IV Hydration Therapy Clinic Or Mobile Unit Setup

Legal Counsel To Help You Start An IV Hydration Therapy Business In Texas

IV hydration therapy, also known as IV vitamin therapy, is a growing trend in Texas and throughout the United States. Many patients seek these services as a method to combat aging, treat hangovers, recover from jet lag, rehydrate muscles after a workout, get a healthy glow, and even alleviate the symptoms of certain medical conditions. Practitioners may offer IV hydration therapy services in an office setting or mobile unit.

Whether you want to open an IV hydration therapy business or “IV bar,” and offer these services in-home, from a mobile unit, or in a med spa setting, there are several legal considerations in Texas to keep in mind.

Before you establish or staff your IV hydration therapy clinic in Texas, call (713) 909-7323 to consult with the experienced healthcare attorneys at Hendershot Cowart P.C.

Who Can Own an IV Hydration Therapy Business?

Texas law prohibits the corporate practice of medicine, placing strict limitations on who can practice medicine or employ those who do. The doctrine is intended to safeguard patient care by protecting doctors from undue influence over their medical judgement by non-practitioners who may prioritize profits over patients.

As a result, only a licensed physician can own an IV therapy practice. Licensed physicians include doctors of medicine (MDs) and doctors of osteopathic medicine (DOs). Physician assistants may own a minority interest in an IV therapy practice.

This does not mean, however, that non-physicians cannot be involved in an IV therapy practice. It does mean that restrictions on the relationships between physicians and non-physicians must be observed when structuring an IV therapy business.

Ownership Models and Legal Entities for IV Hydration Clinics

The Corporate Practice of Medicine doctrine prohibits a non-doctor from employing a physician. As a result, the clinical side of the IV hydration business should be established as a professional entity owned by a physician. Texas has separate entity types for licensed professionals, including a professional limited liability company (PLLC) or a professional association (PA).

Other healthcare professionals, such as RNs or LVNs, and non-practitioners wishing to participate in an IV hydration therapy business can handle the non-medical aspects of the practice through the formation of a Management Services Organization, or MSO.

MSOs are independent entities with an agreement to provide management services to a medical practice. Unlike a medical practice, there are no restrictions on who can own and operate an MSO.

The MSO can own the brand, office space and equipment, etc. and license the brand, lease space, and/or provide services to the physician’s professional entity in exchange for compensation. An MSO can be formed as a Corporation (Corp.) or limited liability company (LLC).

The team of health law and corporate formation attorneys at Hendershot Cowart P.C. can advise you on the best legal entities and organizational structure for your IV hydration business, depending on the individuals involved.

If you want to open an IV therapy practice as a physician or get involved as a non-physician, our experienced Texas attorneys can help.

Who Regulates IV Hydration Therapy In Texas?

IV hydration therapy is subject to oversight from a patchwork of state and federal regulatory agencies, including:

• Texas Department of Licensing and Regulation (TDLR)
• Texas Medical Board (TMB)
• Texas Board of Nursing (TBON)
• Occupational Safety and Health Administration (OSHA)
• U.S. Food and Drug Administration (FDA)
• Federal Trade Commission (FTC)

In addition, while many IV hydration practices choose to operate under a patient cash-pay model, this model does not shield them from scrutiny over violations of Texas’s fraud and abuse laws. For example, the ordering practitioners cannot be paid fees for referrals to the IV hydration clinic. All parties involved in your IV hydration therapy practice must comply with the Texas Solicitation of Patients Act or the Texas Commercial Bribery Statute.

The healthcare attorneys at Hendershot Cowart P.C. can advise you on regulatory compliance based on the licenses and experience of those involved. For example, if your business model includes a licensed vocational nurse (LVN), you will need to know that LVNs may need to complete specific validation courses before providing IV therapy services.

Read our blog: "Physicians: Diagnose & Document Therapeutic Necessity For IV Hydration Treatments," to learn more about key regulations that prohibit medically unnecessary treatments and why your IV hydration clinic needs to be watchful for these compliance issues.

Medical Oversight and Delegation Within an IV Therapy Clinic

While many kinds of practitioners may be involved in the delivery of the IV therapy, the IV hydration therapy must be ordered by a physician, or an advanced practice provider pursuant to a supervision and prescriptive authority agreement.

The Texas Medical Board has strict guidelines for standing delegation orders, including the types of medicines that may be provided under a standing delegation order. Some orders may come from a physician or advanced practice provider who has examined the patient. Telemedicine can be utilized by the physician or advanced practice provider to consult with the patient and order the IV therapy.

Do RNs Or EMTs Need Supervision To Run An IV Therapy Clinic?

Yes. A licensed physician, physician assistant, or nurse practitioner must order the IVs used in IV therapy.

Texas Administrative Code and the Texas Board of Nursing provide detailed guidance on supervision and training requirements for the administration of IV therapy. Review policies and protocols with a healthcare attorney to ensure compliance.

Is IV Therapy Considered the Practice of Medicine?

Yes. "Practicing medicine" means the diagnosis, treatment, or offer to treat a mental or physical disease or disorder or a physical deformity or injury by any system or method, or the attempt to effect cures of those conditions, by a person who:

• Publicly professes to be a physician or surgeon; or
• Directly or indirectly charges money or other compensation for those services.

Recipients of IV therapy believe that they are benefiting from a treatment for a mental or physical disorder – whether that is fatigue, dehydration, a hangover, dull complexion, etc. As a result, receiving prescription vitamins and other drugs through the intravenous infusion process is considered the practice of medicine, whether the patient receives any actual benefit or not.

The payment of money from the patient in exchange for a perceived treatment is the practice of medicine.

This has been confirmed by the Texas Medical Board:  In October 2023, TMB President Dr. Sherif Zaafran, M.D., FASA, wrote that, “despite some of the more innocuous language frequently associated with them such as ‘Immunity Boosting’, ‘Hangover Fix’, or ‘Beautify’, at its core, the use of IV therapy or giving an injection is an invasive medical procedure or treatment.”

IV Therapy Marketing and Advertising

The FTC and Texas Medical Board monitor and regulate health claims in advertising, including social media. Our social media law and health law team can advise you on the requirements for health claims, influencer marketing, and client or physician endorsements so that your marketing and advertising activities can be accurate and in compliance with state and federal guidelines.

Next Steps: Investing in or Opening an IV Therapy Clinic

Our firm has a strong record of results helping healthcare providers navigate the increasingly challenging regulatory environment in Texas. We’ve helped hundreds of medical professionals establish IV hydration and other wellness clinics in compliance with state and federal regulations.

At Hendershot Cowart P.C., we build relationships with our clients, which means we will get to know your healthcare business from the ground up and will be ready to support you throughout the lifespan of your enterprise.

Don’t trust your practice to just anyone. Instead, schedule your consultation with Hendershot Cowart P.C. by calling us at (713) 909-7323 or sending us a message online.