National Coverage Analysis (NCA) Tracking Sheet

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



Foundation Medicine, Inc. is participating in the FDA - CMS Parallel Review Program. CMS received a formal request for a national coverage determination from Foundation Medicine Inc. This request is to establish coverage of comprehensive genomic profile testing for the management of cancer patients with solid tumors that are metastatic, including Stage IV and recurrent, with F1CDx™. F1CDx™ is a next generation sequencing based in vitro diagnostic device for detection of base substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements in 324 genes, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB), using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.

Next generation sequencing 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. The NGS oncology panel tests also provide patients and their providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. NGS oncology panel tests hold potential for patients and providers in optimizing (personalizing) therapies that target specific characteristics of individual patient cancers. However, it is important that these tests produce valid results that are useful in guiding therapies to improve outcomes for patients with advanced cancer.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

National Coverage Determinations

Benefit Category

Diagnostic Laboratory Tests
Diagnostic Services in Outpatient Hospital
Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Vincent A. Miller, MD, Chief Medical Officer, Foundation Medicine, Inc. View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
11/30/2017 - 01/17/2018
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Katherine B. Szarama, PhD
Lead Medical Officers
Carl Li, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

November 30, 2017

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.

December 20, 2017

On December 18, 2017, the FDA released the Approval Order of the Foundation Medicine Inc. FoundationOne CDx™, which is available at CMS has extended the comment period for this proposed decision until Wednesday, January 17, 2018.

March 6, 2018

CMS extended the comment period to accommodate additional public input. We are continuing to review and evaluate the high-volume of public comment, and expect to complete the process soon.

March 16, 2018