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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Feds Lower the Boom on Home Sleep Test False Billing and Kickbacks
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Feds Not Backing Away from Punishing CGx Testing Scams
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
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.
