Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)

Treatment: Laparoscopic surgery

The insurer is denied coverage for laparoscopic surgery for placement of LINX Reflux Management System.

The denial is upheld. 

This patient was then a male (BMI 25 kg/m2) who sought surgical evaluation for the condition of gastroesophageal reflux disease (GERD). The records do not include a surgical consultation that describes this patient's symptoms, presence of dysphagia, or prior treatment efforts. The records do include a letter that described this patient's abnormal esophageal motility and the issue that this may contribute to persistent post-surgical dysphagia. This may require removal of the LINX device. Despite the documented weakened peristalsis and low distal contractile integral (DCI), the doctor has advised LINX.
The patient's esophagogastroduodenoscopy (EGD) showed grade B esophagitis and a 2-3 cm hiatal hernia. There was no intestinal metaplasia on biopsy. The patient's BRAVO pH study showed elevated esophageal acid exposure with a composite DeMeester score of 48.5 (normal < 14.7) over several-days. The patient's esophageal motility testing showed 30% complete clearance, 70% of swallows failed, 20% were weak. Distal contractile intergral (DCI) was marginally low at 490.2 mmHg. There was a 1.5-cm hiatal hernia noted on manometry. The Chicago classification was that of Ineffective esophageal motility.

Based on the submitted clinical data, the proposed LINX procedure is not known to be more beneficial for this patient's diagnosis/condition. There is not evidence-based literature that supports that this procedure will provide improvement in health outcome in the setting of esophageal dysmotility (Ineffective esophageal motility).

Additionally, the records do not include a surgical consultation that describes this patient's symptoms, presence of dysphagia, or prior treatment efforts. While LINX is a proven effective therapy for appropriately selected patients with GERD (pathologic esophageal acid exposure, preserved motility, no alternative diagnosis or contraindication to the procedure), LINX is not proven primary therapy for this patient's symptom of reflux in the setting of esophageal dysfunction.

Specific contraindications to implantation of the LINX device include Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age < 21. In this case there is documentation of esophageal motor pathology (Ineffective esophageal motility). 
This is a contraindication to the LINX procedure.

Based on the submitted documentation, the published literature, and the clinical details of this case, this patient is not a suitable candidate for application of the LINX device and this is not an appropriate, evidence-based therapy for this patient. Thus, the requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of coverage for laparoscopic surgery (43284) for placement of LINX Reflux Management System should be upheld.