November 12, 2021


Statement From NCODA Legislative & Policy Advisory Committee
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
(919) 903-2057



Comment On Proposed LCD DL37810

Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms:

Optimizing Management of Patients in Underserved and Minority Populations


CAZENOVIA, NY – NCODA would like to commend the Centers for Medicare and Medicaid Services (CMS) for initiating the proposed LCD DL37810 for Medicare beneficiaries with advanced solid tumors. As a patient-centered organization, we support the overall intent of LCD DL37810, which increases access to NGS technology and optimizes the management of patients with advanced solid tumors.

We would like to comment on the proposed indications and specific views documented in the Summary of Evidence listed in the proposed LCD in reference to Next Generation Sequence (NGS) Comprehensive Genomic Profile (CGP) testing. NCODA requests that the requirement:

“CGP NGS testing for patient with advanced cancer is reasonable and necessary only when more limited (i.e., individual analyte or targeted panel (5-50 genes)) testing is insufficient…”

in the “Proposed Indications” section be removed to avoid confusion regarding coverage to test for FDA approved indications. Tumor mutation burden (TMB) can only be detected using assays over 200 genes and TMB is listed as an FDA indication for eligibility of pembrolizumab for all solid tumors.

NCODA values CMS’s recognition of the benefits of RNA-based NGS. We agree with supporting both the use of RNA-based NGS and DNA-based NGS given existing technology platforms and current use of both technologies.

NCODA applauds the fact that “NGS CGP testing may especially benefit the 25% of patients with rare cancer types… and underserved minority populations with less access to tumor molecular profiling or off-label therapies.” This dedication to address cancer disparities and rare disease states by recommending NGS CGP testing to help address these populations is in desperate need. NGS CGP facilitates identification of novel uses of existing targeted therapies and/or eligibility for clinical trials with novel genetic alterations, attempting to address such populations.

At NCODA, we are patient-centered and always collaborative. We strive to provide leadership, expertise, quality standards, and forward-thinking solutions to oncology healthcare professionals across the country. While the oncology community has made progress to ensure equity in cancer care over the years, we believe the work is far from over. In addition to ensuring that all cancer patients receive quality care, NCODA believes in providing access to all regardless of status. These disparities need to be reduced and eventually eliminated. Again, we applaud CMS for initiating the proposed LCD DL37810 for Medicare beneficiaries, and we believe that this is a positive step in the right direction toward providing better care for cancer patients from underserved and/or minority populations.

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NCODA is a leading nonprofit organization dedicated to empowering medically integrated oncology practices to deliver positive, patient-centered outcomes by providing leadership, expertise, quality standards, and best practices. For more information about NCODA, its Executive Council, and general updates, visit or follow @NCODAorg on Twitter.