Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

CMS NCA document | source_status=Closed | review_type=1st Recon | public_comment_open=False | document_id=CAG-00450R

A. The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met: The patient has: ovarian or breast cancer; and a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and a risk factor for germline (inherited) breast or ovarian cancer; and not been previously tested with the same germline test using NGS for the same germline genetic content. The diagnostic laboratory test using NGS must have all of the following: Food and Drug Administration (FDA) approval or clearance; and results provided to the treating physician for management of the patient using a report template to specify treatment options. B. Other Medicare Administrative Contractors (MACs) may determine coverage of Next Generation Sequencing (NGS) as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has: any cancer diagnosis; and a clinical indication for germline (inherited) testing of hereditary cancers; and a risk factor for germline (inherited) cancer; and not been previously tested with the same germline test using NGS for the same germline genetic content. We are making other technical, clarifying, and conforming changes in Section 90.2 of the National Coverage Determinations Manual. We are clarifying the existing policy related to diagnostic tests for Somatic (Acquired) Cancer. See Appendix B for the draft manual language. For ease of the reader, this National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer. Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis. MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use. These uses are outside the scope of this NCD.