Yale University
Regional Clinical Research
Management Workshop
February 22, 2010
Stanford's “Epic” Implementation Journey:
Integration of Clinical and Research requirements
Concept to Reality
Nick Gaich
Executive Director and Chief Operating Officer , Spectrum
Setting the background….
2
Assessing Stanford’s Clinical Trials Fiscal Environment:
“Balcony View in 2005”
 Realization of missed reimbursement opportunities, for
clinical research-related routine care charges that were
now allowable by Medicare
 Inconsistent alignment of budgeting, contracting and
informed consent
 Lack of accountability and responsibility fostered by “silobased” operations
 General lack of system wide business discipline and
synchronization with respect to clinical research billing
and budgeting activities
Assessing Stanford’s Clinical Trials Fiscal Environment:
Results of Internal Audits: 1999-2005
 Insufficient knowledge of Medicare rules
 Inadequate invoicing, tracking, collections
 Poor coordination between Investigators and
Hospitals
 Billing isolated from budgeting and contracting
 Confusing and ambiguous billing rules
Challenges
Complexities and ambiguities in the National
Coverage Decision regulations
Each study must be uniquely analyzed to determine
which items and services are billable to
Medicare/third party payers.
Designing a prospective approach.
New systems bring added burdens for Investigators
and Coordinators.
Stanford Clinical Research
Environment in 2005
Well intended but NOT well coordinated
Budgeting
Hospital Billing
Compliance
Accounts
Receivable
KEY PILLARS IN THE CLINICAL RESEARCH
ENTERPRISE AT ACADEMIC HEALTH CENTERS
BIOSTATISTICS
INFORMATICS
BUDGETING
BILLING
CONTRACTING
TRAINING &
EDUCATION
The Solution: Simplified and Automated
Clinical Research Budgeting/Billing
 Budgets prospectively distinguish sponsor and routine care
expense.
Informed consent fully explains routine care expenses and
potential out of pocket liability.
 Billing reflects competitively discounted prices.
 Audit controls of individual studies to ensure compliance.
 Coordination of activities between all key stakeholders
 Structured Training, Education…… and Follow up….
Is in the
Translational Research Task Force
Senior Investigators: 2
Hospital VP’s : 6
Senior Associate Dean: 1
Legal Council: 2
Internal Audit: 1
All the donuts you can eat !!!
State of Clinical Trials Billing Process 2005
• Institutional Account per trial
• Hospital ID card to imprint/emboss orders
• Manually key in participant’s name on charge
• No reports back to PI’s or Nurse Coordinators
other than sending copy of monthly institutional
statement
• No rigorous process to review charges other than
monthly statements
• Review of charges often occurred when PI’s
budget ran out of money
11
Improvement Task Force Established 2005
• Stakeholders: School of Medicine, Hospital,
University Leadership (Clinical Trials Office,
Billing, Managed Care, Compliance, Internal
Audit)
• Improvement Focus
 Control upfront identification of routine vs. trials charges
 Automating the capture of charges upfront and
systematically making a first pass of sorting charges between
routine vs. trial charges
 Creating weekly and monthly reports back to PI’s and
Coordinators
 Improve automation of claim editing software to assign
appropriate clinical trial modifiers and other codes
Improve process across two different hospital billing
systems (SMS and Meditech) and for Professional Fees (IDX)
12
Improvements Implemented 2007 & Beyond:
Establishment of a Budget and Billing Workbook
• Created Tables for routine charges vs. trial charges
• Able to load tables into both hospital billing systems
• Able to create programming points in both systems
to intercept charges based on patient’s medical
record numbers
• Charges system sorted to go to institutional account
(trial charge) vs. straight to billing (routine charge)
• Created weekly reports to PI’s/Nurse Coordinators
for review and adjustment, showing for each trial,
participant’s trial charges vs. charges to billed to
patient’s insurance
13
Improvements Implemented 2007 & Beyond
• Created monthly recap reports to PI’s/Coordinators
• Better automated coding in claim editing software
• Created new positions to facilitate reporting
distribution and communication to PI Coordinators
• Created gap report that caught all late added
participants
• Audits from both University’s Internal Audit
Department and Hospital Compliance found
controls to be adequate
14
The Path to Success
15
Billing “Fork in the Road”
Is this charge an
allowed charge for
this study budget?
Expensed to Trial
Yes
Billed to Payer/Pt.
