Effective 3/16/2018

Next Generation Sequencing (NGS)

The Centers for Medicare & Medicaid Services (CMS) covers diagnostic laboratory tests using Next Generation Sequencing (NGS) when performed in a Clinical Laboratory Improvement Amendments-certified (CLIA-certified) laboratory when ordered by a treating physician and when specific requirements are met.

CMS will cover such testing under the Medicare program for beneficiaries with recurrent, relapsed, refractory, metastatic cancer, or advanced stages III or IV cancer if the beneficiary has 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 test must be ordered by the treating physician, performed in a CLIA-certified laboratory, and meet a specific set of requirements.

For detailed coverage requirements, you may view the full text of the NCD at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290