FDA Approves Five New Tests as Waived Under CLIA

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The Food and Drug Administration has approved five new tests as waived tests under Clinical Laboratory Improvement Amendments, according to a CMS MLN Matters article.

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The tests are valid as soon as they are approved.

 

Here are the approved tests, with their CPT code, effective date and description.

 

CPT Code

Effective Date

Description

87880QW

February 2, 2011

BTNX Rapid Response Strep A Rapid Test Strips

82274QW

G0328QW

March 24, 2011

OC-Light iFOB Test

G0434QW

April 1, 2011

CLIAwaived, Inc. Rapid Drug Test Cup {OTC}

G0434QW

April 1, 2011

Instant Technologies, iCup DX Drug Screen Cup

86318QW

April 7, 2011

Stanbio Rely H. plyori Rapid Test (Whole Blood) (Finger-stick only)

 

The CPT codes for the following new tests MUST have modifier -QW to be recognized as a waived test.

 

Read the MLN Matters article on the new CLIA waived tests (pdf).

 

The information provided should be utilized for educational purposes only. Please consult with your billing and coding expert. Facilities are ultimately responsible for verifying the reporting policies of individual commercial and MAC/FI carriers prior to claim submissions.

 

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