for the Lab Diagnostics industry
We offer four monthly reports, each focused on the industry from a unique angle, covering science & technology, compliance, business, and legislation & regulations.
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Lab Institute Virtual Event: Dealing with a Difficult Economy
Our June virtual event will offer a variety of solutions and strategies for dealing with key issues labs face during times of economic strife.
MASTER GUIDE TO CLINICAL LAB COMPLIANCE
Navigating stepped-up investigations, audits, & enforcement actions
Weekly Enforcement Report: Drug Testing Fraud Dominates
Last week’s three key cases included two involving drug testing that was either medically unnecessary, or not provided at all.
Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.
Quest Expands into MRD Liquid Biopsy with Haystack Oncology Buy
The acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
Compliance Perspectives: How to Perform Excluded Provider Checks
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
Expert Q&A: Trends in Precision Medicine
Christian Olsen, a leader in R&D scientific software, discusses recent developments related to AI and solutions to current precision medicine challenges.
The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
Investigating the Cause of the 2022 Severe Acute Hepatitis Outbreak in Children
AAV2 virus detected with metagenomics, TE sequencing, and PCR in non-A–E hepatitis cases from two cohorts in Scotland/the UK and the US.
New Blood-Based PTSD Biomarkers Revealed
A simple blood test may help screen, identify, intervene, treat, monitor, and eventually, prevent PTSD.
Kentucky $1.74 Million Settlement Illustrates the Danger of Billing Medicare for Nonmedical Urine Drug Tests
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
4 Things to Know About the End of the COVID-19 PHE
The end of the COVID-19 public health emergency on May 11 also brings certain flexibilities for labs and other providers to an end.
Prostate Cancer: National Guidelines Have Not Stopped Overuse of Low-Value PSA Screening in Older Males
New research suggests that the call to rein in low-value prostate cancer screening seems to be falling on deaf ears.
Techniques and Technology to Fight Laboratory Inflation
This presentation will highlight some of the management techniques and newer technologies for labs to consider when battling rising expenses.
In this OIG roundup, we cover the agency’s plans to modernize and improve the useability of its Compliance Program Guidance, which was first published in 1998.