Clinical Lab Reimbursement Experts Discuss PAMA Pressure and Leaving Money on the Table
Attorney Danielle Tangorre and TELCOR’s Darla Wanitschke answered questions during webinar
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Articles and Reports
CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
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Compliance Tool: Addressing EKRA When Selling Your Lab
Key steps to follow when selling your lab to ensure compliance with the Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
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Why You Need to Address EKRA When Selling Your Lab
When selling your laboratory, in order to remain compliant with federal code, EKRA is something you will want to consider
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Marketing Your Clinical Lab
Outreach and advertising can be tricky prospects for the clinical lab—but the right questions and strategies can help guide your efforts
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3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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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
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Tool: Third-Party Risk Management Guide for Medical Labs
Key cybersecurity points to address when working with a third party that has access to protected health information
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FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
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Expert Q&A: Responding to the Change Healthcare Cyberattack
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks
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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
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