LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Theranos in Court: Balwani Gets Nearly 13 Years in Prison
After being convicted on all charges he faced, the former Theranos COO was sentenced to 12 years, 11 months on Dec. 7.
Weekly Enforcement Report: Jail Time for Diagnostic Testing Facility Owners
Co-owners sentenced to three years each for paying millions in kickbacks for referrals to their Brooklyn-based facilities.
OIG Steps Up Enforcement Activity, but Recovery Numbers Still Lag
While civil actions, criminal actions, and exclusions are up, the increased activity isn’t yet reflected in total recoveries.
Which Blood Tests Are Best at Early Alzheimer’s Detection?
A recent study led by a team at the University of Gothenburg shows that multiple biomarkers could ID the disease even in people with no symptoms.
Memo to Lab Compliance Managers: Set Your Goals for 2023
Learn why this is the perfect time of the year to mobilize your board members.
G2 Intelligence Launches Free Trials of Monthly Briefings
Readers can now gain full access to our four briefings for up to seven days for free.
Amazon Launches New Venture to Disrupt Healthcare
The company’s third attempt at shaking up the healthcare industry, Amazon Clinic, might just prove the charm.
Weekly Enforcement Report: A Dearth of Lab-Related Actions
Enforcement actions over our most recent coverage period were related to other areas of the healthcare industry.
Current Diagnostics Merger & Acquisition Trends
M&A deals in the diagnostics industry have been lower in number, but higher in impact in recent months.
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.
