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Yale University Regional Clinical Research Management Workshop February 22, 2010 Stanford's “Epic” Implementation Journey: Integration of Clinical and.

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Presentation on theme: "Yale University Regional Clinical Research Management Workshop February 22, 2010 Stanford's “Epic” Implementation Journey: Integration of Clinical and."— Presentation transcript:

1 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

2 Setting the background…. 2

3  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 “silo- based” 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: “Balcony View in 2005”

4  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 Assessing Stanford’s Clinical Trials Fiscal Environment: Results of Internal Audits:

5  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. Challenges

6 Biostatistics Informatics Budgeting Hospital Pricing Hospital Billing Compliance Contracting Accounts Receivable Stanford Clinical Research Environment in 2005 Well intended but NOT well coordinated

7 BIOSTATISTICS INFORMATICS BUDGETING BILLING CONTRACTING TRAINING & EDUCATION KEY PILLARS IN THE CLINICAL RESEARCH ENTERPRISE AT ACADEMIC HEALTH CENTERS

8  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…. The Solution: Simplified and Automated Clinical Research Budgeting/Billing

9 Is in the

10 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 !!!

11 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

12 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

13 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

14 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

15 15 The Path to Success

16 Billing “Fork in the Road”

17 Utilizing NCD guidelines, services are identified as: Research Related and Routine Care

18 “CENTRALIZED” AUDIT CONTROL POINTS SERVICE CODE SPECIFIC EVENT RELATED ACCOUNTABILITY DRIVEN STANDARDIZED/IMBEDDED DISCOUNT STRUCTURE Budget Work Book

19 Key Accomplishment Centralized “source” document utilized by Investigator, Research Coordinator, Budget Manager, Billing Specialist……….. for the life of the study.

20 1PCWR7140 STANFORD HOSPITAL CLINICAL TRIAL WEEKLY REPORT PAGE 1 03/17/07 CLINICAL TRIAL ACCOUNT 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 STANFORD HOSPITAL CLINICAL TRIAL WEEKLY REPORT PAGE 2 03/17/07 CLINICAL TRIAL ACCOUNT CLINICAL STUDY, XXXXXXXXX PATIENT: MEDICAL RECORD #XXXXXXXXX SERVICES FOR POST DATE 03/11/07 THRU 03/17/07 CLINICAL TRIAL ACCOUNT ACCOUNT PATIENT SERVICE POST SERVICE SERVICE TRIAL CHG UNDISCNTED DISCNT DISCOUNT NEW CHARGE NUMBER NAME DATE DATE CODE DESCRIPTION ARM QTY PRICE PERCENT AMOUNT AMOUNT /10/07 03/12/ ABO TYPING % /11/07 03/12/ ANKLE MIN 3V % /11/07 03/13/ ANKLE MIN 3V % TOTALS CHARGES TO BE BILLED TO PATIENT/INSURANCE ACCOUNT PATIENT SERVICE POST SERVICE SERVICE CHG UNDISCNTED NUMBER NAME DATE DATE CODE DESCRIPTION QTY PRICE /20/07 03/13/ MAGNESIUM SERUM/PL /01/07 03/12/ CBC/PLAT/AUTO DIFF /10/07 03/12/ FLU A ANTIGEN TOTALS

21 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.

22 And then Along comes Epic…………… 22

23 Avoiding the long and winding road

24 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

25 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

26 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

27 EPIC Journey V.9 allows us to enter start/stop end dates at participant level (Go Live April 8 th, 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

28 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

29 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

30 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 like- minded academic medical centers collective advocacy 30

31 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

32 32 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

33 Biostatistics Informatics Budgeting Hospital Pricing Hospital Billing Compliance Contracting Accounts Receivable SPECTRUM


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