In the past four years, there have been several examples of DIGITAL PATHOLOGY codes (like whole slide imaging and ML-AI on either H&E or IHC) coming through the PLA system.
However, in 2025, no more WSI-PLA codes have appeared. As of August 2025, AMA is offering stakeholders a chance to download documents for "TAB 94" fo the September 2025 AMA CPT meeting. This will discuss major and important proposed changes for digital pathology, and concurrently for other types of AI such as in Radiology and advanced imaging.
This documents outlines some of the key issues, while respecting the AMA rules about confidentiality of new proposals (which AMA lets you download only after disclosure agreements).
ACTION POINT "TAB 94"
Go to AMA CPT website for CPT editorial meetings.
https://www.ama-assn.org/member-benefits/events/cpt-editorial-panel-meeting
See the AGENDA for September 2025 meeting.
https://www.ama-assn.org/system/files/cpt-panel-september-2025-agenda.pdf
https://cptsmartapp.ama-assn.org/ipdashboard
At the AMA CPT SMART APP, be sure to click on top for the INTERESTED PARTY PORTAL.
Now scroll down to the agenda list and click forward a couple screens to see TAB 94.
Go to TAB 94 and request permission to view those documents. When I did so, the web site granted me instant access to 2 documents stored under Tab 94 "Clinically meaningful algorithmic analyses" CMAA.
ORIENTATION TO THE AMA CPT ISSUES
THE PLA CODING WORLD
PLA codes go back to about 2016.
PLA codes stem from a PAMA 2014 requirement that CMS make rapidly quarterly codes for ADLT tests. AMA decided rapidly that it, the AMA, wanted to create these codes. Since regular CPT codes take a year, and these codes must be quarterly, AMA had to craft new rules and processes for PLA codes.
AMA decided to take any proprietary lab test, since AMA couldn't make ADLT policy decisions. This gives us the broad and unorganized quarterly coding system for PLA codes we have today. By mid 2025, there are 600 PLA codes.
PLA CODES MEET WHOLE SLIDE IMAGING
One of the first whole slide imaging WSI codes was 0108U, TissueCypher, Cernostics. Later another WSI PLA code, 0261U (HalioScore, acquired by Veracyte) was crosswalked to 0108U.
Then, 0108U was acquired by Castle and became an ADLT, which also doubled the price of 0261U (due to the just-mentioned pricing crosswalk). But later, CMS restored the price of 0261U back downward to its original crosswalk price. Whew.
WSI CODES (BEFORE THEY STOPPED)
Existing slide-based PLA codes include 0108U, 0220U, 0261U, 0295U, 0376U, 0414U, 0418U, 0512U, 0513U. 513U was created a year ago, July 1, 2024, and effective since October 1, 2024. All the codes 376U-513U are $706 at CMS.
Note that CMS classified the WSI codes as CLFS tests and priced them by CLFS methods.
The last WSI code, I think, was July 2024.
Several WSI since then have been applied for, but all "died" in the PLA committee and no WSI codes have been created this year.
WHAT'S UP IN 2025
AMA is planning to create a new category of "dry lab" codes for algorithms. In this proposal, one new CPT section will hold cardiology, radiology, or pathology codes of this type. Indeed, this topic is Agenda Tab 94 at the September 18-20 AMA CPT meeting in Chicago.
TALK BY ZACH HOCHSTETLER
At the NextGenDx conference in DC on August 18, 2025,, Zach Hochstetler of AMA CPT discussed what is going on. You did not need to sign any AMA confidentiality agreement to hear his talk.
A DEEPER EDUCATION IN WHAT'S GOING ON
APPENDIX S
A number of years ago, AMA CPT created a digital medicine coding committee.
I think its output value has been variable. It created Appendix S of the CPT book, which is a one page guide to digital coding plans. Appendix S defines digital services as ASSISTIVE (detects or flags certain cases only). AUGMENTED provides data that contributes to diagnosis or action but requires physician interpretation. For example HEARTFLOW is radiology software that performs very sophisticated math but requires a human to finalize. AUTONOMOUS - provides a final result that does not require physician interpretation. AMA example is a retinal scan that outputs a retinal diagnosis. I think most MAAA tests would be here ("Based on 21 RNA, your Genomic Health score is 15.")
AMA CONCERNS (in my view)
- AMA wants to stay up to date and relevant in an AI world. AMA needs to innovate the coding system for new services.
- AMA wants to avoid having too much flood into the CPT as "physician services" because they deflates/devalues the RVU system by adding RVUs. A code word here "sustainability" = avoid making new RVU-based services that will deflate the RVU system and make it unsustainable.
WHAT's UP FOR SEPTEMBER (TAB 94)
The Digital Medicine Payment Advisory Committee DMPAG proposes an entirely new section of the CPT. It will hold algorithmic codes of all types, such as cardiology, radiology, and lab medicine. They will be proprietary like PLA. They will have minimal review like AMA.
Amer Coll Radiol writes,
The Panel’s Digital Medicine Coding Committee (DMPAG) is considering a foundational coding solution to develop a framework for a new category of CPT codes under the Clinically Meaningful Algorithmic Analyses pathway [CMAA].
The new CPT category would codify algorithmic analyses of clinically relevant patient data (e.g., biophysical signals, imaging data, lab results) to produce clinically meaningful output or conclusions that impact patient care.
Services in CMAA must be FDA authorized.
ISSUES FOR LAB INDUSTRY
- Are we happy with PLA as it is? Or not?
- If AI Digital Pathology tests are CLIA LDT tests, why put some in PLA and some in CMAA?
- Will payers view proposed CMAA as a payable category at all?
- How do AMA policy leaders view AI codes coming into the RVU system?
- How should the lab industry respond to the AMA's proposed requirement to put AI or digital pathology lab codes in CMAA category (where they must be FDA approved) and simultaneously disallow them in the PLA category (where they were placed in the past)..
- Does the lab industry want digital pathology codes placed in the new CMAA category- along with radiology and cardiology tests? Or does the lab industry want to avoid that, because the lab industry has unique issues (such as CLIA rather than FDA authorization).
STAKEHOLDERS
Both special companies (e.g. Artera AI) and large labs (e.g. TEMPUS) are working on digital pathology.
Association stakeholders might include (e.g.) ACLA, Adavmed, even PHRMA (for companion diagnostics access).
SEPTEMBER
One can go to the AMA CPT website, download the agenda for September 2025, and get a copy of the two documents filed as Tab 94.
NERD NOTE
The CMAA says the tests may be either "Augmentive" or "Autonymous." However, AMA also says that CMAA tests do not require physician interpretation, while Augmentive category does require physician interpretation (see Appendix S and Tab 94)..
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See a review of 174 radiology software products.
See a review of 1247 FDA Ai medical devices.
Accoding to NY Times, new CMS plans will reduce the AMA's input to RVU levels.##
Blog discusses the rising and falling price of code 0261U.
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