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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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
Lab Institute Who’s Who: Jane Hermansen
Learn about how the COVID-19 pandemic has shaped the clinical lab industry and how those lessons can lead to better labs for the future.
Radiology Services Company President Gets 15 Years behind Bars for Fraud
In addition to the prison sentence for the x-ray-related fraud scheme, the company president must also pay nearly $2 million in restitution.
COVID-19 Testing Lab Can’t Sue Insurer for Violating CARES Act Obligations
A significant new court ruling from a Minnesota federal court draws a line on how far labs can go when insurers short-change them.
New Insight into Deaths of US Cancer Patients Due to COVID-19
Recent study provides new details on how COVID-19 impacted cancer deaths in the US early in the pandemic and which groups were most affected.
Qiagen Enters Neurology Space with Parkinson’s CDx Collaboration
The developer of NGS-based companion diagnostics targets the growing neurology biomarker market.
Pharmacogenetic Testing Leads to Better Depression Treatment Decisions
A recent study shows pharmacogenetic testing can help caregivers make better decisions when prescribing antidepressants.
New Guideline for Using Lab Tests to Improve Cancer Treatment
The new CAP guidance addresses use of immune checkpoint inhibitors for evaluating and treating patients with specific cancers.
New Joint Commission Health Equity Standard Takes Effect Jan. 1
What the equity rule is, who it affects, and how to comply.
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
Blood-Based Alzheimer’s Tests Are Here, but Not Ready for Widespread Use
While new FDA clearances of blood-based early detection tests for Alzheimer’s represent significant progress, limitations remain.
