Here's a section quoted from my blog on PAMA Pricing 2027:
Lesson: PAMA is brutal on kitted molecular tests
Once again, PAMA Is brutal on kitted molecular tests. Back around 2016, Nanostring got 510K clearance for Prosigna, essentially "Oncotype in a Box," a test which won crosswalk pricing to Oncotype when Prosigna was new.
However, Prosigna got a brutally low price in the 2017 cycle of PAMA, resulting in year-by-year cuts.* (The code was deleted in the 9/2026 AMA CPT meeting.)
Past is Prologue: Prosigna to Illumina
The same story plays out for 0543U, the Illumina Trusight Oncology Comprehensive test. It won a crosswalk price of $2989 (basically the same as 81455), but gets a PAMA price of only $1337. Apparently labs responsible for billing payers and then reporting PAMA prices did a poor job of it, to the detriment of Illumina. CMS doesn't post data on 0543U reported prices, indicating there were fewer than 10 of them in 1H2025.
You can't help seeing the parallel between Prosigna ("oncotype in a box") and Illumina Trusight ("FMI in a box.") Both get chopped in half and tossed out the window via PAMA.
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*The Prosigna story is messy because it was priced as Admin-MAAA 0008M 2016 then upgraded to Cat I 81520 during 2018, but the results are as stated here. See: $3443 to $900.
