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...]

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...]

INDUSTRY TRENDS

Point-of-Care PCR Tests Better Diagnosis, Rx for Kids’ Sore Throats

Given we are still in the midst of cold and flu season, a new study highlights the benefit of point-of-care (POC) polymerase chain reaction (PCR) testing among pediatric patients presenting to the … [Read more...]

COMPLIANCE PLANS

OIG Monthly Work Plan Review: January 2019

This month, there were six new Work Plan items. The two pertaining to labs are detailed below. The first one has widespread implications for labs; the second may have implications for some labs 1. … [Read more...]

PRECISION MEDICINE

Newborn Sequencing Delivers Some Unanticipated Findings

Newborn genomic sequencing (NGS) can identify risk for a wide range of disorders that otherwise may not be detected, even in seemingly healthy babies, according to a study published Jan. 3 in the … [Read more...]

TESTING TRENDS

Zika Blood Screening Not Cost-Effective, Study Finds

Screening blood donors for Zika virus is not cost-effective in the United States or Puerto Rico, according to a study published Jan. 8 in the Annals of Internal Medicine. Despite U.S. Food and Drug … [Read more...]

GUIDELINES

Pre-Op Urine Screening Not Necessary

Routine preoperative urine screening offers no clinical benefit, according to a large study published Dec. 12 in JAMA Surgery. Treating asymptomatic bacteriuria detected by screening does not cut the … [Read more...]

PUBLIC HEALTH

Industry Buzz: Obamacare Repeal Sends Tremors through Insurance Markets

What came as a Christmas gift to many Republicans may be a lump of coal in the stocking of many others. On December 14, a federal judge in Texas ruled that the entire Affordable Care Act (aka, … [Read more...]

UTILIZATION MANAGEMENT

You Make the Call: Incentivizing MDs to Order More Early Screening Tests

A Managed Care Organization (MCO) wants to pay providers incentives to increase early and periodic screenings, diagnostic and treatment (EPSDT) services to Medicaid patients. Payments are capitated, … [Read more...]

PUBLIC HEALTH

FDA Watch: Agency Approves New Flu Tests and Drug

As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease. New Flu Assays On October 24, Abbott announced that the FDA has granted … [Read more...]


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