While the ADLT process for new lab test pricing has been in place for several years, only a handful of tests have been granted ADLT payment status. This list now totals six tests, with the addition of the Myriad myPath Melanoma test in September 2019, "initial period" pricing running from October 1, 2019 to June 30, 2020.
Two Types of ADLTs
ADLT is a special annually revised payment status for tests that are "sole source" tests (not IVD kits) which must be either (A) MAAA type tests covered by Medicare, or (B) sole source lab tests with 510(k) approval. Five of the six ADLTs are MAAA ADLTs; only one is an FDA-pathway ADLT. The abbreviation stands for Advanced Diagnostic Laboratory Tests.
ADLTs Usually Have PLA Codes
Of the six ADLT tests, 4 are represented by PLA codes ("U codes"), one has a Category I code (81538, Biodesix Veristrat test), and one has a TBD code (Castle DecisionDx-Melanoma).
ADLTs usually don't go through the gapfill/crosswalk process, as they are priced for the first 9 months at list price and thereafter at an annually-reset market price. However, an ADLT can qualify as an ADLT late in its life cycle, when it already has a code and CLFS price. In that case, I believe the annual mark-to-market pricing policy starts, but there is no initial "list price" phase.
Seeing ADLT Prices
On the approved ADLT spreadsheet, CMS lists only the "New ADLT Initial Period" price (the list price) and not the later, annually reset price which appears on the Clinical Laboratory Fee Schedule on a calendar year basis. ADLT prices range from $1950 (Myriad myPath Melanoma) to $7193 (Castle DecisionDx Melanoma).
See screenshot below (click to enlarge).
 |
| click to enlarge |
Where To Learn More
See the ADLT home page here. It includes complicated directions about how to apply for ADLT status and details about the ADLT rules.
The PDF showing current ADLTs (as clipped above) is here.