Local Coverage Article Response to Comments

Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Myelodysplastic Syndromes


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Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Myelodysplastic Syndromes
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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 Genomic Sequence Analysis Panels in the Treatment of Myelodysplastic Syndromes LCD. The official notice period for the final LCD begins on October 16, 2017, and the final determination will become effective on December 1, 2017.

Response To Comments


The Association for Molecular Pathology (AMP) and the College of American Pathologists (CAP) made the following joint request:

Please consider adding coverage for the following list of additional diagnosis codes for diseases and conditions other than MDS that have similar signs and symptoms (typically cytopenias of various hematopoietic cell lineages) that can often not be distinguished from MDS, even after a bone marrow biopsy. In patients with these diagnoses, genomic sequencing is clinically useful to ‘rule out’ MDS so that the underlying non-malignant cause of the patient’s cytopenias can be diagnosed and treated. This list is not intended to be comprehensive.  

ICD-10-CM Description
D72.810 Lymphocytopenia
D72.818 Other decreased white blood cell count
D72.819 Decreased white blood cell count, unspecified
D61.818 Other pancytopenia
D69.6 Thrombocytopenia, unspecified
D70.9 Neutropenia, unspecified
D70.8 Other neutropenia
C94.6 Myelodysplastic disease, not classified


NGS agrees and the list of diagnosis codes has been added.



What diagnosis codes does NGS expect providers to report when this test is ordered for a patient who has signs or symptoms of MDS but is not found to have a final diagnosis of MDS after all testing has been completed? I think it would be important to clarify this within the final version of the LCD.


See #1.


The Indications section at the end states that genomics are reasonable and necessary if prior evaluation is non-diagnostic or if newly diagnosed MDS is intermediate risk or of the RARS subtype. The problem is that genomic sequencing would then not be requested on the initial bone marrow specimen which is obtained before we know if the marrow is diagnostic of MDS or what the risk/subtype is. I would favor having it approved for initial blood or bone marrow samples in patients with a clinical suspicion of MDS or MDS/MPN. Otherwise, for patients where samples of the initial marrow were not saved for subsequent genomic testing, obtaining genomics would require repeat performance of a bone marrow aspiration. My lab saves material for genomic testing, but not all practices have that capability.



The draft indication already includes patients with a clinical suspicion for MDS or MDS/MPN. The diagnoses added in comment #1 should help in defining this population.




When we do the diagnostic bone marrow, we often don't know the IPSS or R-IPSS score yet. So I suggest the molecular study is permitted for pt with certain clinical features that will likely be in intermediate-high risk category, such as increased peripheral blast, transfusion dependence, etc.


NGS disagrees. The testing sequence outlined for newly diagnosed MDS or MDS/MPN patients in the draft LCD follows current NCCN guidelines.


Another joint CAP-AMP comment:

‘With regard to the draft LCD’s global non-coverage for repeat genomic sequencing after the initial diagnosis of MDS, we are aware of some limited clinical scenarios whereby repeat testing is clinically indicated. For example, MDS often evolves into frank acute myeloid leukemia, and the spectrum of mutations in that later stage AML is often quite different than in the prior MDS. Repeat genomic sequencing in this instance may be helpful for both prognostic and therapeutic purposes in that it may change the prognostic outlook and/or necessitate a different therapeutic strategy that will reduce waste and maximize therapeutic efficacy. Therefore, from both a patient care and economic perspective, it is sometimes clinically appropriate to molecularly monitor patients with MDS at more than just one time point. Furthermore, NGS’ Local Coverage Determination for Genomic Sequence Analysis Panels in the Treatment of Acute Myelogenous Leukemia (AML) (L36926) does not preclude repeat testing. We request that the LCD include language allowing for repeat genomic testing where clinically indicated and appropriate.” This request for coverage of repeat testing was echoed by several Carrier Advisory Committee (CAC) members.


NGS disagrees. Unlike in AML, NCCN guidelines do not advocate serial testing. However, we welcome evidence for specific criteria for repeat testing that results in actionable changes in management.



Should ASXL1 be added to the 5 genes in the table? It meets the criteria. Technically, it is not needed since Medicare requires only that 5 genes out of up to 50 in the testing panel be accepted by Medicare as necessary for diagnosis and management.


ASXL1 was in the original draft table, but got inadvertently deleted during website formatting. This has been corrected.




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