TAG:
Department of Health and Human Services
2021’s Top 10 Lab Stories Confirm Important Trends
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Florida Laboratory Owner Gets 82-Month Jail Term
CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who vi…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
Comment Period Closing on Federal Surprise Billing Rule
PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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