In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by:

• Routinely waiving co-pays without documenting financial hardship,
  
  
• Shipping unrequested supplies,
  
  
• Allegedly paying kickbacks to boost business.
  
  

While most claims were dismissed—not because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Why? The whistleblowers backed them with actual claim numbers, billing codes, and reimbursement data. That detail made the difference.

If your DTP program involves auto-shipping kits, vague copay waivers, or incentive-based referrals, you could be next. This case shows the DOJ and whistleblowers prioritize programs lacking clear, documented compliance.

Bottom line: Innovation ≠ immunity. Marketing tactics must be clinically justified, legally defensible, and clearly documented.

Need help reviewing your DTP strategy or tightening up compliance documentation?
The Kulkarni Law Firm helps pharma teams bridge innovation and regulation—before enforcement knocks.

Support the show