MIR-2007 04B, April 2007

New Waived Tests (MM5484)

Provider Types Affected
Providers and suppliers who bill Medicare carriers or Medicare Administrative Contractors (A/B MAC) for clinical diagnostic laboratory services

Provider Action Needed
CR 5484, from which this article is taken, notifies your carriers and A/B MACs of the new Food and Drug Administration (FDA)-approved tests (effective October 4, 2006) that are waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), so that they can accurately process your claims.

Background
First, remember that CLIA regulations require a laboratory facility to be appropriately certified for each test it performs. Further, to ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

Some specific background about waived tests may, at this point, also be helpful. These new laboratory tests (which the FDA approves on a flow basis) are valid (and marketed) as soon as they are approved. Therefore, as soon as informed by the FDA of the test approvals, the Centers for Medicare & Medicaid Services (CMS) must immediately notify the carriers and A/B MACs so that they are ready to process claims when submitted. CR 5484, from which this article is taken, announces the latest tests approved by the FDA as waived tests under CLIA. These tests are described in the bulleted paragraph (below), and displayed in red/bold print in Table 1, that follows. Note that each of the Current Procedural Terminology (CPT) codes for these new tests must have the modifier QW (CLIA Waived Test) to be recognized as a waived test, and that these new waived tests are effective on October 4, 2006.

New FDA Waived Tests Under CLIA

• CPT/HCPCS code, 82042QW, has been assigned for the albumin test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 82150QW, has been assigned for the amylase test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 82247QW, has been assigned for the total bilirubin test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 82977QW, has been assigned for the gamma glutamlytransferase (GGT) test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 84075QW, has been assigned for the alkaline phosphatase test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 84157QW, has been assigned for the total protein test performed using the Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood}.
• CPT/HCPCS code, 84520QW, has been assigned for the urea (BUN) test performed using the Arkray SPOTCHEM EZ Chemistry Analyzer.

Table 1 - Latest FDA Waived Tests Under CLIA *

*The Current Procedural Terminology (CPT) codes for these new tests must have the modifier QW to be recognized as a waived test.

In addition, it is also important that you note that the tests displayed in table 2, below, do not require a QW modifier to be recognized as a waived test.

Table 2

Waived Tests That Do Not Require the QW Modifier

Final note: Carriers and A/B MACs do not need to search their files to either retract payment or retroactively pay affected claims processed prior to the implementation of this change, however, they will adjust claims that you bring to their attention.

Additional Information
You can find the official instruction, CR5484, issued to your carrier or A/B MAC by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1195CP.pdf on the CMS Web site. As an attachment to that CR, you will find the complete list of laboratory tests granted waived status under CLIA.

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 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

MLN Matters Number: MM5484
Pub. 100-4, Transmittal# R1195CP, CR# 5484
Related CR Release Date: March 9, 2007
Effective Date: April 1, 2007
Implementation Date: April 2, 2007

Do you have your NPI? National Provider Identifiers (NPIs) will be required on claims sent on or after May 23, 2007. Every health care provider needs to get an NPI. Learn more about the NPI and how to apply for an NPI by visiting http://www.cms.hhs.gov/NationalProvIdentStand/ on the CMS Web site.