July 14, 2014. Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244

ASCP s Statements before the Centers for Medicare and Medicaid Services Regarding Recommendations for Crosswalking/Gapfilling New CPT s for the CLFS for CY 2015 and the Revaluation of the Clinical Laboratory Fee Schedule July 14, 2014 Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244

ASCP s Statement before the Centers for Medicare and Medicaid Services Regarding the Revaluation of the Clinical Laboratory Fee Schedule July 14, 2014 Thank you for the opportunity to comment on the revaluation of the Clinical Laboratory Fee Schedule (CLFS), mandated by Sec. 216, Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, of P.L. 113-93, the Protecting Access to Medicare Act (PAMA) of 2014. My name is Lee Hilborne, MD, MPH, FASCP, DLM(ASCP) CM and I am a Professor of Pathology and Laboratory Medicine at the David Geffen School of Medicine at the University of California Los Angeles, Medical Director for Quest Diagnostics, Southern California, Deputy Director for Global Health at the RAND Corporation in Santa Monica, CA, and a former president of the American Society for Clinical Pathology (ASCP). It is in that latter capacity that I am here today on behalf of the ASCP to provide the Centers for Medicare and Medicaid Services (CMS) with our initial recommendations on the re-valuation of the Clinical Laboratory Fee Schedule (CLFS). The ASCP is a 501(c)(3) nonprofit medical specialty society representing more than 100,000 members. Our members are board certified pathologists, other physicians, clinical scientists, certified medical technologists and technicians, and educators. ASCP is one of our nation s largest medical specialty societies and is the world s largest organization representing the field of laboratory medicine and pathology. As the leading provider of continuing education for pathologists and medical laboratory personnel, ASCP enhances the quality of the profession through comprehensive educational programs, publications, and self-assessment materials. Section 216 of PAMA will result in the most significant changes in the way laboratory tests are reimbursed by Medicare since the creation of the Clinical Laboratory Fee Schedule (CLFS) in 1984. The reform of the CLFS will incorporate pricing and volume data from private payors and will ultimately identify a new price for each of the approximately 1250 CPT codes on the CLFS. These prices will be based on the median of the data CMS obtains from applicable laboratories. As ASCP represents the entire laboratory testing workforce, we have a significant interest in the reshaping of the CLFS. As you work toward developing the proposed rules, ASCP encourages the agency to implement Sec. 216 of PAMA in a manner that minimizes disruption of laboratory services and operations. This is necessary to maintain the stability of the laboratory market and to ensure patient access to quality testing. Key Points We offer the following comments as an overview of some of the key points that we would urge CMS to keep in mind as it moves forward with its development of the proposed regulations.

