The Centers for Medicare and Medicaid Services (CMS) has reopened its controversial national coverage decision (NCD) on the use of next-generation sequencing (NGS) in patients with advanced cancers, following pushback from healthcare groups concerned that the NCD would have a negative impact on certain patients.
Tamara Syrek Jensen, CMS director of the Coverage and Analysis Group, announced the decision to reopen the NCD at the annual meeting of the American Clinical Laboratory Association (ACLA) in March, saying that CMS is sensitive to the concerns of its stakeholders regarding the interpretation of this policy. CMS officially reopened the NCD on April 29, saying it would accept comments until May 29.
CMS published its decision memo on NGS in advanced cancers in March 2018. Under the NCD, any diagnostic test using NGS that is approved or cleared by the Food and Drug Administration (FDA) as a companion diagnostic for patients who meet the criteria for recurrent, relapsed, refractory, metastatic, and advanced stage III or IV cancer would be covered nationally.
While the NCD was originally requested for a somatic-based test, CMS instructed Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer. In a Feb. 1 letter sent to CMS administrator Seema Verma, a number of healthcare groups argued that this interpretation will restrict patients’ access to medically necessary testing of germline mutations. The letter was signed by ACLA, the College of American Pathologists, the Association for Molecular Pathology, and 60 more organizations.
NGS testing is most often performed to determine germline mutations in BRCA1/2 and gauge the risk of breast and ovarian cancer. Medicare contractors historically have covered such tests for patients who already had cancer, but didn’t limit testing depending on the cancer stage. MACs previously have implemented local coverage determinations (LCDs) that provide coverage for germline testing of cancer when supported by clinical guidelines, including NGS-based tests for germline mutations for breast and colon cancers, the groups note in the letter.
This NCD, they say, will supersede existing LCDs that provide coverage for NGS-based testing for hereditary breast and ovarian cancer syndromes and Lynch syndrome in patients who do not have advanced cancer.
“The implication of this interpretation is that both germline and somatic NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer,” the groups write. “Our organizations believe that the inclusion of NGS-based testing for germline mutations represents significant policy overreach by CMS that will have unintended consequences on the care delivered to Medicare beneficiaries, particularly those who may have a genetic predisposition to cancer based on a family history or other relevant criteria.”
Evolution of the NCD
Since receiving the letter, CMS has issued a new transmittal (No. 214, Change Request 10878) on the NCD that provides a new implementation date of April 8, 2019, and acknowledged stakeholder concerns regarding the interpretation of the policy. CMS intends to continue with implementation of the policy even as the decision is reopened.
AMP called for CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing, and requested that this be achieved via communication to the MACs and not through a formal reconsideration process, says Samuel Caughron, MD, FCAP, chair of AMP’s Economic Affairs Committee and lab medical director and chair of pathology at AdventHealth Shawnee Mission (Kansas City).
“We remain committed to working with CMS, local MACs, and other stakeholders to preserve broad patient access to all of the thousands of clinically-and analytically validated NGS-based testing for cancer and other conditions that benefit patients each and every day,” he says.
In reopening the NCD, it appears that CMS would like to narrow the policy to focus just on somatic and germline testing when done in advanced cancer patients, noting that other assessments are not within the scope of the coverage terms. “Specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this investigation,” the agency said.
While AMP is encouraged by CMS’s intent to thoroughly engage with the laboratory community and other stakeholders during the open comment period, Caughron says the association is concerned that during the reconsideration process, testing utilizing older methods will be the only covered option for early-stage cancer patients who need germline NGS-based testing.
“AMP would like to see this particular issue addressed more urgently because this arrangement is suboptimal for patient care and unnecessarily more difficult and costly for laboratories,” says Caughron.
A request for parallel review
The NCD is the result of a request by Foundation Medicine for a parallel review from the FDA and CMS for FoundationOne CDx, a test that gauges somatic variants in 324 genes for tumor tissue samples and guides treatment decisions based on the results. In the NCD, CMS not only approved coverage from that test but also for other similar FDA-approved NGS companion diagnostics.
Since 2010, the FDA-CMS Parallel Review Program has been a collaborative effort intended to reduce the time between FDA marketing approval or clearance and a CMS national coverage determination. Typically, CMS does not engage with manufacturers until after FDA approval. If the manufacturers engage FDA and CMS together while under FDA review, a stronger evidentiary base could be developed in a more efficient manner, accelerating patient access to innovative medical devices, according to CMS.
Since approval of FoundationOne’s CDx test, there have been three other NGS genomic oncology panel tests for advanced cancers approved by the FDA: FoundationFocus CDxBRCA (Foundation Medicine), Oncomine Dx Target Test (Thermo Fisher Scientific), and Praxis Extended RAS Panel (Illumina). In addition, the FDA has granted marketing authorization for MSK-IMPACT (Memorial Sloan Kettering Cancer Center).