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10/16/14 Lab Institute Washington, DC October 16, 2014 Diana W. Voorhees, M.A. CLS, MT, SH, CLCP Principal/CEO DV & Associates, Inc. [email protected] 801.424.5274 DV & Associates, Inc. 2 1 10/16/14 ! Describe pertinent coverage and payment changes associated with Medicare fee schedules for laboratories and pathologists. ! Discuss Coding Changes for 2015 to include drug and molecular testing. ! Highlight other coding and billing challenges including modifier usage. DV & Associates, Inc. 3 2 10/16/14 ! 2014 final rule finalized a process to reexamine the payment amounts for test codes on the (CLFS) for possible payment revision based on technological changes ! PAMA negated the above process by requiring a Medicare payment system based on private payer rates DV & Associates, Inc. 5 ! CMS: “As a result of these provisions, we are not proposing any revisions to payment amounts for test codes on the CLFS based on technological changes and are proposing to remove §414.511. Instead, we will establish through rulemaking the parameters for the collection of private payer rate information and other requirements to implement section 216 of the PAMA.” § Patient Access to Medicare Act (PAMA) DV & Associates, Inc. 6 3 10/16/14 ! PAMA also impacts coverage of testing under LCDs § “A Medicare administrative contractor shall only issue a coverage policy …..in accordance with the process for making a local coverage determination (as defined in section 1869(f)(2) (B)), including the appeals and review process for local coverage determinations….” DV & Associates, Inc. ! 7 Final rule: “…carefully consider the LCD process that is used today and determine if there are certain, limited aspects of the LCD process that may provide an opportunity to better fit the needs of this particular area of medicine. § In addition to the current LCD process, we will examine how the LCD process was applied to a pilot project for molecular diagnostic tests as we are learning important lessons from this ongoing pilot. We believe lessons learned from this project can be applied to all clinical diagnostic laboratory testing and not just molecular.” DV & Associates, Inc. 8 4 10/16/14 ! Final Rule: “In addition to evaluating the effectiveness of certain aspects of the LCD implementation process, we are also examining a pilot project that CMS launched with a single MAC, Palmetto GBA, on November 1, 2011. § While the pilot discussed in this section only includes molecular diagnostic (genetic) laboratory tests, a subset of all clinical diagnostic lab tests, we believe the pilot’s design and some of the lessons learned from the pilot can be applied to all clinical diagnostic laboratory tests.” DV & Associates, Inc. 9 ! New process in place for 1/1/15 § LCDs requested internally or externally § Draft published at Medicare Database § Max 30 day comment period ▪ MAC discretion to extend § MAC review public comments & respond ▪ Discretion to involve CAC, extend comment period § MAC publish final rule within 45 days § LCD effective when published DV & Associates, Inc. 10 5 10/16/14 ! Proposed Rule Estimated Impact on Total Allowed Charges for pathology § 1% overall increase due to changes in PE RVU PAMA overrides the SGR decrease until March 15, 2015 ! CMS include all CMS proposed values and AMA RUC proposed values received by January 15, 2015 ! § Values proposed by the RUC & received after this date, will be delayed for consideration for one year and included in the following year’s PFS Proposed Rule (2017) DV & Associates, Inc. 11 ! In 2014 final rule, CMS proposed to cap PFS payment rates at hospital payment rates when a service provided by a non facility provider exceeded the facility or hospital rate § This former proposed change was not presented again for 2015 DV & Associates, Inc. 12 6 10/16/14 ! Proposed to package additional laboratory services into initial service: § APC § 0342 § 0345 § 0433 § 0624 Mean Cost $56.99 $78.83 $190.21 $83.61 ! Reported with Q1 Service Level I Pathology Level I Transfusion Level II Pathology Phlebotomy and Minor Vascular Access Device Procedures DV & Associates, Inc. 13 ! 