Brief Your Billing & Coding Staff on New Medicare HCPCS & CLIA Code Changes
To avoid claims denials and improper billings, ensure billing and coding staff is aware of, and has adjusted to, all recent coding changes.
Several significant coding changes in the Healthcare Common Procedure Coding System (HCPCS) and Clinical Laboratory Improvement Amendments (CLIA) that may affect your Medicare reimbursements have taken effect since the start of 2022. To avoid claims denials and improper billings, lab compliance officers and managers need to ensure billing and coding staff is aware of, and has adjusted to, all recent coding changes. These changes are summarized in the Centers for Medicare & Medicaid Services (CMS) transmittal, “HCPCS Codes & Clinical Laboratory Improvement Amendments Edits: April 2023, MLN Matters Number: MM13024.”1 Here’s a quick briefing of all the essential changes that you can share with your billing staff:
What’s At Stake
Under CLIA regulations, labs must be appropriately certified for each test they perform. CMS edits each claim for a test that’s considered a CLIA laboratory test for a HCPCS code at the lab’s CLIA certificate level to ensure that Medicare pays only for lab tests that are performed in appropriately certified facilities. If the HCPCS code is for a test that’s not appropriate for the lab of that CLIA certification level to perform, the edit will reject the claim.
Discontinued HCPCS Codes
The new CMS MM13024 transmittal lists HCPCS codes that have recently been discontinued and should no longer be used.
Discontinued HCPCS Codes
| HCPCS Code | Date of Discontinuance | Test |
| 0097U | March 31, 2022 | Test for detection of gastrointestinal disease-causing organism using amplified probe |
| 0151U | March 31, 2022 | Test for detection of respiratory disease-causing organisms in sputum or respiratory tract specimen, 33 target organismal and antibiotic resistance |
| 0012U | September 30, 2022 | Gene analysis for germline disorder |
| 0013U | September 30, 2022 | Gene analysis of solid organ tumor tissue |
| 0014U | September 30, 2022 | DNA test for detecting gene abnormality associated with blood and lymphatic system cancer in blood or bone marrow |
| 0056U | September 30, 2022 | Whole genome sequencing in blood or bone marrow for acute myelogenous leukemia |
New HCPCS Codes
MM13024 also lists new HCPCS codes that are subject to CLIA edits. According to CMS, for these HCPCS code tests to be payable by Medicare, the lab must have one of the following:
- CLIA certificate of registration (certificate type code 9)
- CLIA certificate of compliance (certificate type code 1)
- CLIA certificate of accreditation (certificate type code 3)
New HCPCS Codes Subject to CLIA Edits
| HCPCS Code | Date of Addition | Test |
| 87913 | February 21, 2022 | Genotype analysis of severe acute respiratory syndrome coronavirus 2 (COVID-19) by nucleic acid (DNA or RNA) for identification of mutations in targeted regions |
| 0306U | April 1, 2022 | Initial baseline gene analysis for minimal residual disease in cancer, next-generation targeted sequencing analysis of cell-free DNA, to determine patient-specific panel for future comparisons |
| 0307U | April 1, 2022 | Subsequent gene analysis for minimal residual disease in cancer, next-generation targeted sequencing analysis of cell-free DNA, to determine patient-specific panel for future comparisons |
| 0308U | April 1, 2022 | Analysis of three proteins (high sensitivity [hs] troponin, adiponectin, and kidney injury molecule-1 [KIM-1]) in plasma specimen, algorithm reported as risk score for obstructive coronary artery disease |
| 0309U | April 1, 2022 | Analysis of four proteins (NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 [TIMP-1], and kidney injury molecule-1 [KIM-1]) in plasma specimen, algorithm reported as risk score for major adverse heart event |
| 0310U | April 1, 2022 | Analysis of three biomarkers (NT-proBNP, C-reactive protein, and T-uptake) for Kawasaki disease (KD) in plasma specimen, algorithm reported as risk score for KD |
