The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing. The Centers for Medicare & Medicaid Services (CMS), through the Clinical Laboratory Improvement Amendments (CLIA), regulates all non-research laboratory testing performed on humans in the U.S. and seeks to help ensure quality laboratory testing.

The Centers for Medicare & Medicaid Services (CMS)

There are 3 CLIA categories based on the complexity of the laboratory tests performed: Waived, Moderate Complexity and High Complexity. The more complicated the test is, the more rigorous the CMS requirements are and the higher the category assigned. COVID-19 testing has been approved for the Waived category which means the test is simple and has a low risk for error.

A testing facility must obtain a CLIA Certificate of Waiver, even if just one test is performed, or a patient is tested at no-charge. If your facility only collects specimens to be sent out for testing at another facility, then CLIA certification is not required for your facility.

Certificate for the Waiver category is $180.

The certification will be valid for 2 years from the date of issue.

1. Check state agency for any other state-specific requirements. CLIA is a minimum requirement and some state or local laws may be more stringent.
2. Complete the CMS-116 form (fillable PDF). This can be found on the CMS website or from your local State Agency. Additional help regarding the application can be found below.
3. Send completed application to local State Agency. 
4. Pay fees www.cms.gov/clia

Processing time varies greatly by state. It can take as little as 2 days up to 1 month. 

Processing time varies greatly by state. It can take as little as 2 days up to 1 month. 

Once your practice is CLIA certified, any member of your team can administer the test as no special training or certification is required, however, you must follow the test manufacturer’s instructions.

CMS recommends those that collect a sample by someone suspected to have SARS-CoV-2 use the recommended PPE, such as an N95 or higher-rated respirator (or facemask if respirators are not available), eye protection, gloves, and a gown.

Yes. Data must be reported to the state or local health departments according to the individual state laws or regulations. Most often, electronic reporting is available.

Negative and positive results of each COVID-19 test performed must be reported each day to the state and/or local health departments, and within 24 hours of results being available. Full reporting requirements can be found on the CDC website. 

Dental insurances will have codes effective in 2021 but will likely be the members responsibility. Medical insurance policies will have a benefit, but coverage varies on the individual plan. 

The fee for testing is based on individual practice. Most medical insurance allowables range from $60-$175.