Case of the Month: Another MD-Owned Lab Gets Busted for Urine Drug Test Abuses

Fraudulent utilization and billing of urine drug screening first became a priority for federal enforcers since the $256 million Millennium settlement of 2016. But the opioid crackdown has heightened … [Read more...]


Mass. Pain Management MDs Jailed for Elaborate Drug Testing Conspiracy

Case: After pleading guilty to running "one of the most dangerous pain management practices in Massachusetts," a medical resident was sentenced to 75 months in jail, three years of supervised release … [Read more...]


Compliance Perspectives: How the New OIG Fraud Risk Indicator System Heightens the Imperative of Self-Disclosure

As hard as you try to keep your lab 100% compliant with healthcare fraud and abuse laws, you may discover that an inadvertent violation has occurred. At that point, the compliance imperative switches … [Read more...]


Lab Settles Specimen Collection Fee Kickback Charges for $2.275 Million

Case: Cleveland HeartLab (CHL) has agreed to pay $2,275,094 after self-disclosing to the OIG that it paid remuneration in the form of payments to physicians and physician groups for collecting, … [Read more...]


FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]


OIG Monthly Work Plan Review: March 2019

This month, there were 16 new Work Plan items. Three of these may have implications for some labs as detailed below. Medicare Market Shares of Mail Order Diabetes Test Strips Issue: The … [Read more...]


Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]


Kentucky Pain Clinic Pays $127K to Settle Specimen Validity Test Billing Claims

Case: The Northern Kentucky Center for Pain Relief agreed to pay the OIG $126,799.90 to settle claims of billing Medicare for specimen validity testing (SVT). Explanation: Under Medicare rules, urine … [Read more...]


Brief Your CEO: Notify Your Lab Execs of Upcoming Stark Law Changes

One of the best ways to score points with your lab's executives is to warn them about legal changes before they happen and while there's still time to prepare. And now you have an opportunity to do … [Read more...]


Three key items to negotiate for successful payer contracts

By Steve Selbst  bio The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in … [Read more...]