Medical Policy: 07.03.12
Original Effective Date: May 2019
Reviewed: May 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Ex Vivo refers to a medical procedure in which an organ, cells, or tissue are taken from a living body for a treatment or procedure, and then returned to the living body.
Despite advances in the field of transplantation since its inception over 50 years ago, the approach to donor organ preservation outside of the body remains relatively unchanged. Recently, attempts have been made to replace static cold storage with ex vivo machine perfusion. Rather than cooling the organ on ice to slow metabolic processes, machine perfusion (MP) aims to support normal metabolic function in a near-physiologic environment and to provide a platform on which the organ can be evaluated, preserved, and recovered. Machine perfusion (MP) is a continually evolving technology that might have the potential to optimize the preservation, assessment and rescue of liver, lung, and heart transplants in the future. The use of organs could be expanded through the process by the ability to target organs that currently do not satisfy the standard criteria for organ donation.
With the Ex Vivo System of the Heart, warm oxygenated blood is pumped into the aorta, perfusing the coronary arteries. The coronary sinus flow then passes through the tricuspid valve and is ejected by the right ventricle into a pulmonary artery cannula and returned to the blood reservoir. The perfusate includes insulin, antibiotics methylprednisolone, sodium bicarbonate, multivitamins, and fresh donor blood. Pulsatile flow is generated by a diaphragmatic pump. The system shortens the cold ischemia time by maintaining the organ in warm perfused state during transport.
With the Ex Vivo System for the Lungs (EVLP), there are three different protocols used to prepare and assess the lungs: the Toronto protocol which is the most commonly used protocol; the Lund protocol which is the original protocol of ex vivo, and the OCS™ protocol. The first 2 protocols are similar in a way that after the cold pulmonary flush and the lungs harvest, the lungs are kept in static cold storage (ice) during the transportation time to the recipient hospital when the lungs are connected to the ex vivo device.
With the Ex Vivo System of the Liver, these systems consist of a hepatic artery +/− portal vein pump, a perfusate reservoir, along with an oxygenating chamber of oxygenated perfusion.
The use of ex vivo machine perfusion has allowed for ongoing expansion of the donor pool. The biggest barriers to expansion of this technology are access, cost, and lack of evidence which clearly supports superior outcomes.
According to the FDA, the Organ Care System (OCS™) Lung System (TransMedics, Inc., Andover, MA) received premarket approval (PMA) on March 22, 2018. Per the FDA the TransMedics® OCS Lung System “is a portable organ perfusion, ventilation, and monitoring medical device indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation”. The product labeling for the OCS Lung System notes that the system is contraindicated for donor lungs that have moderate to severe lung injury resulting air leak, as this could result in leakage of fluid and air at the injured area, which will compromise the ability of the OCS Lung System to maintain the donor lungs in good condition.
The OCS Heart and OCS Liver devices are investigational devices and, therefore, are limited by federal law to investigational use in the United States. The OrganOx metra is not currently available in the United States.
The XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate (XVIVO Perfusion Inc., Englewood, CO) received FDA Humanitarian Device Exemption (HDE) approval on August 12, 2014. The device is “indicated for the 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”. The product labeling for the XPS notes that the effectiveness of this device for this use has not been demonstrated.
The use of external organ perfusion systems/ex vivo machine perfusion for transplantation is considered investigational.
Ex vivo perfusion systems (static [for use in a hospital] and/or portable), including but not limited to the following systems are considered investigational
There is insufficient published evidence to assess the risks and benefits of the external organ perfusion systems/ex vivo machine perfusion over standard cold storage techniques for preservation of donor lungs, liver, or hearts at this time.
To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
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