Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
AACC Calls on Laboratories to Take Measures to Minimize Risks of Biotin Interference
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ACMG the Latest to Come Out Against Genetic Testing for All Breast Cancer Patients
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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
New overtime rule now in effect
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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
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
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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.
Maximum Civil Monetary Penalties Increase in 2020
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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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