FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds accused a Missouri lab of submitting false claims to Medicare for travel fees in transporting specimens from April 2011 to December 2014. In addition…
Brief Your CEO: Medicaid Enforcement Trends & Their Impact on Labs
From - G2 Compliance Advisor
While they do not have to embroil themselves in the day-to-day compliance program details, the C-Suiters do need to be on top of…
OIG Work Plan Monthly Review: May 2018
From - G2 Compliance Advisor
Of the seven new Work Plan items, none directly impact labs and lab services. However, one item on Medicare Part B reimbursement of outpatient cardiac and…
Model Drug & Alcohol Testing Policy
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OIG Work Plan Monthly Review: April 2018
From - G2 Compliance Advisor
Four of the six new items that the OIG added to its workplan have an impact–albeit indirect–on labs…
PAMA Reimbursement: CMS Tells Labs How to Secure ADLT Status for New Tests
From - G2 Compliance Advisor
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new…
Getting Paid: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
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