ASCP Statement before CMS Public Meeting on CLFS Revaluation July 14, 2014 (1) Full Representation of the Entire Market for Laboratory Services One of the outstanding issues created by the new statute relates to who must report data and how that data should be analyzed. ASCP believes that it is imperative to create payment rates that properly reflect the market for laboratory services. For this to occur, the major clinical laboratory sectors must be adequately represented in the data collected. This includes reference or independent laboratories, hospital laboratories, and physician office laboratories. Due to the nature of financial relationships between clinical laboratories and payors, we are especially concerned about the possibility that hospital laboratories will not report sufficient data to aid in a proper revaluation of the CLFS. Robust participation in the data reporting of hospital laboratories is imperative to a proper revaluation of the CLFS. Therefore, ASCP urges CMS to require hospital and physician office laboratories to report private payor data that is not part of a bundled payment. Moreover, given the nature of payment rearrangements, ASCP is further concerned that even if the Agency were to require hospital laboratories to report data, the data collected from these entities will likely underrepresent their presence in the market for laboratory services. This could distort the ability of CMS to set payment rates that properly captures the true median price of laboratory services on then CLFS. Moreover, to ensure patient access to quality testing services at all laboratory sites, ASCP believes that it is imperative for prices to accurately represent rates everywhere in accordance with their respective market share. Therefore, ASCP respectfully encourages CMS to weight the data received in accordance with that laboratory type s respective market share. If hospital laboratories represent 50 percent of the market for testing services, then the data for these facilities should be weighted to 50 percent. This will help adjust the data to ensure that CMS s calculated median pricing accurately reflects the true market median price. CMS could further weight the data by location to ensure that calculated rates are reflective of the true urban-rural dynamics existing in the market for laboratory services. (2) Burden and Penalties ASCP is concerned that the current software capabilities for many clinical laboratories, most likely hospital laboratories, small independent laboratories and physician-owned laboratories may not support the reporting of required data. The cost and time necessary to upgrade or reconfigure laboratory software systems to support the reporting of payment rate and volume data may prove costly and difficult, if not impossible, for some laboratories to provide. Still, we believe the inclusions of data from these providers are critical to calculating an accurate median payment for each laboratory service on the CLFS. While this data are critically important, we further believe that weighting the data by market share may provide the agency with greater flexibility to provide regulatory relief to those laboratories that are most likely to struggle with the reporting requirements. We strongly urge CMS to consider weighting the data to market share. Further, we believe that the potential penalties are unrealistically punitive, i.e., $10,000 per day per infraction. Therefore, we would strongly urge CMS to address in its regulations ways in which it can minimize the imposition of excessive penalties as well as create exemptions or lesser penalties for those applicable laboratories making good-faith efforts to comply with the reporting requirements or who make accidental or inadvertent mistakes in reporting data. Page 2

ASCP Statement before CMS Public Meeting on CLFS Revaluation July 14, 2014 (3) Timeframes and Transparency Given the complexity of the data reporting system, ASCP encourages CMS to provide at least six months for laboratories to report data, once the initial collection period begins. This will provide laboratories with the time necessary to verify the adequacy and accuracy of the data collected. ASCP would also encourage CMS to establish an electronic reporting mechanism to collect this data and to establish a pilot phase to test the system s ability to collect the data. Further, to foster transparency, we urge CMS to publish the pilot median rates to allow stakeholders to review and comment on test-specific calculations. (4) Allow for Inclusion of Cost Data Another concern for ASCP is the cost of providing services. We note that payment rates of private payors may not adequately cover costs. Under a revalued CLFS, the newly calculated median prices may not accurately reflect the cost of providing the service. This could result in access problems in cases where price is significantly out-of-line with cost. ASCP urges CMS to establish a process that allows CMS to factor in cost as well as price. Moreover, we urge CMS to create an appeals mechanism to allow stakeholders to seek reconsideration of payment rates that may not adequately cover cost. (5) Adherence to Local Coverage Determination Process ASCP supports provisions in PAMA requiring adherence to Section 1869(f)(2)(B) of the Social Security Act as well as regulations found at 42 CFR 426. ASCP believes it to be critical that Medicare Administrative Contractors (MACs) adhere to the Local Coverage Determination Process (LCDs) requirements, not just for new decisions but also for LCDs up for review. This is needed to address some of the problems that have arisen with transparency and the ability of stakeholders to provide comment. Moreover, to enhance the ability of stakeholders to provide comment and to increase transparency, ASCP urges CMS to utilize the four MACs allowed by statute for the purposes of establishing coverage policies. (6) Utilizing HCPCS s ASCP urges CMS to utilize HCPCS Level 1 CPT codes to the extent possible when implementing new codes. Moreover, ASCP does not support the process utilized by the MolDx program to distinguish between FDA-cleared or approved tests and Laboratory Developed Tests. (7) GAO Study Lastly, we recognize that the following comment pertains mostly to the Government Accountability Office, but we would encourage the agency to work with the GAO to also address in its analysis an assessment of the impact of the new payment rates on hospital laboratories, including an examination of any related outsourcing or discontinuation of laboratory services that may occur in reaction to the changes in the fee schedule. That you for the opportunity today to address some of ASCP s initial concerns regard to the upcoming revaluation of the CLFS. ASCP looks forward to working collaboratively with the agency. Thank you. Page 3

