Medical Policy

 

Subject: Liver Transplantation
Document #: TRANS.00008 Publish Date:    04/25/2018
Status: Reviewed Last Review Date:    03/22/2018

Description/Scope

This document addresses liver transplantation for individuals with end-stage liver disease. Donor livers are obtained from deceased donors, in which a whole or partial (split) liver may be transplanted. Living donors are another possible source from adult to child or adult to adult.

Note: Please see the following for additional information:

Position Statement

Note: Members must meet the disease specific criteria as well as the general Individual Selection Criteria below for the transplantation to be considered medically necessary.

Medically Necessary:

A whole or partial liver transplant using a deceased or living donor is considered medically necessary for selected individuals with end-stage organ failure due to irreversible liver damage that includes, but is not limited to, the following conditions:

  1. Cholestatic liver diseases:
    1. Primary biliary cirrhosis
    2. Primary sclerosing cholangitis
    3. Biliary atresia
    4. Caroli's disease
    5. Familial cholestasis
    6. Arteriohepatic dysplasia (Alagaille's disease)
    7. Cystic Fibrosis
  2. Hepatocellular injury:
    1. Viral-induced Hepatitis
    2. Drug induced
      1. Acetaminophen
      2. Associated with halothane, gold, disulfram, others
    3. Alcohol induced
    4. Toxin exposure: Amanita mushroom poisoning
    5. Autoimmune hepatitis
  3. Inborn errors of metabolism:
    1. Wilson's disease
    2. Organic acidurias
    3. Hemochromatosis
    4. Alpha-1 antitrypsin deficiency
    5. Homozygous type II hyperlipoproteinemia
    6. Crigler-Najjar Syndrome type I
    7. Protoporphyria
    8. Some urea cycle deficiencies
    9. Glycogen storage diseases types I and IV
    10. Tyrosine deficiency
    11. Citrullinemia
    12. Ornithine transcarboxylase deficiency
    13. Familial amyloid polyneuropathy (requires transplantation - polyneuropathy and cardiac amyloidosis development due to the production of a variant transthyretin molecule by the liver)
    14. Oxalosis (primary)
  4. Acute Diseases:
    1. Fulminant hepatic failure
  5. Mass Occupying Lesions:
    1. Polycystic disease of the liver (requiring transplantation due to the anatomic complications of a hugely enlarged liver)
    2. Hepatoblastoma confined to the liver
    3. Primary hepatocellular carcinoma confined to the liver
    4. Hemangioendothelioma
    5. Hilar cholangiocarcinoma (CCA) with a cross-sectional diameter 3 cm or less in conjunction with neoadjuvant chemoradiation therapy and the tumor is unresectable or there is underlying liver disease such that the individual is not a candidate for resection
  6. Vascular disease:
    1. Budd-Chiari Syndrome
  7. Other:
    1. Cryptogenic cirrhosis

Liver Retransplantation

Retransplantation in individuals with graft failure of an initial liver transplant, due to either technical reasons or hyperacute rejection is considered medically necessary.

Retransplantation in individuals due to either chronic rejection or recurrent disease is considered medically necessary when the individual meets general selection criteria as defined below.

Investigational and Not Medically Necessary:

Liver transplants in individuals with extrahepatic malignancy, including, but not limited to, non-hilar extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma or hepatocellular carcinoma when either condition extends beyond the liver, are considered investigational and not medically necessary.

Liver transplants for all other conditions that do not lead to end-stage organ failure due to irreversible liver damage are considered investigational and not medically necessary.

Xenotransplantation is considered investigational and not medically necessary.

Bioartificial liver devices are considered investigational and not medically necessary.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, a member may present with concurrent medical conditions which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the additional organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

General Individual Selection Criteria

In addition to having end stage liver disease, the member must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications- for Transplant Recipients include, but are not limited to, the following:

  1. Metastatic cancer
  2. Ongoing or recurring infections that are not effectively treated
  3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery
  4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured
  5. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations
  6. Potential complications from immunosuppressive medications are unacceptable to the patient
  7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/mm3) unless the following are noted:
    1. CD4 count greater than 200 cells/mm3 for greater than 6 months
    2. HIV-1 RNA undetectable
    3. On stable anti-retroviral therapy greater than 3 months
    4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm)
    5. Meeting all other criteria for liver transplantation*

*Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.

