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

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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.

Five Things Labs Need to Know About the 2023 Clinical Lab and Physician Fee Schedule

By Glenn S. Demby | Nov 11, 2022

In case you don’t feel like reading all 3,300+ pages of the Final Rule, here’s a quick briefing on the main changes you should be aware of.

A female laboratory professional with glasses and a labcoat is sitting at a desk and writing notes on a clipboard. iStock image.

Weekly Enforcement Report: COVID-19-Related Cases Take Center Stage

By Rachel Muenz | Nov 9, 2022

Though light on lab-related cases, last week’s enforcement actions cracked down on COVID-19-related violations.

Purple, red, and black COVID-19 virus illustration. iStock image.

CMS Hikes 2023 Medicare OPPS Reimbursement Rate 3.8 Percent

By Glenn S. Demby | Nov 9, 2022

However, the increase still isn’t enough to keep pace with inflation, providers contend.

A young, male African American hospital staff member meets with an elderly White male patient. iStock image.

Healthcare Staffing Shortages Are Number 1 Issue in Recent Report

By Rachel Muenz | Nov 9, 2022

While likely not a surprise to medical labs, a new report may add more urgency to solving recruitment and retention issues.

A stressed lab worker rests his head on a stack of papers on the lab bench. iStock image.

Call for Speakers & Topics — G2 Intelligence Webinars & Events

By G2 Intelligence Staff | Nov 9, 2022

We’re inviting our readers to share their ideas for topics and presenters, both for future standalone webinars and our virtual events.

A blue and white graphic calling for speakers for G2 Intelligence's webinars and virtual events featuring a microphone.

CMS Publishes Final Clinical Laboratory Fee Schedule for 2023

By Glenn S. Demby | Nov 7, 2022

The Final Rule caps future PAMA cuts at 15 percent per calendar year.

Female laboratory professional in full PPE works on a computer in the lab. iStock image.

Feds Target Directly Billing Medicare for Tests Furnished by Reference Labs

By Glenn S. Demby | Nov 2, 2022

A California health system will pony up $13 million to settle reference lab billing fraud claims.

Closeup of gloved lab worker's hand holding a test tube of urine with a test strip and urine sample container in the background. Urine testing concept. iStock image.

FDA Revises EUAs for COVID-19 Antigen Tests

By Rachel Muenz | Nov 2, 2022

In response to the latest data on repeat testing, on Nov. 1, the agency made a few changes to EUAs for such tests.

Closeup of someone using the dropper to add their sample to a COVID-29 antigen test cartridge. iStock image.

Lab Tests the Theme in Recent Enforcement Actions