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
OIG Work Plan Monthly Review: November 2017
From - G2 Compliance Advisor
The OIG added four new items to its Work Plan this month, all of which have potential indirect effects on clinical labs involved in providing the…
CMS Finalizes Controversial PAMA Fee Schedule
From - G2 Compliance Advisor
It's official. Brushing aside fierce lab industry opposition, CMS has decided to go forward with its PAMA Clinical Laboratory Fee Schedule (CLFS) in 2018…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds charged Mercy Hospital with overbilling Medicare and MaineCare for urinalysis tests. Rather than risk a trial, Mercy has agreed to…
Employment Law Update: The Weinstein Edition
By Mike O'Brien bio
Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? Weinstein is…
Employment Law Update for HR Managers October 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
Conference Ends With Optimistic Outlook for Laboratories
From - G2 Compliance Advisor
Despite the PAMA cloud overhanging the laboratory industry, G2's 35th annual Lab Institute conference (Washington D.C.; Oct. 25-27) ended on an optimistic note with…
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
Keynote Speakers Look to the Future of the Industry
From - G2 Compliance Advisor
The first two keynote speakers at G2 Intelligence's 2017 Laboratory Institute (Washington D.C.; Oct. 25-27) took a forward glance at how…
Case of the Month: Lab Tests Play Key Role in $19 Million Detroit Opioid Scheme
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Compliance Quiz: Spot the HazCom Mistake
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