Appeal type: Experimental/Investigational
Decision: Overturned in Part

Diagnosis: Gastroesophageal Reflux Disease

Treatment: Laparoscopic Esophageal Surgery and Hospital Admission

The insurer denied the laparoscopic esophageal surgery and hospital admission.

The denial was partially overturned.

This is a female patient with a history of gastroesophageal reflux disease (GERD), hypertension (HTN) and scleroderma. She was evaluated by a thoracic and esophageal surgeon who noted that the patient was referred to his office for consideration of anti-reflux surgery. Her workup included a Demeester score of 94.8 by pH study. A motility study showed normal motility with borderline low LES (lower esophageal sphincter) and reflux. It did not have the appearance of a scleroderma type of esophagus. Esophagram showed a small hiatal hernia. The patient's BMI was 34.3. The provider noted that after a lengthy discussion the LINX was the favored procedure for her.

Gastric emptying study showed normal gastric emptying. Esophageal motility study showed normal motility with reflux, with no evidence for scleroderma esophagus despite systemic diagnosis. Ambulatory pH study showed a Demeester score of 94.8 with a 98.2% symptom association probability. Upper endoscopy was performed that showed a patulous lower esophageal sphincter, with a 2 cm hiatal hernia and diffuse inflammation characterized by erosions and erythema.

There is scientific evidence in peer reviewed literature to support and substantiate its improvement in health outcomes as well as its safety and effectiveness. It is approved by the FDA (Food and Drug Administration). It has been recognized by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) and ASGS (American Society of General Surgeons) 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. Most recently Louie et al concluded in "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study" Ann Surg 2019 that the safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD. 

It is not 100% clear if this patient is a good patient for this device given the fact that the patent has been labeled with the diagnosis of scleroderma without being given any details. Yet the patient has an esophageal motility study that showed normal motility with reflux, with no evidence for scleroderma esophagus, despite systemic diagnosis. In addition, her ambulatory pH study showed a Demeester score of 94.8 with a 98.2% symptom association probability thus confirming GERD and the need for intervention. Thus, the diagnosis of scleroderma with GI manifestations in this patient is not apparently present. However, one must bear in mind that the safety and effectiveness of the LINX has not been established in patients with scleroderma. Thus, my inability to say with 100% certainty, that this patient is a good candidate for the LINX. However, if one was to negate the scleroderma diagnosis or negate the possibility that the patient has scleroderma as a GI manifestation in the esophagus and is the cause of the GERD in this patient, then she would be a good candidate. 

It is the least invasive and would provide durable results for this patient. It is also reversible such that if in time it becomes apparent that the patient does have scleroderma of the esophagus as the cause of the GERD, the device can be removed. LINX should be considered as good as a treatment modality as the gold standard which is fundoplication.

This procedure can be performed as an outpatient procedure without full hospital admission. Therefore, based upon the records, denial for the procedure in this case is reversed for the procedure but the denial for the full hospital admission is upheld.

The carrier's denial of laparoscopic esophageal surgery and hospital admission should be partially overturned.