| 0311U | April 1, 2022 | Measurement of bacterial susceptibility to antibiotics, reported as phenotypic minimum inhibitory concentration (MIC) for each organism identified |
| 0312U | April 1, 2022 | Analysis of eight IgG autoantibodies and two cell-bound complement activation products associated with autoimmune disease, using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry, and indirect immunofluorescence in serum specimen or plasma and whole blood specimen, individual components reported along with algorithmic systemic lupus erythematosus-likelihood assessment |
| 0313U | April 1, 2022 | DNA and mRNA next-generation sequencing (NGS) analysis of 74 genes and analysis of CEA (CEACAM5) gene expression in pancreatic cyst fluid specimen, algorithm reported as negative, low probability of cancer of pancreas, or positive with high probability of cancer of pancreas |
| 0314U | April 1, 2022 | mRNA gene expression profiling by real-time polymerase chain reaction (RT-PCR) of 35 genes (32 content and 3 housekeeping) associated with melanoma of skin in formalin-fixed paraffin-embedded (FFPE) tissue specimen, algorithm reported as benign, intermediate, or malignant |
| 0315U | April 1, 2022 | mRNA gene expression profiling by real-time polymerase chain reaction (RT-PCR) of 40 genes (34 content and 6 housekeeping) associated with squamous cell carcinoma of skin in formalin-fixed paraffin-embedded (FFPE) tissue specimen, algorithm reported as benign, intermediate, or malignant |
| 0316U | April 1, 2022 | Evaluation of outer surface protein A (OspA) of Borrelia burgdorferi (Lyme disease) in urine specimen |
| 0317U | April 1, 2022 | Four-probe fluorescence in situ hybridization (FISH) (3q29, 3p22.1, 10q22.3,10cen) assay of whole blood specimen, predictive algorithm-generated evaluation reported as decreased or increased risk for lung cancer |
| 0318U | April 1, 2022 | Whole genome methylation analysis by microarray for 50 or more genes associated with congenital epigenetic disorders in blood specimen |
| 0319U | April 1, 2022 | RNA gene expression profiling by select transcriptome sequencing in peripheral blood specimen taken before kidney transplant, algorithm reported as risk score for early acute rejection |
| 0320U | April 1, 2022 | RNA gene expression profiling by select transcriptome sequencing in peripheral blood specimen taken after kidney transplant, algorithm reported as risk score for acute cellular rejection |
| 0321U | April 1, 2022 | Detection test by nucleic acid (DNA or RNA) multiplex amplified probe technique for identification of 20 bacterial and fungal organisms associated with genital or urinary tract infection and identification of 16 associated antibiotic-resistance genes |
| 0322U | April 1, 2022 | Measurement of 14 acyl carnitines and microbiome-derived metabolites associated with autism spectrum disorders by liquid chromatography with tandem mass spectrometry (LC-MS/MS) in plasma specimen, results reported as negative or positive for risk of metabolic subtypes associated with autism spectrum disorders |
| 0323U | July 1, 2022 | DNA and mRNA next-generation sequencing (NGS) analysis in cerebrospinal fluid specimen for detection of organisms causing disease in central nervous system |
| 0324U | July 1, 2022 | Culture of spheroid ovarian cancer cells for evaluation of four drugs (carboplatin, doxorubicin, gemcitabine, paclitaxel), result reported as tumor chemotherapy response prediction for each drug |
| 0325U | July 1, 2022 | Culture of spheroid ovarian cancer cells for evaluation of poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib, olaparib, rucaparib, velparib), result reported as tumor chemotherapy response prediction for each drug |
| 0326U | July 1, 2022 | Targeted genomic sequence analysis of 83 or more genes in cell-free circulating DNA for detection of abnormalities associated with solid organ cancers |
