Colorectal Cancer denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing. Findings: The physician reviewer found that The patient’s initial history and pathology shows mismatch repair was intact in his tumor. However, his family history showed a maternal aunt with breast cancer, another maternal aunt with lung cancer, maternal grandfather with pancreatic cancer, maternal grandmother with stomach cancer, and paternal uncle with testicular cancer. The patient underwent genetic testing as recommended by his provider with the CancerNext Expanded testing. According to the National Comprehensive Cancer Network (NCCN) guidelines, testing by a multi-gene panel is appropriate when no single disease syndrome can explain the patient’s family history.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the FoundationOne gene test. In keeping with the standard of care as summarized in National Comprehensive Cancer Network (NCCN) for colon cancer, only KRAS, NRAS, BRAF, and MSI genomic molecular markers have been demonstrated to provide improved health outcomes. To demonstrate clinical utility of panel testing for somatic genomic alterations such as FoundationOne assay, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with the standard of care. The available literature on clinical utility consists of a small number of uncontrolled studies, and nonrandomized controlled trials that use imperfect comparators. This evidence is not sufficient to make any conclusions on clinical utility.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Neulasta. The National Cancer Care Network (NCCN) v2.0 2018 guidelines provide criteria for use of myeloid growth factors (MGFs) in patients with cancer receiving chemotherapy. NCCN considers the type of cancer and type of treatment in its criteria, and stratifies by risk of febrile neutropenia into high (>20% risk), intermediate (10-20% risk) and low (< 10% risk.. Recommendations for use of myeloid growth factors in intermediate risk cancer types is further dependent on patient risk factors. These include patients who are 65 years or older, have persistent neutropenia, bone marrow involvement of tumor, recent surgery, liver dysfunction (bilirubin > 2.0), renal dysfunction (creatinine < 50) or prior chemotherapy or radiation therapy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Guardant Reveal genetic testing. In this case, the testing at issue involved circulating tumor DNA analysis which was used as a surveillance test to recognize relapse of the patient’s colorectal cancer after he underwent surgical resection and chemoradiotherapy. There are various guidelines in place for surveillance after definitive surgical resection or chemoradiotherapy. The guidelines focus on the use of imaging in the first three to five years after definitive therapy. Currently, the guidelines do not recommend circulating tumor DNA analysis for surveillance after definitive surgical resection or chemoradiotherapy. The medical literature also varies in its support of circulating tumor DNA analysis.

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 colorectal cancer, then check the rights and deadlines that apply to your plan.