Foundation One denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A female enrollee has requested reimbursement for the gene testing (Foundation One) for evaluation of the enrollee’s oligodendroglioma. Findings: The physician reviewer found that Foundation One testing offers a comprehensive panel of molecular genetic markers on an individual’s tumor with the hopes of identifying markers than can help guide therapy decision making. The National Comprehensive Cancer Network (NCCN) guidelines have not determined that molecular markers are useful in treatment determination (predictive markers) and prognosis other than codeletion of 1p and 19q, isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation, and MGMT promoter methylation. There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the genetic testing called Foundation One for the evaluation of her recurrent metastatic clear cell uterine cancer. Findings: Two physician reviewers found that there is sufficient support for the services at issue in this clinical setting. Adenocarcinoma of the endometrium (lining of the uterus) is the most common type of uterine cancer. This patient’s pathology was consistent with a serous-clear cell morphology. Serous is the second most common histology of endometrial cancer whereas clear cell is uncommon. Both of these histologic types are associated with a worse prognosis and frequently present with extrauterine disease at the time of diagnosis.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the genomic analysis for evaluation of the enrollee’s recurrent breast cancer. Findings: 2/3 of the physician reviewers found that there is a lack of support in the medical literature for the services at issue in this clinical setting. FoundationOne is a molecular assay that explores the mutations of an individual’s cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability of the clinician, nor yields a result that is reliably clinically beneficial.

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for the gene test (Foundation One) for evaluation of the enrollee’s head and neck squamous cell carcinoma. Findings: The physician reviewer found that Foundation One is a molecular assay that explores the mutations of an individual patient’s cancer cells. The goal of the assay is to identify a specific mutation or target which could guide the provider as to which chemotherapeutic agent would be useful. However, there is a paucity of evidence that the Foundation One assay adds to decision making ability, or yields a result that is reliably clinically beneficial. There are non-randomized studies exploring the value of molecular profiling, but the results have not been convincing as to the efficacy of such an approach to treatment (Von Hoff, et al).

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Foundation Onewhen you appeal: reviewers routinely find that denials like yours didn’t hold up.