The recently-revised regulations to the Stark Physician Self-Referral Law have implications that extend beyond clinicians to medtech companies, particularly as the healthcare system increasingly evolves from volume to value-based programs. These expert healthcare attorneys explain why it is essential that medtech companies understand the full ramifications of this law’s current standards. By Melissa Hudzik, Esq., and Jeff Weinstein, Esq., Wilson Sonsini Goodrich & Rosati.
Physicians are nearly as central to a medical technology enterprise as they are to the healthcare practice itself. Through three roles, they exercise enormous influence on medtech—as innovators; lead users of products; and as gatekeepers who offer access to the healthcare market. During our decades in healthcare law, we have counseled medtech companies where physicians were company owners and major investors; contributed critical intellectual property; directed clinical research; spearheaded product development; and afforded indispensable outreach to other physicians as speakers, trainers and marketers. Medtech companies—and physicians, themselves—are often naïve about the circumstances under which laws restrict their financial dealings, however. Below we set out some key takeaways about the famously complex, technical, and unforgiving “Stark Law” for medtech enterprises.