FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Lab Compliance Advisor
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Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
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Enforcement Trends: New DOJ Policy Targeting Whistleblowers with Weak Cases May Make Life Easier for Labs
From - Lab Compliance Advisor
It's not just new laws, regulations or even court cases. Trends in health care fraud enforcement are sometimes driven by changes in prosecution policies, including…
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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…
After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
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OIG Monthly Work Plan Review: February 2019
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New York Doctor Busted for Falsely Billing Medicaid for Lab Drug Tests
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Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats
From - Lab Compliance Advisor
HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the…