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
Medicare Reimbursement: CMS Limits NGS Early Cancer Test Coverage but Industry Fires Back
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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…
Case of the Month: Hospital Employees’ Wage Class Action Lawsuit Goes Terribly Wrong
From - Lab Compliance Advisor
It wasn't the outcome the four hospital employees envisioned when they filed their lawsuit charging the…
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…
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
TOOL: Model Employee Illness/Injury Reporting Policy
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Billing & Coding: Pathology Group Asks CMS to Raise Medicare Prices for BRCA1/2 Sequencing Tests
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Government Shutdown: The Impact on the Agencies that Regulate Labs
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