Monday, July 10, 2023

CMS Creates Two New ADLT Tests (June 30, 2023) (0315U, 0360U)

In 2022, CMS created only 1 new ADLT test (Castle/Cernostics 0108U).   This 2022 ADLT is remarkable for being the first ADLT known to double in price as an ADLT on the fee schedule (from a first year to second year ADLT price, see my June 24 blog here).  Curiously, this also caused an unrelated test from another company, crosswalked to 0108U, to double in price, see the same June 24 blog.

Turning to 2023: ADLT Trifecta

In a May 25 blog, I discussed the creation of the Prelude test, 0295U, as an ADLT.  The pricing jumped from $1897 to $5435.  That was the first ADLT of 2023.  Prelude has a Z code, but no statement about its "coverage," in the MOLDX database DEX.  But that's probably because it is a proteomic test that MolDx was not listing as eithercovered or non covered.   I couldn't find any coverage article at Noridian.

All About 2023 ADLTs: ADLT #2, ADLT #3 on June 30, 2023


One brand new ADLT is 0360U, the Biodesix NODIFY CDT test.   This has no new first-three-quarters price, because, per an asterisk, it is an ADLT already paid by CMS prior to 2018.  (The last new ADLT with such an asterisk was in 2019, which was easier to understand).    See Nodify press release, July 6, here.

Biodesix had a press release it "obtained coverage" for NODIFY CDT on 6/7/2022, find it here.  

However, I wasn't able to find "NODIFY" on the WPS website -

0315U DecisionDX SCC (Squamous)

The other new ADLT is 0315U, Castle, DecisionDX SCC (squamous carcinoma)   This has an ADLT price, for three quarteers, of $8500.   This makes it one of the highest paid tests in the history of the Medicare Part B lab program.  

The test had been in process for a gapfill price at MolDx, of $3159 (June 16 blog here).   MolDx had put out a draft non coverage policy on the test around June 1.  

(Note that I updated this June 1 non coverage blog, with the June 16 gapfill information).

(SCC Blogs:  June 1, non coverage LCD; June 16, gapfill price at $3159; July 10, ADLT topic.)