Wednesday, November 19, 2025

New AMA CPT Text Defines Rules for PLA Code Changes (In a Vague Way)

In a previous blog, I noted that updated online PLA code instructions seem to disallow "distributed testing models" that may be approved by CAP inspections. 

https://www.discoveriesinhealthpolicy.com/2025/11/update-cap-accreditation-allows.html

Here's another PLA item of interest.  

For the CY2026 code book, which just arrived, AMA added some text about when a new PLA code is needed versus when a code with the same number can be revised editorially.

I'm not sure the results of the new language is crystal clear.   But here it is.

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2026 code book, page 1016.  The repeated use of "may" and squishy terms like "material change" seem as vague as ever to me.  But here you go:

A new PLA code is required whenever the existing PLA has been updated in a manner that materially alters the original code descriptor, clinical indications, performance claims, or result reporting.  Examples of changes that MAY trigger the need for a new PLA code include:

1) Additional nucleic acid (DNA, RNA) and or protein analysis added to or removed from the current PLA test.

2) The algorithm (if used) has been materially changed so that it has expanded beyond its original intent, and

3) The name of the PLA test has changed in association with changes in test performance or test characteristics.

The addition of modification of the therapeutic application of the test require the submission of a code change, BUT it MAY not requre a new code number.

Refer to the introduction of the PLA section of the CPT for other details regarding the code set.

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