XVIVO Perfusion Slide Deck Outline
ICD-10-CM PCS Coordination and Maintenance Committee

Slide 1:
A New ICD-10-PCS Code For Donor Organ Perfusion

Presented by:  Edward Cantu, MD
Assistant Professor of Surgery
Surgical Director Lung Transplant Program
University of Pennsylvania

Presented to: ICD-10-CM/PCS Coordination and Maintenance Committee Meeting
Centers for Medicare & Medicaid Services

March 18, 2015

Slide 2:
Donor Lung Perfusion Coalition

Joel Cooper, MD, FACS, FRCS 
Professor of Surgery 
University of Pennsylvania

Duane Davis, MD, MBA
Professor of Surgery, Director of Transplant Services
Duke University

Bart Griffith, MD
Thomas E and Alice Marie Hales Distinguished Professorship in Transplant Surgery
The University of Maryland 

Pablo Sanchez, MD 
Assistant Professor of Surgery
The University of Maryland

Chris Wigfield, MD
Assistant Professor of Surgery, Surgical Director Lung Transplant Program
The University of Chicago

Frank D’Ovidio, MD, Ph.D
Associate Professor of Surgery, Surgical Director Lung Transplant Program
Columbia University 

Thomas Beaver, MD, MPH
Professor and Chief, Endowed Chair, Division of Thoracic and Cardiovascular Surgery
The University of Florida

Christian Bermudez, MD, Ph.D
Chief Division of Cardiothoracic Transplantation
UPMC

Edward Cantu, MD
Assistant Professor of Surgery, Surgical Director Lung Transplant Program
The University of Pennsylvania

Slide 3:

Agenda
• Coding Issue: There is no procedure code for donor organ perfusion-No ICD-9 CM or ICD-10 PCS code
• The Challenge for Organ Transplants Supply / Demand: Not enough viable donor organs 
• Introduction to XVIVO Perfusion System (XPS)
• Lung Transplants
• How the  XPS system transforms marginal lungs into viable donor lungs
• Future applications for XVIVO Organ Perfusion
• Rationale for new ICD-10-PCS Code
• ICD-10-PCS Request
• Questions & Answers

Slide 4:

Coding Issue 

– The perfusion and assessment of donor organs is currently not captured in ICD-9-CM or ICD-10-PCS
– Organ Perfusion is not typically part of Organ Procurement Process
– Organ Perfusion is not part of the “back bench” work

Slide 5:

New Technology Add On Payment

– Currently XVIVO Too New for NTAP
– NTAP will be applied for in  Q4 2015 (for implementation in FY 2017) when hospital data emerges

Slide 6:

Timing for New ICD-10-PCS Code

XVIVO Perfusion with STEEN Solution™ is a brand new technology with FDA HDE approval in August, 2014  

Revolutionary procedure that holds the promise of transforming unacceptable excised donor organs which currently have to be discarded into viable donor organs 

We request consideration for the new procedure code to be available in October 2015 or as soon thereafter as possible

Slide 7:

Lung Transplant Challenges and Statistics

Slide 8:

• More than 2,200 patients waiting for lung transplants 1
• Candidates age 65+ are fastest growing population for lung transplants 1
• High waiting list mortality: 20-25% 2
• Low utilization of lungs: Only 15-20% of lungs offered used2
• Poor organ function and/or no recipient found (80% non-recovery) 2
• Donor lungs are frequently damaged2

1 2011 SRTR & OPTN Annual Report
 2 ISHLT: The International Society for Heart & Lung Transplantation. https://www.ishlt.org/registries/quarterlyDataReportResults.asp?organ=LU&rptType=all&continent=4
Quarterly Data Report.  Last Updated 1/9/2015.  Accessed 2/5/2015. 
3 OPTN: Organ Procurement and Transplantation Network. Data. https://optn.transplant.hrsa.gov/converge/latestdata/rptData.asp Last Updated 1/30/2015. Accessed 2/5/2015

Slide 9:

Leading Causes of Non-recovery

This slide demonstrates the leading causes of non-recovery of consented lungs between 2007 and 2011.
The causes are cardiac arrest, organ unsatisfactory, poor organ function, donor medical/social history, biopsy findings, positive Hepatitis, HIV, HTLV-1, no recipient found or other.  Poor organ function is by far the number one reason for leading causes of non-recovery. 

Source: * UNOS-OPTN 2012.
Slide 10:

Long Wait Time for Donors

The table demonstrates patients wait time for donor lungs in 2013.  The majority of patients wait 6 months or longer for donor lungs. 