ASCP Presumptive Drug Class Screening 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 optical observation including instrumented-assisted when performed (eg, dipsticks, cups, cards, cartridges), per date of service G0434 $19.84 This code is intended for presumptive drug screening procedures with one unit of service per date of service for all drugs tested. Methodology is direct optical observation, including instrumentassisted read. 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 G0431 minus 39% $99.20 less $38.69 $60.51 The crosswalk recommendation is intended to reflect the services performed for the typical patient. Here, the average number of drugs included in this panel is 11. The recommendation reflects the current required resources. 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 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 82491 $24.63 82489 $25.23 Procedures for the drugs on List B require additional resources than those on List A. Units of service are comparable. The methodology for this presumptive drug screen utilizes a thin layer chromatography, as does our recommended crosswalk of CPT 82489. 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 82492 $24.63 This new CPT code utilizes a new methdology not previously listed in the presumptive drug section. Therefore, it should be crosswalked to a similar methodology CPT code within the Path/Lab section of the CPT Manual: CPT 82492. DEFINITIVE DRUG ASSAYS Alcohols 82055 $14.74 Crosswalk to the specific alcohol code, CPT 82055. Alcohol biomarkers; 1 to 2 82055 $14.74 A crosswalk to the specific alcohol code, CPT 82055, should be utilized. Alcohol biomarkers; 3 or more 82055 + 10% $14.74 + $1.47 $16.21 This new definitive drug assay CPT code should be crosswalked to the specific alcohol code, CPT 82055. However, as additional resources are required to complete this procedure an increase about the base code is appropriate. 1

ASCP Alkaloids, not otherwise specified 82542 $24.63 Amphetamines; 1 to 2 82145 $21.20 Amphetamines; 3 to 4 Amphetamines; 5 or more Anabolic steroids; 1-2 82145 + 10% 82145 + 20% 82651 $21.20 + $2.12 $23.32 $21.20 + $4.24 $25.44 $35.22 ASCP recommends crosswalking this code to the methodology code, CPT 82542, generally used for alkaloids. A crosswalk to the specific Amphetamines code, CPT 82145, should be used. ASCP recommends a crosswalk to the specific Amphetamines code, CPT 82145, should be used plus an additional 10% to capture the additional resources utlized to identify additional drugs and/or metabolites. ASCP recommends a crosswalk to the specific Amphetamines code, CPT 82145, should be used plus an additional 20% to capture the additional resources utlized to identify additional drugs and/or metabolites. A crosswalk to the specific Dihydrotestosterone code, CPT 82651, should be used. Anabolic steroids; 3 or more 82651 $35.22 +$3.52 $38.74 A crosswalk to the specific Dihydrotestosterone code, CPT 82651, should be used plus 10% to capture the additional resources utlized to identify additional drugs and/or metabolites. Analgesics, non-opioid; 1 to 2 drugs 82003 $27.61 A crosswalk to the specific code for Acetaminophen, CPT 82003, should be used. Analgesics, non-opioid; 3 to 5 drugs 82003 $27.61 +$2.76 $30.37 A crosswalk to the specific code for Acetaminophen, CPT 82003, should be used plus 10% to cover the additional resources utlized to identify additional drugs and/or metabolites. Analgesics, non-opioid; 6 or more 82003 +20% $27.61 +$5.52 $33.13 A crosswalk to the specific code for Acetaminophen, CPT 82003, should be used plus 20% to cover the additional resources utlized to identify additional drugs and/or metabolites. Antidepressants, serotonergic class; 1 to 2 drugs 82492 $24.63 We recommend crosswalking this presumptive drug screen to a method code, CPT 82492. Antidepressants, serotonergic class; 3 to 5 82492 $24.63 +$2.46 $27.09 A crosswalk to method code, CPT 82492, plus 10% is recommended to capture the additional resources utilized to identify additional drugs and/or metabolites beyond the base code. 2

