Local Coverage Determination (LCD)

Stretta Procedure

L34540

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

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 08/31/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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 312‐893‐6816.

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 Guidance

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.

    Other Comments:

    For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS to process their claims.

    Bill type codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

    Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

    For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.
Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Not applicable

Not applicable

Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. CIGNA Government Services is not responsible for the continuing viability of Web site addresses listed below.

Arts J, Sifrim D, Rutgeerts P, Lerut A, Janssens J, Tack J. Influence of radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) on symptoms, acid exposure, and esophageal sensitivity to acid perfusion in gastroesophageal reflux disease. Dis Sci. 2007;52:2170-2177.

Corley DA, Katz P, WO JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003;125:668-676.

Go MR, 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. 2004;136:786-794.

Kahrilas PJ. Gastroesophageal reflux disease. JAMA. 1996;276:983-988.

Kahrilas PJ. Radiofrequency energy treatment of GERD. Gastroenterology. 2003;125:970-973.

Other Medicare contractor policies consulted in development of this draft:

      Anthem East Health Plans fiscal intermediary LCD New Hampshire/Vermont [L20387]



    Associated Hospital Services fiscal intermediary LCD Maine [L19877], Massachusetts [L20389]

Spicak J. Treatment of gastroesophageal reflux: endoscopic aspects. Dig Dis. 2007;25:183-187.

Tam WC, Schoeman MN,Zhang Q, et al. Delivery of radiofrequency energy to the lower esophageal sphincter and gastric cardia inhibits transient lower esophageal sphincter relaxations and gastro-esophageal reflux in patients with reflux disease. Gut.2003;52:479-485.

Torquati A, Houston HL, Kaiser J, Holzman MD, Richards WO. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc. 2004;18:1475-1479.

Torquati A, Richards WO. Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments. Surg Endosc. 2007;21:697-706.

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. Gastrointest Endosc. 2002;55:149-156.

Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc. 2004;18:1038-1044.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
08/31/2023 R10

R10

Revision Effective: 08/31/2023

Revision Explanation: Annual review, no changes were made.

08/21/2023: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/01/2022 R9

R9

Revision Effective: 09/01/2022

Revision Explanation: Annual review, no changes were made.

08/26/2022: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
08/19/2021 R8

R8

Revision Effective: 08/19/2021

Revision Explanation: Annual review, no changes were made.

08/10/2021: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/26/2019 R7

R7

Revision Effective: n/a

Revision Explanation: Annual review, no changes made.

08/25/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/26/2019 R6

R6

Revision Effective: 09/26/2019 Revision Explanation: Annual review, no changes made.

09/23/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review, no changes made)
09/26/2019 R5

R5

Revision Effective: 09/26/2019 Revision Explanation: Converted to new policy template that no longer includes coding section based on CR 10901.

09/20/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Revisions Due To Code Removal
10/01/2015 R4

R4

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE 08/27/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/01/2015 R3

R3

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE (08/13/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/01/2015 R2

R2

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE (08/28/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.


  • Other (Annual review)
10/01/2015 R1 R3
Revision Effective: 10/01/2015
Revision Explanation: Removed reference to CIGNA Government Services and replaced with CGS Administrators.
  • Typographical Error
N/A

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Articles
A57039 - Billing and Coding: Stretta Procedure
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
08/21/2023 08/31/2023 - N/A Currently in Effect You are here
08/26/2022 09/01/2022 - 08/30/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

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