COMPLIANCE

You Make the Call: Is Replacing Spoiled Products for Free an Anti-Kickback Violation?

The following scenario comes right out of an August 25, 2017 OIG Advisory Opinion. See if you can guess how the OIG ruled. SITUATION A pharmaceutical company manufactures biologics prone to spoilage … [Read more...]

COMPLIANCE

OIG and DOJ Offer Tips for Evaluating Compliance Effectiveness

Labs have two new compliance tools—from the Department of Justice (DOJ) and the Office of Inspector General (OIG)—focused on evaluating the effectiveness of compliance programs. The DOJ's resource … [Read more...]

COMPLIANCE CORNER

Managing Kickback Risks in Lab Sales & Marketing Arrangements

As with any other business, labs need sales and marketing expertise to survive and grow in the competitive diagnostics market. But to the extent you serve patients in Medicare, Medicaid and other … [Read more...]

ENFORCEMENT

Dealing with the FDA: 12 Best Practices for Responding to a Form 483

Laboratory diagnostic tests and affiliation with drug and device manufacturers have made labs a popular target for U.S. Food and Drug Administration (FDA) quality system inspection. Going through an … [Read more...]

NEWS

The 6 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...]

NEWS

Five Things Labs Need to Know About the Trump Travel Ban

We'll leave it to others to argue whether it's legal, moral or wise. What we can tell you is that President Trump issued an Executive Order Jan. 27, 2017, establishing a travel ban that can affect … [Read more...]

HIPAA

10 Things to Include in Your HIPAA Breach Notification Policy

Earlier this month we told you about a $475,000 settlement one provider reached in a HIPAA breach notification case. Privacy lapses can occur despite your best efforts to prevent them. If prevention … [Read more...]

NEWS

Enforcement Firsts: Presence Health Fined $475,000 for Taking Too Long to Report HIPAA Breach

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. A new HIPAA rule took … [Read more...]

HIPAA

How to Create a HIPAA Breach Notification Policy

Privacy lapses can occur despite your best efforts to prevent them. If prevention does fail, the imperative switches to incident response and damage control. One of the key response challenges is … [Read more...]

HIPAA

First HIPAA Breach Notification Settlement Totals $475,000

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Four years ago, a new … [Read more...]


(-0000g2)