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
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.
AI and Digital Pathology: Progress and Potential Pitfalls
Pathologist Rajesh C. Dash, MD, discusses the state of AI and digital pathology, as well as challenges and possible solutions.
How to Meet Diagnostic Lab Staffing Challenges
Two lab staffing experts weigh in on current trends and what labs need to do to attract and retain talent in today’s environment.
M&A Report: Biosynex Looks to Snag Theradiag
A roundup of key mergers, acquisitions, and strategic asset purchases in the healthcare industry in September.
Qiagen Moves into Neurology with Recent Collaboration
The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.
FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
Inadequate Reimbursement Threatens Monkeypox Lab Testing Response
ACLA and public health experts warn that current reimbursement rates will hamper US efforts to contain monkeypox spread.
LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
CMS Sheds New Light on Proper Use of Modifier 59
Due to the common misuse of this modifier, the Centers for Medicare & Medicaid Services recently issued important new guidance on its proper use.
False Billing of Lab Tests and Two Dismissed Lawsuits
This month’s key lab cases involve false billing of urine drug and PGx tests and two lawsuits that were tossed.