Source:  OPTN/SRTR 2014 Annual Data Report: Lung



Side 11:

2012 Payer Mix for Lung Transplants - DRG 007
The table demonstrates the payer mix for lung transplants, DRG 007. 

There is an even distribution between Medicare and Private Payers and a small percentage of patients fall into other/Medicaid/uninsured

Source: Agency for Healthcare Research and Quality. 2012 Nationwide Inpatient Sample. 
http://hcupnet.ahrq.gov/HCUPnet

Slide 12:

Organ Perfusion: a POSSIBLE SOLUTION TO DONOR ORGAN SHORTAGE

Slide 13:

What is XVIVO Organ Perfusion?

• Perfusion of the organ outside the body (ex-vivo perfusion) on a closed loop circuit simulating the in-vivo scenario utilizing a specially developed protective perfusion solution called STEEN Solution™.
• Provides for safe expansion of organ utilization in high-risk marginal organs through amelioration of reversible injuries.
• Currently only 15-20% of donated lungs are utilized within the US. The XPS has enabled an increase utilization rate of donor lungs that otherwise would have been discarded by 56%.
• Goal: expand the donor organ pool and reduce or eliminate mortality and morbidity on the transplant waiting list.

Slide 14:

Initial Target Population for XVIVO Perfusion: Marginal Donor Lungs

• Designed to benefit those patients with end stage lung disease who are awaiting lung transplant. 
– End-stage chronic lung diseases 
• COPD
• Cystic fibrosis
• Idiopathic pulmonary fibrosis
• Other lung diseases
Slide 15:

Marginal Donor Lungs

• Approximately one in five donated lungs are used for transplantation
• Include ideal and extended criteria organs
•  Remainder are discarded or sent for laboratory research

• XPS will reduce this waste, providing a means for more donor organs to be available to patients on waiting lists
Slide 16:

FDA HDE Professional Labeling

• August 12, 2014 FDA approved XVIVO Perfusion System with STEEN Solution™ (by unanimous vote)
• “Authorized by Federal law for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.”
• “This innovative device addresses a critical public health need. With this approval there may be more lungs available for transplant which could allow more people with end stage lung disease who have exhausted all other treatment options” 
– FDA press release 8/12/14 

Slide 17:

HELP/NOVEL

HELP N = 20
* Prospective, non-randomized,  single-center
* ISHLT Extended criteria Lungs 
* 4 hours of EVLP using STEEN Solution™
* Using a ?PaO2 ?350 at 2hr,3hr, or 4 hr of ex vivo perfusion as transplantable with clinician approval of all variables
* Control group are conventional transplants at the same time period
* Endpoints of 30 day survival, PGD, ICU and Hospital LOS

NOVEL N=31
* Prospective, non-randomized, multi-center
* ISHLT Extended criteria Lungs 
* 4 hours of EVLP using STEEN Solution™
* Using a ?PaO2 ?350 at 2hr, 3hr, or 4hr (2 consecutive) of ex vivo perfusion as transplantable with clinician approval of all variables
* Control group are conventional transplants at the same time period
* Endpoints of 30 day survival, PGD, ICU and Hospital LOS

Ex Vivo Lung Perfusion (EVLP)

Slide 18:

Overall Safety Conclusions

• EVLP procedure on the XPS™ with STEEN Solution™ can safely be used in the evaluation of lungs initially considered unacceptable
• EVLP procedure on the XPS™ with STEEN Solution™ generates clinical data used to safely select lungs acceptable for transplantation   
• EVLP on the XPS™ with STEEN Solution™ of a donor lung did not change the safety profile or the risks associated with lung transplantation to the recipient

Image of the container used to transport lungs after harvested from donor

Slide 19:

Probable Benefit Proven

• The sponsored studies demonstrate that Normothermic EVLP with STEEN Solution™
– Provides more information about donor lung quality to the transplanting surgeon
– Increases the availability of donor lungs for transplant by safely reassessing initially refused donor lungs after standard hypothermic procurement
Slide 20:

Beyond the HDE

Manufacturer, XVIVO Perfusion, Inc.  currently sponsoring NOVEL Trial Extension
• Normothermic Ex VIVO Lung Perfusion (EVLP) As An Assessment of Extended/Marginal Donor Lungs for Transplant
• Study Objectives:
– Demonstrate the XVIVO Perfusion System can be safely used for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation
– Obtain PMA

Slide 21:

Future Applications for Organ Perfusion

Vital donor organs
• Heart
• Liver
• Kidney

Slide 22:

About The XVIVO PERFUSION SYSTEM

Slide 23:
XPS System
• XPS System consists of
– XVIVO Cannula Set
– XVIVO Organ Chamber
– XPS Lung Circuit
– XVIVO Lung Disposables Kit
– XPS Machine
– STEEN Solution™
– 
Image of the XPS System 
Slide 24:
STEEN Solution™ Major Characteristics:
• Normal Plasma electrolyte concentration
• Human serum albumin
– Keeps oncotic pressure
• Dextran-40 (40,000 D)
– Scavenges toxic substances
– Coats endothelial cells 

