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AMP and CAP Comment on Palmetto Proposed Guidelines for NGS Testing of Myeloid Disorders

NEW YORK (GenomeWeb) – The Association for Molecular Pathology and College of American Pathologists yesterday released a letter commenting on Medicare administrative contractor Palmetto GBA's proposed coverage policy for MOLDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies.

The organizations provided a list of genes they said they believe are clinically informative regarding diagnosis and treatment of myeloid disorders and suggested several changes to the coverage policy, including recommendations to refine the list of variants tests would be required to cover and to expand the list of appropriate biopsy specimens and make more frequent testing available.

Regarding required variants, AMP and CAP expressed concern that several of the specific loci proposed by Palmetto as necessary for a test to be reimbursed "are of unclear clinical significance… and should not be required for panels to be reimbursed."

Additionally, they noted that in the case of genes linked to myeloid disorders due to loss of protein functions, "any loss of function mutation, and not just mutations at 'hotspots', can contribute to disease pathogenicity."

They proposed creation of an expert working group to finalize a list of genes and variants that must be tested for in any covered assay, suggesting that this list could be compiled by July 2019.

The organizations also proposed allowing for earlier and more frequent testing. Under the Palmetto proposed coverage policy, patients without a diagnosis of a myeloid malignancy "must have an undefined cytopenia for greater than six months." However, AMP and CAP said that earlier testing can identify "clinically relevant clonal evolution," and suggested it be covered.

They also took issue with the proposal's non-coverage of repeat testing within six months, noting that "there is convincing evidence in the literature that six months is too long of a time interval to have to wait for a repeat NGS-based tests."