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
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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
A roundup of recent cases and enforcement actions involving the diagnostics industry
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The Quest Case and Medical Malpractice Liability Risks of Genetic Testing Labs
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Labs and Private Payors Clash Over Reimbursement of COVID-19 Testing
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OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
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Final Rules Offer Real Stark and Kickback Relief but Largely Exclude Labs
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Texas Court Nixes Toxicology Labs’ ERISA Beneficiary Unpaid Claims Lawsuit against United Healthcare
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Pain Management Network Shells Out $1 Million to Settle Lab Testing Kickback Charges
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Out-of-Network Drug Testing Labs Can Sue UnitedHealthcare for Inadequate Reimbursement
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Pennsylvania Medical Assistants Confess to Participating in Genetic Test Fraud Scheme
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Model Substance Abuse and Fitness for Duty Policy
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