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
How to Guard Your Lab from Telehealth Liability Risk
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
When & How to Use Changed Clinical Laboratory Consult Codes
Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.
OIG Calls Out MA Plans for Wrongfully Denying Reimbursement
The new report could be a turning point in the battle to curb payor abuse of preauthorization requirements.
Labs Figure Prominently in New OIG Enforcement Report
While the report’s most significant findings involved labs and lab testing, it wasn’t just the usual finger pointing this time.
Theranos in Court: Jury Finds Balwani Guilty on All 12 Counts
Federal San Jose jury finds ex-Theranos COO guilty of all 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
Congress Acts to End PAMA Price Cutting Reign of Terror
After years of resistance, the lab industry’s hopes and prayers for relief from the flawed pricing scheme may soon be answered.
COVID-19 Test Profits Make Labs Potential Target for Public Backlash
Independent labs accrued a profit of at least $10 on each PCR COVID-19 test performed in the period from May to December 2020, study says.
Becton Dickinson, Cepheid Unveil Monkeypox PCR Test Collaborations
Some of the lab industry’s biggest players are teaming up to develop new monkeypox diagnostics in response to the current outbreak.
DOJ Enforcers Turn Up Heat on Healthcare Private Equity Fund Deals
A hostile government policy has done little to slow consolidation of independent medical practices and hospitals.
