Starting an ECMO Program
Bob Dyga RN, CCP, LP VP, Perfusion Operations UPMC /
2015 ASAIO Journal
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
Extracorporeal Membrane Oxygenation Use has Increased by 433% in Adults in the United States from 2006 to 2011
Seminars in Thoracic and Cardiovascular Surgery
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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
Trending ECMO Statistics
2015 ASAIO Journal
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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
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
Trending ECMO Statistics
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ELSO International Reporting Centers Outcome Results - Effective January 2016
Six Steps in Setting Up an ECMO Program
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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 • Strategic planning • Research • Innovation • Collaboration 1 2 3 4 5 6
• 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
Step 1 – Planning
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• 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
• 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
Step 2 – Development
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• 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
Step 2 – Development (continued)
Step 2 – Development (continued)
Equipment
Thoratec CentriMag® Maquet CardioHelp® Maquet ROTAFLOW® (ICU Package) Sorin Revolution® Console & Motor $43,360 $126,000 $56,000 $71,000 Blood Pump $12,000 $13,781 $447 Tubing Pack with Quadrox-D $2,000 $2,000 Cost per circuit $14,000 $13,781 $2,447 $2,200 Manufacturers’ list prices as of December 2015$2,000 $200
Perfusion Equipment and Supplies
Step 2 – Development (continued)
Source: University of Michigan website
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
Step 2 – Development (continued)
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Cost of Bedside Coverage
• 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
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
Step 2 – Development (continued)
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18 states have licensure
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.
Step 2 – Development (continued)
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
ECMO Costs All Inclusive for 75 Procedures
Type of Model Characteristics Advantages Disadvantages
Consolidated 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
• 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
• 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
Separated ECMO Service Model
• 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
• 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
• 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
Step 2 – Development (continued)
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Comparing ECMO Service Models (Source: Technology Insights, Advisory Board, 2010)
• 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
Step 3 – Implementation
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• 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
• 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
Step 4 – Sustaining the Program
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Step 4 – Sustaining the Program (continued)
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Step 4 – Sustaining the Program (continued)
25 ELSO Respiratory AVG Hours = 288 60% to Discharge ELSO Cardiac AVG Hours = 158 57% to Discharge UPMC Respiratory AVG Hours = 218 62% to Discharge UPMC Cardiac AVG Hours = 112 47% to Discharge 485 1,497 281 1,191ELSO International Results - Reported December 14, 2015
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
Step 4 – Sustaining the Program (continued)
Step 4 – Sustaining the Program (continued)
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Offer ECMO Training Programs
PROCIRCA Comprehensive Adult ECMO Training Course PROCIRCA Boot Camp Adult ECMO Training Course
• 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
Step 5 – Evaluation
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:
Step 5 – Evaluation (continued)
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Biomedicus Revolution CardioHelp Centrimag
Step 5 – Evaluation (continued)
1 1.3
10.8 10.6 10.11 Average No. Days Before Change-out
Cardiohelp Centrimag Biomedicus
61% 15% 80% 43% 66% 83%
Rate of System Change-outs (Initial Device Only)
2014 2013
Procirca Findings
Data was collected on pump use and change-out rates. Results
demonstrated Centrimag® performed better with lower change-out
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
Step 5 – Evaluation (continued)
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Cost comparison of the two
pumps
:
Cardiohelp® : $7,500 each
After one change out…..
Centrimag® : $8,500
Quadrox Oxygenator: $1,100
You can change oxygenator four times
Step 5 – Evaluation (continued)
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$14,000
$15,000
• 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
Step 5 – Evaluation (continued)
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Step 5 – Evaluation (continued)
0% 10% 20% 30% 40% 50% 60%
FY14Q3 FY14Q4 FY15Q1 FY15Q2 FY15Q3 FY15Q4
Resulting Change-out Rates
Longer support periods with expected oxygenator changes
• 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
Step 5 – Evaluation (continued)
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Step 5 – Evaluation (continued)
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, 4th Ed., p.506
Five Key Financial Questions
Step 5 – Evaluation (continued)
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
Step 5 – Evaluation (continued)
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
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
ECMO Professional Fees
Step 5 – Evaluation (continued)
Step 5 – Evaluation (continued)
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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 Managed 23% 41% 35% 27% Medicaid / Medicaid Managed 16% 13% 16% 18% Commercial / Other 61% 46% 49% 55%
Step 5 – Evaluation (continued)
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ECMO Five Year Financial Review
FY11 FY12 FY13 FY14 FY15Patients 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
Step 5 – Evaluation (continued)
*Represents patient accounts that are fully resolved
**Favorable contribution margin is due to variances in payer mix
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**
Step 5 – Evaluation (continued)
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
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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 • Strategic planning • Research • Innovation • Collaboration 1 2 3 4 5 6
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
Step Six Moving Forward
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