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
Thermo Fisher Draws First Blood in Lawsuit Over Defective COVID-19 PCR Tests
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Drug Test Lab Pays $4.8 Million for Charging Medicaid above MFN Rate
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Jury Socks Natera with $44.9 Million False Advertising Verdict
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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A Model Attestation Statement for Laboratories
To guard against reimbursement denials due to improper signatures, labs can give MACs an attestation statement from the physician or NPP.
Medicare Reimbursement Briefing: How Will Recent Changes Affect You?
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Balwani Loses Bid to Bar Incriminating Evidence from Fraud Trial
Even before the trial began, things got off to a rocky start for the ex-Theranos CEO, who faces charges of fraud and wire fraud.
Researcher Loses Reprisal Dismissal Claim
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Lab Company Owners Indicted for False Billing
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Eight Pay $1.1 Million to Settle Lab Test False Billing Charges
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