Payment Innovation: COVID-19
As part of the ongoing White House Coronavirus Task Force efforts, CMS and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting organizations, and taken other related actions.
On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to EUA for COVID-19 during the public health emergency.
The FDA issued two final guidance documents.
CMS releases list of 12 new CLIA-waived tests
The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.
On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.
On December 28, 2018 CMS published its CLIA User Fee Update.
The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.