Starting an ECMO Program Bob Dyga RN, CCP, LP VP, Perfusion Operations UPMC / 2015 ASAIO Journal Extracorporeal Membrane Oxygenation Use has Increased by 433% in Adults in the United States from 2006 to 2011 Christopher M. Saur, David D. Yuh, and Pramod Bonde Purpose: Analyze recent usage in adults, survival rates, and hospitalization rates from 2006 to 2011 and identify trends in the United States Source: Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project Results: Rate Survival Cost 2 1
Seminars in Thoracic and Cardiovascular Surgery Author s Accepted Manuscript Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012 Fenton H. McCarthy, MD, Katherine M. McDermott, BS, Vinay Kini, MD, Jacob T. Gutsche, MD, Joyce W. Wald, DO, Dawei Xie, PhD, Wilson Y. Szeto, MD, Christian A. Bermudez, MD, Pavan Atluri, MD, Michael A. Acker, MD, Nimesh D. Desai, MD, PhD 3 Trending ECMO Statistics 4 2
2015 ASAIO Journal Extracorporeal Life Support: Experience with 2,000 Patients Brian W. Gray, Jonathan W. Haft, Jennifer C. Hirsch, Gail M. Annich, Ronald B. Hirschl, and Robert H. Bartlett Methods: Review of 2,000 patients treated with ECLS at University of Michigan from 1973 to 2010 Survival Rates: 1. 74% weaned from ECLS and 64% survived to hospital discharge 2. For respiratory failure, the survival rates were 84% for neonate, 76% for children and 50% for adults 3. For cardiac failure, the survival rates were 45% for children and 38% for adults 4. For ECPR, the survival rates were 41% Future: 1. Use of next generation ECMO devices, ECMO2; safer, simpler, automatic, less anticoagulant 2. ECLS can be managed by ICU nursing staff instead of ECMO specialist 3. Reduced cost and ease of use 5 Trending ECMO Statistics 6 3
Trending ECMO Statistics ELSO International Reporting Centers Outcome Results - Effective January 2016 7 Six Steps in Setting Up an ECMO Program 1 2 3 4 5 6 Planning Development Implementation Sustaining Evaluation Moving Forward Steering group Needs assessment Strategic plan Setting expectations Assembling the team support ü Clinical ü Technical ü Diagnostic ü Space Education Training Assessment The first patient Maintaining skills Reassessment Continuing education Data collection Quality improvement ü Data reporting ü Clinical reviews ü Outcomes Research Innovation Collaboration Strategic planning Source: Guerguerian A. et al.; Pediatric Critical Care Medicine; June 2013-14; S84-S93 8 4
Step 1 Planning Steering Group Clinical and administrative leaders A. Scoping out the landscape B. Setting achievable and realistic goals C. Successful and efficient implementation Needs Assessment What do we need? A. Unmet and future projections B. Scope and role at hospital and community C. Volume expectations D. Support from other groups Strategic Plan SWOT Analysis A. Layout action steps B. Business plan and budget 9 Step 1 Planning (continued) Phase Endpoints ü Defined scope of service ü Written plan ü Financial and clinical goals and objectives ü Targets quality plan ü Timeline ü Benchmarks ü Define quarterly expectations ü Data management ü ECMO database - PeriApp ü Join ELSO Center of Excellence 10 5
Step 2 Development Organizational Identify Existing Services (perfusion, cardiac surgery, hemodialysis, plasmapheresis, continuous renal replacement, VADs, and CO2 removal) ECMO Team Key Members A. Medical director, coordinator, nurses, respiratory therapist, perfusionists, physical and occupational therapy, nutrition B. ECMO training with ELSO guidelines and simulation C. Physician team capable of meeting all needs D. ECMO coordinator E. ECMO specialist F. Data support Cardiac Backup Define Plan 11 Step 2 Development (continued) Finalize Budget to Establish ECMO Program A. Direct Equipment / Supplies / Drugs Personnel Purchased services Other B. Indirect Utilities / Insurance / Taxes Ancillary Services Other C. Fixed Administration Facility Space Usage Utilities / Depreciation Other 12 6
