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
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Labs in Court: Three Lawsuits Tossed
In this month’s roundup, three cases—including two whistleblower lawsuits and one workplace discrimination case—get dismissed.
What Can Go Wrong with Outsourcing Lab Billing and Coding?
Lab leaders must be able to make a sound assessment of both the costs and benefits, and the liability risks involved.
A Due Diligence Checklist for Vetting Medical Billing Company Compliance
Labs have a duty to inquire into what their billing company is up to and whether it complies with all applicable regulations.
OIG OKs Pharma Company’s Use of Financial Help for Patients
Recent Advisory Opinion sheds light on offering patients financial assistance so they can receive the provider’s products and services.
Simplifying Antidepressant Quantification in Clinical Labs
A recent study provides insights on how to use automation and only 20 μL of a serum sample to quantify blood levels of antidepressants.
Expert Q&A: Recent Trends in the Clinical Lab
G2 Intelligence managing editor Rachel Muenz chats with lab leader Stephanie Whitehead about recent developments affecting clinical labs.
FDA Breaks New Ground in COVID-19 & Concussion Blood Testing Approvals
In the period from Mid-February through mid-March, three different products received first-of-their-kind clearances from the agency.
New Tech Could Improve Diagnostic Accuracy of Prostate Cancer Tests
New technologies show potential for far greater accuracy and the ability to customize treatment options to improve outcomes.
A New ctDNA Test for MRD Surveillance in Colorectal Cancer Patients
The personalized test is designed to help inform post-surgery adjuvant therapies in CRC patients.
Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
