Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast Cancer

Treatment: FoundationOne CDx (broad companion diagnostic) molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment)

The insurer denied coverage for FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment).

The denial is overturned.


This is a female with history of metastatic breast cancer hypothyroidism, migraines, and osteoarthritis (OA). The patient was previously treated with chemotherapy and radiation, and at the time of the requested service, the patient was on Abraxane and Xgeva.
FoundationOne testing to further guide the course of treatment. The request is for the approval of FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment).

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

"The world of molecular profiling has undergone revolutionary changes over the last few years as knowledge, technology, and even standard clinical practice have evolved. Broad molecular profiling is now nearly essential for all patients with metastatic solid tumors. New agents have been approved based on molecular testing instead of tumor site of origin. Molecular profiling methodologies have likewise changed such that tests that were performed on patients a few years ago are no longer complete and possibly inaccurate today. As with all rapid change, medical providers can quickly fall behind or struggle to find up-to-date sources to ensure he or she provides optimum care." (El-Deiry, et al, 2019)

"Sequencing of cancer genomes has yielded insights into the genomic alterations that drive different cancer types and has led to the development of numerous therapies that target genetic vulnerabilities of tumors. With the increasing number of genomic alterations that are either predictive biomarkers for approved targeted therapies or used as inclusion criteria for genomically matched clinical trials, comprehensive genomic profiling of tissue samples using next-generation sequencing (NGS) to evaluate hundreds of cancer-related genes has transitioned from the research setting into an important tool for routine clinical management of patients with cancer." (Clark, et al, 2018)

FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment) performed has final approval from the appropriate regulatory bodies for this diagnosis.

"The National Comprehensive Cancer Network (NCCN) panel recommends that metastatic disease at presentation or first recurrence of disease should be biopsied as a part of the workup for patients with recurrent or stage IV disease. This ensures accurate determination of metastatic/recurrent disease and tumor histology and allows for biomarker determination and selection of appropriate treatment. Soft tissue tumor biopsy is preferred over bone sites unless a portion of the biopsy can be protected from harsh decalcification solution to preserve more accurate assessment of biomarkers. Genetic testing: In the metastatic setting, results from genetic testing may have therapeutic implications." (NCCN, 2022)     

This patient is a good candidate for FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment).

FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment) is the best available treatment for this patient at this time.

The patient is widely metastatic, conventionally treated, and with few remaining alternatives. This will help guide therapy, as there are no other NGS panels of comparable effectiveness.     

The adverse risks are not increased over standard treatment/services.

The patient has had standard conventional treatment. Therefore, there are no adverse risks associated with this request over standard treatment/services.     

The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient because it is non-cancer specific recommendation.  

The carrier's denial of FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment) performed should be overturned.