Print

Date Printed: June 28, 2017: 11:47 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

02-40000-20

Original Effective Date: 02/15/01

Reviewed: 05/22/14

Revised: 01/01/16

Next Review: No Longer Scheduled for Routine Review (NLR)

Subject: Liver Transplant

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Recipients

Liver transplantation is now routinely performed as a treatment of last resort for individuals with end-stage liver disease. Liver transplantation may be performed with liver donation after brain or cardiac death or with a liver segment donation from a living donor. Candidates are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network (OPTN) and the United Network of Organ Sharing (UNOS). The original liver allocation system was based on assignment to Status 1, 2A, 2B, or 3. Status 2A, 2B, and 3 were based on the Child-Turcotte-Pugh score, which included a subjective assessment of symptoms as part of the scoring system. In February 2002, Status 2A, 2B, and 3 were replaced with 2 disease severity scales: the model for end-stage liver disease (MELD), and pediatric end-stage liver disease (PELD), for individuals younger than age 12 years. In June 2013, OPTN/UNOS published its most recent allocation system. Status 1A individuals have acute liver failure with a life expectancy of less than 7 days without a liver transplant. Status 1A individuals also include primary graft nonfunction, hepatic artery thrombosis and acute Wilson’s disease. Status 1A individuals must be recertified as Status 1A every 7 days. Status 1B individuals are pediatric patients (age 0-17 years) with chronic liver disease listed as: fulminant liver failure, primary nonfunction, hepatic artery thrombosis, acute decompensated Wilson’s disease, chronic liver disease; and nonmetastatic hepatoblastoma. Pediatric individuals move to Status 1A upon age18 but still qualify for pediatric indications.

Following Status 1, donor livers will be prioritized to those with the highest scores on MELD or PELD. With this allocation system, the highest priority for liver transplantation is given to individuals receiving the highest number of points. The scoring system for MELD and PELD is a continuous disease severity scale based entirely on objective laboratory values. These scales have been found to be highly predictive of the risk of dying from liver disease for candidates waiting on the transplant list. The MELD score incorporates bilirubin, prothrombin time (i.e., international normalized ratio [INR]), and creatinine into an equation, producing a number that ranges from 6 (less ill) to 40 (gravely ill). The PELD score incorporates albumin, bilirubin, INR growth failure, and age at listing. Waiting time will only be used to break ties among candidates with the same MELD or PELD score and blood type compatibility. In the previous system, waiting time was often a key determinant of liver allocation, and yet, waiting time was found to be a poor predictor of the urgency of liver transplant, because some candidates were listed early in the course of their disease, while others were listed only when they became sicker. In the revised allocation systems, patients with a higher mortality risk and higher MELD/PELD scores will always be considered before those with lower scores, even if some candidates with lower scores have waited longer. Status 7 describes individuals who are temporarily inactive on the transplant waiting list due to being temporarily unsuitable for transplantation.

Donors

Due to the scarcity of donor livers, a variety of strategies have been developed to expand the donor pool. For example, split graft refers to dividing a donor liver into 2 segments that can be used for 2 recipients. Living donor liver transplantation (LDLT) is now commonly performed for adults and children from a related or unrelated donor. Depending on the graft size needed for the recipient, either the right lobe, left lobe or the left lateral segment can be used for LDLT. In addition to addressing the problem of donor organ scarcity, LDLT allows the procedure to be scheduled electively before the recipient’s condition deteriorates or serious complications develop. LDLT also shortens the preservation time for the donor liver, and decreases disease transmission from donor to recipient.

POSITION STATEMENT:

 

Certificate of Medical Necessity

The transplant facility should submit a completed Certificate of Medical Necessity (CMN) along with your request for transplant services to expedite the medical review process.

1. Click this link Solid Organ Transplant - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

A liver transplant, using a cadaver or living donor, meets the definition of medical necessity for carefully selected individuals with end-stage organ failure resulting from irreversible liver damage. Etiologies of end-stage liver disease include, but are not limited to:

A. Hepatocellular disease

• Alcoholic cirrhosis (transplant candidates with liver disease related to alcohol or drug abuse must be actively involved in a treatment program)

• Viral hepatitis (A, B, C, or non-A, non-B)

• Autoimmune hepatitis

• Alpha-1 antitrypsin deficiency

Hemochromatosis

• Non-alcoholic steatohepatitis

• Protoporphyria

• Wilson’s disease.

