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 Semiannual Report: Opioid Crackdown Is Making Labs a Prime Enforcement Target Once Again
From - G2 Compliance Advisor
Once the favorite whipping boy of federal enforcers, labs have been demanding less and less of the OIG's attention in recent years. But the newly published…
Lack of Utility Evidence Still Hampers Adoption of Pharmacogenomic Testing: Benefits Seen in the Field of Psychiatry
From - Diagnostic Testing & Emerging Technologies
For years it had been hoped that pharmacogenetic (PGx) testing would be a leading application for personalized medicine…
How to Adjust to the April 2018 Medicare Beneficiary Cards
By Sean McSweeney bio
In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their planned changes regarding…
Whole-Genome Sequencing Can Improve Blood Transfusion Matches
From - Diagnostic Testing & Emerging Technologies
Antigen typing based on whole-genome sequencing (WGS) can enable more precise matching of blood transfusions, according to a study published online May 17 in…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Anthem Blue Cross Blue Shield is suing Reliance Laboratory Testing for allegedly conspiring with California hospital Sonoma West Medical Center to create a fraudulent…
FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
Case of the Month: Individual Principles Hit with $114.1 Million Verdict for Role in HDL Blood Test Fraud
From - National Intelligence Report
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
Single-Sample Confirmatory Test Ok for Diabetes Diagnosis
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Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap
From - Laboratory Industry Report
Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on…
The End May Be Near for Theranos & Elizabeth Holmes
From - G2 Compliance Advisor
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of…
