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
CMS Responds Positively to Requested Changes in Final PAMA Rule
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Thermo Fisher Scientific Signs Testing Development Deal With Chinese Hospital
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Data Analytics Fuels Billions of Dollars in Fraud Recoveries Says OIG, CMS
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Largest Takedown in Strike Force History Alleges $900 Million in False Medicare Billing
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Department of Justice Nearly Doubles FCA Penalties
From - National Intelligence Report
June 30, the Department of Justice (DOJ) published an Interim Final Rule in the Federal Register that has significant ramifications for enforcement under the…
Supreme Court Turns Down Sequenom’s Patent Petition
From - Laboratory Industry Report
Sequenom, engaged in a hail Mary legal effort to protect a patent previously invalidated by legal action, confirmed this week that…
CDC Expands MicrobeNet Pathogen Library With Help From Industry
From - Diagnostic Testing & Emerging Technologies
The U.S. Centers for Disease Control and Prevention (CDC) recently announced another new partnership with industry to expand the utility of…
Biodiagnostic Laboratory Services LLC Pleads Guilty
From - G2 Compliance Advisor
Amidst the guilty pleas and sentencing of dozens of individuals, the laboratory company Biodiagnostic Laboratory Services LLC (BLS) entered a…
CMS Issues Final PAMA Rule, Delaying Implementation of New Rates to 2018
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Largest Strike Force Takedown in History Charges 300 Individuals
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