Appeal type: Medical necessity
Decision: Overturned


Diagnosis: GERD 

Treatment: LINX-Laparoscopic Surgical Esophageal Sphincter Augmentation Procedure code 43284

The insurer denied coverage for LINX-Laparoscopic Surgical Esophageal Sphincter Augmentation Procedure code 43284. The denial is reversed.

This patient is a female who was referred for evaluation of GERD. The patient complained of heartburn, regurgitation, chest pain, and cough from a water brash and dysphagia. Some of the symptoms had been noted to be present for 10 years. The patient was on omeprazole, but the medication stopped working. The patient recently switched to pantoprazole which she took daily for breakthrough symptoms. The patient's last endoscopy was several years prior. The patient underwent esophagogastroduodenoscopy (EGD) and ambulatory pH monitoring at which time it was determined that her Demeester score was 36.1 with symptom association greater than 80%. The patient was noted to have a 2 cm hiatal hernia. The patient underwent esophagram, which showed mild esophageal dysmotility, and otherwise normal appearing esophagus without evidence of hiatal hernia.

Based on the review of the medical record, this patient's GERD was confirmed by an abnormal 48-hour Bravo pH study with a Demeester score of 36 with symptom association. This patient's significant GERD meets the clinical indication for treatment with LINX-Laparoscopic Surgical Esophageal Sphincter Augmentation. This procedure has been recognized by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and American Society for Gastrointestinal Endoscopy (ASGE) as an option for treating GERD. There are long term results out to 5 years with improvement in the health outcomes for patients undergoing the LINX procedure. Telem et al (2017) in SAGES states that longer term (3-5 years) experience with the LINX confirms the initial safety profile, and the device have been demonstrated to result in long term GERD control.

According to Smith et al (2017), "during a 4-year period in more than 3000 patients, no unanticipated magnetic sphincter augmentation device (MSAD) complications have emerged, and there is no data to suggest a trend of increased events over time. MSAD is considered safe for the widespread treatment of GERD." Extensive literature review indicated that the LINX (MSAD) procedure is effective in improving health outcome for patients with refractory GERD.

According to Schwaitzberg in the surgical management of gastro esophageal reflux in adults, from UpToDate, the eligible patients for the LINX procedure include those with all of the following: Typical GERD symptoms; Abnormal pH study; Partial response to daily proton pump inhibitor (PPI) therapy; Absence of a large hiatal hernia (>3 cm) or severe esophagitis. In this care, the patient met these clinical criteria for anti-reflux procedure. The patient had significant reflux supported by her GERD symptoms and confirmed by her pH study. The patient had been treated with PPI therapy for many years but continued to have significant symptoms, with breakthrough symptoms recently on pantoprazole. LINX procedure is less invasive than a Nissen fundoplication, and this patient is considered a good candidate for this procedure.

Based on the review of the medical record and the literature records, LINX procedure is considered medically necessary to treat this patient's medical condition.The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for LINX-Laparoscopic Surgical Esophageal Sphincter Augmentation Procedure code 43284 should be reversed.  The medical necessity is substantiated.