A brief update on how CMS covers products that are covered by defintion, under an NCD.
The example here is NCD 90.2, Uses of NGS in Cancer. FDA cleared-or-approved companion diagnostics are covered by this NCD for on-label uses. Often, this means PMA CDx approval for one or more indications (gene-drug), and a secondary FDA label which is for detecting mutations in tumor genes in solid tumors, for the use of the physician via guidelines.
So on October 23, 2026, CMS released CR 14653, T 14022, Revisions to NCDs. It's released on October 23, effecitve April 1 2027 (the new quarter) ("unless otherwise stated"), implementation date April 5, 2027.
https://www.cms.gov/files/document/r14022otn.pdf
On page 3 we read that per task order 14653.1, the PGDX Elio Tissue Complete CDx is covered effective back on the FDA approval date July 30, 2026. Use CPT 81459 until a PLA is established.
The last page of the CR includes a link to a cloud zip file for Excel version.
Labcorp web page, 505 total genes and signatues TMB, MSI.
Product brochure 4pp
https://www.labcorp.com/content/dam/labcorp/files/oncology-launch/etc-cdx-oncology-brochure-2026.pdf
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I believe that a version of PGDx elio had FDA clearance (not approval) for tumor profiling, whereas this FDA revisions is a PMA for a BRAF gene in melanoma PLUS tumor profiling use. Here, here.
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It's clear to me that program instructions defined effective date as teh coverage date, and implementation date as the LATEST or LAST date to "implement" that coverage.
https://www.discoveriesinhealthpolicy.com/2026/02/this-may-save-your-reimbursement-nerd.html
However, MACs may say CMS forbids them to cover for that effective date and later, UNTIL the "implementation date" has passed.
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81459 pays $2989 (no PAMA change) and represents,
Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; dna analysis or combined dna and rna analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements
