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

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A. Coverage 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: Patient has: either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and decided to seek further cancer treatment (e.g., therapeutic chemotherapy). The diagnostic laboratory test using NGS must have: FDA approval or clearance as a companion in vitro diagnostic; and an FDA approved or cleared indication for use in that patient’s cancer; 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 other Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a treating physician and the patient has: either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and decided to seek further cancer treatment (e.g., therapeutic chemotherapy). See Appendix D for the NCD manual language.