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Date Printed: December 18, 2017: 11:31 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-23

Original Effective Date: 02/15/04

Reviewed: 09/28/17

Revised: 10/15/17

Subject: Radiofrequency Ablation of Liver Tumors

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Hepatic tumors can arise as primary liver cancer (hepatocellular cancer) or by metastasis to the liver from other tissues. Local therapy for hepatic metastasis may be indicated when there is no extrahepatic disease, which rarely occurs for patients with primary cancers other than colorectal carcinoma or certain neuroendocrine malignancies. At present, surgical resection with adequate margins or liver transplantation constitutes the only treatments available with demonstrated curative potential. However, most hepatic tumors are unresectable at diagnosis, due either to their anatomic location, size, number of lesions, or underlying liver reserve. Patients may also have comorbid conditions and do not qualify for surgical resection.

Neuroendocrine tumors are tumors of cells that possess secretory granules and originate from the neuroectoderm. Neuroendocrine cells have roles both in the endocrine system and in the nervous system. They produce and secrete a variety of regulatory hormones, or neuropeptides, which include neurotransmitters and growth factors. Overproduction of the specific neuropeptides produced by the cancerous cells causes various symptoms, depending on the hormone produced. They are rare, with an incidence of 2 to 4 per 100,000 per year. Treatment of liver metastases is undertaken to prolong survival and to reduce endocrine-related symptoms and hepatic mass related symptoms.

Radiofrequency ablation (RFA) is a procedure in which a probe is inserted into the center of a tumor and heated locally by a high-frequency, alternating current that flows from electrodes. The local heat treats the tissue adjacent to the probe, resulting in a 3-cm to 5-cm sphere of dead tissue. The cells killed by RFA are not removed but are gradually replaced by fibrosis and scar tissue. If there is local recurrence, it occurs at the edge of the treated tissue and, in some cases, is retreated. RFA may be performed percutaneously, laparoscopically, or as an open procedure.

POSITION STATEMENT:

Radiofrequency ablation of primary, inoperable (eg, due to location of lesion[s] and/or comorbid conditions) hepatocellular carcinoma meets the definition of medical necessity under the following conditions:

• As a primary treatment of a single liver nodule of 5cm or less, OR

• As a primary treatment of up to 3 nodules that are less than 3cm each, OR

• As a bridge to transplant, where the intent is to prevent further nodule growth and maintain candidacy for liver transplant

Radiofrequency ablation as a primary treatment of inoperable hepatic metastases meets the definition of medical necessity under the following conditions:

• Metastases are of colorectal origin, and there is a single nodule of 5cm or less, OR

• Metastases are of colorectal origin, and there are up to 3 nodules that are less than 3cm each, OR

• Metastases are of neuroendocrine origin and systemic therapy has failed to control symptoms

Radiofrequency ablation of hepatocellular carcinoma is considered experimental or investigational in the following situations:

• Primary, inoperable, hepatocellular carcinoma when there are more than 3 nodules or when not all sites of tumor foci can be adequately treated, OR

• Primary, inoperable, hepatocellular carcinoma when used to downstage (downsize) hepatocellular carcinoma in patients being considered for liver transplant, OR

• Primary, operable hepatocellular carcinoma

Radiofrequency ablation of hepatic metastases is considered experimental or investigational for:

• Hepatic metastases from other types of cancer except colorectal cancer or neuroendocrine tumors

BILLING/CODING INFORMATION:

CPT Coding:

47370

Laparoscopy, surgical, ablation or 1 or more liver tumor(s); radiofrequency

47380

Ablation, open, or 1 or more liver tumor(s); radiofrequency

47382

Ablation, 1 or more liver tumor(s), percutaneous, radiofrequency

76940

Ultrasound guidance for, and monitoring of parenchymal tissue ablation

77013

Computerized tomography guidance for, and monitoring of parenchymal tissue ablation

77022

Magnetic resonance guidance for, and monitoring of parenchymal tissue ablation

ICD-10 Diagnoses Codes That Support Medical Necessity:

C22.0

Liver cell carcinoma

C22.1

Intrahepatic bile duct carcinoma

C22.2

Hepatoblastoma

C22.7

Other specified carcinomas of liver

C22.8

Malignant neoplasm of liver, primary, unspecified as to type

C22.9

Malignant neoplasm of liver, not specified as primary or secondary

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

D01.5

Carcinoma in situ of liver, gallbladder and bile ducts

D37.6

Neoplasm of uncertain behavior of liver, gallbladder and bile ducts

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Extra-hepatic metastases: cancer that has spread from its original location to other sites within the body, other than the liver.

Hepatic metastases: cancer that has spread from its original location in the body to the liver.

Primary hepatocellular cancer: a cancer that originates within liver cells, as opposed to having spread from other organs; malignant hepatoma.