Rationale

Transplantation for progressive liver disease that will ultimately lead to a fatal outcome, or end-stage liver disease, is currently accepted as a practical and established medical therapy. Technical and pharmaceutical advances have made liver transplantation available to individuals who might not have previously qualified, such as those diagnosed with hepatitis or hepatocellular carcinoma (HCC), also known as malignant hepatoma. The question is no longer whether to perform this complex surgery but how to identify the best candidates. The careful selection of candidates utilizing specific selection criteria has steadily improved the survival rates for those that have undergone liver transplantation. Multiple clinical trials have been conducted on various aspects of liver transplantation including, but not limited to surgical technique, immunosuppressive therapy, diagnosis, and the United Network for Organ Sharing (UNOS) status at the time of transplant. The best available evidence, collected from retrospective registry data on liver transplantation in the U.S., is based on UNOS data collected from 1998-2008 which reports 1- and 10-year survival data. Liver transplant using a deceased or living donor is considered medically necessary for selected individuals with end-stage organ failure due to irreversible liver damage.

The National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines (2017) in Oncology™ for hepatobiliary cancers provides recommendations for liver transplantation. There is retrospective evidence showing selected individuals with hilar CCA receiving preoperative chemoradiation therapy followed by liver transplantation to have significantly improved overall survival compared with individuals undergoing resection. “Liver transplantation should be considered only for highly selected patients with either unresectable disease with otherwise normal biliary and hepatic function or underlying chronic liver disease precluding surgery.” The 2018 UNOS liver allocation policy includes criteria for MELD (Model for End-stage Liver Disease) exception for liver transplantation candidates with hilar CCA. Criteria includes exception for candidates who have received neoadjuvant therapy prior to transplantation and present with cross-sectional imaging study demonstrating a mass measuring 3 cm or less.

Although the potential benefits are considerable, the use of xenotransplantation raises concerns regarding the potential infection of recipients with both recognized and unrecognized infectious agents and the possible subsequent transmission to their close contacts and into the general human population. A particular public health concern is the potential for cross-species infection by retroviruses, which may be latent and lead to disease years after infection. Moreover, new infectious agents may not be readily identifiable with current techniques. At the present time xenotransplantation is considered investigational and not medically necessary.

A bioartificial liver device is a device that uses living liver cells housed in extracorporeal (outside the body) cartridges to provide temporary liver function. For some medical conditions, the device would be used to keep individuals alive and healthier until a transplantable liver becomes available. At this time there is limited scientific evidence available to support the safety and efficacy of this device and therefore bioartificial liver devices are considered investigational.

Background/Overview

A liver transplant consists of replacing an end-stage diseased liver with a healthy one. The liver is obtained from either a deceased or a living donor (a living donor gives only a segment of his/her liver to the recipient). In an orthotopic liver transplantation, the donor liver is placed in its correct anatomic location. A heterotopic liver transplantation refers to placement of the donor liver in a different location, typically with the native liver remaining in situ. The overwhelming majority of liver transplantations are orthotopic.

Split liver transplantation refers to dividing a donor liver into two grafts that can be used for two recipients. Generally, a pediatric recipient receives the left lobe and an adult recipient receives the right lobe.

Living-related donor transplantation of the left lateral segment primarily benefits children and is usually performed between parent and child. Adult-to-adult living donor transplantation uses the right lobe of the liver from a related or unrelated donor. Living donation allows the procedure to be scheduled electively, shortens the preservation time for the donor liver and allows time to optimize the recipient’s condition pre-transplant.

