Foundation Medicine's National Coverage Determination Reopened by CMS

In a session held during the Florida Society of Clinical Oncology’s annual meeting in April, panelist James Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and previously a medical officer at CMS in the Coverage Analysis Group, announced that he expected the National Coverage Determination (NCD) to be reopened at any time for Foundation Medicine’s FDA-approved broad companion diagnostic for solid tumors. By the end of the month, CMS revealed that they had done just that.

“The NCD that was ultimately issued has flaws in it. The NCD does not allow for the same test to be used more than once, with 1 exception,…” said Almas. He explained that the decision to reopen the NCD was based primarily on the hesitance around the evidence of next-generation sequencing (NGS). “Most of these tests are FDA approved but they have not gone through the equivalence of a phase 3 study done for drugs. Evidence, in some cases, is weak. You have to ask solid questions when you have a lab [that] you’re basing treatment decisions off of. You have to assess the lab and then face the challenge of reimbursement,” he said.

While the announcement that the NCD had been reopened pleased most labs and patient advocates who had spoken out about the negative impact the current policy could have by limiting patients’ ability to access genetic testing to learn their risk for cancer, reopening the NCD also offers stakeholders another chance to either narrow or broaden the national coverage terms for NGS tumor panels.

At the start this year, the NCD was at odds with some local coverage determinations (LCDs) in terms of NGS testing allowed for BRCA1/2 mutations. The NCD for Foundation Medicine only allows testing of these patients with late-stage disease, while Medicare contractor Palmetto GBA allowed for the testing in early-stage patients. Palmetto was instructed to revise its coverage determination at the instruction of CMS to align its terms with the NCD.

However, based on the language in the original NCD, stakeholders believed the policy was restricted to when NGS testing was used for tumor-profiling tests for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV disease.

This policy caused confusion amongst laboratories, as it was viewed as removing coverage for germline NGS testing for early-stage patients, a type of test commonly performed to detect germline mutations in BRCA1/2 to gauge patients’ risk of breast and ovarian cancer.

In February, 63 healthcare companies and organizations, including the American Medical Association, the American Clinical Laboratory Association, and more, wrote to CMS to express their concerns that the approach would restrict patient access to essential clinical tests and adversely affect cancer care and outcomes.

CMS accepted public comments through May 29. A proposed decision memo is due October 29, and the new NCD is expected to be finalized by January 27, 2020.