80500 ....... Lab pathology consultation. ! 80502 ....... Lab pathology consultation. ! 85097 ....... Bone marrow interpretation. ! 86510 ....... Histoplasmosis skin test. ! 86850 ....... Rbc antibody screen. ! 86870 ....... Rbc antibody identification. ! 86880 ....... Coombs test direct. ! 86885 ....... Coombs test indirect qual. ! 86886 ....... Coombs test indirect titer. DV & Associates, Inc. 14 7 10/16/14 ! 86900 ....... Blood typing abo. ! 86901 ....... Blood typing rh (d). ! 86904 ....... Blood typing patient serum. ! 86905 ....... Blood typing rbc antigens. ! 86906 ....... Blood typing rh phenotype. ! 86930 ....... Frozen blood prep. ! 86970 ....... Rbc pretx incubatj w/chemicl. ! 86977 ....... Rbc serum pretx incubj/inhib. DV & Associates, Inc. ! ! ! ! ! ! ! ! ! ! ! 15 88104 ....... Cytopath fl nongyn smears. 88106 ....... Cytopath fl nongyn filter. 88107 ....... Cytopath fl nongyn sm/fltr. 88108 ....... Cytopath concentrate tech. 88112 ....... Cytopath cell enhance tech. 88120 ....... Cytp urne 3–5 probes ea spec. 88160 ....... Cytopath smear other source. 88161 ....... Cytopath smear other source. 88162 ....... Cytopath smear other source. 88172 ....... Cytp dx eval fna 1st ea site. 88173 ....... Cytopath eval fna report. DV & Associates, Inc. 16 8 10/16/14 ! 88182 ....... Cell marker study. ! 88184 ....... Flowcytometry/tc 1 marker. ! 88189 ....... Flowcytometry/read 16 & >. ! 88300 ....... Surgical path gross. ! 88302 ....... Tissue exam by pathologist. ! 88304 ....... Tissue exam by pathologist. ! 88305 ....... Tissue exam by pathologist. ! 88307 ....... Tissue exam by pathologist. DV & Associates, Inc. ! ! ! ! ! ! ! ! ! ! ! 17 88312 ....... Special stains group 1. 88313 ....... Special stains group 2. 88321 ....... Microslide consultation. 88323 ....... Microslide consultation. 88325 ....... Comprehensive review of data. 88329 ....... Path consult introp. 88331 ....... Path consult intraop 1 bloc. 88342 ....... Immunohisto antibody slide. 88346 ....... Immunofluorescent study. 88347 ....... Immunofluorescent study. 88348 ....... Electron microscopy. DV & Associates, Inc. 18 9 10/16/14 ! ! ! ! ! ! ! ! ! ! ! 88358 ....... Analysis tumor. 88360 ....... Tumor immunohistochem/manual. 88361 ....... Tumor immunohistochem/comput. 88365 ....... Insitu hybridization (fish). 88368 ....... Insitu hybridization manual. 88385 ....... Eval molecul probes 51–250. 88386 ....... Eval molecul probes 251–500. 89049 ....... Chct for mal hyperthermia. 89220 ....... Sputum specimen collection. 89230 ....... Collect sweat for test. 89240 ....... Pathology lab procedure. DV & Associates, Inc. 19 10 10/16/14 ! ! CPT Description 83006 Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-‐1) § ST2 is a biomarker that has been shown to predict adverse outcomes and death in individuals with established heart failure and is also a prognostic marker for future cardiovascular disease in the general population. § Higher levels of circulating ST2 can be detected in apparently healthy individuals and precede adverse outcomes. ▪ X-‐walk 82777 ($30) DV & Associates, Inc. ! ! 