Leading health-care companies and organizations representing patients, providers, academic medical centers, laboratories, and diagnostic manufacturers urged the Centers for Medicare & 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, MD, 63 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’ latest guidance directly undermines beneficiaries’ coverage as finalized in last year’s NCD. NGS-based testing is now the standard of care for patients with cancer, and the current interpretation implies NGS-based testing will become noncovered for many Medicare beneficiaries. This has a direct result on beneficiaries’ access and coverage to essential testing that can make a fundamental difference in their treatment.
In particular, those 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. 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.
To view the full letter and list of undersigned organizations, please visit www.amp.org/NGSNCDLetter.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.