ACLA
While the year wasn't without challenges, rising valuations, a recovery in routine test volumes, and expansion into new, lucrative areas bode well for the lab business.
Observers expect that any reform will involve moving to a sampling-based approach to price data collection, which could ensure broader representation of lab pricing.
Nearly 600 clinical laboratory tests could have their reimbursement from Medicare slashed starting in 2023, which would disproportionately affect small, rural labs.
FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies
The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.
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