No
SCHEDULE OF EVENTS
Basic Metabolic Panel
Throacentesis Tray
Creatinine
IV Tubing
CT Scan (Head)
1
x
x
2
3
x
x
x
x
x
x
4
5
6
x
7
8
9
x
x
x
x
10
11
12
x
x
x
x
x
KEY
X
X
ROUTINE CARE
STUDY RELATED
ROUTINE CARE
ROUTINE CARE SERVICES FORM
CONFIDENTIAL (For Internal Use Only)
RESEARCH COSTS
RESEARCH PARTICIPANT SERVICES FORM
CONFIDENTIAL (For Internal Use Only)
Instructions: To begin the budgeting process for studies involving patient care, please complete the sections highlighted in yellow.
PI Name:
0
IRB Number:
Study Coordinator Name:
0
SPO Number:
Department:
0
Study Period Start Date:
1/0/00
Study Title:
0
Study Period End Date:
1/0/00
Sponsor Name:
0
0
0
IRB Number:
Study Coordinator Name:
SPO Number:
Department:
Study Period Start Date:
Study Title:
Study Period End Date:
Study/Account Name (14 character limit)
SHC or LPCH?
Instructions: Using the Schedule of Events, please list all routine care that you anticipate will be provided to subjects as part of the study protocol,
and not paid by the sponsor.
Service Description
Sponsor Name:
Is this a Medicare NCD Qualifying
Study? (yes or no)
Is this a Federal sponsor?
(yes or no)
If Federal, will subjects be
outpatients? (yes or no)
Project Number:
Task Number:
Award Number:
* If federally funded and any services are provided at LPCH , then the RPM needs to apply the current DHHS negotiated rates
(See S:\Certs - F & A Rates\Stanford DHHS Agreements\Packard
A
Service Description
SHC/LPCH Laboratory Testing
PI Name:
Service Code
SHC/LPCH Technical Fees & Non-181 Supplies
SHC/LPCH MRI's. CT's ECHO's Technical Fees
SHC/LPCH Professional Fees
SHC/LPCH Supply Costs with 181 Service Code Only
CPT Code
Occurences per
Subject per
Study Period:
B
C
*Discounted
Full Price
Price
55.0%
Laboratory Testing Subtotal
55.0%
Technical Fees & Non-181 Supplies Subtotal
72.0%
MRI's. CT's ECHO's Technical Fees Subtotal
60.0%
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Utilizing NCD guidelines, services
are identified as:
Research Related and Routine Care
Professional Fees Subtotal
85.0%
Supply Costs with 181 Service Code Only Subtotal
Other (Services Not Billed through 98/Mnemonic Account)
Per Subject Totals
(Equals A x B x C)
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Occurences per
Subject per
Study Period:
Comments as needed
RESEARCH
COSTS
HOSPITAL
RESEARCH
SERVICES
FORM
CONFIDENTIAL
(For Internal Use
Only)
Budget Work Book
Instructions: To begin the budgeting process for studies involving patient care, please complete the sections highlighted in yellow.
PI Name:
Steve Alexander
IRB Number:
Study Coordinator Name:
Nick Gaich
SPO Number:
Department:
Study Title:
MEDICINE
BREAKTHROUGH
MEDICINE
Study/Account Name (14 character limit)
STEVE BT
SHC or LPCH?
Sponsor Name:
MEDTRONIC
Is this a Medicare
NCD Qualifying
Study?
or
Is
this a (yes
Federal
sponsor?
(yes
or no)will
If
Federal,
subjects be
outpatients?
“CENTRALIZED”
AUDIT CONTROL POINTS
Project Number:
Task Number:
Award Number:
* If federally funded and any services are
provided at LPCH , then the RPM needs to apply
the current DHHS negotiated rates
Service Description
SHC/LPCH Laboratory Testing
BASIC METABOLIC PANEL
CREATININE
Service Code
CPT Code
A
Occurences per
Subject per
Study Period:
1111
2222
Study Period Start Date:
2/1/06
Study Period End Date:
2/1/07
SHC
YES
YES
YES
B
C
Full Price
*Discounted Price
209XXXX
209XXXX
2
2
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Laboratory Testing Subtotal
72.0%
SHC/LPCH Technical Fees & Non-181 Supplies
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Technical Fees & Non-181 Supplies Subtotal
SHC/LPCH MRI's. CT's ECHO's Technical Fees
CT HEAD SCAN
72.0%
409XXXX
1
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
MRI's. CT's ECHO's Technical Fees Subtotal
60.0%
SHC/LPCH Professional Fees
SHC/LPCH Supply Costs with 181 Service Code
Only
IV TUBING
THROCENTESIS TRAY
Per Subject Totals
(Equals A x B x C)
72.0%
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Professional Fees Subtotal
85.0%
181XXXX
181XXXX
2
2
Supply Costs with 181 Service Code Only Subtotal
Other (Services Not Billed through 98/Mnemonic Account)
Other (Services Not Billed through 98/Mnemonic Account) Subtotal
Invoiceable Budget Items (Occasional, not occurring on all subjects)
Variable Budget Items Subtotal
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
The Principal Investigator's signature below
indicates that he/she has reviewed this study
protocol and to the best of his/her knowledge
has identified the routine care vs. research
items required by this protocol. In accordance
with this assessment, the above list includes all
Principal Investigator Signature
STEVE ALEXANDER
Date: __1____/_20______/06_______
RESEARCH COSTS
Key Accomplishment
Centralized “source”
document utilized by
Investigator, Research
Coordinator, Budget
Manager, Billing
Specialist………..
