Texas Toxicology Lab Settles Self-Disclosed Anti-Kickback Law Charges for $1.54 Million

Case: The American Institute of Toxicology, Inc., d/b/a AIT Laboratories has agreed to pay $1,541,062 to settle charges of violating the anti-kickback law. OIG alleges that AIT, through its agent, … [Read more...]

ENFORCEMENT

OCR Continues HIPAA Right of Access Crackdown, but at a Much Slower Pace

Twenty different providers have been hit with fines since the Department of Health and Human Services’ Office for Civil Rights (OCR) launched its HIPAA Right of Access Initiative in April 2019. … [Read more...]

Labs In Court

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

Fort Worth Hospital Settles Upcoding Charges for $3.3 Million Case: A compliance officer morphed into a whistleblower when hospital leaders ignored her warnings about widespread billing and coding … [Read more...]

M&A Report

PerkinElmer Acquires BioLegend While FTC Warns Against Non-Approved Mergers

M&A activity in the general healthcare sector has yet to rebound from COVID-19. However, while overall deal numbers remain below pre-pandemic historical averages, deal size has increased. … [Read more...]

FDA Watch

Agency Tells EUA SARS-CoV-2 Test Makers to Account for Viral Mutations

On Sept. 23, FDA issued a letter requiring producers of SARS-CoV-2 tests with Emergency Use Authorization (EUA) to take additional steps to account for viral variants. The new Conditions of … [Read more...]

INNOVATION

Becton Dickinson Gets EUA for At-Home COVID-19 Antigen Test Providing Results by Phone

At-home rapid SARS-CoV-2 antigen testing has become a gold mine. Expanding availability, affordability and use of those tests is a central element of President Biden’s new COVID-19 response plan. The … [Read more...]

Labs in Court

Court Rules that Hologic Didn’t Steal Minerva’s Patented Technology

Case: Minerva Surgical Instruments sued Hologic for illegally incorporating Minerva’s patented technology for endometric ablation into its NovaSure ADVANCED and CLASSIC devices. Hologic argued that it … [Read more...]

Brief Your CEO

Make Sure Lab Staff Know about New CMS Clarification of IDTF Billing Rules

If your lab or facility is an Independent Diagnostic Testing Facility (IDTF), you need to know and brief your C-Suite about the new Centers for Medicare & Medicaid Services (CMS) issued new … [Read more...]

FALSE CLAIMS

Courts Create New Defense for False Claims Based on Reasonable Mistakes about Regulatory Requirements

The False Claims Act (FCA) bans labs and other providers from “knowingly” submitting false claims. “Knowingly” is a curious word. Medicare coverage and billing rules can be intricate, confusing and … [Read more...]

Emerging Tests

New Study Supports Efficacy of Using Rapid, At-Home Antigen Testing to Stop Spread of COVID-19

As it was with the previous administration, widespread distribution and use of rapid, self-administered COVID-19 antigen tests are a crucial element of the Biden pandemic response strategy. But the … [Read more...]


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