| 0327U | July 1, 2022 | DNA sequence analysis of selected regions for detection of abnormal fetal chromosome number (trisomy 13, 18, and 21) in maternal plasma specimen, algorithm reported as risk score for each trisomy, includes sex reporting, if performed |
| 0328U | July 1, 2022 | Definitive drug testing for 120 or more drugs and metabolites in urine specimen |
| 0329U | July 1, 2022 | Exome and transcriptome sequence analysis of DNA and RNA from tumor with DNA from normal blood or saliva for subtraction, report of clinically significant mutations with therapy associations |
| 0330U | July 1, 2022 | Amplified nucleic acid probe for identification of 27 vaginal disease agents in vaginal swab specimen |
| 0331U | July 1, 2022 | Optical genome mapping of DNA from blood or bone marrow specimen, report of clinically significant alterations associated with blood or lymph system cancers |
| 87593 | July 26, 2022 | Infectious agent detection by nucleic acid (DNA or RNA) of orthopoxvirus (e.g., monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each |
| 0332U | October 1, 2022 | Genetic profiling of eight epigenetic markers to evaluate probability of responding to immune checkpoint-inhibitor therapy for cancer |
| 0333U | October 1, 2022 | Surveillance for liver cancer in high-risk patients using algorithm |
| 0334U | October 1, 2022 | Targeted genomic sequence analysis of 84 or more genes for detection of abnormalities associated with cancer of body organ |
| 0335U | October 1, 2022 | Whole genome sequence analysis of fetal sample for detection of abnormalities associated with rare constitutional/heritable diseases |
| 0336U | October 1, 2022 | Whole genome sequence analysis of comparator genome (parent) for detection of abnormalities associated with rare constitutional/heritable diseases |
| 0337U | October 1, 2022 | Evaluation of plasma cells for detection of abnormalities associated with plasma cell disorders and myeloma |
| 0338U | October 1, 2022 | Evaluation of circulating solid tumor cells in peripheral blood |
| 0339U | October 1, 2022 | mRNA expression profiling of genes associated with high-grade prostate cancer |
| 0340U | October 1, 2022 | DNA assays for detection of minimal residual disease in cancer |
| 0341U | October 1, 2022 | Fetal DNA sequencing of products of conception for detection of abnormal chromosome number |
| 0342U | October 1, 2022 | Multiplex immunoassay for markers of pancreatic cancer in serum |
| 0343U | October 1, 2022 | Exosome-based analysis of 442 small noncoding RNAs in urine to evaluate risk of prostate cancer |
| 0344U | October 1, 2022 | Evaluation of 28 lipid markers for risk of nonalcoholic fatty liver disease |
| 0345U | October 1, 2022 | Genomic analysis panel of 15 genes for detection of abnormalities associated with mental health disorders |
| 0346U | October 1, 2022 | Evaluation of beta-amyloid AB40 and AB42 ratio |
| 0347U | October 1, 2022 | DNA analysis of 16 genes involved in drug metabolism or processing |
| 0348U | October 1, 2022 | DNA analysis of 25 genes involved in drug metabolism or processing |
| 0349U | October 1, 2022 | DNA analysis of 27 genes involved in drug metabolism or processing, report including gene-drug interactions |
| 0350U | October 1, 2022 | DNA analysis of 27 genes involved in drug metabolism or processing, analysis and reported phenotypes |
| 0351U | October 1, 2022 | Biochemical assays for markers of bacterial infection |
| 0352U | October 1, 2022 | Detection of bacteria causing vaginosis and vaginitis by multiplex amplified nucleic acid probe technique |
| 0353U | October 1, 2022 | Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by multiplex amplified DNA probe technique |
| 0354U | October 1, 2022 | Human papillomavirus (HPV) by quantitative polymerase chain reaction (qPCR) |
| 0355U | January 1, 2023 | APOL1 (apolipoprotein L1) (e.g., chronic kidney disease), risk variants (G1, G2) |
