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

Medicare/Noridian New Waived Tests - Revised November 2013

New Waived Tests - Revised

MLN Matters® Number: MM8439 Revised
Related Change Request (CR) #: CR 8439
Related CR Release Date: October 28, 2013
Effective Date: January 1, 2014
Related CR Transmittal #: R2804CP
Implementation Date: January 6, 2014

This article was revised on October 29, 2013, to reflect a new Change Request (CR). The CR corrects the spelling of "Premier Integrity Solutions P/Tox Drug Screen Cup." The transmittal number, CR release date and web link to the transmittal was also changed. All other information remains the same.

Provider Types Affected
This MLN Matters® Article is intended for clinical diagnostic laboratories submitting claims to Medicare Claims Administration Contractors (Medicare Contractors) for services to Medicare beneficiaries.

Provider Action Needed
If you do not have a valid, current, Clinical Laboratory Improvement Amendments of 1998 (CLIA) certificate and submit a claim to your Medicare Carrier or A/B MAC for a Current Procedural Terminology (CPT) code that is considered to be a laboratory test requiring a CLIA certificate, your Medicare payment may be impacted.
CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. The CPT codes that the Centers for Medicare & Medicaid Services (CMS) consider to be laboratory tests under CLIA (and thus requiring certification) change each year. Change Request (CR) 8439, from which this article is taken, informs carriers and MACs about the latest new CPT codes that are subject to CLIA edits.
Make sure that your billing staffs are aware of these CLIA-related changes for 2014 and that you remain current with certification requirements.

Background
Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the tests mentioned on the first page of the list attached to CR8439 (i.e., CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.
The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:  

• G0434QW, January 23, 2008, Phamatech At Home 12 Drug Test (Model 9308T); 
• G0434QW, January 23, 2008, Phamatech At Home 12 Drug Test (Model 9308Z); 
• 81003QW, January 29, 2013, Henry Schein Urispec Plus Urine Analyzer;  
• G0434QW, February 27, 2013, CLIA waived, Inc. Rapid Drug Test Cup; 
• G0434QW, February 27, 2013, Clinical Reference Laboratory, Inc. Intelligent Transport Cup; 
• G0434QW, February 27, 2013, Noble Medical Inc. Noble 1 Step Cup; 
• G0434QW, February 27, 2013, Premier Integrity Solutions P/Tox Drug Screen Cup; 
• G0434QW, February 27, 2013, US Diagnostics ProScreen Drugs of Abuse Cup; 
• 84443QW, March 5, 2013, BTNX Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood); 
• 86308QW, March 11, 2013, Henry Schein OneStep Pro+ Mono {Whole Blood}; 
• G0434QW, May 15, 2013, UCP Biosciences, Inc. UCP Home Drug Screening Test Cups; 
• G0434QW, May 17, 2013, Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup; 
• G0434QW, June 24, 2013, Advin Multi-Drug Screen Test; and 
• 87880QW, July 3, 2013, Henry Schein OneStep Pro+ Strep A Cassette.

Additional Information
The official instruction, CR8439, issued to your MAC regarding this change may be viewed at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2804CP.pdf  on the CMS website.  

Last Updated Nov 04, 2013