Pathology/Lab Coding Alert

Consider new ART-related codes, too.

Get ready for a third quarter CPT^® update with seven new Proprietary Laboratory Analyses (PLA) codes and an update to section guidelines effective July 1.

We’re here to help you learn the new codes and make sure you know how to place these services in the lab-test coding universe.

Call on New Codes for Cancer, Reproductive Medicine Testing

Three new PLA codes describe tests to provide personalized medicine treatment guidance for cancer patients, as follows:

• 0248U (Oncology (brain), spheroid cell culture in a 3D microenvironment, 12 drug panel, tumor-response prediction for each drug) for 3D Predict Glioma from KIYATEC^®, Inc.
• 0249U (Oncology (breast), semiquantitative analysis of 32 phosphoproteins and protein analytes, includes laser capture microdissection, with algorithmic analysis and interpretative report) for Theralink^® Reverse Phase Protein Array (RPPA) assay by Theralink^® Technologies, Inc.
• 0250U (Oncology (solid organ neoplasm), targeted genomic sequence DNA analysis of 505 genes, interrogation for somatic alterations (SNVs [single nucleotide variant], small insertions and deletions, one amplification, and four translocations), microsatellite instability and tumor-mutation burden) for PGDx elioTM tissue complete from Personal Genome Diagnostics, Inc.

Code 0248U describes a test using live cells from a specimen such as a recurrent glioma biopsy to create a 3D cell culture technology platform for testing tumor response to potential cancer drug therapies. The test proved “valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas” in a case series, according to a 2020 Society of Neuro-Oncology presentation by Lindsay Lipinski, MD, assistant professor of oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center in Buffalo, NY. “Our results show that we are far along in the paradigm shift toward individualized medicine,” she said.

Following this success in recurrent cases, current studies seek to evaluate clinical utility of the test in newly-diagnosed glioblastoma cases, according to Matthew Gevaert, PhD, CEO of KIYATEC in a press release.

Personalized by protein: Code 0249U describes a test that measures phosphorylated protein activity in a solid tumor tissue specimen and uses bioinformatics to evaluate tumor-specific cell surface receptors for therapeutic drug targets, providing actionable information not available through current genomic testing. For instance, a current study of HER2+ breast cancer patients aims to achieve clinical validation for using diagnostic biopsy tissue to evaluate protein activation state as predictive for specific drug treatment, which “might mean a change in the standard of care for all women newly diagnosed with HER2+ breast cancer,” according to Mick Ruxin, M.D., president & CEO of Theralink Technologies in a press release.

Upgrade ART success: The following three new PLA codes from Igenomix^® USA can potentially help patients undergoing assisted reproduction treatment (ART) toward a successful pregnancy:

• 0252U (Fetal aneuploidy short tandem–repeat comparative analysis, fetal DNA from products of conception, reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy) for the POC (Products of Conception) test
• 0253U (Reproductive medicine (endometrial receptivity analysis), RNA gene expression profile, 238 genes by next-generation sequencing, endometrial tissue, predictive algorithm reported as endometrial window of implantation (eg, pre-receptive, receptive, post-receptive)) for the ERA^® (Endometrial Receptivity Analysis) test
• 0254U (Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using embryonic DNA genomic sequence analysis for aneuploidy, and a mitochondrial DNA score in euploid embryos, results reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy, per embryo tested) for the SMART PGT-A (Preimplantation Genetic Testing - Aneuploidy) test

Code 0254U describes a test that clinicians can use on biopsies from each embryo produced in an in vitro fertilization (IVF) cycle to identify the embryos most likely to engender a successful pregnancy based on the absence of chromosomal aneuploidy and an “embryonic energy” estimation based on mitochondrial DNA.

In addition to identifying the “best” embryos for implantation, code 0253U describes a test that evaluates RNA gene expression in endometrial tissue to predict the optimum “receptivity window” for embryo implantation. Clinicians may order this test to increase implantation success in IVF, particularly for patients who have had previous unsuccessful attempts.

Although 0252U describes a test to evaluate the fetus from a miscarriage to see if an aneuploidy was the cause, clinicians may order this following an unsuccessful IVF attempt to help guide future cycles.

Finally: The last of the new PLA codes is 0251U (Hepcidin-25, enzyme-linked immunosorbent assay (ELISA), serum or plasma) for Intrinsic Hepcidin IDxTM Test from Intrinsic LifeSciencesTM LLC, which uses a monoclonal antibody that binds to hepcidin in the serum or plasma specimen to evaluate hepcidin levels for clinical applications related to iron therapy.

Review and Update Guidelines

PLA codes appear at the end of the CPT^® Pathology and Laboratory section and are updated quarterly.

Basics: Remember that PLA codes take precedence over the usual 80000 series codes for laboratory/pathology. Use a PLA code only for its specific proprietary test, which is named in CPT^® Appendix O. Do not report the test using any other CPT^® code.

CPT^® 2021 updated the guidelines for PLA codes, adding instructions for “who” and “how” to maintain existing codes: “The accuracy of a PLA code is to be maintained by the original applicant, or the current owner of the test kit or laboratory performing the proprietary test.”

The instructions offer further guidance about when an existing code may need to be replaced, as follows:

• when additional DNA, RNA, or protein analys(es) added to the test
• when code name changed due to test performance or characteristic changes

However, the AMA will determine if a new code number is needed in those cases, according to the updated guidelines.