Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux and Barrett's Esophagus.
Treatment: LINX Procedure.
The insurer denied the LINX Procedure.
The denial is overturned.

This patient is a woman. Her BMI (body mass index) was documented as 27. She sought surgical evaluation for the condition of GERD (gastroesophageal reflux disease).  Her symptoms include heartburn.  There is also reported to be biopsy proven Barrett's metaplasia per the progress note.  She is treated with Pantoprazole and Tums for reflux symptoms, but has breakthrough symptoms.

The patient's evaluation has included the following diagnostics: EGD (esophagogastroduodenoscopy) identified erosive esophagitis and a 1-2 cm (centimeter) hiatal hernia.  There was biopsy proven Barrett's esophagitis.  pH testing  was performed while on acid suppressing medication and showed a DeMeester score of 9.5 (normal < [less than] 14.7).  EGD (esophagogastroduodenoscopy) showed erosive esophagitis, an irregular Z-line, and a 3-cm (centimeter) hiatal hernia.  The pathology report showed no Barrett's metaplasia. pH testing was performed while off acid suppressing medications and showed a 48-hour composite DeMeester score of 40.4 (normal <  [less than] 14.7).  Symptom correlation was strong from heartburn and chest pain. Esophageal manometry testing showed normal peristaltic pressures.

The treating surgeon has proposed the LINX procedure as treatment of GERD (gastroesophageal reflux disease).  The health plan has denied coverage of this treatment based on the contention that LINX is E/I (experimental/investigational). This denial is being appealed.

Yes, the health plan should cover the LINX procedure.
Based on the current evidence-based literature and the patient-specific objective clinical evaluation in this case, the LINX procedure is medically appropriate and is not investigational / experimental. This therapy should be a coverage benefit for the patient.

The LINX procedure is a minimally invasive procedure for the treatment of GERD (gastroesophageal reflux disease) and the recently published body of literature includes conclusions of ongoing clinical trials that support the long-term safety and efficacy of this procedure. 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.

LINX (Magnetic Sphincter Augmentation [MSA]) has been approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use for several years. LINX is not subject to review and approval by any institutional review board for the proposed use. LINX is not the subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA (United States Food and Drug Administration) regulations. Finally, there is sufficient long-term data to support that this therapy is as efficacious as the established alternative (laparoscopic fundoplication).

Since the SAGES 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-HRQL (gastroesophageal reflux disease- 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. 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 5-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 5-year conclusion of the clinical trial NCT00776997. [Ganz et al] The FDA (United States Food and Drug Administration)-required 5-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.

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).

The patient has symptoms of chronic GERD (gastroesophageal reflux disease), including heartburn and chest pain. She has been appropriately evaluated with EGD (esophagogastroduodenoscopy) that showed a 3-cm (centimeter) hiatal hernia. The most recent endoscopic biopsy report showed no Barrett's metaplasia. There is no contraindicating esophageal motor condition based on the esophageal motility study. There is confirmed pathologic esophageal acid exposure with elevated esophageal acid exposure (composite DeMeester score of 40.4, normal is < [less than] 14.7). Finally, the patient does not have specific precaution to implantation of the LINX device such as Scleroderma, suspected or confirmed esophagogastric cancer, prior esophageal or gastric surgery or endoscopic intervention, esophageal motor pathology, symptoms of dysphagia more than once per week, esophageal stricture or other gross anatomic abnormalities, esophageal or gastric varices, lactating, pregnant or plan to become pregnant, morbid obesity, or age < [less than] 21.

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 LINX procedure is medically appropriate in this case and should be a coverage benefit for her. LINX should not be considered to be experimental or investigational for appropriately selected patients, as in this case.

Yes, the LINX procedure is more beneficial.
This patient has symptoms of GERD (gastroesophageal reflux disease). The symptoms are refractory to medicinal therapy and diet modification. She has pathologic esophageal acid exposure as documented by pH testing. She has been appropriately evaluated with endoscopy, motility testing, and pH testing that confirm adequate motor function and no alternative diagnosis. An antireflux procedure is warranted. Standard of care treatment options include ongoing medicinal treatment, laparoscopic fundoplication, transoral incisionless fundoplication (TIF), and the LINX magnetic sphincter augmentation procedure. The LINX procedure offers benefits over traditional surgical fundoplication with equivalent reduction in esophageal acid exposure with preservation of the ability to belch / vomit. LINX offers improved symptom control compared to ongoing medicinal therapy with reduction in need for anti-acid medications and reduction in regurgitation. For these reasons, the proposed LINX procedure will be more beneficial than standard treatment for this patient's condition of GERD (gastroesophageal reflux disease).