Endoscopic Treatment of GERD (L30473)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L30473

LCD Title
Endoscopic Treatment of GERD

Contractor's Determination Number
GI-010

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region


Original Determination Effective Date
For services performed on or after 04/15/2010

Original Determination Ending Date


Revision Effective Date
For services performed on or after 03/01/2012

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Indications and Limitations of Coverage and/or Medical Necessity
Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta ® procedure, the Bard EndoCinch Suturing System, Plicator , Enteryx ®, EsophyX or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.

Currently, these procedures are considered non-covered due to the fact that current peer-reviewed literature does not support the efficacy of the services. Claims will be denied as "not proven effective."

The Stretta ® procedure is an endoluminal treatment for GERD in which radiofrequency energy is delivered to smooth muscle of the lower esophageal sphincter (LES). A flexible catheter equipped with special needle electrodes for precise energy delivery is placed by mouth into the esophagus and carefully controlled radiofrequency energy is then delivered to the LES and gastric cardia, creating thermal lesions. The manufacturer maintains that the changes that occur immediately, and over time, result in a "tighter" LES and a less compliant gastric cardia. Additionally, the interruption of nerve pathways in the LES area is believed to reduce the incidence of inappropriate LES "relaxations," leading to an improvement in GERD symptoms. Substantial peer-reviewed evidence to fully support these assumptions remains to be published.

The Bard EndoCinch Suturing System and the Plicator are intended for use in endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for treatment of symptomatic gastroesophageal reflux disease.

EsophyX is a device for performing transoral incisionless fundoplication surgery for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevents acid reflux.

Enteryx ® is an endoscopic, minimally-invasive procedure in which an ethylene vinyl alcohol polymer solution is injected into your lower esophageal sphincter muscle using a small needle. This product was recalled in September 2005 due to adverse patient events.

These procedures are promising for treatment of patients in whom proton pump inhibitor therapy fails. Clinical data from various studies are emerging. At this time, open-label studies or patient registries with short term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remain equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective. Therefore, they are not reimbursable even though some of the treatments may have associated CPT or OPPS codes.


Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.


Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.



CPT/HCPCS Codes
43257 UPPER GASTROINTESTINAL ENDOSCOPY INCLUDING ESOPHAGUS, STOMACH, AND EITHER THE DUODENUM AND/OR JEJUNUM AS APPROPRIATE; WITH DELIVERY OF THERMAL ENERGY TO THE MUSCLE OF LOWER ESOPHAGEAL SPHINCTER AND/OR GASTRIC CARDIA, FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE
43499 UNLISTED PROCEDURE, ESOPHAGUS
43999 UNLISTED PROCEDURE, STOMACH
49999 UNLISTED PROCEDURE, ABDOMEN, PERITONEUM AND OMENTUM
C9724 ENDOSCOPIC FULL-THICKNESS PLICATION IN THE GASTRIC CARDIA USING ENDOSCOPIC PLICATION SYSTEM (EPS); INCLUDES ENDOSCOPY

ICD-9 Codes that Support Medical Necessity
Note: ICD-9 codes must be coded to the highest level of specificity.
NA

XX000 Not Applicable


Diagnoses that Support Medical Necessity
NA
ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity


General Information

Documentations Requirements
NA

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision
1. A. Marinis et al. Endoluminal fundoplication for the treatment of GERD: A preliminary report of a new transoral approach; Annals of Gastroenterology 2008, 21(2):

2. Jafri Sm et al, What is left of the endoscopic antireflux devices? Current Opinion Gastroenterology 2009 July 25(4): 352-7

3. Medical Letter Volume 6 (Issue 72) August 2008, Treatment of Peptic Ulcers and GERD

4. Other Medicare Contractor Local Coverage Determinations and article of coverage

5. Alessandro Repici et.al, Endoluminal Fundoplication (ELF) for GERD Using EsophyX: a 12-Month Follow-up in a Single-Center Experience; J Gastrointest Surg (2010) 14:1 6

6. Guy-Bernard Cadie're et. al, Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX, Surg Endosc Received: 12 June 2008 / Accepted: 12 January 2009

7. Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, WO JM, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS. The STRETTA procedure for the treatment of GERD: 6 and 12-month follow-up of the U.S. open label trial. Gastrointestinal Endoscopy 2002 Feb; 55 (2): 149-156

8. Hogan, Walter J MD; ASGE leadership: Promoting or validating endoscopic technology?; Gastrointestinal Endoscopy Vol 60 No 2 August 2004

9. Blue Cross Blue Shield Association Technology Evaluation Center; Transesophageal Endoscopic Treatments for Gastroesophageal Disease Assessment Program; Vol 18 No 20 Feb 2004

10. Kahrilas, Peter J MD; Technology Review: Radiofrequency therapy of the lower esophageal sphincter for treatment of GERD; Gastrointestinal Endoscopy Vol 57 No 6 May 2003

11. Hogan, Walter J MD, Shaker, Reza MD; A Critical review of endoscopic therapy for gastroesophageal reflux disease; Am J Med Vol 115 No 3 August 18, 2003

12. Metz, David C MD; Managing gastroesophageal reflux disease for the lifetime of the patient: Evaluating the long-term options; Am J of Med Supplements Vol 117 No 5A September 6, 2004

13. William O. Richards, M.D., F.A.C.S.; Gastroesophageal Reflux Disease and the Truth About Endoluminal Therapy

14. Go, Dundon, et. al.; Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux; Surgery, Vol 136 No 4 October 2004

15. George Triadafilopoulos, M.D.; Stretta: An Effective, Minimally Invasive Treatment of Gastroesophageal Reflux Disease; The Am J. of Med. Vol 115, August 18, 2003

16. Wolfson & Richards; The Stretta Procedure for the Treatment of GERD: A Registry of 558 patients; Journal of Laparoendoscopic & Advanced Surgical Techniques, Vol 12 No 6 2002

17. Cohen et al; Enteryx Implantation for GERD: Expanded multicenter Trial Results and Interim Postapproval Follow-Up to 24 months; Gastrointestinal Endoscopy, Vol 61 no 6: May 2005

Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 9/25/09
Illinois 9/16/09
Michigan 9/09/09
Minnesota 09/24/09
J5 MAC 10/08/09

Open Meeting Date 08/19/2009

Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.

Start Date of Comment Period
10/08/2009
End Date of Comment Period
11/23/2009
Start Date of Notice Period
03/01/2010
Revision History Number
X

Revision History Explanation
04/19/2010 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor  Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor   Palmetto.

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

02/21/2011 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

04/01/2011- Annual review- no change to coverage.

03/01/2012- Annual Review, no change to coverage;

Reason for Change
Maintenance (annual review with new changes, formatting, etc.)

Related Documents
This LCD has no Related Documents.

LCD Attachments

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Page Last Updated: Thursday, 01-Mar-2012 14:11:32 CST