Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Treatment: Laparoscopic Esophageal Surgery and Hospital Admission (43284) (Pre-Service)
The insurer denied the Laparoscopic Esophageal Surgery and Hospital Admission (43284) (Pre-Service). 
The denial is upheld. 

This patient is a woman (BMI 29.7 kg/m2) who sought surgical evaluation for symptoms attributed to GERD (Gastroesophageal Reflux Disease).  She has been treated for this condition with Omeprazole with refractory and worsening symptoms. She is reported to have symptoms of dysphagia.  

Evaluation includes:
Esophagram showed mild esophageal dysmotility with significant stasis of contrast in the distal thoracic esophagus.  There was a small hiatal hernia and no GE reflux during the study.

EGD showed a normal esophagus with no esophagitis and a 2-cm hiatal hernia.  

pH testing records that the DeMeester score on this study was 41 (normal < 14.7). 

Esophageal motility study showed 40% of swallows were fragmented or failed6and 10% were generally normal.  The impression was that of mild ineffective esophageal motility.  

The treating surgeon has proposed the LINX procedure as treatment of GERD.   

No.  The health plan should not cover the proposed LINX procedure and the related hospital admission.

Based on the submitted clinical material and the published literature and manufacturer selection criteria for LINX, the proposed LINX is not known to be more beneficial than any standard treatment for the insured's condition/disease.  

LINX is not proven therapy in this case based on published literature and manufacturer selection criteria.  LINX is not known to be health beneficial for this patient's symptoms attributed to GERD in the setting of dysphagia and esophageal dysmotility as noted on the contrast UGI and motility study.  

While LINX magnetic sphincter augmentation has been shown by scientific evidence to be safe and effective for the condition of GERD with proven elevated esophageal acid exposure, preserved motility and no alternative diagnosis, in this case the records indicate a history of dysphagia and esophageal dysmotility.
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 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:
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 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
5. Symptoms of dysphagia more than once per week within the last 3 months
6. Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, hiatal hernia, etc.)
7. Esophageal or gastric varices
8. Lactating, pregnant or plan to become pregnant
9. Morbid obesity (BMI >35)
10. Age < 21
This patient has dysphagia and ineffective esophageal motility.  The device manufacturer criteria were initially limited to use of LINX in patients without any of the listed precautions/contraindications.  For this reason, the proposed LINX and associated inpatient admission is not known to be beneficial and would be considered experimental/investigational in this case.