Equipment Console & Motor Step 2 Development (continued) Thoratec CentriMag Blood Pump $12,000 Tubing Pack with Quadrox-D Cost per circuit Perfusion Equipment and Supplies Maquet CardioHelp Maquet ROTAFLOW (ICU Package) Sorin Revolution $43,360 $126,000 $56,000 $71,000 $13,781 $447 $2,000 $2,000 $14,000 $13,781 $2,447 $2,200 Manufacturers list prices as of December 2015 $200 $2,000 Step 2 Development (continued) ELSO ECMO Center Staff Guidelines Source: University of Michigan website 7
Step 2 Development (continued) Cost of Bedside Coverage Costs OPTION 1 Perfusionist OPTION 2 RN, RT, PA + Perfusion Q 2 hrs. OPTION 3 RN, RT, PA + Perfusion off-site OPTION 4 Solo RN, RT, PA Salary $93,600 $72,800 $72,800 $72,800 Benefits 21% $18,700 $15,300 $15,300 $15,300 Extra Call N/A N/A $4,000 N/A Overhead 11% $11,300 $9,700 $9,700 $9,700 Training N/A $1,000 $1,000 $1,000 TOTAL $123,600 $98,800 $102,800 $98,800 Difference + 25% Low +4% Low 15 Step 2 Development (continued) Technical back-up, storage, and space A. Equipment, safety, and monitoring B. Facility considerations Non-ICU Support Services A. Diagnostic and laboratory support services B. Technology support C. Clinical support services, short and long-term 16 8
Step 2 Development (continued) Pennsylvania Perfusion License Requirements 1. Perfusionist with ABCP Certification and PA license 2. Licensed caregiver including RN, RRT, and PA with ELSO training ELSO training requires 24-36 hours of course work with wet lab and 36 hours of clinical mentoring for busy centers As above, plus animal/wet lab work Written and clinical exams 18 states have licensure 17 Step 2 Development (continued) ECMO Staged Coverage Criteria Class 1 First eight hours requires PA licensed perfusionist bedside until patient is Class 2. Class 2 - Requires frequent interventions. Perfusionist in house 24/7 and within five minutes of bedside. Class 3 Stable with minimal intervention. No perfusionist required. 9
Step 2 Development (continued) ECMO Costs All Inclusive for 75 Procedures Costs Year 1 Year 2+ Equipment (1) $340,000 $30,000 Supplies (2) $990,000 $990,000 Personnel (3) $1,450,000 $1,450,000 Training $30,000 $30,000 ELSO $10,000 $10,000 Continuing Ed. $5,000 $5,000 TOTAL $2,825,000 $2,515,000 (1) 6-Centrimag, 3-Cardiohelp (2) Centrimag -65%, CardioHelp -35% (3) Perfusionist - 18,000 hours X $48/hour + benefits + overhead Step 2 Development (continued) Comparing ECMO Service Models (Source: Technology Insights, Advisory Board, 2010) 20 Type of Model Characteristics Advantages Disadvantages Consolidated ECMO Service Model Separated ECMO Service Model A single ECMO Team initiates ECMO for all patients Physicians and supporting staff have a home in one ICU but are able to perform ECMO for all populations Each ICU (adult, pediatrics, and neonate) has its own medical director There is little or no cross-over of respiratory therapists or other support staff ECMO volumes are typically low, giving limited learning time for individuals A consolidated model concentrates limited ECMO experience among select individuals, giving them optimal training Equipment can be housed and maintained by a single group Greater consideration can be given to the clinical factors specific to a patient s condition (i.e. physiology, diagnosis) ICU beds are only in use when there is a patient on ECMO, providing optimal utilization of scarce ICU beds While the transition between adults and pediatric patients is simple, neonates can present challenges for those unfamiliar with their physiology Limited staff require that they are spread thin when there are multiple ECMO circuits available, possibly leading to exhaustion Physicians from different ICUs can recommend ECMO more subjectively, causing confusion among staff The increasing number of adult ECMO patients is more difficult to accommodate, as the adult ICU staff would not be prepared to handle these patients 10