The limiting factor for liver transplantation is the short supply of donor organs. At the time of this writing, the procurement and distribution of organs for transplantation in the United States is under the direction of the United Network for Organ Sharing (UNOS). In 1990, UNOS established an organ allocation system based on the principles of medical urgency and local priority. In 2002, UNOS replaced the original liver allocation system with a new scoring system based on objective laboratory data, referred to as MELD/PELD (Pediatric End-stage Liver Disease). Transplant candidates can also receive additional points to increase their MELD/PELD score for conditions such as primary HCC, when tumors meet the modified Tumor-Node-Metastasis (TNM) staging classification. UNOS maintains a national database of transplant candidates, donors, recipients, donor-recipient matching and histocompatibility (UNOS, 2018).

Xenotransplantation is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex-vivo contact with live nonhuman animal cells, tissues or organs. The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply.

Definitions

Cadaver: The physical remains of a deceased person.

End-stage: Being or occurring in the final stages of a terminal disease or condition.

Extrahepatic disease: Cancer that is located outside of the liver.

Fulminant liver failure: The onset of hepatic encephalopathy within 8 weeks of the first symptoms of liver disease.

Hepatoblastoma: A rare cancerous liver tumor occurring in infants and children that is composed of tissue resembling fetal or mature liver cells.

Heterotopic: Grafted or transplanted into an abnormal position.

In situ: In the natural or original position.

MELD: Model for End-Stage Liver Disease.

Orthotopic: Relating to the grafting of tissue in a natural position.

PELD: Pediatric end-stage liver disease.

Primary hepatocellular cancer: A cancer that originates within liver cells, as opposed to having spread to the liver from other organs.

Xenotransplantation: The surgical removal of an organ or tissue from an animal species and transplanting it into a human.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

00796

Anesthesia for intraperitoneal procedures in upper abdomen including laparoscopy; liver transplant (recipient)

47133

Donor hepatectomy, (including cold preservation), from cadaver donor

47135

Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age

47140

Donor hepatectomy (including cold preservation), from living donor; left lateral segment only (segments II and III)

47141

Donor hepatectomy (including cold preservation), from living donor; total left lobectomy (segments II, III, IV)

47142

Donor hepatectomy (including cold preservation), from living donor; total right lobectomy (segments V, VI, VII and VIII)

47143

Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; without trisegment or lobe split

47144

Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; with trisegment split of whole liver graft into 2 partial liver grafts (ie, left lateral segment [segments II and III] and right trisegment [segments I and IV through VIII])

47145

Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; with lobe split of whole liver graft into 2 partial liver grafts (ie, left lobe [segments II, III, and IV] and right lobe [segments I and V through VIII])

47146

Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; venous anastomosis, each

47147

Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; arterial anastomosis, each

 

 

ICD-10 Procedure

 

0FT00ZZ

Resection of liver, open approach

0FT04ZZ

Resection of liver, percutaneous endoscopic approach

0FY00Z0

Transplantation of liver, allogeneic, open approach

0FY00Z1

Transplantation of liver, syngeneic, open approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:

ICD-10 Procedure

 

