PAMA law, passed in 2014, requires CMS to create codes for new "advanced diagnostic laboratory tests" (ADLTs) as well as any new FDA cleared or approved tests (FDACOATs) that request a code.
While CMS could create these with the G code system, AMA has initiated rapidly quarterly creation of "PLA" codes based on a simple abbreviated application form. The abbreviation stands for AMA "Proprietary Laboratory Analysis" codes.
The PLA code system will allow a wider set of tests to be coded than the PAMA requirement, as PLA includes ADLTs, additional sole source tests that don't meet the fine points of ADLT rules, as well as FDA cleared or approved tests. I wasn't sure how readily CMS would adopt the PLA code system - especially when PLA codes were created for things that wouldn't have gotten ADLT codes under PAMA. Verbally, I had heard someone remark that he had heard that someone had said CMS would be using all the PLA codes.
However, solid evidence in a new hospital outpatient policy transmittal suggests that CMS will be adopting all the PLA codes as they come out, on a rolling basis. Transmittal "R3783CP" includes classification of the two newest PLA codes, 0004U and 0005U. (For hospital policy purposes, 0004U is separately payable and 0005U is bundled to hospital outpatient services.)
CMS notes that its policy cycles do not necessarily match the AMA CPT PLA publication cycles. For example, these two codes will be added to the July 2017 editor but with effective dates retrograde to May 1. These are code files only; CMS coverage and payment would be determined separately.
The CMS publication is here.
The AMA website for PLA codes is here.
The current list of PLA codes is here.
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This could mean that PLA codes will be put in the annual CMS July crosswalk/gapfill cycle. The agenda for this year's crosswalk/gapfill cycle has not been announced as of May 31. Administrative MAAA codes have been incorporated in crosswalk/gapfill meetings as they appeared.
CMS May Have Done Something Backwards
Code 0004U is a molecular panel for 27 bacterial resistance genes. It is status "A" as payable. 0005U is a prostate cancer 3-gene expression panel and risk score. It is "Q4" as conditionally bundled.
I believe CMS has this backwards, based on their own precedents. In general, all clinical chemistry tests as well as non-human genomic tests (e.g. infectious disease) are bundled to hospital outpatient visits (Q4). But human genetic tests (e.g. 81200 series) are payable (A). Based on precedent, the two U codes are categorized backwards in this transmittal.