Posted December 7, 2022
Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988).
The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows:
- 82010QW, 82962, May 27, 2022, AmVentureX Inc. BioCoach Blood Glucose and Ketone Monitoring System;
- 80305QW, June 07, 2022, Micro Distributing STATDIP One Step Drug Test;
- 80305QW, June 07, 2022, Micro Distributing STATCup II One Step Drug Test Cup;
- 87880QW, June 09, 2022, Clarity Diagnostics LLC Clarity Strep A Rapid Test Strip;
- 87880QW, June 09, 2022, Independent Medical Co-op Inc. IMCO Strep A Rapid Test Strip;
- 80305QW, August 31, 2022, Instant Technologies Inc. iSCREEN Urine Test Dx Drug Screen Square Cup;
- 80305QW, August 31, 2022, Verséa Holdings Inc. Verséa THC One Step Marijuana Test Strip; and
- 86386QW, September 06, 2022, Abbott Diagnostics Scarborough Inc. NMP22 BladderChek Test (Prescription Home Use) and (Professional Use)
Some home health and hospice agencies perform tests that are considered waived under the CLIA which requires the home health agency or hospice to have a CLIA Certificate of Waiver. Waived tests a home health or hospice agency may perform include, but are not limited to:
- Blood glucose by glucose monitoring devices cleared by the FDA for home use
- Prothrombin time home tests (PT/INR)
- Dipstick or tablet reagent urinalysis
- Flu test
- Drug test
Performing these types of tests, and any included in the Tests Granted Waived Status Under CLIA table, requires the agency to have a current CLIA certificate of waiver. An agency that obtains a sample and takes it to a laboratory for testing is not required to hold a CLIA certificate of waiver for that particular test, i.e. PT/INR where the agency’s personnel obtain a blood sample from the patient and take that sample to a laboratory for testing.
Source: NAHC
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