FOCUS ON

Surviving PAMA: Keep an Eye on Industry Disruptors

A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]

FOCUS ON

New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics

Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in the lab industry, it has also created new legal challenges that few … [Read more...]

COMPLIANCE

DOJ Explains What It Wants from a Compliance Program

While it may not prevent all violations, the right compliance program can help your lab get lighter penalties if things go wrong. But what exactly is "the right compliance program." On April 30, 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...]

FOCUS ON

Medicare Reimbursement: New Guidance on Date of Service Rules for Part B Billing of Hospital Outpatient Lab Tests

In 2018, new date-of-service rules took effect for billing and coding of outpatient lab tests under Medicare Part B, rather than as part of the Hospital Outpatient Prospective Payment System (HOPPS) … [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...]

FOCUS ON

The Worker Shortage and Your Lab

If you're having trouble finding employees, all you have to do is look at the numbers to understand the problem. The national unemployment rate stands at 3.7%—and in some states it's even lower. In … [Read more...]

LEGISLATION

New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more

By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]

FOCUS ON

LDTs: FDA Announces New Approach to 510(k) Approvals

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

FOCUS ON

Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019

The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to resolution notwithstanding the ACLA's recent court loss. But even as the legal battle … [Read more...]


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