Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
FDA Warns of Cybersecurity Vulnerability in Certain NGS Instruments
A glitch in the local run management software may open the door to hacking, agency says.
Test-To-Treat Locations Now Up to 2,500
White House releases an update on the progress of the initiative to provide equitable access to COVID-19 testing and treatments in the US.
Twenty Percent of DME Suppliers Non-Compliant When Billing Medicare
OIG report finds that $8 million of $40 million in claims made by such suppliers in a recent audit did not meet Medicare requirements.
Does Offering Free Access to Drug Pricing Tool Cross the Kickback Line?
NY federal court ruling sheds light on what constitutes “remuneration” banned by the Anti-Kickback Statute.
Illumina and Precision Health Team Up for Population Study
Partnership will make use of Illumina’s capabilities and expertise in large-scale genomic sequencing and quickly generate high-quality data.
New Senate Bill Targets PBM Consumer Abuses
Lawmakers blame pharmacy benefit managers for high drug prices, introducing a bill to prevent what they term unfair practices.
The Sun Sets on the Controversial SUNSET Rule
HHS pulls the plug on a Trump rule requiring regulations to expire automatically after 10 years.
DOJ Adds 6 Texas Physicians to Improper Lab Test Claims Complaint
In this week’s Labs in Court roundup, six physicians were accused of billing for unnecessary lab tests in connection with an earlier lab fraud complaint.
BioMérieux and Sema4 Complete Strategic Acquisitions
Two of the biggest merger and acquisition-related deals that came down in May involved BioMérieux and Sema4
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
