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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
Enforcement Trends: Feds Administer a Double Dose of Civil Monetary Penalty Increases
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FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response
From - National Intelligence Report
With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates…
Latest Legal Challenge to ACA May Mean a Hot Mess for Insurance Markets
From - Laboratory Industry Report
After a series of setbacks, Republicans challenging the constitutionality of the Affordable Care Act (ACA) and its individual mandate are…
Point-of-Care Test Can Increase Access to Toxoplasma Testing
From - Diagnostic Testing & Emerging Technologies
A novel fingerstick test may improve access to Toxoplasma gondii testing for pregnant women, according to…
Case of the Month: Anthem Settles Massive HIPAA Breach Case for Record $16 Million
From - G2 Compliance Advisor
Pop Quiz: What's the highest amount a health care entity ever paid to the HHS Office for Civil Rights (OCR) to settle a HIPAA violation…
TOOL: Model Religious Accommodations Policy
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Monthly Work Plan Review: October 2018
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Alabama Hospital and Lab Subsidiary Agree to $4.25 Million Kickback Settlement
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Medicare Reimbursement: Labs Propose Solutions to PAMA Part B Pricing Problem
From - National Intelligence Report
CMS recently issued its annual proposed rule on 2019 Medicare Part B reimbursement. For many labs, the number one concern is…
