
202101-134573
2021
Fidelis Care New York
Medicaid
Digestive System/ Gastrointestinal
Surgical Services
Experimental/Investigational
Upheld
Case Summary
Diagnosis: Digestive System/Gastrointestinal.
Treatment: Surgical Services.
The insurer denied surgical procedure on esophagus.
The denial is upheld.
This male patient has chronic gastroesophageal reflux disease (GERD) which has worsened following a peroral endoscopic myotomy (POEM) procedure done to treat achalasia Type 2. He has tried multiple proton-pump inhibitors (PPIs) without relief of his symptoms. He had an esophageal pH study that demonstrates significant reflux. The attending provider would like to do a transoral incisionless fundoplication (TIF) procedure to treat this patient's GERD. The subject under review is whether the procedure would be more beneficial than any standard treatment for the patient's condition.
The health plan's determination is upheld.
the proposed health service or treatment surgical procedure on esophagus is not more likely to be more beneficial than any standard treatment or treatments for the patient's condition. There are two endoscopic interventions for GERD that are currently available in the United States they are the Stretta procedure, and transoral incisionless fundoplication (TIF). In studies evaluating these endoscopic interventions, patients with significant structural Esophagogastric junction disruption (e.g., hiatus hernia larger than 2 centimeter [cm]), significant esophagitis (Los Angeles Classification of GERD grade C or D), and GERD complications (Barrett's esophagus [BE], peptic stricture) were excluded. In a multicenter study that compared TIF to a sham procedure and PPI therapy, esophageal pH decreased, and regurgitation was better resolved 6 months after TIF, although TIF did not reduce GERD symptom scores.
A randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease by Witteman and colleagues showed that although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved. Similarly, in a systematic review and network meta-analysis of trials of patients with GERD, Richter and colleagues found laparoscopic Nissen fundoplication (LNF) to have the greatest ability to improve physiologic parameters of GERD, including increased lower esophageal sphincter LES pressure and percent time at pH less than (<) 4. Although transoral incisionless fundoplication (TIF) produced the largest increase in health-related quality of life, this could be due to the shorter follow-up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, the authors do not recommend it as a long-term alternative to PPI or LNF for treatment of GERD.