CMS NGS NCD RIP?

Publication Date: Mar 29, 2019

The Centers for Medicare and Medicaid Services (CMS) is heeding ASCP’s request to revise a recent National Coverage Determination (NCD). During the March 26American Clinical Laboratory Association’s (ACLA) Annual Meeting, CMS staff announced that the Agency would soon be revising its 2018 NCD that blocks Medicare coverage of Next Generation Sequencing (NGS) tests for Medicare beneficiaries with stage I or II cancers. The current NCD allows for coverage only in cases of “recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.”

ASCP has urged CMS to reconsider this policy, recommending that Medicare provide coverage to all Medicare beneficiaries with cancer, regardless of its stage. In a previous letter to CMS, ASCP argued that CMS’s proposed coverage limitation to stage III and IV cancers potentially causes patient harm at a point in time when accurate diagnoses and treatments are most effective. While CMS plans to reconsider this coverage policy, CMS staff stated that the Agency does not intend to delay or suspend implementation of its current policy. The result is that the CMS will maintain its policy of not covering NGS-based germline testing. ASCP is concerned that this position will result in early-stage cancer patients losing access to medically necessary genetic tests for hereditary cancer.

ASCP will be following this issue closely and will be in touch with CMS to urge the Agency to provide broader coverage of these tests.

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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.

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