Local Coverage Article Response to Comments

Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases


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Article Title
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases
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Response to Comments
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting. 

We would like to thank those who suggested changes to the LCD for Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases. The official notice period for the final LCD begins on June 14, 2018 and the final determination will become effective for services rendered on or after August 1, 2018.


Response To Comments


In a joint comment the College of American Pathologists (CAP) and the Association for Molecular Pathology (AMP) urged coverage of CPT 81455 (Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes). They note: “It is now common for more than 50 genes to be implicated in the pathogenesis, molecular biology, and progression of myeloid disorders and acute leukemia. As many as 72 genes have been shown to be important in the diagnosis, prognosis, and therapy for acute and chronic myeloid diseases (Mukherjee et al., 2017). These 72 genes do not include the additional genes recently included in the 2017 World Health Organization classification of hematologic malignancies."


NGS policy on biomarker panels is to cover when the minimum number of genes described in the code are determined to meet Medicare coverage criteria (for example, NCCN Biomarkers Compendium Evidence Category I or 2A and associated clinical utility).






Another joint AMP/CAP comment recommended the inclusion of additional ICD-10 diagnosis codes for MPN that would fulfill criteria for the policy. “The proposed policy lists 16 ICD-10 codes for AML, 19 for MDS, and 3 for MPN. We agree that a specific myeloproliferative neoplasm diagnosis and ICD-10 should be required for previously diagnosed patients who have not responded to therapy or show evidence of relapse. However, the ICD-10 codes included in the policy do not accommodate diseases such as CMML, atypical CML, and others which demonstrate features of both MPN and MDS. In addition, we request addition of ICD-10 codes associated with the appropriate clinical criteria raising the suspicion of MPN that would appropriately trigger the hematologist’s request for this testing. For example, NGS-based mutation profiling is certainly warranted in a patient with thrombocytosis, splenomegaly, and leukocytosis, but with a “borderline” bone marrow lacking minimal diagnostic criteria for an MPN. Such a patient could not appropriately be given one of the 3 specific MPN ICD-10 codes included in this draft LCD."

We agree and have added the recommended diagnosis codes.

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