Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  GERD (gastroesophageal reflux disease).
Treatment:  LINX Procedure.

The insurer denied the LINX procedure.  The denial is overturned.

The patient is a male.  His BMI (body mass index) is 27 kg (kilograms)/m2 (meters squared).  He sought surgical evaluation for the symptoms of heartburn and regurgitation.  The records indicate that he is treated for dyspepsia with acid suppressing medications (omeprazole), but he does have breakthrough symptoms.  He has no reported dysphagia.

The patient has been evaluated for this condition with the following:  1) Gastric emptying study showed rapid gastric emptying; 2) EGD (esophagogastroduodenoscopy) that showed distal esophagitis.  There was a four-cm (centimeter) hiatal hernia.  Biopsies of the esophagus were negative for diagnostic abnormality; 3) pH (potential of hydrogen) testing was performed while the patient was off prescribed heartburn medication, and it showed elevated esophageal acid exposure with a composite DeMeester score of 58.8 (normal less than [<] 14.7) over 48 hours; 4) Esophageal motility showed normal esophageal peristalsis.  There was no hiatal hernia noted on manometry testing.  There was normal distal wave amplitude.  There was no Chicago Classification abnormality found.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease), along with the scheduled hiatal hernia surgery.  This is proposed as an alternative to fundoplication.  The health plan determination is that the Plan considers LINX to be experimental investigational for the treatment of GERD (gastroesophageal reflux disease).

Yes, the health plan should cover the LINX procedure.

Yes, the proposed LINX procedure, in conjunction with repair of the hiatal hernia, is likely to be more beneficial than standard treatment for the insured's condition.  The proposed LINX has been granted FDA (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.  The use of the LINX device in patients with a hiatal hernia larger than three-centimeters (cm) should include hiatal hernia repair to reduce the hernia to less than three-centimeters.

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 five-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); five years after device placement this score decreased to four.  All patients used PPIs (proton pump inhibitors) at baseline; this value decreased to 15.3% at five years.  Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at five 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 five-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 five-year
conclusion of the clinical trial NCT00776997.  [Ganz et al.]  The FDA (Food and Drug Administration)-required five-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 EGD (esophagogastroduodenoscopy), pH (potential of
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 (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.

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 five-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 (Food and Drug Administration) approval, the medical appropriateness of the proposed LINX procedure, in conjunction with the hiatal hernia repair, 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 compared to surgical fundoplication.