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Liver transplantation is currently performed routinely as a treatment of last resort for patients 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. Patients 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 severity of illness is determined by the model for end-stage liver disease (MELD) and pediatric end-stage liver disease (PELD) scores.
Liver transplantation is now routinely performed as a treatment of last resort for patients 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. Patients 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 patients younger than age 12 years scoring systems. In June 2013, OPTN/UNOS published its most recent allocation system, which previously expanded Status1 to Status 1A and 1B in September 2012. Status 1A patients have acute liver failure with a life expectancy of less than 7 days without a liver transplant. Status 1A patients also include primary graft nonfunction, hepatic artery thrombosis and acute Wilson’s disease. Status 1A patients must be recertified as Status 1A every 7 days. Status 1B patients are pediatric patients (age range, 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 patients 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 patients 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 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 6 to 40. The PELD score incorporates albumin, bilirubin, INR growth failure, and age at listing. 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 because some patients 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 higher mortality risk and higher MELD/PELD scores will always be considered before those with lower scores, even if some patients with lower scores have waited longer. Status 7 describes patients who are temporarily inactive on the transplant waiting list due to being temporarily unsuitable for transplantation. Pediatric patients who turn 18 are status X.
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.
Management of acute rejection of liver transplant using either intravenous immunoglobulin or plasmapheresis is discussed separately in the Immune Globulin Replacement Therapy and Plasma Exchange policies, respectively. In addition, the role of chemoembolization or radiofrequency ablation as a bridge to transplant in patients with hepatocellular cancer is addressed separately in the Transcatheter Arterial Chemoembolization to Treat Primary or Metastatic Liver Malignancies and Radiofrequency Ablation (RFA) of Primary or Metastatic Liver Tumors policies, respectively.
POLICYNo benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
A liver transplant, using a cadaver or living donor, may be considered 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
Liver transplantation may be considered medically necessary in patients with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.
Liver transplantation may be considered medically necessary in patients with unresectable hilar cholangiocarcinoma* (see Policy Guidelines for patient selection criteria).
Liver transplantation may be considered medically necessary in pediatric patients with nonmetastatic hepatoblastoma.
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:
Liver transplantation is considered investigational in all other situations not described above.
HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients.
* See Policy Guidelines section for patient selection criteria.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Potential contraindications subject to the judgment of the transplant center:
Liver-Specific Patient Selection Criteria
The MELD and PELD scores range from 6 (less ill) to 40 (gravely ill). The MELD and PELD scores will change during the course of a patient's tenure on the waiting list.
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. The MELD/PELD score may not apply to these cases. One of the following complications should be present:
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. MELD/PELD exception criteria and scores may apply to these cases. 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.
Criteria used for patient selection of hepatocellular carcinoma patients eligible for liver transplant include the Milan criteria, which is considered the criterion standard, the University of California, San Francisco (UCSF) expanded criteria, and UNOS criteria.
A single tumor 5 cm or less in diameter or 2 to 3 tumors 3 cm or less
UCSF Expanded Criteria
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
UNOS T2 Criteria
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. UNOS criteria, which were updated in 2013, may prioritize T2 HCC that meet specified staging and imaging criteria by allocating additional points equivalent to a MELD score predicting a 15% probability of death within 3 months.
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.
Note that liver transplantation for those with T3 HCC is not prohibited by UNOS guidelines, but these patients do not receive any priority on the waiting list. All patients with HCC awaiting transplantation are reassessed at 3-month intervals. Those whose tumors have progressed and are no longer T2 tumors will lose the additional allocation points.
Additionally, nodules identified through imaging of cirrhotic livers are given a class 5 designation. Class 5B and 5T nodules are eligible for automatic priority. Class 5B criteria consist of a single nodule 2 cm or larger and up to 5 cm (T2 stage) that meets specified imaging criteria. Class 5T nodules have undergone subsequent loco-regional treatment after being automatically approved on initial application or extension. A single class 5A nodule (>1 cm and <2 cm) corresponds to T1 HCC and does not qualify for automatic priority. However, combinations of class 5A nodules are eligible for automatic priority if they meet stage T2 criteria. Class 5X lesions are outside of stage T2 and are not eligible for automatic exception points. Nodules less than 1 cm are considered indeterminate and are not considered for additional priority. Therefore, the UNOS allocation system provides strong incentives to use loco-regional therapies to downsize tumors to T2 status and to prevent progression while on the waiting list.
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:
Donor Criteria: Living Donor Liver Transplant
Donor morbidity and mortality are prime concerns in donors undergoing right lobe, left lobe, or left lateral segment donor partial hepatectomy as part of living-donor liver transplantation. Partial hepatectomy is a technically demanding surgery, the success of which may be related to the availability of an experienced surgical team. In 2000, the American Society of Transplant Surgeons proposed the following guidelines for living donors:
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
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.
05/22/2014: Policy reviewed; description updated. Policy statement regarding a liver transplant using a cadaver or living donor changed from "is" medically necessary to "may be considered" medically necessary. Policy statement revised to move polycystic disease of the liver to a separate policy statement: "Liver transplantation may be considered medically necessary in patients with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment." Added policy statement that liver transplantation may be considered medically necessary in pediatric patients with nonmetastatic hepatoblastoma. Added investigational statement that liver transplantation is considered investigational in all other situations not described. Policy statement revised to remove "patients with an active infection" from the list of indications when liver transplantation is considered not medically necessary. Policy guidelines updated to add the MELD and PELD score range and to note that these scores may or may not apply to certain cases. Removed deleted ICD-9 codes 275.0, 277.3, and 279.4 from the Code Reference section.
02/16/2015: Policy reviewed; description updated regarding pediatric patients. Added the following statement to the policy statement section: * See Policy Guidelines section for patient selection criteria. Policy guidelines updated regarding selection criteria for hepatocellular carcinoma patients and donor criteria for living donor liver transplant.
08/27/2015: Code Reference section updated for ICD-10.
12/31/2015: Code Reference section updated to add CPT code 47399.
06/01/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes E78.00 and E78.01.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.03.06
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.