CLIA Waived Test Kits

The FDA policy specified that CLIA waived tests are the simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. Now the CLIA waiver requirements are corrected and this is clear that test devices approved for home use by the Food and Drug Administration mechanically become the CLIA waived. Professional use versions of home use tests are not automatically waived. On the other hand, professional edition of such test kits do become qualified for simple waiver evaluation if the only differences between tests versions need to be studied to conclude whether the professional version qualifies for waiver.

CPT Codes and Reimbursement Information for the CLIA Waived Test Kits
Test Description	Average Reimbursement National Limit*	CPT Code
Strep A Test Kit Strip or Device	$16.76	87880
Drugs of Abuse Urine Multi Drug Panel, Cassette or Cups	$20.32 per drug class	80101
Drugs of Abuse Urine Test GC or HLPC Method	$19.24	80100
Hemosure Immunological Fecal Occult Blood Test	$22.22	Diagnostic 87774QW Screening G0328QW
Thyroid Gland Test Thyrocheck	$23.00	84443
* - The above listed Average Reimbursement Limit are provided for estimates only and are subject to change and not guaranteed. For the current actual state by state rates schedule, please visit: www.cms.hhs.gov BILLING NOTE FOR DRUGS OF ABUSE TESTS: DOA drug screens are usually billed out as 80101 x the drug class. So, for a NIDA 5 (AMP/COC/OPI/PCP/THC), it would be 80101 x 5. If it's a modified NIDA -5, however, like AMP/MAMP/COC/OPI/THC, it's only 80101 x 4 since Amp and Meth are both in the same drug class. Be aware that CLIA waived drug tests have a modifier next to their CPT code...QW80101. With drug screens, different reagents (antibodies/antigens) must be used to detect the different drug/drug class that is why you bill per class. The average reimbursement rate per drug class in this method is $19.24. There is another billing code 80100. That one refers to a chromatographic method (such as GC or HPLC) where the same reagents are used to detect multiple drugs/drug classes simultaneously. In the case of 80100, the reagents are static. And you bill once for all drugs combined. The average reimbursement here total is $20.32.