Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Foundation One gene test for treatment of the enrollees malignant neoplasm of pineal gland-papillary type. The patient has recurrent papillary type tumor of the pineal. The patient was found to have obstructive hydrocephalus, which was shunted. In July 2015, the patient was diagnosed with a papillary type of pineal tumor. This was excised, and the patient began radiation therapy. In December 2015, the patient was treated with chemotherapy. However, there was progression of tumor noted in June 2016, at which time a resection was performed and the patient was started on carboplatin chemotherapy. A tissue sample from the June 2016 resection was sent for Foundation One assay. The patient has requested reimbursement for Foundation One gene test. The Health Plan has denied this request and reported that the services at issue were investigational for the evaluation of this patient.There is a lack of support for the services at issue in this clinical setting.  FoundationOne is a molecular assay that explores the mutations of an individuals 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. There are various nonrandomized studies exploring the value of molecular profiling but these studies are not convincing.  A randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets. Recent studies have expressed serious reservations about this approach in general. In sum, Foundation One testing was not likely to have been of greater clinical benefit when compared to the standard options available for the evaluation of this patients medical condition. Final Result: Two of three reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.