0FY00Z2

Transplantation of liver, zooplastic, open approach

5A1C00Z

Performance of biliary filtration, single

5A1C60Z

Performance of biliary filtration, multiple

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Abecassis M, Adams M, Adams P, et al. Consensus statement on the live organ donor. JAMA. 2000; 284(22):2919-2926.
  2. Abouna GJM. Emergency adult to adult living donor liver transplantation for fulminant hepatic failure-is it justifiable?  Transplantation. 2001; 71(10):1498-1500.
  3. Allen JW, Hassanein T, Bhatia SN. Advances in bioartificial liver devices. Hepatology. 2001; 34(3):447-455.
  4. Chamuleau RA. Bioartificial liver support. Metab Brain Dis. 2002; 17(4):485-491.
  5. Ding YT, Qiu YD, Chen Z, et al. The development of a new bioartificial liver and its application in 12 acute liver failure patients. World J Gastroenterol. 2003; 9(4):829-832.
  6. Dumortier J, Czyglik O, Poncet G, et al. Eversion thrombectomy for portal vein thrombosis during liver transplantation. Am J Transplant. 2002; 2(10):934-938.
  7. Efrati O, Barak A, Modan-Moses D, et al. Liver cirrhosis and portal hypertension in cystic fibrosis. Eur J Gastroenterol Hepatol. 2003; 15(10):1073-1078.
  8. Emre S, Kitibayashi K, Schwartz ME, et al. Liver transplantation in a patient with acute liver failure due to sickle cell intrahepatic cholestasis. Transplantation. 2000; 69(4):675-676.
  9. Fridell JA, Bond GJ, Mazariegos GV, et al. Liver transplantation in children with cystic fibrosis: a long term longitudinal review of a single center's experience. J Pediatr Surg. 2003; 38(8):1152-1156.
  10. Haberal M, Karakayali H, Emiroğlu R, et al. Living-donor split-liver transplantation. Transplant Proc. 2001; 33(5):2726-2729.
  11. Heimbach JK, Haddock MG, Alberts SR, et al. Transplantation for hilar cholangiocarcinoma. Liver Transpl. 2004; 10(10 Suppl 2):S65-68.
  12. Huang KW, Chao A, Chou NK, Ko WJ. Hepatic encephalopathy and cerebral blood flow improved by liver dialysis. Int J Artif Organs. 2003; 26(2):149-151.
  13. Kim-Schluger L, Florman SS, Gondolesi G, et al. Liver transplantation at Mount Sinai. Clin Transpl. 2000; Chapter 21:247-253.
  14. Lim KJ, Keeffe EB. Liver transplantation for alcoholic liver disease: current concepts and length of sobriety. Liver Transpl. 2004; 10(10 Suppl 2):S31-38.
  15. Mazzaferro V. Results of liver transplantation: with or without Milan criteria? Liver Transpl. 2007; 13(11 Suppl 2):S44-47.
  16. Michler RE. Xenotransplantation: risks, clinical potential and future prospects. Emerg Infect Dis. 1996; 2(1):64-70.
  17. Molmenti EP, Roodhouse TW, Molmenti H, et al. Thrombendvenectomy for organized portal vein thrombosis at the time of liver transplantation. Ann Surg. 2002; 235(2):292-296.
  18. Molmenti EP, Squires RH, Nagata D, et al. Liver transplantation for cholestasis associated with cystic fibrosis in the pediatric population. Pediatr Transplant. 2003; 7(2):93-97.
  19. Moreno-Gonzalez E, Meneu-Diaz JC, Garcia G, et al. Simultaneous liver-kidney transplant for combined renal and hepatic end-stage disease. Transplant Proc. 2003; 35(5):1863-1865.
  20. Nair S, Verma S, Thuluvath PJ. Obesity and its effect on survival in patients undergoing orthotopic liver transplantation in the United States. Hepatology. 2002; 3591):105-109.
  21. Nishizaki T, Ikegami T, Hiroshige S, et al. Small graft for living donor liver transplantation. Ann Surg. 2001; 233(4):575-580.
  22. Pomfret EA, Pomposelli JJ, Lewis WD, et al. Live donor adult liver transplantation using right lobe grafts: donor evaluation and surgical outcome. Arch Surg. 2001; 13694):425-433.
  23. Rea DJ, Heimbach JK, Rosen CB, et al. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005; 242(3):451-458; discussion 458-461.
  24. Sakamoto S, Uemoto S, Uryuhara K, et al. Graft size assessment and analysis of donors for living donor liver transplantation using right lobe. Transplantation. 2001; 71(10):1407-1413.
  25. Smith CM, Davies DB, McBride MA. Liver transplantation in the United States: A report from the organ procurement and transplantation network. Clin Transpl. 2000; Chapter 2:19-30.
  26. Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.
  27. Sugawara Y, Makuuchi M, Takayama T, et al. Small-for-size grafts in living-related liver transplantation. J Am Coll Surg. 2001; 192(4):510-513.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Association for the Study of Liver Diseases (AASLD). Practice Guidelines: Evaluation for liver transplantation in adults: 2013 practice guideline by the American Association for the Study of Liver Disease and the American Society of Transplantation. October 2014. Available at: http://www.aasld.org/sites/default/files/guideline_documents/evaluationadultltenhanced.pdf. Accessed on February 12, 2018.
  2. American Association for the Study of Liver Disease (AASLD). Practice Guidelines. Evaluation of the pediatric patient for liver transplantation: 2014 practice guideline by the American Association for the Study of Liver Diseases, American Society of Transplantation and The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. October 2014. Available at: http://www.aasld.org/sites/default/files/guideline_documents/EvaluationPediatricLT2014.pdf. Accessed on February 12, 2018.
  3. American Society of Transplant Surgeons' position paper on adult-to-adult living donor liver transplantation. Liver Transplant 2000; 6(6):815-817.
  4. Centers for Medicare and Medicaid Services. National Coverage Determination. Available at: http://www.cms.hhs.gov/mcd/index_chapter_list.asp. Accessed on February 12, 2018.
    • Adult Liver Transplantation. NCD #260.1. Effective June 21, 2012.
    • Pediatric Liver Transplantation. NCD #260.2. Effective April 21, 1991.
  5. NCCN Clinical Practice Guidelines in Oncology™ (NCCN). © 2018 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website at: http://www.nccn.org/index.asp. Accessed on February 12, 2018.
    • Hepatobiliary Cancers (V4.2017) Revised October 9, 2017.
  6. United Network for Organ Sharing (UNOS). Organ Procurement and Transplantation Network. Policies: 9: allocation of livers and liver-intestines. Revised February 5, 2018. Available at: http://optn.transplant.hrsa.gov/governance/policies/. Accessed on February 12, 2018.
Websites for Additional Information
  1. Centers for Disease Control. Using viral load data to monitor HIV burden and treatment outcomes in the United States. March 3 2014. Available at: https://npin.cdc.gov/publication/using-viral-load-data-monitor-hiv-burden-and-treatment-outcomes-united-states. Accessed on February 12, 2018.
  2. United Network for Organ Sharing. Available at: http://www.unos.org. Accessed on February 12, 2018.
Index

