Local Coverage Determination (LCD) for Endoscopic Treatment of GERD (L28256)

Transcription

1 Search Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & Education People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Print Back to Local Coverage Determinations (LCDs) for Palmetto GBA (01192, MAC - Part B) Local Coverage Determination (LCD) for Endoscopic Treatment of GERD (L28256) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B LCD Information Document Information LCD ID Number L28256 LCD Title Endoscopic Treatment of GERD Contractor's Determination Number J1B L AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or Primary Geographic Jurisdiction California - Southern Oversight Region Region X Original Determination Effective Date For services performed on or after 09/02/2008 Original Determination Ending Date Revision Effective Date For services performed on or after 04/15/2011

2 dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Revision Ending Date CMS National Coverage Policy Title XVIII of the Social Security Act, 1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be medically reasonable and necessary. Title XVIII of the Social Security Act, 1833(e). 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 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 by this A/B MAC 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. Enteryx an ethylenevinyl alcohol polymer, was approved by the FDA via premarketing application (PMA) approval in April 2003 for the treatment of GERD symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors. 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, Palmetto GBA has determined that 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.

3 Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review. 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. 999x Not Applicable 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 Not Applicable CPT/HCPCS Codes 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 UNLISTED PROCEDURE, ESOPHAGUS UNLISTED PROCEDURE, STOMACH ICD-9 Codes that Support Medical Necessity XX000 Not Applicable Diagnoses that Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity

4 ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity General Information Documentations Requirements The medical record must be made available to Medicare upon request. Appendices Utilization Guidelines Sources of Information and Basis for Decision Triadafilopoulos G, DiBaise JK, Nostrant TT, et al. The STRETTA procedure for the treatment of GERD: 6 and 12-month follow-up of the U.S. open label trial. Gastrointestinal Endoscopy. Feb 2002;55(2): Hogan WJ. ASGE leadership: Promoting or validating endoscopic technology? Gastrointestinal Endoscopy. Aug 2004;60(2) Blue Cross Blue Shield Association Technology Evaluation Center; Transesophageal Endoscopic Treatments for Gastroesophageal Disease Assessment Program; Feb 2004;18(20). Other Medicare Contractor Local Coverage Determinations and articles on coverage Kahrilas PJ. Technology Review: Radiofrequency therapy of the lower esophageal sphincter for treatment of GERD. Gastrointestinal Endoscopy. May 2003;57(6): Hogan WJ, Shaker R. A Critical review of endoscopic therapy for gastroesophageal reflux disease. Am J Med. Aug 2003;115(3): Metz DC. Managing gastroesophageal reflux disease for the lifetime of the patient: Evaluating the long-term options. Am J of Med Supplements. Sep 2004;117 Suppl5A:49S -55S. Richards WO. Gastroesophageal Reflux Disease and the Truth About Endoluminal Therapy. J Gastrointest Surg. Dec 2004;8(8) Go D, Dundon JM, Karlowicz DJ, Domingo CB. Muscarella P, Melvin WS. Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Surgery. Oct 2004;136(4) Triadafiloppulos GT. Stretta: An Effective, Minimally Invasive Treatment of Gastroesophageal Reflux Disease. Am J. of Med. Aug 2003;115(3)S1: Wolfson HC, Richards WO. The Stretta Procedure for the Treatment of GERD: A Registry of 558 patients. Journal of Laparoendoscopic & Advanced Surgical Techniques. 2002;12 (6). Cohen B, Johnson DA, Ganz RA, et al. Enteryx Implantation for GERD: Expanded

5 multicenter Trial Results and Interim Postapproval Follow-Up to 24 months. Gastrointestinal Endoscopy. May 2005;61(6): Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which include representatives from the affected provider community. Contractor Advisory Committee meeting dates: California - Hawaii - Nevada - Start Date of Comment Period End Date of Comment Period Start Date of Notice Period 06/16/2008 Revision History Number Revision #4 Revision History Explanation Revision #4 effective for dates of service on or after 04/15/2011 Revisions made: Under Sources of Information and Basis for Decision, added page numbers to article titled ASGE leadership: Promoting or validating endoscopic technology? Added page numbers to article titled Technology Review: Radiofrequency therapy of the lower esophageal sphincter for treatment of GERD. Added the page numbers for article titled A Critical review of endoscopic therapy for gastroesophageal reflux disease. Added Supplement issue number and pages to the article titled Managing gastroesophageal reflux disease for the lifetime of the patient: Evaluating the long-term options. Corrected the authors name, added journal name in which article was published and the publishing year, volume, issue and pages for article titled Gastroesophageal Reflux Disease and the Truth About Endoluminal Therapy. Added additional authors names, and page numbers where article can be located in the journal to article titled Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux. Corrected the authors name and added the issue number and page numbers to article titled Stretta: An Effective, Minimally Invasive Treatment of Gastroesophageal Reflux Disease. Added the authors initials to the citation reference titled The Stretta Procedure for the Treatment of GERD: A Registry of 558 patients. Authors initials and two additional authors were added to the citation and added the pages to the article titled Enteryx Implantation for GERD: Expanded multicenter Trial Results and Interim Postapproval Follow-Up to 24 months. Revision #3 effective for dates of service on or after 04/16/2009 Revisions made: Under "Indications and Limitations of Coverage and/or Medical Necessity" section the word "outgoing contractor" was replaced with Palmetto GBA. Under "Sources of Information and Basis for Decision" the references were placed in AMA citation format. Revision #2, 02/26/2009 This LCD is being revised to implement the streamlining of the Part B LCDs per the published article Palmetto Team to Streamline Part B LCDs in Jurisdiction 1 (J1). This article can be viewed at by searching for the above article name. This revision will become effective on 02/26/2009.

6 Revision #1, 09/02/2008 This LCD is being revised to add Bill Type 999X because the automated system transcription process was incomplete. Reason for Change Maintenance (annual review with new changes, formatting, etc.) Typographical Correction Related Documents This LCD has no Related Documents. LCD Attachments There are no attachments for this LCD. All Versions Updated on 03/08/2012 with effective dates 04/15/ N/A Updated on 04/06/2011 with effective dates 04/15/ N/A Updated on 04/09/2010 with effective dates 04/16/ /14/2011 Updated on 04/10/2009 with effective dates 04/16/ N/A Some older versions have been archived. Please visit the MCD Archive Site them. to retrieve Read the LCD Disclaimer Department of Health & Human Services Medicare.gov USA.gov Web Policies & Important Links Privacy Policy Freedom of Information Act No Fear Act Centers for Medicare & Medicaid Services, 7500 Security Boulevard Baltimore, MD