CMS released a National Coverage Determination (NCD) on next-generation sequencing (NGS) for Medicare beneficiaries with advanced cancer. The agency determined that NGS as a diagnostic laboratory test is “reasonable and necessary and covered nationally” when performed in a CLIA-certified laboratory and when ordered by a treating physician. The following are other criteria that must be met for coverage:
- The patient has either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; has not been previously tested using the same NGS test for the same primary diagnosis of cancer or is receiving repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
- The diagnostic laboratory test using NGS must have FDA approval or clearance as a companion in vitro diagnostic; an FDA-approved or cleared indication for use in that patient’s cancer; and results provided to the treating physician for management of the patient using a report template to specify treatment options.
The final policy will allow local Medicare administrative contractors to continue covering NGS-based tests that are not automatically covered by the NCD. Several local determinations for coverage of hematologic malignancies will remain in effect.
The American Society of Hematology (ASH) and more than 300 other medical and industry groups submitted comments on this proposal, and in response, CMS significantly revised the policy by removing both the “coverage with evidence development” requirements and non-coverage portions of the proposal. “These revisions represent a significant victory for stakeholders who were concerned that the proposal would drastically limit patient access to NGS-based testing,” according to a statement from ASH.
Sources: Centers for Medicare & Medicaid Services memo, March 16, 2018; American Society of Hematology, March 21, 2018.