Medical Policy: 07.03.06 

Original Effective Date: November 2009 

Reviewed: November 2020 

Revised: November 2020 

 

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:

The primary goal of lung transplantation is extended survival. For most patient's lung transplant is a palliative rather than curative treatment intended for patients with end-stage lung disease who have failed to respond to alternative medical or surgical treatment.

 

Lung transplantation (single or double)

Lung transplantation involves either single-lung or double-lung replacement. One or both lungs are transplanted from a donor with pronounced brain death into the chest cavity of the recipient.

 

Lobar lung transplant

A lobar lung transplant refers to the transplant of a lobe excised from the donor's lung that is sized appropriately for the recipient's thoracic dimensions. Lobar lung transplant donors are primarily living related donors, with one lobe obtained from each of two donors in cases where a bilateral transplant is required.

 

The type of lung transplant is based upon the patient’s condition and the indication for transplant. Living-donor lobar-lung transplant refers to the transplantation of either the right or left lower lobe from one or two healthy donors to replace one or both lungs. The procedure was devised to assist in alleviating the limited availability of cadaveric lungs and thereby prolong survival in patients who are likely to die before a cadaveric organ becomes available.

 

Registry data and case series reports have demonstrated favorable outcomes with lung retransplantation in certain populations, such as in patients who meet criteria for initial lung transplantation.

 

Professional Guidelines and Position Statements

American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA):

The 2018 ACC/AHA guideline for the management of adults with congenital heart disease (ACHD) stated in patients with ACHD and Eisenmenger syndrome exhibiting deteriorating functional ability, mechanical circulatory and pulmonary support, lung transplantation with concomitant repair of anatomic cardiovascular defects, and heart–lung transplantation have been applied.

 

Regulatory Status

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Lung transplants are included in these regulations.

 

In November 2016, the Lung Assist Perfusion System received a CE mark certification permitting commercial distribution in Europe. FDA has not yet cleared the Lung Assist Perfusion System for use in the United States.

 

Prior Approval:

Prior approval is required.

 

Policy:

Lung or lobar lung transplantation and retransplantation may be considered medically necessary in patients with end-stage disease of lung parenchyma, airway and pulmonary vasculature that is not amenable to maximum alternative medical and surgical therapies when one the following criteria are met:

  • Severe, progressive symptoms with a functional status of New York Heart Association (NYHA) class III or IV despite optimal medical management, resulting in an unacceptable quality of life
  • Patients must meet United Network for Organ Sharing guidelines for a Lung Allocation Score greater than zero 

 

Categories of lung disease for which transplant may be indicated include, but are not limited to:

  • Restrictive lung diseases such as idiopathic pulmonary fibrosis, pulmonary fibrosis from other causes, interstitial lung disease, sarcoidosis, asbestosis
  • Chronic obstructive lung diseases such as emphysema, alpha-1 antitrypsin deficiency, chronic bronchitis, bronchiolitis obliterans, lymphangioleiomyomatosis
  • Septic lung diseases such as cystic fibrosis, bronchiectasis
  • Pulmonary vascular diseases such as pulmonary hypertension, Eisenmenger syndrome, recurrent pulmonary embolism

 

Lung and lobar lung transplant and retransplant is considered not medically necessary for patients with the following contraindications:

  • Persistent, recurrent or unsuccessfully treated major or systemic infections, making immunosuppression unsafe
  • Systemic illness or comorbidities that would be expected to substantially negatively impact the successful completion and/or outcome of transplant surgery or would be exacerbated by immunosuppression
  • Untreatable advanced dysfunction of another organ system such as heart, liver, or kidney disease
  • Coronary artery disease not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function
  • Significant chest wall deformity
  • A pattern of noncompliance which would place a transplanted organ at serious risk of failure
  • Current malignancy

 

The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.

 

The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:

  • CD4 count ≥ 200 cells/mm-3 for > 6 months
  • HIV-1 RNA undetectable
  • On stable anti-retroviral therapy > 3 months
  • No other complications from AIDS (e.g., opportunistic infection including aspergillus, tuberculosis, coccidioses mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm)
  • Meeting all other criteria for organ transplantation

 

It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.

 

Lung xenotransplantation (e.g., porcine xenografts) is considered investigational for any pulmonary conditions because of insufficient evidence in the peer-reviewed literature.

 

Procedure Codes and Billing Guidelines:

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

  • 32851 Lung transplant, single; without cardiopulmonary bypass
  • 32852 Lung transplant, single; with cardiopulmonary bypass
  • 32853 Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass
  • 32854 Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass
  • S2060 Lobar lung transplant
  • S2061 Donor lobectomy (lung) for transplantation, living donor

 

Selected References:

