The budgetary and policy climate will greatly impact laboratories in 2013. With the increased growth shift toward the adoption of accountable care organizations (ACOs), as well as bundled reimbursement strategies under this model, it is essential that labs understand correct coding and potential payment changes.While the molecular coding issue has been addressed, pricing for codes is far from finalized. The Centers for Medicare and Medicaid Services (CMS) announced in its calendar year 2013 physician fee schedule (PFS) final ruling that it will place the new molecular pathology codes under the clinical laboratory fee schedule (CLFS). Part of this determination stemmed from the fact that approximately 80 percent of most molecular tests were interpreted by nonphysicians in 2010.¹ As the PFS payments are ordinarily for services requiring a physician to perform, and as the CLFS is in existence as an alternative fee schedule, it was chosen for the molecular tests fee schedule. CMS will not publish the national payment amounts for these codes as reimbursement for CY2013 will be set by the gap-filling method. This isn’t a well-used methodology as compared to “crosswalking” and has a history of issues among contractors, with a particular example of note involving HbA1c testing. With more than 100 molecular tests to be gap-filled, labs can expect a wide range in pricing. The payments for these codes will be published at a later date as Medicare contractors (MACs, carriers) complete the gap-filling methodology. It is estimated the CLFS will be reduced by 4.95 percent. Should the sequestering issue be resolved before year-end, which represents 2 percent of this total, then the CLFS will only be reduced by 2.95 percent. Keep in mind that Part B lab spending represented only 1.6 percent of the total Medicare spending in 2011. With one of the largest single additions to the CPT code set in 2012, the American Medical Association (AMA) continues in 2013 by adding additional codes in the Molecular Pathology section of the code book. In conjunction with the move to the new coding system for molecular pathology, the AMA deleted all of the “stacking codes” (83890-83914) for 2013. Expect to see increased editing by payers for the new codes. With this transition from stack codes to single codes, it makes possible tighter editing within their systems for diagnosis coverage decisions. In addition, the array-based evaluation codes (88384-88386) have also been deleted. The molecular pathology Tier 1 and Tier 2 codes will be used exclusively for molecular diagnostic coding in 2013. Thirteen new codes have been added to Tier 1 and the base descriptor of the 81400-81408 code series (Tier 2 codes) has been revised to include 183 new analytes in this section, plus one additional code for unlisted molecular pathology procedures. The AMA added a new subsection and heading, Multianalyte Assays with Algorithmic Analyses (MAAAs) in the category 1 introductory guidelines. These procedures utilize multiple results derived from assays of various types (including molecular pathology, fluorescent in situ hybridization, and non-nucleic acid-based assays). In concert with the addition of this new subsection, the CPT code set also contains a new administrative code list (Appendix O). However, at least for 2013, CMS will not recognize these codes for payment purposes, but CMS did state in the CY2013 PFS final ruling that it would accept comments and revisit these codes for 2014. New definitions for inversion, loss of heterozygosity, and uniparental disomy have been added to the introduction of the Molecular Pathology section. In addition to the molecular pathology changes, additional code changes in the Pathology and Laboratory section occurred: 10 codes have been revised and 18 additional codes have been added to the Immunology, Tissue Typing, Microbiology, and Chemistry sections. With the deletion of the 83912-26 code by the AMA for CY2013, CMS introduced a new G-code to replace 83912-26. G0452-26 will be used by pathologists when an interpretation of a molecular pathology test is performed. Importantly, however, nonphysician practitioners (e.g., Ph.D. scientists etc.) are not eligible to report this code for Medicare services; only physicians may bill this code. G0452 must be billed with modifier 26 since it was placed in a category of code that CMS considers interpretation services of clinical laboratory tests. CMS designated the G0452 code as an interim code and stated that it will be monitoring the use of the code, likely for accuracy and volume. Since CMS only allowed one unit of service per Medicare beneficiary per date of service for the 83912-26 code regardless of the number of molecular tests interpreted in that patient case, the G0452 code will likely follow that requirement as well. Right now it is uncertain how the commercial payers will address this interpretation code, but most expect they will likely accept the G0452-26 code as a replacement for 83912-26. The following is a list of the new, deleted, and revised codes for 2013 in the Pathology and Laboratory Medicine section.

