Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
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Articles and Reports
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
A Primer on PAMA
The impending legislation that may determine Medicare lab fees from 2025 onward
CAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA Lawsuit
From - G2 Compliance Advisor
The College of American Pathologists (CAP) filed an amicus curiae brief in support of a motion by the American Clinical Laboratory Association (ACLA) for summary judgement to…
Enforcement Trends: Opioid Crackdown Zeroes in on Urine Drug Testing-Today the Doctors, Tomorrow the Labs
From - G2 Compliance Advisor
A 67-year-old Michigan M.D. is the most recent doctor taken down in what has become a crucial part of the federal government's opioid drug crusade…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Texas-based United Allergy Services (UAS) is suing Quest Diagnostics for conspiring with…
Compliance Perspectives: Can You Require Lab Workers to Get a Flu Shot?
From - G2 Compliance Advisor
Bottom Line on Top: Yes, a mandatory flu vaccination policy is legally justifiable as long as…
OIG Work Plan Monthly Review: January 2018
From - G2 Compliance Advisor
Opioid drug-related issues continue to command the lion's share of OIG Work Plan attention, including two of this month's six new items. While none of the new…
Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…