  • American College of Chest Physicians. A guide to lung transplantation. 2006.
  • Aurora P, Carby M, Sweet S. Selection of cystic fibrosis patients for lung transplantation. Curr Opin Pulm Med. 2008 Nov;14(6):589-94.
  • Kaza AK, Dietz JF, Kern JA et al. Coronary risk stratification in patients with end-stage lung disease. J Heart Lung Transplant. 2002 Mar;21(3):334-9.
  • Chang AC, Chan KM, Lonigro RJ et al. Surgical patient outcomes after the increased use of bilateral lung transplantation. J Thorac Cardiovasc Surg. 2007 Feb;133(2):532-40. [Epub Dec 29, 2006]
  • Steinman TI, Becker BN, Frost AE et al. Clinical Practice Committee, American Society of Transplantation. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001 May 15;71(9):1189-204.
  • Kozower BD, Meyers BF, Smith MA et al. The impact of lung allocation score on short-term transplantation outcomes: a multicenter study. J Thorac Cardiovasc Surg 2008;135(1):166-71.
  • Orens JB, Garrity ER Jr. General overview of lung transplantation and review of organ allocation. Proc Am Thorac Soc 2009;6(1):128-36.
  • Orens JB, Estenne M, Arcasoy S et al. International Guidelines for the Selection of Lung Transplant Candidates: 2006 Update-A Consensus Report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2006 Jul; 25(7):745-55.
  • Sherman W, Rabkin DG, Ross D et al. Lung transplantation and coronary artery disease. Ann Thorac Surg. 2011 Jul; 92(1):303-8.
  • Benden C, Edwards LB, Kucheryavaya AY et al. The registry of the International Society for Heart and Lung Transplantation: fifteenth pediatric lung and heart-lung transplantation report--2012. J Heart Lung Transplant 2012; 31(10):1087-95.
  • Shafii AE, Mason DP, Brown CR, et al. Too high for transplantation? Single-center analysis of the lung allocation score. Ann Thorac Surg. Nov 2014;98(5):1730-1736. PMID 25218678
  • Kistler KD, Nalysnyk L, Rotella P, et al. Lung transplantation in idiopathic pulmonary fibrosis: a systematic review of the literature. BMC Pulm Med. 2014;14:139. PMID 25127540
  • Date H, Sato M, Aoyama A, et al. Living-donor lobar lung transplantation provides similar survival to cadaveric lung transplantation even for very ill patientsdagger. Eur J Cardiothorac Surg. Sep 16 2014. PMID  25228745
  • Slama A, Ghanim B, Klikovits T, et al. Lobar lung transplantation--is it comparable with standard lung transplantation? Transpl Int. Sep 2014;27(9):909-916. PMID 24810771
  • Kilic A, Beaty CA, Merlo CA, et al. Functional status is highly predictive of outcomes after redo lung transplantation: an analysis of 390 cases in the modern era. Ann Thorac Surg. Nov 2013;96(5):1804-1811. PMID 23968759
  • Gulack BC, Ganapathi AM, Speicher PJ, et al. What Is the Optimal Transplant for Older Patients With Idiopathic Pulmonary Fibrosis? Ann Thorac Surg 2015; 100:1826
  • Schaffer JM, Singh SK, Reitz BA, et al. Single- vs double-lung transplantation in patients with chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis since the implementation of lung allocation based on medical need. JAMA 2015; 313:936.
  • Weill D, Benden C, Corris PA, et al. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant 2015; 34:1.
  • Thomas M, Belli EV, Rawal B, et al. Survival After Lung Retransplantation in the United States in the Current Era (2004 to 2013): Better or Worse? Ann Thorac Surg 2015; 100:452.
  • Yusen RD, Edwards LB, Dipchand AI, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Lung and Heart-Lung Transplant Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016;35(10):1170-1184. PMID 27772669
  • Organ Procurement and Transplantation Network (OPTN). Organ Distribution: Allocation of Lungs. Policy 10. 2017
  • Eberlein, M., Reed, R. M., Chahla, M., Bolukbas, S., Blevins, A., Van Raemdonck, D., Stanzi, A., Inci, I., Marasco, S., Shigemura, N., Aigner, C., … Deuse, T. (2017). Lobar lung transplantation from deceased donors: A systematic review. World journal of transplantation, 7(1), 70-80.
  • Warnecke G, Van Raemdonck D, 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. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9. Erratum in: Lancet Respir Med. 20018 Jun;6(6):e27.
  • Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. 
  • Stout KK, Broberg CS, Book WM, Cecchin F, Chen JM, Dimopoulos K, et al. Chronic Heart Failure in Congenital Heart Disease A Scientific Statement From the American Heart Association. Circulation. 2016 Feb 23;133(8):770-801.
  • Paraskeva MA, Edwards LB, Levvey B, et al.(2018) Outcomes of adolescent recipients after lung transplantation: An analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant. Feb 17 2018;37(3):323-331. PMID 28320631
  • ECRI Institute. Lung Assist Perfusion System (Organ Assist Products B.V.) for Preserving Donated Lungs. Plymouth Meeting (PA): ECRI Institute; 2020 Jan 13. (Custom Product Brief).
  • Zhang, ZL, van Suylen, V, van Zanden, JE, Van De Wauwer, C, Verschuuren, EAM, van der Bij, W, and Erasmus, ME. First experience with ex vivo lung perfusion for initially discarded donor lungs in the Netherlands: a single-centre study. Eur J Cardiothorac Surg. 2019;55(5):920-926.

 

Policy History:

  • November 2020 - Annual Review, Policy Revised
  • November 2019 - Annual Review, Policy Renewed
  • November 2018 - Annual Review, Policy Renewed
  • November 2017 - Annual Review, Policy Renewed
  • November 2016 - Annual Review, Policy Renewed
  • November 2015 - Annual Review, Policy Revised
  • December 2014 - Annual Review, Policy Revised
  • February 2014 - Annual Review, Policy Revised
  • March 2013 - Annual Review, Policy Renewed
  • March 201  - Annual Review, Policy Renewed
  • April 2011 - Annual Review, Policy Renewed

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.

 

*CPT® is a registered trademark of the American Medical Association.