The CLIA regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare and Medicaid only pay for laboratory tests in a facility with a valid, current Clinical Laboratory Improvement Amendments (CLIA) certificate, laboratory claims are currently edited at the CLIA certificate level.
The codes that are considered a laboratory test under CLIA change each year; providers need to know about the new codes that are both subject to and excluded from CLIA edits.
Change request 9035 informs Medicare contractors about numerous codes that were discontinued December 31 and added for 2015. Note: This does not include new codes for waived tests or provider-performed procedures.
Note: The code 89337 (frozen preservation of mature eggs) is new for 2015; it is excluded from CLIA edits and does not require a facility to have any CLIA certificate.
CLIA regulations require a facility to be appropriately certified for each test performed. To ensure that the Centers for Medicare & Medicaid Services (CMS) 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, and your Medicare 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, 2014.
| Table 1: HCPCS Codes Discontinued on December 31, 2014 | |
| HCPCS | Code Descriptor |
| G0417 | Surgical pathology, gross and microscopic examination, for prostate needle biopsy, any method, 21-40 specimens |
| G0418 | Surgical pathology, gross and microscopic examination, for prostate needle biopsy, any method, 41-60 specimens |
| G0419 | Surgical pathology, gross and microscopic examination, for prostate needle biopsy, any method, >60 specimens |
| 80100 | Drug screen, multiple drugs |
| 80101 | Drug screen |
| 80102 | Drug confirmation test |
| 80103 | Tissue preparation for drug analysis |
| 80104 | Drug screen, multiple drugs |
| 80152 | Amitriptyline (antidepressant) level |
| 80154 | Benzodiazepines level |
| 80160 | Desipramine level |
| 80166 | Assay of doxepin |
| 80172 | Gold level |
| 80174 | Imipramine level |
| 80182 | Nortriptyline level |
| 80196 | Salicylate (aspirin) level |
| 80440 | Thyrotropin releasing hormone (TRH) (hypothalamus hormone) stimulation panel |
| 82000 | Acetaldehyde blood test |
| 82003 | Acetaminophen level |
| 82055 | Alcohol (ethanol) level |
| 82101 | Urine alkaloids level |
| 82145 | Amphetamine or methamphetamine level |
| 82205 | Barbiturates level |
| 82520 | Cocaine (drug) level |
| 82646 | Dihydrocodeinone (drug) measurement |
| 82649 | Dihydromorphinone (drug) level |
| 82651 | Dihydrotestosterone (DHT) level |
| 82654 | Dimethadione (drug) level |
| 82666 | Epiandrosterone (synthetic hormone) level |
| 82690 | Ethchlorvynol (drug) level |
| 82742 | Flurazepam (drug) level |
| 82953 | Glucose (sugar) tolerance test |
| 82975 | Glutamine (amino acid by product) level |
| 82980 | Glutethimide (drug) level |
| 83008 | Guanosine monophosphate (cellular chemical) level |
| 83055 | Sulfhemoglobin (hemoglobin) analysis |
| 83071 | Hemosiderin (hemoglobin breakdown product) level |
| 83634 | Urine lactose (carbohydrate) analysis |
| 83805 | Meprobamate (sedative) level |
| 83840 | Methadone level |
| 83858 | Methsuximide (drug) level |
| 83866 | Mucopolysaccharides (protein) screening test |
| 83887 | Nicotine level |
| 83925 | Opiates (drug) measurement |
| 84022 | Phenothiazine (drug) level |
| 84127 | Stool porphyrins (metabolism substance) analysis |
| 87001 | Animal inoculation, small animal with observation |
| 87620 | Detection test for human papillomavirus (HPV) |
| 87621 | Detection test for human papillomavirus (HPV) |
| 87622 | Detection test for human papillomavirus (HPV) |
| 88343 | Immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear each additional separately identifiable antibody per slide (list separately in addition to code for primary procedure) |
| 88349 | Assessment using electron microscopy |
New HCPCS Codes for 2015
The HCPCS codes listed in Table 2 below are new for 2015 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 in Table 2 require a facility to have either a:
1.CLIA certificate of registration (certificate type code 9);
2.CLIA certificate of compliance (certificate type code 1); or
3.CLIA certificate of accreditation (certificate type code 3).
