- CMS Monday reopened its national coverage determination (NCD) for next generation sequencing (NGS).
- The move follows pressure from healthcare organizations that argued the agency's original decision on NGS would prevent Medicare beneficiaries with early-stage cancer from accessing the tests.
- CMS, in a tracking sheet, said it is reconsidering only the evidence available for tests of germline mutations to identify patients with hereditary cancer who may benefit from targeted treatments based on their test results.
Genetic variations in cancer help predict how an individual is likely to respond to potential treatments. Next generation sequencing tests read the order of nucleotide molecules on DNA to provide information on multiple genetic alterations, as well as a more comprehensive genetic profile of the cancer.
Medicare's original NCD extended coverage of the tumor-profiling tests for patients with recurrent, relapsed, refractory, metastatic or advanced stage III or IV disease.
A research note from Cowen Washington Research Group said the policy caused confusion in the lab industry by instructing regional Medicare contractors to align local policies with the NCD. The policy was interpreted as removing coverage for germline NGS testing for early-stage patients. About 60% of cancer patients have stage I or II disease, the analysts said.
"In our view, CMS reopening the NCD so soon after it was introduced likely means they are strongly considering a change," the analysts wrote in a research report.
In February, 63 healthcare companies and organizations — including AdvaMed, the American Clinical Laboratory Association, the American Medical Association and sequencing test makers Illumina and Myriad Genetics — sent a letter to CMS Administrator Seema Verma asking the agency to revise the NCD, arguing the policy would restrict patient access to essential clinical tests and adversely affect cancer care and outcomes.
The original 2018 NCD included FDA approval and CMS coverage of NGS testing for Medicare beneficiaries with advanced cancer, including Foundation Medicine's F1CDx test. CMS had delayed implementation of the NCD from March until this month. The delay suggested the agency was reviewing stakeholder concerns over the policy's implementation.
CMS is accepting public comments through May 29. A proposed decision memo is due Oct. 29, and the new NCD is expected to be finalized by Jan. 27, 2020.