Provider Types Affected

Physicians, providers, and suppliers who bill Medicare carriers or Part A/B Medicare Administrative Contractors (A/B MAC) for clinical diagnostic laboratory services

What You Need to Know

The list of tests approved by the Food and Drug Administration (FDA) as waived tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) has been updated.

Background

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

The chart below identifies the newly added waived tests and their effective dates. The Current Procedural Terminology (CPT) codes for these tests must have the QW modifier to be recognized as a waived test.

The new waived CPT/HCPCS code, 80047QW, has been assigned for the ionized calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, and urea nitrogen tests performed using the Abbott i-STAT Chem8+ Cartridge {Whole Blood}. This CPT code may be used for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after January 1, 2008.

The new waived CPT/HCPCS code, 80048QW, has been assigned for the calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, and urea nitrogen tests performed using the Abaxis Piccolo Blood Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood} and the Abaxis Piccolo xpress Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood}. This CPT code may be used for claims with dates of service on or after January 16, 2008, submitted by facilities with a valid, current CLIA certificate of waiver.

The new waived CPT/HCPCS code, 80051QW, has been assigned for the carbon dioxide, chloride, potassium, and sodium tests performed using the Abaxis Piccolo Blood Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood}, the Abaxis Piccolo Blood Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood} and the Abaxis Piccolo Blood Chemistry Analyzer (Electrolyte Metabolic Reagent Disc){Whole Blood}. This CPT code may be used for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after October 30, 2007.

The new waived CPT/HCPCS code, 80053QW, has been assigned for the alanine amino transferase, aspartate amino transferase, albumin, total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose, alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen tests performed using the Abaxis Piccolo Blood Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood} and the Abaxis Piccolo xpress Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood}. This CPT code may be used for claims with dates of service on or after January 16, 2008, submitted by facilities with a valid, current CLIA certificate of waiver.

The following CPT codes do not require the QW modifier in order to be recognized as waived tests:

CPT Code Description

Your Medicare carrier or A/B 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

To see the official instruction (CR5913) issued to your Medicare carrier or A/B MAC visit http://www.cms.hhs.gov/Transmittals/downloads/R1477CP.pdf on the CMS Web site. A complete list of tests granted waived status under CLIA is attached to CR5913. For more information about CLIA, refer to http://www.cms.hhs.gov/CLIA/01_Overview.asp#TopOfPage 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.