The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and...more
On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to...more
On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more