RESEARCH PARTICIPANT SERVICES FORM
CONFIDENTIAL (For Internal Use Only)
Instructions: To begin the budgeting process for studies involving patient care, please complete the sections highlighted in yellow.
PI Name:
IRB Number:
Study Coordinator Name:
SPO Number:
Department:
Study Period Start Date:
Study Title:
Study Period End Date:
Study/Account Name (14 character limit)
SHC or LPCH?
Sponsor Name:
Is this a Medicare NCD Qualifying
Study? (yes or no)
Is this a Federal sponsor?
(yes or no)
If Federal, will subjects be
outpatients? (yes or no)
Project Number:
Task Number:
Award Number:
* If federally funded and any services are provided at LPCH , then the RPM needs to apply the current DHHS negotiated rates
(See S:\Certs - F & A Rates\Stanford DHHS Agreements\Packard
A
Service Description
SHC/LPCH Laboratory Testing
Service Code
SHC/LPCH Technical Fees & Non-181 Supplies
for the life of the study.
SHC/LPCH MRI's. CT's ECHO's Technical Fees
SHC/LPCH Professional Fees
SHC/LPCH Supply Costs with 181 Service Code Only
CPT Code
Occurences per
Subject per
Study Period:
B
C
*Discounted
Full Price
Price
55.0%
Laboratory Testing Subtotal
55.0%
Technical Fees & Non-181 Supplies Subtotal
72.0%
MRI's. CT's ECHO's Technical Fees Subtotal
60.0%
Professional Fees Subtotal
85.0%
Supply Costs with 181 Service Code Only Subtotal
Per Subject Totals
(Equals A x B x C)
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Other (Services Not Billed through 98/Mnemonic Account)
$0.00
1PCWR7140
03/17/07
STANFORD HOSPITAL CLINICAL TRIAL WEEKLY REPORT
PAGE
1
PAGE
2
CLINICAL TRIAL ACCOUNT 98000052 A CLINICAL STUDY, XXXXXXXX
PATIENT:
MEDICAL RECORD #XXXXXXXX
SERVICES FOR POST DATE 03/11/07 THRU 03/17/07
PI OR DESIGNEE ______________________________
DATE __________
PLEASE REVIEW THE STUDY RELATED SERVICES FOR THIS PATIENT ACCORDING TO THE BUDGETED PROTOCOL AND COMPARE
THEM TO THE ROUTINE CARE AND NON-STUDY RELATED SERVICES BILLABLE TO THE PATIENT OR PATIENTS INSURANCE.
CHARGE CORRECTIONS AND DELETIONS CAN BE MADE ON THIS REPORT WITHIN SEVEN (7) DAYS OF THE REPORT DATE. SIGN
AND DATE THE REPORT AND THEN FAX THE ENTIRE REPORT WITH CORRECTIONS NOTED IF APPLICABLE TO JANE SMITH
SHC PFS SPECIAL BILLING TEAM, AT XXXXXXXXXX. QUESTIONS? CONCERNS? PLEASE CALL JANE SMITH AT XXXXXXXXX
1PCWR7140
03/17/07
STANFORD HOSPITAL CLINICAL TRIAL WEEKLY REPORT
CLINICAL TRIAL ACCOUNT 98000052 CLINICAL STUDY, XXXXXXXXX
PATIENT:
MEDICAL RECORD #XXXXXXXXX
SERVICES FOR POST DATE 03/11/07 THRU 03/17/07
CLINICAL TRIAL ACCOUNT 98000052
ACCOUNT
PATIENT
NUMBER
NAME
080098000052
080098000052
080098000052
SERVICE
DATE
01/10/07
03/11/07
03/11/07
POST
DATE
03/12/07
03/12/07
03/13/07
SERVICE
CODE
47200654
41304304
41304304
SERVICE
DESCRIPTION
ABO TYPING
ANKLE MIN 3V
ANKLE MIN 3V
TRIAL
ARM
ACCOUNT
PATIENT
NUMBER
NAME
060005800143
060005799956
060005799956
SERVICE
DATE
01/20/07
03/01/07
03/10/07
CHARGES
POST
DATE
03/13/07
03/12/07
03/12/07
TO BE BILLED TO PATIENT/INSURANCE
SERVICE SERVICE
CODE
DESCRIPTION
59402909 MAGNESIUM SERUM/PL
59300236 CBC/PLAT/AUTO DIFF
59140186 FLU A ANTIGEN
TOTALS
003
TOTALS
CHG
QTY
1
1
1
3
UNDISCNTED
PRICE
67.00
433.00
433.00
933.00
CHG
QTY
1
1
1
3
UNDISCNTED
PRICE
20.00
72.00
84.00
176.00
DISCNT
PERCENT
70.00%
55.00%
55.00%
DISCOUNT NEW CHARGE
AMOUNT
AMOUNT
46.90
20.10
238.15
194.85
238.15
194.85
523.20
409.80
Auditing Process/Controls/Reports
Results:
The system works!