B. Cholestatic liver disease

• Primary biliary cirrhosis

• Primary sclerosing cholangitis with development of secondary biliary cirrhosis

Biliary atresia.

C. Vascular disease

Budd-Chiari syndrome.

D. Primary hepatocellular carcinoma with ONE of the following:

• A single tumor 5 cm or less in diameter or 2 to 3 tumors 3 cm or less, OR

• A single tumor 6.5 cm or less or up to 3 tumors 4.5 cm or less, and a total tumor size of 8 cm or less, OR

• A single tumor 1 cm or greater and up to 5 cm or less in diameter or 2 to 3 tumors 1 cm or greater and up to 3 cm or less and without extrahepatic spread or macrovascular invasion.

E. Inborn errors of metabolism, including but not limited to:

• Organic acidurias

• Homozygous type II hyperlipoproteinemia

• Crigler-Najjar Syndrome type I

• Some urea cycle deficiencies

• Glycogen storage diseases types I and IV

• Tyrosine deficiency

• Citrullinemia

• Ornithine transcarboxylase deficiency

• Oxalosis (primary)

F. Trauma and toxic reactions

G. Miscellaneous

• Familial amyloid polyneuropathy*

• Polycystic disease of the liver*, with at least ONE of the following:

o Enlargement of liver impinging on respiratory function

o Extremely painful enlargement of liver

o Enlargement of liver significantly compressing and interfering with function of other abdominal organs

• Unresectable hilar cholangiocarcinoma

• Nonmetastatic hepatoblastoma

* NOTE: Individuals with familial amyloid polyneuropathy do not experience liver disease, per se, but develop polyneuropathy and cardiac amyloidosis due to the production of a variant transthyretin molecule by the liver. Individuals with polycystic disease of the liver do not develop liver failure, but may require transplantation due to the anatomic complications of a massively enlarged liver.

Liver transplant does not meet the definition of medical necessity for the following conditions:

• Hepatocellular carcinoma that has extended beyond the liver

• Ongoing alcohol and/or drug abuse

Liver transplant is considered experimental or investigational for the following conditions, as available clinical evidence does not support safety and effectiveness:

• Intrahepatic cholangiocarcinoma

• Neuroendocrine tumors metastatic to the liver

Potential contraindications to liver transplant (subject to the judgment of the transplant center) include:

• Known current malignancy, including metastatic cancer

• Recent malignancy with high risk of recurrence

• Untreated systemic infection making immunosuppression unsafe, including chronic infection

• Other irreversible end-stage disease not attributed to liver disease

• History of cancer with a moderate risk of recurrence

• Systemic disease that could be exacerbated by immunosuppression

• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Liver retransplantation meets the definition of medical necessity in individuals with:

• Primary graft nonfunction

• Hepatic artery thrombosis

• Chronic rejection

• Ischemic type biliary lesions after donation after cardiac death

• Recurrent nonneoplastic disease causing late graft failure

Transplant associated services which meet the definition of medical necessity include:

• Hospitalization of the recipient for medically recognized transplants from a donor to a transplant recipient

• Evaluation tests requiring hospitalization to determine the suitability of both potential and actual donors, when such tests cannot be safely and effectively performed on an outpatient basis

• Hospital room, board, and general nursing in semi-private rooms

• Special care units, such as coronary and intensive care

• Hospital ancillary services

• Physicians’ services for surgery, technical assistance, administration of anesthetics, and medical care

• Acquisition, preparation, transportation, and storage of organ

• Diagnostic services

• Drugs that require a prescription by federal law.

BILLING/CODING INFORMATION:

CPT Coding:

47133

Donor hepatectomy (including cold preservation), from cadaver donor

47135

Liver allotransplantation; orthoptic; 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, with preparation and maintenance of allograft, from living donor; total left lobectomy (segments II, III and IV)

47142

Donor hepatectomy, with preparation and maintenance of allograft, 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 (i.e., 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 (i.e., left lobe (segments II, III, and IV) and right lobe (segments I and V thorough VIII)

47146

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

47147

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

REIMBURSEMENT INFORMATION:

None indicated.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Adult Liver Transplantation (260.1) and Pediatric Liver Transplantation (260.2), located at cms.gov.

