CLIA Waived drug tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.

CLIA requirements do apply to entities that perform drug test on ..."materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements.   If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program.

 

Must note that CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets.

 

 

In order for a CLIA facility to be reimbursed for a drug test they must reference CPT code QW 80101. The reimbursement is per drug class NOT per drug test. So, for a NIDA 5 (AMP/COC/OPI/PCP/THC), it would be QW80101 x 5. If it's a modified NIDA -5, however, like AMP/MAMP/COC/OPI/THC, it's only QW80101 x 4 since AMP and MAMP are both in the same drug class. With drug screens, different reagents (antibodies/antigens) must be used to detect the different drug/drug classes that is why you bill per class.