FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
Brief Your CEO: The New Joint Commission Health Equity Standard
As of January 1, 2023, your lab may need to develop and implement a full-blown health equity plan to maintain its Joint Commission accreditation.
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.
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.
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.
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
Final Surprise Billing Rules Seek to Provide Fairer Price Dispute Resolution
Revised final rule essentially disarms the threat of insurers having the advantage in out-of-network price disputes.
Labcorp Continues Its Outreach Labs Buying Spree
While the overall M&A market has been slow in 2022, Labcorp has been on a bit of an acquisitions binge.
Amazon Ends Telehealth Services, but Forges Ahead with Healthcare Disruption
In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
