Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the genomic analysis for evaluation of the enrollees 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 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 a variety of nonrandomized studies exploring the value of molecular profiling but none of which have been convincing as to the efficacy of these analyses. While colleagues noted these ongoing studies, they also expressed serious limitations of such studies. This viewpoint was also expressed in an editorial by West in 2016. Moreover, a randomized trial by colleagues did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus the oncologists clinical judgment. Finding a mutation does not guarantee that a treatment directed at the mutation will produce a clinically meaningful response. In this patients case, the decision was to proceed with advanced hormonal therapy, which was not based on the FoundationOne assay. Therefore, the genomic analysis provided was not likely to have been superior over the standard options available for the evaluation of this patients medical condition. Final Result: 2/3 of the 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.