Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Molecular Testing Avoids Significant Pay Cuts in 2017 CLFS
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Labs Beware: New Rules Impose Harsher Civil Monetary Penalties
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Semiannual OIG Report to Congress Outlines Challenges as Well as Successes
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New OIG Advisory Opinion Repeats Warning that Free Labeling Services Can Be Kickbacks
OIG says a laboratory's proposal to offer dialysis clinics free labeling services would likely violate the Anti-Kickback Statute
Labs Can Take Advantage of Transportation Anti-Kickback Safe Harbor
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OIG Says No to Lab Providing Free Labeling Services to Dialysis Facility
From - G2 Compliance Advisor
Reiterating its longstanding aversion to labs providing free items or services to referral sources, the Department of Health & Human Services Office of Inspector General (OIG) issued an…
Abbott Asks Court to Pull the Plug on Alere Merger
From - Laboratory Industry Report
Abbott officially wants out of its $5.8 billion merger with Alere. Last week, the Illinois-based diagnostics giant asked a Delaware Chancery Court to…
Epigenetic Testing May Predict Aging, Mortality
From - Diagnostic Testing & Emerging Technologies
Epigenetic changes, measured by DNA methylation, may be a predictor of biological age, according to a study published in…
OIG Report Highlights Aggressive Enforcement
From - National Intelligence Report
The OIG's latest semiannual report to Congress as usual touts its successes with oversight and enforcement and provides a guide to…
21st Century Cures Act: Moves Closer to Becoming Law
From - Diagnostic Testing & Emerging Technologies
In a show of bipartisanship and further support of precision medicine and health care innovation—including genomics and other diagnostic innovations…
