The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but BlueWave Healthcare Consultants, their marketing firm. And it raises … [Read more...]
ENFORCEMENT
Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers
May 17, 2017
GENETIC TESTING
Genetic Test Evaluation Framework to Aid Clinical Usefulness of Testing
May 17, 2017
Anew report by the National Academies of Sciences, Engineering, and Medicine provides a new decision framework for the use of genetic tests in clinical care. An Evidence Framework for Genetic Testing … [Read more...]
HEALTH CARE REFORM
Potential Negative Impact of AHCA on Genetic Testing
May 17, 2017
While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of Americans under the … [Read more...]
HEALTH CARE REFORM
Will AHCA Adversely Affect Genetic Testing?
May 9, 2017
While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of Americans under the … [Read more...]
LITIGATION
Abbott and Alere Abandon Litigation and Reach New Terms for Acquisition
April 26, 2017
Abbott's deal to acquire Alere is back on. Both companies announced Friday, April 14, 2017, that they will move forward with the deal and have revised its terms. Abbott, a global health care company … [Read more...]
PRECISION MEDICINE
Discordant Results of Next Gen Tumor Profiling Raise Concerns
April 26, 2017
Conversations regarding oversight of diagnostic testing focus on the clinical and analytical validity of such testing and the ability to replicate results reliably. For example, the U.S. Food and Drug … [Read more...]
EMPLOYER COMPLIANCE
The New Overtime Rules are Put on Hold. What Does That Mean for You?
March 28, 2017
By Mike O'Brien bio As most of you know by now, I'm sure, the United States Department of Labor (DOL) has finalized a new Fair Labor Standards Act (FLSA) rule that, among other things, … [Read more...]
LEGISLATION
House Proposes Replacement Health Care Legislation
March 13, 2017
Efforts to replace Obamacare are moving forward with legislation called the American Health Care Act proposed by two House committees—the Ways and Means and Energy and Commerce Committees. Energy … [Read more...]
OIG
OIG Fraud Alert Warns of Hotline Scammers
March 7, 2017
The OIG issued a Fraud Alert recently—but it didn't warn about improper referral arrangements or billing for medically unnecessary testing. It was a warning that scammers are representing themselves … [Read more...]
NEWS
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
February 27, 2017
Quest Pays $315K for Self-Disclosed Rent Kickbacks to MDs. Case: Quest Diagnostics agreed to pay $315,093 for allegedly paying kickbacks to a referral source. Quest self-disclosed the conduct which … [Read more...]
