Coverage Policies

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Current policies effective through April 30, 2024.

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 12/07/2011 Title: Transesophageal Therapy for GERD: Endoscopic Radiofrequency
Revision Date: 08/06/2015 Document: BI327:00
CPT Code(s): 43257
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

  1. Radiofrequency thermal destruction of tissue has been applied to the lower esophageal sphincter to treat gastro esophageal reflux disease. 
  2. This technique has not been demonstrated to improve health outcomes and is not covered.

Medical Statement

Endoscopic application of radiofrequency energy treatment to the lower esophageal sphincter, using the Stretta device or any other, for the treatment of gastro esophageal reflux disease is considered experimental/investigational and is not covered.

 

 

Codes Used In This BI:

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 gastro esophageal reflux disease


Background

Evidence comparing Stretta with PPI alone typically shows outcomes at least as good as PPI alone, but with limited follow up.  Comparisons of Stretta to laparoscopic fundoplication generally favor laparoscopic fundoplication.

 

In 2003, Corley et al enrolled patients with symptoms at least partially responsive to proton pump inhibitors, a pH study showing abnormal acid exposure, and the usual exclusions including severe esophagitis or significant anatomic defect. The sham procedure involved balloon inflation but no needle deployment or energy delivery. A total of 64 patients were randomized and partial or complete 6-month follow-up data were available on 56 patients.

 

The results of this trial were inconsistent. Although improvement in heartburn symptoms, quality of life, and general physical quality of life was observed in the active treatment group compared to the sham group, there were no differences in medication usage and esophageal acid exposure. Thus in terms of the objective measures of GERD, the findings are equivocal. In addition, data is also needed from controlled comparison with other treatment for GERD, such as Nissen fundoplication to better characterize outcomes relative to the risks involved.

 

The Med Letter reviewed the effectiveness of the Stretta device.  "The Stretta procedure appears to decrease reflux symptoms, but a decrease in esophageal exposure to acid has not been clearly demonstrated and it has not been evaluated at all in the most difficult-to-treat patients, such as those with large hiatal hernias or high-grade esophagitis.  The long-term efficacy and safety of this procedure are unknown."

 

In a position paper published in 2008 the American Gastroenterological Association made the following statement:

 

Grade Insuff: no recommendation, insufficient evidence to recommend for or against.

The use of currently commercially available endoluminal anti-reflux procedures in the management of patients with an esophageal syndrome.

 

NICE Interventional Procedure Guidance 461 states that the evidence of safety of endoscopic radiofrequency ablation is adequate in the short and medium term, but there is uncertainty regarding longer-term outcomes.  There is evidence of symptomatic relief but objective evidence on reduction of reflux is inconclusive.  RF ablation was therefore only to be used under special arrangements. 

 

There is one study listed on ClinicalTrials.gov (NCT01682265) as actively recruiting to determine the efficacy of the Stretta procedure.


Reference

American Gastroenterological Association. (2008) American Gastroenterological Association Medical Position Statement on the Management of Gastro esophageal Reflux Disease. Gastroenterol, 2008; 135:1383-91.

Corley DA, Katz P, Wo JM, et al. (2003) Improvement of gastro esophageal reflux symptoms after radiofrequency energy: a randomized sham-controlled trial. Gastroenterology. 2003; 125(3):668-676.

Hogan WJ. (2001) Endoscopic treatment modalities for GERD: Technologic score or scare. Gastro Endosc 2001; 53:541-5 (editorial).

Kahrilas PJ. (2003) Radiofrequency therapy of the lower esophageal sphincter for treatment of GERD. Technological review. Gastrointest Endosc 2003; 57:723-31.

The Stretta procedure for GERD. The Med Letter Drugs Therap, 2006; 48:99-100.

Triadafilopoulos G, Dibaise JK, et al. (2001) Radiofrequency energy delivery to the gastro esophageal junction for the treatment of GERD. Gastro Endosc 2001; 53:541-5.

Hayes Medical Technology Directory.  Endoscopic therapy for gastro esophageal reflux disease.  Published 30 July 2015.  Accessed 3 August 2015


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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