Medicare Seeks Input on More Than 100 New Lab Test Codes
The Centers for Medicare and Medicaid Services (CMS) in July will consider pricing recommendations on more than 100 new clinical laboratory codes that will be priced on the 2015 Clinical Laboratory Fee Schedule. More than 60 of the new codes are related to drug testing. The meeting will be held July 14 at CMS headquarters in Baltimore. Attendees may register for the meeting online at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/. Proposed pricing for the new codes should be published in September, with final pricing released in November. New Test Codes Presumptive Drug Class Screening 803XX Drug screen, any number of drug classes from Drug Class List A; any number of non-TLC devices or procedures, (e.g., immunoassay) capable of being read by direct optical observation including instrumented-assisted when performed (e.g., dipsticks, cups, cards, cartridges), per date of service 803XX Drug screen, any number of drug classes from Drug Class List A; single drug class method, by instrumented test systems (e.g., discrete multichannel chemistry analyzers utilizing immunoassay or enzyme assay), per date of service 803XX Drug screen, presumptive, single drug class from Drug Class List B, by immunoassay (e.g., ELISA) or non-TLC chromatography without mass spectrometry (e.g., GC, HPLC), each procedure 803XX Drug screen, any number […]
New Test Codes | |
Presumptive Drug Class Screening | |
803XX | Drug screen, any number of drug classes from Drug Class List A; any number of non-TLC devices or procedures, (e.g., immunoassay) capable of being read by direct optical observation including instrumented-assisted when performed (e.g., dipsticks, cups, cards, cartridges), per date of service |
803XX | Drug screen, any number of drug classes from Drug Class List A; single drug class method, by instrumented test systems (e.g., discrete multichannel chemistry analyzers utilizing immunoassay or enzyme assay), per date of service |
803XX | Drug screen, presumptive, single drug class from Drug Class List B, by immunoassay (e.g., ELISA) or non-TLC chromatography without mass spectrometry (e.g., GC, HPLC), each procedure |
803XX | Drug screen, any number of drug classes, presumptive, single or multiple drug class method; thin layer chromatography procedure(s) (TLC) (e.g., acid, neutral, alkaloid plate), per date of service |
803XX | Drug screen, any number of drug classes, presumptive, single or multiple drug class method; not otherwise specified presumptive procedure (e.g., TOF, MALDI, LDTD, DESI, DART), each procedure |
Definitive Drug Testing | |
803XX | Alcohols |
803XX | Alcohol biomarkers; 1 or 2 |
803XX | Alcohol biomarkers; 3 or more |
803XX | Alkaloids, not otherwise specified |
803XX | Amphetamines; 1 or 2 |
803XX | Amphetamines; 3 or 4 |
803XX | Amphetamines; 5 or more |
803XX | Anabolic steroids; 1 or 2 |
803XX | Anabolic steroids; 3 or more |
803XX | Analgesics, non-opioid; 1 or 2 drugs |
803XX | Analgesics, non-opioid; 3-5 |
803XX | Analgesics, non-opioid; 6 or more |
803XX | Antidepressants, serotonergic class; 1 or 2 drugs |
803XX | Antidepressants, serotonergic class; 3 |
803XX | Antidepressants, serotonergic class; 6 or more |
803XX | Antidepressants, tricyclic and other cyclicals; 1 or 2 drugs |
803XX | Antidepressants, tricyclic and other cyclicals; 3-5 |
803XX | Antidepressants, tricyclic and other cyclicals; 6 or more |
803XX | Antidepressants, not otherwise specified |
803XX | Antiepileptics, not otherwise specified; 1-3 drugs |
803XX | Antiepileptics, not otherwise specified; 4-6 |
803XX | Antiepileptics, not otherwise specified; 7 or more |
803XX | Antipsychotics, not otherwise specified; 1-3 drugs |
803XX | Antipsychotics, not otherwise specified; 4-6 |
803XX | Antipsychotics, not otherwise specified; 7 or more |
803XX | Barbiturates |
803XX | Benzodiazepines; 1-12 |
803XX | Benzodiazepines; 13 or more |
803XX | Buprenorphine |
803XX | Cannabinoids, natural |
803XX | Cannabinoids, synthetic; 1-3 |
803XX | Cannabinoids, synthetic; 4-6 |
803XX | Cannabinoids, synthetic; 7 or more |
803XX | Cocaine |
803XX | Fentanyl |
803XX | Gabapentin, non-blood |
803XX | Heroin metabolite |
803XX | Ketamine and norketamine |
803XX | Methadone |
803XX | Methylenedioxyamphetamines (MDA, MDEA, MDMA) |
803XX | Methylphenidate |
803XX | Opiates, 1 or more |
803XX | Opioids and opiate analogs; 1 or 2 |
803XX | Opioids and opiate analogs; 3 or 4 |
803XX | Opioids and opiate analogs; 5 or more |
803XX | Oxycodone |
803XX | Pregabalin |
803XX | Propoxyphene |
803XX | Sedative hypnotics (non-benzodiazepines) |
803XX | Skeletal muscle relaxants; 1 or 2 |
803XX | Skeletal muscle relaxants; 3 or more |
803XX | Stimulants, synthetic |
803XX | Tapentadol |
803XX | Tramadol |
803XX | Stereoisomer (enantiomer) analysis, single drug class |
803XX | Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3 |
803XX | Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4-6 |
803XX | Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more |
Therapeutic Drug Assays | |
801XX | Digoxin; free |
801XX | Valproic acid (dipropylacetic acid); free |
Tier 1 Molecular Pathology Procedures | |
812XX | FLT3 (fms-related tyrosine kinase 3) (e.g., acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (e.g., D835, I836) |
