Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: Transoral incisionless fundoplication
The health plan should not cover the Transoral incisionless fundoplication.
The Transoral incisionless fundoplication is not likely to be more beneficial.

Appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD (gastroesophageal reflux disease), "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 much of this pre-operative assessment. Available records neither support that his GERD is advanced, that his LES is dysfunctional, nor that there is any correlation of chest pain symptoms with acid reflux events.

Trans-oral 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)  

However, in the patient's case, there is no provided documentation of esophagitis. Further, the patient's LES anatomy and function is intact. The medical appropriateness is not clear here for LES surgical augmentation. Finally, the patient's response to PPI (proton pump inhibitor) therapy per available records has been generally excellent. As such, the risk of a surgical procedure is outweighed by benefits derived from ongoing and therapeutic medical management. Indeed, available records support that the patient well tolerates PPIs without contraindication. As such, the TIF procedure is not likely to be more beneficial than the combination of lifestyle modification and standard proton pump inhibitor treatment for the insured's condition.