Congress
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.
Rand Paul Reintroduces Bill Aimed at Blocking FDA Regulation of LDTs
First introduced in March of 2020, the VITAL Act would have LDTs regulated by the US Health and Human Services secretary under the Public Health Services Act.
Bill Introduced in Congress to Provide $4.5B in Lab Infrastructure Funding
The bill would provide $4.5 billion from 2022 to 2026 to support clinical lab infrastructure to improve SARS-CoV-2 and COVID-19 testing and response.
CAP Sends Letter to Congress Supporting $46B Funding for COVID-19 Testing
The organization also supported the recommendation to include $1.75 billion in funding for the US Centers for Disease Control and Prevention.
While some remain concerned that the bill will reduce labs' leverage with payors, provisions like the use of arbitration for disputes are a win for providers.