TOP OF THE NEWS

LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]

INDUSTRY TRENDS

FDA Continues Easing DTC, Home Use Test Regulations

In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled loosened regulations in November that will effectively … [Read more...]

HEALTH CARE REFORM

High-Deductible Plans Tied to Reduced Use of Health Care, Including Diagnostic Testing

People enrolled in high-deductible health plans (HDHPs) cut their use of health services, including laboratory testing, according to a study published in the October issue of Health Affairs. HDHPs … [Read more...]

TOP OF THE NEWS

Malpractice Lawsuit Calls Out Lack of Genetic Counseling

A 36-year-old Oregon woman filed a $1.8 million medical malpractice lawsuit against her doctors and a southwest Oregon medical center for "negligent diagnosis and treatment" resulting from … [Read more...]

PAMA

CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times

By Kyle Fetter  bio The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA … [Read more...]

TOP OF THE NEWS

Newly Proposed PAMA Rates for 2018 Confirm Lab Industry’s Worst Fears

The Centers for Medicare and Medicaid Services' (CMS') preliminary 2018 prices for clinical laboratory tests issued under the Protecting Access to Medicare Act (PAMA) came as a big disappointment to … [Read more...]

EMPLOYMENT LAW

Employment Law Update: The Weinstein Edition

By Mike O'Brien  bio Harvey Weinstein all over our news feeds Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? … [Read more...]

UNANIMOUS ABOUT PRIORITY

Association Representatives Say PAMA is #1 Concern for Lab Industry

In the kick-off event of G2 Intelligence's 2017 Laboratory Institute (Washington D.C.; Oct. 25-27), representatives of the biggest laboratory-related associations shared their top priorities, which … [Read more...]

TOP OF THE NEWS

Payers Turning to Automated Pre-Approval Systems for Genetic Tests

Payers are turning to automated systems for pre-approval of genetic tests as a way to contain costs and ensure proper utilization in the face of a dizzying number of news tests. UnitedHealthcare … [Read more...]

INNOVATION

2017 Looking Good for Health Care Investment;
Diagnostic Industry Poised for Large, Future Exits

So far, 2017 is proving to be a good year for fundraising and investment in the broad health care industry, according to report by Silicon Valley Bank (SVB). There have been some big bets placed in … [Read more...]


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