
DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
$14M Fine Says This “Free” Offer Wasn’t Legal
In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid.
This wasn’t just bad billing—it was a marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal liabilities.
Key takeaways:
- Value can become a liability – Helpful services may violate anti-kickback laws if not vetted legally.
- Volume-based strategies invite scrutiny – More testing isn’t always better—especially without medical necessity.
- You’re accountable—even if you don’t bill – Diopsys didn’t submit claims but still paid $14M for allegedly enabling them.
For legal and compliance teams, this is a compliance case study in what happens when oversight misses the risk signals. From fair market value to OIG advisory opinions—this episode explores what should have been done and how you can avoid the same fate.
Are your support services audit-proof? If you're unsure, this episode is for you. Tune in, stay informed, and stay compliant.
Questions? Contact the Kulkarni Law Firm to assess your risk before you become the DOJ’s next target.