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
Carreyrou Captivates Lab Institute With Inside Look at Theranos Fall
From - G2 Compliance Advisor
The tale could be headed to movie theaters around the nation soon. It is a gripping story of a Steve Jobs–wannabe—a young Stanford dropout with…
Enforcement Trends: Feds Administer a Double Dose of Civil Monetary Penalty Increases
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Case of the Month: Anthem Settles Massive HIPAA Breach Case for Record $16 Million
From - G2 Compliance Advisor
Pop Quiz: What's the highest amount a health care entity ever paid to the HHS Office for Civil Rights (OCR) to settle a HIPAA violation…
TOOL: Model Religious Accommodations Policy
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Monthly Work Plan Review: October 2018
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Alabama Hospital and Lab Subsidiary Agree to $4.25 Million Kickback Settlement
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Case of the Month: ACA Constitutionality Is Back in Play & This Time It May Get Taken Down
From - G2 Compliance Advisor
After a series of court setbacks, Republicans challenging the constitutionality of Obamacare, aka, the Affordable Care Act (ACA) are back at it…
California Lab, Owner Excluded 5 Years for Medicare Screening Test Billings
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Compliance Perspectives: Managing Kickback Liability Risks of Specimen Processing Fees
From - G2 Compliance Advisor
It's common practice for labs to pay physicians a fee for collecting and processing blood, urine, tissue, and other specimens from the patients they refer to…
