On September 27, 2023, after market close, CMS released proposed prices for 85 new laboratory test codes.
This triggers a comment period through October 27, 2023. The proposed prices follow a public comment meeting in June and a public expert panel meeting in July.
The biggest surprise, AMA introduced a set of new CPT codes for genomic procedures like tumor gene panels with TMB or MSI. CMS offers to price these at only the lowest price of a small tumor panel (about $600, CW 81445, 81450). This bears out the fears of some stakeholders last spring, that omitting gene panel numbers could trigger low pricing by CMS. AMP, CAP, and others will be commenting on this. One result would be gapfill by Moldx in 2024, but that would leave the codes formally unpriced all year long (for CMS and for payers that reference CMS).
Here's the CMS CLFS page:
Scross down to Meeting Notice, Agenda, and Other Important Materials and click to open this section of the webpage. Scroll down further to a zip file of "2024 proposed prices."
I counted 18/85 codes where "CMS disagreed with the majority of the panel" and CMS proposed something different. So this result is not rare, but not common. There were 3 other codes where CMS used the term "agreed with the majority of the title."
At least one code flipped on appeal, 0329U, where CMS writes it now understands the code and crosswalk better and will flip from "gapfill" (which is currently in process) to CW 0242U based on this year's appeal.
I count 22 codes proposed for "gapfill," about the same as last September. But more codes may flip into the gapfill column by the final decision, as some stakeholders will complain about a low price crosswalk and get gapfill as a consolation prize. About 32 codes were actually gapfilled in 2023.
Nearly all crosswalk codes are crosswalked to 1 single code at exactly its value. There's a fractional crosswalk for 0387U, a melanoma IHC code. There's a two-code crosswalk for 0367U.
There were several codes with slide-based imaging and AI or ML, 0376U, x084U, X088U. Like the expert panel, CMS crosswalks these to 0220U. That's $706, the Precise Dx breast cancer test. Now, a similar class of test, the Prelude DCISioniRT, 0295U, won ADLT status last spring and thus a price at $5435. (This triggered the same $5435 for a test that was crosswalked to 0295U at its original price). This means that tests under the same paradigm - several slides and ML - are priced almost 10X apart.
Further, at least one of these codes, 0376U, is classed by CMS as not payable in the hospital outpatient setting, where a lot of biopsies originate. (It gets status Q4, bundled). The same problem impairs the new AMA Category III codes for whole slide imaging (status N, not paid separately). Possibly these codes would meet an unbundling exception for proteomic cancer MAAA tests found in the date of service rule. 42 CFR 414.510.b.5. CMS has ruled that these slide-based tests are "proteomic" tests because they have to be to be eligble for ADLT status, which a few get.
Below, government accounts visit the clinical laboratory.