Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gastroesophageal Reflux Disease (GERD)
Treatment: proposed service code 43210 (esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed)
The insurer denied coverage for proposed service code 43210 (esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed).
The denial is upheld.

This is an adult with gastroesophageal reflux disease (GERD). The patient was previously evaluated for possible anti reflux intervention with transoral incisionless fundoplication (TIF). The patient's symptom history includes heartburn, nocturnal choking, dry cough, throat cleaning and no dysphagia. Treatment has included Protonix and Zantac. The patient's last esophagogastroduodenoscopy (EGD) was years ago. No barium esophagram was done. Esophageal manometry in 2019 showed normal manometry with 0.2 centimeters (cm) manometric hiatal hernia. No pH (potential of hydrogen) impedance study or Bravo study was done. The impression was GERD with esophagitis. The provider noted the patient would be a good candidate for anti-reflux surgery given the good response to therapy and the patient not wanting to take proton pump inhibitor (PPI) long-term due to medication's adverse drug reaction (ADR) profile and young age. The patient underwent an upper endoscopy which showed the gastroesophageal flap valve classified as Hill Grade II. A few sessile polyps were found. The esophagus was found to be normal.

The scientific evidence in peer-reviewed literature does not support a result of improvement in  health outcomes. There is a lack of significant literature showing long-term follow up and efficacy. According to Milliman Care Guideline (MCG) Health Ambulatory Care 26th edition Transoral (endoluminal) gastroplication or suturing, the current role remains uncertain. Based on review of existing evidence, there are currently no clinical indications for this technology. 

MCG notes that, "For gastroesophageal reflux disease that has not responded fully to medical treatment, evidence is insufficient, conflicting, or poor and demonstrates an incomplete assessment of net benefit vs harm; additional research is recommended." Long-term safety and efficacy data have not been consistently reported for transoral incisionless fundoplication. A systematic review and meta-analysis of 32 studies (1475 patients, including 5 randomized controlled trials) evaluating the efficacy of transoral gastroplication for refractory gastroesophageal reflux disease reported, at a mean follow-up of 16 months, showed a significant improvement in GERD healthcare quality-of-life, gastroesophageal reflux symptom, and reflux symptom index scores. In addition, 89% (percent) of patients were able to discontinue proton pump inhibitors. However, the authors recommended additional controlled trials to directly compare long-term outcomes for transoral gastroplication and Nissen fundoplication. 

The procedure has the approval of the appropriate regulatory body (Food and Drug Administration).

The patient is not a suitable candidate for the TIF procedure as there is no DeMeester score and has not been shown to have symptoms consistent with acid reflux. 

The proposed procedure is not the best available treatment at this time for two reasons. The literature is still not consistent in terms of long-term results for the TIF. As noted by MCG the current role remains uncertain. More importantly, the provider has not proven that a procedure is even necessary. The only test he did was manometry which was normal and EGD for which there was no evidence of esophagitis.

In summary, the denial of proposed service code 43210 (esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk may be increased over standard treatments.