Tuesday, November 18, 2025

Update: CAP Accreditation Allows "Distributed Model" Testing - But AMA CPT PLA Will Not

In recent quarters, a number of PLA applications have been rejected either because they were "dry lab only" services (e.g. starting from a digital image of an H&E section) or because they were in a "distributed model" for example with sequencing in one location and bioinformatics in another.

CAP clearly allows certain kinds of distributing model services.  I wrote a blog on this on November 13 - here.

That's CAP for CLIA.

However, AMA CPT has a specific PLA FAQ that specifically disallows this model as eligible for PLA coding.   I'm not sure when the text was specifically updated.   Find the FAQ and the text clipped below.


  • For requesting laboratories, all aspects of the analysis must be performed in a single (“sole-source,” including the same or different locations, owned and operated by the same entity) CLIA-certified or accredited clinical laboratory or licensed or marketed to multiple providing laboratories (e.g., cleared or approved by the Food and Drug Administration [FDA]).   

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Here's some additional text from that FAQ you may want to be aware of.

  • Proprietary laboratory analyses (PLA) codes are alpha-numeric CPT® codes with a corresponding descriptor, for labs or manufacturers to more specifically identify their test. PLA codes can be provided either by a single (“sole-source” including the same or different locations, owned and operated by the same entity) laboratory or licensed or marketed to multiple providing laboratories (e.g., cleared or approved by the Food and Drug Administration [FDA]). Tests with PLA codes must be performed on human specimens, do not have a physician work component, and must be requested by the clinical laboratory or manufacturer that offers the test.

Summary 
PLA Distributed Model
    Not allowed (quoted above).
Physician work.
    NO physician work is allowed, including required physician work to review and confirm data, prior to a PhD's sign out at the end.
Dry Lab
   I've seen the term "dry lab" used occasoinally (e.g. digital only analysis of an H&E image), but I haven't seen this excluded from PLA coding in writing.  However, I believe the PLA committee will reject what it perceives as a "dry lab" application, in practice.   [Regardless of possible past acceptances in earlier years].