ASCP Antidepressants, serotonergic class; 6 or more 82492 +20% $24.63 +$4.92 $29.55 A crosswalk to method code, CPT 82492, plus 20% is recommended to capture the additional resources utilized to identify additional drugs and/or metabolites beyond the base code. Antidepressants, tricyclic and other cyclicals; 1 to 2 drugs 80152 $24.42 This code should be crosswalked to existing code for Amitriptyline, CPT 80152. Antidepressants, tricyclic and other cyclicals; 3 to 5 80152 $24.42 +$2.44 $26.86 A crosswalk to the Amitriptyline code, CPT 80152, plus an additional 10% to capture the additional resources utilized to test for additional drugs and/or metabolites beyond the base code. Antidepressants, tricyclic and other cyclicals; 6 or more 80152 +20% $24.42 +$4.88 $29.30 A crosswalk to the Amitriptyline code, CPT 80152, plus an additional 20% to capture the additional resources utilized to test for additional drugs and/or metabolites beyond the base code. Antidepressants, not otherwise specified 82492 $24.63 Antiepileptics, not otherwise specified; 1 to 3 drugs 80156 $19.87 ASCP recommends crosswalking this new code to method code, CPT 82492. A crosswalk to the code for antiepileptic Carbamazapine, CPT 80156, should be utitlized. Antiepileptics, not otherwise specified; 4 to 6 80156 $19.87 +$1.98 $21.85 A crosswalk to the code for antiepileptic Carbamazapine, CPT 80156, should be utilized plus an additional 10% to cover the additional resources involved in testing for additional drugs and/or metabolites. Antiepileptics, not otherwise specified; 7 or more 80156 +20% $19.87 +$3.97 $23.84 A crosswalk to the code for antiepileptic Carbamazapine, CPT 80156, should be utilized plus an additional 20% to cover the additional resources involved in testing for additional drugs and/or metabolites. Antipsychotics, not otherwise specified; 1 to 3 drugs 80159 $25.23 A crosswalk to the code for Clozapine, CPT 80159, is recommended. Antipsychotics, not otherwise specified; 4 to 6 80159 $25.23 +$2.52 $27.75 A crosswalk to the code for Clozapine, CPT 80159, is recommended plus an additional 10% to cover the additional resources expended to test for additional drugs and/or metabolites. 3

ASCP Antipsychotics, not otherwise specified; 7 or more 80159 +20% $25.23 +$5.04 $30.27 A crosswalk to the code for Clozapine, CPT 80159, is recommended plus an additional 20% to cover the additional resources expended to test for additional drugs and/or metabolites. Barbiturates 82205 $15.62 A crosswalk to the code for Barbiturates, CPT 82205, is recommended. Benzodiazepines; 1-12 80154 $25.23 A crosswalk to the code for Benzodiazepines, CPT 80154, is recommended. Benzodiazepines; 13 or more 80154 $25.23 +$2.52 $27.75 A crosswalk to the code for Benzodiazepines, CPT 80154, is recommended plus an additional 10% to cover the additional resources expended to test for additional drugs and/or metabolites. Buprenorphine 83925 $26.54 A crosswalk to the code for Opiates, CPT 83925, is recommended. Cannabinoids, natural 82542 $24.63 We recommend crosswalking to the method code CPT 82542. Cannabinoids, synthetic; 1 to 3 82542 $24.63 We recommend crosswalking to the method code CPT 82542. Cannabinoids, synthetic; 4 to 6 Cannabinoids, synthetic; 7 or more 82492 82492 +20% $24.63 +$2.46 $27.09 $24.63 +$4.92 $29.55 A crosswalk to method code CPT 82492 plus an additional 10% to cover the additional resources utilized to test for additional drugs and/or metabolites. A crosswalk to method code CPT 82492 plus an additional 20% to cover the additional resources utilized to test for additional drugs and/or metabolites. Cocaine 82520 $20.68 ASCP recommends a crosswalk to the code for Cocaine, CPT 82520. Fentanyl 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Gabapentin, non-blood 80171 $18.09 A crosswalk to the code specific to Gabapentin, CPT 80171, is recommended. Heroin metabolite 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Ketamine and norketamine 82542 $24.63 Crosswalk to the method code 82542. 4

