MIR-2007-3AB, March 2007

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

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, 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 5457, from which this article is taken, informs carriers and A/B MACS about the new HCPCS codes for 2007 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 2007 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 5457, from which this article is taken, informs carriers and A/B MACs about the new HCPCS codes for 2007 that are both subject to, and excluded from, CLIA edits.

The HCPCS codes listed in the Table 1, below, are new for 2007 and are subject to CLIA edits (the list does not include new HCPCS codes for waived tests or provider-performed procedures.) This means that laboratory facilities performing these tests must 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). Conversely, 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) will not be paid for these tests and the claims will be denied.  

Table 1

CR 5457 also provides HCPCS codes that were discontinued on 12/31/2006.

Table 2

Note: Carriers and A/B MACS will add the LC code of 610 for the specialty of histopathology to the new Mohs HCPCS codes (17311, 17312, 17313, 17314, and 17315) even though are not currently edited at the laboratory certification (LC) level.

Remember that carriers and A/B MACs will return as unprocessable claims submitted with the HCPCS codes displayed in Table 1, above, without a CLIA number. Also, carriers and A/B MACs will deny payment for claims submitted without a valid current CLIA certificate, or with a CLIA certificate of waiver (certificate type code 2), or a CLIA certificate for provider-performed microscopy procedures (certificate type code 4). Finally, carriers and A/B MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims processed prior to the April 2, 2007, implementation date. They will adjust claims that are brought to their attention.

Additional Information
You can find the official instruction, CR 5457, issued to your carrier or A/B MAC by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1165CP.pdf on the CMS Web site

If you have any questions, please contact your 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 site.

Flu Shot Reminder - It’s Not Too Late to Give and Get the Flu Shot!
The peak of flu season typically occurs between late December and March; however, flu season can last until May. Protect yourself, your patients, and your family and friends by getting and giving the flu shot. Each office visit presents an opportunity for you to talk with your patients about the importance of getting an annual flu shot and a lifetime pneumococcal vaccination. Remember - influenza and pneumococcal vaccination and their administration are covered Part B benefits. Note that influenza and pneumococcal vaccines are NOT Part D covered drugs. For more information about Medicare’s coverage of adult immunizations and educational resources, go to CMS’ Web site: http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0667.pdf.

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.

MLN Matters Number: MM5457
Pub. 100-4, Transmittal# R1165CP, CR# 5457
Related CR Release Date: January 26, 2007
Effective Date: January 1, 2007
Implementation Date: April 2, 2007