Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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Articles and Reports
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases
From - National Intelligence Report
A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the…
EHR: Private Whistleblowers Getting in on “Meaningful Use” Crackdown
From - National Intelligence Report
Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in federal health care fraud enforcement…
Labs Figure Prominently in OIG’s Newest Top 10 Challenges List
From - National Intelligence Report
Although the OIG has its flaws, lack of transparency is not among them. Exhibit A: the agency's ongoing list of top 10 management and…
New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine
From - National Intelligence Report
One patient claims it is and wants $1.8 million in damages because she never got it…
Enforcement Trends: 5 Takeaways from OIG’s New Semiannual Report
From - National Intelligence Report
Veteran OIG semiannual report aficionados will find little in the most recent edition to distinguish it markedly from its predecessors. But while a new…
Millennium Labs Bankruptcy Plan Stays on Track despite Lender Opposition
From - National Intelligence Report
It has been nearly two years since Millennium went into Chapter 11 but the case continues to make news. After agreeing to…
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…