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DESCRIPTIONTranscatheter 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. The rationale for TACE is that infusions of viscous material containing one or more antineoplastic agents may exert synergistic effects: cytotoxicity from the chemotherapy, potentiated by anoxia in the infarcted region. The beneficial effect of chemoembolization may be further potentiated by labeling the infusate with radioactive isotopes for localized radiotherapy. 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. Another rationale is that TACE delivers effective local doses, while possibly minimizing systemic toxicities associated with oral or intravenous chemotherapy.
However, TACE of the liver is associated with its own constellation of 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, and to treat liver metastases, most commonly from colorectal cancer. 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.
The TACE procedure requires hospitalization for placement of the hepatic artery catheter and workup to establish eligibility for chemoembolization. Prior to 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.
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.
POLICY GUIDELINESWhen 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 5cm or no more than three (3) tumors each less than 3cm in size, absence of extrahepatic disease or vascular invasion, and Child-Pugh score of either A or B.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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.
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.