Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  GERD.
Treatment:  Esophageal surgery and inpatient stay.
  
The insurer denied the Esophageal surgery and inpatient stay.  The denial is overturned, in part. 

This patient is a man (BMI 26 kg/m2).  He sought surgical evaluation for the symptoms of heartburn, cough and regurgitation.  The records indicate that he is treated for dyspepsia with acid suppressing medications (famotidine and lansoprazole), but he does have breakthrough symptoms.  He has no dysphagia.

The patient has been evaluated for this condition with the following:  1)  EGD (esophagogastroduodenoscopy) showed no esophagitis.  There was a small hiatal hernia; 2)  pH testing was performed while off prescribed heartburn medication and showed esophageal acid exposure with a DeMeester score of 127.6 (normal < 14.7). Symptom correlation was strong for heartburn, regurgitation and cough;  3)  Esophageal motility showed normal esophageal peristalsis.  There was no hiatal hernia noted on manometry testing. There was normal distal contractile integral; and 4)  Contrast UGI (upper gastrointestinal series) showed no hiatal hernia and severe gastroesophageal reflux during the study.  The swallowing mechanism was normal.

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

Yes, the proposed LINX procedure is likely to be more beneficial than standard treatment for the insured's condition.  However, this procedure could be performed with an outpatient designation and does not require inpatient admission.  An outpatient level of care would allow for provision of the operative intervention, post-surgical monitoring and care, and diet progression, including overnight observation if needed.  An inpatient level of care is not required or medically appropriate.

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.

As stated above, the LINX procedure in this case could safely and appropriately be performed with an outpatient level of care.  This level of care would provide for the surgical procedure, perioperative care, provision of pain medication and antiemetic medications and diet progression.  An inpatient level of care is not required based on the submitted documentation.