Radiofrequency ablation (RFA): a surgical procedure where cancerous or diseased cells are destroyed using heat produced by high-frequency radiowaves.

Unresectable: a property of a tumor where it is unable to be removed surgically.

RELATED GUIDELINES:

Cryoablation of Liver Tumors, 02-40000-22

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Assessment. Radiofrequency Ablation of Unresectable Hepatic Tumors, TEC Assessments 2003, Volume 18, Tab No. 13.
  2. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 7.01.91 Radiofrequency Ablation of Primary or Metastatic Liver Tumors, 03/11/10.
  3. Clinical Trials.gov. Study of Percutaneous Radiofrequency Ablation (RFA) of Hepatocellular Carcinoma in Cirrhotic Patients. Phase I trial. Identifier NCT00399958 Verified by M.D. Anderson Cancer Center
  4. ClinicalTrials.gov. Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer, Phase II trial. Identifier NCT00019604. Verified by National Cancer Institute, 01/07.
  5. ClinicalTrials.gov. Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis. Phase II trial. Identifier NCT00132041. (Verified by National Cancer Institute, 12/06).
  6. ECRI Health Technology Assessment, “Radiofrequency Ablation for the Treatment of Primary and Metastatic Liver Cancer”, (04/03)
  7. Egger J, Busse H, et al. Interactive Volumetry Of Liver Ablation Zones. Sci Rep. 2015 Oct 20;5:15373.
  8. Galandi D, Antes G. Radiofrequency thermal ablation versus other interventions for hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD003046. DOI: 10.1002/14651858. CD003046.pub2.
  9. Hao Y, Numata K, et al. Rate of local tumor progression following radiofrequency ablation of pathologically early hepatocellular carcinoma. World J Gastroenterol. 2017 May 7;23(17):3111-3121.
  10. Hayes Medical Technology Directory, Radiofrequency Ablation for Primary and Metastatic Cancers Of The Liver (04/04; update report 10/02/07).
  11. Hung AK, Guy J. Hepatocellular carcinoma in the elderly: Meta-analysis and systematic literature review. World J Gastroenterol. 2015 Nov 14;21(42):12197-210.
  12. Kim JW, Shin SS, et al. Ultrasound-Guided Percutaneous Radiofrequency Ablation of Liver Tumors: How We Do It Safely and Completely. Korean J Radiol. 2015 Nov-Dec;16(6):1226-39.
  13. Na BG, Kim JM, et al. Clinical outcomes of laparoscopic radiofrequency ablation of single primary or recurrent hepatocellular carcinoma (≤3 cm). Ann Surg Treat Res. 2017 May;92(5):355-360.
  14. National Cancer Institute, “Adult Primary Liver Cancer (PDQ®): Treatment”, (10/31/08).
  15. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma Version 3.2017 (8/15/17). Accessed at https://www.nccn.org.
  16. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 2.2017 (3/13/17). Accessed at https://www.nccn.org.
  17. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine Tumors. Version 3.2017 (6/13/17). Accessed at https://www.nccn.org.
  18. United Network for Organ Sharing (UNOS) policies; accessed at website 03/10.
  19. Yang W, Yan K, et al. Radiofrequency ablation of hepatocellular carcinoma in difficult locations: Strategies and long-term outcomes. World J Gastroenterol. 2015 Feb 7;21(5):1554-66.
  20. Yun Ku Cho, Jae Kyun Kim, Mi Young Kim, Hyunchul Rhim, Joon Koo Han. Systematic review of randomized trials for hepatocellular carcinoma treated with percutaneous ablation therapies. DOI: 10.1002/hep.22648.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/28/17.

GUIDELINE UPDATE INFORMATION:

02/15/04

Reviewed Radiofrequency/Cryoablation of Liver Tumors MCG #02-40000-22 and separated into two different policies Radiofrequency Ablation of Liver Tumors and Cryosurgical Ablation of Liver Tumors; coverage statement changed for radiofrequency ablation of liver tumors.

06/15/04

Revision consisting of removal of ICD-9 diagnosis code for benign liver tumors.

05/15/05

Scheduled review; no change in coverage statement.

03/15/06

Scheduled review; expand coverage to include metastatic liver tumors.

03/15/07

Scheduled review; no change in coverage statement; update coding section and references.

06/15/07

Reformatted guideline.

03/15/08

Scheduled review; no change in position statement. Update references.

04/15/09

Scheduled review; no change in position statement. Update references.

01/01/10

Annual HCPCS coding update: revise descriptors for CPT codes 47370, 47380, & 47382.

04/15/10

Annual review; no change in position statement. References updated.

10/15/10

Revision; related ICD-10 codes added.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

10/15/17

Scheduled review. Revised description section and position statement section. Updated references.

10/23/17

Revision to Position Statement.

Date Printed: December 18, 2017: 11:31 AM