21 CPT Description G0464 Colorectal cancer screening; stool-‐ based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3) § Detect three (3) independent families of markers § Stool is analyzed for 11 biomarkers and produces a single, positive/negative result based on an optimized logarithmic algorithm that weights the individual scores (Cologuard – FDA approved) ▪ X-‐walk 81315 + 81275 +82274 ($502) (CMS $400) DV & Associates, Inc. 22 11 10/16/14 ! ! CPT Description 87505 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, 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 § X-‐walk 87631 ($175) DV & Associates, Inc. 24 12 10/16/14 ! ! CPT Description 87506 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, 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 § X-‐walk 87632 ($291) DV & Associates, Inc. ! ! 25 CPT Description 87507 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, 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 § X-‐walk 87633 ($568) DV & Associates, Inc. 26 13 10/16/14 ! ! CPT Description 87623 Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-‐risk types (eg, 6, 11, 42, 43, 44) § X-‐walk 87621 ($48) ! 87624 Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-‐risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) § X-‐walk 87621 ($48 ) DV & Associates, Inc. 27 ! CPT ! 87625 Description Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed § X-‐walk 87621 ($48) ! (When both low-‐risk and high-‐risk HPV types are performed in a single assay, use only 87624) DV & Associates, Inc. 28 14 10/16/14 ! 87806 Infectious agent antigen detection by immunoassay with direct optical observation; HIV-‐1 antigen(s), with HIV-‐1 and HIV-‐2 antibodies § X-‐walk 87389 ($33) DV & Associates, Inc. 29 15 10/16/14 ! CPT ! 89337 Description Cryopreservation, mature oocyte(s) § Currently have coding for cryopreservation of embryos and sperm (89258 & 89259) § Also have cryopreservation of testicular tissue (89335) and ovarian tissue (89240 which is not listed in CPT) § Other coding is for storage and thawing ▪ X-‐walk to 89337 -‐ not on CLFS; not to b on CLFS DV & Associates, Inc. 31 16 10/16/14 ! CMS plans to defer the use of new clinical chemistry drug testing codes ! No fee schedule amounts identified ! Concerned about overpayment when billing for individual drugs versus a code for single code for multiple drugs DV & Associates, Inc. ! CPT ! 80100 ! 80101 ! 80102 ! 80103 ! 80104 33 Procedure Screen, multiple qualitative, chromatography Screen, single qualitative, IA Confirmation Tissue preparation for drug analysis Screen, multiple qualitative, not chromatography DV & Associates, Inc. 34 17 10/16/14 ! CPT ! 80300 Description Drug screen, any number of drug classes from Drug Class List A; any number of non-‐ TLC devices or procedures, (eg, immunoassay) capable of being read by direct optical observation including instrumented-‐assisted when performed (eg, dipsticks, cups, cards, cartridges), per date of service DV & Associates, Inc. 35 ! CPT ! 80301 Description Drug screen, any number of drug classes from Drug Class List A; single drug class method, by instrumented test systems (eg, discrete multichannel chemistry analyzers utilizing immunoassay or enzyme assay), per date of service DV & Associates, Inc. 36 18 10/16/14 ! ! ! ! ! ! ! ! ! Alcohol (Ethanol) Amphetamines Barbiturates Benzodiazepines Buprenorphine Cocaine metabolite Heroin metabolite (6-‐monoacetylmorphine) Methadone Methadone metabolite (EDDP) DV & Associates, Inc. 37 Methamphetamine Methaqualone Methylenedioxymethamphetamine (MDMA) Opiates Oxycodone Phencyclidine Propoxyphene Tetrahydrocannabinol (THC) metabolites (marijuana) ! Tricyclic Antidepressants ! ! ! ! ! ! ! ! DV & Associates, Inc. 38 19 10/16/14 ! CPT ! 80302 Description Drug screen, presumptive, single drug class from Drug Class List B, by immunoassay (eg, ELISA) or non-‐TLC chromatography without mass spectrometry (eg, GC, HPLC), each procedure DV & Associates, Inc. ! ! ! ! ! ! ! ! ! ! ! ! ! ! Acetaminophen Carisoprodol/Meprobamate Ethyl Glucuronide Fentanyl Ketamine Meperidine Methylphenidate Nicotine/Cotinine Salicylate Synthetic Cannabinoids Tapentadol Tramadol Zolpidem Not otherwise specified DV & Associates, Inc. 39 40 20 10/16/14 ! Class A § Typically POC testing or multichannel chemistry analyzer testing ! Class B § Typically “added on” for panel screens or tested singularly DV & Associates, Inc. 41 ! CPT ! 