Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pancreatic cyst

Treatment: Pancragen Pathfinder TG test

The insurer denied coverage for Pancragen Pathfinder TG test. The denial was reversed.

This patient is a male with a past medical history of prostate cancer who underwent an upper endoscopic ultrasound due to a pancreatic cyst detected on a magnetic resonance imaging (MRI) test. An endoscopic ultrasound (EUS) with fine needle aspiration was performed.  A pancreatic cyst was visualized and fluid was aspirated.  The fluid was sent for DNA analysis.  No mutations were found.  The cyst was determined to be benign.

The diagnosis and management of pancreatic cysts is a common problem.  Abdominal imaging is finding these lesions, but their natural history and optimal management is unclear.  To help differentiate aggressive cysts, DNA analysis of the fluid can be done. Gastrointestinal Endoscopy May 2009 Volume 69; 1095-1109 has an article on "Pancreatic Cyst Fluid DNA Analysis in Evaluating Pancreatic Cysts."  The conclusion was that elevated amounts of pancreatic cyst fluid DNA, high amplitude mutations, and specific mutation acquisition sequences are indicators of possible malignancy.  The presence of a K-RAS mutation is indicative of an aggressive cyst.  DNA analysis should be considered when cyst cytologic examination is negative for malignancy.

Clinical Gastroenterology, 2016 Volume 50: 649-657 has an article titled "Management of Patients with Pancreatic Cysts: Analysis of Possible False Negative Cases of Malignancy."  The article looked at the utility of using DNA molecular pathology in managing the surveillance of pancreatic cysts.  The conclusion was that adjunct use of this technology can provide evidence for relaxed surveillance of patients with benign cysts.  In the absence of frank cytologic malignancy following EUS, the molecular analysis can guide management of pancreatic cysts and give confidence that further observation of the cyst is safe, allowing longer surveillance interval.

Gastroenterology, November 2015, Volume 149: 1501-1510 has an article titled "A Combination of Molecular Markers and Clinical Features Improves the Classification of Pancreatic Cysts."  A study of 130 patients with pancreatic cysts had a resection.  Cystic fluid was analyzed for gene mutations.  It was found that more than half of the patients who underwent a surgical resection were found to have benign disease and could have potentially had continued surveillance rather than pancreatic surgical resection.  The article states that with the use of molecular markers, the cysts can be classified with 90-100% sensitivity and 92-98% specificity.  The molecular marker panel correctly identified 67 of the 74 patients who did not require surgery and could therefore reduce the number of unnecessary operations by 91%.

This patient had a pancreatic cyst.  Based on the scientific literature, it has been shown that DNA analysis of the fluid from the cyst has an important role in determining the malignant nature of the cyst.  A determination that the cyst is benign is a reason to avoid surgery.  In this case, the fluid molecular DNA analysis showed that the cyst was benign.  The healthcare plan did not act reasonably or with sound medical judgment or in the best interest of the patient.  The Pathfinder TG test is a medically necessary test.

The carrier's denial of coverage for the Pancragen Pathfinder TG test is reversed.  The medical necessity is substantiated.