Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute Myeloblastic Leukemia (AML).
Treatment: FoundationOne heme test for targeted genomic sequence analysis panel, solid organ or hemolymphoid neoplasm, DNA (deoxyribonucleic acid) analysis, and RNA (Ribonucleic acid) analysis when performed, 51 or greater genes (genetic laboratory test to determine if the patient has gene mutations present that are linked with developing specific diseases or conditions), code 81455.

The insurer denied coverage for FoundationOne heme test for targeted genomic sequence analysis panel, solid organ or hemolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (genetic laboratory test to determine if the patient has gene mutations present that are linked with developing specific diseases or conditions), code 81455.
The denial is overturned.

The patient is a male with a history of acute myeloblastic leukemia (AML). He had a bone marrow biopsy AML. The AML had relapsed. The patient had FoundationOne heme test performed.

According to He, et al, "The spectrum of somatic alterations in hematologic malignancies includes substitutions, insertions/deletions (indels), copy number alterations (CNAs), and a wide range of gene fusions; no current clinically available single assay captures the different types of alterations. We developed a novel next-generation sequencing-based assay to identify all classes of genomic alterations using archived formalin-fixed paraffin-embedded blood and bone marrow samples with high accuracy in a clinically relevant time frame, which is performed in our Clinical Laboratory Improvement Amendments-certified College of American Pathologists-accredited laboratory. Targeted capture of DNA/RNA and next-generation sequencing reliably identifies substitutions, indels, CNAs, and gene fusions, with similar accuracy to lower-throughput assays that focus on specific genes and types of genomic alterations. Profiling of 3696 samples identified recurrent somatic alterations that impact diagnosis, prognosis, and therapy selection. This comprehensive genomic profiling approach has proved effective in detecting all types of genomic alterations, including fusion transcripts, which increases the ability to identify clinically relevant genomic alterations with therapeutic relevance."

FoundationOne Heme is a comprehensive genomic profiling (CGP) test combining DNA and RNA sequencing for patients with hematologic malignancies, sarcomas or solid tumors where RNA sequencing is desired. In this case, it is being done for AML. Current peer review literature and applicable guidelines support the use of this testing for this patient's clinical indication. Therefore, the FoundationOne heme test for targeted genomic sequence analysis panel, solid organ or hemolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (genetic laboratory test to determine if the patient has gene mutations present that are linked with developing specific diseases or conditions), code 81455, performed for the diagnosis of acute myeloblastic leukemia (AML), in relapse is considered medically necessary for this patient.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.      

The insurer's denial of coverage for FoundationOne heme test for targeted genomic sequence analysis panel, solid organ or hemolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (genetic laboratory test to determine if the patient has gene mutations present that are linked with developing specific diseases or conditions), code 81455, performed for the diagnosis of acute myeloblastic leukemia (AML), in relapse is overturned. Medical Necessity is substantiated.