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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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
Pain Management Clinic, 2 MDs Pay $99K to Settle Millennium Free POCT Cup Kickback Claims
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OIG Monthly Work Plan Review: April 2019
From - Lab Compliance Advisor
Among the 10 new Work Plan items this month, three may have potential ramifications for at least some labs…
Texas Pathology Lab Settles EHR Consulting Kickback Claims for $63.5 Million
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Case of the Month: Another MD-Owned Lab Gets Busted for Urine Drug Test Abuses
From - Lab Compliance Advisor
Fraudulent utilization and billing of urine drug screening first became a priority for federal enforcers since the…
Mass. Pain Management MDs Jailed for Elaborate Drug Testing Conspiracy
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Compliance Perspectives: How the New OIG Fraud Risk Indicator System Heightens the Imperative of Self-Disclosure
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Lab Settles Specimen Collection Fee Kickback Charges for $2.275 Million
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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
OIG Monthly Work Plan Review: March 2019
From - Lab Compliance Advisor
This month, there were 16 new Work Plan items. Three of these may have implications for some labs as…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory