Waived CLIA Tests for Medicare and approved by the FDA

If you are a certified CLIA facility, you know that the Centers for Medicare & Medicaid Services (CMS) only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, and if the laboratory claims are edited at the CLIA certificate level.


Once new waived tests are approved by the FDA they become valid for use. The new waived tests announced by CR 6179 (and their effective dates) are in the following table:


Note: QW modifier tells Medicare that these are waived tests and should always be billed on the claim with the correct procedure code.


CPT: Modifier Approved Date: Description:
87880 QW June 28, 2007 PSS World Medical Select Diagnostics Strep A Twist
87880 QW March 19, 2008 Jant Pharmacal Accutest Integrated Strep A Rapid Test Device
87880 QW March 19, 2008 Inverness Medical Biostar Acceava Strep A Twist
87880 QW April 8, 2008 Diagnostic Test Group Clarity Strep A Rapid Test Strips
80061 QW April 14, 2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
82465 QW April 14, 2008 Abaxis, Piccolo xpress Chemistry Analyzer{Lipid Panel Reagent Disc} (Whole Blood)
83718 QW April 14, 2008 Abaxis, Piccolo xpress Chemistry Analyzer{Lipid Panel Reagent Disc} (Whole Blood)
84478 QW April 14, 2008 Abaxis, Piccolo xpress Chemistry Analyzer{Lipid Panel Reagent Disc} (Whole Blood)
82465 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
82947 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
82950 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
82951 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
82952 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
83718 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
84478 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
84450 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
84460 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Lipid Panel Plus Reagent Disc} (Whole Blood)}
82042 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
82150 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
82247 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
82977 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
84157 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
84075 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
84450 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
84460 QW April 14, 2008 Abaxis Piccolo xpress Chemistry Analyzer{Liver Panel Plus} (Whole Blood)
89300 QW June 12, 2008 SpermCheck Vasectomy
83520 QW June 13, 2008 HemoCue Albumin 201 System


In addition to this list the CR 6179 also announces that:
The new waived CPT/HCPCS code 87809 has been assigned to the infectious agent antigen detection by immunoassay with direct optical observation; adenovirus. The HCPCS code assigned to the Rapid Pathogen Screening PRS


Adeno Detector test has been changed to 87809QW with an effective date of January 1, 2008.


•The new waived CPT code, 83520QW has been assigned for the albumin test performed using the A HemoCue Albumin 201 System with an effective date of June 13, 2008.


•As of May 1, 2008, the following test systems are either discontinued or are no longer manufactured, and their names have been removed from the list of tests granted waived status under CLIA:oMetrika A1c Now for Prescription Home Use (K020234),oMetrika A1c Now™ - Professional Use (K000887),oMetrika A1c Now for Professional Use (K020235),oMetrika DRx® HbA1c (Professional Use Test System),oBayer DCA 2000 – glycosylated hemoglobin (Hgb A1c), andoBayer DCA 2000+ - glycosylated hemoglobin (Hgb A1c).


•The Bayer A1CNow+ {For Professional Use} was granted waived complexity categorization because of its home (over the counter) use. Effective May 1, 2008, the CPT code for Bayer A1CNow+ {For Professional Use} test system has been changed from 83036QW to 83037QW on the list of tests granted waived status under CLIA.

The attachment to CR 6179 includes the list of tests granted waived status under CLIA. The tests mentioned on the first page of this attachment (i.e., CPT codes: 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

If you have previously billed claims incorrectly resubmit them to your Medicare carrier or MAC and request them to review and reprocess your claims with these new changes.


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