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
The Year in Dx VC Investment: Dx/Tools Outperforms Health Care & Liquid Biopsy/AI/ Informatics Outperforms Dx/Tools
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Case of the Month: Judge Who Said Labs Must Independently Verify Medical Necessity Takes It Back
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Basket Study Shows Early Efficacy Targeting Cancer Only On Alterations
From - Diagnostic Testing & Emerging Technologies
Early results from an ongoing "basket study" show that targeted therapies may be effective strictly based on the tumor's molecular profile, and not primary tumor type…
Compliance Perspectives: Can You Require Lab Workers to Get a Flu Shot?
From - G2 Compliance Advisor
Bottom Line on Top: Yes, a mandatory flu vaccination policy is legally justifiable as long as…
PAMA-geddon: Lab Industry Asks Court to Stop New Medicare Fee Schedule
From - Laboratory Industry Report
With CMS refusing to back down, the lab industry has escalated the dispute and asked a U.S. District Court to step in and prevent enforcement of the 2018 PAMA-inspired…
EHR: Private Whistleblowers Getting in on “Meaningful Use” Crackdown
From - National Intelligence Report
Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in federal health care fraud enforcement…
Gene Expression Panels Less Cost-Effective in Real-World Settings
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New Guidance on the Use of Lab Testing to Monitor Pain Management Patients
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Internet-Based Testing for STIs Increase Uptake
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Tools: Model Flu Vaccination Policies—Mandatory & Voluntary
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