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Local Coverage Determination (LCD)

Stretta Procedure

L34553

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Proposed LCD
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Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34553
Original ICD-9 LCD ID
Not Applicable
LCD Title
Stretta Procedure
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL34553
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 09/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
07/18/2024
Notice Period End Date
08/31/2024

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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

No changes between Proposed LCD and Final LCD.

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 reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract

Gastroesophageal reflux disease (GERD) is defined by the presence of chronic symptoms or mucosal damage caused by an abnormal reflux of gastric contents into the esophagus. GERD may be caused by a weakness in the lower esophageal sphincter (LES), the presence of a hiatal hernia (HH), transient LES relaxation, alterations in the gastroesophageal pressure gradient, and esophageal factors such as poor clearance and changes in motility. Heartburn (pyrosis) and regurgitation, the most common and highly specific symptoms of GERD, may be experienced alone or in combination after eating a meal. Severe complications of GERD include the development of strictures, erosive esophagitis, and Barrett’s esophagus.

The Stretta system (Mederi Therapeutics Inc., Greenwich, Connecticut) is a radiofrequency (RF) treatment for GERD. The system, including its specialized catheters and RF generators were originally cleared by the United States (U.S.) Food and Drug Administration (FDA) for use in 2000 and was issued an updated clearance on the RF generator in 2011. The transoral Stretta catheter system uses a proprietary algorithmic application of low power (5 Watts) RF energy and generates low tissue temperatures (65°C to 85°C) during a series of 1-minute treatment cycles. The endoluminal Stretta therapy remodels (thickens) the musculature of the LES and gastric cardia. Clinical results demonstrate that the Stretta RF treatment results in significant reductions in tissue compliance and transient LES relaxations. These mechanisms act to restore the natural barrier function of the LES as well as to significantly reduce spontaneous regurgitation caused by transient inappropriate relaxations of the sphincter.

Limitations

An extensive literature review documented the following information:

The results show that RF treatment significantly improved heartburn scores and produced significant improvements in quality of life (QOL) as measured by the GERD Health-Related Quality of Life (GERD-HRQL) scale and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. Esophageal acid exposure decreased but did not normalize, and while the procedure did not significantly increase LES pressure, there was a trend toward improvement.

More than 30 peer reviewed studies, including randomized, controlled studies, a comprehensive meta-analysis and multiple prospective clinical trials have documented the safety and efficacy of the Stretta procedure. Durable treatment outcomes to at least 120 months have been demonstrated. In multiple studies, significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores have been demonstrated. Stretta may be recommended as an appropriate therapeutic option for patients with chronic GERD who meet current indications and patient selection criteria and choose endoluminal therapy over the gold standard of laparoscopic fundoplication (Noar, et al. 2014).

Those criteria include:

    • Adult patients (age ≥ 18) with symptoms of chronic GERD, heartburn, regurgitation, or both for ≥ 6 months who have been partially or completely refractory to antisecretory pharmacologic therapy.
    • Adult patients who do not wish to continue long-term medication use or are not appropriate surgical candidates or do not wish to undergo surgery if there were a less invasive treatment option available. 

The procedure has not been studied and should not be applied in treating patients with severe esophagitis, hiatal hernias > 2 cm, long segment Barrett’s esophagus, dysphagia, or those with a history of autoimmune disease, collagen vascular disease, and/or coagulation disorders.
Summary of Evidence

A systematic review and meta-analysis to determine the efficacy of Stretta for the treatment of GERD was performed. Randomized controlled trials (RCTs) and cohort studies evaluating the Stretta for treatment of GERD were included in the analysis, with the search spanning from database inception to May 2016. The analysis included 28 studies (4 RCTs, 23 cohort studies, 1 registry study). Pooled results found that Stretta decreased (i.e., improved) mean health-related QOL score by -14.6 (95% CI, -16.48 to 12.73; P<0.001). Pooled mean heartburn standardized score was also decreased by Stretta group by -1.53 (95% CI, -1.97 to 1.09; P<0.001). Following Stretta, only 49% of patients who used proton-pump inhibitors (PPIs) at baseline still needed medication at follow-up (P<0.001). Reductions in the incidence of erosive esophagitis (24%; P<0.001) and esophageal acid exposure (mean of -3.01 [95% CI, -3.72 to -2.30]; P<0.001) also occurred with Stretta treatment. However, LES basal pressure was nonsignificantly increased following Stretta therapy by a mean of 1.73 (95% CI, -0.29 to 3.74) mm Hg. The authors concluded that subjective and objective clinical outcomes are improved by the Stretta procedure, and the procedure should be considered as an alternative for the management of GERD (Fass, et al. 2017).
Analysis of Evidence (Rationale for Determination)

A select group of carefully selected patients with chronic reflux would benefit from Stretta as demonstrated by numerous peer-reviewed publications. Patients that could benefit from Stretta generally suffer from refractory symptoms despite adequate treatment with available medications. These patients do not wish to continue long-term medication use.

