Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: gastroesophageal reflux disease

Treatment: surgical procedure (Current Procedural Terminology (CPT) code 43284)

The insurer denied coverage for surgical procedure (Current Procedural Terminology (CPT) code 43284)

The denial is upheld

According to the medical records, the patient is an adult noted to have evidence of Gastro esophageal reflux disease (GERD) and complications of GERD. The patient is noted to have positive Bravo Power of hydrogen (pH) (acidity level) study which was evidence of GERD. The patient was also noted to have evidence of Los Angeles (LA) Class C erosive esophagitis and Barrett's esophagus. The patient is noted to have an unremarkable barium esophagram. The patient is currently being treated with once-a-day Proton-pump inhibitors (PPIs) therapy.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

There is evidence that LINX procedure can provide symptomatic benefit in certain patients with refractory GERD.      

The surgical procedure (Current Procedural Terminology (CPT) code 43284) has been approved by the Food and Drug Administration (FDA) since 2012.     

This patient is not a good candidate for surgical procedure (CPT code 43284).

The patient needs to have a high-resolution esophageal manometry prior to undergoing LINX. The patient needs to have a high-resolution esophageal manometry to rule out the presence of achalasia. Therefore, this patient is not a good candidate for surgical procedure (CPT code 43284).     

The surgical procedure (CPT code 43284) is not the best available treatment for this patient at this time.

Once achalasia is ruled out and there is no response to twice a day (BID) proton pump inhibitors (PPI) therapy, then the patient would be a good candidate for LINX procedure.
  
The adverse risks are increased over standard treatment.

The patient has to undergo an operation in order to have the LINX placed. There are risks with undergoing an operation. Since the patient is noted to have refractory GERD, once achalasia is ruled out and there is no response to twice a day (BID) proton pump inhibitors (PPI) therapy, the benefits would outweigh the risks.

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The patient is noted to have refractory GERD but has not failed maximum Proton-pump inhibitors (PPIs) therapy.

As far as endoscopic treatment modalities are concerned, the usage of current endoscopic therapies cannot be recommended as an alternative to medical or traditional surgical therapy.  A laparoscopically implanted sphincter augmentation device has recently been proposed but more data on long-term efficacy, safety, and costs are required before widespread usage can be recommended" (Frazzoni, M. et al. 2014).

The expert panel convened by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (2017) concluded the following: "The incidence of initial dysphagia following LINX implantation is high. Difficulty swallowing was more commonly reported at 12 and 24 months following LINX implantation than at baseline. Patients should be advised about the possibility that it may be more difficult to swallow following surgery, and that this symptom may persist. The LINX device may provide an option currently lacking in clinical practice for patients with medically refractory GERD who have not yet progressed to end-stage reflux disease with associated complications. Direct comparative studies between the LINX procedure and Nissen fundoplication will be needed" (Telem, D. A. et al. 2017).

In summary, the denial of surgical procedure (CPT code 43284) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.