New Waived Tests Have Retroactive Effective Dates

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  • July 26, 2012
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The Centers for Medicare & Medicaid Services (CMS) recently notified contractors of 11 new tests approved by the U.S. Food and Drug Administration (FDA) as waived tests under Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Effective Oct. 1, 2012, appropriately certified facilities may be reimbursed for the following 11 new waived tests:

CPT® Code Effective Date Description
G0434QW March 14, 2012 Wondfo Oxycodone Urine Test {Dip card format}
G0434QW March 14, 2012 Wondfo Oxycodone Urine Test {Cup format}
87880QW March 23, 2012 McKesson Strep A Test – Dipstick
87880QW March 23, 2012 McKesson Strep A Test – Twist
86318QW April 3, 2012 McKesson H. pylori Test (Whole Blood)
87804QW April 20, 2012 Sofia Analyzer and Influenza A+B FIA (for user with nasal swabs and nasopharyngeal swabs)
85610QW May 8, 2012 AlereINRatio®2 PT/INR Home Monitoring System {Prescription Home Use}
83986QW May 8, 2012 Dale Medical Products, Inc. RightLevel pH
83986QW May 8, 2012 Dale Medical Products, Inc. RightSpot pH
G0434QW May 22, 2012 Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests
G0434QW May 22, 2012 Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug

Note the effective date for each test. Contractors will not search their files to retroactively pay claims, but facilities may bring such claims to the attention of their contractor.
See CMS transmittal 2496 for the complete list of waived tests.

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