Next Generation Sequencing (NGS)

CMS National Coverage Determination | ncd_id=372 | manual_section=90.2 | coverage_level_code=2 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications 1. Somatic (Acquired) Cancer Effective for services performed on or after March 16, 2018, 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 Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met: a. Patient has: either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and not been previously tested with the same test using NGS for the same cancer genetic content, and decided to seek further cancer treatment (e.g., therapeutic chemotherapy). b. The diagnostic laboratory test using NGS must have: Food & Drug Administration (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. 2. Germline (Inherited) Cancer Effective for services performed on or after January 27, 2020, CMS has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met: a. 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. b. The diagnostic laboratory test using NGS must have all of the following: FDA-approval or clearance; and, results provided to the treating physician for management of the patient using a report template to specify treatment options. C. Nationally Non-Covered Indications 1. Somatic (Acquired) Cancer Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1., above. D. Other 1. Somatic (Acquired) Cancer Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has: either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and, not been previously tested with the same test using NGS for the same cancer genetic content, and decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 2. Germline (Inherited) Cancer Effective for services performed on or after January 27, 2020, MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is 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. (This NCD last reviewed January 2020)