Some of these patients are not appropriate surgical candidates or do not wish to undergo surgery if there were a less invasive treatment option available. These patients could potentially benefit from a non-invasive procedure such as Stretta.

Stretta is considered appropriate therapy in a select group of patients being treated for chronic GERD who are 18 years of age or older, who have had symptoms of chronic GERD, heartburn, regurgitation, or both for 6 months or more, who have been partially or completely refractory to antisecretory pharmacologic therapy, and who have declined laparoscopic fundoplication.

Proposed Process Information

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Associated Information
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Bibliography
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This request was MAC initiated.
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Coding Information

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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 Group 1 Codes:

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

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 Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient's medical record and made available to the A/B MAC upon request.
Sources of Information
N/A
Bibliography
  1. Arts J, Bisschops R, Blondeau K, et al. A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD. Am J Gastroenterol. 2012;107(2):222-230.
  2. 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. Dig Dis Sci. 2007;52(9):2170-2177.
  3. Auyang ED, Carter P, Rauth T, Fanelli RD. SAGES clinical spotlight review: Endoluminal treatments for gastroesophageal reflux disease (GERD). Surg Endosc. 2013;27(8):2658-2672.
  4. Aziz AM, El-Khayat HR, Sadek A, et al. A prospective randomized trial of sham, single-dose Stretta, and double-dose stretta for the treatment of gastroesophageal reflux disease. Surg Endosc. 2010;24(4):818-825.
  5. Chen D, Barber C, McLoughlin P, Thavaneswaran P, Jamieson GG, Maddern GJ. Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg. 2009;96(2):128-136.
  6. Comay D, Adam V, da Silveira EB, Kennedy W, Mayrand S, Barkun AN. The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: A cost-effectiveness analysis. Can J Gastroenterol. 2008;22(6):552-558.
  7. Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: A randomized, sham-controlled trial. Gastroenterology. 2003;125(3):668-676.
  8. Coron E, Sebille V, Cadiot G, et al. Clinical trial: Radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther. 2008;28(9):1147-1158.
  9. Credentialing Resource Center (CRC). Gastrointestinal endoscopy. Clin Privil White Pap. 2012;(23):1-17.
  10. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005;100(1):190-200.
  11. Dughera L, Rotondano G, De Cento M, Cassolino P, Cisaro F. Durability of Stretta radiofrequency treatment for GERD: Results of an 8-year follow-up. Gastroenterol Res Pract. 2014;531907.
  12. Falk GW, Fennerty MB, Rothstein RI. AGA institute medical position statement on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006;131(4):1313-1314.
  13. Falk GW, Fennerty MB, Rothstein RI. AGA institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006;131(4):1315-1336.
  14. Fass R, Cahn F, Scotti DJ, Gregory DA. Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surg Endosc. 2017;31(12):4865-4882.
  15. Fry LC, Monkemuller K, Malfertheiner P. Systematic review: Endoluminal therapy for gastro-oesophageal reflux disease: Evidence from clinical trials. Eur J Gastroenterol Hepatol. 2007;19(12):1125-1139.
  16. Fuchs KH, Babic B, Breithaupt W, et al. EAES recommendations for the management of gastroesophageal reflux disease. Surg Endosc. 2014;28(6):1753-1773.
  17. Funk LM, Zhang JY, Drosdeck JM, Melvin WS, Walker JP, Perry KA. Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease. Surgery. 2015;157(1):126-136.
  18. Gawron AJ, French DD, Pandolfino JE, Howden CW. Economic evaluations of gastroesophageal reflux disease medical management: A systematic review. Pharmacoeconomics. 2014;32(8):745-758.
  19. 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(4):786-794.
  20. Heidelbaugh JJ, Nostrant TT, Kim C, Van Harrison R. Management of gastroesophageal reflux disease. Am Fam Physician. 2003;68(7):1311-1318.
  21. Hu Z, Wu J, Wang Z, Zhang Y, Liang W, Yan C. Outcome of Stretta radiofrequency and fundoplication for GERD-related severe asthmatic symptoms. Front Med. 2015;9(4):437-443.
  22. Kahrilas PJ. Radiofrequency energy treatment of GERD. Gastroenterology. 2003;125(3):970-973.
  23. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135(4):1383-1391.
  24. Kahrilas PJ, Smith JA, Dicpinigaitis PV. A causal relationship between cough and gastroesophageal reflux disease (GERD) has been established: A pro/con debate. Lung. 2014;192(1):39-46.
  25. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):308-328.
  26. Liang WT, Wu JM, Hu ZW, Wang ZG, Zhu GC, Zhang C. Laparoscopic Nissen fundoplication is more effective in treating patients with GERD-related chronic cough than Stretta radiofrequency. Minerva Chir. 2014;69(3):121-127.
