National Government Services, Inc. Medicare Monthly Review Part A and B
A Combined Part A and Part B Newsletter

MMR-2007 11B, November 2007

New Waived Tests

Provider Types Affected
Physicians, providers, and suppliers submitting claims to Medicare carriers and/or Part A/B Medicare Administrative Contractors (A/B MAC) for services provided to Medicare beneficiaries

Provider Action Needed
This article is based on Change Request (CR) 5715 which informs carriers and A/B MACS of new waived tests approved by the Food and Drug Administration (FDA) under Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Background
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test they perform. Laboratory claims are currently edited at the CLIA certificate level in order to ensure that the Centers for Medicare & Medicaid Services (CMS) only pays for laboratory tests categorized as waived complexity under CLIA (for facilities with a CLIA certificate of waiver).

New waived tests are approved by the FDA on a flow basis, and the tests are valid as soon as they are approved. The new waived tests announced by CR5715 are in the following table:

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

Also, the new waived CPT/HCPCS code, 82310QW, has been assigned for the total calcium test performed using the Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}. The new waived CPT/HCPCS code, 82565QW, has been assigned for the creatinine test performed using the Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}. The new waived CPT/HCPCS code, 89321QW, has been assigned for the semen motility test performed using the Fertell Male Fertility Test.

Your Medicare carrier or MAC will not automatically adjust claims processed prior to the implementation of these changes. However, they will adjust such claims that you bring to their attention.

Additional Information
For complete details, please see the official instruction, CR5715, issued to your carrier or A/B MAC regarding this change. That instruction may be viewed at http://www.cms.hhs.gov/transmittals/downloads/R1346CP.pdf on the CMS Web site. The attachment to CR 5715 includes the list of tests granted waived status under CLIA, and the tests mentioned on the first page of the attachment (i.e., CPT codes: 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

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.