ASCP Methadone 83840 $22.28 A crosswalk to the code for Methadone, CPT 83840, is recommended. Methylenedioxyamphetamines (MDA, MDEA, MDMA) 82145 $21.20 A crosswalk to the code for Amphetamines, CPT 82145, is recommended. Methylphenidate 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Opiates, one or more 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Opioids and opiate analogs; 1 to 2 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Opioids and opiate analogs; 3 to 4 Opioids and opiate analogs; 5 or more 83925 83925 +20% $26.54 +$2.65 $29.19 $26.54 +$5.30 $31.84 ASCP recommends a crosswalk to the Opiates code 83925 plus an additional 10% to cover the additional resources used to test for additional drugs and/or metabolites. ASCP recommends a crosswalk to the Opiates code 83925 plus an additional 20% to cover the additional resources used to test for additional drugs and/or metabolites. Oxycodone 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Phencyclidine 83992 $20.05 Crosswalk to the specific code for Phencyclidine 83992. Pregabalin 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Propoxyphene 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Sedative hypnotics (non-benzodiazepines) 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Skeletal muscle relaxants; 1-2 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Skeletal muscle relaxants; 3 or more 82542 $24.63 +$2.46 $27.09 ASCP recommends crosswalking to the method code CPT 82542 plus and additional 10% to cover the additional resources utitlized to test for more drugs and/or metabolites. Stimulants, synthetic 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Tapentadol 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. 5

ASCP Tramadol 83925 $26.54 ASCP recommends a crosswalk to the code for Opiates, CPT 83925. Stereoisomer (enantiomer) analysis, single drug class 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1 to 3 82542 $24.63 ASCP recommends crosswalking to the method code CPT 82542. Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4 to 6 82542 $24.63 +$2.46 $27.09 ASCP recommends crosswalking to the method code CPT 82542 plus an additional 10% to cover the additional resources utitlized to test for more drugs and/or metabolites. 801XY47 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more 83925 +20% $24.63 +$4.92 $29.55 ASCP recommends crosswalking to the method code CPT 82542 plus an additional 20% to cover the additional resources utitlized to test for more drugs and/or metabolites. THERAPEUTIC DRUG ASSAYS - 801XX 801XX Digoxin; free 80162 $18.12 A crosswalk to the code for Digoxin, CPT 80162, is recommended. 801XX Valproic acid (dipropylacetic acid); free 80164 $18.49 A crosswalk to the code for Dipropylacetic acid (valproic acid) 80164 is recommended. Moleculars Tier 1 812XX FLT3 (FMS-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis tyrosine kinase domain (TKD) variants (eg, D835, I836) 81245 $165.92 FLT3 TKD uses similar methodology to 81245 and also is similar in resources in that covers the same number of variants and is in the same gene code family. 812XX MLH1 (mutl homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis 81294 $190.68 MLH1 promoter methylation analysis is similar in resources to 81294 MLH1 in that it covers the same number of variants and is in the same genecode family. 8131X3 PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer) 81293 $256.06 ASCP supports crosswalking PCA3 to 81293, MLH1 known variants. This crosswalk reflects similar resources as identified by a Palmetto cost analysis of $256. Based on its analysis, Palmetto set a rate of $260, which is similar to the $259.06 of 81293. 6

