This document addresses use of a portable normothermic organ machine perfusion and monitoring medical device used to preserve donor organs in a near-normothermic state from retrieval until transplantation. This document does not address static cold storage or other forms of solid organ preservation.

Note: Please see the following transplant documents for information related to transplant specific criteria:

• TRANS.00008 Liver Transplantation
• TRANS.00009 Lung and Lobar Transplantation
• TRANS.00033 Heart Transplantation
• CG-TRANS-02 Kidney Transplantation

Position Statement

Medically Necessary:

Portable normothermic organ perfusion systems are considered medically necessary when the following criteria are met (both criteria set A and criteria set B):

1. General Criteria (both 1 and 2 below):
   1. Used as part of the acquisition, collection and storage of a covered and medically necessary organ transplant; and
   2. Involving donor organ(s) initially deemed unacceptable for procurement and transplantation based on limitations of cold storage preservation; 
      and
2. Organ-Specific Criteria (1 or 2 or 3 below):
   1. Lung perfusion (for example, Organ Care System Lung^™) involving donor lung pairs with one or more of the following risk factors:
      1. Donor after circulatory death (DCD); or
      2. Age greater than 55 years; or
      3. PaO2/FiO2 less than 300 mmHg; or
      4. Ischemic time greater than 6 hours; 
         or
   2. Liver perfusion when criteria are met (a or b below):
      1. Organ Care System Liver: liver allografts
         1. From DCD less than or equal to 55 years old; and
         2. With less than or equal to 30 minutes of warm ischemic time; and
         3. Macrosteatosis less than or equal to 15%.
      2. OrganOx^® metra^® System: liver allografts
         1. From DCD less than or equal to 40 years of age; and
         2. With less than or equal to 20 minutes of functional warm ischemic time; and
         3. Macrosteatosis less than or equal to 15%; 
            or
   3. Heart perfusion (for example, Organ Care System Heart^™) when criteria are met:
      1. From DCD 18 to 49 years of age; and
      2. Classified as Maastricht category III (persons who became donors after controlled withdrawal of life support and subsequent cardiac arrest and cardiocirculatory death); and
      3. Functional warm ischemic time (defined as time from mean systolic arterial blood pressure less than 50 mm Hg or peripheral oxygen saturation less than 70% to aortic cross-clamp and administration of cold cardioplegia) is 30 minutes or less. 

Investigational and Not Medically Necessary:

Portable normothermic portable organ machine perfusion is considered investigational and not medically necessary when the above criteria are not met, including but not limited to use as part of the acquisition, collection and storage of a covered and medically necessary organ transplant involving other solid donor organs or donor organs deemed acceptable for transplant according to standard criteria.