Clinical Laboratory Improvement Amendments (CLIA) Edits

Provider Types Affected
Providers and clinical laboratories that submit claims to Medicare carriers for CLIA-related services

Key Points
The HCPCS codes that are considered laboratory tests under CLIA are subject to change each year. Effective January 1, 2006, there are new HCPCS codes, including modifiers, for 2006 that are either subject to CLIA edits or excluded from CLIA edits.

HCPCS codes subject to or excluded from CLIA edits are described in Change Request (CR) 4321 and in the attachments to that CR which revise the Medicare Claims Processing Manual (Publication 100-04), Chapter 16, Laboratory Services.

The new 2006 HCPCS codes are listed in Table 1 of this article. Please note that this list does not include new HCPCS codes for waived tests or provider-performed procedures.

These HCPCS codes are subject to CLIA edits, therefore a CLIA number must be submitted on claims by facilities for these HCPCS codes. The HCPCS codes listed in the Table 1 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).

Facilities will not be permitted to bill for the tests listed in Table 1 of this article:

• If they do not have a valid, current, CLIA certificate;



• If they have a current CLIA certificate of waiver (certificate type code 2); or



• If they have a current CLIA certificate for provider-performed microscopy procedures (certificate type code 4).

Effective January 19, 1993, a laboratory that holds a certificate for provider-performed microscopy procedures may perform only those tests specified as provider-performed microscopy procedures and waived tests and no others. The provider-performed microscopy procedures are described in Table 2 of this article.

The following new HCPCS codes for 2006 in the 80000 series are excluded from CLIA edits and do not require a facility to have any CLIA certificate:

• 86923 - Compatibility test each unit; electronic;



• 86960 - Volume reduction of blood or blood products (e.g., red blood cells or platelets), each unit; and



• 87900 - Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics.

Relevant Links
For a complete list of the specific HCPCS codes subject to CLIA edits please refer to http://www.cms.hhs.gov/CLIA/downloads/Subject.to.CLIA.pdf on the Centers for Medicare & Medicaid Services (CMS) website.

For a complete list of the specific HCPCS codes in the 80000 series that are excluded from CLIA edits please refer to http://www.cms.hhs.gov/CLIA/downloads/cpt4exc.pdf on the CMS website.

CR4321 is the official instruction issued to your carrier regarding changes mentioned in this article, MM4321. CR4321 may be found by going to http://www.cms.hhs.gov/Transmittals/downloads/R865CP.pdf on the CMS website.

If you have any questions, please contact your state's Provider Contact Center.

Table 1

The HCPCS codes listed in the chart on the next page are new for 2006 and are subject to CLIA edits. The list does not include new HCPCS codes for waived tests or provider-performed procedures. Effective January 1, 2006, 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).

Effective January 19, 1993, a laboratory that holds a certificate for provider performed microscopy procedures may perform only waived tests and those tests specified as provider-performed microscopy procedures in the following table, and no others.

MLN Matters MM4321