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