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Liver transplantation is now routinely performed as a treatment of last resort for patients with end-stage liver disease. Patients are prioritized for transplant according to length of time on the waiting list and severity of illness criteria developed by the United Network of Organ Sharing (UNOS). On February 27, 2002, UNOS eliminated the original liver allocation system, which was based on assignment to Status 1, 2A, 2B, or 3. The new system retains Status 1, which is intended to describe patients with acute liver failure who have a life expectancy of less than 7 days, and Status 7, which describes patients who are temporarily inactive due to intercurrent medical problems. Status 2A, 2B, and 3 were replaced with a new scoring system: model for end-stage liver disease (MELD) and pediatric end-stage liver disease (PELD) for patients younger than age 1812 years. 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. MELD and PELD are 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 patients 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 1 to 40. The PELD score incorporates albumin, bilirubin, INR growth failure, and age at listing. Aside from Status 1, donor livers will be prioritized to those with the highest MELD or PELD number; waiting time will only be used to break ties among patients 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, since some patients were listed early in the course of their disease, while others were listed only when they became sicker. In the new MELD/PELD allocation system, patients with higher MELD/PELD scores will always be considered before those with lower scores, even if some patients with lower scores have waited longer.

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 transplantation of the left lateral segment is now commonly performed between parent and child. Recently, adult-to-adult living-donor transplantation has been investigated, using the right lobe of the liver from a related or unrelated donor. In addition to addressing the problem of donor organ scarcity, 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 pretransplant.

A liver transplant, using a cadaver or living donor, is medically necessary for carefully selected patients with end-stage liver failure due to irreversibly damaged livers.

Etiologies of end-stage liver disease include, but are not limited to, the following:

1.  Hepatocellular diseases

2.  Cholestatic liver diseases

3.  Vascular disease

4.  Primary hepatocellular carcinoma

5.  Inborn errors of metabolism

6.  Trauma and toxic reactions

7.  Miscellaneous

• Polycystic disease of the liver
• Familial amyloid polyneuropathy

Liver transplantation may be considered medically necessary in patients with unresectable hilar cholangiocarcinoma (see Policy Guidelines for patient selection criteria).

Liver retransplantation may be considered medically necessary in patients with:

Liver transplantation is considered investigational in the following patients:

Liver transplantation is considered not medically necessary in the following patients:

HIV positivity is not an absolute contraindication to transplant.  Each individual transplant center will determine patient selection criteria for HIV positive patients.

None

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

General

Potential contraindications subject to the judgment of the transplant center:

1. Known current malignancy, including metastatic cancer
2. Recent malignancy with high risk of recurrence
3. Untreated systemic infection making immunosuppression unsafe, including chronic infection
4. Other irreversible end-stage disease not attributed to liver disease
5. History of cancer with a moderate risk of recurrence
6. Systemic disease that could be exacerbated by immunosuppression
7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Liver Specific

Patients formally listed as Status 1 or with a MELD (PELD) > 6 can be considered to have end-stage liver disease. Patients typically are not listed initially as Status 7 (temporarily inactive for a maximum of 30 days due to intercurrent medical problem), but are temporally placed on the inactive list due to the development of a temporary contraindication to transplant, such as infection. If precertification or prior authorization is sought while the patient is listed as Status 7, the case should be deferred and reevaluated when the patient once again becomes an active transplant candidate.

Patients with liver disease related to alcohol or drug abuse must be actively involved in a treatment program.

Patients with polycystic disease of the liver do not develop liver failure but may require transplantation due to the anatomic complications of a hugely enlarged liver. One of the following complications should be present:

• Enlargement of liver impinging on respiratory function
• Extremely painful enlargement of liver
• Enlargement of liver significantly compressing and interfering with function of other abdominal organs

Patients 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. Candidacy for liver transplant is an individual consideration based on the morbidity of the polyneuropathy. Many patients may not be candidates for liver transplant alone due to coexisting cardiac disease.

Patients with hepatocellular carcinoma are appropriate candidates for liver transplant only if the disease remains confined to the liver. Therefore, the patient should be periodically monitored while on the waiting list, and if metastatic disease develops, the patient should be removed from the transplant waiting list. In addition, at the time of transplant a backup candidate should be scheduled. If locally extensive or metastatic cancer is discovered at the time of exploration prior to hepatectomy, the transplant should be aborted, and the backup candidate scheduled for transplant.

