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Medicare's PAMA 2014 law, section 216, created a new pricing system, involving a triennial market-based repricing of the lab fee schedule.
In addition, PAMA defined a new test category, ADLT or Advanced Diagnostic Laboratory Tests. These tests must be sole-source tests, and must be one of two types, (a) a MAAA type test or (b) a sole source FDA cleared or approved tests.
CMS controversially added several additional rules for ADLT tests, such as the Type (a) tests must be dissimilar to any existing test. (This wouldn't make sense for Type (b) tests, since they can be 510(k) tests). In addition, Type (a) tests must be originated by the laboratory and, at least based on rulemaking tests, not licensed in from academia to a commercialization lab.
The only test until last week that was an ADLT was the Foundation Medicine F1 CDx test, code 0037U. This test has been priced at its market price of $3500 for three quarters, July 2018-March 2019, after which point, it will be repriced annually at its FMI private payer market price.
Just in time for Christmas, CMS has created a second ADLT test on December 21, 2018.
The Biodesix test is approved as an ADLT test, but not as a new ADLT test (existing code 81358). Therefore, it doesn't get any first-year special list price pricing. Since it isn't new.
However, Veristrat will be repriced annually as an ADLT, rather than every 3 years, as a regular lab test. Its 2019 price is $2871.
