CMS closely describes MAC claims handling for tests under NCD 90.2, NGS tests for cancer patients. They have newly added coverage of the TEMPUS FDA-version test to the NGS NCD (see Nov 9, transmittal 13278).
For reasons I couldn't have predicted, they want the test coded as 81479 (other genomic test) not as 81455 (comprehensive genomic profiling, 51 genes or more).
For more background, see TEMPUS 5/2023 press release on their FDA approval, which includes CDx for CRC and also includes "mutation profiling of solid cancers" to aid physicians. I suspect Tempus applied pretty quickly in May-June for CMS NCD coverage, and it appears now in print in November. The wheels of the gods turn slowly.
https://www.cms.gov/files/document/r12355otn.pdf
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Separately, in the same transmittal, CMS also gave coverage to a new AGILENT test, for lung cancer cases. It has its own code (0397U but see odd notes below). The AGILENT test for LBx for KRAS was approved in 12/2022. A press release says it "includes 109 genes as a professional service." Writing, As a professional service* [CLIA only, the ctDX FIRST test report includes broad genomic profiling on 109 genes across four] types of alterations: single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions.
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If I tracked the quarterly AMA CPT PLA announcements correctly, 0397U was created and released in 1H2023, then also deleted, which is why (I think) it doesn't appear in the September proposed crosswalk prices for new codes.
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Quote from TEMPUS May 2023 press release: Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx. xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
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CMS rescinded NCD-based coverage of LDT prostate test 0379U and asked MACs to retrospectively recoup any paid claims.
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Confusingly, a slightly earlier-dated NCD revision, Nov. 3, CR13391, had "end-dated coverage" of 0397U, presumably because the code came and went in the PLA system (oddly). Here.
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xTCDx nearly makes a palindrome.
