Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
NCI-MATCH to Launch Simultaneous Trials of 20+ Targeted Therapies
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The precision medicine trial NCI-MATCH (National Cancer Institute-Molecular Analysis for Therapy Choice) will open for patient enrollment in July. The multicenter trial will evaluate the...
Novel Marker Shows Promise for Early Detection of Pancreatic Cancer
By Stephanie Murg, Managing Director, G2 Intelligence Tiny particles known as exosomes may be a powerful cancer screening and diagnostic tool—the trick is detecting and isolating those that are derived from cancer cells. Researchers at the University of Texas MD...
ABIM Grant Awarded to Reduce Unnecessary Pap Tests
By Kelly A. Briganti, Editorial Director, G2 Intelligence In keeping with the national focus on reducing unnecessary medical care and getting the right test to the right patient at the right time, the American Board of Internal Medicine (ABIM) Foundation awarded a...
Medicare Fraud Takedown Touted as Largest in Strike Force History
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Accountable Care: Final Shared Savings Rule and Updates to ACO Model
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Health Diagnostic Laboratory Files for Bankruptcy Protection
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Sequenom Loses Patent Dispute on Appeal
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Medicare Fraud Takedown Touted as Largest in Strike Force History
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Department of Health and Human Services (HHS), its Office of Inspector General, the Federal Bureau of Investigation, and the Justice Department's Criminal Division announced a nationwide "takedown"...
AACC Calls for Coverage, Reimbursement of Companion Diagnostics
By Stephanie Murg, Managing Director, G2 Intelligence With "precision medicine" and "personalized medicine" initiatives in the spotlight, the American Association for Clinical Chemistry (AACC) is looking to seize the momentum with a call for policies that ensure...