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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Enforcement Trends: False Claims Act Recoveries Increase as Labs Remain in Firing Line
The dollars paid by healthcare providers in federal False Claims Act settlements and judgments increased for the second year in row in 2019. After a surprising decline in 2017, total recoveries rebounded
Enforcement Trends: The Top 5 Lab False Claims Act Settlements of 2019
Labs were on the paying end of at least eight million-dollar False Claims Act (FCA) settlements or judgments in the 2019 fiscal year. Here’s a review of the top 5 reported FCA recoveries against a lab or lab services company.
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Massachusetts Practice Busted for Taking Free POCT Cups from Millennium
Case: A northern Massachusetts medical practice and Detroit pain clinic became the latest downstream providers to pay the OIG a five-figure fine to settle kickback claims in the form of accepting free point of care test cups from
The DX Pipeline: New Invitae App Leverages Apple Watch Data for Studying Disease Genetics
Invitae’s newly launched Invitae Discover app is in many ways the perfect manifestation of where consumer-based precision medicine diagnostics is heading. The app combines health and activity data from Apple Health and the
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Industry Buzz: The 10 Biggest DX Mergers of 2019
Conspicuous by its absence from the list is the proposed $1.2 billion Illumina takeover of Pacific Biosciences which suddenly seems to be in major trouble. Here are the 10-highest value M&A diagnostics deals that did come off in 2019.
In Brief: OIG Opens Second Avenue for Anti-Kickback Statute Revisions
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FDA Targets Sale of IVD Reagents without Premarket Approval
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By the Numbers: Improper Medicare Payments Hit 10-Year Low
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