Next Generation Sequencing (NGS) is a technology to read the order of nucleotide molecules on DNA and more effectively provides detailed information on multiple types of genetic alternations simultaneously. NGS oncology panel tests also provide patients and their providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments.
Section 90.2 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for NGS. Specifically, the Centers for Medicare & Medicaid Services (CMS) established coverage of NGS as a diagnostic laboratory test when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, ordered by a treating physician, and specific criteria are met. These criteria apply to NGS tests of somatic and germline mutations.
To provide a complete picture of the cancer patient, a clinician may order both tests of somatic (cancer) and germline (inherited) mutations. It is important that tests detect these mutations accurately and produce valid results that are useful in guiding therapies to improve outcomes for patients with cancer. Therefore, CMS is internally opening this decision. Specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this reconsideration.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and address the scope of this reconsideration.
