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
EKRA: More than a Year Out, Major Questions Remain Unresolved
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Compliance Tool: Model In-Office Phlebotomist Agreement
The following Model Agreement between a testing lab and a referring physician was created by Savannah, GA, lab compliance attorney Adam Walters and structured to minimize kickback liability risks to each party in
Enforcement Trends: False Claims Act Recoveries Increase as Labs Remain in Firing Line
The dollars paid by healthcare providers in federal False Claims Act settlements and judgments increased for the second year in row in 2019. After a surprising decline in 2017, total recoveries rebounded
Enforcement Trends: The Top 5 Lab False Claims Act Settlements of 2019
Labs were on the paying end of at least eight million-dollar False Claims Act (FCA) settlements or judgments in the 2019 fiscal year. Here’s a review of the top 5 reported FCA recoveries against a lab or lab services company.
Test Quality: New Study Casts Doubt on Whole Exome Sequencing’s Accuracy in Diagnosing Genetic Disorders
Depending on the reporting laboratory, patients who undergo whole exome sequencing may receive false negatives or incomplete test results. That is the finding of a new study published in Clinical Chemistry
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
Finding the “Backdoor” into Payer Networks
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Lab Uses Billing Info of Another Lab to Get Around Payment Restrictions
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Targeted Genetic Risk-Based Prostate Cancer Screening Would Save the Most Lives at the Best Costs: UK Study
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Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification
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