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
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...]
INDUSTRY TRENDS
Point-of-Care PCR Tests Better Diagnosis, Rx for Kids’ Sore Throats
February 5, 2019
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
January 23, 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
January 22, 2019
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
January 22, 2019
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
December 31, 2018
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
December 18, 2018
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
December 17, 2018
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
December 14, 2018
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...]
