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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National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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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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Compliance Tool: Model Bring Your Own Device (BYOD) Policy
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.
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Expected Audit Targets for 2024 and How Laboratories Can Ensure Compliance
An overview of likely lab audit targets for the coming year, and how laboratories can ensure they’re prepared.
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Lab Marketing & Staffing: 4 Common Kickback Pitfalls to Avoid
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
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Expert Q&A: How Technology is Improving Access to Lab Testing
Healthcare leader Steve Serota discusses a new partnership and how it is bringing high-quality lab testing to underserved areas.
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Laboratory Relocation: 6 Common Pitfalls to Avoid
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
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Dx Deal Roundup: A Major Proteomics Merger, Ginkgo Makes Pharma Inroads, and More Legal Woes for Illumina
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
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FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
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Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
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Compliance Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
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