CLIA Waiver

A type of CLIA certificate that allows a practice to perform simple, low-risk laboratory tests that have been approved by the FDA for waived testing.

A CLIA waiver is what most small practices operate under for lab testing. If you do rapid strep tests, urine dip sticks, glucose monitoring, rapid flu tests, COVID antigen tests, or any other FDA-waived test, you need a Certificate of Waiver. It is the simplest and least expensive CLIA certificate. The waiver application is CMS-116, submitted through your state's CLIA office or directly through CMS. The application asks what tests you perform, your expected testing volume, and who serves as your laboratory director. For waived testing, the laboratory director can be any provider authorized by the state to order tests. The biennial certificate fee for a Certificate of Waiver is currently $180. You renew every two years. The renewal process is straightforward but easy to forget. Set a calendar reminder 90 days before expiration. Here is the catch that trips up some practices: even though waived tests are considered low-risk, you still need to follow the manufacturer's instructions exactly. If the rapid strep kit says to wait five minutes before reading the result, you wait five minutes. If it says to use the control test with every new box of kits, you run the control. Failure to follow instructions can result in a citation during a state survey. Your CLIA waiver number goes on credentialing applications and must be included on claims for laboratory services. If you bill a waived test without a valid CLIA certificate, the claim will deny. Some payers verify CLIA status during credentialing and flag it if your certificate has expired. If your practice expands beyond waived testing into moderate or high complexity tests, you need to upgrade your CLIA certificate. This is a significantly more involved process with personnel requirements, proficiency testing, and regular inspections.