Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Heartburn, epigastric pain and bloating
Treatment: Upper GI endoscopy- esophagogastroduodenoscopy with radiofrequency ablation (RFA)
The insurer denied Upper GI endoscopy- esophagogastroduodenoscopy with radiofrequency ablation (RFA).
The determination is upheld.

The patient has a history of Roux-en-Y gastric bypass (RYGB) and substantial weight loss. She is being evaluated for symptoms of heartburn, epigastric pain and bloating. Potential hydrogen (pH), endoscopy and manometry studies have demonstrated a low lower esophageal sphincter (LES) pressure and dysmotility without a hiatal hernia. The absence of abnormal acid exposure and low correlation of symptoms to reflux events were noted. The patient is noted to have persistent symptoms despite proton pump inhibitor (PPI), Baclofen and Gaviscon medication therapies.
At issue is whether the proposed health service or treatment Upper GI endoscopy- esophagogastroduodenoscopy with radiofrequency ablation (RFA) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed esophagogastroduodenoscopy (EGD) and RFA therapy or Stretta procedure is not likely to be more beneficial than standard therapies. The proposed RFA procedure has not undergone sufficient study among patient with RYGB anatomy to demonstrate effectiveness over standard therapies with medication, dietary and lifestyle change, and cruroplasty surgery. In this case, the patient has symptoms of unclear etiology, with low correlation of symptoms to reflux episodes, and complaints that include bloating and epigastric pain which may be difficult to ascribe to the documented low lower esophageal sphincter (LES) pressure. The Stretta procedure may offer some improvement and continues to be studied with patients with documented acid reflux, something this patient does not have.
As Xie's 2021 metanalysis of Stretta and endoscopic therapies for gastroesophageal reflux disease (GERD) describes, "This evidence should be interpreted with caution given the small number of included studies and inherent heterogeneity." (1)
Nevins reports in 2021 a small series of 11 patients with prior gastric surgery, mostly Nissen fundoplications, writing, "The small sample size is a limitation of this case series. Nevertheless, though STRETTA is not routinely used for recurrent or primary GERD after gastric surgery, we believe this is the second-largest cohort of patients on this topic [7]. An additional limitation is the lack of post-operative pH or manometry studies to help establish reasons for the success or failure of the STRETTA procedure. " (2)
This patient does not have evidence to support the concept for Stretta, namely that improving the low LES pressure or reducing reflux events might improve her symptoms. Nor are there data in patients with prior gastric bypass sufficient to warrant a conclusion that this proposed procedure would be beneficial.
As Vaezi writes in a comprehensive review in Gastroenterology, "This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood."(3) The role of the proposed endoscopic RFA procedure for this patient is not well defined, not believed to be superior to standard therapies, and not considered medically necessary.