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New York State Requirements More Stringent Than CMS on Testing When Awaiting CLIA Certificate of Waiver

On Dec. 14th, the Department of Health (DOH) shared guidance issued by the Centers for Medicare and Medicaid Services (CMS) regarding any entity that may perform COVID-19 testing under a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. The guidance speaks to CMS's enforcement discretion to allow any entity with a COVID-19 point-of-care testing device (including BinaxNOW) to begin using the device once they have applied for their CLIA certificate; however, the document states that facilities should check with their state agencies regarding any additional state requirements.

LeadingAge NY reached out to the State’s Clinical Laboratory Evaluation Program (CLEP), which provided important clarification, as New York’s laws are more stringent than CMS. In New York, you may begin testing once notification of approval has been received. In the past, testing was only allowed after the physical certificate had been received. Specifically, you may begin testing once CLEP has notified you via email that the Limited Service Laboratory registration has been processed. Such emails will include a PDF copy of the certificate and the mandatory public health reporting requirements for COVID-19 test results.

Contact: Diane Darbyshire, ddarbyshire@leadingageny.org, 518-867-8828