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Setting the background….

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….

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Setting the background….

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  1. Yale UniversityRegional Clinical Research Management WorkshopFebruary 22, 2010Stanford's “Epic” Implementation Journey:Integration of Clinical and Research requirementsConcept to RealityNick GaichExecutive Director and Chief Operating Officer , Spectrum

  2. Setting the background….

  3. 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 “silo- based” operations • General lack of system wide business discipline and synchronization with respect to clinical research billing and budgeting activities

  4. 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

  5. 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.

  6. Biostatistics Stanford Clinical Research Environment in 2005 Well intended but NOT well coordinated Hospital Pricing Informatics Budgeting HospitalBilling AccountsReceivable Compliance Contracting

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

  8. 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….

  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

  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)

  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

  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

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

  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 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 STANFORD HOSPITAL CLINICAL TRIAL WEEKLY REPORT PAGE 2 03/17/07 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 SERVICE POST SERVICE SERVICE TRIAL CHG UNDISCNTED DISCNT DISCOUNT NEW CHARGE NUMBER NAME DATE DATE CODE DESCRIPTION ARM QTY PRICE PERCENT AMOUNT AMOUNT 080098000052 01/10/07 03/12/07 47200654 ABO TYPING 1 67.00 70.00% 46.90 20.10 080098000052 03/11/07 03/12/07 41304304 ANKLE MIN 3V 1 433.00 55.00% 238.15 194.85 080098000052 03/11/07 03/13/07 41304304 ANKLE MIN 3V 003 1 433.00 55.00% 238.15 194.85 TOTALS 3 933.00 523.20 409.80 CHARGES TO BE BILLED TO PATIENT/INSURANCE ACCOUNT PATIENT SERVICE POST SERVICE SERVICE CHG UNDISCNTED NUMBER NAME DATE DATE CODE DESCRIPTION QTY PRICE 060005800143 01/20/07 03/13/07 59402909 MAGNESIUM SERUM/PL 1 20.00 060005799956 03/01/07 03/12/07 59300236 CBC/PLAT/AUTO DIFF 1 72.00 060005799956 03/10/07 03/12/07 59140186 FLU A ANTIGEN 1 84.00 TOTALS 3 176.00

  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……………

  23. Avoiding the long and winding road

  24. EPIC Journey • As part of the RFP selection process we informed EPICof 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

  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

  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

  27. 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

  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

  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

  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

  31. EPIC Lessons Learned: • EPIChas demonstrated • Excellent partnering • Ability to listen to the voice of the customer • Skilled staff and subject matter experts • Quality Code Release

  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 HospitalPricing Budgeting SPECTRUM AccountsReceivable Compliance HospitalBilling Contracting

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