CMS Interim Rule on COVID-19 Data Reporting Requirements

iAssay automatically sends COVID-19 test results to the Cloud! This has always been a part of the plan because of its anticipated importance. Now that HHS has mandated that COVID-19 test results be sent to them periodically, iAssay will have you covered! Comply with us!

Courtesy of Patricia Jones, PhD and The AACC

On September 2, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule in the Federal Register (pages 54820-54874), which established new regulatory requirements for healthcare providers performing COVID-19 testing. 

The rule, effective immediately, requires that all CLIA laboratories, including Certificate of Waiver testing facilities, must report SARS-C0V-2 test results.  The results must be submitted in a standardized format to the Department of Health and Human Services (HHS) at a frequency determined by the Secretary. 

Laboratories failing to comply are subject to a $1,000 fine for the first day and $500 for each subsequent day.  The lab must report all positive and negative results for each method.  HHS spelled out how labs must report the data in a June 4th guidance.  AACC provided feedback to HHS on the document.