The Centers for Medicare and Medicaid Services has finalized coverage of Next Generation Sequencing for cancer patients.
The advanced genomic diagnostic laboratory FDA-approved tests are now covered by Medicare.
CMS has approved the innovative personalized medicine as a national coverage determination for patients with advanced cancer such as recurrent, metastatic, relapsed, refractory, or stages III or IV cancer.
When these tests are used as a companion diagnostic to identify patients with certain genetic mutations, they can assist patients and their oncologists in making more informed treatment decisions, CMS said.
Additionally, when a known cancer mutation cannot be matched to a treatment then results from the diagnostic lab test using NGS can help determine a patient's candidacy for cancer clinical trials.
The decision was made following the parallel review with the FDA, which granted its approval of the FoundationOne CDx test on Nov. 30, 2017.
F1CDx is the first breakthrough-designated, Next Generation Sequencing-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies. It can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.
"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."
In addition to covering the FDA-approved F1CDx, CMS is covering FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient's cancer and results are provided to the treating physician
using a report template to 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. "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."
Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met.
Coverage determinations for other diagnostic laboratory tests using NGS for Medicare patients with advanced cancer will be made by local Medicare Administrative Contractors.
After considering all public comments, this final decision expanded coverage to patients with relapsed, refractory or stage III cancers. The final decision also extends coverage to repeat testing when the patient has a new primary diagnosis of cancer.
CMS has removed coverage with evidence development in this final NCD. Many commenters reported that they were already developing or have developed the evidence to demonstrate these diagnostic laboratory tests using NGS – or are equipped to conduct their own studies.