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Medicare Seeks Input on More Than 100 New Lab Test Codes

by | Feb 25, 2015 | CMS-nir, Essential, National Lab Reporter

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 […]

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 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.

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