When the COVID-19 pandemic hit the United States, federal and state agencies rushed to waive laws and create flexibilities to get needed COVID-19 testing to the public. This included the U.S. Food & Drug Administration (FDA) creating an unprecedented regulatory pathway to issue emergency use authorizations for tests not formally approved by the FDA, the Centers for Medicare and Medicaid Services (CMS) waiving its normal reimbursement criteria for lab testing and stating it would exercise enforcement discretion related to CLIA compliance, and state agencies trying to formally or informally create policies to be in accordance with the federal objectives for COVID-19 testing. Additionally, Congress enacted the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security Act (the CARES Act), which included mandates for insurers related to payment of COVID-19 testing.
However, six months into the pandemic, not all the legal “puzzle pieces” are fitting. Conflicting agency guidance and laws are creating legal hazards for those involved in any aspect of COVID-19 testing, from manufacturers, clinical laboratories, ordering physicians, collection site staff, marketing companies, and even state or local government agencies. Furthermore, insurance companies are not uniformly following the federal payment mandates of the FFCRA and CARES Act.
Given the above, this free webinar will cover the existing legal framework and the risks that anyone involved in COVID-19 testing will need to navigate.
Agenda: THURSDAY, OCTOBER 1, 2020
12:00-1:00 PM MDT
Location: Webinar Only
Questions? Please contact email@example.com..