Stretta Procedure

LCD Information Document Information Source LCD ID N/A LCD ID L34540 Original ICD-9 LCD ID Not Applicable LCD Title Stretta Procedure Proposed LCD in Comment Period N/A Source Proposed LCD N/A Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 09/04/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. 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 dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. Current Dental Terminology © 2025 American Dental Association. All rights reserved. Copyright © 2026, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at ub04@aha.org or 312‐422‐3366. Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates. Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations, and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. CMS Publications: CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1: 100.9 Implantation of Anti-Gastroesophageal Reflux Device Coverage Indications, Limitations, and/or Medical Necessity Abstract: The Stretta procedure delivers radiofrequency thermal energy to the lower esophagus as a treatment for gastroesophageal reflux disease (GERD). CGS Administrators considers the Stretta procedure to be investigational and therefore non-covered. Limitations: An extensive literature review documented the following information: efficacy based on objective physiologic measurements has not been shown; a clear mechanism of action has not been determined, and; significant long-term studies confirming efficacy and safety have not been carried out. The Stretta procedure is considered investigational and is not covered. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

Abstract: The Stretta procedure delivers radiofrequency thermal energy to the lower esophagus as a treatment for gastroesophageal reflux disease (GERD). CGS Administrators considers the Stretta procedure to be investigational and therefore non-covered. Limitations: An extensive literature review documented the following information: efficacy based on objective physiologic measurements has not been shown; a clear mechanism of action has not been determined, and; significant long-term studies confirming efficacy and safety have not been carried out. The Stretta procedure is considered investigational and is not covered.