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cap.org v. # College of American Pathologists Clinical Laboratory Fee Schedule Recommendations Michael D. McEachin, MD, CPT Advisor AMA-CPT Advisory Committee July 10, 2013

Cap.org v. # College of American Pathologists Clinical Laboratory Fee Schedule Recommendations Michael D. McEachin, MD, CPT Advisor AMA-CPT Advisory Committee

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cap.org v. #

College of American Pathologists Clinical Laboratory Fee Schedule Recommendations

Michael D. McEachin, MD, CPT Advisor AMA-CPT Advisory Committee

July 10, 2013

New 2014 Code DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Therapeutic Drug Assays

801XX1 Caffeine Crosswalk

82491 Chromatography, quantitative, column (eg, gas liquid or HPLC); single analyte not elsewhere specified, single stationary and mobile phase Current Medicare National Limit Amount: $24.82.

CPT code 801XX1 Caffeine was created for the Therapeutic drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Caffeine. Crosswalk to CPT code 82491 Chromatography, quantitative, column (eg, gas liquid or HPLC); single analyte not elsewhere specified, single stationary and mobile phase is recommended as a comparable quantitative methodology is used.

801XXClozapine

Crosswalk80154 Benzodiazepines Current Medicare National Limit Amount: $25.43.

CPT code 801XX2 Clozapine was created for the Therapeutic drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Clozapine. Crosswalk to CPT code 80154 Benzodiazepines is recommended as comparable quantitative methodology is used.

© 2013 College of American Pathologists. All rights reserved. 2

New 2014 Code

DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Therapeutic Drug Assays

801XX3 Everolimus Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase Current Medicare National Limit Amount: $24.82.

CPT code 801XX3 Everolimus was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Everolimus. Crosswalk to CPT code 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

801XX4 Gabapentin Crosswalk

82491 Chromatography, quantitative, column (eg, gas liquid or HPLC); single analyte not elsewhere specified, single stationary and mobile phase Current Medicare National Limit Amount: $24.82.

CPT code 801XX4 Gabapentin was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Gabapentin. Crosswalk to CPT code 82491 Chromatography, quantitative, column (eg, gas liquid or HPLC); single analyte not elsewhere specified, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

© 2013 College of American Pathologists. All rights reserved. 3

New 2014 Code

DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Therapeutic Drug Assays

801XX5 Lamotrigine Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase Current Medicare National Limit Amount: $24.82.

CPT code 801XX5 Lamotrigine was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Lamotrigine. Crosswalk to 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

801XX6 Levetiracetam Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase  Current Medicare National Limit Amount: $24.82.

CPT code 801XX6 Levetiracetam was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Levetiracetam. Crosswalk to 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

© 2013 College of American Pathologists. All rights reserved. 4

New 2014 Code DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Therapeutic Drug Assays

801XX7Mycophenolate (mycophenolic acid)

Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase

Current Medicare National Limit Amount: $24.82.

CPT code 801XX7 Mycophenolate was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Mycophenolate. Crosswalk to CPT code 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

801XX8 Oxcabazepine Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase

Current Medicare National Limit Amount: $24.82.

CPT code 801XX8 Oxcarbazepine was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Oxcarbazepine. Crosswalk to CPT code 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

© 2013 College of American Pathologists. All rights reserved. 5

New 2014 Code DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Therapeutic Drug Assays

801XX9 Tiagabine Crosswalk

82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase

Current Medicare National Limit Amount: $24.82.

CPT code 801XX9 Tiagabine was created for the Therapeutic Drug Assays subsection of CPT through the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Tiagabine. Crosswalk to CPT code 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

802XX Zonisamide Crosswalk

CPT 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase

Current Medicare National Limit Amount: $24.82.

CPT code 802XX Zonisamide was created for the Therapeutic Drug Assays subsection of CPTthrough the efforts of the AMA-CPT Quantitative Drug Testing Workgroup to report quantitative assessment of Zonisamide. Crosswalk to CPT code 82542 Column chromatography/mass spectrometry (eg, GC/MS, or HPLC/MS), analyte not elsewhere specified; quantitative, single stationary and mobile phase is recommended as comparable quantitative methodology is used.

© 2013 College of American Pathologists. All rights reserved. 6

New 2014 Code DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Molecular PathologyTier 1 Molecular Pathology Procedures

81161

DMD (dystrophin) (eg, Duchenne/Becker muscular dystrophy) deletion analysis, and duplication analysis, if performed

Crosswalk

81407 Molecular pathology procedure, Level 8 (eg, analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform) 

There is no current Medicare National Limit amount at this time.

CAP supported physician schedule placement for this code and still does. As part of the RUC process, CPT code 81161 was recognized as equivalent in practice expense and physician work to Tier 2 code 81407 Level 8 Molecular pathology procedure, Level 8 (eg, analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform). Considering its current placement on the CLFS, CAP recommends the technical aspects of 81161 be crosswalked to 81407.

