ACLA
Biden Administration Details Expanded Testing as Part of Broader COVID-19 Action Plan
President Biden said he would use the Defense Production Act to expand manufacturing of rapid point-of-care and at-home COVID-19 tests, among other initiatives. Â
While prosecutions under the law have been few in number, recent cases indicate it won't be confined to the toxicology labs it was initially designed to target.
US House and Senate Reintroduce Bill That Would Give FDA Authority to Regulate LDTs
Originally introduced in 2020, the bill, called the VALID Act, would create a new risk-based oversight framework for LDTs and kits with FDA regulating them.
ACLA Files Notice of Appeal in PAMA Lawsuit
The notice is the latest move in the organization's fight to challenge HHS' implementation of the act and specifically its approach to collecting test pricing data.
While the reforms ease some providers' shift to value-based care, their exclusion of labs could hamper the industry's move into population health and other areas.