Brief Your CEO: It May Become Easier to Get CMS Stark Clearance for Business Deals with Referral Sources

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

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

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

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

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?

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...]


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