Case: The owner of a northern Florida substance abuse treatment center pleaded guilty for his role in a $57 million pass-through lab testing billing and money laundering scheme. The way it worked: The … [Read more...]
Labs in Court
Drug Abuse Treatment Owner Guilty of $57 Million Drug Test Pass-Thru Billing Conspiracy
February 6, 2020
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Industry Buzz
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
January 30, 2020
Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
Labs In Court
Lab Management Contract Dispute Must Go to Binding Arbitration
January 27, 2020
Case: A lab management services contract sent conflicting messages: Clause 32 said that all disputes under the contract would be resolved by binding arbitration; but Clause 7 said that all claims … [Read more...]
OIG
OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting
January 27, 2020
The five new items the OIG added to its Work Plan have no direct impact on labs or lab services, although three of them might have an indirect effect on some labs. Here’s the rundown. CDC … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
January 27, 2020
Reference Lab Pays $26.7 Million to Settle False Claim Charges Case: The feds claim that Laboratory Boston Heart Diagnostics contracted to provide lab testing services to Texas hospitals in … [Read more...]
Industry Buzz: Supreme Court Declines Chance to End Agony of ACA Uncertainty
January 27, 2020
If you’re worried about the fate of the Affordable Care Act and was hoping for a quick solution, forget it. On Jan. 21, the U.S. Supreme Court declined a Democratic request to fast-track the current … [Read more...]
Whistleblowers: Hospitals, Labs Dodge a Major Stark/False Claims Act Bullet
January 27, 2020
It’s the moment of truth in a whistleblower case. The defendant claims the whistleblower’s claims aren’t legally valid and asks the court to dismiss the case without a trial. If the motion is … [Read more...]
HIPAA Compliance: Quest Pays $195K to Settle Class Action for HIV Data Breach
January 27, 2020
Government fines, public embarrassment, loss of provider and patient trust. As if these consequences weren’t scary enough, massive PHI breaches can expose your lab to a new kind of risk: class action … [Read more...]
Managing Lab Staff: Supervisor Liability for Subordinate Misconduct Under Civil Rights Law
January 27, 2020
Pop Quiz: Name five bad things that can happen if you fail to properly supervise your lab’s testing staff. Chances are, your response included testing inaccuracy leading to patient endangerment, … [Read more...]
