Budget Blueprint: Funding for Tech Down But Increases for Enforcement

The headlines are harsh. "Terrible," devastating," and "crippling," are words the biomedical industry is using to describe President Trump's proposed cuts to science and medical research in his 2018 … [Read more...]


Wellness Program Bill Threatens Privacy of Genetic Test Results

A new bill promoted as supporting workplace wellness programs has met with significant backlash, criticized as forcing employees to give their employers genetic testing results. The bill proposed in … [Read more...]


House Proposes Replacement Health Care Legislation

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 Fraud Alert Warns of Hotline Scammers

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...]


Flu Antigen Tests Reclassified as Class II Devices

Effective this month, the U.S. Food and Drug Administration (FDA) has reclassified antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used directly on clinical specimens from … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

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...]


Health Care Organizations Urge Congress to Update LDT Oversight

Late last year, the U.S. Food and Drug Administration (FDA) announced that it would not finalize its 2014 proposed guidance on agency oversight of laboratory developed tests (LDTs) but would work with … [Read more...]


New EO Calls for Agencies to Appoint Regulatory Reform Officers and Task Forces

On Friday, Feb. 24, 2017, President Donald Trump issued an Executive Order (EO) aimed at furthering the promise to reduce regulatory burdens and costs. This latest EO requires regulatory agencies each … [Read more...]


The 7 Things Labs Need to Know About the Trump Travel Ban

We'll leave it to others to argue whether the Trump travel ban is legal, moral or wise. What we can tell you is that while it may be on temporary hold, the travel ban and the policy it embodies are … [Read more...]


Emphasis on Individual Responsibility Likely to Continue Even After Yates Departure

Pursuing False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs is just one of the things the U.S. Department of Justice does to crack down on corporate wrongdoing. On Sept. 9, 2015, … [Read more...]