Medical Policy: 07.03.12 

Original Effective Date: May 2019 

Reviewed: May 2020 

Revised:  

 

Notice:

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.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

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.

 

Description:

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.

 

Regulatory Status

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.

 

Prior Approval:

Not applicable

 

Policy:

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

  • XVIVO Perfusion System (XPS; XVIVO Perfusion AB, Goteborg, Sweden),
  • Organ Care System (OCS) Lung (TransMedics, Andover, MA, USA),
  • Organ Care System (OCS) Heart (TransMedics, Andover, MA, USA),
  • Organ Care System (OCS) Liver (TransMedics, Andover, MA, USA),
  • VivoLine LS1 (VivoLine Medical; Lund, Sweden) (acquired by XVIVO Perfusion June 2016),
  • Lung Assist (Organ Assist; Groningen, The Netherlands),
  • OrganOx (University of Oxford, UK)

 

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.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 0494T Surgical preparation and cannulation of marginal (extended) cadaver donor lung(s) to ex vivo organ perfusion system, including decannulation, separation from the perfusion system, and cold preservation of the allograft prior to implantation, when performed
  • 0495T Initiation and monitoring marginal (extended) cadaver donor lung(s) organ perfusion system by physician or qualified health care professional, including physiological and laboratory assessment (eg, pulmonary artery flow, pulmonary artery pressure, left atrial pressure, pulmonary vascular resistance, mean/peak and plateau airway pressure, dynamic compliance and perfusate gas analysis), including bronchoscopy and X ray when performed; first two hours in sterile field
  • 0496T Initiation and monitoring marginal (extended) cadaver donor lung(s) organ perfusion system by physician or qualified health care professional, including physiological and laboratory assessment (eg, pulmonary artery flow, pulmonary artery pressure, left atrial pressure, pulmonary vascular resistance, mean/peak and plateau airway pressure, dynamic compliance and perfusate gas analysis), including bronchoscopy and X ray when performed; each additional hour (List separately in addition to code for primary procedure)
  • 33999 Unlisted procedure, cardiac surgery
  • 47399 Unlisted procedure, liver

 

Selected References:

  • Ardehali A,EsmailianF, PROCEEDII trial investigators, etal: Ex-vivo perfusion  of donor hearts for human heart transplantation(PROCEED II): A prospective, open-label, multi centre, randomized non-inferiority trial. [S0140-6736(15)60261-6].Lancet385:2577–2584, 2015
  • Czigany Z, Lurje I, Tolba RH, Neumann UP, Tacke F, Lurje G. Machine perfusion for liver transplantation in the era of marginal organs—New kids on the block. Liver Int. 2019;39:228–249. 
  • He X, Guo Z, Zhao Q, et al. The first case of ischemia- free organ transplantation  in  humans:  a  proof  of  concept. Am Journal Transplant 2018;18(3):737-744.
  • Ravaioli  M,  De  Pace  V,  Cescon  M,  et  al.  Hypothermic  oxygenated machine perfusion in liver and kidney transplantation of extended criteria donors: a phase- 1 of clinical trial. Am Journ Transplant. 2018;17(suppl 4):984.
  • Nasralla  D,  Coussios  CC,  Mergental  H,  et  al.  A  randomized  trial of  normothermic  preservation  in  liver  transplantation.  Nature. 2018;557:50-56.
  • Pinezich, M., & Vunjak-Novakovic, G. (2019). Bioengineering approaches to organ preservation ex vivo. Experimental Biology and Medicine. 
  • Slama A, Schillab L, Barta M, Benedek A, Mitterbauer A, Hoetzenecker K, et al. Standard donor lung procurement with normothermic ex vivo lung perfusion: A prospective randomized clinical trial. J Heart Lung Transplant. 2017 Jul;36(7):744-753.
  • Warnecke G, Van Raemdonck D, Smith MA, et al. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367.
  • Dean P. Schraufnagel, Robert J. Steffen, Patrick R. Vargo, Tamer Attia, Haytham Elgharably, Saad M. Hasan, Alejandro Bribriesco & Per Wierup (2018) Devices for ex vivo heart and lung perfusion, Expert Review of Medical Devices, 15:3, 183-191, DOI: 10.1080/17434440.2018.1430568
  • Machuca TN, Mercier O, Collaud S, et al. Lung Transplantation With Donation After Circulatory Determination of Death Donors and the Impact of Ex Vivo Lung Perfusion. Am J Transplant 2015;15:993-1002. 10.1111/ajt.13124
  • Beuth J, Falter F, Pinto Ribeiro RV, Badiwala M, Meineri M. New Strategies to Expand and Optimize Heart Donor Pool: Ex Vivo Heart Perfusion and Donation After Circulatory Death: A Review of Current Research and Future Trends. Anesth Analg. 2019 Mar;128(3):406-413.
  • Dhital KK, Chew HC, Macdonald PS. Donation after circulatory death heart transplantation. Curr Opin Organ Transplant. 2017 Jun;22(3):189-197.
  • Messer S, Page A, Axell R, Berman M, et. al. Outcome after heart transplantation from donation after circulatory-determined death donors. J Heart Lung Transplant. 2017 Dec;36(12):1311-1318.
  • White CW, Messer SJ, Large SR, et al. Transplantation of Hearts Donated after Circulatory Death. Front Cardiovasc Med. 2018;5:8. Published 2018 Feb 13. doi:10.3389/fcvm.2018.00008
  • Beswick N. The TransMedics organ care system (OCS) heart technology was used to perform the world's first series of adult human heart transplants from donors after circulatory death (DCD donors) at St. Vincent's hospital in Sydney, Australia. [internet]. Andover (MA): TransMedics, Inc.; 2014 Oct 24 [2 p].
  • Yeter R, Pasic M, Hubler M, Dandel M, Hiemann N, Kemper D, Wellnhofer E, Hetzer R, Knosalla C. Extended donor criteria in heart transplantation: 4-year results of the experience with the Organ Care system. Thorac Cardiovasc Surg. 2014 Jan;62(Suppl 1)
  • PricePaid [database online]. Plymouth Meeting (PA): ECRI Institute; [accessed 2014 Aug 25]. PricePaid search summary: OCS lung. [1 p].
  • National Institute for Health and Care Excellence (NICE). Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death. London (UK): National Institute for Health and Care Excellence (NICE); 2016 Feb 24. 6 p. (Interventional procedure guidance; no.549).
  • Himmat S, Alzamil A, Aboelnazar N, et al. A Decrease in hypoxic pulmonary vasoconstriction correlates with increased inflammation during extended normothermic ex vivo lung perfusion. Artif Organs. 2018;42(3):271-279.
  • Hsin MK, Zamel R, Cypel M, et al. Metabolic profile of ex vivo lung perfusate yields biomarkers for lung transplant outcomes. Ann Surg. 2018;267(1):196-197.
  • D'Cunha HC, Rojas M. Ex vivo lung perfusion: Past, present, and future. ASAIO J. 2018;64(2):135-139.

 

Policy History:

  • May 2020 - Annual Review, Policy Renewed
  • May 2019 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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