CMS Reopens National Coverage Determination for NGS Testing in Advanced Cancer

National Coverage Analysis (NCA) Tracking Sheet for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R)

The government payor is accepting public comments from April 29 to May 29 and expects to issue a draft decision on October 29. CMS said it is particularly interested in comments referencing scientific evidence on the ability of germline testing to identify treatment benefit for individuals with a hereditary cancer syndrome.

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.

Important Dates

Formal Request Accepted and Review Initiated04/29/2019
Expected NCA Completion Date01/27/2020
Public Comment Period04/29/2019 – 05/29/2019
Proposed Decision Memo Due Date10/29/2019
Comments for this NCAView Public Comments

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.

CMS initiates this national coverage analysis for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. The 30-day public comment period on the proposed decision begins with this posting date, and ends after 30 calendar days. CMS considers all public comments and is particularly interested in comments that include clinical studies and other scientific evidence relevant to the topic under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the orange “Comment” button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

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.


Categories: Genetics