Printer Friendly Version
Printer Friendly Version
Printer Friendly Version
A.8.01.11
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. Transcatheter arterial chemoembolization 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.
Transcatheter Arterial Chemoembolization
Transcatheter arterial chemoembolization (TACE) is a minimally invasive procedure performed by interventional radiologists who inject highly concentrated doses of chemotherapeutic agents into the tumor tissues and embolic agent(s) to restrict tumor blood supply. The embolic agent(s) causes ischemia and necrosis of the tumor and slows anticancer drug washout. The most common anticancer drugs used in published TACE studies for hepatocellular carcinoma include doxorubicin (36%), followed by cisplatin (31%), epirubicin (12%), mitoxantrone (8%), and mitomycin C (8%).
The TACE procedure requires hospitalization for placement of a 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 5 days to 6 weeks later. In addition, because the embolized vessel recanalizes, chemoembolization can be repeated as many times as necessary.
Adverse EventsTranscatheter arterial chemoembolization of the liver has been associated with potentially life-threatening toxicities and complications, including severe postembolization syndrome, hepatic insufficiency, abscess, or infarction. Transcatheter arterial chemoembolization has been investigated to treat resectable, unresectable, and recurrent hepatocellular carcinoma, intrahepatic cholangiocarcinoma, liver metastases, and in the liver transplant setting. Treatment alternatives include resection when possible, other locally ablative techniques (eg, radiofrequency ablation, cryoablation), and chemotherapy administered systemically or by hepatic artery infusion. Hepatic artery infusion involves the continuous infusion of chemotherapy with an implanted pump, while TACE is administered episodically. Hepatic artery infusion does not involve the use of embolic material.
Chemoembolization for hepatic tumors is a medical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration. However, the embolizing agents and drugs are subject to U.S. Food and Drug Administration approval.
Transcatheter arterial chemoembolization of the liver may be considered medically necessary:
to treat hepatocellular cancer that is unresectable but confined to the liver and not associated with portal vein thrombosis and liver function not characterized as Child-Pugh class C.
as a bridge to transplant in individuals with hepatocellular cancer where the intent is to prevent further tumor growth and to maintain an individual's candidacy for liver transplant. (See Policy Guidelines)
to treat liver metastasis in symptomatic individuals with metastatic neuroendocrine tumors whose symptoms persist despite systemic therapy and who are not candidates for surgical resection.
to treat liver metastasis in individuals with liver-dominant metastatic uveal melanoma.
Transcatheter arterial chemoembolization of the liver is considered investigational:
as neoadjuvant or adjuvant therapy in hepatocellular cancer that is considered resectable.
as part of combination therapy (with radiofrequency ablation) for resectable or unresectable hepatocellular carcinoma.
to treat unresectable intrahepatic cholangiocarcinoma.
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.
to treat hepatocellular tumors prior to liver transplantation except as noted above.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
When using transcatheter arterial chemoembolization of the liver as a bridge to transplantation to prevent further tumor growth, the candidate should have the following characteristics: a single tumor less than 5 cm or no more than three tumors each less than 3 cm in size, absence of extrahepatic disease or vascular invasion, and Child-Pugh class 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 Mental Health Disorders, 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 medical necessity, “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.
11/1997: 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.
05/25/2016: Policy number A.8.01.11 added.
09/23/2016: Policy description updated to add section headings. Policy statements unchanged.
08/08/2017: Policy description updated regarding the transcatheter arterial chemoembolization procedure. Policy statements revised to change "transcatheter hepatic arterial chemoembolization" to "transcatheter arterial chemoembolization." Medically necessary statement updated to state that transcatheter arterial chemoembolization of the liver may be considered medically necessary to treat hepatocellular cancer that is unresectable but confined to the liver and not associated with portal vein thrombosis and liver function not characterized as Child-Pugh class C. Policy Guidelines updated.
08/13/2018: Policy description updated regarding estimated cases of hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Policy statements unchanged.
08/15/2019: Policy description revised. Policy statements unchanged.
11/16/2020: Policy description updated regarding treatment alternatives. Policy statement updated to add that transcatheter arterial chemoembolization of the liver is considered investigational as part of combination therapy (with radiofrequency ablation) for resectable or unresectable hepatocellular carcinoma.
02/23/2022: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
08/11/2022: Policy reviewed. Policy statements updated to change "patients" to "individuals."
08/10/2023: Policy reviewed; no changes.
08/16/2024: Policy description and policy statement updated to specify "intrahepatic cholangiocarcinoma."
09/12/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 8.01.11
This 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.
Code Number | Description | ||
CPT-4 | |||
37243 | Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction | ||
75894 | Transcatheter therapy, embolization, any method, radiological supervision and interpretation | ||
HCPCS | |||
Q0083 | Chemotherapy administration by other than infusion technique only | ||
ICD-9 Procedure | ICD-10 Procedure | ||
99.25 | Injection or infusion of cancer chemotherapeutic substance | 3E06005, 3E06305 | Introduction of chemotherapeutic substance into central artery (Hepatic Artery) |
ICD-9 Diagnosis | ICD-10 Diagnosis | ||
155.0 155.1 155.2 | Malignant neoplasm of liver, primary Intrahepatic bile ducts Liver, not specified as primary or secondary | C22.0 – C22.9 | Malignant neoplasm of liver and intrahepatic bile ducts code range |
C24.0 – C24.9 | Malignant neoplasm of other and unspecified parts of biliary tract | ||
197.7 | Secondary malignant neoplasm of liver | C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct |
209.72 | Secondary neuroendocrine tumor of liver | C7B.02 | Secondary carcinoid tumors of liver (neuroendocrine) |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.