Wellness is the new trend in healthcare. For some bespoke providers, the emphasis on preventative care alleviates the crisis of chronic conditions and calls for innovation. For others, mental health is closely tied to a patient's perceptions of appearance and requires intervention. And for almost all providers, the emergence of telehealth as an industry staple over the last half-decade has signaled the ability to get people access to the weight management, mental and behavioral health and maintenance therapies they seek.
The wellness industry has experienced explosive growth in recent years, driven by consumer demand for weight management treatments, anti-aging therapies, hormone optimization, ketamine-assisted therapy, intravenous (IV) vitamin infusions, drips, hydration therapy and other wellness treatments. This growth has been fueled in part by the expansion of telehealth platforms, direct-to-consumer marketing and the proliferation of cash-pay wellness clinics that operate outside of traditional insurance-based models.
As a result of these sweeping industry trends, the regulatory environment for wellness providers has undergone a dramatic transformation over the past 18 months. Federal agencies and state medical boards are coordinating enforcement efforts targeting cash-pay wellness clinics, concierge medicine practices, telehealth platforms, ketamine clinics and IV therapy providers, including vitamin IV drip bars, infusion lounges and hydration therapy clinics. These enforcement actions reflect a growing concern among regulators that the wellness industry's rapid expansion has outpaced the regulatory frameworks designed to protect patient safety.
This blog post provides an overview of the key regulatory trends affecting wellness providers, summarizes recent enforcement developments, and offers practical compliance recommendations for brick-and-mortar clinics and telehealth platforms alike.
State medical boards have become increasingly active in investigating and disciplining practitioners associated with wellness clinics and concierge medicine practices. Common areas of concern include:
Similarly, ketamine clinics and IV therapy businesses combine controlled substance prescribing or invasive treatment delivery with significant scope-of-practice and patient-safety obligations. Regulators are increasingly examining the following issues:
From a marketing perspective, the Federal Trade Commission (FTC) has issued updated guidance through its Health Products Compliance Guidance and has brought enforcement actions against wellness providers and clinics that make unsupported health claims in advertising and marketing materials. The FTC has targeted claims related to weight management outcomes, anti-aging benefits and the efficacy of wellness treatments. Providers should be aware that the FTC applies a rigorous standard of substantiation and has the authority to impose significant civil penalties.
Finally, the regulatory landscape for telehealth prescribing has also tightened significantly. Key developments include:
Brick-and-mortar wellness clinics face a unique set of regulatory risks given their direct patient interactions and the direct delivery of wellness treatments. Key areas of concern include:
In addition to the above considerations for providers with physical practice locations, expansive telehealth platforms and large-scale concierge practices face additional regulatory considerations, particularly given their reliance on remote patient interactions and, in many cases, multi-state operations.
In light of the current regulatory environment, the following proactive steps are integral for the wellness industry today:
The wellness industry continues to offer tremendous opportunities for healthcare providers, but the regulatory landscape has shifted significantly. Federal and state regulators have made clear that they intend to hold wellness providers to the same rigorous standards that apply throughout healthcare. Providers who take a proactive approach to compliance by auditing their operations, tightening their prescribing protocols and substantiating their marketing claims will be best positioned to thrive in this environment.
Holland & Knight's Healthcare & Life Sciences Team regularly advises wellness providers, concierge medicine practices and telehealth platforms on the regulatory issues discussed in this article. Contact the author to discuss how these developments may affect your practice.
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