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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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
Brief Your CEO: Use New OIG Work Plan to Keep Your Lab Compliant in 2017
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Is Billing Medicare for Tests a False Claim If Your Lab Has Committed a CLIA Violation?
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What Happens Next: Is a Trump Presidency Really the End for ACA?
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Labs Among Top 10 Management Challenges Facing HHS
From - G2 Compliance Advisor
The U.S. Department of Health and Human Services (HHS) Office of Inspector General recently spotlighted 10 top management challenges it says…
Anti-kickback and Stark Law Compliance Tips
From - G2 Compliance Advisor
There have been a number of anti-kickback and physician self-referral (Stark) cases involving laboratories in…
Complying with ACA’s Nondiscrimination Requirements
From - G2 Compliance Advisor
Section 1557 of the Affordable Care Act (ACA) requires covered entities to take certain actions to ensure they comply with their duty not to…
Compliance Issues Permeate Discussions Throughout Lab Institute
From - G2 Compliance Advisor
During three days of presentations, compliance issues for laboratories and pathologists permeated most of the discussions. Beginning with a workshop on…
3 Things We Learned from New OIG Report on 2015’s Top 25 Lab Tests by Medicare Payment
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PAMA Update: OIG Status Report on Implementing New Medicare Fee Schedule for Part B Lab Tests
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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