In its haste to guarantee payment for one breakthrough test, the Centers for Medicare and Medicaid Services (CMS) may have stumbled as the agency ventures into contentious territory around laboratory developed tests (LDT). This could spell trouble for labs using other methods, according to AACC and other laboratory organizations.
That the test has significant potential for patient care is not in question. Developed by Foundation Medicine, the FoundationOne CDx (F1CDx) test gained approval through the Food and Drug Administration’s (FDA) expedited breakthrough device program at the same time as CMS proposed coverage, only the second such test to pass this hurdle. The first was Exact Sciences’ Cologuard colorectal cancer test in 2014.
F1CDx is unique in the breadth of information it provides. Rather than matching one test to one drug, the test uses next-generation sequencing (NGS) to detect 324 genetic mutations and two genomic signatures in solid tumors. It also identifies patients who could benefit from 15 FDA-approved targeted treatment options and immunotherapies, potentially benefiting up to 1 in 3 patients across five common advanced cancers.
However, according to critics of the parallel CMS coverage proposal, the agency erred in creating payment policy recommendations that may affect all LDTs. The proposal would supersede current NGS local coverage determinations and would establish FDA approval as the basis for Medicare reimbursement of NGS tests unless a patient is enrolled in a clinical trial sponsored by the National Institutes of Health.
The proposal “would interfere with current federal regulatory policy by essentially barring clinical laboratories from performing [other] NGS tests, since they would not be reimbursed,” AACC wrote in a letter to CMS. If the current CMS proposal moves forward, it will have a “chilling effect” on scientific advancement in NGS testing and force academic medical centers to stop developing and offering tests that are becoming a routine, essential part of patient care, AACC added. Current local coverage determinations for NGS remain in effect until CMS issues a final decision.