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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
OIG Monthly Work Plan Review: August 2019
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Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform
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Business Trends: More Hospitals Looking to Outsource Their Lab Testing
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New Laws: Congress Tables Bill to Make Whole-Genome Sequencing Available to Medicaid Kids
From - National Intelligence Report
In early August, Representatives Scott Peters (D-CA) and John Shimkus (R-IL) introduced in the…
Compliance Perspectives: What to Do When Respiratory Safety & Religious Rights Collide
From - Lab Compliance Advisor
A lab requires all employees who work with or near materials emitting toxic vapors to wear respirators with…
DX Earnings Report: Markets Soften, Payors Harden but Growth Continues
From - Laboratory Industry Report
Lab business is getting tougher. While PAMA cuts are hurting Medicare revenues, pressure from private payors may…
Pennsylvania M.D. Used Addiction Clinics as Front for Opioid Scheme
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