Image of a bottle of STEEN Solution

Slide 25:

XPS Perfusion System with STEEN Solution™ Procedure Steps

• After donor lung procurement, donor lungs are transported to transplant facility
• XPS System with STEEN Solution™ is applied via left atrial cannulation and pulmonary artery cannulation 
• Donor lungs are warmed to normal body temperature and continuously flushed with sterile fluid (STEEN Solution™)
• STEEN Solution™ preserves the lungs and removes waste products

Slide 26:

XPS Perfusion System with STEEN Solution™ Procedure Steps (continued)

• XPS ventilates the lungs, which oxygenates the cells and makes it possible for the transplant team to examine the lungs’ airways with bronchoscope 
• Donor lungs are then evaluated every hour to assess lung function and transplant suitability
• Donor lungs can stay on the machine for up to four hours (new study is for 6 hours)
• Can assess the improvement of the lung with an X-ray while on the XPS machine

Slide 27: 

EVLP Timeline

Image of detailing EVLP timeline.

Physiological Parameters Assessed
XPS Hemodynamic Monitor
• PVR (Pulmonary Vascular Resistance)
• PAP (Pulmonary Artery Pressure)
• LAP (Left Arterial Pressure)
XPS Hamilton ICU Ventilator
• Peak awP (Peak Airway Pressure)
• Mean awP (Mean Airway Pressure)
• pPlat (peak Plateau)
• CDyn (Dynamic compliance)
• cStat (Static compliance)
• VT (Tidal Volume)
Blood Gas Machine
• PaO2 (Pulmonary Artery Oxygen)
• PvO2 (Pulmonary Vein Oxygen)

Slide 28:

Organ Perfusion Not Usually Part of Organ Procurement Process

• Procurement is related to cold static storage for minimization of metabolic activity (arrow pointing to image)
• Transplant facilities responsible for purchasing and maintaining the equipment used for perfusion
• Transplant facility incurs the cost of the equipment and disposables
• Bottom Line: Considerable resources expended by hospitals but no way to track data without new code

Image of the container used to transport lungs after harvested from donor

Slide 29:

Organ Perfusion Not Part of Backbench Workup

• Backbench work is organ preparation for implantation (sizing cuffs and repairing any procurement mishaps) which is also at 4 degrees in order to minimize metabolic activity.
• EVLP is an active assessment and rehabilitation procedure occurring at physiologic temperatures requiring continuous monitoring and modification of perfusion and ventilation mechanics in tune with organ appearance and characteristics.

Slide 30:

ICD-10-PCS Code REQUEST

Slide 31:

Rationale for New ICD-10-PCS Code

• New code required for tracking hospital data
• Utilization
• Costs
• Resources (equipment, disposable supplies)
• Distinct procedure with its own beginning, middle and end separate from actual lung transplant surgery
• Not part of organ procurement
• Not part of back bench work
• (continued next slide)
Slide 32:

Rationale for New ICD-10-PCS Code (continued)

• Requires significant time (typically 6-8 hours)
• Improves Patient Transplant Outcomes
• Improves pool of viable donor lungs/reduces recipient wait time
• NTAP Application will be submitted in Quarter 4 2015 for possible implementation in FY 2017

Slide 33:

Recommended ICD-10-PCS Code

Option 3:
Create new codes in Section 6. Extracorporeal Therapies, to capture organ successful perfusion for transplant as indicated below. 

Extracorporeal Therapies        6             Extracorporeal Therapies
Body System                              A             Physiological Systems
Operation                              ADD B         Perfusion:  Extracorporeal treatment by diffusion of therapeutic fluid

Body System
ADD 5 Circulatory System
ADD B Respiratory System
ADD F Hepatobiliary System and Pancreas
ADD T Urinary System 

Duration
0 Single

Qualifier
ADD B Donor Organ

Qualifier
Z No Qualifier

NOTE: XVIVO/XPS should also be included in Code Book INDEX for ease of procedure code identification


Slide 34:

Conclusion

• XPS is a revolutionary process for how donor lungs and eventually other donor organs are preserved and revitalized for transplant
• There is a huge unmet clinical need
• FDA is extremely excited about the advancement of technology
• Hospitals expend considerable resources on XVIVO disposables and equipment
• New hospital procedure code needed to track statistics
• New ICD-10-PCS code should be implemented in 2015 to avoid delays in hospital reporting

Slide 35:

Questions/Answers

Image of the XPS System with lungs in the chamber. 

XVIVO Perfusion Slide Deck Outline


