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Date Printed: October 20, 2017: 02:06 PM

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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.

02-40000-22

Original Effective Date: 08/15/01

Reviewed: 01/26/12

Revised: 04/20/17

Subject: Cryoablation 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:

Various locoregional therapies for unresectable liver tumors are being studied. These include cryosurgical ablation (CSA) (cryosurgery), radiofrequency ablation (RFA) laser ablation, transhepatic artery embolization/ chemoembolization, microwave coagulation, and percutaneous ethanol injection. This coverage guideline will address cryosurgical ablation of liver tumors.

Cryosurgical ablation (i.e., cryoablation, cryosurgery) involves freezing of target tissues. A probe is inserted into the tumor, through which coolant is circulated. Cryosurgical ablation is performed primarily as an open surgical technique, but may be performed percutaneously or laparoscopically, all with ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) guidance.

Ablation occurs in tissue that has been frozen by at least 3 mechanisms: 1) formation of ice crystals within cells thereby disrupting membranes, and interrupting cellular metabolism among other processes; 2) coagulation of blood, thereby interrupting blood flow to the tissue in turn causing ischemia and cell death; and 3) induction of apoptosis (cell death).

Hepatic tumors can arise either as primary liver cancer or by metastasis to the liver from other tissues. The liver is the most common site of metastasis for neoplasms disseminated via blood circulation. Local therapy for hepatic metastases is indicated only when there is no extra-hepatic disease. Presently, surgical resections with adequate margins or liver transplantation are the only treatments available with demonstrated curative potential. The majority of hepatic tumors are unresectable at diagnosis, due either to their anatomic location, size, number of lesions, or underlying liver reserve.

POSITION STATEMENT:

Cryoablation of tumors in the liver meets the definition of medical necessity for the treatment of primary hepatic tumors or metastatic tumors when the following criteria are met:

BILLING/CODING INFORMATION:

CPT Coding

47371

Laparoscopy, surgical, ablation or one or more liver tumor(s); cryosurgical

47381

Ablation, open, or one or more liver tumor(s); cryosurgical

47383

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

76362

Computerized axial tomographic guidance for, and monitoring of tissue ablation

76394

Magnetic resonance guidance for, and monitoring of, tissue ablation

76940

Ultrasound guidance for, and monitoring of, parenchymal tissue ablation

LOINC Codes

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, treatment plan, radiology and/or other diagnostic studies, documentation of co-morbid disease.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Radiology report

18726-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Diagnostic studies (non-lab)

27899-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Co-morbidities and complications

42126-3

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

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:

Cryosurgical ablation: a surgical procedure where cancerous or diseased cells are destroyed using extreme cold; also called cryoablation, cryosurgery, cryotherapy.

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.

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

RELATED GUIDELINES:

Radiofrequency Ablation of Liver Tumors, 02-40000-23
Cryosurgical Ablation of the Prostate (CSAP), 02-54000-14

Cryosurgical Ablation of Solid Tumors Other Than Liver or Prostate Tumors, 02-99221-12

OTHER:

None applicable.

