On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more
On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more
It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more
11/21/2023
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Outpatient Prospective Payment System (OPPS) ,
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On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its annual final rule (Final Rule) setting the payment rates and coverage policies for items and services reimbursed under the Outpatient...more