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Date Printed: June 28, 2017: 11:57 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.

01-91000-10

Original Effective Date: 01/15/13

Reviewed: 12/04/14

Revised: 11/01/15

Subject: Endoscopic Radiofrequency Ablation or Cryosurgical Ablation for Barrett’s Esophagus

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:

Barrett’s esophagus is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia, in response to irritation and injury caused by gastroesophageal reflux disease (GERD). Barrett’s esophagus occurs in the distal esophagus, may be of any length, may be focal or circumferential, and can be visualized by the endoscopist as being a different color than the background squamous mucosa. Confirmation of Barrett’s esophagus requires biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia. Intestinal metaplasia is a precursor to esophageal adenocarcinoma, and esophageal adenocarcinoma is thought to result from a stepwise accumulation of genetic abnormalities in the specialized epithelium, which results in the phenotypic expression of histologic features of low-grade dysplasia (LGD) to high-grade dysplasia (HGD) to carcinoma.

The current management of Barrett’s esophagus includes treatment of GERD and surveillance endoscopy to detect progression to HGD or adenocarcinoma. The finding of LGD typically warrants only follow-up and surveillance biopsies, whereas the finding of HGD or early-stage adenocarcinoma warrants mucosal ablation or resection (either endoscopic mucosal resection [EMR] or esophagectomy). EMR, either focal or circumferential, provides a histologic specimen for examination and staging (unlike ablative techniques). Mucosal ablation techniques that are available consist of one of several thermal (multipolar electrocoagulation [MPEC], argon plasma coagulation [APC], heater probe, Nd:YAG laser, KTP-YAG laser, diode laser, argon laser, and cryoablation) or nonthermal (5-aminolevulinic acid [5-ALA] and photofrin photodynamic therapy [PDT]) techniques. The

CryoSpray Ablation™ System (formerly the SprayGenix™ Cryo Ablation System, CSA Medical, Inc.) uses a low-pressure spray for spraying liquid nitrogen through an upper endoscope. Cryotherapy allows for treatment of uneven surfaces; however, disadvantages include the uneven application inherent in spraying the cryogen.

The HALO System from BÂRRX Medical, Inc. (Sunnyvale, Calif.) uses radiofrequency (RF) energy and consists of 2 components: an energy generator and an ablation catheter. The generator provides rapid (i.e., less than 1 second) delivery of a predetermined amount of RF energy to the catheter. Both the HALO90 and HALO360 are inserted into the esophagus with an endoscope, using standard endoscopic techniques. The HALO90 catheter is plate-based and used for focal ablation of areas of Barrett’s esophagus up to 3 cm. The HALO360 uses a balloon catheter that is sized to fit the individual esophagus and is inflated to allow for circumferential ablation.

POSITION STATEMENT:

Radiofrequency ablation meets the definition of medical necessity when performed for the treatment of Barrett’s esophagus with high-grade dysplasia.

Radiofrequency ablation meets the definition of medical necessity when performed for the treatment of Barrett’s esophagus with low-grade dysplasia, when the initial diagnosis of low-grade dysplasia is confirmed by two pathologists.

Radiofrequency ablation is considered experimental or investigational for the treatment of Barrett’s esophagus in the absence of dysplasia. There is insufficient clinical evidence to establish effectiveness of RFA for the treatment of Barrett’s esophagus in the absence of dysplasia.

Cryosurgical ablation is considered experimental or investigational for the treatment of Barrett’s esophagus, with or without dysplasia. Further clinical studies with long-term follow-up are necessary to determine the effectiveness and safety of cryoablation in the treatment of Barrett’s esophagus.

Refer to section entitled DECISION TREE.

BILLING/CODING INFORMATION:

There is no CPT procedure code specific to radiofrequency or cryoablation of tissue in the esophagus. These procedures would likely be coded using one of the following CPT codes:

43229: Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)

43257: Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease

43270 Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)

43499: Unlisted procedure, esophagus.

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

D13.0

Benign neoplasm of esophagus

K22.710

Barrett’s esophagus with low grade dysplasia

K22.711

Barrett's esophagus with high grade dysplasia

K22.719

Barrett's esophagus with dysplasia, unspecified

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:

Dysplasia: in pathology, abnormal cell growth or growth patterns in tissues or organs

RELATED GUIDELINES:

Cryosurgical Ablation of Solid Tumors Other Than Liver or Prostate Tumors, 02-99221-12
Esophageal pH Monitoring, 01-91000-01

Radiofrequency Ablation of Solid Tumors Other Than Liver Tumors, 02-99221-13

Transendoscopic Therapies for Gastroesophageal Reflux Disease (GERD), 01-91000-03

OTHER:

None applicable

REFERENCES:

