Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs

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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.

Lab Industry Advisor to the Rescue! Lab Industry Advisor provides comprehensive, up-to-date insights and analyses tailored to your needs. With expert commentary and actionable advice, you’ll stay ahead of the curve. No more sifting through endless sources—everything you need is right here!

Start your free trial today and see how Lab Industry Advisor can transform your approach. Get instant access to invaluable resources designed to keep you informed and competitive. Explore detailed reports, in-depth articles, and exclusive industry insights that help you make better decisions faster. Choose from three subscription levels tailored to fit your needs: Essential, Premium, and Elite.

Essential

Insight for every clinical laboratory

Subscribe today for updates on key developments in the clinical lab industry.

Premium

Exclusive, in-depth monthly reports

Subscribe today for additional insider reports about important lab trends.

Elite

Expert analysis & technology advice

Subscribe today for quarterly expert analysis & Clinical Diagnostics Insider.

Additional Business Intelligence Offerings

Clinical Diagnostics Insider

Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies

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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
Healthcare-related laws
FDA approvals
Business deals in the diagnostics space, and more

Latest Articles

LDTs Rule Update: More Support for Legal Challenges Against FDA

By Rachel Muenz | Oct 10, 2024

Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”

A closeup of someone looking at legal documents at a desk

New FDA LDTs Guidance Offers Useful Summary, But Questions Remain

By Rachel Muenz | Jun 27, 2024

Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details

A wooden stamp lies on a red surface next to stamped white

CMS Slated to Close Change Healthcare Payment Program

By Centers for Medicare & Medicaid Services | Jun 21, 2024

Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July

A medical billing professional sits at a computer with two monitors and reads paperwork, illustrating a healthcare reimbursement concept.

Medicare Reimbursement: CMS Proposes to Cut Part B Payments to Physicians

By Glenn S. Demby | Aug 24, 2023

The proposed PFS rule also includes other changes that will affect physician, lab, and other reimbursements in 2024 and beyond.

New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices

By Glenn S. Demby | Aug 24, 2023

Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.

2023 Lab Industry Layoffs: Where Do Things Stand?

By Rachel Muenz | Aug 24, 2023

An overview of the layoffs announced by major lab diagnostic companies in the first half of 2023 and the key trends.

Layoffs are illustrated by an oversized pair of scissors, that looms over seven workers sitting in office chairs suspended by strings. Employees use their laptop computers and mobile devices, but some of their jobs could be cut at any time, as they are shown hanging by a thread. Their jobs are on the line. Conceptual illustration uses a flat, limited color palette over a dark blue background, presented in isometric view on a 16x9 artboard.

Expert Discusses Key Developments in Breath Biopsy

By Rachel Muenz | Aug 24, 2023

Owlstone Medical CEO discusses recent trends, the advantages of breath testing, and the challenges that must be met for wider clinical use.

Elderly male patient who is clutching his chest meets with his male doctor, illustrating the concept of respiratory problems and breath testing.

Expert Q&A: The Latest in Breath Biopsy

By Rachel Muenz | Aug 23, 2023

Owlstone Medical CEO Billy Boyle discusses the latest developments in breath biopsy and issues related to its wider clinical adoption.

Uncovering the True Cost of Paper Forms: Why Forgoing Automation to Save Money May Cost You

By G2 Intelligence Staff | Aug 4, 2023

This webinar will analyze the true cost of using manual paper requisition forms for laboratory testing, highlighting the financial and medical risks involved.

A blue and white banner promoting the G2 Intelligence Webinar,

SCOTUS Ruling May Save Labs from Baseless Qui Tam Lawsuits

By Rachel Muenz | Aug 3, 2023

The recent 8-1 decision expands the DOJ’s power to request such cases be thrown out.

image of whistle and gavel on dark wooden desk

Insights into Attracting Top Talent to Your Lab

By Rachel Muenz | Aug 3, 2023

Lab staffing expert shares three key strategies for recruiting and retaining talent during difficult economic times.

lab manager shaking hands with job candidate

August 2023 FDA Watch

By Glenn S. Demby | Aug 1, 2023

Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.

Buy or Lease: Seven Things to Consider When You Need a New Instrument