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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
Recent FDA Approvals Show Growing Sophistication of At-Home Tests
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
Special Report: How to Avoid Problematic Lab Business Arrangements
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
Expert Q&A: Trends and Challenges in Lab Billing and Coding
Ann Lambrix, vice president of RCM Solutions at Lighthouse Lab Services, discusses key developments in lab billing and coding.
February 2024 Labs in Court
Recent cases show labs should be wary of issues such as improper relationships, medical necessity, kickbacks, and potential telehealth fraud.
At-Home Answers in Infectious Disease
Demand for at-home sample collection and infectious disease testing is at an all-time high—and still growing.
Expert Q&A: Adapting to the Expanding Market of At-Home Testing
Medical director William G. Finn, MD, discusses key trends, challenges, and opportunities related to the expansion of at-home testing.
Screening Shortfalls and Self-Collected Samples
Is at-home sample collection the solution to lagging cancer screening uptake—or does this approach introduce a new set of challenges?
Advancements in Antimicrobial Susceptibility Testing: Part 2
Several methods are being developed that improve the ability to rapidly identify organisms and report susceptibility results.
Comprehensive Coding
Understanding the 2024 CLFS update—and the changes that are still to come.
Billing and Coding: The Value of Clinical Validation
What clinical validation really means—and why every member of the laboratory should understand it.
