Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD (gastroesophageal reflux disease) 
Treatment: Linx Reflux Management System
The insurer denied the Linx Reflux Management System
The denial is overturned. 

The patient is a man (BMI [body mass index] 23 kg/m2 [kilograms per meter squared]). He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease), e.g., heartburn, chest spasms.  The submitted records include a surgical history and physical exam that details his symptoms.  He has been treated with Pepcid, Omeprazole and Carafate with refractory symptoms.  He reports no dysphagia.  He has completed evaluation for this condition with the following:

Esophagram showed a small hiatal hernia and reflux to the level of the clavicles. There was normal motility.

EGD (esophagogastroduodenoscopy) showed a 1-cm (centimeter) hiatal hernia.  The esophagus was normal.

Esophageal pH (potential of hydrogen) testing was performed while off all acid suppressing medications and reported a normal DeMeester score of 40 (normal < 14.7).  The esophageal acid exposure was elevated on each of the four days.  There was strong symptom correlation with heartburn and chest pain.

The motility study showed instances of weak peristalsis-40% weak distal contractile integral values.  This was a normal study by Chicago classification.  There was a small hiatal hernia by manometry.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease).

Yes, the health plan should cover the Linx procedure.
The health plan denial letter states that LINX is considered by the plan to be experimental or investigational.  However, there is ample literature cited below that supports the efficacy of the LINX procedure for properly selected patients.  Published literature does include randomized controlled and comparative data studies as are listed in the references below.  [1, 2, 8, 11]. These publications support the safety and efficacy of the proposed LINX procedure for appropriately selected patient as in this case.

The proposed LINX has been granted FDA (United States Food and Drug Administration) approval.  It is not the subject of phase I, II or III clinical trials.  Based on the volume and quality of the peer-reviewed literature cited below, the safety, effectiveness, and effect on health outcomes has been established. Reliable evidence shows that the LINX procedure is safe and effective for the treatment of GERD (gastroesophageal reflux disease) as is documented to exist in this case.  LINX is a proven effective therapy for the condition of GERD (gastroesophageal reflux disease) and is generally recognized by the medical community as effective and appropriate for the specific diagnosis of this patient.

The LINX procedure as proposed in this case is not experimental or investigational.  There has been completion of ongoing clinical trials NCT00776997 and NCT01624506 that provide the necessary long term follow up regarding LINX.  These studies, in conjunction with previously published data, support the long-term safety and efficacy of the LINX and reinforce that this procedure has withstood appropriate scrutiny and should be included in the armamentarium of proven-effective therapy for the treatment of GERD (gastroesophageal reflux disease) in selected patients.

Since the SAGES(Society of American Gastrointestinal and Endoscopic Surgeons) Safety and Effectiveness Analysis and a study by Ganz et al., there has been additional analysis that provides long-term data to 5-years post implantation.  The follow up analysis reports that over the follow-up period there were no endoluminal erosions, migrations, or malfunctions of the LINX device. At baseline, the median GERD (gastroesophageal reflux disease)-HRQL (health-related quality of life) scores were 27 in patients not taking PPIs (proton pump inhibitors) and 11 in patients on PPIs (proton pump inhibitors); 5 years after device placement this score decreased to 4. All patients used PPIs (proton pump inhibitors) at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed.  The study concluded that MSA (magnetic sphincter augmentation) with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD (gastroesophageal reflux disease). This study provides the 5-year conclusion of the clinical trial NCT00776997. [Ganz et al]  The FDA (United States Food and Drug Administration)-required 5-year follow up of 100 patients from the investigational device exemption pivotal study has been completed and supports the safety and efficacy of the procedure.

Clinical trial NCT01624506 is an Anti-Reflux Surgical Study that is an observational study designed to collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation [MSA] and Fundoplication) in clinical practice.  This study also tracked the clinical course of patients.  One-year data showed that both MSA (magnetic sphincter augmentation) and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates.  [Riegler M, et al]

This patient has symptomatic GERD (gastroesophageal reflux disease).  He has completed evaluation with pH (potential of hydrogen) testing, EGD (esophagogastroduodenoscopy), esophagram, and esophageal motility testing.  These studies confirm that there is pathologic esophageal acid exposure and no alternative diagnosis or contraindication to application of the LINX device.  An anti-reflux procedure such as LINX is medically appropriate for this patient.

Yes, the Linx procedure is more beneficial.
LINX is a medically appropriate service, is consistent with the symptoms and diagnosis of proven pathologic esophageal acid exposure, and is in accordance with the standards of good medical practice.  This treatment is FDA (United States Food and Drug Administration) approved.  LINX is widely accepted as necessary and appropriate treatment for the condition of GERD (gastroesophageal reflux disease) as is documented to exist in this case and is not E/I (experimental/investigational) based on the quality and quantity of published peer-reviewed literature.   Finally, LINX offers this patient control of acid reflux on par with surgical fundoplication, but with an improved preservation of the ability to belch and vomit compared to fundoplication.  Therefore, LINX is more beneficial than standard treatment for this patient's condition of GERD (gastroesophageal reflux disease).