812XX | MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis |
813XX | PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate-specific antigen]) ratio (e.g., prostate cancer) |
Genomic Sequencing Procedures (GSPs) and other Molecular Multianalyte Assays | |
814XX | Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); genomic sequence analysis panel, must include sequencing of at least 9 genes, including FBN1, TGFBR1, TGFBR2, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, and MYLK |
814XX | Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); duplication/deletion analysis, panel must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1 |
814XX | Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis |
814XX | Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator exome (e.g., parents, siblings) (List separately in addition to code for primary procedure) (Use 81416 in conjunction with 81415) |
814XX | Exome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained exome sequence (e.g., updated knowledge or unrelated condition/syndrome) |
814XX | Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21 |
814XX | Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis |
814XX | Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator genome (e.g., parents, siblings) (List separately in addition to code for primary procedure) (Use 81426 in conjunction with 81425) |
814XX | Genome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence (e.g., updated knowledge or unrelated condition/syndrome) |
814XX | Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); genomic sequence analysis panel, must include sequencing of at least 60 genes, including CDH23, CLRN1, GJB2, GPR98, MTRNR1, MYO7A, MYO15A, PCDH15, OTOF, SLC26A4, TMC1, TMPRSS3, USH1C, USH1G, USH2A, and WFS1 |
814XX | Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); duplication/deletion analysis panel, must include copy number analyses for STRC and DFNB1 deletions in GJB2 and GJB6 genes |
814XX | Hereditary colon cancer syndromes (e.g., Lynch syndrome, familial adenomatosis polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2 |
814XX | Hereditary colon cancer syndromes (e.g., Lynch syndrome, familial adenomatosis polyposis); duplication/deletion gene analysis panel, must include analysis of at least 8 genes, including APC, MLH1, MSH2, MSH6, PMS2, EPCAM, CHEK2, and MUTYH |
814XX | Nuclear encoded mitochondrial genes (e.g., neurologic or myopathic phenotypes), genomic sequence panel, must include analysis of at least 100 genes, including BCS1L, C10orf2, COQ2, COX10, DGUOK, MPV17, OPA1, PDSS2, POLG, POLG2, RRM2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP |
814XX | Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, 5-50 genes (e.g., ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed |
814XX | Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA and RNA analysis when performed, 5-50 genes (e.g., BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed |
814XX | Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis when performed, 51 or greater genes (e.g., ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed |
814XX | Whole mitochondrial genome (e.g., Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERRF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection |
814XX | Whole mitochondrial genome large deletion analysis panel (e.g., Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed |
814XX | X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); genomic sequence analysis panel, must include sequencing of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 |
814XX | X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); duplication/deletion gene analysis, must include analysis of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 |
Multianalyte Assays with Algorithmic Analyses | |
XXXXM | Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier |
XXXXM | Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a namogram of tumor disease index |
XXXXM | Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score/td> |
815XX | Oncology (breast), mRNA, gene expression profiling by real-time PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score |
Chemistry | |
830XX | Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1) |
Microbiology | |
875XX | Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets |
875XX | Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets |
875XX | Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets |
876XX | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (e.g., 6, 11, 42, 43, 44) |
876XX | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) |
876XX | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed |
878XX | Infectious agent antigen detection by immunoassay with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies |
Reproductive Medicine Procedures | |
89XXX | Cryopreservation, mature oocyte(s) |
G Codes | |
GXXXX | Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3). |
Source: www.cms.gov/ClinicalLabFeeSched/. Click on “Laboratory Public Meetings” to access the download. Numbering of new codes will be finalized at a later date. CPT codes copyright American Medical Association. |
Subscribe to view Essential
Start a Free Trial for immediate access to this article