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CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies

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CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies Clinical UM Guideline Subject: Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies Guideline #: CG-SURG-78 Publish Date: 04/15/2020 Status: Revised Last Review Date: 02/20/2020 Description This document addresses surgical excision and locoregional therapies to treat primary or metastatic cancer of the liver. Treatment focuses on excising tumors or inducing tumor necrosis and can be used as a curative or palliative therapy, as a bridge to liver transplantation or in those who may become eligible for liver transplantation with treatment. Locoregional therapies both ablative and arterially directed therapies: • Ablative Therapy o Cryosurgical ablation, or cryotherapy o Microwave ablation (MWA) o Percutaneous ethanol injection (PEI) o Radiofrequency ablation (RFA) • Arterially directed therapy o Transcatheter arterial chemoembolization (TACE) o Transcatheter arterial embolization (TAE) o Selective internal radiation therapy (SIRT); also known as transarterial radioembolization (TARE) Note: For related topics, please see the following: • CG-SURG-61 Cryosurgical or Radiofrequency Ablation to Treat Solid Tumors Outside the Liver • RAD.00059 Catheter-based Embolization Procedures for Malignant Lesions Outside the Liver • SURG.00126 Irreversible Electroporation • TRANS.00008 Liver Transplantation Clinical Indications Medically Necessary: I. Primary Hepatic Carcinoma A. Surgical excision* of primary hepatobiliary carcinoma (including but not limited to hepatocellular carcinoma and cholangiocarcinoma) is considered medically necessary when all of the following criteria are met: 1. Complete excision of the carcinoma is anticipated; and 2. Two contiguous hepatic segments are preserved; and Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to implement a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card. Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. © CPT Only – American Medical Association Page 1 of 50 Clinical UM Guideline CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies 3. At least 20% of the total estimated liver volume is anticipated to be preserved; and 4. Extrahepatic disease, if present, has been or will be resected. B. Local ablative techniques* (specifically, percutaneous ethanol injection [PEI], radiofrequency [RFA], cryosurgical, or microwave ablation) are considered medically necessary in individuals with hepatocellular carcinoma who meet all of the following criteria: 1. The individual must be a poor candidate for surgical resection or unwilling to undergo surgical resection; and 2. The presence of 3 lesions or less, as documented by MRI or computerized tomography (CT) scan; and 3. Each lesion measures no more than 5 cm in diameter; and 4. No evidence of extra-hepatic disease; and 5. All foci of disease are amenable to ablative therapy; and 6. If a repeat procedure, at least 6 months have elapsed since the prior surgical resection or ablation. C. Transcatheter arterial chemoembolization (TACE), transcatheter arterial embolization (TAE) is considered medically necessary for either of the following indications: 1. Primary treatment for surgically unresectable primary hepatocellular carcinoma (HCC) when all of the following criteria are met: a. Preserved liver function defined as Childs-Turcotte-Pugh Class A or B; and b. Three or fewer encapsulated nodules, and each nodule is less than or equal to 5 centimeters in diameter; and c. No evidence of extra-hepatic metastases; and d. No evidence of severe renal function impairment; and e. No evidence of portal vein occlusion. 2. Palliative treatment of specific liver-related symptoms due to tumor bulk (for example, pain) from a primary hepatic tumor. D. SIRT/TARE is considered medically necessary for either of the following conditions: 1. Palliative treatment for individuals with specific liver-related symptoms due to tumor bulk (for example, pain) from a primary hepatic tumor, or 2. Primary treatment of surgically unresectable primary hepatocellular carcinoma when all of the following criteria are met: a. Preserved liver function defined as Childs-Turcotte-Pugh Class A or B; and b. Three or fewer encapsulated nodules and each nodule is less than or equal to 5 centimeters in diameter; and c. No evidence of extra-hepatic metastases; and d. No evidence of severe renal function impairment; and e. No evidence of portal vein occlusion. Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to implement a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card. Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. © CPT Only – American Medical Association Page 2 of 50 Clinical UM Guideline CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies II. Metastatic Tumors to the Liver A. Surgical excision* of liver metastases from colorectal cancer or functioning neuroendocrine tumors is considered medically necessary when all of the following criteria are met: 1. Complete excision of the carcinoma is anticipated; and 2. Two contiguous hepatic segments are preserved; and 3. At least 20% of the total estimated liver volume is anticipated to be preserved; and 4. Extrahepatic disease, if present, has been or will be resected; and 5. If a repeat procedure, at least 6 months have elapsed since the prior surgical resection or ablation. B. Surgical excision* of liver metastases from other solid tumors is considered medically necessary when all of the following criteria are met: 1. The presence of 3 lesions or less, as documented by MRI or computerized tomography (CT) scan; and 2. Each lesion measures no more than 5 centimeters (cm) in diameter; and 3. Complete excision of the carcinoma is anticipated; and 4. Two contiguous hepatic segments are preserved; and 5. At least 20% of the total estimated liver volume is anticipated to be preserved; and 6. Extrahepatic disease, if present, has been or will be resected; and 7. If a repeat procedure, at least 6 months have elapsed since the prior surgical resection or ablation. C. Local ablative techniques* (specifically, percutaneous ethanol injection [PEI], radiofrequency [RFA], cryosurgical, or microwave ablation) are considered medically necessary in individuals with liver metastases from colorectal cancer or functioning neuroendocrine tumors who meet all of the following criteria: 1. The individual must be a poor candidate for surgical resection or unwilling to undergo surgical resection; and 2. The presence of 3 lesions or less, as documented by MRI or computerized tomography (CT) scan; and 3. Each lesion measures no more than 5 cm in diameter; and 4. No evidence of extra-hepatic disease; and 5. All foci of disease are amenable to ablative therapy; and 6. If a repeat procedure, at least 6 months have elapsed since the prior surgical resection
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