Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Myelodysplastic syndrome.
Treatment: 81455 - Comprehensive Genomic Profile.
The insurer denied the 81455 - Comprehensive Genomic Profile.
The denial is upheld.

The patient is a female with newly diagnosed myelodysplastic syndrome. 

A Myeloid Disorders Profile was performed. This panel included more than 63 genes. 

This was denied by the plan, as there is not enough evidence that this testing is useful in the management of pancytopenia and is considered experimental/investigational per the plan. 

No, the health plan should not cover the proposed testing.

The Neogenomics Myeloid Disorders Profile is a 63 gene panel that targets known mutations associated with acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic leukemia (JMML) (https://neogenomics.com/test-menu/neotyper-myeloid-disorders-profile). 

The National Comprehensive Cancer Network (NCCN; URL: www.nccn.org) is an organization whose members are drawn from the nation's National Cancer Institute designated comprehensive cancer centers. NCCN provides detailed practice guidelines for the treatment of individual cancers. Guidelines are written by panels of experts drawn from the member institutions. The NCCN Guidelines are the most commonly used reference for determining the standard of care in clinical oncology. The NCCN Guidelines recommendation for the evaluation of myelodysplastic syndrome reads:

"Genetic testing for somatic mutations (i.e., acquired mutations) in genes associated with myelogenous leukemia is highly recommended." [2]

The NCCN Guidelines clarify this recommendation in a footnote:

"Bone marrow or peripheral blood cells should be assayed for MDS (myelodysplastic syndrome) -associated gene mutations using gene panels that include genes listed on MDS-C (Myeloid-derived suppressor cells). These gene mutations can establish the presence of clonal hematopoiesis, which can help exclude benign causes of cytopenias in cases with non-diagnostic morphology, but do not establish a diagnosis of MDS (myelodysplastic syndrome) in the absence of clinical diagnostic criteria (See Genes Frequently Somatically Mutated in MDS (myelodysplastic syndrome) [MDS-C] and Discussion)..." [2]

MDS-C (Myeloid-derived suppressor cells) referenced above only includes 30 genes. The NCCN Guidelines only support sequencing 30 genes for the evaluation of myelodysplastic syndrome. 

The reference provided by the attending physician found mutations in only 39 of the genes studied. [3] 

The testing performed, which also sequenced genes only relevant to chronic myelogenous leukemia, chronic myelogenous leukemia and juvenile myelomonocytic leukemia, is in excess of the testing that was required to provide optimum care of the patient. Sequencing genes that are not relevant to myelodysplastic syndrome is of unproven benefit and therefore is experimental in the management of myelodysplastic syndrome.

The requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.

This testing is not more beneficial than more targeted myeloid mutation panels that sequence genes only altered in myelodysplastic syndrome.