80303 Description Drug screen, any number of drug classes, presumptive, single or multiple drug class method; thin layer chromatography procedure(s) (TLC) (eg, acid, neutral, alkaloid plate), per date of service DV & Associates, Inc. 42 21 10/16/14 ! CPT ! 80304 Description Drug screen, any number of drug classes, presumptive, single or multiple drug class method; not otherwise specified presumptive procedure (eg, TOF, MALDI, LDTD, DESI, DART), each procedure § Presumptive equates to qualitative DV & Associates, Inc. 43 ! Definitive equates to quantitative ! ! ! ! ! ! ! ! ! ! CPT 80152 80154 80160 80166 80172 80174 80182 84228 80196 Description Amitriptyline Benzodiazepines Desipramine Doxepin Gold Imipramine Nortriptyline Quinine Salicylate DV & Associates, Inc. 44 22 10/16/14 ! CPT ! 82000 ! 82003 ! 82055 ! 82101 ! 82145 ! 82205 ! 82520 Description Acetaldehyde, blood Acetaminophen Alcohol (ethanol); any specimen except breath Alkaloids, urine, quantitative Amphetamine or methamphetamine Barbiturates, not elsewhere specified Cocaine or metabolite DV & Associates, Inc. ! CPT ! 82646 ! 82649 ! 82651 ! 82654 ! 82666 ! 82690 ! 82742 45 Description Dihydrocodeinone Dihydromorphinone Dihydrotestosterone (DHT) Dimethadione Epiandrosterone Ethchlorvynol Flurazepam DV & Associates, Inc. 46 23 10/16/14 ! CPT ! 82980 ! 83840 ! 83858 ! 83887 ! 83925 ! 84022 Description Glutethimide Methadone Methsuximide Nicotine Opiate(s), drug and metabolites, each procedure Phenothiazine DV & Associates, Inc. 47 ! CPT ! 80162 ! 80164 Description Digoxin; total Dipropylacetic acid (valproic acid) Valproic acid (dipropylacetic acid); total ! 80171 Gabapentin, whole blood, serum or plasma ! 80299 Quantitation of therapeutic drug, not elsewhere specified DV & Associates, Inc. 48 24 10/16/14 ! CPT ! 82541 Description Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), non-‐ drug analyte not elsewhere specified; qualitative, single stationary and mobile phase ! 82544 stable isotope dilution, multiple analytes, quantitative, single stationary and mobile phase DV & Associates, Inc. 49 ! CPT ! 84600 Description Volatiles (eg, acetic anhydride, carbon tetrachloride,dichloroethane, dichloromethane, diethylether, isopropyl alcohol, methanol) DV & Associates, Inc. 50 25 10/16/14 ! ! ! ! ! ! ! ! ! ! CPT 80320 80321 80322 80323 80324 80325 80326 80327 80328 Description Alcohols Alcohol biomarkers; 1 to 2 3 or more Alkaloids, not otherwise specified Amphetamines, 1 to 2 3 to 4 5 or more Anabolic steroids 1-‐2 3 or more DV & Associates, Inc. CPT 80329 80 330 80331 80332 ! 80333 ! 80334 ! 80335 ! 80336 ! 80337 ! ! ! ! ! 51 Description Analgesics, non-‐opioid; 1 to 2 drugs 3 to 5 6 or more Antidepressants, serotonergic class; 1 to 2 drugs to 5 6 or more Antidepressants, tricyclic and other cyclicals; 1 to 2 drugs 3 to 5 6 or more DV & Associates, Inc. 52 26 10/16/14 CPT 80338 ! 80339 ! 80340 ! 80341 ! 80342 ! 80343 ! 80344 ! 80345 ! ! Description Antidepressants, not otherwise specified Antiepileptics, not otherwise specified; 1 to 3 drugs 4 to 6 7 or more Antispychotics, not otherwise specified; 1 to 3 drugs 4 to 6 7 or more Barbiturates DV & Associates, Inc. ! CPT ! 80346 ! 80347 ! 80348 ! 80349 ! 80350 ! 80351 ! 80352 53 Description Benzodiazepines; 1-‐12 13 or more Buprenorphine Cannabinoids, natural Cannabinoids, synthetic 1 to 3 4 to 6 7 or more DV & Associates, Inc. 54 27 10/16/14 ! CPT ! 80353 ! 80354 ! 80355 ! 80356 ! 80357 ! 80358 ! 