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
Compliance is About More than Kickbacks, Referrals, & False Claims Liability: Check Our Top 3 Compliance Areas You May be Overlooking
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New Variant Sharing Community to Tackle 'Red Herring' Variants
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Through creation of a shared pool of anonymized genomic variant information the founders of the Allele Frequency Community believe genome sequencing data can be more useful and actionable,...
CMS Reports Latest ACO Performance Results Demonstrate Continuing Success
By Kelly A. Briganti, Editorial Director, G2 Intelligence CMS announced that 2014 quality and financial performance results demonstrate the power of coordinated health care delivery via Affordable Care Organizations (ACOs). The performance data reveals over $411...
Sequenom Enters Into Collaboration With UC San Diego to Fine Tune Liquid Biopsy Cancer Test
By Ron Shinkman, Editor, Laboratory Industry Report Sequenom, the San Diego-based genetic laboratory, has entered into a research collaboration with the Moores Cancer Center at the University of California at San Diego to determine the utility of the company's...
FTC Issues Guidance on Unfair Competition Enforcement
By Kelly A. Briganti, Editorial Director, G2 Intelligence While experts have not proclaimed it an overwhelmingly helpful resource, the Federal Trade Commission (FTC) released a Statement of Enforcement Principles Regarding "Unfair Methods of Competition" Under...
Lab Payment Issues Lead CMS to Propose Some Outpatient Cuts
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Federal Court Defines “Identified” for Purposes of 60-Day Overpayment Deadline
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Two Lab Cases Lead U.S. Patent Office to Update Interim Guidance on Natural Phenomena
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Senior Medicare Patrol Had Significant Drop in Fraud Recoveries Last Year
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AMP Offers Proposal for Regulation of Laboratory-Developed Tests
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