Appeal type: Medical necessity
Decision: Upheld

Diagnosis: GERD
Treatment: Transoral incisionless fundoplication (TIF)

The TIF is not medically necessary. 

Appropriate patient selection is crucial before anti-reflux procedures.  In prelude to surgical intervention for gastroesophageal reflux disease (GERD), "it is critical to document the presence of abnormal distal esophageal acid exposure, especially when anti-reflux surgery is considered, and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. Each testing modality has a specific role in the diagnosis and workup of GERD, and no single test alone can provide the entire clinical picture. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach.  CONCLUSIONS: Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery." (1) The patient has undergone only some of this pre-operative assessment.  

Transoral incisionless fundoplication (TIF procedure) as proposed for the patient has shown merit and durable response for some GERD patients. "The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability." (2) 

In Testoni's recent series: "Patients were followed for up to six years (mean 52.7  19.7 months). In all, 83.7, 79.6, 87.8, and 84.4 % of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill's grade I of the newly created valve persisted in all pre-procedure Hill's grade I patients, in 66.7 % of grade II and 58.3 % of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill's grade I-II, no hiatal hernia or hernia <= 2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01). CONCLUSIONS: TIF achieved lasting elimination of daily dependence on PPI in 75-80 % of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients." (3)  

In a meta-analysis of "fifteen studies reporting on over 550 procedures. Both GERD-HRQL scores (21.9 vs. 5.9, p < 0.0001) and RSI scores (24.5 vs. 5.4, p < 0.0001) were significantly reduced after TIF. Overall patient satisfaction was 72 %. The overall rate of PPI discontinuation was 67 % across all studies, with a mean follow-up of 8.3 months. pH metrics were not consistently normalized. The major complication rate was 3.2 % and the failure rate was 7.2 % across all studies." (4)

However, in this patient's case there is no provided documentation of esophagitis, no pH study correlation of heartburn symptoms with acid reflux events, nor of lack of response or intolerance to proton pump inhibitor therapy (available records support only Zantac treatment).

Finally, there is limited data to support a re-do TIF.  In Stefanidis series (5): "three patients chose to undergo a redo procedure, because they continued to use PPIs at a full of half dose for more than 50% of the preceding follow up period. Out of these three patients, two chose to undergo a laparoscopic Nissen fundoplication with an excellent outcome, while the third one chose to undergo a second TIF procedure; however, with no favorable results."  Redo TIFs are uncommon, and current literature supports alternative options.