The Centers for Medicare & Medicaid Services (CMS) has announced that it will cover diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer.
In a national coverage determination (NCD) issued March 16, CMS said it will provide genomic testing for patients with recurrent, metastatic, relapsed, refractory, or stages III/IV cancer. The agency said such tests can help patients and physicians make more informed treatment decisions.
We want patients with cancer to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways, CMS administrator Seema Verma said in a statement. “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 issued a proposed NCD in November when the FoundationOne CDx (F1CDx) test won simultaneous FDA approval and CMS coverage. This NCD means that CMS will cover FDA-approved or cleared in vitro diagnostics when the test has a companion FDA-approved or cleared treatment option, and results are provided to the treating physician for management of the patient using a report template to specify treatment options.
Medicare Administrative Contractors may determine local coverage of other NGS tests as a diagnostic laboratory test for patients with cancer, such as MSK-IMPACT. The NCD also provides coverage for repeat testing when a Medicare patient has a new primary diagnosis of cancer.
“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.”
F1CDx was approved in November 2017 under the Parallel Review Program, a voluntary program from FDA and CMS designed to help Medicare beneficiaries get earlier access to innovative medical technologies.
The F1CDx had not been previously submitted for the FDA’s review because it is a laboratory-developed test. The agency has not generally enforced premarket review and other applicable requirements for such tests. However, at the request of Foundation Medicine, developer of the F1CDx, the FDA approved the assay for the newly established Breakthrough Device Program because of the test’s potential to consolidate multiple companion diagnostic claims for patients and healthcare providers in a single test.
According to the final language of the decision memo, the NCD also covers the FoundationFocus CDxBRCA for qualitative detection of BRCA1
alterations in formalin-fixed, paraffin-embedded (FFPE) ovarian tumor tissue, Praxis Extended RAS Panel for the detection of 56 specific mutations in KRAS exons 2, 3, and 4 and NRAS
exons 2, 3, and 4 in DNA extracted from FFPE colorectal cancer tissue samples, and Thermo Fisher Scientific’s Oncomine Dx Target Test (ODxTT) to detect single nucleotide variants and deletions in 23 genes from DNA and fusions in ROS1
from RNA isolated from FFPE tumor tissue samples from patients with non–small cell lung cancer.
“The extension of coverage to 50 percent of the US population underscores the significant traction NGS-based tests are gaining to more effectively select targeted therapies in this age of precision medicine," Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific, said in a statement. “As more health plans recognize their value, further adoption of these companion diagnostics will follow—enabling patients to benefit from improved health outcomes and better efficiencies in the cost of their treatments.”