Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
Compliance-nir
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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
CMS, OIG Reps Address PAMA, Fraud Enforcement at ACLA Annual Meeting
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OIG and DOJ Provide Tips for Determining Effectiveness of Compliance Programs
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Breach Notification Violation Ends in $475,000 Settlement
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OIG Updates Threshold for Nominal Value Gifts
From - National Intelligence Report
Just as the civil monetary penalties have gotten an update to adjust for inflation so too have the thresholds for…
DOJ Surveys False Claims Victories for 2016
From - National Intelligence Report
As we closed out the calendar year, the U.S. Department of Justice (DOJ) reflected on its successes for the fiscal year 2016 (FY 2016) which ended…
Labs Beware: New Rules Impose Harsher Civil Monetary Penalties
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New OIG Advisory Opinion Repeats Warning that Free Labeling Services Can Be Kickbacks
OIG says a laboratory's proposal to offer dialysis clinics free labeling services would likely violate the Anti-Kickback Statute
2017 OIG Work Plan Holds Few Surprises for Labs
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OIG Releases 2017 Work Plan
From - National Intelligence Report
There are few surprises in the Health and Human Services Office of Inspector General's 2017 Work Plan. The OIG's annual Work Plan provides…