The day when oncologists can order a Medicare-covered next-generation sequencing diagnostic test may be near at hand, but once this change goes into effect, will oncologists be limited to certain tests, labs, and cancer settings? The answer is unclear.
On November 30, 2017, CMS released a draft national coverage determination (NCD) for NGS for Medicare beneficiaries with advanced or recurrent cancer.
The NCD received support from the medical community. However, coverage limitations were noted within the proposal. The Community Oncology Alliance, in collaboration with ADVI, a Washington, DC, consultancy that specializes in healthcare payment strategies, recently held a webinar discussion of the specifications and implications of the proposal, in advance of the end of the public comment period on the NCD.
Coverage of laboratory tests is not the same as coverage of oncology drugs, said Michael Kolodziej, MD, vice president of ADVI. Approvals for laboratory tests have taken a different course than those for therapeutics, he said.
Generally, the FDA has reviewed companion diagnostics in tandem with approval determinations for companion therapeutics, but this has not been the case for laboratory-developed tests (LDTs), a type of diagnostic test that is designed, manufactured, and used within 1 particular laboratory. “The FDA has not been particularly active in this space. But this is about to change,” said Kolodziej.
The only consistency in this space is that payers have regularly not covered NGS tests, despite proven need for them in the oncology field. For example, the National Comprehensive Cancer Network’s guidelines for the treatment of patients with nonsmall cell lung cancer recommend the use of NGS to guide treatment decisions due to the high number of mutations in this tumor type, “but even this has not resonated with payers,” Kolodziej said.
Foundation Medicine’s large panel FoundationOne CDx cancer biomarker assay may be among the few exceptions for both the FDA and CMS coverage. On November 30, 2017, the NGS-based test received both FDA approval and confirmation that CMS will pay for the test. Those decisions followed a parallel review with both agencies. The same day, CMS released the proposed NCD for coverage of NGS tests.
However, FDA approval of LDTs has not strongly influenced payer determinations on coverage. Approval of these LDTs often comes via the Clinical Laboratory Improvement Amendments (CLIA) program, which is supported and overseen by the FDA, CMS, and the Centers for Disease Control, with coverage decisions at the discretion of individual payers. “Approval of a specific laboratory test by a specific regulatory agency does not necessarily mean that the payers, either Medicare or a local payer, are going to cover it,” Kolodziej said. For Medicare at least, this would change with the approval of the NGS NCD, as the decision would supersede all local coverage decisions.
The proposed plan would make an NGS test eligible for coverage under section 1862(a)(1)(A) of the Social Security Act when the test is FDA approved, and when the cancer type has at least 1 treatment with a companion diagnostic that is FDA approved. If the test is not approved by the FDA, or if there is no approved companion diagnostic for the cancer type in question, coverage with evidence development (CED) is proposed. If neither applies, the test is not covered. Currently these conditions and the subsequent coverage only apply to tests within the field of oncology.
Proposed criteria for the patient receiving the test require that the patient has recurrent, metastatic, or advanced stage IV cancer; has not previously undergone testing with the same test; and is seeking further treatment for cancer. For all tests, CLIA lab certification is required along with results that indicate the potential treatment options based on the results.
CED determines coverage based on a National Institutes of Health (NIH) Genetic Testing Registry or an NIH/NCI National Clinical Trial Network clinical trial when the evidence for the test is not conclusive. The CED serves as proof that the test can affect the clinical outcome of the patient’s disease and can contribute to treatment decision making. For the sake of diagnostic tests, a potential cure does not have to be the rationale for the test. Instead, the test can be justified if it enables a patient to avoid alternative treatments or surgeries that could be futile.
“There are some stakeholders, even though they are not fundamentally opposed to CED, [who] are engaging with CMS to see if the proposed CED framework is the one that is most likely to be readily implementable and reflect those [data] that are absolutely crucial,” explained Louis Jacques, MD, chief clinical officer of ADVI, during the webinar.
Kolodziej said that although the CMS NCD is important for oncologists, there are many unanswered questions about the proposed determination. A response comment issued by ASCO raised concerns over restrictions of the proposal, such as limiting use of such tests to one-time only per patient. “As written, the NCD language that the ‘patient has not been previously tested using the same NGS test’ is ambiguous and could preclude coverage of medically appropriate retesting and therefore coverage and access to treatment,” wrote Bruce E. Johnson, MD, FASCO, president of ASCO in the response comment. “In many cases repeating the ‘same’ NGS test is preferred so that changes in the tumor genomic profile over time can be more readily identified. If different tests are used, it may be more difficult to determine if a newly detected alteration was present previously or not.”
Kolodziej raised a concern about the proposed limitations on laboratories that can participate in the CED and provide these cleared NGS tests. “This is probably one of the biggest questions out there. If you read what has been written very literally, it almost sounds like CMS is simply not going to pay for most of the [work by] laboratories that are currently doing NGS. And I think that they’ve received a lot of comments about this,” he said.
Academic medical center laboratories also have reservations about the proposal. “The NCD, as it stands, risks effectively removing an entire segment of the testing community, namely academic medical centers providing NGS testing for cancer to our local patient population in [New York State],” said a response comment from the Columbia University Laboratory of Personalized Genomic Medicine. The proposed NCD would limit the tests that academic medical center labs could offer, including LDTs.
Most academic center laboratories also opposed the limitations on the use of LDTs to FDA-approved tests only, and they recommended that validated, CLIA-compliant tests should fall under the scope of the NCD as well. “The NCD as written currently restricts CED, outside of a clinical trial, to FDAapproved or -cleared NGS tests. While ASCO supports increased oversight of NGS tests directing cancer therapy, a more flexible framework is critical to the clinical research enterprise and to support the rapid development of necessary evidence on the clinical utility of NGS tests. Requirements for CED should be broadened in order for NGS tests to develop the data to justify full coverage as well as FDA clearance,” Johnson clarified in the ASCO public comment. The final decision for the NCD is scheduled to be made by February 28, 2018.
Proposed decision memo for next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450N). CMS website. cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=290&bc=AAAAAAAAAAQAAA%3D%3D&. Published November 30, 2017. Accessed January 13, 2018.