By Diagnostics World Staff
February 1, 2019 Yesterday members of 63 leading health care companies and organizations representing patients, providers, academic medical centers, laboratories, and diagnostic manufacturers urged the Centers for Medicare and Medicaid Services (CMS) to revise its interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS). In a letter to CMS Administrator Seema Verma, the organizations expressed serious concerns that the overly broad interpretation will restrict patient access to medically necessary and relevant clinical tests and adversely impact cancer care and outcomes.
CMS guidance issued last March seems to limit NGS testing to patients with “either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer” among other criteria. The wording groups all NGS tests together—not distinguishing germline from somatic tests—and suggests that patients with early-stage cancer who may have a genetic predisposition based on family history or other acceptable criteria will not be eligible for testing using NGS-based methods.
“It is our understanding that despite the NCD being requested for a somatic-based test, CMS has instructed Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer. The implication of this interpretation is both germline and somatic tumor NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer,” the group writes. “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.”
NGS-based testing is now the standard of care for cancer patients, the group argues, and the current interpretation will have a direct result on beneficiaries’ access and coverage to essential testing that can make a fundamental difference in their treatment. Restricting patients with early-stage cancers from accessing hereditary testing may lead to poorer outcomes as they are not receiving optimal therapy based on their genetic status, the group claims.
The letter is signed by a broad range of companies including sequencing technology companies like Illumina and Thermo Fisher; diagnostic test companies Invitae, Ambry Genetics, Sema4; patient advocacy groups like Susan G. Komen Foundation and FORCE: Facing Our Risk of Cancer Empowered; and associations including the American Medical Association, the American College of Medical Genetics and Genomics; Association for Molecular Pathology. It’s a varied group, but united in its concern.
“CMS’ interpretation of the NGS NCD contradicts and reverses previously established policies. The NCD supersedes existing local coverage determinations that provide crucial coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes—like BRCA mutations and Lynch syndrome—in patients without advanced cancer,” said Sue Friedman, Executive Director of FORCE: Facing Our Risk of Cancer Empowered, in a statement. “This action will harm patients! We are extremely disappointed that there was never an opportunity for patient advocacy groups to formally comment or discuss the implementation of this policy and frustrated that these medically necessary tests are now not eligible for Medicare coverage.”
“AMP is committed to working with key stakeholders to preserve broad patient access to the thousands of clinically- and analytically-validated NGS-based testing for cancer and other conditions that benefit patients each and every day,” said Mary Steele Williams, Executive Director of Association for Molecular Pathology, in the same statement. “Rather than creating additional barriers, we urge CMS to consider the collective comments from this diverse community of health care organizations and reinstate coverage for these medically necessary hereditary cancer tests. Without precision diagnostics, there is no precision medicine.”