State Labs Exempt from CLIA

Situation Report | April 5, 2021

The U.S. Centers for Medicare and Medicaid Services (CMS) has announced that New York State-licensed laboratories are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of six years as long as they possess a valid permit under the New York State Public Health Law.

The exemption is effective from March 26, 2021 to March 26, 2027. 

The law generally says that no laboratory may perform tests on human specimens unless it has a certificate to perform that category of tests issued by the Secretary of the Department of Health and Human Services (HHS). 

The law also provides exemptions in states that enact legal requirements that are equal to or more stringent than CLIA’s statutory and regulatory requirements.

HHS found that New York’s licensure program meets certain requirements and, thus, all state-licensed or state-approved laboratories are exempt from CLIA program requirements.