  27. Liang WT, Wu JM, Wang F, Hu ZW, Wang ZG. Stretta radiofrequency for gastroesophageal reflux disease-related respiratory symptoms: A prospective 5-year study. Minerva Chir. 2014;69(5):293-299.
  28. Liang WT, Wu JN, Wang F, et al. Five-year follow-up of a prospective study comparing laparoscopic Nissen fundoplication with Stretta radiofrequency for gastroesophageal reflux disease. Minerva Chir. 2014;69(4):217-223.
  29. Lipka S, Kumar A, Richter JE. No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2015;13(6):1058-1067.
  30. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: Clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45(2):172-180.
  31. Moayyedi P, Talley NJ. Gastro-oesophageal reflux disease. Lancet. 2006;367(9528):2086-2100.
  32. Muthusamy VR, Lightdale JR, Acosta RD, et al. The role of endoscopy in the management of GERD. Gastrointest Endosc. 2015;81(6):1305-1310.
  33. National Institute for Health and Care Excellence (NICE). Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease. NICE Interventional Procedure Guidance No. 461. London, UK: National Institute for Health and Care Excellence; 2013. Accessed 5/23/2024.
  34. National Institute for Health and Care Excellence (NICE). Gastro-oesophageal reflux disease and dyspepsia in adults: Investigation and management. NICE Clinical Guideline No. 184. London, UK: National Institute for Health and Care Excellence; 2014. Accessed 5/23/2024.
  35. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Diagnosis of GER & GERD. Accessed 5/23/2024.
  36. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Treatment for GER & GERD. Accessed 5/23/2024.
  37. News-Medical.net. Mederi’s second generation Stretta and Secca Systems granted CE Mark approval. November 8, 2010. Accessed 5/23/2024.
  38. Noar M, Squires P, Noar E, Lee M. Long-term maintenance effect of radiofrequency energy delivery for refractory gerd: A decade later. Surg Endosc. 2014;28(8):2323-2333.
  39. Noar M, Squires P, Khan S. Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort. Surg Endosc. 2017;31(7):2854-2862.
  40. Pandolfino JE, Krishnan K. Clinical perspectives: Do endoscopic antireflux procedures fit in the current treatment paradigm of GERD? Clin Gastroenterol Hepatol. 2014;12(4):544-554.
  41. Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012;143(5):1179-1187.
  42. Perry KA, Banerjee A, Melvin WS. Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: A systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2012;22(4):283-288.
  43. Richards WO, Houston HL, Torquati A, Khaitan L, Holzman MD, Sharp KW. Paradigm shift in the management of gastroesophageal reflux disease. Ann Surg. 2003;237(5):638-649.
  44. Richter JE. Gastroesophageal reflux disease treatment: Side effects and complications of fundoplication. Clin Gastroenterol Hepatol. 2013;11(5):465-471.
  45. Rubenstein JH, Chen JW. Epidemiology of gastroesophageal reflux disease. Gastroenterol Clin North Am. 2014;43(1):1-14.
  46. Shaheen N, Ransohoff DF. Gastroesophageal reflux, barrett esophagus, and esophageal cancer: Scientific review. JAMA. 2002;287(15):1972-1981.
  47. Shaheen NJ, Weinberg DS, Denberg TD, Chou R, Qaseem A, Shekelle P. Upper endoscopy for gastroesophageal reflux disease: Best practice advice from the clinical guidelines committee of the American College of Physicians. Ann Intern Med. 2012;157(11):808-816.
  48. Spicak J. Treatment of gastroesophageal reflux: Endoscopic aspects. Dig Dis. 2007;25(3):183-187.
  49. Subramanian CR, Triadafilopoulos G. Refractory gastroesophageal reflux disease. Gastroenterol Rep. 2015;3(1):41-53.
  50. Tam WC, Schoeman MN, Zhang Q, et al. Delivery of radiofrequency energy to the lower esophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease. Gut. 2003;52(4):479-485.
  51. 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(10):1475-1479.
  52. Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc. 2004;18(7):1038-1044.
  53. 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(2):149-156.
  54. Tsuda S. Endoscopic Therapy for GERD. Society of American Gastrointestinal and Endoscopic Surgeons. Accessed 5/23/2024.
  55. Tutuian R, Castell DO. Management of gastroesophageal reflux disease. Am J Med Sci. 2003;326(5):309-318.
  56. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R. The Montreal definition and classification of gastroesophageal reflux disease: A global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-1920.
  57. Yan C, Liang WT, Wang ZG, et al. Comparison of Stretta procedure and Toupet fundoplication for gastroesophageal reflux disease-related extra-esophageal symptoms. World J Gastroenterol. 2015;21(45):12882-12887.
  58. Zhang H, Yang Z, Ni Z, Shi Y. A meta-analysis and systematic review of the efficacy of twice daily PPIs versus once daily for treatment of gastroesophageal reflux disease. Gastroenterol Res Pract. 2017;9865963.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
08/18/2024 R12

