By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
COMPLIANCE GUIDANCE
Compliance Perspectives: Avoid Kickback Liability by Steering Clear of MD Processing Fees
December 10, 2018
Editor's Note: Two months ago, we talked about paying referring physicians a fee for collecting and processing blood, urine, tissue and other specimens. (G2 Compliance Advisor, Oct. 9, 2018, p. 1). … [Read more...]
FALSE CLAIMS
Feds Target Providers Who Took Free Test Cup Kickbacks from Millennium Labs
June 18, 2018
Free point-of-care test cups from Millennium Labs have become radioactive. So far, at least six different providers have agreed to fork over significant amounts (ranging from $40K to $186K) to settle … [Read more...]
COMPLIANCE
You Make the Call: Is Replacing Spoiled Products for Free an Anti-Kickback Violation?
October 16, 2017
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
April 25, 2017
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
March 14, 2017
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
March 14, 2017
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
February 22, 2017
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
February 7, 2017
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
January 30, 2017
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...]
