Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Gastroesophageal reflux disease (GERD).
Treatment:  LINX procedure.

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

This patient is a woman (body mass index [BMI] 24 kg/m2) who sought surgical evaluation for the symptoms of atypical chest pain, heartburn, and reflux.  The records indicate that she is treated for dyspepsia with acid suppressing medications (Omeprazole) but does have breakthrough symptoms.  She has no reported dysphagia.

The patient has been evaluated for this condition with:  1) Esophagogastroduodenoscopy (EGD) that showed no esophagitis.  There was no hiatal hernia.  Biopsies of the esophagus were negative for diagnostic abnormality; 2)  Esophagram showed a small sliding hiatal hernia and a non-obstructing cervical esophageal web; 3) pH testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a DeMeester score of 70.4 (normal less than [<] 14.7).  Symptom correlation was strong for heartburn; and 4)  Esophageal motility showed normal esophageal peristalsis.  There was no hiatal hernia noted on manometry testing.  There was normal distal contractile integral.  There was no Chicago Classification abnormality found.

The treating surgeon has proposed the LINX procedure as treatment of GERD.  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.

Yes, 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 approval since 2012.  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.

This patient has symptomatic GERD.  She has completed evaluation with UGI, EGD, pH 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 approved.  LINX is widely accepted as necessary and appropriate treatment for the condition of GERD as is documented to exist in this case and is not experimental / investigational based on the quality and quantity of published peer-reviewed literature.   

Based on the status of peer reviewed literature and adequate long-term follow up, specialty surgical society position statement affirmation regarding LINX and FDA approval, the medical necessity 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 (as the ability to belch and vomit are preserved compared to surgical fundoplication).