
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!
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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
Telehealth Done Right
The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant under the personal services and management contracts safe harbor.
This matters for pharma, digital therapeutics, and connected device companies increasingly partnering with telehealth platforms. The opinion clarifies that digital marketing services promoting physician practices can be paid for—if structured correctly. Key compliance factors include fair market value, written agreements, and fixed fees not tied to patient volume.
But beware: this opinion doesn’t bind the DOJ, doesn’t address state law or Stark, and hinges on a narrow fact pattern. If your telehealth strategy involves clinician leasing or third-party reimbursement, now’s the time to review your management services agreement.
Bottom line: this is both a roadmap and a red flag. Get the structure right—or risk regulatory trouble.