Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Reflux Disease (GERD)
Treatment: LINX procedure
The insurer denied the LINX procedure.
The denial is overturned.

This patient is a woman (BMI [body mass index] 29 kg [kilograms]/m2 [meters squared]) who sought surgical evaluation for the condition of longstanding GERD (gastroesophageal reflux disease) that is refractory to medicinal therapy (PPIs [proton pump inhibitors]).  Symptoms consist of heartburn, chest and abdominal pain, globus sensation and satiety.  Symptoms have been present for the past three years.  

While there is some improvement in symptoms with medications, the patient continues to have breakthrough symptoms. There is no reported dysphagia.  She has tried sleeping with the head of the bed elevated without improvement.

The EGD (esophagogastroduodenoscopy) report that was performed  describes a normal esophagus and gastroesophageal junction and no hiatal hernia.  

A prior EGD (esophagogastroduodenoscopy) showed an irregular Z-line and a hiatal hernia (3-cm [centimeter]).  Biopsy was negative for intestinal metaplasia.

pH study showed an elevated DeMeester score of 21 (normal < 14.7) over 48-hours.  The study was positive for increased esophageal acid exposure on both days of the two-day study.  

Barium UGI (upper gastrointestinal series) showed a normal gastroesophageal junction.

Esophageal manometry showed normally preserved esophageal peristalsis.  Distal contractile integral was normal at 985 mmHg (millimeter of mercury)/cm/second.  A hiatal hernia was not detected by manometry.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease). This is proposed as an alternative to surgical fundoplication.  The health plan rationale for denial is that the LINX procedure is unproven.

Yes, the LINX procedure is medically necessary.

The LINX procedure is not unproven.  The proposed LINX has been granted FDA (Food and Drug Administration) 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 (gastroesophageal reflux disease) as is documented to exist in this case.  

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 LINX procedure has been evaluated in comparison to alternative surgical therapy in peer-reviewed publications cited below [3,6,7,8,9].  These studies confirm the safety and efficacy of the LINX procedure for an appropriately selected patient such as this patient.

Since the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Safety and Effectiveness Analysis and a study by Ganz et al. (2013), there has been additional analysis that provides long-term data to five-years post implantation.  The 2015 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; five years after device placement this score decreased to 4. All patients used PPIs 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, 2015]. 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, 2015]

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 proposed LINX procedure is not unproven for this patient.

LINX is a medically necessary service for this patient.  

In this case, a physician exercising prudent clinical judgment has proposed LINX as treatment of medically refractory GERD (gastroesophageal reflux disease).  This therapy is in accordance with generally accepted standards of medical practice, is clinically appropriate and considered effective for the patient's illness and is not for the convenience of anyone.  This treatment is at least as likely to produce equivalent results as alternative treatment.  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.  This therapy is consistent with the diagnosis and treatment of GERD (gastroesophageal reflux disease) and is in keeping with generally accepted medical practice standards.

General precautions listed by the manufacturer for LINX implantation include a diagnosis of Barrett's as the safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification [Los Angeles Classification of Gastroesophageal Reflux Disease]) esophagitis.   

Other precautions (per the manufacturer) to LINX implant where the safety and effectiveness of the LINX Reflux Management System has not been established include:
1)	Scleroderma
2)	Suspected or confirmed esophageal or gastric cancer
3)	Prior esophageal or gastric surgery or endoscopic intervention
4)	Distal esophageal motility less than 35 mmHg (millimeter of mercury) peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES (lower esophageal sphincter)
5)	Symptoms of dysphagia more than once per week within the last three months
6)	Esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, hiatal hernia, etc.)
7)	Esophageal or gastric varices
8)	Lactating, pregnant or plan to become pregnant
9)	Morbid obesity (BMI [body mass index] > 35)
10)	Age < 21

In this case, none of these listed contraindications exist based on the comprehensive pre-surgical evaluation.

This patient has been appropriately evaluated for the condition of GERD (gastroesophageal reflux disease).  She has completed objective testing with EGD (esophagogastroduodenoscopy) and barium UGI (upper gastrointestinal series) that showed no esophagitis and no hiatal hernia. Objective pH testing documents elevated esophageal acid exposure with an elevated composite DeMeester score over 48-hours.  Esophageal motility testing showed preserved esophageal peristalsis. An antireflux procedure such as LINX is appropriate and medically necessary therapy based on the documentation provided.