This LCD is being presented for notice. No changes were made from the proposed LCD that was presented for comment.
  • Provider Education/Guidance
11/02/2023 R11

Under Coverage Indications, Limitations and/or Medical Necessity subheading Limitations removed the verbiage “…Stefanidis, et al. 2017 and…” from the last sentence in the third paragraph. Under Bibliography reference #49 was deleted as this web addresses is no longer available. Remaining references were renumbered accordingly. Acronyms were inserted and defined where appropriate throughout the LCD. Typographical errors were corrected throughout the LCD.
  • Provider Education/Guidance
10/07/2021 R10

Under Bibliography reference #31, #32, and #33 were deleted as these web addresses are no longer available. Remaining references were renumbered accordingly. Typographical errors were corrected throughout the LCD.
  • Provider Education/Guidance
12/27/2020 R9

This LCD is being presented for notice. No changes were made from the proposed LCD that was presented for comment.

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.
  • Provider Education/Guidance
10/24/2019 R8

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Stretta Procedure A56703 article. Typographical errors were corrected throughout the LCD.

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.
  • Provider Education/Guidance
07/18/2019 R7

All coding located in the Coding Information section has been moved into the related Billing and Coding: Stretta Procedure A56703 article and removed from the LCD.

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.
  • Provider Education/Guidance
04/25/2019 R6

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

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.
  • Provider Education/Guidance
01/29/2018 R5 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
04/13/2017 R4 Under Coverage Indications, Limitations and/or Medical Necessity – Limitations removed the words “and safety” from the third bullet and revised the verbiage to read “significant long-term studies confirming efficacy have not been carried out”.
  • Provider Education/Guidance
  • Other
01/22/2016 R3 Under CMS National Coverage Policy deleted the following citation for implantable anti-gastroesophageal reflux devices as Stretta is not an implantable device: CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §100.9, Implantation of Anti-Gastroesophageal Reflux Device. Under ICD-10 Codes That Support Medical Necessity deleted the verbiage as it is redundant.
  • Other
10/01/2015 R2 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R1 Under CMS National Coverage Policy deleted §100 cited in the National Coverage Determinations (NCD) reference. Under Coverage Indications, Limitations and/or Medical Necessity deleted “Services” in the second sentence. During a quality review of this LCD it was identified that revenue code 0350 (CT scan-general classification) was inadvertently included among the billing revenue codes listed under Revenue Codes . This revenue code was deleted without substantive change (non-substantive revision) to the non-coverage of the Stretta procedure. The following revenue codes were added: 0360, 0361, 0450 and 0510. Under ICD-10 Codes that Support Medical Necessity added the following verbiage: ICD-10 CM codes do not support the medical necessity for CPT/HCPCS code 43257, as it is always non-covered. Under Associated Information-Documentation Requirements added new verbiage to be consistent with the ICD-9 version of the LCD. Under Sources of Information and Basis for Decision supplement numbers were added to multiple cited journal articles and the journal name was corrected for the following to now read: 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. Dig Dis Sci. 2007;52(9):2170-2177.
  • Provider Education/Guidance
N/A

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10/25/2023 11/02/2023 - 08/31/2024 Superseded View
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