Current Diagnostics Merger & Acquisition Trends
M&A deals in the diagnostics industry have been lower in number, but higher in impact in recent months.
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Clinical Lab Owner Pleads Guilty to Healthcare-Related Scheme
On Nov. 15, a psychiatrist and clinical lab owner pled guilty to his role in a complicated $3.8 million fraud scheme.
White House Proposes New AI “Bill of Rights”
US takes first steps to rein in abusive and privacy-invasive use of AI by corporations.
Feds Target Directly Billing Medicare for Tests Furnished by Reference Labs
A California health system will pony up $13 million to settle reference lab billing fraud claims.
FDA Revises EUAs for COVID-19 Antigen Tests
In response to the latest data on repeat testing, on Nov. 1, the agency made a few changes to EUAs for such tests.
Lab Tests the Theme in Recent Enforcement Actions
A doctor settles alleged FCA violations involving genetic tests, while a clinical lab owner pleads guilty for his role in another scheme.
Rise in Telehealth Expands Need for In-Home Phlebotomy Services
Mobile phlebotomist services have become a dynamic new segment of the medical labs market.
ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort
Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.
Sutter Health Pays Millions to Settle Improper Billing Claims
The healthcare services provider will be on the hook for $13 million for alleged improper billing of lab tests.
Healthcare Providers Frequently Targeted in Racial Incidents
A new analysis by ECRI shows that, while patients are also common targets, providers had to face racist behavior or comments most often.
Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
Congress Passes New FDA Medical Devices User Fee Amendments (MDUFA V) Deal
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
