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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Genetic Risk Score Could Improve Diagnosis of Atrial Fibrillation
From - Diagnostic Testing & Emerging Technologies
A genetic risk score (GRS) may identify patients at highest risk for developing atrial fibrillation (AF), according to a study published…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Fluidigm, Qiagen and MNG Laboratories launched multiple products. Here's a rundown of the key diagnostic product launches from late March through mid-April…
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…