Accurate Cost Projections for CT Scans in Clinical Trials
This study conducted by Emory University aims to address budget shortfalls in clinical trials by improving cost projections for CT scans. The team members in the Office for Clinical Research play key roles in budget development and negotiation. The lack of standardized processes for determining procedure costs and verifying budget adequacy are key concerns addressed in this research focusing on CT scans of the head, neck, chest, abdomen, and pelvis. By analyzing charges for specific CT scans, the study seeks to enhance financial projections for clinical trials.
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REDUCING BUDGET SHORTFALLS IN CLINICAL TRIALS: ACCURATE COST PROJECTIONS FOR CT SCANS Bonita Feinstein & Carolyn Stefanski EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH 1
TEAM MEMBERS Name Role Robin Ginn, RN, MBA, CHC, CHRC, CIP Executive Director, Office for Clinical Research Pamela Terry, RN, MBA, CHRC Associate Executive Director, Pre-Award, OCR B. Feinstein, C. Stefanski, C. Cogan, H. Howlett- Smith, S. Mountcastle, J. Robinson, S. Smith, K. Storey, D. Stout Lead CRFMs, OCR (budget development) Associate Director, Clinical Research Accounts, OCR (Invoicing data source) Michelle Robinson, MBA Manager, Clinical Trials Billing Dept, EHC (post- award billing review - data source) Tiffani Pierce, MBA Patricia Ochuko, MPH Coach, Project Manager, EHI Office of Quality EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
BACKGROUND Office for Clinical Research, Pre-Award division - responsible for budget development & negotiation for all University clinical trials Research charges are set by EHI Contracting office based on EUH Chargemaster Research Fee schedule is revised twice yearly for FY and Medicare changes OCR Lead Finance Managers act independently in using the research fee schedules and clinical knowledge to develop budgets for all university clinical trials. Leads negotiate budget with many industry sponsors all different ideas of what is FMV EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
BACKGROUND CONT. Concern 1: No standardized process exists for determining costs for procedures with multiple CPT codes/components or ancillary costs Concern 2: No feedback loop exists for verifying adequacy of clinical trials budgets EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
BACKGROUND CONT. Decided to limit investigation to charges for CT scans of the head, neck, chest, abdomen, and pelvis performed by the Emory Department of Radiology as part of an industry funded clinical trial conducted FY15 to present (studies opened 9/1/2014 3/1/2016) 70470 CT head/brain w/o & w/dye 70460 CT head/brain w/dye 70492 CT neck w/o & w/ dye 70491 CT neck w/ dye 71270 CT thorax w/o & w/dye 71260 CT thorax w/dye 74170 CT abdomen w/o & w/dye 74160 CT abdomen w/dye 74178 CT abd&pelv 1+ section/regns 74177 CT abdomen&pelvis w/contrast 72194 CT pelvis w/o & w/dye 72193 CT pelvis w/dye EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
BACKGROUND CONT. Fee schedule at left provides basic costs; EUH clinic bills below show multiple costs associated with CT scans. EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
CURRENT (BASELINE) CONDITIONS Development of budgets for clinical trials and assignment of charges to grant account Research charges provided Research budget development Budget negotiation, contract execution Study enrollment, patient treated, charges incurred Step Contract execution Bill review Invoicing Sponsor payment Issue research fee schedules Technical +professional Stephanie Carson, Asst Dir, EHI Contracting % of EUH Chargemaster Cycle time = twice yearly (January & Sept) Negotiate Budget with Industry sponsor Develop Budget Lead CRFM (n=9) Cycle time = 2 weeks Cycle time = 1-2 months Budget entered in ERMS for visit tracking CTA executed OSP Senior Analyst Cycle time = 2 months EUH Bills (technical) 1. Patients enrolled 2. Patient treated on study 3. Charges incurred 4. Visits trackedin ERMS 5. Charges pulled from EHC billing Study Team (PI, study coordinators) TEC Bills (professional) Cycle time = 2-5 years Post Award (CTDB - Clinical Trials Billing Department) Bills adjudicated "within 30 days" Cycle time = 12-24 months Charges sent to pt. insurance vs. grant or sponsor Invoicing Team Cycle time = quarterly (q3 months) Money deposited in grant account CRO or Sponsor Cycle = 45 days EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
CURRENT (BASELINE) CONDITIONS FOCUS: Pre-award budget development Nine different Lead CRFMs prepare CT budgets All operate independently and autonomously There is no standardized process for cost calculations for CT scans in clinical trial budgets negotiated by the Pre- Award group in the Office for Clinical Research. EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
AIM STATEMENT Aim Statement: Accurate Cost Projections for CT Scans Implement a standardized process that will simplify the budgeting of CT scans Reduce variability Improve the ability of OCR Pre-Award to accurately project costs Prospective budgets will cover charges for CT scans and all ancillary charges in industry-funded clinical trials for the duration of the study. EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
