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
Case of the Month: Alabama Hospital Lab Settles Data Breach Class Action Suit
From - National Intelligence Report
Class action lawsuits by patients victimized by data breaches have become increasingly common. And, more often than not, they prove unsuccessful…
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Enforcement Trends: OIG Report Suggests that Urine Drug Testing Is Making Labs a Juicy Target Once Again
From - National Intelligence Report
The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2017 through March 31, 2018). Here are the key things labs and lab managers need to…
Enforcement Trends: Private Insurers Are Cracking Down on the Labs that Scam Them
From - National Intelligence Report
Once the almost exclusive domain of federal law enforcers and inside whistleblowers, the lucrative industry of going after labs for improper billing has…
Medicaid Fraud: Enforcement Continues to Trend Down as Labs Drift Deeper into the Background
From - National Intelligence Report
Last month, the OIG published its annual summary of Medicaid Fraud Control Unit (MCFU) activity for FY 2017. Here is a summary of the key findings, trends and…
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
From - National Intelligence Report
Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite…
Enforcement Trends: Labs Getting Swept into the Opioid Crackdown Vortex
From - National Intelligence Report
Best known for its employment applications, urine drug testing is also medical protocol for patients prescribed opioid drugs…