Telehealth Legal: Stark, Anti-Kickback, Fee-Splitting, Structure

Telehealth Legal: Stark, Anti-Kickback, Fee-Splitting, Structure

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    In today’s video, we talk about how we helped one telehealth practice navigate a range of legal issues including Stark and anti-kickback, fee-splitting, consents, and business structure questions.

    I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients navigate healthcare and FDA legal issues and launch and/or successfully grow their health and wellness product or service.

    Dr. Joe has a telehealth practice and his cousin, Danny is a life coach.  Dr. Joe wants to hire Danny to provide life coaching services to his patients.  Dr. Joe has a wellness protocol, does functional medicine, recommends dietary supplements through a portal, reviews labs, and wants to treat patients across states.

    The first thing we do with a client like Dr. Joe is normally schedule a Legal Strategy Session with a member of our Legal Team.  This short, focused process in which we devote time to an intake and fact-gathering, and some initial legal research, and then have a call in which we issue-spot and give preliminary recommendations.  In issue-spotting, we look for the legal issues and talk about your risk.

    Dr. Joe raised a number of questions, one after another, for his Legal Strategy Session.

    He did extensive marketing and screening to get patients; at what time did he form a doctor-patient relationship that could expose him to liability?

    Could he reach into other states to get patients, and treat them through telehealth only?

    Did his concierge model conflict with his obligations under his insurance participation agreement?

    Would it be wise, to limit potential liability exposure, to disclaim primary care? Is that appropriate or strategic?

    What about profiting off the work of his cousin Danny, the life coach?  Would this be considered a kickback in it off itself?

    In terms of business structure, what if he put Danny on the Board?  As someone without a healthcare license, could Danny even own shares?  What about setting up an MSO together?

    Did he have to follow HIPAA, or could he have more informal privacy and security standards?

    Did he have to follow all the sub rules of HIPAA?

    What about a Business Associate agreement?

    Would his off-label prescribing practices and specific therapies raise standard of care issues for the board?

    Could Dr. Joe hire an acupuncturist, an independent contractor, or, an employee – and could the acupuncture order and review labs, within her scope of practice under state law?

    Could he or she make money off the lab referrals at all or would that be considered in itself fee-splitting and get them into regulatory trouble?

    Who could order and own the medical equipment?

    You can see while the Legal Strategy is only a first cut, and may in fact also require at least one additional call, we can get very deep in the weeds in terms of addressing some fundamental concerns and clearing the brush at the outset of providing clarity.

    Thanks for watching. If you still have questions, click on the link below,, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we look forward to speaking with you very soon.


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      Richard Freedland GRAMedical, CEO
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      James Riviezzo Practice On Your Terms

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