Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Pathology, Cytology Face Potential Cuts in 2017 Physician Fee Schedule
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Congressional Leaders Query FDA and CMS about Theranos
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Job Interviews:
How to Ask Personal Questions without Committing Discrimination
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News at a Glance – August 2016
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Follow the OIG’s Lead and Use Analytics to Power Your Compliance Efforts
From - G2 Compliance Advisor
Labs need to use the power of data to make compliance programs more focused, efficient and successful. Take a lesson from…
Senate Committee Hearing Contemplates Changes for Stark Law to Make Compliance Easier
From - Diagnostic Testing & Emerging Technologies
In mid-July, the Senate Finance Committee heard testimony from stakeholders arguing for changes to the Stark Law that could make compliance easier and…
Labs Face Nearly Doubled FCA Penalties under DOJ’s Interim Final Rule
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Theranos Faces More Questions and Challenges And Ramps Up Efforts to Improve Compliance
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Lab Is Sentenced as Prosecution of Individuals for Lab Kickbacks Continues
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CMS Latest Data Release Offers Labs a Tool to Spot Potential Compliance Red Flags
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