Keep reading to learn what they are, the benefits and how to apply for one!
Want to know more about CLIA Waivers and how they can benefit your pharmacy?
What is a CLIA Waiver?
A Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver is a certification that allows a facility, like your pharmacy, to legally conduct waived tests in order to help diagnose and determine treatment. Each CLIA Certificate of Waiver includes a ten-digit CLIA number, issued by the U.S. Department of Health and Human Services, that corresponds to a specific facility to location. The purpose of a CLIA Certificate of Waiver is to ensure that laboratory standards are met which ensure timeliness, accuracy, and reliability of laboratory test results for patients. CLIA Waivers are valid for 2 years.
Certificates like the CLIA Certificate of Waiver are used to enforce and regulate laboratories. This makes sure that there is a high standard of accuracy and reliability of test results from laboratories, regardless of its location.
There are various types of CLIA certificates, each based on the types of diagnostic tests a laboratory may run. CLIA is run by a partnership between the FDA, CMS, and CDC All carry different responsibilities regarding CLIA and CLIA Certificate of Waivers. Any facility that intends to perform laboratory tests on “human specimens for the purpose of diagnosis and/or treatment” is required by federal law and, often, state law to have a CLIA Certificate of Waiver for some tests. CLIA-waived tests must be performed at the laboratory/pharmacy location and be performed by a pharmacist, pharmacy technician, or pharmacy intern.
CLIA Waivers allow your pharmacy to perform Rapid Flu, Strep, and COVID tests, among others.
How to apply?
It is important to note that requirements differ between states.*
Fill out the CMS-116 form and fax or mail it to your State Health Department. After your application has been received, CMS will send an invoice of $180 to your pharmacy location. The fee can be paid at Pay.gov or via mailed check.
After purchasing our Telehealth Services, please fill out this form, and our CLIA Waiver Specialist will help fill out the application for your pharmacy location.
*For detailed information about differing requirements across states, we offer help with the purchase of Physician 360 Telehealth Service Subscription.