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.

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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.

Electronic Prior Authorization Bill Reintroduced in Congress

By Tara Cepull, MA | Sep 3, 2024

For clinical labs, the proposed law could bring more consistency to test ordering

An older female patient discusses test results with her female doctor, who is holding a clipboard.

Dx Deals: Quest Makes Big North American Expansion with LifeLabs Acquisition

By Ron Shinkman | Aug 30, 2024

The roughly $1 billion deal will boost the company’s annual revenue by about 7 percent, and will give Quest a stronger presence in Canada

LifeLabs head office building in Etobicoke, Ontario, Canada

Diagnostics Pipeline: Scientists Ask Agency to Rescind Approval for Opioid Management Test

By Ron Shinkman | Aug 30, 2024

Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’

A large group of prescription medication bottles sit on a table in front of a distraught man who is leaning on his hand as he sits at his dining room table. The image is photographed with a very shallow depth of field with the focus being on the pill bottles in the foreground, illustrating the concept of opioid abuse.

Loper Bright Renews Interest in the VALID Act

By Christine P. Bump | Aug 30, 2024

The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation

Capitol building in Washington DC illuminated against a stormy sky

September 2024 Labs in Court

By Danielle H. Tangorre, Seth B. Orkand | Aug 30, 2024

Recent DOJ settlements continue to focus on issues involving medical necessity and marketer compensation

Lawyer meeting with client to sign paper work, illustrating the concept of a legal settlement

What Labs Need to Know About MolDX®

By Michael Schubert, PhD | Aug 30, 2024

How the MolDX® program works, what it covers, and how it can support better test access, use, and reimbursement in the clinical lab

An illustrated representation of medical coding and billing, featuring symbols representative of healthcare (such as a clipboard with medical documents) and finance (such as a wallet and money).

Special Report: The 2024 Lab Enforcement Landscape

By Scott Wallask | Aug 29, 2024

Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing

A female laboratory professional looks at a tablet while standing in a darkened laboratory, illustrating the review of laboratory enforcement actions.

Syndromes Without a Name Bring Labs an Uphill Battle

By Michael Schubert, PhD | Aug 29, 2024

In an era when genetic and genomic testing are theoretically affordable and accessible, why do so many patients remain undiagnosed?

A child having blood drawn for lab testing. Over two-thirds of rare diseases have an exclusively pediatric onset.

Advances in Point of Care Tech Alter the Genetic Testing Landscape

By Oscelle Boye, MBiomed | Aug 29, 2024

How are advances in point-of-care testing altering the genetic testing landscape, and what does this mean for the clinical lab?

Illustration of tablet with DNA strands surrounded by three sample tubes, a syringe, human figure, another DNA strand, and a magnifying glance, representing the concept of portable genetic testing.

Molecular Mysteries in the Blood