Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroesophageal reflux (GERD)

Treatment: Current Procedural Terminology (CPT) Code 43284; Laparoscopic Anti-Reflux Surgery (Linx)

The insurer denied coverage for Current Procedural Terminology (CPT) Code 43284; Laparoscopic Anti-Reflux Surgery (Linx). The denial is reversed.

This is a female patient with a long history of gastroesophageal reflux disease (GERD) with primary symptoms of heartburn and regurgitation. The patient had noticed progressive worsening of symptoms. The patient had been on daily proton pump inhibitor (PPI) therapy for then the last few years with improvement in symptoms but without resolution.  Also noted was that in that year, the patient's medication was increased to 80 milligrams of PPI per day but, she continued to have some refractory symptoms of heartburn and regurgitation. The patient's DeMeester score was positive at 23.1 and there was good symptom correlation for heartburn and acid reflux, as well as regurgitation and acid reflux. The patient's pathology results of biopsies were negative for intestinal metaplasia. The patient's high resolution motility showed normal resting and relaxation pressure.  The patient's manometry showed 100% complete clearance with normal esophageal motility.  The patient wished to proceed with the LINX procedure.

There is scientific evidence in peer reviewed literature to support and substantiate the safety and effectiveness of LINX (magnetic sphincter augmentation) procedure for the treatment of GERD.  There are long term results out to 5 years with improvement in the health outcomes for patients undergoing the LINX procedure.  As noted in the article by Ganz et al (2015), there is now data supporting the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD.  Telem et al (2017) noted in SAGES technology and value assessment committee (TAVAC) safety and effectiveness analysis: LINX reflux management system, that longer term (3-5 years) experience with the LINX confirms the initial safety profile and the device has been demonstrated to result in long term GERD control. An additional article by Smith et al (2017) stated that during a 4-year period in more than 3000 patients, there have not been any unanticipated MSA device complications, and no data to suggest a trend of increased events over time.  The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD.  The study concluded that the MSA devise is considered safe for the widespread treatment of GERD. 

According to Schwaitzberg noted in surgical management of gastro esophageal reflux in adults, in Up-to-date, this patient met the clinical indications for a surgical treatment for her GERD. The patient had been treated for many years with daily PPI therapy with minimal relief to her GERD symptoms, and had a confirming abnormal pH study. Thus, LINX 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 Current Procedural Terminology (CPT) Code 43284; Laparoscopic Anti-Reflux Surgery (Linx) is reversed.  The medical necessity is substantiated.