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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Compliance Perspectives: PAMA Pitfalls & Survival Strategies
From - Lab Compliance Advisor
PAMA's deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should…
Big Data Can Reshape Lab Reference Values in the Era of Personalized Medicine
From - Diagnostic Testing & Emerging Technologies
As might be expected, there are substantial differences in "normal" laboratory values determined by healthy outpatients and critically ill patients in…
Post-PAMA: Government Report Warns of Medicare Overspending(!) for Lab Tests
From - National Intelligence Report
As if the deep price cuts inflicted by PAMA weren't infuriating enough, now the US Government Accountability Office (GAO) is claiming that…
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019
From - National Intelligence Report
The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to…