Pancreatic Cancer denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing service, Guardant360. Pancreatic cancer has a poor prognosis and is fatal in most patients. While inoperable advanced pancreatic cancer is an incurable disease, chemotherapy may prolong survival but not induce a cure. In all cases, the genetic mutations present within the pancreatic cancer may be of prognostic significance and help direct therapy. The National Comprehensive Cancer Network (NCCN) guidelines include mutational analysis as part of its algorithms, although this is restricted to testing on the primary tumor samples. The NCCN notes that germline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Molecular Pathology.Findings: The physician reviewer found that In all cases, the genetic mutations that are present with pancreatic cancer can provide prognostic significance and can help direct therapy. Mutational analysis is part of the algorithms that are included within the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for pancreatic cancer. According to the NCCN guidelines, germline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes. The guidelines recommend genetic counseling for patients who test positive for a pathogenic mutation or for patients with a positive family history of cancer, especially pancreatic cancer, regardless of mutation status.

Where the denial was upheld

Physician 1: The patient is a 60-year-old man who underwent a Whipple’s procedure for a well-differentiated pancreatic cancer stage T3, N1, M0 in March 2005. The tumor extended into the peripancreatic fat and all gross tumor was removed. The 3.5 cm tumor was associated with the involvement of 8 of 13 lymph nodes. The patient next underwent chemotherapy, which was completed at the end of November 2005. He is now ready for radiation therapy and there is a dispute on the method: intensity modulated radiation therapy (IMRT) versus conventional radiation therapy. The Health Plan has denied authorization and coverage for IMRT based upon their determination that it is an investigational therapy in the treatment of pancreatic cancer.The patient has a defined chance of local recurrence because of the extension of the cancer into the peripancreatic fat and the lymph node involvement.

Physician 1The patient is a 62-year-old woman who was diagnosed with extensive cancer of the pancreas in September 2002. She had bilateral pulmonary metastases. Her condition was that of an unresectable cancer of the pancreas, stage IV. The patient was treated with 14 cycles of chemotherapy, which after 16 months is failing to be effective. On 4/23/04, CT scans showed progression of pulmonary metastases to 7mm in diameter. The pancreatic mass has increased and so has the lateral hepatic mass extending to the right intercostal space. The patient’s medical oncologist wishes to enroll the patient in a phase I clinical trial involving a Cytoxan-Celebrex combination. The Health Plan has denied authorization for the requested therapy on the basis that it is considered experimental.Since September 2002 the patient has had stage IV pancreatic cancer, which has a poor prognosis.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving pancreatic cancer, then check the rights and deadlines that apply to your plan.