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
Supreme Court Preserves ACA’s Insurance Subsidies for Federal Exchange Enrollees
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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...
OraSure Receives HHS Contract to Develop Ebola POC Test
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Rapid diagnosis of infectious pathogens is key to controlling outbreaks. Time to diagnosis is particularly critical for deadly infections such as Ebola. The U.S. Department of Health and Human...
UCSF, Kaiser Say They Have Developed Method for Gauging Genetic Prostate Cancer Risk
By Ron Shinkman, Editor, Laboratory Industry Report The University of California, San Francisco (UCSF) and Kaiser Permanente have concluded that a blood or urine-based laboratory test may be developed that can determine a patient's genetic risk for developing...
New App Aims to Reduce Unnecessary Preoperative Testing
By Kelly A. Briganti, Editorial Director, G2 Intelligence In the effort to reduce unnecessary utilization and health care costs and focus on quality and value, pre-operative testing has been receiving significant attention. In last week's Insider, we highlighted a...