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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
After a busy July, the pace and volume of new product launches slowed significantly in August…
Proposed 2019 Medicare PFS: The 5 Things Labs Need to Know
From - G2 Compliance Advisor
On July 12, CMS issued the proposed 2019 Medicare physician fee schedule (PFS), with comments scheduled to end on Sept. 10. Takeaways…
New Test Aids Lung Cancer Risk Assessment, But Survival Benefit of Comprehensive Sequencing Questioned
From - Diagnostic Testing & Emerging Technologies
Lung cancer-related testing is receiving a lot of attention, but recent results appear to show mixed benefits for these emerging tests…
AAB and NILA comments allege unlawful implementation of PAMA by CMS
From - National Intelligence Report
The National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB) has formally commented to the…
FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
OIG Monthly Work Plan Review: August 2018
From - G2 Compliance Advisor
Of the 12 new Work Plan items, four have direct implications for labs and billing of lab tests…