliance
Investigators
 External Customer
 eThority
 Internal Customers
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Business Development
MICHR CTO
Office of Research
IT Support (MSIS, ITS,
MCIT)
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Subjects
University Audit
Revenue Cycle
Executive Committee
Staffing-Current
Director
Admin Asst
1
2
1
Analysts
1
1
3
2
Asst Analysts
CRB Project Mgr
CRB Support Asst
Coding & Audit Analysts
Staffing Trends
 FY 10 - 6 FTE’s
 FY 11 - 9 FTE’s
 Coders moved from UMHS Rev Cycle to
reduce process review turnaround time
 FY 12 – 11FTE’s
 Implementation of MBECT
 Training, help desk, training manual, etc.
 MiChart CRB project
Study Statistics
July 2010 – June 2011
Current Tactical Initiatives
• Final roll out of M Budget Enrollment
Calendar Tool (MBECT)
– Milestones & Analysis with Invoicing
– New platform in 2012
• CRB Policy Implementation
• Development of best practice policy &
procedures
• Identify root causes & trends of CRB issues
and implement solutions
• Re-design of content of website
Efficiency Opportunities
• Integrate MCRU billing calendar and
budget in MBECT
– Negates duplicative work for study team
members
• Continue collaboration with the IRB and
DRDA in order to improve the approval
process of studies
Thank You
Appendix
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Mission and Goals
Organization Chart
Key Performance Indicators
Clinical Research Improvements
Mission and Goal
• Mission:
The mission of the Calendar Review & Analysis Office (CRAO) is to
complete a Medicare Coverage Analysis (MCA) and Billing Calendar
Review for all Human Subject Clinical Trials that have billable items
and services to assure consistency with all five core documents to
support the appropriate adjudication of charges.
• Vision:
The CRAO’s vision is to support and collaborate with researchers
and study teams to produce a uniform process for the Research
Billing Calendar, Budget and Enrollment. We provide stellar
customer service and foster partnerships with various other research
support areas internal and external to UMHS.
• Goal:
The CRAO would like to ensure the Clinical Research Billing
process is universally utilized throughout the research continuum
and is compliant.
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CRB and CRAO Timeline
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June 2000 – President Clinton signs executive memorandum to authorizing “(Medicare)
payment for routine patient care costs. . .and costs due to medical complications
associated with participation in clinical trials”
 Sept. 2000 – National Coverage Decision (NCD) defined how Medicare will
reimburse providers for services to patients on trial
2003 – Rush University Medical Center voluntarily disclosed billing errors related to NCD
2005 – UM Clinical Research Billing Team formed to review and recommend
improvements to clinical research billing process
November 2006 – Billing calendars required by investigators (no hard stop)
January 2007 – CRBU organized under MICHR
April 2008 – CRBU re-organized under Office of Research
• Rebuilding staff and significant operational changes
• Transitioning from ‘policing’ to ‘service’ model
March 2009 – Implemented automatic workflow tracking system (Jira)
September 2009 – Senior Manager hired and office named changed to CRAO
Fall 2009 – Lean principles process
March 2010 – Ancillary Committee status in eResearch (eRRM)
October 2010 – M Budget Enrollment Calendar Tool (MBECT) roll out
Organizational Structure
UMMS Office of Research
Calendar Review & Analysis Office
CRAO
Samuel Silver, M.D., Ph.D
Medical Director CRAO
Assistant Dean Research
Associate Medical Director FGP
Research Billing Compliance
Teri Grieb, Ph.D
Senior Director Administration
Office of Research
Gina Vuocolo-Branch
Director
Calendar Review &
Analysis Office (CRAO)
Paula Greene
Administrative
Assistnat
Paulina
Radenbaugh
CRB System
Coordinator
Brigette Myers
Coding & Auditing
Analyst
Collin Boyd
CRB Support
Specialist
DeLynn Forman
Coding & Auditing
Analyst
Lynda Hodges
Associate Analyst
Tina Felt
Assistant Analyst
Annie Browning
Associate Analyst
Wendi
Schumacher
Assistant Analyst
Cindy Benedict
Associate Analyst
Key Performance Indicators
• CRAO review turn-around-time
• Number of new studies approved by each
Analyst
• Number of amendments approved by each
Analyst
• Number of CRB issues
– Incorrectly billed as routine care (healthcare
plan)
– Incorrectly billed to Sponsor/7000 account
Clinical Research Improvements
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Instituted steeper clinical discounts for professional and hospital fees
for clinical research
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Implemented lean initiative to remove bottlenecks and increase
efficiency of billing calendar workflow
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Reduced turnaround time for the CRAO review process for new
applications and amendments from 164 days to 15; average is now
13 days for new and 6 days for amendments
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Launched clinical research pricing tool to assist study teams in
preparing study budgets
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Offered training workshops for faculty and study coordinators on the
nuts and bolts of billing calendars
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Improved access to clinical research support services by moving
CRAO, IRBMED, MICHR and CCC Clinical Trials Office to NCRC
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Partnered with Hospital to fund mechanism for payment for subject
injury when not covered by sponsor (includes NIH)
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Established CRAO as an Ancillary Committee within eResearch
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Implement of M Budget Enrollment Calendar Tool; a robust clinical
trials software application
THANK YOU!
www.med.umich.edu/u/medschool-crao/mbect.htm