ASCP Genomic Sequencing Procedures - CMS 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 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 Exome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis 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) Exome (eg, unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained exome sequence (eg, updated knowledge or unrelated condition/syndrome) 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 Genome (eg, unexplained constitutional or heritable disorder or syndrome); sequence analysis 7

ASCP 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) Genome (eg, unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence (eg, updated knowledge or unrelated condition/syndrome) 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 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 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 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 8

ASCP Nuclear encoded mitochondrial genes (eg, neurologic or myopathic phenotypes), genomic sequence panel, must include analysis of at least 100 genes. Including, BCSIL, C10orf2, COQ2, COX 10, DGUOK, MPV17, OPA1, PDSS2 POLG, POLG2, RRM2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP 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 Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMAT3A, 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 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 9

ASCP Whole mitochondrial genome (eg, Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and strokelike episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERFF], neuropathy, ataxis and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON], genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection Whole mitochondrial genome large deletion analysis panel (eg, Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed X-linked intellectual disability (XLID) (eg, syndromic and nonsyndromic XLID); genomic sequence analysis panel, must include sequencing of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KCM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 X-linked intellectual disability (XLID) (eg, syndromic and nonsyndromic XLID); duplication/deletion gene analysis, must include analysis of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KCM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 Multianalyte Assays with Algorithmic Analyses (MAAA, Category I) Administrative s not listed 815XX Oncology (breast), mrna, gene expression profiling by realtime RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score Oncotype DX Breast Cancer Assay (Genomic Health, Inc.) 10

ASCP CHEMISTRY - CMS 830XX 830XX Growth stimulation expressed gene 2 (ST2, interleukin I receptor like-1) 82777 $30.01 The ST2 assay is a quantitative 2-site manual enzyme-linked immunosorbent assay (ELISA) and is an FDA 510K-cleared in vitro diagnostic procedure used for cardiac patient management. The test should be crosswalked to Galectin-3, CPT 82777, as it is similar in methodology and clinical utility. MICROBIOLOGY 875XX 875XX 875XX 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 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 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 87631 $175.02 87632 $291.18 87633 $568.60 This gastrointestinal microorganism multiplex nucleic acid-based assay should be crosswalked to CPT 87631. Both assays involve multiplex reverse transcription and amplified probe technique for 3-5 targets. This gastrointestinal microorganism multiplex nucleic acid-based assay should be crosswalked to CPT 87632. Both assays involve multiplex reverse transcription and amplified probe technique for 6-11 targets. This gastrointestinal microorganism multiplex nucleic acid-based assay should be crosswalked to CPT 87633. Both assays involve multiplex reverse transcription and amplified probe technique for 12-25 targets. 875XX Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (eg 6,11,42,43,44) 87621 $47.87 The three new HPV CPT codes were added to provide specificity to the type of procedures and to antigens tested. The technology is the same as that of CPT 87621. Therefore, this new code should be crossed walking to 87621. 11

ASCP 875XX 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) 87621 $47.87 The three new HPV CPT codes were added to provide specificity to the type of procedures and to antigens tested. The technology is the same as that of CPT 87621. Therefore, this new code should be crosswalked to 87621. 875XX Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45 if performed 87621 $47.87 The three new HPV CPT codes were added to provide specificity to the type of procedures and to antigens tested. The technology is the same as that of CPT 87621. Therefore, this new code should be crossedwalked to 87621. 875XX Infectious agent antigen detection by immunoassay with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies 87389 $32.86 The new code should be crosswalked to similar immunoassay, CPT 87389, HIV antigen and HIV antibodies in a single result. The new code is somewhat different than the proposed crosswalk in that differentiates between the antigen and antibodies providing two results. Other Procedures 89XXX Cryopreservation; mature oocytes 89258 GXXXX G s Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3) gap-fill no listed in the 2014 CLFS The procedure is similar to 89258 Cryopreservation; embryo(s). 12