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. #
New 2014 Code
Descriptor
Gap 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.
80154 Benzodiazepines
801XX
Clozapine
Crosswalk
© 2013 College of American Pathologists. All rights reserved.
Current Medicare National
Limit Amount: $25.43.
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.
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.
2
New 2014
Code
Descriptor
Gap 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.
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.
© 2013 College of American Pathologists. All rights reserved.
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.
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.
3
New 2014
Code
Descriptor
Gap 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.
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.
© 2013 College of American Pathologists. All rights reserved.
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.
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.
4
New 2014 Code
Descriptor
Gap fill or
Crosswalk
If crosswalk, then to what
existing code?
Rationale
Therapeutic Drug
Assays
801XX7
Mycophenolate
(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.
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.
© 2013 College of American Pathologists. All rights reserved.
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.
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.
5
New 2014 Code
Descriptor
Gap 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.
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.
© 2013 College of American Pathologists. All rights reserved.
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.
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.
6
New 2014 Code
Descriptor
Gap fill or
Crosswalk
If crosswalk, then to what
existing code?
Rationale
Molecular
Pathology
Tier 1 Molecular
Pathology
Procedures
81161
DMD (dystrophin) (eg,
Duchenne/Becker
muscular dystrophy)
deletion analysis, and
duplication analysis, if
performed
© 2013 College of American Pathologists. All rights reserved.
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.
7
New 2014 Code
Descriptor
Gap fill or
Crosswalk
If crosswalk, then to what
existing code?
Rationale
Molecular
Pathology
Tier 1 Molecular
Pathology
Procedures
812XX
MGMT (O6methylguanine 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
© 2013 College of American Pathologists. All rights reserved.
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 (O6methylguanine 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.
8
New 2014 Code
Descriptor
Gap fill
or
If crosswalk, then to what
Crosswal existing code?
k
Rationale
Multianalyte
Assays
with Algorithmic
Analyses
(Category I)
81508
Fetal congenital
abnormalities,
biochemical assays of
two proteins (PAPPA, hCG [any form]),
utilizing maternal
serum, algorithm
reported as a risk
score
84702 Gonadotropin, chorionic
(hCG); quantitative ) with a
CLFS NLA of $20.70
plus
Crosswalk
© 2013 College of American Pathologists. All rights reserved.
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.
9
New 2014
Code
Descriptor
Gap 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
No comment at this time
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
© 2013 College of American Pathologists. All rights reserved.
N/A
10
New 2014
Code
Descriptor
Gap 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
© 2013 College of American Pathologists. All rights reserved.
87511 Infectious
agent detection by
nucleic acid (DNA or
RNA); Gardnerella
vaginalis, amplified
probe technique
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.
Current Medicare
National Limit
Amount: $48.24
11
Other Codes
Descriptor
Gap fill or
Crosswalk
If crosswalk, then to
what existing code?
No additional
comment at
this time
NA
No additional
comment at
this time
NA
Rationale
Reconsideration
Requests
0001M
0002M
Infectious disease, HCV, six
biochemical assays (ALT, A2macroglobulin, apolipoprotein
A-1, total bilirubin, GGT, and
haptoglobin) utilizing serum,
prognostic algorithm reported as
scores for fibrosis and
necroinflammatory activity in
liver
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)
© 2013 College of American Pathologists. All rights reserved.
No additional comment at
this time
No additional comment at
this time
12
Other Codes
Descriptor
Gap 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 time
NA
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 time
NA
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 time
NA
No additional comment at
this time
© 2013 College of American Pathologists. All rights reserved.
No additional comment at
this time
13
Other Codes
Descriptor
Gap fill or
Crosswalk
If crosswalk, then
to what existing
code?
Rationale
Reconsideration
Requests
Endocrinology (type 2 diabetes),
biochemical assays of seven analytes
(glucose, HbAlc, insulin, hs-CRP,
81506
adoponectin, ferritin, interleukin 2receptor alpha), utilizing serum or
plasma, algorithm reporting a risk
score
Fetal congenital abnormalities,
biochemical assays of three proteins
81509
(PAPP-A, hCG [any form], DIA),
utilizing maternal serum, algorithm
reported as a risk score
Fetal congenital abnormalities,
biochemical assays of three analytes
81510
(AFP, uE3, hCG [any form]),
utilizing maternal serum, algorithm
reported as a risk score
Fetal congenital abnormalities,
biochemical assays of four analytes
(AFP, uE3, hCG [any form], DIA)
81511
utilizing maternal serum, algorithm
reported as a risk score (may include
additional results from previous
© 2013 College of American Pathologists. All rights reserved.
biochemical testing)
No additional comment at this
time
No additional
comment at
this time
NA
No additional
comment at
this time
NA
No additional comment at this
time
No additional
comment at
this time
NA
No additional comment at this
time
No additional
comment at
this time
No additional comment at this
time
NA
14
Other Codes
Descriptor
Gap fill or
Crosswalk
If crosswalk,
then to what
existing code?
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
Galectin-3
No
additional
comment at
this time
NA
Rationale
Reconsideration
Requests
81512
82777
© 2013 College of American Pathologists. All rights reserved.
No additional comment at this time
No additional comment at this time
15
