Skip to Content

CMS Proposes Next Generation Sequencing Coverage for Medicare Beneficiaries with Advanced Cancer
December 01, 2017

Last month, the U.S. Food and Drug Administration (“FDA”) approved the FoundationOne CDx, a next generation sequencing device (“F1CDx™”). Shortly after announcing FDA approval, CMS received a formal request (See: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id290.pdf)   to establish coverage for comprehensive genomic profile testing for the management of cancer patients with solid, metastatic tumors (including Stage IV and recurrent tumors) with F1CDx™.

Next generation sequencing provides detailed information on multiple types of genetic alternations simultaneously, providing a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. Providers and patients believe the technology holds potential for personalized cancer therapy.

CMS is soliciting public comment relevant to the request through December 29, 2017.
Related Practices
Health Care
Related Industries
Health Care
©2025 Carlton Fields, P.A. Carlton Fields practices law in California through Carlton Fields, LLP. Carlton Fields publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information and educational purposes only, and should not be relied on as if it were advice about a particular fact situation. The distribution of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship with Carlton Fields. This publication may not be quoted or referred to in any other publication or proceeding without the prior written consent of the firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our Contact Us form via the link below. The views set forth herein are the personal views of the author and do not necessarily reflect those of the firm. This site may contain hypertext links to information created and maintained by other entities. Carlton Fields does not control or guarantee the accuracy or completeness of this outside information, nor is the inclusion of a link to be intended as an endorsement of those outside sites.

Disclaimer

The information on this website is presented as a service for our clients and Internet users and is not intended to be legal advice, nor should you consider it as such. Although we welcome your inquiries, please keep in mind that merely contacting us will not establish an attorney-client relationship between us. Consequently, you should not convey any confidential information to us until a formal attorney-client relationship has been established. Please remember that electronic correspondence on the internet is not secure and that you should not include sensitive or confidential information in messages. With that in mind, we look forward to hearing from you.