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
April 15, 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
April 8, 2019
"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
April 8, 2019
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
March 26, 2019
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
March 26, 2019
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
March 11, 2019
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
February 25, 2019
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
February 22, 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
February 18, 2019
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...]
