Press release

CMS finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients

CMS finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients
A new opportunity for cancer patients as advanced diagnostic laboratory tests now have expanded Medicare coverage

Today the Centers for Medicare & Medicaid Services (CMS) took action to advance innovative personalized medicine for Medicare patients with cancer. CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer). CMS believes when these tests are used as a companion diagnostic to identify patients with certain genetic mutations that may benefit from U.S. Food and Drug Administration (FDA)-approved treatments, these tests can assist patients and their oncologists in making more informed treatment decisions. 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.

This decision was made following the parallel review with the FDA, which granted its approval of the FoundationOne CDx (F1CDx™) test on Nov. 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 as well as 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 for management of the patient 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, M.D., 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.”

This NCD recognizes the importance of analytical and clinical validation of the diagnostic laboratory test that is part of FDA approval or clearance and provides national coverage after demonstration that use of the diagnostic laboratory test guides the management and treatment of the patient improves health outcomes. 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. In addition, 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.

After reviewing all the public comments for this specific determination, we have removed coverage with evidence development in this final NCD. Many commenters reported that they are already developing or have developed the evidence to demonstrate these diagnostic laboratory tests using NGS to improve health outcomes for Medicare beneficiaries with cancer – or are equipped to conduct their own studies to generate evidence that use of the test guides management and treatment, and improves health outcomes for the Medicare population. We strongly encourage continuing and publishing the results of these important studies, especially on the endpoints of overall survival, progression free survival, objective response, and patient reported outcomes relevant to the quality of life for Medicare beneficiaries. This is not only important to ensuring that patients, caregivers and their providers can make informed decisions, but also to continue to develop and publish results to develop new technologies in the healthcare system.

For more information:

CMS: Medicare Coverage Center
CMS: National Coverage Analyses (NCAs) Alphabetical Index
CMS: Public Comments
CMS: Coverage with Evidence Development 

The CMS, an agency within the U.S. Department of Health and Human Services, directs the planning, coordination, and implementation of the programs under the Social Security Act and related statutes, to administer Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace. The agency also directs the development of effective relationships between these programs and private and federally supported health-related programs.

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