Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

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

Industry Buzz: Supreme Court Declines Chance to End Agony of ACA Uncertainty

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

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

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

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...]

EKRA: More than a Year Out, Major Questions Remain Unresolved

One of the scariest new lab compliance laws in recent memory is the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). While laws banning remuneration in exchange for referrals is nothing new to … [Read more...]

Labs In Court

Lab Uses Billing Info of Another Lab to Get Around Payment Restrictions

Case: In 2015, Kentucky Medicaid and private payors began having doubts about the legitimacy of urine drug test claims submitted by CAL Laboratory Services and restricted payments to the toxicology … [Read more...]

EMERGING TESTS

Targeted Genetic Risk-Based Prostate Cancer Screening Would Save the Most Lives at the Best Costs: UK Study

Targeted screening of men at high genetic risk of the disease could prevent nearly one in six prostate cancer deaths. That is the tantalizing finding of a new computer modeling study led by the … [Read more...]

EMERGING TESTS

Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification

The deadliness of muscle invasive bladder cancer has made the development of new diagnostic and treatment methods imperative. One strategy involves the use of molecular genetic testing to subtype … [Read more...]

TEST QUALITY

AACC Calls on Laboratories to Take Measures to Minimize Risks of Biotin Interference

Biotin interference with test accuracy has become a matter of growing concern in recent months. Last November, the U.S. Food and Drug Administration (FDA) updated a previous safety communication … [Read more...]


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