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New FDA Bill Bypasses LDTs Reform—Again
It now appears that Congress is going to dash the lab industry’s hopes yet again by reauthorizing FDA user fees without VALID.
Clinical Lab Owner Pleads Guilty to Three Healthcare Fraud Schemes
The owner of several clinical labs and other businesses will pay big for the schemes that involved money laundering, kickbacks, and fraud.
House Passes Legislation to Better MA Prior Authorization Process
According to healthcare groups, the Improving Seniors’ Timely Access to Care Act would help fix problems with current system.
G2’s Lab Institute Returns in Virtual Format
This digital event will help labs meet the various legal, compliance, business, and technology challenges of the industry, today and tomorrow.
Is Your Lab Ready to Comply with the New Equity Standard?
You’ll need a healthcare equity plan to maintain Joint Commission accreditation after Jan. 1.
CMS Dishes Out First Penalties for Hospital Price Transparency Violations
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
Eight New CLIA-Waived Tests Your Lab Staff Need to Know About
CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.
Arrayit President Convicted of Silicon Valley Blood Testing Scam
Mark Schena was convicted of swindling investors and running a $77 million kickback scheme involving COVID-19 and allergy tests.
US Government Suspends Free At-Home COVID-19 Antigen Test Program
Biden administration blames the decision on Congress’ failure to provide the additional funding necessary to keep the program going.
Final Surprise Billing Regulations Cut Insurer Control—Sort Of
It remains far from clear whether the new surprise billing rule goes far enough to fix the problem of insurers having too much power in disputes.
Arrayit President Convicted in Massive Allergy and COVID-19 Testing Scam
Mark Schena was found guilty of defrauding investors, as well as running an illegal kickback and healthcare fraud scheme.
FDA to Issue EUA for Monkeypox Tests
The agency will also allow CLIA labs to use serology and antigen tests without EUA.
FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
