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...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
FOCUS ON
LDTs: FDA Announces New Approach to 510(k) Approvals
January 7, 2019
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
December 21, 2018
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...]
MARKETING
Industry Trends: Continued Momentum for Lab-Retail Collaboration
December 14, 2018
The Theranos debacle hasn't dissuaded retailers from partnering with labs. Here's a rundown of some recent deals. LabCorp & Walgreens In fact, Walgreens, Theranos's ex-retail partner, has moved … [Read more...]
DATA
6 Steps to Data-Driven Transformation
November 26, 2018
By Nir Kaldero bio We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the Third brought … [Read more...]
FOCUS ON
Industry Buzz: ACA Constitutionality Is Back in Play
October 11, 2018
After a series of court setbacks, Republicans challenging the constitutionality of Obamacare, aka, the Affordable Care Act (ACA) are back at it. And this time they may win. Beating a Dead Horse? The … [Read more...]
SPECIAL FOCUS
Cost Avoidance vs Cost Savings: What’s the Difference?
August 31, 2018
By Jennifer Dawson, MHA, DLM (ASCP) bio As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to … [Read more...]
FOCUS ON
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
August 6, 2018
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]
LITIGATION
Are Genetic Testing Labs Liable for Medical Malpractice?
July 30, 2018
Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth: malpractice liability. In the past … [Read more...]
FOCUS ON
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
June 19, 2018
In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The … [Read more...]