80359 Description Cocaine Fentanyl Gabapentin, non-‐blood Heroin metabolite Ketamine and norketamine Methadone Methylenedioxyamphetamines (MDA, MDEA, MDMA) ! 80360 Methylphenidate DV & Associates, Inc. ! ! ! ! ! ! ! ! ! CPT 80361 80362 80363 80364 80365 80366 80367 80368 55 Description Opiates, one or more Opioids and opiate analogs; 1 to 2 3 to 4 5 or more Oxycodone Pregabalin Propoxyphene Sedative hypnotics (non-‐ benzodiazepines) DV & Associates, Inc. 56 28 10/16/14 ! CPT ! 80369 ! 80370 ! 80371 ! 80372 ! 80373 ! 80374 Description Skeletal muscle relaxants; 1-‐2 3 or more Stimulants, synthetic Tapentadol Tramadol Stereoisomer (enantiomer) analysis, single drug class DV & Associates, Inc. CPT Description 80375 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1 to 3 ! 80376 4 to 6 ! 80377 7 or more ! 80163 Digoxin, free ! ! 57 § X-‐walk 80162 ($18) ! 80165 Valproic acid (dipropylacetic acid); free § X-‐walk 80164 ($18) DV & Associates, Inc. 58 29 10/16/14 ! CMS places the new genomic codes for 2015 into the gapfill process ! Medicare contractors will identify pricing in first quarter of 2015 and release for public comment ! Final reimbursement submitted by contractors in about August ! 2016 reimbursement based on identified medians for 2015 DV & Associates, Inc. 60 30 10/16/14 CPT Description 81246 FLT3 (fms-‐related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (eg, D835, I836) ! 81288 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-‐polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis ! ! DV & Associates, Inc. 61 ! CPT ! 81313 Description PCA3/KLK3 (prostate cancer antigen 3 [non-‐protein coding]/kallikrein-‐ related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer) DV & Associates, Inc. 62 31 10/16/14 ! ! CPT Description 81410 Aortic dysfunction or dilation (eg, 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 DV & Associates, Inc. 63 CPT Description 81411 Aortic dysfunction or dilation (eg, 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 ! 81415 Exome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis ! ! DV & Associates, Inc. 64 32 10/16/14 CPT Description 81416 Exome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator exome (eg, parents, siblings) (List separately in addition to code for primary procedure) (Use 81416 in conjunction with 81415) ! 81417 Exome (eg, unexplained constitutional or heritable disorder or syndrome); re-‐ evaluation of previously obtained exome sequence (eg, updated knowledge or unrelated condition/syndrome) ! ! DV & Associates, Inc. 65 ! CPT ! 81420 Description Fetal chromosomal aneuploidy (eg, 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 ! 81425 Genome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis DV & Associates, Inc. 66 33 10/16/14 CPT Description 81426 Genome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator genome (eg, parents, siblings) (List separately in addition to code for primary procedure) (Use 81426 in conjunction with 81425) ! 81427 Genome (eg, unexplained constitutional or heritable disorder or syndrome); re-‐ evaluation of previously obtained genome sequence (eg, updated knowledge or unrelated condition/syndrome) ! ! DV & Associates, Inc. ! ! CPT Description 81430 Hearing loss (eg, 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 DV & Associates, Inc. 67 68 34 10/16/14 ! ! ! CPT Description 81431 Hearing loss (eg, 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 81435 Hereditary colon cancer syndromes (eg, 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 DV & Associates, Inc. 69 ! CPT ! 81436 Description Hereditary colon cancer syndromes (eg, 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 DV & Associates, Inc. 70 35 10/16/14 ! 81440 Nuclear encoded mitochondrial genes (eg, 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 DV & Associates, Inc. 71 ! CPT ! 