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
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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Enforcement Trends: OIG Calls Out CMS for Not Preventing Medicare Genetic Testing Overpayments
Inadequate CMS oversight resulted in $888.2 million in improper payments for the highest reimbursing molecular pathology genetic tests, report says.
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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…
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…
