Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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Articles and Reports
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
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
Compliance Perspectives: Feds Using Medicare Laws to Prosecute Non-Medicare Arrangements
From - Lab Compliance Advisor
Myth: Risk of federal prosecution for health fraud and abuse applies only when you deal with…
Compliance Perspectives: Use New DOJ Criteria to Vet the Effectiveness of Your Lab Compliance Program
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New OIG Report Confirms that Labs Are Still on the Enforcement Radar
From - Lab Compliance Advisor
After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the…
Compliance Perspectives: How the New OIG Fraud Risk Indicator System Heightens the Imperative of Self-Disclosure
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Compliance Perspectives: How to Spot & Avoid Kickback Risks under New EKRA Law
From - Lab Compliance Advisor
A new law passed to deal with the opioid epidemic has significant ramifications for labs including but not limited to those involved in drug addiction and…
Compliance Perspectives: CMS Reviews PAMA Reporting Basics for Hospital Outreach Labs
From - Lab Compliance Advisor
PAMA reporting is tricky business in which mistakes and omissions carry the risk of civil monetary penalties of up to $10,000 per day. So, whether you're with…
Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules
From - Lab Compliance Advisor
January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are…
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
Compliance Perspectives: PAMA Pitfalls & Survival Strategies
From - Lab Compliance Advisor
PAMA's deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should…
