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
How Could Cheaper Genomic Sequencing Affect the Clinical Testing Industry?
Recently released NGS systems will be helpful to researchers but are unlikely to immediately impact diagnostics, expert says.
It’s Decision Day for Makers of FDA-Approved COVID-19 Tests
COVID-19 test makers will either have to get full marketing approval, or take the product off the market.
Compliance Alert: Start Using New ABN Form on June 30
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
AACC Offers New Guidance for HPV and Cervical Cancer Screening
New document aims to help clinicians navigate screening guidelines, choose testing strategies, and analyze test results.
The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
New Device Predicts the Efficacy of Hypnosis Treatment for Pain
The inexpensive POC device is a biosensor that performs COMT genotyping as a biomarker for hypnotizability.
Medicaid Fraud Recoveries Drop Significantly in 2022
At $1.1 billion, total recoveries in 2022 did exceed $1 billion for the fourth year in a row, but dropped from $1.7 billion in FY 2021
Weekly Enforcement Report: Unlicensed Professionals
Last week’s lone lab-related enforcement action involved a prison sentence for a woman posing as a licensed physician’s assistant.
FCA Recoveries Decline despite Increase in Enforcement Activity
The DOJ's 2022 Fraud Statistics Overview shows it raked in less than 50 percent of what it recovered in FY 2021.
Illegal Marketing Commissions Arrangements Cost Toxicology Lab $5.9 Million
Recent case shows that toxicology labs and drug testing remain a primary target for federal enforcement agencies.
