While President Trump's proposed $4.75 trillion budget may be the largest in U.S. history, it calls for important cuts affecting health care in general and labs in particular. Here are the six things … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]
NEWS
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
March 25, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
ANTI-KICKBACK
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
March 15, 2019
On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to lower the prices and out-of-pocket costs of prescription drugs by having manufacturers give discounts … [Read more...]
NEWS
Medical Marijuana: CBD Doesn’t Get You “High” But May Make You Fail a Drug Test
February 25, 2019
Testing for marijuana isn't as simple as it used to be thanks to the increased use of cannabidiol (CBD) products. Based on oils extracted from hemp plants, CBD contains little to no … [Read more...]
NEWS
ASCP Agreement with G2 Broadens Member Access to Quality Pathology and Diagnostics Content
February 11, 2019
Collaboration Allows ASCP to Better Meet Member Needs ASCP has entered into an agreement with G2 Intelligence, a division of Plain Language Media LLP, a leading provider of multimedia specialty … [Read more...]
NEWS
New Study Finds Lab Automation Market Poised for Continued Growth, Focus on Genomics Solutions
February 5, 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...]
COMPLIANCE
Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back
January 21, 2019
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...]
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...]
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...]