Step 3 Implementation Education and training A. Current knowledge level B. Use of simulation for training, evaluation, and critical event management C. Completion of credentialing requirements and knowledge of P&P, equipment, supplies, and personnel Care models A. Internal training highly variable B. Responsibility of the medical director and the coordinator C. Creation of site-specific training program 21 Step 3 Implementation (continued) Current training and competency recommendations A. ELSO Guidelines for Training and Education and Guidelines for ECMO Centers B. ELSO Red Book C. Local ECMO training programs D. Wet lab, animal lab, Simulation Center E. ELSO survey results from SIM Centers - 71% competency, 77% safety, 82% ECLS skills F. Assessment of competencies 1. Theoretical and practical 2. Cognitive, technical and behavioral G. The first patient case 22 11
Step 4 Sustaining the Program Clinical demand and patient population A. Volume data trends B. Outcomes data C. Professional opportunities for staff Maintaining skills A. Train the trainer program B. Bi-weekly ECMO simulation sessions C. Annual ECMO seminar and training course D. Annual written and clinical competency 23 Step 4 Sustaining the Program (continued) ELSO International Outcome Results Effective January 2016 24 12
Step 4 Sustaining the Program (continued) ELSO International Results - Reported December 14, 2015 485 1,497 ELSO Respiratory AVG Hours = 288 60% to Discharge UPMC Respiratory AVG Hours = 218 62% to Discharge 281 1,191 ELSO Cardiac AVG Hours = 158 57% to Discharge UPMC Cardiac AVG Hours = 112 47% to Discharge 25 Step 4 Sustaining the Program (continued) ECMO Education Opportunities ü Monthly SIM sessions ü Annual CE ECMO program ü Offer internal and external adult training sessions ü Monthly ECMO M&M sessions ü ELSO Center of Excellence ü Invite expert guest lecturers ü Publish experiences ü Quality program ü Start your own training courses 26 13
Step 4 Sustaining the Program (continued) Offer ECMO Training Programs PROCIRCA Comprehensive Adult ECMO Training Course PROCIRCA Boot Camp Adult ECMO Training Course 27 Step 5 Evaluation Data collection A. Internal IRB quality project B. Dedicated data manager C. Demographics, indications, cannulation, complications, mechanical failures, organ failure, and outcomes D. Internal monitoring of care guidelines, transfusion rate, anticoagulation, time to initiate treatment, and transport Quality improvement review Monthly and quarterly Outcomes A. Survival to decannulation and discharge to home B. Six to12 month survival 28 14
Project Aim Statement Procirca hypothesized that by changing our guidelines and using Centrimag as the primary pump, the change-out rates would decrease resulting in lower costs and increased safety for our ECMO patients. PROCIRCA was using four different ECMO pumps including: Biomedicus Revolution CardioHelp Centrimag 29 Procirca Findings Data was collected on pump use and change-out rates. Results demonstrated Centrimag performed better with lower change-out rates. Average No. Days Before Change-out 10.8 10.6 10.11 Rate of System Change-outs (Initial Device Only) 2014 2013 80% 83% 61% 66% 1 1.3 43% 15% Cardiohelp Centrimag Biomedicus 15
Procirca compared two pumps for further analysis Cardiohelp is the complete circuit High disposable cost High maintenance cost Unable to change-out components Centrimag is just the pump Rarely fails one pump failure in past two years Can change the oxygenator as a component rather than the whole system 31 Cost comparison of the two pumps: Cardiohelp : $7,500 each $15,000 After one change out.. Centrimag : $8,500 Quadrox Oxygenator: $1,100 You can change oxygenator four times $14,000 32 16
Results provided standardization of the ECMO system ü Disposable cost per patient dropped 23% Q1 ü No reported events ü Fewer interventions on ECMO ü Simplicity and routine improved for CCPs ü Improved nursing acceptance ü Improved safety for our patients 33 60% Resulting Change-out Rates 50% 40% 30% Longer support periods with expected oxygenator changes 20% 10% 0% FY14Q3 FY14Q4 FY15Q1 FY15Q2 FY15Q3 FY15Q4 34 17
