MLN Matters® Number: MM6812
Related Change Request (CR) #: 6812
Related CR Release Date: February 5, 2010
Effective Date: January 1, 2010
Related CR Transmittal #: R1912CP
Implementation Date: April 5, 2010
Provider Types Affected
Clinical laboratories and providers that submit claims to Medicare carriers or Medicare Administrative Contractors (MACs) for laboratory test services provided to Medicare beneficiaries may be impacted by this issue.
Provider Action Needed
CR 6812, from which this article is taken, informs your carriers and MACs about the new HCPCS codes for 2010 that are subject to, and those that are excluded from, CLIA edits. Please see the Background section, below, for details.
Background
The Clinical Laboratory Improvement Amendments (CLIA) regulations require a facility to be appropriately certified for each test it performs; and moreover, to ensure that Medicare & Medicaid only pay for laboratory tests that are 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.
Since the HCPCS codes that are considered a laboratory test under CLIA change each year, the Center for Medicare & Medicaid Services (CMS) needs to inform carriers and MACs about the new HCPCS codes that are subject to CLIA edits and those that are excluded from CLIA edits. CR 6812, from which this article is taken, provides them this information for 2010.
HCPCS/CPT Codes Subject to CLIA Edits
The HCPCS/CPT codes listed in the following table are new for 2010 and are subject to CLIA edits; and 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).
A facility without a valid, current, CLIA certificate, or with a current CLIA certificate of waiver (certificate type code 2) or a current CLIA certificate for provider-performed microscopy procedures (certificate type code 4) must not be permitted to be paid for these tests.
The table does not include new HCPCS codes for waived tests or provider-performed procedures.
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HCPCS Code
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Description
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G0430
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Drug screen qualitative; multiple drug classes other than
chromographic method, each procedure
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G0431
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Drug screen qualitative; single drug class method (e.g., immunoassay), each drug class
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CPT Code
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Description
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84145
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Procalcitonin (PCT)
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84431
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Thromboxane metabolite(s), including thromboxane , if performed, urine
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86305
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Human epididymis protein 4 (HE4)
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86352
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Cellular function assay involving stimulation (e.g., mitogen or antigen) and detection of biomarker (e.g., APT)
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86780
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Antibody; Treponema pallidum
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86825
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Human leukocyte antigen (HLA) crossmatch, non-cytoxic (e.g., using flow cytometry); first serum sample or dilution
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86826
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Human leukocyte antigen (HLA) crossmatch, non-cytoxic (e.g., using flow cytometry); each additional serum sample or sample dilution (List separately in addition to primary procedure)
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87150
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Culture, typing; identification by nucleic acid (DNA or RNA) amplified probe technique, per culture or isolate, each organism probed
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87153
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Culture, typing; identification by nucleic acid sequencing method; each isolate (e.g., sequencing of 16S rRNA gene)
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87493
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Infectious agent detection by nucleic acid (DNA or RNA); Clostridium difficile toxin gene(s), amplified probe technique
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88387
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Macroscopic examination, dissection, and preparation of tissue for non-microscopic analytical studies (e.g., nucleic acid-based molecular studies); each tissue preparation (e.g., a single lymph node)
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88388
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Macroscopic examination, dissection, and preparation of tissue for non-microscopic analytical studies (e.g., nucleic acid-based molecular studies); in conjunction with a touch imprint, intraoperative consultation, or frozen section, each tissue preparation (e.g., a single lymph node) (list separately in addition to code for primary procedure)
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Discontinued HCPCS Codes
The following CPT codes were discontinued on December 31, 2009:
- 82307 – Calciferol (Vitamin D);
- 86781 – Antibody; Treponema pallidum confirmatory test (e.g., FTA-ABS); and
- 0087T – Sperm evaluation, hyaluronan sperm binding test.
New Codes Excluded from CLIA Edits
For 2010, the following CPT codes are new and excluded from CLIA edits and do not require a facility to have any CLIA certificate:
- 83987 – pH; exhaled breath condensate;
- 88738 – Hemoglobin (Hgb), quantitative, transcutaneous; and
- 89398 – Unlisted reproductive medicine laboratory procedure.
Additional Information
You should be aware that your carriers or MACs will return (as unprocessable) claims that you submit for the HCPCS codes in the above table (those subject to CLIA edits), if you don’t include a CLIA number. Further, while they are not required to search their files to either retract payment for claims already paid or to retroactively pay claims processed prior to implementation of CR 6812, your carrier or MAC will adjust claims that you bring to their attention.
If you have any questions, please contact the Palmetto GBA Provider Contact Center at their toll-free number (866) 332-7025 (Ohio and West Virginia) or (888) 828-2092 (South Carolina Part B).
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2009 American Medical Association.