Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
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
Digital Pathology Business Arrangements Bring Fraud and Kickback Worries
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
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.
Enforcement Trends: Six Ways Your Lab Can Avoid HIPAA Right of Access Issues
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
July 2023 Enforcement Roundup
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
Kentucky $1.74 Million Settlement Illustrates the Danger of Billing Medicare for Nonmedical Urine Drug Tests
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
Urine Drug & Genetic Testing Remain Top Enforcement Targets
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
CMS to Crack Down on Unnecessary COVID-19 Add-on Tests
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