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. ACR Appropriateness Criteria® hepatic malignancy. Guideline Summary NGC-5989. January 2007. (Accessed 01/03/12.)
  2. AHRQ National Guideline Clearinghouse. Management of hepatocellular carcinoma: an update. Guideline Summary NGC-8006. November 2005 (revised July 2010). Accessed 01/03/12.
  3. AHRQ National Guideline Clearinghouse. Society of Interventional Radiology position statement on chemoembolization of hepatic malignancies. Guideline Summary NGC-8342. July 2009. Accessed 01/03/12.
  4. Benson AB, Abrams TA et al. NCCN Practice Guidelines in Oncology. Hepatobiliary Cancers. V2.2010. ©2010 National Comprehensive Cancer Network, Inc.
  5. Benson AB, Abrams TA et al. NCCN Practice Guidelines in Oncology. Hepatobiliary Cancers. V2.2012. 10/28/11. ©2011 National Comprehensive Cancer Network, Inc.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.01.75, Cryoablation of Primary or Metastatic Liver Tumors, (08/14/08).
  7. Blue Cross Blue Shield Association TEC Assessments. Cryosurgical Ablation of Unresectable Hepatic Tumors & Radiofrequency Ablation Unresectable Hepatic Tumors, (11/00).
  8. “Cryotherapy for hepatic colorectal carcinoma metastases”, Ellis Fischel Cancer Center University of Missouri Health Care", (03/01).
  9. ECRI Health Technology Forecast. “Expanding indications for cryosurgery for malignant tumors” (06/25/07).
  10. Hayes Medical Technology Directory, Cryosurgery for Primary And Metastatic Cancers Of The Liver (10/04; update 11/19/06).
  11. Irvin M. Modlin, Igor Latich, Mark Kidd, Michelle Zikusoka, Geeta Eick et al. Therapeutic Options for Gastrointestinal Carcinoids. Clinical Gastroenterology and Hepatology Vol. 4, Issue 5, Pages 526-547. May 2006.
  12. National Cancer Institute (NCI) Adult Primary Liver Cancer PDQ: Treatment (Physician’s Data Query) (accessed at NCI website on 07/03/07).
  13. National Cancer Institute. U.S. National Institutes of Health. Adult Primary Liver Cancer Treatment (PDQ®). Last modified 07/08/10. (Accessed at NCI website on12/10/10).
  14. National Institute for Health and Clinical Excellence. Cryotherapy for the treatment of liver metastases: Guidance document IPG369. Last updated December 15, 2010. Copyright© 2010 National Institute for Health and Clinical Excellence. (Accessed 01/03/12).
  15. Sandra L. Wong, Pamela B. Mangu, Michael A. Choti, Todd S. Crocenzi, Gerald D. Dodd III, Gary S. Dorfman, Cathy Eng, Yuman Fong, Andrew F. Giusti, David Lu, Thomas A. Marsland, Rob Michelson, Graeme J. Poston, Deborah Schrag, Jerome Seidenfeld and Al B. Benson III. American Society of Clinical Oncology 2009 Clinical Evidence Review on Radiofrequency Ablation of Hepatic Metastases from Colorectal Cancer. Journal of Clinical Oncology. Volume 28. Number 3. January 20, 2010.
  16. Thomas, Melanie B. Hepatocellular Carcinoma: The Need for Progress. Journal of Clinical Oncology, 23:2892-2899. 05/01/05.
  17. Wu B, Xiao Y-Y, Zhang X, Zhang A-L, Li H-J, Gao D-F. Magnetic resonance imaging-guided percutaneous cryoablation of hepatocellular carcinoma in special regions. Hepatobiliary Pancreat Dis Int. 2010 Aug;9(4):384-92.
  18. Zhou L, Yang Y-P, Feng Y-Y, Lu Y-Y, Wang C-P, Wang X-Z, An L-J, Zhang X, Wang F-S. Clinical Research Paper: Efficacy of argon-helium cryosurgical ablation on primary hepatocellular carcinoma. A pilot clinical study. Chinese Journal of Cancer 28:1, 45-48; January 2009]; ©2009 Sun Yat-Sen University Cancer Center.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/26/12.

GUIDELINE UPDATE INFORMATION:

08/15/01

Medical Coverage Guideline Reformatted.

01/01/02

HCPCS Changes.

12/15/02

Annual review for investigational; no change.

11/15/03

Changed policy number from 04-77260-15 to 02-40000-22.

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.

03/15/05

Scheduled review; no change in coverage statement; Program Exception added for Medicare Advantage products.

02/15/06

Scheduled review; investigational status removed; coverage criteria and ICD-9 diagnosis codes added.

08/15/07

Scheduled review; reformatted guideline; updated references.

02/15/09

Scheduled review; no change in position statement.

10/15/10

Revision; related ICD-10 codes added.

02/15/11

Annual review; no change in position statement. Revised description section; added CPT code 76940; updated references; reformatted guideline.

09/15/11

Revision; formatting changes.

02/15/12

Scheduled review; no change in position statement. Revised description section and updated references.

05/11/14

Revision: Program Exceptions section updated.

01/01/15

Annual CPT/HCPCS update. Added 47383.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision: Billing/Coding Information section updated.

04/20/17

Revision: deleted code 76490 and reformatted guideline.

Date Printed: October 20, 2017: 02:06 PM