The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed broad national coverage for next-generation sequencing (NGS) in Medicare patients to check for germline mutations under certain testing conditions.
The agency's review and terms and conditions on the matter were published on October 29 in a proposed national coverage determination (NCD). The agency advised coverage for next-generation sequencing with physician-ordered companion diagnostic tests approved or cleared by the U.S. Food and Drug Administration (FDA) and performed in a CLIA-certified lab. Patients must meet a range of conditions, according to CMS. They must have ovarian or breast cancer, have clinical indications for testing for hereditary cancer, and have never received a prior NGS test. Results will be provided to the treating physician.
This would expand the current national coverage policy for NGS, which is restricted to patients with advanced cancers that are recurrent or metastatic and who are eligible for testing with an FDA-approved companion diagnostic. Instead, the disease stage is not specified.
"As a result of current evidence and our present analysis, we now believe that the use of NGS has additional benefits," Tamara Syrek Jensen, director of the CMS Coverage and Analysis Group, and colleagues wrote in the agency's proposed decision document. "It is an important tool in managing other types of hereditary cancer to reduce mortality and improve other health outcomes for Medicare beneficiaries."
The CMS proposal is based on reports in the literature for NGS as a diagnostic test in symptomatic patients with certain inherited cancers; studies of NGS for screening asymptomatic patients without cancer were not considered. The proposed expanded policy explicitly does not cover testing for somatic mutations, which are not passed on to offspring.
"The evidence for cancer of the breast and ovary suggests that NGS as a diagnostic tool can identify the germline mutations most likely to be targeted by a treatment regimen tailored to certain germline [mutations]," CMS wrote. "It is likely that the identification of such tailored treatment regimens in the clinical management of inherited cancers of the breast and ovary diagnosed by NGS will improve health outcomes of Medicare beneficiaries."
The agency found less evidence for NGS testing based on hereditary risk for other tumor types. It has proposed that Medicare Administrative Contractors determine coverage when patients have tumor types other than breast or ovarian cancer.
"We believe that, for other cancers, the evidence is rapidly developing," CMS wrote. "We are therefore maintaining the Medicare Administrative Contractors (MACs) discretion to make coverage decisions on diagnostic uses of NGS testing for patients with inherited cancers based on new evidence that may arise."
The proposed decision is open for comment for one month.
BRCA status guides treatment
The current NGS coverage policy has been in place since March 2018. CMS announced in May that it was beginning a national coverage analysis of NGS, with plans to issue a proposed decision this month and to complete the review in January. The agency noted that during a 30-day period after the May announcement, it received 82 comments from a range of stakeholders, including academic medical centers, hospitals, laboratories, and manufacturers.
"The comments were supportive of CMS' decision to reconsider the current NCD and recognized this as an opportunity to refine the policy," the agency added.
The news comes at a time of scrutiny of the underuse of testing for BRCA1/2 mutations, which are associated with worse outcomes for patients with breast and ovarian cancer, as well as other tumor types. Mutation status affects decisions about treatment, including preventive surgeries and drug treatments. The U.S. Preventive Services Task Force recently expanded its recommendations on testing for BRCA mutations to include people with a personal history of breast or ovarian cancer.
In its proposed decision document, CMS noted that sequencing technology has improved to a point where it provides detailed information on multiple genomic alterations simultaneously, with a comprehensive profile of cancer relevant to potential treatments.
"NGS oncology panel tests hold potential for patients and providers in optimizing (personalizing) therapies that target specific characteristics of individual patient cancers," CMS wrote. "However, it is important that these tests produce valid results that are useful in guiding therapies to improve outcomes for patients with germline cancer."