| 0356U | January 1, 2023 | Oncology (oropharyngeal), evaluation of 17 DNA biomarkers using droplet digital PCR (ddPCR) and cell-free DNA, algorithm reported as a prognostic risk score for cancer recurrence |
| 0357U | January 1, 2023 | Oncology (melanoma), artificial intelligence (AI)-enabled quantitative mass spectrometry analysis of 142 unique pairs of glycopeptide and product fragments, plasma, prognostic, and predictive algorithm reported as likely, unlikely, or uncertain benefit from immunotherapy agents |
| 0358U | January 1, 2023 | Neurology (mild cognitive impairment), analysis of β-amyloid 1-42 and 1-40, chemiluminescence enzyme immunoassay, cerebral spinal fluid, reported as positive, likely positive, or negative |
| 0359U | January 1, 2023 | Oncology (prostate cancer), analysis of all prostate-specific antigen (PSA) structural isoforms by phase separation and immunoassay, plasma, algorithm reports risk of cancer |
| 0360U | January 1, 2023 | Oncology (lung), enzyme-linked immunosorbent assay (ELISA) of seven autoantibodies (p53, NY-ESO-1, CAGE, GBU4-5, SOX2, MAGE A4, and HuD), plasma, algorithm reported as a categorical result for risk of malignancy |
| 0361U | January 1, 2023 | Neurofilament light chain, digital immunoassay, plasma, quantitative |
| 0362U | January 1, 2023 | Oncology (papillary thyroid cancer), gene-expression profiling via targeted hybrid capture-enrichment RNA sequencing of 82 content genes and 10 housekeeping genes, formalin-fixed paraffin embedded (FFPE) tissue, algorithm reported as one of three molecular subtypes |
| 0363U | January 1, 2023 | Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR22), utilizing urine, algorithm incorporates age, sex, smoking history, and macrohematuria frequency, reported as a risk score for urothelial carcinoma |
| 81418 | January 1, 2023 | Genomic sequence analysis panel of at least six genes associated with drug metabolism |
| 81441 | January 1, 2023 | Gene sequence analysis panel of at least 30 genes associated with inherited bone marrow failure syndromes |
| 81449 | January 1, 2023 | Targeted genomic sequence analysis panel of RNA of five-50 genes associated with solid organ neoplasm |
| 81451 | January 1, 2023 | Targeted genomic sequence analysis panel of RNA of five-50 genes associated with blood and lymphatic system disorders |
| 81456 | January 1, 2023 | Targeted genomic sequence analysis panel of RNA of 51 or greater genes associated with blood and lymphatic system disorders |
| 84433 | January 1, 2023 | Evaluation of thiopurine S-methyltransferase (TPMT) |
| 87467 | January 1, 2023 | Measurement of Hepatitis B surface antigen (HBsAg) |
| 87468 | January 1, 2023 | Detection of Anaplasma phagocytophilum by amplified nucleic acid probe technique |
| 87469 | January 1, 2023 | Detection of Babesia microtim by amplified nucleic acid probe technique |
| 87478 | January 1, 2023 | Detection of Borrelia miyamotoi by amplified nucleic acid probe technique |
| 87484 | January 1, 2023 | Detection of Ehrlichia chaffeensis by amplified nucleic acid probe technique |
Takeaway
The lists don’t include new HCPCS codes for waived tests or provider-performed microscopy procedures. Rule: The listed tests aren’t payable to a facility that doesn’t have a valid, current, CLIA certificate, or that only has a current CLIA certificate of waiver (certificate type code 2) or a current CLIA certificate for provider-performed microscopy procedures (certificate type code 4). Exception: A facility with a current certificate type code 2 or 4 may be paid if it bills the appropriate HCPCS service code with a QW modifier.
Bottom Line: It’s up to you to ensure that the HCPCS codes you’ve billed to Medicare since February 2022 are in line with your CLIA certification. CMS notes that Medicare Administrative Contractors (MACs) won’t search their files either to retract payment for claims already paid, or to pay claims retroactively. However, MACs will adjust any claims that you bring to their attention.
References:
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