Diagnosis: Pancreatic sufficient cystic fibrosis

Treatment: Durable Medical Equipment (DME)

The insurer denied coverage for Relizorb - DME B4105 x 730

The denial is upheld.

This patient was a male child who was diagnosed with pancreatic sufficient cystic fibrosis (CF), scoliosis, failure to thrive, celiac disease, and recurrent pancreatitis. He has a gastrostomy tube (G-tube) and was prescribed pancreatic enzymes. His treating physician requested coverage for Relizorb, which is a tube containing products to help digestion for G-tube feedings. It was noted that the patient had an increase in abdominal bloating when not receiving the tube feedings through the Relizorb device. The CF medical care providers recommended the Relizorb device containing pancreatic enzymes during his nocturnal gastrostomy tube feedings to improve digestion of his absorption and increase his weight gain.

Based on the review of the medical record, the patient had recent normal fecal elastase measurement. Pancreatic enzyme replacement therapy is not indicated for CF patients who are pancreatic sufficient but in view of the history of recurrent pancreatitis in this patient, there should be ongoing monitoring of fecal elastase and fecal fat to detect the development of pancreatic insufficiency over time. In addition, it should be noted that the L997F mutation which this patient has is not considered a CF causing mutation.

The Relizorb device contains pancreatic enzymes and it is routinely employed to treat pancreatic insufficiency related to nocturnal tube feedings for children and adults with CF. This device is FDA approved and considered appropriate and is becoming the standard of care for all nocturnal gastrostomy tube feedings for CF with pancreatic insufficiency. If this patient develops pancreatic insufficiency in the future, then Relizorb would be appropriate for nocturnal gastrostomy tube feedings, but it is not clear from the available record that this patient's failure to gain weight has improved with pancreatic enzyme supplementation.

Thus, based on the review of the medical record submitted, the requested DME Relizorb is not considered medically necessary for this patient.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for Durable Medical Equipment (B4105 x 730) should be upheld. The medical necessity is not substantiated.