81445 Description Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, 5-‐50 genes (eg, 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 DV & Associates, Inc. 72 36 10/16/14 ! ! CPT Description 81450 Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA and RNA analysis when performed, 5-‐50 genes (eg, 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 DV & Associates, Inc. ! ! 73 CPT Description 81455 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis when performed, 51 or greater genes (eg, 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 DV & Associates, Inc. 74 37 10/16/14 ! ! CPT Description 81460 Whole mitochondrial genome (eg, Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-‐like episodes [MELAS], myoclonic epilepsy with ragged-‐red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection DV & Associates, Inc. 75 ! CPT ! 81465 Description Whole mitochondrial genome large deletion analysis panel (eg, Kearns-‐Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed DV & Associates, Inc. 76 38 10/16/14 ! CPT ! 81470 Description X-‐linked intellectual disability (XLID) (eg, 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 DV & Associates, Inc. 77 ! CPT ! 81471 Description X-‐linked intellectual disability (XLID) (eg, 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 DV & Associates, Inc. 78 39 10/16/14 ! CPT Description ! 0006M Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-‐fetoprotein level, algorithm reported as a risk classifier § HeproDX-‐TM, GoPath Laboratories, LLC § Effective 7/1/14 DV & Associates, Inc. 79 ! 0007M 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 § NETest, Wren Laboratories, LLC § Effective 7/1/14 DV & Associates, Inc. 80 40 10/16/14 ! CPT Description ! 0008M Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-‐fixed paraffin-‐embedded (FFPE) tissue, prognostic algorithm reported as a risk score § Prosigna Breast CA Assay, NanoString § Effective 7/1/14 DV & Associates, Inc. 81 ! 81519 Oncology (breast), mRNA, gene expression profiling by real-‐time RT-‐ PCR of 21 genes, utilizing formalin-‐ fixed paraffin embedded tissue, algorithm reported as recurrence score § Oncotype DX DV & Associates, Inc. 82 41 10/16/14 ! CPT ! 81210 Procedure BRAF § Revise 81210 to include testing for melanoma and any V600 variant(s) Proposed & Not effected ! 81245 FLFLT3 § Revise 81245 to add internal tandem duplication (ITD) variants (ie, exons 14, 15) DV & Associates, Inc. 83 ! 81275 ! 81401 ! 81405 KRAS ABL KRAS ! 81406 BRAF § Revise 81275, 81401 (ABL), 81405 (KRAS), 81406 (BRAF) to include updated full gene names approved by the HUGO Gene Nomenclature Committee Proposed & Not effected DV & Associates, Inc. 84 42 10/16/14 ! CPT Description ! 81355 VKORC1 Proposed & Not effected § Revise 81355 to allow reporting of a singular common variant or multiple common variants ! 81403 KRAS Proposed & Not effected ! 812xx KRAS Proposed & Not effected § Revise 81403 to remove KRAS from the list of tests reported with 81403 and add 812XX to report this test § Codon 3 vs current 81275 (codons 12 & 13) DV & Associates, Inc. ! ! ! CPT 81403 812xx 85 Description CEBPA Proposed & Not effected CEBPA Proposed & Not effected § Revise 81403 to remove CEBPA from the list of tests reported with 81403 and add 812XX for acute myeloid leukemia ! ! 81403 812xx ABL1 Proposed & Not effected ABL1 Proposed & Not effected § Revise 81403 to remove ABL1 from the list of tests reported with 81403 and add 812XX to report this test DV & Associates, Inc. 86 43 10/16/14 ! ! ! CPT Description 81404 NRAS Proposed & Not effected 812xx NRAS Proposed & Not effected § Revise 81404 to remove NRAS from the list of tests reported with 81404 and add 812XX to report this test ! ! 