HCPCS Codes Subject To/Excluded From CLIA Edits

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HCPCS Codes Subject to and Excluded from CLIA Edits

Jurisdiction E

California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands

https://med.noridianmedicare.com/web/jeb/article-detail/-/view/10542/hcpcs-codes-subject-to-and-excluded-from-clia-edits

MLN Matters® Number: MM9502
Related Change Request (CR) #: CR 9502
Related CR Release Date: January 15, 2016
Effective Date: January 1, 2016
Related CR Transmittal #: R3439CP
Implementation Date: April 4, 2016

Provider Types Affected

This MLN Matters® Article is intended for clinical diagnostic laboratories submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Provider Action Needed

Change Request (CR) 9502 informs MACs about the Healthcare Common Procedure Coding System (HCPCS) codes for 2016 that are both subject to, and excluded from, Clinical Laboratory Improvement Amendments (CLIA) edits; and also includes the HCPCS codes discontinued as of December 31, 2015. Make sure that your billing staffs are aware of these CLIA-related changes for 2016.

Background

The Clinical Laboratory Improvement Amendments (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory tests performed in certified facilities, each claim for a HCPCS code that is considered a CLIA laboratory test is currently edited at the CLIA certificate level.

The HCPCS codes that are considered a laboratory test under CLIA change each year.

Contractors need to be informed about the new HCPCS codes that are both subject to CLIA edits and excluded from CLIA edits.

Discontinued HCPCS Codes

The HCPCS codes listed in table 1 below were discontinued on December 31, 2015

Table 1: HCPCS Codes Discontinued on December 31, 2015

HCPCS Code	Descriptor
G0431	Drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter
G0434	Drug screen, other than chromatographic; any number of drug classes, by clia waived test or moderate complexity test, per patient encounter
G6030	Amitriptyline
G6031	Benzodiazepines
G6032	Desipramine
G6034	Doxepin
G6035	Gold
G6036	Assay of imipramine
G6037	Nortriptyline
G6038	Salicylate
G6039	Acetaminophen
G6040	Alcohol (ethanol); any specimen except breath
G6041	Alkaloids, urine, quantitative
G6042	Amphetamine or methamphetamine
G6043	Barbiturates, not elsewhere specified
G6044	Cocaine or metabolite
G6045	Dihydrocodeinone
G6046	Dihydromorphinone
G6047	Dihydrotestosterone
G6048	Dimethadione
G6049	Epiandrosterone
G6050	Ethchlorvynol
G6051	Flurazepam
G6052	Meprobamate
G6053	Methadone
G6054	Methsuximide
G6055	Nicotine
G6056	Opiate(s), drug and metabolites, each procedure
G6057	Phenothiazine
G6058	Drug confirmation, each procedure
82486	Chemical analysis
82487	Chemical analysis
82488	Chemical analysis
82489	Chemical analysis
82491	Chemical analysis
82492	Chemical analysis
82541	Chemical analysis using chromatography technique
82543	Chemical analysis using chromatography technique
82544	Chemical analysis using chromatography technique
83788	Mass spectrometry (laboratory testing method
88347	Antibody evaluation
0103T	Measurement of vitamin B-12 deficiency marker

New HCPCS Codes for 2016

The HCPCS codes listed in table 2, below, are new for 2016 and are subject to CLIA edits.

The list does not include new HCPCS codes for waived tests or provider-performed procedures. The HCPCS codes listed below require a facility to have either a:

CLIA certificate of registration (certificate type code 9);
CLIA certificate of compliance (certificate type code 1); or
CLIA certificate of accreditation (certificate type code 3).

The following facilities are not permitted to be paid for these tests:

A facility without a valid, current, CLIA certificate;
A facility with a current CLIA certificate of waiver (certificate type code 2); or
A facility with a current CLIA certificate for provider-performed microscopy procedures (certificate type code 4).

Table 2: New HCPCS Codes Subject to CLIA Edits for 2016

HCPCS Code	Descriptor
G0477	Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (eg immunoassay) capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service
G0478	Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (eg immunoassay) read by instrument-assisted direct optical observation (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service
G0479	Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures by instrumented chemistry analyzers utilizing immunoassay, enzyme assay, TOF, MALDI, LDTD, DESI, DART, GHPC, GC mass spectrometry), includes sample validation when performed, per date of service
G0480	Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources(s), includes specimen validity testing, per day, 1-7 drug class(es), including metabolite(s) if performed
G0481	Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources(s), includes specimen validity testing, per day, 8-14 drug class(es), including metabolite(s) if performed
G0482	Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources(s), includes specimen validity testing, per day, 15-21 drug class(es), including metabolite(s) if performed
G0483	Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase)); qualitative or quantitative, all sources(s), includes specimen validity testing, per day, 22 or more drug class(es), including metabolite(s) if performed
80081	Blood test panel for obstetrics ( cbc, differential wbc count, hepatitis b, hiv, rubella, syphilis, antibody screening, rbc, blood typing)
81162	Gene analysis (breast cancer 1 and 2) full sequence and duplication or deletion variants
81170	Gene analysis (ABL proto-oncogene 1, non-receptor tyrosine kinase)
81218	Gene analysis (ccaat/enhancer binding protein [c/ebp], alpha) full gene sequence
81219	Gene analysis (calreticulin), common variants
81272	Gene analysis (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog), targeted sequence
81273	Gene analysis (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog), D816 variants
81276	Gene analysis (Kirsten rat sarcoma viral oncogene homolog), additional variants;
81311	Gene analysis for cancer (neuroblastoma)
81314	Gene analysis ((platelet-derived growth factor receptor, alpha polypeptide) targeted sequence
81412	Test for detecting genes for disorders related to Ashkenazi Jews
81432	Gene analysis (breast and related cancers), genomic sequence
81433	Gene analysis (breast and related cancers), duplication or deletion variants
81434	Gene analysis (retinal disorders), genomic sequence
81437	Gene analysis (neuroendocrine tumors), genomic sequence
81438	Gene analysis (neuroendocrine tumors), duplication and deletion variants
81442	Gene analysis (noonan syndrome) genomic sequence analysis
81490	Test for detecting genes associated with rheumatoid arthritis using immunoassay technique
81493	Test for detecting genes associated with heart vessels diseases
81525	Gene analysis (colon related cancer)
81528	Gene analysis (colorectal cancer)
81535	Culture of live tumor cells and chemotherapy drug response by staining
81536	Culture of live tumor cells and chemotherapy drug response by staining
81538	Testing of lung tumor cells for prediction of survival
81540	Gene analysis (cancer)
81545	Gene analysis (thyroid cancer)
81595	Test for detecting genes associated with heart diseases
88350	Antibody evaluation
0009M	Fetal aneuploidy (trisomy 21, and 18) dna sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy
0010M	Oncology (high-grade prostate cancer), biochemical assay of four proteins (total psa, free psa, intact psa and human kallidrein 2 (hk2)) plus patient age, digital rectal examination status, and no history of positive prostate biopsy, utilizing plasma, prognostic algorithm reported as a probability score

MACs will not search their files to either retract payment for claims already paid or retroactively pay claims, but will adjust claims that brought to their attention.

Additional Information

The official instruction, CR 9502 issued to your MAC regarding this change is available at http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3439CP.pdf on the CMS website.

Last Updated Jan 29, 2016

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