•Independent audits by University Internal
Audit, Hospital Compliance and outside
consultant (Huron) have confirmed accuracy of
automated system.
Errors discovered:
Only $7,200 improperly billed out
of the first $1,800,000 total billed.
And then Along comes Epic……………
22
Avoiding the long and winding road
EPIC Journey
• As part of the RFP selection process we informed
EPIC of the need to accommodate our design
functionality into their application
• Design meetings were held with EPIC to make
custom changes retro to EPIC version v.7 to
mirror current system functionality – exampling
best practice (demonstrated EPIC’s willingness to
partner and support)
• SHC Clinical went live 04/08 on v.7
• SHC Rev Cycle live 09/01 on v.7 though v.8/9
available, owing to need not to impose another
conversion effort so soon on clinical/medical staff
24
EPIC Journey
• SHC unique in terms of outsourcing IT EPIC
application support to Accenture
• SHC unique in terms of outsourcing EPIC
Report Writing to CSC
• Required nearly five months post-go-live to get
reports to PI Coordinators (weekly/monthly) to be
fully correct
• EPIC demonstrated support and engagement in
assisting and providing technical guidance
• Voice of the Customer (PI/Coordinators) needs
were accommodated and met end user satisfaction
25
EPIC Journey – issues
• “Leapfrog Syndrome”
• Known factor that HB (Hospital Billing) and PB
(Pro-Fee Billing) can differ in functionality
• EPIC v.7 more automated for HB and more manual
for PB
• Study end dates had to be monitored manually
and entered
• Report distribution to PI/Coordinators still
hardcopy
26
EPIC Journey
• V.9 allows us to enter start/stop end dates at
participant level (Go Live April 8th, 2010)
• Accounts identified and organized in a more
structured manner now via the Research
Enrollment Record (direct entry into EPIC)
• Research Participant “Flag” identification
capabilities
27
EPIC Journey
• Desired Future Changes v10:
 Automating electronic report distribution
 Creating of system work queues for PI Coordinators to
adjust charges (moving accountability upfront)
 Looking to achieve parity of functionality for hospital billing and
pro fee billing
 Discounts to reflect on reports
 Automatically produce a credit billing statement – today only
debit balance reports produce
 Easier linkage to patient name/MRN when posting charges
and/or charge credits/transfers (currently must key in MRN in
charge description field in order to link a charge description with
corresponding patient name/MRN
 Edits/alerts to prevent duplicate charge entry service codes in
the research file
28
Advocating within EPIC – External Voice
Participating in the Forums
• Financial Advisory Councils (Meets in April)
 HB, PB
•
•
•
•
•
Research Advisory Council
Research Forum
Academic Advisory Council
Executive Forum
UGM (User Group Meeting – Meets in Sept.)
• Organization’s own Business System’s Analyst
and EPIC assigned application Technical
Support (TS) lead
29
Advocating within EPIC – Internal Voice
• Participation in EPIC and User Community Forums
• Strong partnership between Business System
Analysts of HB/PB with their EPIC TS
counterparts
• SHC has, a close foundational relationship with
EPIC when it comes to advocating changes with
EPIC’s programming and development
leadership
• But still the most effective advocacy is likeminded academic medical centers collective
advocacy
30
EPIC Lessons Learned:
• EPIC has demonstrated
• Excellent partnering
• Ability to listen to the voice of the customer
• Skilled staff and subject matter experts
• Quality Code Release
31
Journey continues….. but constant vigilance to
research needs must be keep first of mind……
To succeed in the future, need to network
with other like-minded-academic clients and
advocate/prioritize with a collective voice
32
Informatics
Biostatistics
Hospital Pricing
Budgeting
SPECTRUM
Contracting
Accounts
Receivable