CLIA (Clinical Laboratory Improvement Act)

The TearLab Osmolarity System, as an in-vitro laboratory device, is regulated under the Federal CLIA regulations (http://www.cms.gov/CLIA/) and is categorized as Moderate Complex. The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing and if an entity, including a doctor's office, performs in-vitro diagnostic testing, it is considered a laboratory under CLIA and must register with the CLIA program. CMS requires all entities that perform laboratory testing, including a doctor's office (each separate location), to be CLIA registered in order to qualify for reimbursement (CPT 83861).

TearLab offers a simple program for those doctors who wish to obtain a CLIA Moderate Complex Certificate. Click here for more information.

For additional information regarding the TearLab Osmolarity System and CLIA please contact customerservice@tearlab.com