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CDC Receives Funding to Expand Laboratory Harmonization Efforts
From - Diagnostic Testing & Emerging Technologies
The FY 2018 omnibus appropriations bill, passed by Congress in late March, included a little noticed provision that could ultimately bring significant changes to the laboratory industry…
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…
Market Report: 2018 Shaping Up as Record Year for Healthcare Industry Mergers & Acquisitions
From - Laboratory Industry Report
While healthcare industry merger and acquisition activity has been on the rise for several years, the early returns suggest that 2018 will be the biggest…
Enforcement Trends: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
From - National Intelligence Report
While the federal enforcement community has made urine drug testing of opioid drug patients its number one target for lab-related…
Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing
From - Diagnostic Testing & Emerging Technologies
Raw data from direct-to-consumer (DTC) genetic tests have an "alarmingly high" false-positive rate, according to a study published…
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
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…
Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - National Intelligence Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…