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.

This patient is a male with BMI (body mass index) of 24.7. He sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease) in the form of chest pain and regurgitation.  The submitted records include a surgical history and physical exam that details the symptoms.  He has been treated with Pepcid, Prevacid, Omeprazole, and Carafate with refractory symptoms.  He reports occasional dysphagia.  He has completed evaluation for this condition with the following:

Esophagram showed a small hiatal hernia and multiple episodes of gastroesophageal reflux to the mid-esophagus.

EGD (esophagogastroduodenoscopy) showed no esophagitis and a 1-cm (centimeter) hiatal hernia.  The Z-line was irregular.  Pathology of the GE (gastroesophageal) junction biopsy did show reflux esophagitis.

72-hour esophageal pH (potential of hydrogen) testing reported an elevated DeMeester score on day 1 (17.9), an elevated DeMeester score on Day 2 (15.8), and an elevated DeMeester score on Day 3 (15.2) (normal <  [less than] 14.7).  There was strong symptom correlation with chest pain and regurgitation.

The motility study showed no manometric hiatal hernia. Normal peristalsis was seen with 93% of swallows.

Gastric emptying study was normal.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease).  The prior denial reason was that the proposed LINX is experimental / investigational.  The reason for appeal is that the patient and his doctor disagree that LINX is experimental / investigational.

Yes, the health plan should cover the LINX procedure.
The health plan denial letter states that LINX has not been shown in the medical literature to be effective.  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]

Yes, the LINX procedure is more beneficial.
This patient has symptomatic GERD (gastroesophageal reflux disease).  He has completed evaluation with pH (potential of hydrogen) testing, EGD (esophagogastroduodenoscopy), Esophagram, gastric emptying study, 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.

In this case LINX is consistent with the symptoms and diagnosis of proven pathologic esophageal acid exposure.  LINX is performed by a licensed provider and is in accordance with the standards of good medical practice.  LINX is not for the convenience of anyone. 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 experimental/investigational based on the quality and quantity of published peer-reviewed literature.
The body of published literature regarding the LINX procedure has expanded with data supporting the efficacy and safety of magnetic sphincter augmentation.  Reynolds et al found that analogous GERD (gastroesophageal reflux disease) patients had similar control of reflux symptoms after both MSA (magnetic sphincter augmentation) and laparoscopic Nissen fundoplication and the inability to belch and vomit were significantly fewer with Magnetic sphincter augmentation (MSA). The authors concluded that the results support the use of MSA (magnetic sphincter augmentation) as first-line therapy in patients with mild to moderate GERD (gastroesophageal reflux disease).  One-year data from the NCT01624506 trial showed that both MSA (magnetic sphincter augmentation) and fundoplication resulted in significant improvements in reflux control with similar safety and reoperation rates. The NCT00776997 clinical trial validates the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD (gastroesophageal reflux disease) with 5-year follow up.

Finally, The American Society of General Surgeons has released a position statement that supports the inclusion of the LINX procedure into the armamentarium of treatment options for appropriately selected patients with GERD (gastroesophageal reflux disease).  Therefore, based on the status of peer reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA (United States Food and Drug Administration) approval, the medical appropriateness of the proposed LINX procedure is established for this patient, and this therapy is more beneficial for the patient's condition of GERD (gastroesophageal reflux disease) than standard treatment (ongoing medicinal treatment or surgical fundoplication).