University of Michigan Medical School Calendar Review & Analysis Office

(CRAO)

Gina Vuocolo-Branch, DirectorNovember 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?

• Northwestern University $5.5 million settlement • John Hopkins $2.6 million settlement • Hospital Settlement $5.4 million cardiac device

settlement• TJU $2.6 million settlement• Univ of Louisville Mandated to review 1,151 open

studies• Beth Israel Deaconess $920,000 settlement• Medical College of Georgia $6.1 million settlement • Univ of CA at San Diego $4.7 million settlement• Mayo $6.5 million • University of Alabama $3.4 million• Dr LaHaye $1.1 million settlement• Yale University 194,000• Rush University More than $ 1 million

* Exclusion from government contracting, subcontracting or involvement in procurement programs can also be imposed

CRB Issues Statistics

2 1 0 1 30

125

109

1

15

51

116

78

38

0 1

27

0

20

40

60

80

100

120

140

CRB Issues Received Incorrectly chargedto patient account

Incorrectly chargedto study account

Other Avg Days to Close Open CRB Issues

Clinical Research Billing Issues Reporting2011

Jul-11

Aug-11

Sep-11

CategoriesCost DiscrepancySpecial Request for account review

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

IRBMED Study Team

Members Grants Office UMHS Revenue

Cycle DRDA CCC CTO UMHS Compliance Investigators

Internal Customers Business

Development MICHR CTO Office of Research IT Support (MSIS, ITS,

MCIT) Subjects University Audit Revenue Cycle

Executive Committee

External Customer

eThority

Staffing-Current

11

3

2

1

1

2

Director

Admin Asst

Analysts

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

• Mission and Goals• Organization Chart• Key Performance Indicators• Clinical Research Improvements

Mission and Goal

•15

• 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.

CRB and CRAO Timeline 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

Teri Grieb, Ph.D Senior Director Administration

Office of Research

Samuel Silver, M.D., Ph.DMedical Director CRAO

Assistant Dean Research Associate Medical Director FGP

Research Billing Compliance

Gina Vuocolo-BranchDirector

Calendar Review & Analysis Office (CRAO)

Lynda HodgesAssociate Analyst

Paulina RadenbaughCRB System Coordinator

Collin BoydCRB Support

Specialist

Paula GreeneAdministrative

Assistnat

Brigette MyersCoding & Auditing

Analyst

DeLynn FormanCoding & Auditing

Analyst

Tina FeltAssistant Analyst

Annie Browning Associate Analyst

Wendi Schumacher

Assistant Analyst

Cindy BenedictAssociate Analyst

UMMS Office of ResearchCalendar Review & Analysis Office

CRAO

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

• Instituted steeper clinical discounts for professional and hospital fees for clinical research

• Implemented lean initiative to remove bottlenecks and increase efficiency of billing calendar workflow

• 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

• Launched clinical research pricing tool to assist study teams in preparing study budgets

• Offered training workshops for faculty and study coordinators on the nuts and bolts of billing calendars

• Improved access to clinical research support services by moving CRAO, IRBMED, MICHR and CCC Clinical Trials Office to NCRC

• Partnered with Hospital to fund mechanism for payment for subject injury when not covered by sponsor (includes NIH)

• Established CRAO as an Ancillary Committee within eResearch

• Implement of M Budget Enrollment Calendar Tool; a robust clinical trials software application

THANK YOU!

www.med.umich.edu/u/medschool-crao/mbect.htm