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Medicare Seeks Input on More Than 100 New Lab Test Codes

by | Feb 25, 2015

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 […]

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
803XXDrug 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
803XXDrug 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
803XXDrug 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
803XXDrug 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
803XXDrug 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
803XXAlcohols
803XXAlcohol biomarkers; 1 or 2
803XXAlcohol biomarkers; 3 or more
803XXAlkaloids, not otherwise specified
803XXAmphetamines; 1 or 2
803XXAmphetamines; 3 or 4
803XXAmphetamines; 5 or more
803XXAnabolic steroids; 1 or 2
803XXAnabolic steroids; 3 or more
803XXAnalgesics, non-opioid; 1 or 2 drugs
803XXAnalgesics, non-opioid; 3-5
803XXAnalgesics, non-opioid; 6 or more
803XXAntidepressants, serotonergic class; 1 or 2 drugs
803XXAntidepressants, serotonergic class; 3
803XXAntidepressants, serotonergic class; 6 or more
803XXAntidepressants, tricyclic and other cyclicals; 1 or 2 drugs
803XXAntidepressants, tricyclic and other cyclicals; 3-5
803XXAntidepressants, tricyclic and other cyclicals; 6 or more
803XXAntidepressants, not otherwise specified
803XXAntiepileptics, not otherwise specified; 1-3 drugs
803XXAntiepileptics, not otherwise specified; 4-6
803XXAntiepileptics, not otherwise specified; 7 or more
803XXAntipsychotics, not otherwise specified; 1-3 drugs
803XXAntipsychotics, not otherwise specified; 4-6
803XXAntipsychotics, not otherwise specified; 7 or more
803XXBarbiturates
803XXBenzodiazepines; 1-12
803XXBenzodiazepines; 13 or more
803XXBuprenorphine
803XXCannabinoids, natural
803XXCannabinoids, synthetic; 1-3
803XXCannabinoids, synthetic; 4-6
803XXCannabinoids, synthetic; 7 or more
803XXCocaine
803XXFentanyl
803XXGabapentin, non-blood
803XXHeroin metabolite
803XXKetamine and norketamine
803XXMethadone
803XXMethylenedioxyamphetamines (MDA, MDEA, MDMA)
803XXMethylphenidate
803XXOpiates, 1 or more
803XXOpioids and opiate analogs; 1 or 2
803XXOpioids and opiate analogs; 3 or 4
803XXOpioids and opiate analogs; 5 or more
803XXOxycodone
803XXPregabalin
803XXPropoxyphene
803XXSedative hypnotics (non-benzodiazepines)
803XXSkeletal muscle relaxants; 1 or 2
803XXSkeletal muscle relaxants; 3 or more
803XXStimulants, synthetic
803XXTapentadol
803XXTramadol
803XXStereoisomer (enantiomer) analysis, single drug class
803XXDrug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3
803XXDrug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4-6
803XXDrug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more
Therapeutic Drug Assays
801XXDigoxin; free
801XXValproic acid (dipropylacetic acid); free
Tier 1 Molecular Pathology Procedures
812XXFLT3 (fms-related tyrosine kinase 3) (e.g., acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (e.g., D835, I836)
812XXMLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis
813XXPCA3/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
814XXAortic 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
814XXAortic 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
814XXExome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis
814XXExome (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)
814XXExome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained exome sequence (e.g., updated knowledge or unrelated condition/syndrome)
814XXFetal 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
814XXGenome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis
814XXGenome (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)
814XXGenome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence (e.g., updated knowledge or unrelated condition/syndrome)
814XXHearing 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
814XXHearing 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
814XXHereditary 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
814XXHereditary 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
814XXNuclear 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
814XXTargeted 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
814XXTargeted 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
814XXTargeted 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
814XXWhole 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
814XXWhole mitochondrial genome large deletion analysis panel (e.g., Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed
814XXX-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
814XXX-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
XXXXMOncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier
XXXXMOncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a namogram of tumor disease index
XXXXMOncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score/td>
815XXOncology (breast), mRNA, gene expression profiling by real-time PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score
Chemistry
830XXGrowth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1)
Microbiology
875XXInfectious 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
875XXInfectious 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
875XXInfectious 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
876XXInfectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (e.g., 6, 11, 42, 43, 44)
876XXInfectious 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)
876XXInfectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed
878XXInfectious agent antigen detection by immunoassay with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies
Reproductive Medicine Procedures
89XXXCryopreservation, mature oocyte(s)
G Codes
GXXXXColorectal 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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