MOLECULAR BIOLOGY
NEW CODES	CODE DESCRIPTION
G0452	Molecular pathology procedure; physician interpretation and report
81201	Gene analysis (adenomatous polyposis coli), full gene sequence
81202	Gene analysis (adenomatous polyposis coli), known familial variants
81203	Gene analysis (adenomatous polyposis coli), duplication/deletion variants
81235	Gene analysis (epidermal growth factor receptor), common variants
81252	Gene analysis (gap junction protein, beta 2, 26kDa; connexin 26), full gene sequence
81253	Gene analysis (gap junction protein, beta 2, 26kDa; connexin 26), known familial variants
81254	Gene analysis (gap junction protein, beta 6, 30kDa, connexin 30), common variants
81321	Gene analysis (phosphatase and tensin homolog), full sequence analysis
81322	Gene analysis (phosphatase and tensin homolog), known familial variant
81323	Gene analysis (phosphatase and tensin homolog), duplication/deletion variant
81324	Gene analysis (peripheral myelin protein 22), duplication/deletion analysis
81325	Gene analysis (peripheral myelin protein 22), full sequence analysis
81326	Gene analysis (peripheral myelin protein 22), known familial variant
81479	Unlisted molecular pathology procedure
CHEMISTRY
NEW CODES	CODE DESCRIPTION
82777	Galectin-3 level
IMMUNOLOGY
NEW CODES	CODE DESCRIPTION
86152	Cell enumeration using immunologic selection and identification in fluid specimen
86153	Cell enumeration using immunologic selection and identification in fluid specimen; physician interpretation and report, when required
86711	Analysis for antibody to John Cunningham virus
TISSUE TYPING
NEW CODES	CODE DESCRIPTION
86828	Assessment of antibody to human leukocyte antigens (HLA) for the presence or absence of antibody(ies) to HLA Class I and Class II HLA antigens
86829	Assessment of antibody to human leukocyte antigens (HLA) for the presence or absence of antibody(ies) to HLA Class I and Class II HLA antigens
86830	Assessment of antibody to human leukocyte antigens (HLA) with antibody identification by qualitative panel using complete HLA phenotypes, HLA Class I
86831	Assessment of antibody to human leukocyte antigens (HLA) with antibody identification by qualitative panel using complete HLA phenotypes, HLA Class II
86832	Assessment of antibody to human leukocyte antigens (HLA) with high definition qualitative panel for identification of antibody specificities, HLA Class I
86833	Assessment of antibody to human leukocyte antigens (HLA) with high definition qualitative panel for identification of antibody specificities, HLA Class II
86834	Assessment of antibody to human leukocyte antigens (HLA), HLA Class I
86835	Assessment of antibody to human leukocyte antigens (HLA) with solid phase assays, HLA Class II
MICROBIOLOGY
NEW CODES	CODE DESCRIPTION
87631	Detection test for respiratory virus, multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 3-5 targets
87632	Detection test for respiratory virus, multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 6-11 targets
87633	Detection test for respiratory virus, multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 12-25 targets
87910	Analysis test for cytomegalovirus
87912	Analysis test for hepatitis B virus
SURGICAL PATHOLOGY
NEW CODES	CODE DESCRIPTION
88375	Microscopic imaging using an endoscope, interpretation and report, real-time or referred
MULTIANALYTE ASSAYS WITH ALGORITHMIC ANALYSES (MAAA)
NEW CODES	CODE DESCRIPTION
81500	Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
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
81506	Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, adoponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reported as a risk score
81508	Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
81509	Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score
81510	Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
81511	Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) utilizing maternal serum, algorithm reported as a risk score
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
81599	Unlisted multianalyte assay procedure with algorithmic analysis
REVISED CODE DESCRIPTORS (Items underlined represent revised verbiage, strikethrough represents deleted verbiage)
REVISED CODES	CODE DESCRIPTION
82009	Acetone or other ketone bodies Ketone body(s) (eg, acetone, acetoacetic acid, serum beta-hydroxybutyrate); qualitative
87498	Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, reverse transcription and amplified probe technique
87521	Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, reverse transcription and amplified probe technique
87522	Infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, reverse transcription and quantification
87535	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, reverse transcription and amplified probe technique
87536	Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, reverse transcription and quantification
87538	Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, reverse transcription and amplified probe technique
87539	Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, reverse transcription and quantification
81401	FGFR3 (fibroblast growth factor receptor 3) (eg, achondroplasia, hypochondroplasia), common variants (eg, 1138G>A, 1138G>C, 1620C>A, 1620C>G)HTT (huntingtin) (eg, Huntington disease), evaluation to detect abnormal (eg, Huntington disease), evaluation to detect abnormal expanded alleles) expanded
81402	Molecular pathology procedure, Level 3 (eg, >10 SNPs, 2-10 methylated variants, or 2-10 somatic variants [typically using non-sequencing target variant analysis], immunoglobulin and T-cell receptor gene rearrangements, duplication/deletion variants of 1 exon, loss of heterozygosity [LOH], uniparental disomy [UPD])
81403	KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma), gene analysis, variant(s) in exon 23 (eg, codon 61)
DELETED CODES	CODE DESCRIPTION
83890	Molecule isolate
83891	Molecule isolate nucleic
83892	Molecular diagnostics
83893	Molecule dot/slot/blot
83894	Molecule gel electrophor
83896	Molecular diagnostics
83897	Molecule nucleic transfer
83898	Molecule nucleic ampli each
83900	Molecule nucleic ampli 2 seq
83901	Molecule nucleic ampli addon
83902	Molecular diagnostics
83903	Molecule mutation scan
83904	Molecule mutation identify
83905	Molecule mutation identify
83906	Molecule mutation identify
83907	Lyse cells for nucleic ext
83908	Nucleic acid signal ampli
83909	Nucleic acid high resolute
83912	Genetic examination
83914	Mutation ident ola/sbce/aspe
88385	Eval molecul probes 51-250
88386	Eval molecul probes 251-500
CPT codes © American Medical Association

  Laboratories should begin with the coding crosswalks for the old stacking code assignments to the new molecular pathology codes. Precise assignment of the codes should be followed with an update to the chargemaster for these new codes. The chargemaster is the data file that contains the laboratory pricing and coding information used to populate service claims. Outdated information in the file can cause a claim to be rejected and quickly affect cash flow. While there are still many uncertainties regarding the CMS contractor pricing, there are even more where the private payers are concerned. With the volume of ACO growth, the management of cost will be imperative. Strategies to recoup lost revenue due to pricing reductions should be carefully explored and accessed for profitability margins to ensure the continued fiscal viability of the lab. Donna Beasley can be reached at Donna.Beasley@McKesson.com, and Rick Oliver can be reached at Rick.Oliver@McKesson.com. 1. American Medical Association