New Waived Tests

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The tests are valid as soon as they are approved. The CPT codes for the following new tests MUST have the modifier QW to be recognized as a waived test.

CPT CodeEffective DateDescription
80101QWMarch 10, 2009Amedica Biotech Amedica Drug Screen Test Cup
80101QWMay 11, 2009Twin Spirit, Inc. DrugSmart Cup
84443QWJune 3, 2009CLIA waived Inc. Thyroid Test Rapid TSH Cassette {Whole Blood}
86308QWJuly 16, 2009ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only)
86318QWAugust 7, 2009Pro-Advantage by NDC H. pylori Device (Whole Blood)
87804QWAugust 18, 2009BinaxNOW Influenza A & B Test, K092223
Other Key Points of CR6685

For 2009, the description for the CPT code 84155 was modified from “Protein, total, except by refractometry; serum” to “Protein, total, except by refractometry; serum, plasma or whole blood.” Therefore, the CPT codes assigned for the total protein test performed on the following test systems have been changed from 84157QW to 84155QW:

  • Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood},
  • Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 Panel){Whole Blood},
  • Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood},
  • Abaxis Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood), and
  • Arkay SPOTCHEM EZ Chemistry Analyzer (Spotchem II Basicpanel 2){Whole Blood}.

As a result, Medicare will permit the use of 84155QW for claims submitted by facilities with a valid and current CLIA certificate of waiver with dates of service on or after January 1, 2009, but Medicare will deny the use of code 84157QW from such facilities with the dates of service on or after January 1, 2010.

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