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
Case of the Month: Facing 3 against 1, Texas Lab Settles EHR Consulting Kickback Charges
From - Lab Compliance Advisor
Question: What happens when multiple whistleblowers bring separate qui tam lawsuits against a lab for the same offense…
Wisconsin Health System Settles Stark Claims for $12 Million
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How to Determine Date of Service for Part B Billing of Outpatient Lab Tests
From - Lab Compliance Advisor
Date of service rules affect whether outpatient lab tests are part of the Hospital Outpatient Prospective Payment System (HOPPS) bundled payment or…
Pain Clinic Co-Owner Pleads Guilty to Drug Testing Kickback Charges
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Owner of MD Practices Settles Fraud Charges for $3.07 Million
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Enforcement Trends: New DOJ Policy Targeting Whistleblowers with Weak Cases May Make Life Easier for Labs
From - Lab Compliance Advisor
It's not just new laws, regulations or even court cases. Trends in health care fraud enforcement are sometimes driven by changes in prosecution policies, including…
North Carolina Hospital Settles Self-Disclosed Kickback Claims for $2.2+ Million
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Compliance Perspectives: CMS Reviews PAMA Reporting Basics for Hospital Outreach Labs
From - Lab Compliance Advisor
PAMA reporting is tricky business in which mistakes and omissions carry the risk of civil monetary penalties of up to $10,000 per day. So, whether you're with…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
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