Pathology/Lab Coding Alert

April 1 is the first day of the second quarter when these codes go into effect.

Quarterly updates to Proprietary Laboratory Analyses (PLA) should keep you on your toes — remember that you can’t use a Category I or other CPT^® code for a test if a specific PLA code is available.

Look for two new codes for pan-cancer blood tests, plus cardiac risk assays and infectious agent testing options in the mix.

Check out this rundown of PLA code changes that go into effect on April 1 to make sure you avoid using method or other non-specific codes when a new, specific code is available.

Focus: 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 or bill for tests you send to a reference lab, you can avoid claims denials by reporting the unique PLA code.

Brush Up on Expanding Oncology Test Options

The American Medical Association (AMA) approved six new cancer diagnosis/prognosis PLA codes for use starting April 1.

Skin cancer: The following two new PLA codes describe tests for melanoma and squamous cell carcinoma to categorize tumors according to risk.

• 0314U (Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 35 genes (32 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical result (ie, benign, intermediate, malignant))
• 0315U (Oncology (cutaneous squamous cell carcinoma), mRNA gene expression profiling by RT-PCR of 40 genes (34 content and 6 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical risk result (ie, Class 1, Class 2A, Class 2B))

Pancreatic cancer: Imaging methods can identify pancreatic cysts, but a significant percentage of these are classified as “indeterminate.” To help clinicians avoid performing unnecessary biopsies or risk missing potential cancerous changes, a new PLA code offers a solution. If your lab sends out one of these tests to the University of Pittsburgh Medical Center, code the case as 0313U (Oncology (pancreas), DNA and mRNA next-generation sequencing analysis of 74 genes and analysis of CEA (CEACAM5) gene expression, pancreatic cyst fluid, algorithm reported as a categorical result (ie, negative, low probability of neoplasia or positive, high probability of neoplasia)).

Lung cancer: Similar to 0313U, new code 0317U (Oncology (lung cancer), four-probe FISH (3q29, 3p22.1, 10q22.3, 10cen) assay, whole blood, predictive algorithm-generated evaluation reported as decreased or increased risk for lung cancer) provides a noninvasive test to determine the likelihood of cancer for an indeterminant imaging test — for a lung nodule, in this case. Clinicians may use the test results to inform the decision to proceed to biopsy or follow a more conservative treatment route of noninvasive monitoring.

Pan-cancer: Two new pan-cancer codes from Invitae are 0306U and 0307U (Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis…). MRD is the low level of cancer cells remaining in the body following cancer treatment.

Code 0306U (… initial (baseline) assessment to determine a patient specific panel for future comparisons to evaluate for MRD) involves creating a genetic tumor profile based on a formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen. Subsequent testing on a blood sample uses 0307U (… patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD).

Taken together, the two codes provide a system to evaluate circulating tumor DNA (ctDNA) fragments from cancer cells, first following treatment to establish an initial MRD as a measure of treatment effectiveness, and subsequently to monitor cancer recurrence.

The tests may help patients “be spared from unnecessary and potentially harmful adjuvant therapy, while those at risk of relapse can be diagnosed earlier and treated with the necessary therapies,” said Robert Nussbaum, MD, chief medical officer of Invitae in a release.

Focus Coding for Unique Cardiac Testing

Three new PLA blood tests focus on facilitating earlier diagnosis and intervention for specific cardiac conditions.

The HART CADhs^® kit described by 0308U (Cardiology (coronary artery disease [CAD]), analysis of 3 proteins (high sensitivity [hs] troponin, adiponectin, and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as a risk score for obstructive CAD) determines whether a patient has low, moderate, or high risk of developing coronary artery stenosis (narrowing) or obstruction.

To further drill down to the risk of a cardiovascular incident such as heart attack or stroke within a year, clinicians may turn to new code 0309U (Cardiology (cardiovascular disease), analysis of 4 proteins (NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 [TIMP-1], and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as a risk score for major adverse cardiac event).

Pediatrics: Because Kawasaki disease (KD) may cause damage to coronary arteries in pediatric patients, another new test can aid clinicians in early diagnosis of the condition: 0310U (Pediatrics (vasculitis, Kawasaki disease [KD]), analysis of 3 biomarkers (NTproBNP, C-reactive protein, and T-uptake), plasma, algorithm reported as a risk score for KD).

Taken together these three tests “have important roles in safely, cost-effectively, and accurately diagnosing obstructive heart disease and Kawasaki disease as well as improving cardiac risk identification,” according to Rhonda F. Rhyne, president and chief executive officer of Prevencio Inc. in a release.

Update Coding for Specific Immunology PLA Tests

If your lab is tapping into the rapid antimicrobial susceptibility testing (AST) by Accelerate Diagnostics Inc., you should understand the new and existing PLA codes for the system. Code 0311U (Infectious disease (bacterial), quantitative antimicrobial susceptibility reported as phenotypic minimum inhibitory concentration (MIC)–based antimicrobial susceptibility for each organisms identified) describes a new configuration for labs that already have a rapid infectious agent identification system. The new test will help labs that “need fast susceptibilities to support getting patients on the right therapy as soon as possible,” said Jack Phillips, chief executive officer of Accelerate Diagnostics in a release.

Contrast: An existing PLA code describes the combined rapid infectious agent identification and AST test: 0086U (Infectious disease (bacterial and fungal), organism identification, blood culture, using rRNA FISH, 6 or more organism targets, reported as positive or negative with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibility). Don’t report the two codes together.

Pathogens: The following two new immunology PLA codes describe tests to identify specific infectious agents in urine:

• 0316U (Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine)
• 0321U (Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms and identification of 16 associated antibiotic-resistance genes, multiplex amplified probe technique)

Autoimmune: Another new immunology PLA code describes a test to help with differential diagnosis of lupus: 0312U (Autoimmune diseases (eg, systemic lupus erythematosus [SLE]), analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry and indirect immunofluorescence, serum, or plasma and whole blood, individual components reported along with an algorithmic SLE-likelihood assessment).

Labs Shed Light on Developmental Delays

Two new PLA codes describe tests that may help clinicians diagnose epigenetic conditions characterized by developmental delays or other specific physical or behavioral markers.

To help with autism diagnosis and classification, you now have 0322U (Neurology (autism spectrum disorder [ASD]), quantitative measurements of 14 acyl carnitines and microbiome-derived metabolites, liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma, results reported as negative or positive for risk of metabolic subtypes associated with ASD).

For a broader screening that can identify markers for myriad congenital developmental disabilities such as Prader-Willi syndrome or Fragile X syndrome, see 0318U (Pediatrics (congenital epigenetic disorders), whole genome methylation analysis by microarray for 50 or more genes, blood). The test analyzes patterns of methyl group attachment to cytosine bases at specific points in DNA. Methyl groups may impact how a gene is expressed, such as “turning off” the gene, leading to a specific condition. Conditions linked to gene expression rather than genetic mutations are called epigenetic. The test can detect methylation changes that are “epigenetic signatures” of over 50 specific conditions characterized by developmental delays and other specific traits.