HCPCS Codes Subject to and Excluded from CLIA Edits: NOridian/Medicare

HCPCS Codes Subject to and Excluded from CLIA Edits

MLN Matters®Number: MM8567
Related Change Request (CR) #: CR 8567
Related CR Release Date: January 17, 2014
Effective Date: January 1, 2014
Related CR Transmittal #: R2857CP
Implementation Date: April 7, 2014
Provider Types Affected

This MLN Matters® Article is intended for physicians, other providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs), including Durable Medical Equipment Medicare Administrative Contractors (DME/MACs), for services to Medicare beneficiaries.

Provider Action Needed
This article is based on Change Request (CR) 8567 which informs MACs about changes to HCPCS codes that are new for 2014 and are subject to Clinical Laboratory Improvement Amendments (CLIA) edits. The CLIA regulations require a facility to be appropriately certified for each test performed. Make sure your billing staffs are aware of these changes.

Background
The Clinical Laboratory Improvement Amendments (CLIA) regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare and 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 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.

The HCPCS codes listed below are new for 2014 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), 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, with a current CLIA certificate of waiver (certificate type code 2) or with a current CLIA certificate for provider-performed microscopy procedures (certificate type code 4) must not be permitted to be paid for these tests.

• G0461 - Immunohistochemistry or immunocytochemistry, per specimen; first single or multiplex antibody stain; 
• G0462 - Immunohistochemistry or immunocytochemistry, per specimen; each additional single or multiplex antibody stain (list separately in addition to code for primary procedure); 
• 80155 - Caffeine level; 
• 80159 - Clozapine level; 
• 80169 - Everolimus level; 
• 80171 - Gabapentin level; 
• 80175 - Lamotrigine level; 
• 80177 - Levetiracetam level; 
• 80180 - Mycophenolate (mycophenolic acid) level; 
• 80183 - Oxcarbazepine level; 
• 80199 - Tiagabine level; 
• 80203 - Zonisamide level; 
• 81287 - MGMT (O-6-methylguanine-DNA methyltransferase) gene analysis;
• 81504 - Genetic profiling on oncology biopsy lesions; 
• 81507 - DNA analysis using maternal plasma; and 
• 87661 - Infectious agent detection by nucleic acid (dna or rna); trichomonas vaginalis, amplified probe technique. 

In 2014, there was one new HCPCS code for immunohistochemistry or immunocytochemistry [i.e., 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)]. The testing described by this code is subject to the CLIA regulations. It is not payable by Medicare in calendar year (CY) 2014. Therefore, this new code was not included in CR 8567.

Additional Information
The official instruction, CR 8567 issued to your MAC regarding this change may be viewed at http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads /R2857CP.pdf  on the Centers for Medicare & Medicaid Services (CMS) website.   

Last Updated Jan 23, 2014