How to Protect Your Medical Practice While Expanding Into Research

Adding a research arm to your medical practice can unlock growth, but it also creates real compliance risk if done wrong. In this episode, Darshan explains how to structure research activities without exposing your core practice to fraud, billing, or regulatory problems.

Episode Summary

Expanding into clinical research sounds exciting, but it can put your existing medical practice at risk if roles, payments, and responsibilities are not clearly separated. Darshan walks through common pitfalls like billing overlap, malpractice gaps, and conflicts of interest. He explains why separate entities, updated agreements, proper insurance coverage, and clean consent processes matter. This episode focuses on smart growth without triggering enforcement issues or jeopardizing your core business.

Show Notes

• Why mixing clinical care and research creates risk
• Billing overlap and fraud exposure
• Malpractice and insurance gaps
• Conflicts of interest regulators look for
• When and why to form a separate research entity
• Using MSOs to support compliant growth
• Updating professional practice agreements
• Fixing consent forms for dual roles

Call to Action

Thinking about expanding into research? Reach out before problems start. Call, click, or email to talk it through.

www.kulkarnilawfirm.com

Transcript

Darshan: 0:00

So, how do I protect my existing medical practice while adding a research arm? So expanding into research is obviously exciting, but it can expose your core practice to a new risk, especially if these two are not separated carefully. You have to worry about issues like billing overlap, malpractice coverage, conflicts of interest that must be addressed. Without safeguards, sponsors, patients, or regulators may and have questioned your independence. Here's what I tend to recommend: create a separate entity or legal arm to handle the research side. This structure protects your clinical operations and makes regulatory compliance easier. I tend to review and adjust professional practice agreements, insurance policies, and patient consent forms so they clearly address dual roles. My approach ensures that you don't actually trigger fraud claims, start anti-kickback issues, now practice gaps, all while you're expanding into research. Think about MSOs, management services organizations. That's going to be a key. The key and the goal is growth, but you don't want to have growth while jeopardizing your medical practice. Call, click, or email.