CMS Updates Coverage of Next Generation Sequencing in Breast, Ovarian, and Advanced Cancers

February 4, 2020

On January 27, the Centers for Medicare & Medicaid Services (CMS) announced that it is expanding its coverage of next generation sequencing (NGS) for use as a diagnostic tool for certain patients with cancer.

Specifically, CMS will now cover FDA-approved or cleared laboratory diagnostic tests detecting germline mutations for patients with breast and ovarian cancer, or somatic mutations for patients with advanced cancer. This National Coverage Decision (NCD) expands on CMS’ previous decision to cover NGS laboratory diagnostic tests for certain patients with advanced cancer.

In order to receive coverage, the NGS test must be ordered by a treating physician, the patient must have a risk factor and a clinical indication for germline breast or ovarian cancer, and the patient must not have already been tested for the same mutation using NGS.

CMS also provided Medicare Administrative Contractors (MACs) with the flexibility to cover additional clinically indicated NGS tests for patients with other cancer diagnoses.

The American Society of Clinical Oncology (ASCO) has urged CMS to cover appropriate NGS-based testing so that Medicare beneficiaries have access to medically necessary and relevant clinical testing to improve the treatment of their cancer.

Read CMS’ NCD.

Learn more about NGS in ASCO's new policy brief.

Visit ASCO in Action for updates on this issue and breaking cancer policy news.