DEFINITIONS:

Allotransplantation: transplantation of tissue from one individual to another of the same species, but of different genotypes.

Ascites: accumulation of serous fluid in the abdominal cavity.

Biliary atresia: obliteration of one or more components of the bile ducts due to arrested fetal development resulting in persistent jaundice and liver damage ranging from biliary stasis to cirrhosis, with spleen enlargement as portal hypertension progresses.

Budd-Chiari syndrome: symptomatic obstruction or occlusion of the hepatic veins eventually resulting in liver failure; death can occur within days in cases of complete occlusion.

Child-Turcote-Pugh (CTP) score: a scoring system for liver function based on the presence of encephalopathy AND/OR ascites, and laboratory measures of bilirubin, albumin, and prothrombin time; this scoring system was used prior to implementation of the MELD and PELD scoring system.

Encephalopathy: condition usually occurring secondarily to advanced liver disease, marked by disturbances of consciousness with may progress to coma (hepatic coma).

Hemochromatosis: disorder where deposits of intercellular storage of iron in the parenchymal cells of the liver, causing tissue damage and dysfunction of the liver.

Hepatectomy: excision of all or part of the liver.

Hepatic: referring to the liver.

Heterotopic transplantation: refers to the placement of the donor liver in a different location, typically with the native liver remaining in site.

INR: International Normalized Ratio; variables and sensitivities of thromboplastins.

Intrinsic: entirely within or pertaining exclusively to a part.

Necrotizing: changes indicative of cell death caused by progressive deteriorating action of enzymes, affecting groups of cells or part of a structure or organ.

Orthotopic: refers to placement of the donor liver in its correct anatomic location.

Sclerosing cholangitis: fibrosing inflammation of the bile ducts of unknown cause, most commonly in young men and frequently associated with chronic ulcerative colitis.

UNOS: United Network of Organ Sharing.

Wilson’s disease: inherited disease involving metabolism of copper and resulting in accumulation of copper in the liver, brain, kidney, cornea, and other tissues; characterized by cirrhosis of the liver and generative changes in the brain.

RELATED GUIDELINES:

Small Bowel Transplant, 02-40000-18
Small Bowel, Liver and Multivisceral Transplant, 02-40000-19

OTHER:

None applicable.

REFERENCES:

