ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
ACLA and public health experts warn that current reimbursement rates will hamper US efforts to contain monkeypox spread.
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
Due to the common misuse of this modifier, the Centers for Medicare & Medicaid Services recently issued important new guidance on its proper use.
This month’s key lab cases involve false billing of urine drug and PGx tests and two lawsuits that were tossed.
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
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.
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.
Mark Schena was convicted of swindling investors and running a $77 million kickback scheme involving COVID-19 and allergy tests.