Pathology/Lab Coding Alert

Find 30 new ‘U’ codes in CPT^® 2022

You won’t find the 30 new, fourth quarter (Q4) Proprietary Laboratory Analyses (PLA) codes in the CPT^® manual until 2022, even though they’re effective Oct. 1.

Don’t wait to get your manual. Read on for a heads up about the new codes.

Warning: Remember that you can’t use a Category I or other CPT^® code for a test if a specific PLA code is available. Each PLA code describes a unique lab test from a specific manufacturer or performed by a specific lab. If you use the specific test kit, you need to know and report the unique PLA code.

Find New Oncology Options

Gene expression profiling is a way to determine which genes are “activated,” meaning that the DNA is transcribing to complementary mRNA, which then translates to the corresponding protein.

Instead of tests that simply evaluate DNA mutations, targeting mRNA has led to a “breakthrough in genetic testing for various cancers,” says Kelly Loya, CPC-I, CHC, CPhT, CRMA, associate partner at Pinnacle Enterprise Risk Consulting Services LLC in Charlotte, North Carolina.

For instance: The new PLA code for OncoSignal 7 Pathway Signal from Protean BioDiagnostics and Philips Electronics is 0262U (Oncology (solid tumor), gene expression profiling by real-time RT-PCR of 7 gene pathways (ER, AR, PI3K, MAPK, HH, TGFB, Notch), formalin-fixed paraffin-embedded (FFPE), algorithm reported as gene pathway activity score). The test measures mRNA expression patterns that indicate activity of seven signaling pathways that can drive tumor growth, including estrogen receptor (ER), androgen receptor (AR), Phosphoinositide 3-Kinase (PI3K), mitogen activated protean kinase (MAPK), Hedgehog pathway (HH), transforming growth factor receptor beta (TGFbeta), and notch signal pathways (NOTCH). The test’s findings — a gene-pathway activity score — may aid clinicians in selecting specific targeted therapies for many solid tumors, such as breast, prostate, ovarian, or colon cancer.

Similarly: CPT^® 2022 also introduces a new Catego-ry I code 81523 (Oncology (breast), mRNA, next-generation sequencing gene expression profiling of 70 content genes and 31 housekeeping genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk to distant metastasis). Based on mRNA expression patterns of 70 genes in breast tumor tissue, a “score” for the likelihood of distant metastasis provides clinicians with actionable information to match patients to optimum treatment options.

Colorectal cancer: Immunoscore® from HalioDx describes another new PLA code, which uses a different methodology for colon cancer evaluation: 0261U (Oncology (colorectal cancer), image analysis with artificial intelligence assessment of 4 histologic and immunohistochemical features (CD3 and CD8 within tumor-stroma border and tumor core), tissue, reported as immune response and recurrence-risk score).

“This test uses digital analysis of microscopic slide images of formalin-fixed paraffin-embedded (FFPE) colon cancer tissue,” says R.M. Stainton Jr., MD, president of Doctors’ Anatomic Pathology Services in Jonesboro, Ark. The test targets the digital images to determine levels of CD3 and CD8, which are T-cell co-receptors, to measure host immune response at the tumor border and core. Compared to typical diagnostic tools to define tumor cell characteristics (histopathology) and to assess relevant genetic mutations, this test uniquely evaluates the body’s immune response to the tumor, indicating a high or low risk of relapse, and can guide clinical treatment choices.

Consider ‘Constitutional Disorder’ Codes

Several new PLA codes describe tests to help identify the genetic basis of constitutional/heritable disorders based on a wide range of analysis methods.

For instance, 0260U and 0264U descriptors are identical: Rare constitutional and other heritable disorders, whole genome and mitochondrial DNA sequence analysis, blood, frozen and formalin-fixed paraffin-embedded (FFPE) tissue, saliva, buccal swabs or cell lines, identification of single nucleotide and copy number variants. Code 0267U definition is the same, except the descriptor adds, “and whole genome sequencing.”

Code 0260U describes Augusta Optical Genome Mapping from Georgia Esoteric and Molecular (GEM) Laboratory, LLC, while 0264U describes Praxis Optical Genome Mapping from Praxis Genomics, LLC, and 0267U describes Praxis Combined Whole Genome Sequencing and Optical Genome Mapping from the same lab.

When a clinician suspects a constitutional condition, such as a neurodevelopmental genetic disorder like autism in a pediatric patient, these new tests may help streamline testing to reach a diagnosis.

Current testing protocols may begin with a test for Fragile X, followed by comparative genomic hybridization (CGH) and possibly karyotyping to identify any structural variants that may indicate a specific condition. These three new PLA tests use optical genome mapping (OGM) performed with Bionano Genomics, Inc.’s Saphyr System to provide similar structural-variant data by evaluating the patient’s chromosomes for large scale changes in DNA such as copy number variations, inversions, insertions, deletions, and translocations.

“We have been impressed by the ability of OGM to identify all structural variant types, which could be associated with a genetic disorder,” commented Ravindra Kolhe, MD, PhD, FCAP in a press release for GEM Laboratory.

Other methods: Q4 PLA codes also include the following tests for constitutional/heritable disorders using lab methods other than OGM:

• 0265U (Rare constitutional and other heritable disorders, whole genome and mitochondrial DNA sequence analysis, blood, frozen and formalin-fixed paraffin-embedded (FFPE) tissue, saliva, buccal swabs or cell lines, identification of single nucleotide and copy number variants)
• 0266U (Unexplained constitutional or other heritable disorders or syndromes, tissue-specific gene expression by whole-transcriptome and next-generation sequencing, blood, formalin-fixed paraffin-embedded (FFPE) tissue or fresh frozen tissue, reported as presence or absence of splicing or expression changes)

Look for Hematology Assessments

Among the 30 new Q4 PLA codes, 17 describe hematology tests from Versiti™ Diagnostic Laboratories. Many of these proprietary tests involve genomic sequence analysis for genes associated with the following conditions:

• Atypical hemolytic uremic syndrome (aHUS): 0268U
• Congenital coagulation disorders: 0270U
• Congenital neutropenia: 0271U
• Genetic bleeding disorders: 0272U
• Genetic hyperfibrinolysis, delayed bleeding: 0273U
• Genetic platelet disorders: 0274U, 0277U
• Genetic thrombosis: 0278U
• Red blood cell antigen genotyping: 0282U
• Thrombocytopenia: 0269U, 0275U, 0276U. Code 0275U for heparin-induced thrombocytopenia uses flow cytometry to evaluate platelet antibody reactivity
• Von Willebrand disease (VWD): 0279U, 0280U, 0281U, 0283U, 0284U. These tests involve immunoassay tests for VWF binding evaluations.