Foundation One Testing denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for FoundationOne testing. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of metastatic lung cancer.Findings: The therapy for advanced non-small cell adenocarcinoma has been revolutionized by the finding of EGFR mutations in adenocarcinomas, especially in this patient who is a non-smoker. The medical literature indicates that even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimens.

Nature of Statutory Criteria/Case Summary: An enrollee has requested epidermal growth factor receptor (EGFR) gene analysis and Foundation One testing for evaluation of his medical condition. Findings: Two physician reviewers found that the EGFR gene analysis and Foundation One testing were likely to be more beneficial for evaluation of the patient’s medical condition than any available standard therapy. Glioblastoma multiforme (GBM) is an incurable disease. The standard of care is resection of the GBM maximally followed by treatment with temozolomide. On temozolomide treatment concomitant with radiation therapy, a randomized clinical trial showed only 26.5% two-year survival compared to 10.4% in the cohort receiving radiation only. Most GBM tumors recur and then the treatment options are limited.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the panel of gene tests for evaluation of the enrollee’s malignant melanoma. Findings: The 3 physician reviewers found that FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individual’s tumor with the hopes of identifying markers that can help guide therapy decision making. Per the National Comprehensive Cancer Network guidelines, it has not been determined if molecular markers are useful in treatment determination (predictive markers) and prognosis. Gene expression profiling for melanoma could be a valuable contribution to understanding the biology of the disease.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene testing for evaluation of the enrollee who has been diagnosed with malignant melanoma. Findings: 2/3 of the physician reviewers found that FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individual’s tumor with the hopes of identifying markers that can help guide therapy decision making. Per the National Comprehensive Cancer Network guidelines, it has not been determined if molecular markers are useful in treatment determination (predictive markers) and prognosis for other than BRAF and c-KIT mutational analyses which are clinically useful only for patients with advanced disease considering these molecular targeted therapies.

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 One Testingwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.