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Background
Just last week, I wrote an update on the history of ADLT tests, a special pricing category created by Congress in 2014. Iin a decade, there were only about 15 ADLT tests created. ADLT's must be sole source tests that are either FDA approved (like Foundation Medicine F1) or covered tests of the MAAA type that provide "unique clinical information." The update blog included at bottom an elaborate chart of all things ADLT. Here. Read about the elaborate application process for ADLTs, here.
New ADLT Code
On March 18, 2024, CMS created a new ADLT, code 0356U, NavDx from Naveris. PDF here. Classification as ADLT removes 0356Ufrom the current year gapfill process. (Gapfill had been requested by Naveris last summer, endorsed by the CMS expert panel, and decided by CMS).
The price the first nine months starting April 1 will be $1800. After that, the price will reset annually to the median of NavDx commercial payor prices.
Ins and Outs
According to my December 2023 blog, at the time Naveris announced LCD coverage under the MolDx MRD LCD, MolDx's online directory "Dex" listed the locally-set price at $900. Here. That would have been the result of a spreadsheet and rulebook that MolDx calls its "EPM, Equitable Pricing Model." The price I see in DEX today (March 25, 2024) is $827. (Click to enlarge). I believe that on April 1, MolDx will delist that local price and instead say "See CPT code" which means the CMS CLFS fee schedule which will in turn display the $1800 just-set ADLT price.
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DEX: Not Just a Code Directory
Note that the DEX page includes not merely a description of the test, but a summary of its Medicare-covered use(s). Here, the test is covered as an MRD test both for surveillance (if it recurs) and to detect if MRD shows "residual" cancer, presumably (I think) at a timepoint that is shortly post-surgical or post-{XRT-chemo}.
DEX: Oncology (oropharyngeal and anal), cell-free DNA, droplet digital PCR to profile the fragmentation pattern of tumor tissue modified viral (TTMV) HPV DNA using 17 DNA biomarkers, weighted fragment size distribution algorithmic analysis, whole blood, algorithm reported as a prognostic TTMV risk score for cancer recurrence. (NavDx(r), Naveris Inc.) The intended use of the test is for monitoring patients with previously diagnosed HPV-driven head and neck cancers for recurrent and or residual HPV-driven oropharyngeal cancer.
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ddPCR: Big Impact on CMS Policy!
This is one of relatively few tests for MRD that use "droplet digital PCR." Because it does not use next generation sequencing, MolDx isn't bound by the outdated rules against serial testing of the CMS NGS NCD (NCD 90.2). I discussed how outdated 90.2 is, in the context of a new massive ARPA-H grant, recently here.
Here's the AMA PLA code text:
Oncology (oropharyngeal) evaluation of 17 DNA biomarkers using
droplet digital PCR (ddPCR), cell-free DNA, algorithm reported as a
prognostic risk score for cancer recurrence.
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For anyone who thinks there is a quick one-and-done pathway to Coverage, see the extensive listing of Naveris clinical accuracy publications here.