Strategic planning meeting A. Review non-clinical aspects and set short, medium, and long-term goals B. Some common areas to consider new indications, clinical techniques, and new services that require funding C. Include other departments such as finance, blood bank Financial endpoints A. Procedure volume B. Type of insurance C. Reimbursement per case D. Budget adjustments 35 Five Key Financial Questions 1. What was the total number of patients referred for or admitted because of ECMO? 2. How many patients were turned away and why? 3. How many of these patients were treated with ECMO? 4. For those admitted, what was the total hospital bill per patient? 5. What was the reimbursement for each patient? Source: Annich,GM et. Al., ECMO in Critical Care, 4 th Ed., p.506 18
How does ECMO reimbursement work? Hospital reimbursement A. DRG Commonly coded 003 Transplant DRGs / Other DRGs LOS Cost outliers Discharge disposition Payer Mix Physician reimbursement CPT Code Reimbursement Pearls ü Maximize reimbursement 1. Identify ECMO procedure from the start 2. Dedicated team that understands correct coding guidelines 3. Understanding of carrier-specific agreement and policies 4. Including Medicare and Medicaid 5. Observe (prior) authorization process and referral guidelines 6. Observe case and disease management protocols by carrier 7. Documentation must be appropriate for quality control 8. Submit electronically ASAP 19
ECMO Professional Fees CPT Code Description Charge Reimbursement 36822 Cannulation $1,445 $390 33960 First 24 hours $3,946 $1,003 33961 Subsequent 24 hours $2,139 $554 99291 Critical care first hour $829 $264 99292 Critical care per hour $410 $118 Average $50,000 X 26% = $13,000 DRG Mix and Payer Mix Five Year Review FY11 FY12 FY13 FY14 FY15 DRG Mix (%) ECMO 81% 88% 81% 86% Transplant 9% 9% 10% 9% Other 10% 10% 10% 5% Payor Mix Medicare / Medicare 23% 41% 35% 27% Managed Medicaid / Medicaid 16% 13% 16% 18% Managed Commercial / Other 61% 46% 49% 55% 40 20
ECMO Five Year Financial Review FY11 FY12 FY13 FY14 FY15 Patients 81 68 72 100 ECMO Hours 11,111 12,612 10,120 24,258 Avg. Direct Cost 102,116 135,212 147,435 130,023 Avg. Contribution Margin* 123,989 169,019 123,206 279,969 ALOS 25.7 33.9 36.8 38.1 Avg. Billed Hours 136 191 141 243 Avg. Days on ECMO 5.7 4.9 4.3 10.3 *Variance in contribution margin is due to payor mix 41 Estimated Annual Costs and Reimbursement Fiscal Year 2015 FY15 Summary Total Payments $40,999,220* Total Direct Costs $13,002,300 Total Contribution Amount $27,996,920 Avg. Payment $409,992 Avg. Direct Cost $130,023 Avg. Contribution Margin $279,969** *Represents patient accounts that are fully resolved **Favorable contribution margin is due to variances in payer mix 21
ü Avoid common submission errors 1. Incomplete claim forms 2. Lack of adherence to (prior) authorization process and referral guidelines 3. Coding errors based on documentation ü Maximize outliers that improve reimbursement 1. Co-morbidities 2. LOS 3. Higher cost to provide Six Steps in Setting Up an ECMO Program 1 2 3 4 5 6 Planning Development Implementation Sustaining Evaluation Moving Forward Steering group Needs assessment Strategic plan Setting expectations Assembling the team support ü Clinical ü Technical ü Diagnostic ü Space Education Training Assessment The first patient Maintaining skills Reassessment Continuing education Data collection Quality improvement ü Data reporting ü Clinical reviews ü Outcomes Research Innovation Collaboration Strategic planning Source: Guerguerian A. et al.; Pediatric Critical Care Medicine; June 2013-14; S84-S93 44 22
Step Six Moving Forward ü Transport program ü Comprehensive and inclusive database ü Maintain ELSO membership ü Regular quality and clinical practice reviews ü Monthly M&M meeting, case reviews ü Participate in ELSO reviews ü Publish your data Key Elements for Successful ECMO Program Advancement 45 Step Six Moving Forward (continued) Monday Morning Ideas ü Involve finance team from start to finish ü Simplify and standardized ECMO system ü Consolidate service delivery ü Change staffing model ü Regional referral centers ü Simulation training ü Comprehensive data management ü ECMO M&M meeting ü Start transport team 46 23
Thank You Bob Dyga RN, CCP, LP dygarm@upmc.edu 412.352.0781 47 24