ASCP’s Advocacy Yields Key Changes in NGS Coverage Policy

Publication Date: Feb 6, 2020

ASCP is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has integrated our recommendations into its final National Coverage Decision on Next Generation Sequencing (NGS). The policy, released on January 27, outlines coverage for NGS testing for breast and ovarian cancers.

When ASCP commented on the draft policy, it urged CMS in a formal comment letter to expand coverage for NGS testing. The draft policy would have only allowed coverage of Food and Drug Administration-approved or -cleared NGS tests for these cancers. At the time the draft policy was released, no such tests had yet been approved. In addition, CMS’s draft policy would have barred Medicare Administrative Contractors (MAC) from covering NGS Laboratory Developed Tests (LDTs) for these cancers. Taken as a whole, the draft policy would have resulted in Medicare not providing coverage of NGS testing for these cancers.

ASCP urged that CMS expand coverage to allow the MACs to coverage NGS LDTs for these and other cancers developed in compliance with the Clinical Laboratory Improvement Amendments of 1988. And CMS did. Moreover, ASCP urged CMS to revise its limitation on NGS testing of one per lifetime to allow patients previously tested using NGS to be tested again provided it is not for the same genetic profile or germline test. And CMS did.

Other articles in the February 2020 ePolicy News:

To read more articles from ePolicy News click here.

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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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