LCD Reference Article Response To Comments Article

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

A59984

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Source Article ID
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Article ID
A59984
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases
Article Type
Response to Comments
Original Effective Date
07/13/2025
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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 Hematolymphoid Diseases LCD. The official notice period for the final LCD begins on May 29, 2025, and the final determination will become effective on July 13, 2025.

Response To Comments

Number Comment Response
1

Comment: Tempus AI, (“Tempus”) commended National Government Services for its continued commitment to align medical coverage policies with consensus guidelines. " We support the proposed changes outlined in DL37606 and agree with aligning coverage indications and defining which genomic biomarkers have established utility based on National Cancer Network (NCCN) guidelines and World Health Organization (WHO) classifications.”

NGS appreciates your supportive comment. Thank you.

2

Several individuals recommended the addition of CPT codes 81455 and 81456 to the Billing and Coding Article.

NGS agrees and will add CPT codes 81455 and 81456 to the Billing and Coding Article as appropriate.

3

The Association of Molecular Pathology (AMP) suggested the addition of updated citations for Acute Myelogenous Leukemia, Myelodysplastic Syndromes, and Myeloproliferative Neoplasms.

We appreciate AMP's input regarding the need for updated citations. While our existing bibliography aligns with the literature provided in the Reconsideration Request, NGS is committed to thoroughly reviewing and considering the integration of additional citations to ensure our policies remain at the forefront of the latest clinical research and guidelines.

4

AMP recommends that the proposed LCD explicitly state in Coverage Indications that germline testing is covered within the policy.

 

Thank you for highlighting the importance of explicitly stating germline testing coverage. NGS is currently examining the policy language to ensure it clearly reflects the inclusion of germline testing within the Coverage Indications, thereby aligning our policy with best practices and stakeholder expectations

5

AMP commented that "Minimal Residual Disease (MRD) testing is important to monitor disease and best determine if a treatment is working. It has been proven that MRD testing directly impacts survival outcomes of patients with AML”. AMP recommends the inclusion of explicit language to account for MRD testing in patients.

We recognize the significance of MRD testing in the management of AML and are actively evaluating how to best incorporate explicit references to MRD testing within our policy. Our goal is to support clinical decision-making and optimize patient care through comprehensive testing guidelines.

6

AMP requested the addition of the following genes (TET2, NRAS, and FLT3TKD- NCCN Biomarker Category 2A) be added to Table 1 under the Analysis of Evidence section of the LCD. 

NGS acknowledges the value of aligning with NCCN guidelines and will update Table 1 to include the recommended biomarkers. This enhancement will ensure our policy adequately encompasses relevant diagnostic markers, facilitating better patient outcomes

7

AMP also expressed their appreciation for NGS’ approach to coverage in the policy and believes that the updated genomic biomarkers will ensure patients with acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN) will have access to the molecular testing necessary to guide their treatment.

 

We sincerely thank AMP for their positive feedback regarding our coverage policy. NGS remains dedicated to providing policies that enhance access to vital testing and support the highest standards of patient care.

8

The American Society of Hematology (ASH) commented, “Molecular oncology experts from the CAP have reviewed the proposed genomic biomarker updates for acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN), and agree that the updates in the draft are appropriate and that the specified genes and genetic alterations are medically necessary for each condition. We further support NGS’ decision to broaden coverage to include genomic sequential analysis panel testing for all newly diagnosed or relapsed/refractory AML patients who are candidates for treatment, regardless of karyotype We believe that the updates to this policy will ensure patients have access to the molecular testing necessary to guide their treatment.”

 

We sincerely appreciate your thoughtful comments.

 

9

“Molecular oncology experts from the CAP have reviewed the proposed genomic biomarker updates for acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN), and agree that the updates in the draft are appropriate and that the specified genes and genetic alterations are medically necessary for each condition. We further support NGS’ decision to broaden coverage to include genomic sequential analysis panel testing for all newly diagnosed or relapsed/refractory AML patients who are candidates for treatment, regardless of karyotype findings. We believe that the updates to this policy will ensure patients have access to the molecular testing necessary to guide their treatment.”

 

We appreciate CAP's thoughtful and supportive comments.

10

One commenter requested a review of coverage for 81455 to include hematolymphoid disorders.Billing and Coding, Article A56793 - Billing and Coding: Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases, covers CPT codes 81450 and 81451in this policy. Both CPT codes allow for billing of 5-50 genes, which is much less than the number of genes currently being tested with CPT 81455.”

Please see Response #2 above.

11

Foundation Medicine requested expansion of coverage to include panels with 51 or greater genes (CPT Code 81455) and that multiple ICD10 codes be added to the appropriate ICD10 grouping (i.e. Group 1, 2, or 3) in DA56793

NGS agrees and will add the diagnosis codes requested as well as CPT code 81455 (please see #2 above).

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