Securing a CLIA Certificate of Waiver
The Metrika A1cNow is classified as a CLIA Waived Category test by the FDA. A CLIA
certificate is required any time a clinical laboratory test is performed; however, waived
category tests require only a CLIA Certificate of Waiver. Certificate of Waiver labs must
register with Medicare, pay a $150.00 fee every two years and agree to follow
manufacture’s instructions. No inspections or other CLIA regulations apply.
Who Can Apply for a Certificate of Waiver.
Anyone can apply for a Certificate of Waiver unless your state has imposed additional
restrictions. Under CLIA, there are no personnel qualifications for the Laboratory Director or
individuals who perform waived tests. For example, Pharmacists may be granted a
Certificate of Waiver in all states except NY and PA. However, a number of states require
them to comply with additional requirements (AL, AZ, FL, ME, MD. MA, NJ, OR, TN and
RI). Always check with your State Agency if the Director for the Certificate of Waiver
laboratory is not an MD or other licensed health care provider.
To apply for a Certificate of Waiver, go to the internet at www.hcfa.gov/medicaid/clia and
download a CLIA application form (HCFA-116) and follow the instructions provided, or
complete the attached application form and send it to the appropriate state agency. A list of
State Agency addresses is attached and is also available on the internet at
www.hcfa.gov/medicaid/clia/saaddres.