  1. American Gastroenterological Association, Spechler SJ, Sharma P, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011; 140(3):1084-1091.
  2. American Society for Gastrointestinal Endoscopy. Technology status evaluation report: Mucosal ablation devices. 2008.
  3. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 2.01.80 Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus 04/10/14.
  4. Blue Cross and Blue Shield Association TEC Assessment 2010. "Radiofrequency Ablation of Nondysplastic or Low-Grade Dysplastic Barrett's Esophagus." BlueCross BlueShield Association Technology Evaluation Center, Vol. 25, Tab 5.
  5. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update, Comparative Effectiveness Review Number 29. AHRQ Publication No. 11-EHC049-EF. September 2011.
  6. ECRI Emerging Technology Report. Endoscopic radiofrequency ablation for Barrett’s esophagus (2009).
  7. ECRI Product Brief. trūFreeze Cryospray System (CSA Medical, Inc.) for Ablating Tissue (May, 2014).
  8. Fleischer DE, Sharma VK. Endoscopic ablation of Barrett's esophagus using the Halo system. Dig Dis. 2008;26(4):280-4. Epub 2009 Jan 30.
  9. Garman KS, Shaheen NJ.Ablative therapies for Barrett's esophagus. Curr Gastroenterol Rep. 2011 Jun;13(3):226-39.
  10. Gray NA, Odze RD, Spechler SJ. Buried metaplasia after endoscopic ablation of Barrett's esophagus: a systematic review. Am J Gastroenterol. 2011 Nov;106(11):1899-908; quiz 1909. doi: 10.1038/ajg.2011.255. Epub 2011 Aug 9.
  11. Greenwald BD, Dumot JA, Horwhat JD, Lightdale CJ, Abrams JA. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus. 2010 Jan;23(1):13-9. Epub 2009 Jun 9.
  12. Ip S, Chung M, Moorthy D, Yu WW, Lee J, Chan JA, Bonis PA, Lau J. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update. Comparative Effectiveness Review No. 29. (Prepared by Tufts Medical Center Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I.) AHRQ Publication No. 11-EHC049-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011.
  13. National Comprehensive Cancer Network (NCCN) Guidelines. Esophageal and Esophagogastric Junction Cancers (v.2.2012).
  14. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Esophageal cancer V.2.2013.
  15. Peery AF, Shaheen NJ. Esophagus: Endoscopic therapy for flat, dysplastic Barrett esophagus. Nat Rev Gastroenterol Hepatol. 2011 Apr;8(4):186-7. Epub 2011 Mar 8.
  16. Shaheen NJ, Greenwald BD, Peery AF, et al. Safety and efficacy of endoscopic spray cryotherapy for Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 2010 Apr;71(4):680-5.
  17. Shaheen NJ, Overholt BF, Sampliner RE, et al. Durability of radiofrequency ablation in Barrett's esophagus with dysplasia. Gastroenterology. 2011 Aug;141(2):460-8. Epub 2011 May 6.
  18. Shaheen NJ, Peery AF, Hawes RH, Rothstein RI, et al. Quality of life following radiofrequency ablation of dysplastic Barrett's esophagus. Endoscopy. 2010 Oct;42(10):790-9. Epub 2010 Sep 30.
  19. Shaheen NJ, Peery AF, Overholt BF, et al. Biopsy depth after radiofrequency ablation of dysplastic Barrett's esophagus. Gastrointest Endosc. 2010 Sep;72(3):490-496.e1. Epub 2010 Jul 3.
  20. Shaheen NJ, Sharma P, Overholt BF, Wolfsen HC, et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. N Engl J Med. 2009 May 28;360(22):2277-88.
  21. Society of the American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease (GERD). Practice/Clinical Guidelines published 02/2010.
  22. Stefanidis D, Hope WW, Kohn GP et al. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg. Endosc. 2010; 24(11):2647-69.
  23. US Food and Drug Administration. CryoSpray Ablation System. No. K072651. 510(k) Premarket Notification Database. 2007.
  24. US Food and Drug Administration. BARRX MODELS HALO360 AND HALO360+ COAGULATION CAT. No. K080557. 510(k) Premarket Notification Database. 2008.
  25. Wang KK, Sampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett's esophagus. Am J Gastroenterol. 2008; 103(3):788-797.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/04/14.

GUIDELINE UPDATE INFORMATION:

01/15/13

New Medical Coverage Guideline.

12/15/13

Annual review; position statements unchanged; Program Exceptions section updated; references updated.

01/01/14

Annual HCPCS coding update: added 43229 and 43270; deleted 43228 and 43258; revised 43257.

01/15/15

Annual review; position statement unchanged; references updated.

10/01/15

Revision; updated ICD10 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 28, 2017: 11:57 PM