© 2013 College of American Pathologists. All rights reserved. 7

New 2014 Code DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Molecular PathologyTier 1 Molecular Pathology Procedures

812XX

MGMT (O6-methylguanine DNA methyltransferase) (eg, Brain Cancer) allele specific identification of dense promoter methylation, analysis of the MGMT gene, prognostic/predictive for response for treatment which include alkylating agents such as temozolamide therapy in tumor tissue

Crosswalk

81401 Molecular pathology procedure, Level 2 (eg, 2-10 SNPs, 1 methylated variant, or 1 somatic variant [typically using nonsequencing target variant analysis], or detection of a dynamic mutation disorder/triplet repeat)

There is no current Medicare National Limit amount at this time.

New code 812XX MGMT was created to allow more specific reporting of MGMT (O6-methylguanine DNA methyltransferase) (eg, Brain Cancer) allele specific identification of dense promoter methylation, analysis of the MGMT gene, prognostic/predictive for response for treatment which include alkylating agents such as temozolamide therapy in tumor tissue.CAP recommends the technical aspects of 812XX be crosswalked to 81401 as similar technical resources are required.

© 2013 College of American Pathologists. All rights reserved. 8

New 2014 Code Descriptor

Gap fill or

Crosswalk

If crosswalk, then to what existing code?

Rationale

Multianalyte Assays

with Algorithmic Analyses

(Category I)

81508

Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score

Crosswalk

84702 Gonadotropin, chorionic (hCG); quantitative ) with a CLFS NLA of $20.70

plus

84163 Pregnancy-associated plasma protein-A (PAPP-A) with a CLFS NLA of $20.70

Current Medicare National Limit Amount: $20.70 + $20.70 = $41.40

Code 81508 Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score was established for CPT 2013 within the new subsection of CPT for Multianalyte Assays with Algorithmic Analyses (MAAAs) for procedures that utilize multiple results derived from assays of various types. Algorithmic analysis using the results of these assays as well as other patient information (if used) is the performed and reported typically as a numeric score(s) or as a probability. A crosswalk to 84702 Gonadotropin, chorionic (hCG); quantitative with a CLFS NLA of $20.70 plus  84163 Pregnancy-associated plasma protein-A (PAPP-A) with a CLFS NLA of $20.70 is recommended as similar clinical resources are used to generate laboratory results for each analyte.If there is an additional cost associated with the generation/maintenance of the algorithm for new MAAA code 81508, it should be recognized as well.

© 2013 College of American Pathologists. All rights reserved. 9

New 2014 Code

DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Multianalyte Assays

with Algorithmic

Analyses (Category I)

815XX1

Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores

N/A

No comment at this time

815XX3

Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

N/A

No comment at this time.

© 2013 College of American Pathologists. All rights reserved. 10

New 2014 Code

DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Microbiology

876XX

Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique

Crosswalk

87511 Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, amplified probe technique

Current Medicare National Limit Amount: $48.24

New code 876XX was established to report Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique.

A crosswalk to 87511 is recommended as a similar amplified probe technique is used.

© 2013 College of American Pathologists. All rights reserved. 11

Other Codes DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Reconsideration Requests

0001M

Infectious disease, HCV, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver

No additional comment at

this timeNA No additional comment at

this time

0002M

Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH)

No additional comment at

this timeNA

No additional comment at this time

© 2013 College of American Pathologists. All rights reserved. 12

Other Codes DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Reconsideration Requests

0003M

Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH)

No additional comment at

this timeNA

No additional comment at this time

81500

Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score

No additional comment at

this timeNA

No additional comment at this time

81503

Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score

No additional comment at

this timeNA

No additional comment at this time

© 2013 College of American Pathologists. All rights reserved. 13

Other Codes DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Reconsideration Requests

81506

Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbAlc, insulin, hs-CRP, adoponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score

No additional comment at

this timeNA

No additional comment at this time

81509

Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score

No additional comment at

this timeNA

No additional comment at this time

81510

Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score

No additional comment at

this timeNA

No additional comment at this time

81511

Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing)

No additional comment at

this timeNA

No additional comment at this time

© 2013 College of American Pathologists. All rights reserved. 14

Other Codes DescriptorGap fill or Crosswalk

If crosswalk, then to what existing code?

Rationale

Reconsideration Requests

81512

Fetal congenital abnormalities, biochemical assays of five analytes (AFP, uE3, total hCG, hyperglycosylated hCG, DIA) utilizing maternal serum, algorithm reported as a risk score

No additional

comment at this time

NA No additional comment at this time

82777 Galectin-3

No additional

comment at this time

NANo additional comment at this time

© 2013 College of American Pathologists. All rights reserved. 15