- CMS has finalized a National Coverage Determination (NCD) that will reimburse providers for diagnostic laboratory tests using next-generation sequencing (NGS) for patients with advanced cancer.
“We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,” said Seema Verma, CMS Administrator.
“That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.”
CMS believes that oncologists can use these tests as a companion diagnostic to make more informed treatment decisions. The test results can help providers identify patients with certain genetic mutations who may benefit from FDA-approved treatments.
Results from diagnostic lab tests using NGS can also help determine a patient’s candidacy for cancer clinical trials when a known cancer mutation cannot be matched to a treatment.
CMS made the decision after the FDA granted its approval of the FoundationOne CDx (F1CDx) test on November 30, 2017. At the same time, CMS issued a proposed NCD for NGS cancer diagnostics.
F1CDx is the first breakthrough-designated, NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies. The test can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.
In addition to covering F1CDx, CMS will cover FDA-approved or cleared companion in vitro diagnostics, provided the test has an FDA-approved or cleared indication for use in that patient’s cancer and the results given to a physician specify treatment options.
“These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” said Kate Goodrich, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality (CCSQ).
“The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”
Under this final NCD, tests that gain FDA approval or clearance as an in-vitro companion diagnostic test will automatically receive full coverage, provided other coverage criteria are also met.
This final decision also expands coverage to repeat testing when patients have a new primary diagnosis of cancer.
Local Medicare Administrative Contractors will make coverage determinations for other diagnostic laboratory tests using NGS for Medicare patients with advanced cancer.
After reviewing public comments for this determination, CMS has removed coverage with evidence development in this final NCD. Many commenters reported that they have already developed evidence that these diagnostic laboratory tests improve health outcomes, or they reported that they are equipped to conduct their own studies on the subject.
CMS strongly encourages researchers to keep conducting these important studies. This research will be integral to ensuring patients, caregivers, and providers will make more informed decisions, and will continue to help develop new technologies in the healthcare system.