Cholangiocarcinoma

According to the OPTN policy on liver allocation, candidates with cholangiocarcinoma (CCA) meeting the following criteria will be eligible for a MELD/PELD exception with a 10% mortality equivalent increase every 3 months:

• Centers must submit a written protocol for patient care to the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee before requesting a MELD score exception for a candidate with CCA. This protocol should include selection criteria, administration of neoadjuvant therapy before transplantation, and operative staging to exclude patients with regional hepatic lymph node metastases, intrahepatic metastases, and/or extrahepatic disease. The protocol should include data collection as deemed necessary by the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee.
• Candidates must satisfy diagnostic criteria for hilar CCA: malignant-appearing stricture on cholangiography and one of the following: carbohydrate antigen 19-9 100 U/mL, or and biopsy or cytology results demonstrating malignancy, or aneuploidy. The tumor should be considered unresectable on the basis of technical considerations or underlying liver disease (e.g., primary sclerosing cholangitis).
• If cross-sectional imaging studies (computed tomography [CT] scan, ultrasound, magnetic resonance imaging [MRI]) demonstrate a mass, the mass should be 3 cm or less.
• Intra- and extrahepatic metastases should be excluded by cross-sectional imaging studies of the chest and abdomen at the time of initial exception and every 3 months before score increases.
• Regional hepatic lymph node involvement and peritoneal metastases should be assessed by operative staging after completion of neoadjuvant therapy and before liver transplantation. Endoscopic ultrasound-guided aspiration of regional hepatic lymph nodes may be advisable to exclude patients with obvious metastases before neoadjuvant therapy is initiated.
• Transperitoneal aspiration or biopsy of the primary tumor (either by endoscopic ultrasound, operative, or percutaneous approaches) should be avoided because of the high risk of tumor seeding associated with these procedures.

While charges for the retrieval of organs are considered eligible for coverage when patient criteria are met, any charges for the organ itself are considered ineligible for coverage.

2/2001: Reviewed by MPAC; The evidence of abstinence for a minimum of 6 months will no longer be required.

7/9/2001: Code Reference section updated; 356.0, 459.9, 576.2 and 576.8 ICD-9 diagnosis codes deleted

2/14/2002: Investigational definition added

5/1/2002: Type of Service and Place of Service deleted

5/14/2002: Description and Policy Guidelines sections revised; UNOS status categories deleted

7/21/2005: Reviewed by MPAC; "HIV positivity is not an absolute contraindication to transplant.  Each individual transplant center will determine patient selection criteria for HIV positive patients."

10/17/2005: Code Reference table updated; codes S2152, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147 added.  V59.6, 285.0, 751.62 deleted; ICD-9 procedure codes 00.91, 00.92, 00.93 added; diagnosis codes 070.70, 070.71, 273.4, 279.4 added.  Deleted Non-Covered Codes table.

10/25/2005: Description revised for CPT-4 codes: 47133, 47135, 47136.  Description revised for ICD-9 diagnosis codes: 070.0, 070.1, 070.20-070.23, 070.30-070.33, 070.51- 070.54, 070.59, 121.1, 121.3, 155.0, 270.0-270.9, 271.0-271.4, 271.8, 271.9, 272.0-272.9, 275.0, 275.1, 277.1, 277.3, 357.4, 571.6, 573.1, 573.2, 573.3.  ICD-9 Diagnosis codes range detailed: 864.00-864.05, 864.09-864.15, 864.19. 

03/14/2006: Coding updated. CPT4 2006 revisions added to policy.

9/13/2006: Coding updated.  ICD9 2006 revisions added to policy.

12/19/2008: Policy reviewed, no changes

9/28/2009: Code reference section updated. New ICD-9 diagnosis codes 279.41 and 279.49 added to covered table. Deleted statement added to ICD-9 diagnosis code 279.4 deleted as of 10-1-2009.

10/14/2010: Annual ICD-9 code update: 275.0 deleted/expanded to the fifth digit. Added 275.01 - 275.09 to the Covered Codes table.

12/13/2011:  Policy description updated. Added Biliary atresia to the medically necessary policy statement.  Added   neuroendocrine tumor metastases to investigational statement. Policy statement regarding hepatocellular carcinoma that has extended beyond the liver, active infection, and ongoing alcohol and/or drug abuse was changed from investigational to not medically necessary.  Deleted outdated references from the Sources section.

04/18/2013: Policy statement revised to add alcoholic steatohepatitis cirrhosis as medically necessary, to add medically necessary indications for retransplantation, and to indicate that  xtrahepatic peri-hilar or hilar cholangiocarcinoma may be considered medically necessary. Other intrahepatic or extrahepatic malignancies including non-peri-hilar or non-hilar cholangiocarcinoma and recurrent hepatocellular carcinoma salvage treatment added to the investigational policy statement. Added potential contraindications to transplant and cholangiocarcinoma selection criteria to the policy guidelines.  

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

Appendix

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