Appeal type: Experimental/Investigational
Decision: Overturned

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

The insurer denied the LINX Reflux Management System (LINX) (43284). 
The denial is overturned. 

This patient is a woman (body mass index 20.5) who sought surgical evaluation for the symptoms of heartburn, belching, and regurgitation of several years duration. The records indicate that she is treated for dyspepsia with acid suppressing medications (Aciphex), but does have breakthrough symptoms. She has no dysphagia. 

The patient has been evaluated for this condition with the following: 

EGD (esophagogastroduodenoscopy) showed no esophagitis. There was no hiatal hernia. Biopsy of the esophagus was negative for intestinal metaplasia. 

pH testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a composite DeMeester score of 27.8 (normal < [greater than] 14.7) over 96-hours of study. Symptom correlation was strong for heartburn, regurgitation and belching. 

Esophageal motility testing showed normal esophageal peristalsis. 

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophgeal reflux disease). The health plan determination is that the Plan considers LINX to be experimental / investigational for the treatment of GERD.

Yes, the health plan should cover the LINX procedure. 

LINX is medically appropriate and consistent with peer-reviewed literature for this patient. The health plan should cover this treatment. 

Yes, the LINX procedure is more beneficial. 

The proposed LINX procedure is likely to be more beneficial than standard treatment for the insured's condition. 

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 as is documented to exist in this case. LINX is a proven effective therapy for the condition of GERD 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 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. 

This patient has symptomatic GERD (gastroesophageal reflux disease). She has completed evaluation with EGD (esophagogastroduodenoscopy), pH (potential Hydrogen) testing and esophageal motility testing. 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 MSA (magnetic sphincter augmentation). 

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 procedure would be expected to be more beneficial than standard treatment for the insured's condition of GERD (gastroesophageal reflux disease) (as the ability to belch and vomit are preserved).