FDA Approves New Waived Tests
- By admin aapc
- In Industry News
- August 28, 2009
- Comments Off on 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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