Tuesday, July 28, 2026

AMA Releases Cat III Codes; CMS Prices New Digital Pathology Cat III Codes

 A lot of action on the digital pathology front.

#1
AMA RELEASES Dig Path CODES

After the equivalent of a moratorium on new digital pathology codes, AMA began adding some to the Category III code set at February 2026 and May 2026 CPT meetings.   Those codes, while not active until January 2027, were published by AMA CPT on July 10.

Find the AMA home page for Cat III here.  Jump straight to the 17-page PDF of new codes here.

Let's focus on five new digital pathology codes created since the moratorium thawed:

1063T

Oncology (bladder), augmentative algorithmic analysis of histomorphologic features in digitized slides from formalin-fixed paraffin-embedded (FFPE) bladder cancer tissue (high-grade, non-muscle invasive), with clinicopathologic variables entered by the qualified health care professional; algorithm-derived parameters reported as prognostic of recurrence and progression, including hematoxylin and eosin staining of tissue sections, and digitization of glass microscope slides, when performed.

1064T

[Oncology (bladder)...same text...]....algorithm-derived parameters reported as predictive of response to Bacillus Calmette-Guérin (BCG) therapy, including hematoxylin and eosin staining of tissue sections, and digitization of glass microscope slides, when performed.

1097T

Oncology (pancreas), augmentative algorithmic analysis of histomorphologic features in digitized slides from formalin-fixed paraffin-embedded pancreatic cancer tissue, algorithm-derived parameters reported as prediction of response to fluorouracil backbone versus gemcitabine backbone chemotherapy, including hematoxylin and eosin staining of tissue sections and digitization of glass microscope slides, when performed

1106T

Oncology (breast), augmentative algorithmic analysis of histomorphologic features in digitized hematoxylin and eosin stained slides from formalin-fixed paraffinembedded (FFPE) breast cancer tissue, algorithm-derived parameters reported as 5-year and 10-year risks of distant metastasis, including digitization of glass microscope slides and hematoxylin and eosin staining of tissue sections, when performed.

1107T

Oncology (prostate), augmentative algorithmic analysis of histomorphologic features in digitized hematoxylin and eosin stained slide(s) from formalin-fixed paraffin-embedded (FFPE) prostate cancer tissue, algorithm-derived parameters reported as 10-year risk of distant metastasis and prostate cancer specific mortality, including hematoxylin and eosin staining of tissue sections, and digitization of glass microscope slides, when performed.


All codes share this closing parenthetical of exclusions, whether for breast, bladder, pancreas:

  • (Do not report 1106T in conjunction with 88305, 88307, 88309, 88363 for hematoxylin and eosin staining, when performed [i.e. when such slide is made] solely for augmentative algorithmic analysis of histomorphologic features of [xxx] cancer tissue)
  • I think if you make a new H&E slide, don't bill it separately.


#2
Medicare Proposes Prices

As I discussed several weeks ago, CMS released proposals to pull digital pathology or digital genomics codes off the Clin Lab Fee Schedule, and in the outpatient setting, pay them by APC category, and in the Part B setting, pay them by "contractor pricing."

It's not rare that Part B prices are left to "contractor pricing," but  in the hospital outpatient setting, CMS establishes prices for all new Cat I and Cat III codes.   In the case of the four codes above, CMS included them in OPPS Appendix B, effective January 2027.  CMS did not comment on them specifically in the body of the rule; they only appear as new codes and a new price in the Excel tables (Appendix A, B).   However, one can comment on them just like any other part of the OPPS rulemaking.

Find proposed 2027 APC-OPPS prices here:

Digital Pathology Proposed APC Prices:



#3
Valar Comments on Prices


Three of the five new Dig Path codes are commented on by Valar Labs, a leading computational pathology laboratory.  These are commented under the temporary names used by CMS as well as the permenent names Valar had access to.

Find the 8pp Valar comment on OPPS Proposed (P) Rule 1850-P:




X568T = 1063T = Vesta "Bladder Risk Stratify" Test
X569T = 1064T = Vesta "Bladder BCGPredict" Test
X614T = 1097T = Vitara "Pancreas ChemoPredict" Test

Here are the APC prices proposed by CMS:

X568T = 1063T = Vesta "Bladder Risk Stratify" Test = APC 1542 = $350.50
X569T = 1064T = Vesta "Bladder BCGPredict" Test = APC 1542 = $350.50

X614T = 1097T = Vitara "Pancreas ChemoPredict" Test = APC 1509 = $750.50

While CMS makes no public comment on why it priced as it did, CMS may have expected 1063T and 1064T to be ordered together and proposed to have them add up to $750.50.

##
Valar provides CMS with a very detailed, 8-page comment letter, and includes a number of extensive tables of its own, including (for example) OPPS pricing of 0376U, Artera AI Prostate ($750) and 0512U, Tempus p-MSI  ($750).   

This reminds us that there were quite a number of digital pathology codes on the books (and as "U" codes or PLA codes, not "T" codes or Category III codes) ...prior to 2026.
 
Partial view of the useful tables provided byValar:



Chat GPT did a great summary of Valar's letter, and added some insights.  Many readers will enjoy this, but I'll leave it as a sidebar.

Footnote

While the "U" PLA codes are proprietary, the equally detailed new "T" codes are not proprietary.  for example, only Tempus can submit code 0512U for its algorithmic MSI test, but any company with a prostate test fitting the text of 1107T can use 1107T.