Question:

What penalties is CMS imposing if a lab fails to comply with the new CLIA COVID requirements?

Answer:

Regarding monetary penalties, CMS states: “The regulatory amendments at §§ 493.41 and 493.1100(a) require all CLIA-certified laboratories, including those holding a CoW and PPM, to report SARS-CoV-2 test results to the Secretary for the duration of the PHE for COVID-19, and, that failure to do so will result in a condition level violation of the CLIA regulations.” Should a laboratory fail to report all required COVID-19 test results, CMS will take action to impose a civil monetary penalty (CMP), which is mandated under §§ 493.1804 and 493.1834. The agency outlines that the penalty will be $1000 for the first day of noncompliance with new reporting requirements, while each subsequent day will be penalized at $500.

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