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 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.