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Transcatheter arterial chemoembolization (TACE) of the liver is a proposed alternative to conventional systemic or intra-arterial chemotherapy, and to various nonsurgical ablative techniques, to treat resectable and nonresectable tumors. TACE combines the infusion of chemotherapeutic drugs with particle embolization. Tumor ischemia secondary to the embolization raises the drug concentration compared with infusion alone, extending the retention of the chemotherapeutic agent and decreasing systemic toxicity. The liver is especially amenable to such an approach, given its distinct lobular anatomy, the existence of two (2) independent blood supplies, and the ability of healthy hepatic tissue to grow and thus compensate for tissue mass lost during chemoembolization.
TACE of the liver has been associated with potentially life-threatening toxicities and complications, including severe postembolization syndrome, hepatic insufficiency, abscess, or infarction. TACE has been investigated to treat resectable, unresectable, and recurrent hepatocellular carcinoma (HCC), cholangiocarcinoma, liver metastases, and in the liver transplant setting. Treatment alternatives include resection when possible, chemotherapy administered systemically or by hepatic artery infusion (HAI). HAI involves continuous infusion of chemotherapy with an implanted pump, while TACE is administered episodically. Also, HAI does not involve the use of embolic material.
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy after HCC (10% vs 90%, respectively). Surgical resection represents the only form of curative therapy, however, most ICC patients are not surgical candidates due to their advanced disease at the time of diagnosis, which is caused by the lack of symptoms until late in the disease. The overall prognosis of ICC is far worse than for extrahepatic cholangiocarcinoma because of its late presentation. Most patients with ICC qualify for palliative therapy, including systemic chemotherapy and radiotherapy. However, such palliative options afford little to no survival improvement over supportive therapy alone, because ICC responds poorly to such existing therapies. Survival prognosis for patients with unresectable ICC is approximately 5 to 8 months.
TACE has been explored in various settings: as a technique to prevent tumor progression in patients on the liver transplant waiting list, to downstage tumors such that the patient is considered a better candidate for liver transplantation, and to decrease the incidence of post-transplant recurrence in patients with larger (T3) tumors. All of these uses are in part related to the United Network for Organ Sharing (UNOS) liver allocation policy, which prioritizes patients for receiving donor livers. The UNOS policy and the previous three uses are discussed further in the following sections.
Neuroendocrine tumors are a heterogeneous group of typically slow-growing tumors with an indolent course, with the capacity to synthesize and secrete hormones. Liver metastases may result in significant hormonal symptoms and are associated with a poor prognosis. Systemic chemotherapy for these tumors has shown modest response rates of limited duration, and, although somatostatin analogs are usually effective in controlling symptoms, the disease eventually becomes refractory. Therefore, liver-directed therapies aim to reduce tumor burden to lower hormone levels and to palliate symptoms in patients with unresectable neuroendocrine metastases.
Uveal (ocular) melanoma is the most common primary ocular malignancy in adults and shows a strong predilection for liver metastases. Even with successful treatment of the primary tumor, up to 50% of patients will subsequently develop systemic metastases, with liver involvement in up to 90% of these patients. Metastatic uveal melanoma is resistant to systemic chemotherapy, leading to the evaluation of locoregional treatment modalities to control tumor progression in the liver, including TACE.
The TACE procedure requires hospitalization for placement of the hepatic artery catheter and workup to establish eligibility for chemoembolization. Before the procedure, the patency of the portal vein must be demonstrated to ensure an adequate post-treatment hepatic blood supply. With the patient under local anesthesia and mild sedation, a superselective catheter is inserted via the femoral artery and threaded into the hepatic artery. Angiography is then performed to delineate the hepatic vasculature, followed by injection of the embolic chemotherapy mixture. Embolic material varies, but may include a viscous collagen agent, polyvinyl alcohol particles, or ethiodized oil. Typically, only one (1) lobe of the liver is treated during a single session, with subsequent embolization procedures scheduled from 5 days to 6 weeks later. In addition, since the embolized vessel recanalizes, chemoembolization can be repeated as many times as necessary.
UNOS Liver Allocation Policy
T1: 1 nodule greater than 1 cm and 1.9 cm or smaller
In considering how to allocate the scarce donor organs, UNOS sought to balance risk of death on the waiting list against risk of recurrence after transplant. Patients with T1 lesions are considered at low risk of death on the waiting list, while those with T3 lesions are at high risk of post-transplant recurrence and are generally not considered transplant candidates. Patients with T2 tumors have an increased risk of dying while on the waiting list compared with those with T1 lesions, and are an acceptable risk of post-transplant tumor recurrence. Therefore, UNOS criteria, which were updated in 2013, prioritize only T2 HCC patients who meet specified staging and imaging criteria by allocating additional points equivalent to a MELD score predicting a 15% probability of death within 3 months. This definition of T2 lesions is often referred to as the Milan criteria, in reference to a key 1996 study that examined the recurrence rate of HCC according to the size of the initial tumor. Liver transplantation for those with T3 HCC is not prohibited, 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 an OPTN (Organ Procurement and Transplantation Network) 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 locoregional 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.
