Changes to CLIA Waived Tests

The Food and Drug Administration (FDA) has approved new waived tests under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The latest news comes in a Centers for Medicare & Medicaid Services (CMS) transmittal issued June 5.

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The Current Procedural Terminology (CPT®) codes for these tests must have the modifier QW CLIA Waived test to be recognized as a waived test.

CPT® Code

Effective Date

Description

87880QW

September 25, 2008

Quidel QuickVue In-Line Strep A {direct from throat swab}(K934484/A013)

80069QW

December 4, 2008

Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Renal Function Panel){Whole Blood}

80069QW

December 4, 2008

Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Renal Function Panel){Whole Blood}

82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW, 84520QW

December 4, 2008

Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood}

82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW, 84520QW

December 4, 2008

Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood}

81003QW

January 5, 2009

Jant Pharmacal Corporation Accustrip URS Reader

80101QW

January 5, 2009

Aventir Biotech LLC Home Check Multiple Drug Cup Test {Professional version}

80101QW

January 5, 2009

Syntron Bioresearch Quikscreen Multiple Drug Cup Test {Professional version}

Note: CPT® codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 do not require a QW modifier to be recognized as a waived test.

The new waived CPT® code, 80069QW Renal function panel has been assigned for the albumin, total calcium, carbon dioxide, chloride, creatinine, glucose, phosphorus, potassium, sodium and urea nitrogen tests performed using the Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Renal Function Panel) {Whole Blood} and the Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Renal Function Panel) {Whole Blood}.

The new waived CPT® code, 82550QW Creatine kinase (CK), (CPK); total has been assigned for the creatine kinase test performed using the Abaxis Piccolo Blood Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood} and the Abaxis Piccolo xpress Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {Whole Blood}.

For 2009, the description for CPT® code 82040 was modified from Albumin; serum to Albumin; serum, plasma or whole blood. The CPT® code assigned to the whole blood albumin tests performed on the following test systems has been changed from 82042QW Albumin; urine or other source quantitative, each specimen to 82040QW with an effective date of Jan. 1:

  • Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {Whole blood};
  • Abaxis Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood);
  • Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood};
  • Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel) {Whole Blood}; and
  • Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 Panel) {Whole Blood}.

You can further review this information in CMS Transmittal 1751, Change Request (CR) 6459.

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