Foundation Medicine Announces Final National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS), Including Coverage for FoundationOne CDx™ Across All Solid Tumors
-- Final NCD Significantly Expands Patient Access Beyond the Preliminary NCD --
Preliminary NCD | Final NCD | |||||
Patient Eligibility | Coverage for Stage IV metastatic, recurrent cancers | Coverage for Stage III and Stage IV, metastatic, recurrent, relapsed, or refractory cancers | ||||
Breadth of Coverage for FoundationOne CDx | Coverage for companion diagnostic claims across five tumor types including non-small cell lung, colorectal, breast, ovarian cancers and melanoma. (Approximately 50% of solid tumors based on Foundation Medicine's volume). | Coverage across all solid tumors | ||||
Repeat Testing | No repeat testing included | Repeat testing is covered when a new primary cancer diagnosis is made by the treating physician and the patient meets other clinical criteria | ||||
Coverage with | Included | Removed; Coverage for FoundationOne CDx is for all solid tumors | ||||
Based on the final CMS coverage policy, FoundationOne CDx is the first and only NGS assay that presently meets the requirements of the policy, enabling national coverage for all solid tumors. For an NGS diagnostic assay to be covered under the policy, the NGS diagnostic assay must:
- be an
FDA approved orFDA 510(k) cleared test with a companion diagnostic claim; - have a product label from
FDA with an indication for use in the patient's cancer; and, - report results to a treating physician for management of the patient using a report template to specify treatment options.
There are currently no NGS assays that have
"We applaud CMS for issuing this final National Coverage Determination that significantly expands coverage beyond the preliminary draft policy. Most notably, the NCD, as it applies to FoundationOne CDx, will provide coverage for eligible patients across all solid tumors," said
Similar to the coverage available today via local Medicare Administrative Contractors (MACs), the NCD coverage policy will enable NGS assays, including those performed in CLIA-certified laboratories, such as FoundationOne®, FoundationOne® Heme and FoundationACT®, as well as
Please visit CMS.gov to view the final decision memo.
About FoundationOne CDx
FoundationOne CDx is indicated as both (i) a broad companion diagnostic test for approved companion diagnostic claims including, NSCLC, CRC, melanoma, breast and ovarian cancers and (ii) to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, 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. For the complete intended use statement, including companion diagnostic indications, please see the FoundationOne CDx Technical Information, www.foundationmedicine.com/f1cdx.
About
Cautionary Note Regarding Forward-Looking Statements for
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the ability of certain Medicare patients who receive FoundationOne CDx testing to receive Medicare coverage for costs associated with FoundationOne CDx, the ability of the NCD, and FoundationOne CDx as an assay covered under the NCD, to enhance access to comprehensive genomic profiling and biomarker-driven treatments; whether the changes contained in the final NCD as compared to the preliminary NCD will expand the access to reimbursement for certain Medicare beneficiaries; the interpretation of how the NCD will operate and the potential access to Medicare coverage through LCDs from MACs that may exist for certain
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