How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Lab Compliance Advisor
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
A Primer on PAMA
The impending legislation that may determine Medicare lab fees from 2025 onward
April 2024 Labs in Court
Recent enforcement actions include convictions and guilty pleas for false claims-related allegations involving toxicology labs.
Billing and Coding: The Secrets of Effective Queries
Formulating queries that are compliant, informative, and effective—even in tricky situations.
AI Pilot Program Proposed to Detect Medicare Fraud
Program outlined in a recently introduced bill would test AI’s effectiveness in detecting suspect payments for diagnostic tests and DME.
Championing Change
How clinical laboratory professionals can advocate for legislative and regulatory improvements
Expert Q&A: What’s New with PAMA and SALSA?
Joyce Gresko, partner at Alston & Bird, discusses the latest on PAMA and what will likely need to happen for SALSA to pass in 2024.
Staying on Top of Medical Necessity and Marketer Compliance
Recent enforcement actions show that clinical laboratories must remain vigilant about compliance relating to these areas
Special Report: 5 Lab Kickback Risks Involving Incentives
Strategies to avoid compliance issues related to registries, space rentals, and other common incentives.
