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
Lab Compliance Advisor
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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
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
Civil Monetary Penalties Rules Updated
From - G2 Compliance Advisor
One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse. That includes…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Enforcement Trends: 5 Insights from the OIG Semi-Annual Report
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New OIG Rules Make It Easier to Sock Labs with Civil Monetary Penalties
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Brief Your CEO: The New Anti-Kickback Safe Harbors & Their Impact on Your Lab
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Lab Safety Compliance: Match Your PPE to the Hazard
From - G2 Compliance Advisor
The Occupational Health and Safety Act requires employers protect workers from hazards in the workplace. PPE such as…
Crosswalked Codes in 2017 Clinical Laboratory Fee Schedule
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OIG Highlights Hotline to Encourage Fraud Reporting
From - G2 Compliance Advisor
Reporting compliance concerns is a key component of effective compliance plans. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) podcast highlights…
FDA Puts Final LDT Guidance on Ice—Agency Decides to Wait for Trump Administration
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2017 Medicare Lab Payments: The 9 Changes that May Affect Your Reimbursements
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