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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 Work Plan Monthly Review: December 2017
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New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
From - G2 Compliance Advisor
While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is…
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
From - G2 Compliance Advisor
The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system…
Medicare Exclusions: One Week, Two Different Labs Get the Boot
From - G2 Compliance Advisor
Exclusion of a clinical lab from participating in Medicare or other government health programs is a relatively rare penalty…
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
By Kyle Fetter bio
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA process was…
The 10 Assumptions NOT to Make when Doing Your OSHA 300s
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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OIG Work Plan Monthly Review: November 2017
From - G2 Compliance Advisor
The OIG added four new items to its Work Plan this month, all of which have potential indirect effects on clinical labs involved in providing the…
CMS Finalizes Controversial PAMA Fee Schedule
From - G2 Compliance Advisor
It's official. Brushing aside fierce lab industry opposition, CMS has decided to go forward with its PAMA Clinical Laboratory Fee Schedule (CLFS) in 2018…