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2016 CPT Code Changes


2016 Newly Added Lab Codes List

80081 Obstetric panel (includes HIV testing)

This new code is identical to the 80055 code (Obstetric panel) except the HIV testing was added. In order to bill this code all components of the panel must be performed. The added service for this new panel includes HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result (87389).

MOLECULAR PATHOLOGY TIER 1 MOLECULAR PATHOLOGY PROCEDURES

The following are the new codes for 2016 for gene-specific and genomic procedures. Molecular pathology codes include all analytical services performed in the test. This includes cell lysis, nucleic acid stabilization, extraction, digestion, amplification, and detection. Any procedures required prior to cell lysis such as microdissection (88380, 88381) are reported separately. AMA instructs coders to use 87149-87153, 87470-87801, and 87900-87904 for any molecular testing done for microbial identification. This means molecular testing for infectious agents, such as HPV are NOT reported in the molecular pathology section of the code book. You should look to the Microbiology section for those codes.

For in situ hybridization, use the 88271-88275 (when interpreted by scientist instead of pathologist) and 88365-88368 when interpreted by a pathologist.

81170 ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain

81162 BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis. Do not report 81162 in conjunction with 81211, 81213, 81214, 81216)

81218 CEBPA (CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), gene analysis, full gene sequence

81219 CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9

81272 KIT (v-kit Hardy-Zukerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18)

81273 KIT (v-kit Hardy-Zukerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis, D816 variants(s)

81276 KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma gene analysis; additional variants(s) (eg, codon 61, codon 146)

81311 NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) (eg, colorectal carcinoma), gene analysis, variants in exon 2 (eg, codons 12 and 13) and exon 3 (eg, codon 61)

81314 PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (eg, gastrointestinal stromal tumor [GIST]), gene analysis, targeted sequence analysis (eg, exons 12, 18)

GENOMIC SEQUENCING PROCEDURES AND OTHER MOLECULAR MULTIANALYTE ASSAYS

This new section of genomic sequencing procedures (GSPs) are DNA or RNA sequence analysis methods that simultaneously assay multiple genes or genetic regions relevant 

to a clinical situation. Most commonly referred to a “Next Gen Sequencing” (NGS) or “Massively Parallel Sequencing” (MPS) in the laboratory, are tests intended to 

evaluate the genetic material in totality or near totality.

The codes in this section should be used when the components of the descriptor(s) are met regardless of the technique used, unless specifically noted in the code descriptor. 

If all the components are NOT performed, then you must assign code(s) in the Tier 1 or Tier 2 section or if they aren’t listed in the Tier codes, use the unlisted code 

81479. AMA provides two parenthetical statements after this introduction section:

• For cytogenomic microarray analyses, see 81228, 81229, 81405, 81406.
• For long QT syndrome gene analyses, see 81280, 81282 

81412 Ashkenazi Jewish associated disorders (eg, Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at least 9 genes, including ASPA, BLM, CFTR, FANCC, GA, HEXA, IKBKAP, MCOLN1, and SMPD1

81432 Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 14 genes, include ATM, BRCA1, BRIP1, CHD1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53

81433 Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81434 Hereditary retinal disorders (eg, retinitis pigmentosa, Leber congenital amaurosis, cone-rod dystrophy), genomic sequence analysis panel, must include sequencing of at least 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31, PRPH2, RDH12, RHO, RP1, RP2, RPE65, RPGR, and USH2A

81437 Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma; genomic sequence analysis panel, must include sequencing of at least 6 genes, including MAX, SDHB, SDHC, SDHD, TMEM127, and VHL

81438 Hereditary neuroendocrine tumor disorders (eg, medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma; duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and VHL

81442 Noonan spectrum disorders (eg, Noonan syndrome, cardio-facio-cutaneous syndrome, Costello syndrome, LEOPARD syndrome, Noonan-like syndrome), genomic sequence
analysis panel, must include sequencing of at least 12 genes, including BRAF, CBL, HRAS, KRAS, MAP2K1, MAP2K2, NRAS, PTPN11, RAF1, RIT1, SHOC2, and SOS1

The CPT codes listed above in this section are panels associated with various disorders where the testing is performed by genomic sequence analysis. In each of the CPT panel codes the code descriptors define specifically what genes must be tested in that panel as well as the minimum number of genes that must be tested in order to assign that given CPT code.

MULTIANALYTE ASSAYS WITH ALGORITHMIC ANALYSES

Multianalyte Assays with Algorithmic Analyses (MAAAs) are procedures that utilize multiple results derived from assays of various types, including molecular pathology assays, fluorescent in situ hybridization assays and nonnucleic acid based assays (eg, proteins, polypeptides, lipids, carbohydrates). Algorithmic analysis using the results of these assays as well as other patient information, if used, is then performed and reported typically as a numeric score(s) or as a probability.

MAAAs are typically unique to a single clinical laboratory or manufacturer. The results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated laboratory report; however, these assays are not reported separately using additional codes. For more information on these codes, please see the MAAA section of the 2016 CPT code book and Appendix O in your 2016 Code book

81490 Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays, utilizing serum, prognostic algorithm reported as a disease activity score. Do not report 81490 in conjunction with 86140

81493 Coronary artery disease, mRNA, gene expression profiling by real-time RT-PCR of 23 genes, utilizing whole peripheral blood, algorithm reported as a risk score

81525 Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence score

81528 Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result. Do not report 81528 in conjunction with 81275, 82274

81535 Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; first single drug or drug combination

+81536 Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (List separately in addition to code for primary procedure) Do not report 81536 in conjunction with 81535

81538 Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival

81540 Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81545 Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)

81595 Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subfraction of peripheral blood, algorithm reported as a rejection risk score

0009M Fetal aneuploidy (trisomy 21, and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

0010M Oncology (High-Grade Prostate Cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA and human kallikrein 2 [hK2]) plus patient age, digital rectal examination status, and no history of positive prostate biopsy, utilizing plasma, prognostic algorithm reported as a probability score

SURGICAL PATHOLOGY

Immunofluorescence Stains

AMA has added one code for 2016, an add-on code for immunofluorescence stains. This code represents any additional stains that are performed above the initial first stain which is assigned CPT 88346. The “unit of service” is defined as each additional “single antibody stain procedure” from that designated specimen. It is not solely each additional stain performed, it has to be a separate stain procedure for that given stain, hence the descriptor “single antibody stain procedure.”

Also please note in the parenthetical that the AMA specifically states to not report 88346 and 88350 when the stain performed is a multiplex immunofluorescence stain(s)… it directs to the coder to assign the miscellaneous code 88399.

NOTE that 88350 has a + sign denoting an add-on code and can only be billed when 88346 is also billed. 

+88350 Immunofluoroscence, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure) Report 88350 in conjunction with 88346. Do not report 88346 and 88350 for fluorescent in situ hybridization studies, see 88364, 88365, 88366, 88367, 88368, 88369, 88373, 88374, and 

88377. Do not report 88346 and 88350 for multiplex immunofluorescence analysis, use 88399

CMS newly added codes

G0475 Hiv antigen/antibody, combination assay, screening

G0476 Infectious agent detection by nucleic acid (dna or rna); human papillomavirus (hpv), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) for cervical cancer screening, must be performed in addition to pap test.


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