Bioartificial Liver Device (BAL)
Liver Transplant: Orthotopic and Heterotopic
LIVERx 200 Bioartificial Liver System
Sybiol® Synthetic Bio-Liver Device
Transplant, Liver
Xenotransplantation

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, References and Websites sections.

Reviewed

05/04/2017

MPTAC review. Updated formatting in position statement section. Updated References and Websites sections.

Revised

05/05/2016

MPTAC review. Defined abbreviation in absolute contraindication section and corrected grammatically error in position statement. Updated Rationale, References and Websites sections.

 

01/01/2016

Updated Coding section with 01/01/2016 CPT changes, removed 47136 deleted 12/31/2015; also removed ICD-9 codes.

Reviewed

05/07/2015

MPTAC review. Updated Description, Rationale, References and Websites.

Reviewed

05/15/2014

MPTAC review. Updated References and Websites.

Revised

05/09/2013

MPTAC review.

Revised

05/08/2013

Hematology/Oncology Subcommittee. Added medically necessary clinical indication for mass occupying lesion: hilar cholangiocarcinoma. Updated investigational and not medically necessary statement for extrahepatic malignancy to include non-hilar extrahepatic cholangiocarcinoma and intrahepatic cholangiocarcinoma. Updated Rationale, References and Websites.

Reviewed

11/08/2012

MPTAC review. Updated Background, References and Websites.

Reviewed

11/17/2011

MPTAC review. Updated References and Websites.

Revised

11/18/2010

MPTAC review. Updated medically necessary covered conditions for liver transplantation. Definitions, References and Websites updated.

Reviewed

11/19/2009

MPTAC review. Clarification of Investigational and Not Medically Necessary statement. Updated definitions and references.

Reviewed

11/20/2008

MPTAC review. Updated references.

Reviewed

11/29/2007

MPTAC review. Updated references. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.”

Reviewed

12/07/2006

MPTAC review. References updated. Coding updated; removed CPT 47134 deleted 12/31/03.

Revised

12/01/2005

MPTAC review. Addition of cryptogenic cirrhosis under the list of liver diseases leading to end organ liver failure. Clarification of investigational/not medically necessary statement.

 

11/17/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

07/14/2005

MPTAC review.

Revised

04/28/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

09/18/2004

TRANS.00008

Liver Transplant

WellPoint Health Networks, Inc. 12/02/2004 7.06.02 Liver Transplantation