FDA Approves New Waived Tests

The Food and Drug Administration (FDA) recently approved a number of new tests categorized as waived complexity under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

CPT® codes for the following new tests must have the modifier QW (CLIA waived test) to be recognized as waived, with the exception of codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651.

CPT® Code

Effective Date

Description

82274QW

G0328QW

Dec. 4, 2008

Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT)

84703QW

Jan. 26, 2009

Siemens Clinitek Status Urine Chemistry Analyzer

82962,

82465QW

Jan. 29, 2009

Roche Diagnostics Accutrend Plus System {fingerstick whole blood}

82274QW

G0328QW

March 5, 2009

Henry Schein One Step+ iFOBT

81003QW, 82044QW,

82570QW

March 5, 2009

Siemens Clinitek Status Urine Chemistry Analyzer

87804QW

March 10, 2009

EarlyDetect Pro Influenza A Test

87804QW

March 10, 2009

EarlyDetect Pro Influenza B Test

83986QW

March 16, 2009

Lil’ Drug Store Products Inc. Vagi-Screen Vaginal Health Test

86308QW

April 14, 2009

Acceava Mono II {Whole Blood}

80101QW

April 30, 2009

1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split Key Cup II

87880QW

May 21, 2009

Inverness Medical Signify Strep A Cassette (Inverness Medical Innovations)

86318QW

May 21, 2009

Inverness Medical Signify H. Pylori Whole Blood

86318QW

May 21, 2009

EarlyDetect H. Pylori Whole Blood Rapid Test

Note: Change Request (CR) 6179 assigned 83520QW to the HemoCue Albumin 201 System. Based on a concern received from the laboratory industry, this code has been changed to 82043QW with an effective date of Oct. 1, 2009.

These new waived tests have been added to the Centers for Medicare & Medicaid Services (CMS) Medicare Claims Processing Manual, pub. 100-04, chapter 16, section 70.8.

CMS Transmittal 1799, CR 6570, issued Aug. 21, includes an attachment with an up-to-date list of tests granted waived status under CLIA.

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