ASCP Urges CMS to Reconsider NGS NCD

Publication Date: Feb 6, 2019

ASCP recently joined with more than 60 other laboratory, healthcare and patient advocacy organizations in urging the Centers for Medicare and Medicaid Services (CMS) to reconsider its interpretation of a 2018 final National Coverage Decision (NCD) on Next Generation Sequencing (NGS). That policy outlined CMS’s coverage policy for NGS, limiting its coverage of NGS to Medicare beneficiaries with advanced cancers. That NCD created two pathways for Medicare coverage of a test. CMS created one route for national coverage of Food and Drug Administration (FDA)-approved testing when it served as a companion diagnostic. Medicare Administrative Contractors (MACs) were authorized to cover “other tests,” such as those that are not companion diagnostics. Recently, however, CMS argued that this second coverage track does not allow for the coverage of germline testing, except in cases of advanced cancers (Stages III and IV). CMS’s position would seemingly cancel out MAC Local Coverage Decisions (LCDs) that provide coverage for germline testing of cancer supported by clinical guidelines, including those for germline mutations for breast and colon cancers. The letter sent in by ASCP urges CMS to limit the NCD’s limitations to somatic tumor testing.

This would re-open the doors to germline testing for non-advanced cancers, for which coverage is now in jeopardy.

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

ASCP ePolicy News is supported by an unrestricted grant from Hologic.

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