The following facilities are not permitted to be paid for these tests:
1.A facility without a valid, current, CLIA certificate;
2.A facility with a current CLIA certificate of waiver (certificate type code 2); or
3.A facility with a current CLIAcertificate for provider-performed microscopy procedures (certificate type code 4).
Note: The HCPCS code 89337 [Frozen preservation of mature eggs] is new for 2015, is excluded from CLIA edits and does not require a facility to have any CLIA certificate.
| Table 2: New HCPCS Codes Subject to CLIA Edits for 2015 | |
| HCPCS | Code Descriptor |
| G0464 | Colorectal cancer screening; stool-based dna and fecal occult hemoglobin (e.g., kras, ndrg4 and bmp3) |
| 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 |
| 80163 | Digoxin level |
| 80165 | Valproic acid level |
| 80300-80304 | Drug screen |
| 80320-80377 | Alcohols levels |
| 81246 | Test for detecting genes associated with blood cancer |
| 81288 | Test for detecting genes associated with colon cancer |
| 81313 | Test for detecting genes associated with prostate cancer |
| 81410 | Test for detecting genes associated with heart disease |
| 81411 | Test for detecting genes associated with heart disease |
| 81415 | Test for detecting genes associated with diseases |
| 81416 | Test for detecting genes associated with disease |
| 81417 | Reevaluation test for detecting genes associated with disease |
| 81420 | Test for detecting genes associated with fetal disease |
| 81425 | Test for detecting genes associated with disease |
| 81426 | Test for detecting genes associated with disease |
| 81427 | Reevaluation test for detecting genes associated with disease |
| 81430 | Test for detecting genes causing hearing loss |
| 81431 | Test for detecting genes causing hearing loss |
| 81435 | Test for detecting genes associated with colon cancer |
| 81436 | Test for detecting genes associated with colon cancer |
| 81440 | Test for detecting genes associated with cancer of body organ |
| 81445 | Test for detecting genes associated with cancer of body organ |
| 81450 | Test for detecting genes associated with blood related cancer |
| 81455 | Test for detecting genes associated with cancer |
| 81460 | Test for detecting genes associated with disease |
| 81465 | Test for detecting genes associated with disease |
| 81470-81471 | Test for detecting genes associated with intellectual disability |
| 81519 | Test for detecting genes associated with breast cancer |
| 87505-87507 | Detection test for digestive tract pathogen; |
| 83006 | Test for detecting genes associated with growth stimulation |
| 87623-87625 | Detection test for human papillomavirus (hpv) |
| 87806 | Detection test for HIV1 |
| 88341 | Special stained specimen slides to examine tissue |
| 88344 | Special stained specimen slides to examine tissue |
| 88364 | Cell examination |
| 88366 | Cell examination |
| 88369 | Microscopic genetic examination manual |
| 88373 | Microscopic genetic examination using computerassisted technology |
| 88374 | Microscopic genetic examination using computerassisted technology |
| 88377 | Microscopic genetic examination manual. |
Note: Does not include new HCPCS codes for waived tests or provider-performed procedures.
On November 19, 2014, CMS released CR 8871 which mentioned that effective for services performed on or after June 2, 2014, the new HCPCS G0472, HCV screening, will be recognized as a covered service. G0472 is a code that:
•Is considered a test under CLIA;
•Is subject to CLIA edits; and
•Would require a facility to have either:
•A CLIA certificate of registration (certificate type code 9),
•A CLIA certificate of compliance (certificate type code 1), or
•A CLIA certificate of accreditation (certificate type code 3).