81404 PDGFRA Proposed & Not effected 812xx PDGFRA Proposed & Not effected § Revise 81404 to remove PDGFRA from the list of tests reported with 81404 and add 812XX to report this test DV & Associates, Inc. ! CPT ! 81404 ! 812xx 87 Description KIT Proposed & Not effected KIT Proposed & Not effected § Revise 81404 to remove KIT (c-‐KIT) from the list of tests reported with 81404 and add 812XX for the KIT test for acute myeloid leukemia, melanoma DV & Associates, Inc. 88 44 10/16/14 ! CPT ! 81402 Procedure PCR and sequencing analysis for detection of 19p-‐1q co-‐deletion as a 81404 DV & Associates, Inc. ! ! CPT 89 Procedure 81403 Human erythrocyte antigen gene analyses (eg, SLC14A1 [Kidd blood group], BCAM [Lutheran blood group], ICAM4 [Landsteiner-‐ Wiener blood group], SLC4A1 [Diego blood group], AQP1 [Colton blood group], ERMAP [Scianna blood group], RHCE [Rh blood group, CcEe antigens], KEL [Kell blood group], DARC (Duffy blood group], GYPA, GYPB, GYPE [MNS blood group], ART4 [Dombrock blood group]) (eg, sickle-‐cell disease, thalassemia, hemolytic transfusion reactions, hemolytic disease of the fetus or newborn), common variants DV & Associates, Inc. 90 45 10/16/14 ! ! ! ! CPT Procedure 81403 RHD (Rh blood group, D antigen) (eg, hemolytic disease of the fetus and newborn, Rh maternal/fetal compatibility), deletion analysis (eg, exons 4, 5, and 7, pseudogene) 81403 RHD (Rh blood group, D antigen) (eg, hemolytic disease of the fetus and newborn, Rh maternal/fetal compatibility), deletion analysis (eg, exons, 4, 5, and 7, pseudogene), performed on cell-‐free fetal DNA in maternal blood (For human erythrocyte gene analysis of RHD, use a separate unit of 81403) DV & Associates, Inc. 91 ! CPT ! 81404 Procedure MPV17 (MpV17 mitochondrial inner membrane protein) (eg, mitochondrial DNA depletion syndrome), duplication/deletion analysis ! 81404 Targeted sequence analysis for detection of PIK3CA to assist in drug therapy selection for colorectal cancer DV & Associates, Inc. 92 46 10/16/14 ! CPT ! 88346 ! 88347 Procedure Immunofluorescent Studies Immunofluorescent Studies § Add 8834X5 § Appears that no changes were made DV & Associates, Inc. 94 47 10/16/14 ! CPT ! 88342 Description Immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear per specimen; first separately identifiable antibody per slide initial single antibody stain procedure DV & Associates, Inc. 95 ! CPT ! 88343 Description Immunohistochemistry or immunocytochemistry, per specimen; each additional separately identifiable antibody per slide (List separately in addition to code for primary procedure) DV & Associates, Inc. 96 48 10/16/14 CPT Description 88341 Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure) ! 88344 each multiplex antibody stain procedure ! (88343 has been deleted. For multiplex antibody stain procedure, use 88344) ! ! DV & Associates, Inc. 97 (Use 88341 88343 in conjunction with 88342) (For multiplex antibody stain procedure, use 88344) ! (Do not use more than one unit of 88341, 88342, 88344 for each separately identifiable antibody per specimen) ! (Do not report 88341, 88342, 88344 in conjunction with 88360 or 88361 for the same antibody unless each procedure is for a different antibody) ! ! DV & Associates, Inc. 98 49 10/16/14 (When multiple separately identifiable antibodies are applied to the same slide specimen [ie, multiplex antibody stain procedure], use one unit of 88344 88342 for the first separately identifiable antibody and one unit of 88343 for each additional identifiable antibody) ! (When multiple antibodies are applied to the same slide that are not separately identifiable [eg, antibody cocktails], use 88342, unless an additional separately identifiable antibody is also used, then use 88344) ! DV & Associates, Inc. 99 CPT Description 88360 Morphometric analysis, tumor immunohistochemistry (eg, Her-‐2/neu, estrogen receptor, progesterone receptor), quantitative or semi-‐ quantitative, each antibody per specimen, each single antibody stain procedure; manual ! 