Labs remain at the forefront of the federal government’s suspicious persons list and health care fraud enforcement agenda. But in addition to the customary laws that labs are used to, the government … [Read more...]
Compliance Perspectives: New Laws & the Top 5 Challenges Lab Compliance Officers Face in 2020
January 2, 2020
Brief Your CEO: It May Become Easier to Get CMS Stark Clearance for Business Deals with Referral Sources
October 17, 2019
Part of the challenge of running a lab compliance program is making your officers aware of how business transactions your lab makes with a physician that refers patients to you for testing creates the … [Read more...]
SAFETY
Ergonomics in the Laboratory Setting
July 28, 2019
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio Sometimes when I am talking about lab safety and the topic turns to ergonomics, I get an unusual reaction from the audience—laughter. It … [Read more...]
LEGISLATION
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
January 14, 2019
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...]
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...]
