CLIA LAB Code CPT Update – 80163, 80165, 81246, 81288, 81313,81410,81519, 83006, 87505,87506

Code 80163 (Digoxin; free).
Industry Recommendation: Crosswalk to Code 80162 (Digoxin).
CMS Recommendation: Crosswalk to Code 80162 (Digoxin).
Rationale: CMS agrees with the commenters recommending the crosswalk to Code 80162,based on similarities in function.


Code 80165 (Valproic acid (dipropylacetic acid); free).
Industry Recommendation: Crosswalk to Code 80164 (Dipropylacetic acid (valproic acid)).
CMS Recommendation: Crosswalk to Code 80164 (Dipropylacetic acid (valproic acid)).
Rationale: CMS agrees with the commenters recommending the crosswalk to Code 80164,
based on similarities in function.

Code 81246 (FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (eg, D835, I836)).

Code 81288 (MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary nonpolyposis
colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis).

Code 81313 (PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)).

Industry Recommendations: Various crosswalks to other Tier 1 codes.
CMS Recommendation: Gapfill.
Rationale: As we have done with past molecular codes, our final recommendation is that this series of new Tier 1 molecular pathology codes be gapfilled for 2015. This will allow CMS and its contractors the opportunity to gather current information about the manner in which the tests are performed and the resources necessary to provide them, so that ultimately CMS can set an appropriate payment rate for these tests.

Codes 81410 through 81471 (21 codes)
Industry Recommendation: Various crosswalks to other codes or gapfill.
CMS Recommendation: Gapfill.
Rationale: As we have done with past molecular codes, our final recommendation is that this series of new Tier 2 molecular pathology codes be gapfilled for 2015. This will allow CMS and its contractors the opportunity to gather current information about the manner in which the tests are performed and the resources necessary to provide them, so that ultimately CMS can set an appropriate payment rate for these tests.

Code 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).

Code 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).

Code 0008M (Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalinfixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score).

Code 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).

Industry Recommendations: Gapfill.
CMS Recommendation: Gapfill if the Medicare contractor determines the code is payable.
Rationale: The above codes have been classified beginning in 2015 as Multianalyte Assays with Algorithmic Analysis (MAAA). However, we do not believe there is a single consistent definition for a MAAA that allows us to make a categorical determination of whether these codes constitute diagnostic laboratory tests. The Medicare Administrator Contractor will continue to consider each individual test that is classified by the CPT as a MAAA for coverage and payment.

Code 83006 (Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1)).
Industry Recommendation: Crosswalk to Code 82777 (Galectin-3).
CMS Recommendation: Crosswalk to Code 82777.
Rationale: CMS agrees with the commenters recommending the crosswalk to Code 82777, based on similarities in function.

Code 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).

Industry Recommendation: Crosswalk to code 87631 (Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 3-5 targets).
CMS Recommendation: Crosswalk to code 87631.
Rationale: CMS agrees with the commenters recommending the crosswalk to Code 87631,
based on similarities in function.

Code 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).

Industry Recommendation: Crosswalk to Code 87632 (Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 6-11 targets).
CMS Recommendation: Crosswalk to Code 87632.
Rationale: CMS agrees with the commenters recommending the crosswalk to Code 87632,based on similarities in function.