Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD (gastroesophageal reflux disease).
Treatment: LINX Reflux Management System (43284) and Inpatient Stay.

The insurer denied the LINX Reflux Management System (43284) and Inpatient Stay. The denial is upheld. 

The patient is a man. He has BMI (body mass index) of 36.6 kg (kilograms)/m2 (meters squared). He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) of more than one-year duration.  The surgical H&P (history and physical) describes symptoms of heartburn, belching, chest pain early satiety, globus, sore throat, and a hoarse voice.  He has been treated with PPIs (proton pump inhibitors) and antacids with limited response.  He has no dysphagia.  He sleeps with the head of the bed elevated and has modified his diet without clinical improvement.

Due to his ongoing symptoms, the patient was evaluated with the following:

A 48-hour pH (potential of hydrogen) study identified a DeMeester score of 43.7 on Day 1 (normal < 14.7).  On Day 2 the DeMeester score was 18.7.  The study was consistent with abnormally elevated esophageal acid exposure.

EGD (esophagogastroduodenoscopy) that showed a 2-cm (centimeter) hiatal hernia and a ring at the GE (gastroesophageal) junction.  There were ulcers in the duodenum and an ulcer at the GE (gastroesophageal) junction.  There were concentric rings of the middle third of the esophagus.  The biopsy report identified mild chronic inflammation and no evidence for eosinophilic esophagitis.  

Barium swallow showed a small hiatal hernia.  There was mild esophageal dysmotility noted on this study.

Esophageal motility showed preserved esophageal peristalsis and no Chicago Classification abnormality.  There was a 1.2-cm (centimeter) hiatal hernia noted on manometry.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease).  The health plan has denied this treatment based on the contention that LINX is E/I (experimental/investigational). 

No, the health plan should not cover the LINX Reflux Management System (43284) and Inpatient Stay.

No, LINX Reflux Management System (43284) and Inpatient Stay is not likely to be more beneficial.  

LINX and the related inpatient hospital stay is not medically appropriate in this case based on published literature.  LINX is not known to be more health beneficial for this patient's condition of GERD (gastroesophageal reflux disease) than standard treatment.  LINX has not been adequately studied in patients with BMI (body mass index) in excess of 35 kg (kilograms)/m2 (meters squared).  This patient has a body mass index (BMI) of 36.6 kg (kilograms)/m2 (meters squared).

While LINX magnetic sphincter augmentation has been shown by scientific evidence to be safe and effective for the condition of GERD (gastroesophageal reflux disease) with proven elevated esophageal acid exposure, in this case the records indicate a BMI (body mass index) > 35 kg (kilograms)/m2 (meters squared).

General precautions listed by the manufacturer for LINX implantation include a diagnosis of Barrett's as the safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA [Los Angeles] classification) esophagitis.    
Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include the following:
1) Scleroderma
2) Suspected or confirmed esophageal or gastric cancer
3) Prior esophageal or gastric surgery or endoscopic intervention
4) Distal esophageal motility less than 35 mmHg (millimeter of mercury) peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES (lower esophageal sphincter)
5) Symptoms of dysphagia more than once per week within the last three months
6) Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc [et cetera].)
7) Esophageal or gastric varices
8) Lactating, pregnant or plan to become pregnant
9) Morbid obesity (BMI [body mass index] >35)
10) Age < 21

This patient has a BMI (body mass index) greater than 35 kg (kilograms)/m2 (meters squared).  LINX has not been adequately tested in such a clinical scenario.  For this reason, the proposed LINX is not known to be more beneficial than standard therapy (ongoing medical treatment or laparoscopic hiatal hernia repair and fundoplication) and is not medically appropriate.