  1. American Association for the Study of Liver Diseases (AASLD). Practice Guidelines: Evaluation of the Patient for Liver Transplantation. 2005. Accessed at: http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/Liver%20Transplant.pdf. on 04/25/14.
  2. American Society of Transplantation position statements. Accessed 05/20/08.
  3. Blue Cross Blue Shield Association Medical Policy – Liver Transplant # 7.03.06, (January 2014).
  4. Blue Cross Blue Shield Association TEC Assessments (p. 351), (1988).
  5. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination Manual, Adult Liver Transplantation: Publication 100-3, Section 260.1, (06/21/12).
  6. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination Manual, Pediatric Liver Transplantation: Publication 100-3, Section 260.2, (04/21/91).
  7. Clavien PA, Lesurtel M, Bossuyt PM et al. Recommendations for liver transplantation for hepatocellular carcinoma: an international consensus conference report. Lancet Oncol 2012; 13(1):e11-22.
  8. Clinical Trials.gov. Liver Transplants in People With HIV Infection. Identifier: NCT00473629. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
  9. ECRI Health Technology Assessment: Liver Transplantation for Treatment of Hereditary Amyloidosis-Transthyretin Type (ATTR), (09/05).
  10. ECRI. Custom Hotline Response. Liver and kidney Transplantation in HIV – Positive Patients. Plymouth Meeting, PA. ECRI. Updated 12/11/07.
  11. ECRI. Target Report. Kidney/Liver transplantation in human immunodeficiency virus (HIV) + patients. Plymouth Meeting, PA. ECRI. 04/08.
  12. Friman S, Foss A, Isoniemi H et al. Liver transplantation for cholangiocarcinoma: selection is essential for acceptable results. Scand J Gastroenterol 2011; 46(3):370-5.
  13. HAYES, Inc. Medical Technology Directory: Liver Transplantation, Adult. Lansdale, PA: Hayes, Inc 07/02; updated 07/29/07.
  14. HAYES, Inc. Medical Technology Directory: Liver Transplantation, Pediatric. Lansdale, PA: Hayes, Inc; 07/02; updated 07/31/07.
  15. HAYES, Inc. Medical Technology Directory: Living Donor Liver Transplantation. Lansdale, PA: Hayes, Inc; 05/22/02; updated 03/20/07.
  16. HCFA Program Memorandum, Transmittal AB-00-17: Clarification of Liver Transplant Policy, (March, 2000).
  17. InterQual® 2013.2. CP Procedures: Transplantation, Liver.
  18. MELD Information for Liver Transplant Professionals.
  19. National Institutes of Health; Kidney and Liver Transplantation in People with HIV, (02/04).
  20. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers; v2:2014. Accessed at: http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf on 04/26/14.
  21. National Guideline Clearinghouse Guideline Summary NGC-8006: Management of hepatocellular carcinoma: an update. Alexandria (VA): American Association for the Study of Liver Diseases; 2010 Jul.
  22. National Institute for Health and Clinical Excellence (NICE). Interventional Procedure Guidance (IPG) 194: Living-donor liver transplantation (May 2006). Accessed at http://www.nice.org.uk/ on 04/27/14.
  23. Newsome PN, Allison ME, Andrews PA et al. Guidelines for liver transplantation for patients with non-alcoholic steatohepatitis. Gut 2012; 61(4):484-500.
  24. Organ Procurement and Transplantation Network Policies (04/10/14). Accessed at: http://optn.transplant.hrsa.gov/policiesAndBylaws/policies.asp on 04/26/14.
  25. Remiszewski P, Kalinowski P, Dudek K et al. Influence of selected factors on survival after liver retransplantation. Transplant Proc 2011; 43(8):3025-8.
  26. United Network of Organ Sharing (UNOS) Policy 3.6. Allocation of Livers. Updated March 3, 2009. Accessed 06/09/09.
  27. United Network of Organ Sharing (UNOS) Policy 4.2.1 (2004). Accessed 05/20/08.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/22/14.

GUIDELINE UPDATE INFORMATION:

02/15/01

Medical Coverage Guideline Developed.

03/15/02

Reviewed investigational status – maintained.

09/26/02

Revised to include new MELD and PELD scoring system criteria.

01/01/04

Annual HCPCS coding update.

03/15/04

Scheduled reviewed with formatting revisions; no change in coverage statement.

01/01/05

HCPCS coding update: added new codes for liver transplantation; revised 47133 and 47140 descriptors.

06/15/05

Revision to guideline, consisting of removal of investigational statement regarding HIV-positive recipients.

06/15/06

Scheduled review; no change in coverage statement.

06/15/07

Scheduled review; reformatted guideline; updated references.

09/15/07

Revision consisting of removal of criteria restricting coverage to patients over the age of 70 years.

07/15/08

Scheduled review; no change in position statement. Update references.

07/15/09

Scheduled review; no change in position statement. Update description section.

01/01/10

Annual HCPCS coding update: revise descriptors for CPT codes 47144 & 47145.

10/01/10

4th Quarter HCPCS coding update: ICD-9 diagnosis code 275.0 deleted; ICD-9 diagnosis codes 275.01, 275.02, 275.03 and 275.09 added.

10/15/10

Revision; related ICD-10 codes added.

04/01/12

Revision; updated ICD10 coding with new and revised codes.

08/15/12

Revision; added Medicare Advantage program exception in accordance with CMS Decision Memo (CAG-00091R).

06/15/14

Scheduled review. Revised description section, position statement and program exceptions section. Updated references.

01/01/16

Annual CPT/HCPCS coding update. Deleted code 47136.

Date Printed: June 28, 2017: 11:47 PM