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
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - Lab Compliance Advisor
Case: A new DOJ lawsuit accuses a West Virginia non-profit hospital and its business consultant of seeking to dominate the Ohio Valley market by…
Serial CRP Results Predict Continued Risk Following Heart Attack
From - Diagnostic Testing & Emerging Technologies
Serial measurement of high-sensitivity C-reactive protein (hsCRP) levels following acute coronary syndrome may help…
Case of the Month: Milwaukee Clinic the Latest MD-Owned Lab Busted for Urine Drug Test Abuses
From - National Intelligence Report
Fraudulent utilization and billing of urine drug screening first became a priority for federal enforcers since the…
Pain Management Clinic, 2 MDs Pay $99K to Settle Millennium Free POCT Cup Kickback Claims
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The President’s Proposed 2019 Federal Budget: The 6 Things Labs Must Know
From - National Intelligence Report
While President Trump's proposed $4.75 trillion budget may be the largest in U.S. history, it calls for…
OIG Monthly Work Plan Review: April 2019
From - Lab Compliance Advisor
Among the 10 new Work Plan items this month, three may have potential ramifications for at least some labs…
New Point-of Care Paper Test May Improve Diagnosis of Preeclampsia
From - Diagnostic Testing & Emerging Technologies
The Congo Red Dot (CRD) Paper Test is a simple, rapid, non-invasive tool that that may improve triage and the accuracy of preeclampsia (PE) diagnosis at the point of care, according to…
Texas Pathology Lab Settles EHR Consulting Kickback Claims for $63.5 Million
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FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
From - Laboratory Industry Report
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on…
Microbiology Testing Rates Low For Hospital-Acquired Infections
From - Diagnostic Testing & Emerging Technologies
The European Centre for Disease Control and Prevention (ECDC) estimates that there are 9 million cases of health care-associated infections…
