CMS halts production of COVID-19 tests from unqualified labs

Oct 16, 2020
The Bottom Line

A plethora of laboratories across the United States are rapidly producing COVID-19 tests, but a recent record check by CMS resulted in 171 cease and desist letters to labs, halting production of tests at labs without the proper qualifications.

 The record check found that those labs did not have up-to-date Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications. CLIA certifications ensure that labs meet federal performance, quality, and safety standards to properly diagnose, prevent, and treat diseases, as stated by CMS.

Of the 171 letters, 34% were issued to labs testing for COVID-19 without a proper CLIA certificate, and 66% were issued to labs preforming tests outside the scope of their existing CLIA certification.

Quarterly Member Calls

Members-only calls

Enjoy upcoming and past Quarterly Calls with your AMBR Membership! Click here!

Access sample white papers, tools, analysis, and resources.

Featured Event

Tuesday, October 6, 2020 - 07:00

2019 Revenue Integrity Symposium

The 2020 Revenue Integrity Symposium covers topics essential to revenue integrity, Medicare compliance, and the revenue cycle in acute care and long-term care settings.