The UNOS allocation system provides strong incentives to use locoregional therapies to downsize tumors to T2 status and to prevent progression while on the waiting list. A 2010 report of a national conference in the United States addressed the need to better characterize the long-term outcomes of liver transplantation for patients with HCC and to assess whether it is justified to continue the policy of assigning increased priority for candidates with early-stage HCC on the U.S. transplant waiting list. There was a general consensus at the meeting for the development of a calculated continuous HCC priority score for ranking HCC candidates on the list that would incorporate the calculated MELD score, α-fetoprotein, tumor size, and rate of tumor growth and that only candidates with at least stage T2 tumors would receive additional HCC priority points. The report addressed the role of locoregional therapy to downstage patients from T3 to T2 and stated that the results of downstaging before liver transplantation are heterogeneous, with no upper limits for tumor size and number before downstaging across studies, and the use of different end points for downstaging before transplantation.
Chemoembolization for hepatic tumors is a medical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). However, the embolizing agents and drugs are subject to FDA approval.
POLICYTranscatheter hepatic arterial chemoembolization may be considered medically necessary to treat hepatocellular cancer that is unresectable but confined to the liver and not associated with portal vein thrombosis.
Transcatheter hepatic arterial chemoembolization may be considered medically necessary to treat liver metastasis in symptomatic patients with metastatic neuroendocrine tumors whose symptoms persist despite systemic therapy and who are not candidates for surgical resection.
Transcatheter hepatic arterial chemoembolization may be considered medically necessary to treat liver metastasis in patients with liver-dominant metastatic uveal melanoma.
Transcatheter hepatic arterial chemoembolization may be considered medically necessary as a bridge to transplant in patients with hepatocellular cancer where the intent is to prevent further tumor growth and to maintain a patient’s candidacy for liver transplant. (See Policy Guidelines )
Transcatheter hepatic arterial chemoembolization is considered investigational to treat liver metastases from any other tumors or to treat hepatocellular cancer that does not meet the criteria noted above, including recurrent hepatocellular carcinoma.
Transcatheter hepatic arterial chemoembolization is considered investigational as neoadjuvant or adjuvant therapy in hepatocellular cancer that is considered resectable.
Transcatheter hepatic arterial chemoembolization is considered investigational to treat hepatocellular tumors prior to liver transplantation except as noted above.
Transcatheter hepatic arterial chemoembolization is considered investigational to treat unresectable cholangiocarcinoma.
When using transcatheter hepatic arterial chemoembolization as a bridge to transplantation to prevent further tumor growth, the following patient characteristics apply: a single tumor less than 5 cm or no more than three (3) tumors each less than 3 cm in size, absence of extrahepatic disease or vascular invasion, and Child-Pugh score of either A or B.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1997: Approved by the Medical Policy Advisory Committee (MPAC)
7/2/2001: Sources and Code Reference sections updated, non-covered code table added
4/10/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
9/20/2002: Policy reviewed, Hayes report number added
7/23/2003: Hayes report number deleted
11/5/2003: Code Reference section updated, HCPCS Q0083 deleted
7/27/2006: Policy updated. Updates approved per Medical Policy Advisory Committee (MPAC)
9/1/2006: Code reference section updated. Diagnosis codes 155.1, 155.2 added to noncovered table. HCPC Q0083 added to noncovered table.
2/21/2008: Policy section changed from investigational and revised to indicate that when specific criteria are met TACE may be considered medically necessary in cases of unresectable hepatocellular cancer, symptomatic metastatic, neuroendocrine tumors, and metastatic uveal melanomas. TACE as a bridge to transplant changed from investigational to medically necessary. Added patient characteristics for TACE as bridge to transplantation under the Policy Guidelines section. Non-covered codes moved to covered. Policy name changed from "Chemoembolization" to "Transcatheter Arterial Chemoembolization to Treat Primary or Metastatic Liver Malignancies".
7/10/2009: Policy reviewed, no changes
10/2/2009: Code reference section updated. ICD-9 diagnosis code 209.72 added to covered table.
12/30/2010: Policy statement added to indicate that transcatheter hepatic arterial chemoembolization is considered investigational as neoadjuvant or adjuvant therapy in hepatocellular cancer that is considered resectable. Deleted outdated references from the Sources section.
04/26/2012: Added the following policy statement: Transcatheter hepatic arterial chemoembolization is considered investigational to treat unresectable cholangiocarcinoma.
12/13/2012: Policy reviewed; no changes.
01/22/2014: Policy reviewed; no changes to policy statement. Added the following new 2014 CPT code(s) to the Code Reference section: 37243.
11/14/2014: Policy reviewed; description updated. Policy statements unchanged. Removed deleted CPT code 37204 from the Code Reference section.
08/26/2015: Code Reference section updated for ICD-10.
11/10/2015: Policy description updated to add information regarding intrahepatic cholangiocarcinoma, neuroendocrine tumors, uveal melanoma, and the UNOS liver allocation policy. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.11
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.