Medicare Reimbursement Restrictions on Next-Generation Sequencing Could Hinder Clinical Decision-Making
Requiring FDA approval for next-generation sequencing assays may restrict scientific development and strangle innovation.
Next-generation sequencing (NGS) tests have emerged as a powerful tool for oncologists, allowing them to detect variants in the genomes of patients diagnosed with cancer and make clinical decisions as a result, tailoring the choice of medication selected for patients in some cases.
Though the US Centers for Medicare & Medicaid Services (CMS) expanded the national coverage determination (NCD) to include coverage of NGS assays for any solid tumor, the agency also specified that the tests used for clinical decision-making must be approved by the U.S. Food and Drug Administration (FDA).
But only a few NGS tests have received FDA clearance so far — and many of the sequencing assays used in research settings are developed in-house, or are FDA-approved assays that have been modified to address a specific research question.
Another major problem with the final coverage decision, writes Frank Luh, MD, of the Sino-American Cancer Foundation in Temple City, California — who is lead author of an article in JAMA Oncology on this topic — is that it eliminated reimbursement of non-FDA-approved NGS assays if they are used for evidence development.1
Dr Luh wrote this will be overly restrictive for oncologists at hospital laboratories and academic centers that use laboratory-developed tests (LDTs) to detect analytes of interest. It could prevent participation of Medicare beneficiaries in important cancer clinical trials where NGS testing is a component of the trial. This sentiment was echoed by the American Society of Clinical Oncologists (ASCO), who urged CMS in a letter earlier this year to consider expanded coverage of NGS “to ensure patients are not subject to unexpected costs.”2
Further, the NCD requirements could prohibit easy access to liquid biopsies and circulating tumor cells, which harness the power of NGS.
The CMS ruling also specifies what type of sample preparation is acceptable for a test to be covered — a condition that could feasibly be among those that ASCO has characterized as “excessively burdensome data collection” requirements.3 As a separate but related article in the same issue of JAMA Oncology points out, “the use of specimens other than formalin-fixed paraffin-embedded samples of the specified tumor type for the [FDA-approved companion diagnostics] is off-label, resulting in reclassification of the assay as an LDT.”4
While using FDA approval as a qualifier to validate the accuracy of NGS assays may seem like a reasonable exercise, when compared, the assay performance — or the variant-detecting power — of both LDTs and FDA-approved tests were determined to be comparable. Both were found to be approximately 97% accurate.4
The authors of the Dr Luh-led study concluded that although the true “actionability” or clinical utility of some NGS assays may still be a work in progress, the CMS conditions for insurance coverage of the assays should be revised.
- Luh F, Yen Y. Benefits and harms of the Centers for Medicare & Medicaid Services ruling on next-generation sequencing . JAMA Oncol. [published online June 28, 2018]. doi: 10.1001/jamaoncol.2018.1948
- ASCO submits comments to CMS on next generation sequencing. https://www.asco.org/advocacy-policy/asco-in-action/asco-submits-comments-cms-next-generation-sequencing. Published January 18, 2018. Accessed June 28, 2018.
- American Society of Clinical Oncology. Next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer [letter to Seema Verma from the Centers for Medicare & Medicaid Services]. https://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/pdf/2018-comment-letter-CMS-NGS.pdf. Dated January 16, 2018. Accessed June 28, 2018.
- Kim AS, Bartley AN, Bridge JA. Comparison of laboratory-developed tests and FDA-approved assays for BRAF, EGFR, and KRAS testing. JAMA Oncol. 2018;4(6):838-841. doi: 10.1001/jamaoncol.2017.4021