GOAL Our Goal: Reduce Budget Shortfalls in Clinical Trials 100% compliance with the process for budget development by all CRFMs by September 1, 2016. Benefit: Clinical Trial budgets willcover actual costs of CT scans, thus reducing or eliminating deficits during future conduct of research studies. EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Methods Technology People Bills incorrectly sent to grant rather than insurance, or vise versa Variation in clinical or coding knowledge Research Fee schedule errors Costs not anticipated realistically, lack of clinical knowledge No standardized process for costing No feedback loop w/ billing info Data cumbersome, multiple steps to obtain Individual autonomy (in budget development) There is no way to know if clinical trial budgets have sufficient amount budgeted to cover cost of CT scans Variation in execution of scans Insufficient sponsor funding, tight budget Supplies/ancillary costs unknown Unknown patient variables i.e. weight, renal function, disease Different contrast Delays in study opening; interim charge increases products and delivery methods Study goes on too long, costs increase Materials Measurement Environment EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Data collection: multi-step process Data requested from IT: 1)ERMS (Emory Research Tracking System): System used to track patient visits, triggers patient bills to be held for bill review by post-award Data requested from Invoicing division of OCR: 2)Hospital billing system (technical component) 3)Clinic billing system (professional component) EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS TALLY SHEET ERMS Data: Patient tracking. Visits 'kept' indicate grant charges incurred. Total number of individual scan records Number of encounters* reported (visits kept in ERMS) Number of encounters* added after bill review (visit not kept in ERMS) Total number of encounters* *Encounter = single patient, single date of service, 1 or more scans 404 163 23 186 C C/A Chest/abd A/P Misc C/A/P Chest/abd/pel N/C/A/P Neck/chest/abd/pel Chest alone Abdomen/pelvis Head/brain, other 110 23 22 18 7 6 After hospital and clinic bill review . . . . Number of encounters missing hospital portion of bill Number of encounters missing clinic portion of bill Number of encounters with other error (no billing data at all; costs grossly incorrect; wrong scans done; duplicate entries; otherwise unusable data) 9 5% 12% 23 110 59% Total number of events with usable data 44 24% C C/A Chest/abd A/P Misc C/A/P Chest/abd/pel N/C/A/P Neck/chest/abd/pel Chest alone Abdomen/pelvis Head/brain, other 22 1 5 14 2 EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Use your improvement tools (one slide per tool) Fishbone Tally sheets Pareto chart Value stream map EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Projected costs (budgeted) vs. actual cost $9,000 $8,000 $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 $1,000 $0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Actual (charge) Projected (budget) EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Data actually showed SURPLUS rather than deficit in CT scan budgets. MIN 5% MAX 171% MED 48% MEAN 57% EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROBLEM ANALYSIS Use your improvement tools (one slide per tool) Fishbone Tally sheets Pareto chart Value stream map EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PLANNED TEST OF CHANGE EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
MOBILIZING COMMITMENT Proposal: Each Lead will be provided a CT scan Cost Calculator Tool to be used to provide standardized minimal costs to be budgeted for each type of scan to ensure charges are covered. What is your level of willingness to try this tool? Please mention your concerns as well as any positive thoughts. Monderately Moderately Supportive Supportive Strongly Strongly Neutral Against Against Key Stakeholder (name, role) Issues/Concerns "Wins" Influence Strategy Keep informed, ask for help as needed Lead 1 - CC X Takes extra time Might be easier No personal responsibility to cover costs (automated) Education, demonstrate ease of use Lead 2 - DS X More paperwork Don't have any use for this Assures cost of scans is covered Lead 3 - SS X Focus on evidence Keep informed, ask for help as needed Lead 4 - SM X none Easier, faster Wouldn't feel assured costs are covered without detail Lead 5 - JMR X Quick results Focus on evidence Assures cost of scans is covered Education, demonstrate ease of use Lead 6 - HHS X It's an extra step Already have a method that works Could potentially be faster Keep informed, ask for help as needed Lead 7 - KS X EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
METRICS/RESULTS Indicate what metric(s) you are following Show an annotated run chart of your data EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
FOLLOW UP/NEXT STEPS EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
PROJECT SCORING Category Points available Criteria Aim statement 2 How much, by when, on whom = 2, Two of these = 1 Metrics 2 Annotated data on run chart = 1 Use of >1 PI tools (flow, fishbone, etc.)= 1 Tests of change 2 One TOC = 1 > 1 TOC = 2 Reliability 2 Use of Reliability Design Strategy = 1 Use of human factors in design to achieve >95% reliability = 1 Effective use of tools 2 Used A3 format correctly = 1 Use of quantitative data to drive TOCs = 1 EMORY UNIVERSITY OFFICE FOR CLINICAL RESEARCH
