Provider Types Affected

Clinical diagnostic laboratories billing Medicare carriers or Part A/B Medicare Administrative Contractors (A/B MAC) for laboratory tests

Provider Action Needed

Impact to You

If you do not have a valid, current, CLIA certificate and submit a claim to your Medicare carrier or A/B MAC for a HCPCS code that is considered to be a laboratory test requiring a CLIA certificate, your Medicare payment may be impacted.

What You Need to Know

The Clinical Laboratory Improvement Amendments of 1998 (CLIA) requires that for each test it performs, a laboratory facility must be appropriately certified. The HCPCS codes that CMS considers to be laboratory tests under CLIA (and thus requiring certification) change each year. CR 5926, from which this article is taken, informs carriers and A/B MACS about the new HCPCS codes for 2008 that are subject to CLIA edits and also about those that are now excluded from CLIA edits.

What You Need to Do

Make sure that your billing staffs are aware of these CLIA-related HCPCS changes for 2008 and that you remain current with certification requirements.

Background

The Clinical Laboratory Improvement Amendments of 1998 (CLIA) require a laboratory facility to be appropriately certified for each test it performs.

To ensure that Medicare and Medicaid only pay for laboratory tests that are performed by certified facilities, carriers, and A/B MACs will edit each Medicare claim submitted for a HCPCS code considered to be a CLIA laboratory test. These HCPCS codes change each year, and CR 5926, from which this article is taken, informs carriers and A/B MACs about the new HCPCS codes for 2008 that are both subject to, and excluded from, CLIA edits.

The HCPCS codes listed in the chart that follows are new for 2008 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) will not be paid for these tests and the claims will be denied. Failure to submit your CLIA number on claims containing one of these HCPCS codes will result in the Medicare carrier or A/B MAC returning your claim as unprocessable.

Other Key Points

• The HCPCS code 86586 [Unlisted antigen, each] was discontinued on December 31, 2007.
• For 2008, the new HCPCS code 86486 [Skin test; unlisted antigen, each] is excluded from CLIA edits and does not require a facility to have any CLIA certificate.

Additional Information

To see the official instruction (CR5926) issued to your Medicare carrier or A/B MAC visit http://www.cms.hhs.gov/Transmittals/downloads/R1471CP.pdf on the CMS Web site.

If you have questions, please contact your Medicare carrier or A/B MAC at their toll-free number which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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 2007 American Medical Association.