88361 using computer-‐assisted technology ! ! DV & Associates, Inc. 100 50 10/16/14 ! (Do not report 88360, 88361 in conjunction with 88341, 88342, or 88344 unless each procedure is for a different antibody) ! (Morphometric analysis of a multiplex antibody stain should be reported with one unit of 88360 or 88361, per specimen) DV & Associates, Inc. 101 ! CPT ! 88365 Procedure In situ hybridization (eg, FISH), each probe per specimen; initial single probe stain procedure DV & Associates, Inc. 102 51 10/16/14 CPT Procedure 88364 Morphometric analysis, in situ hybridization (quantitative or semi-‐ quantitative), each probe; using computer-‐assisted technology, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure) ! 88366 each multiplex probe stain procedure ! ! DV & Associates, Inc. 103 ! (Use 88364 in conjunction with 88365) ! (Do not report 88365, 88366 in conjunction with 88367, 88368, 88374, 88377 for the same probe) DV & Associates, Inc. 104 52 10/16/14 ! CPT ! 88367 Procedure Morphometric analysis, in situ hybridization (quantitative or semi-‐ quantitative), each probe; using computer-‐assisted technology, per specimen; initial single probe stain procedure DV & Associates, Inc. 105 CPT Procedure 88373 Morphometric analysis, in situ hybridization (quantitative or semi-‐ quantitative), each probe; using computer-‐assisted technology, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure) ! 88374 each multiplex probe stain procedure ! ! DV & Associates, Inc. 106 53 10/16/14 ! (Use 88373 in conjunction with 88367) ! (Do not report 88367, 88374 in conjunction with 88365, 88366, 88368, 88377 for the same probe) DV & Associates, Inc. 107 ! CPT ! 88368 Procedure Morphometric analysis, in situ hybridization (quantitative or semi-‐ quantitative), manual, per specimen; initial single probe stain procedure DV & Associates, Inc. 108 54 10/16/14 ! CPT ! 88369 Procedure Morphometric analysis, in situ hybridization (quantitative or semi-‐ quantitative), manual, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure) ! 88377 each multiplex probe stain procedure DV & Associates, Inc. 109 ! (Use 88369 in conjunction with 88368) ! (Do not report 88368 or 88377 in conjunction with 88365, 88366, 88367, 88374 for the same probe) DV & Associates, Inc. 110 55 10/16/14 ! CPT ! 88348 ! 88349 Procedure Electron microscopy; diagnostic scanning ! (88349 has been deleted. To report, use 88348) DV & Associates, Inc. ! ! 111 Perceived Misvalued Codes CMS modified the “G” code descriptors so codes used for any method of prostate needle biopsy services and not just prostate saturation biopsies: § G0416 Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 10–20 specimens). § G0417 21–40 specimens § G0418 41–60 specimens § G0419 greater than 60 specimens DV & Associates, Inc. 112 56 10/16/14 ! ! ! ! G0416 (10-‐20 specimens) has highest billing volume To establish “straightforward coding and maintaining accurate payment, we believe it would be appropriate to use only one code to report prostate biopsy pathology services.” Propose to revise the descriptor for G0416 to define the service regardless of the number of specimens, and to delete codes G0417, G0418, and G0419 G0416 is the code that currently is valued and used for between 10 and 12 specimens ($650) -‐ Proposing to use the existing values for G0416 for CY 2015 DV & Associates, Inc. 113 ! Perceived Misvalued Code § Greater than $10M in allowed charges § No decrease for 2015, expect 5.3% increase § Code evaluated in 2015 DV & Associates, Inc. 114 57 10/16/14 Discussion Diana 58
