Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
OIG Work Plan Monthly Review: March 2018
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Enforcement Trends: Why Fending Off Whistleblowers Might Have Just Gotten Easier
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Brief Your CEO: The New CMS Appeals Process & How to Use It to Get Medicare to Pay
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Theranos & Its CEO Settle Stock Fraud Charges with SEC
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Happy Endings: Guardant & Foundation Make Sweet Lemonade Out of False Advertising Lemons
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FDA Watch: Personalized Medicine Approvals Continue to Flow
From - Laboratory Industry Report
After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown…
DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases
From - National Intelligence Report
A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the…
Dermatology Conference Highlights Gene Expression Tests for Skin Cancer
From - Diagnostic Testing & Emerging Technologies
Several companies presented findings at the American Academy of Dermatology's annual meeting (Feb. 16-18, San Diego) indicating that…
Out of Network: 6 Frequently Asked Questions
By Richa Singh bio
As labs face an increasingly challenging reimbursement environment, more providers are doubling down on out-of-network strategies to maximize on collections opportunities…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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