NEWS

The President’s Proposed 2019 Federal Budget: The 6 Things Labs Must Know

While President Trump's proposed $4.75 trillion budget may be the largest in U.S. history, it calls for important cuts affecting health care in general and labs in particular. Here are the six things … [Read more...]

COMPLIANCE PLANS

OIG Monthly Work Plan Review: March 2019

This month, there were 16 new Work Plan items. Three of these may have implications for some labs as detailed below. Medicare Market Shares of Mail Order Diabetes Test Strips Issue: The … [Read more...]

FOCUS ON

Genomic Data Sharing: From Utopian Principle to Practical Reality

"Publicly available data should be treated as open data, a shared resource with unrestricted use for analysis, interpretation, and publication." --The journal Science report on genomic data … [Read more...]

TOP OF THE NEWS

New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics

Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health … [Read more...]

TESTING STRATEGY

Preventive Genomic Screening In Young Adults Highly Cost Effective

A new model shows that universal preventive genomic screening for multiple conditions in early adulthood could be highly cost-effective in a single-payer health care system, according to a study … [Read more...]

INSIDE THE DIAGNOSTICS INDUSTRY

The Practice of Early Gestational Diabetes Screening Evaluated

The U.S. Centers for Disease Control and Prevention estimates that each year, gestational diabetes mellitus (GDM) affects between 2 percent and 10 percent of pregnancies. Experts say there has been a … [Read more...]

FDA

FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests

While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together … [Read more...]

TESTING TRENDS

Current Metal Sensitivity Testing Not Adequate for Diagnosing Immune-Related Knee Replacement Failure

Metal sensitivity test results, including lymphocyte transformation testing (LTT), are insufficient to diagnose knee replacement failure due to an immune reaction, according to a study published Feb. … [Read more...]

COMPLIANCE PLANS

OIG Monthly Work Plan Review: February 2019

This month, there were two new Work Plan items. One of these may have implications for some labs and is detailed below. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or … [Read more...]

FOCUS ON

How the Opioid Crackdown Is Affecting Lab Enforcement & Test Utilization

103 in 1: Odds of dying in a motor vehicle crash 96 in 1: Odds of dying from an opioid overdose The alarming finding that a person is now more statistically likely to die of an opioid overdose … [Read more...]


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