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
10 Things to Include in Your HIPAA Breach Notification Policy
From - G2 Compliance Advisor
Earlier this month we told you about a $475,000 settlement one provider reached in a HIPAA breach notification case. Privacy lapses can occur despite…
DOJ Touts 2016 as Bumper Year for False Claim Act Recoveries
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Forget 2014: New Discussion Paper Outlines FDA’s Current Thinking on LDT Regulation
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Enforcement Firsts: Presence Health Fined $475,000 for Taking Too Long to Report HIPAA Breach
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How to Create a HIPAA Breach Notification Policy
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Is Offering Free Labelling Services to Dialysis Facilities a Kickback?
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New Anti-Kickback Safe Harbor Allows Free Transportation Services
From - G2 Compliance Advisor
There are many benefits laboratories can't provide to beneficiaries or referral sources without running afoul of the Anti-Kickback Statute. New changes to safe harbor regulations, however…
First HIPAA Breach Notification Settlement Totals $475,000
From - G2 Compliance Advisor
Patient health information breaches—whether from hacking, glitches or just plain old carelessness…
OIG Targets Sleep Study Tests
From - G2 Compliance Advisor
If your lab performs sleep studies on Medicare patients, beware. It is now a high-priority target for federal fraud and…
Civil Monetary Penalties Rules Updated
From - G2 Compliance Advisor
One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse. That includes…
