Although the False Claims Act (FCA) remains a federal enforcement cash cow, the growth rate has fallen off in recent years, at least in the healthcare sector. But that short-term trend could be in … [Read more...]
COMPLIANCE
Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back
January 21, 2019
CMS
CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
January 15, 2019
As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will be going up 20%, effective this year. Background For those of you who are new to … [Read more...]
ENFORCEMENT
New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution
January 15, 2019
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]
COURT CASES
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
January 15, 2019
Wisconsin Health System Settles Stark Claims for $12 Million Case: In a case that began as a whistleblower suit, a company affiliated with Advocate Aurora Health, Inc. has agreed to pay $12 … [Read more...]
HEALTH CARE REFORM
Industry Buzz: When It Comes to Obamacare, Uncertainty Is the Only Certainty
January 15, 2019
Last month, a U.S. District Court Judge ruled that the Affordable Care Act, aka Obamacare, is unconstitutional—not just the individual mandate but the whole bloody law. But if you were expecting … [Read more...]
NEWS
New Study Finds Lab Automation Market Poised for Continued Growth, Focus on Genomics Solutions
January 15, 2019
The lab automation market is expected to reach $5.20 billion by 2022 from an estimated $4.06 billion in 2017, at a CAGR rate of 5.1%, according to leading B2B research company MarketsandMarkets. The … [Read more...]
FOCUS ON
The Worker Shortage and Your Lab
January 15, 2019
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...]
MARKETING
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
January 14, 2019
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
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
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...]
