In October, the Texas Medical Board addressed the emergence of medical business models that may violate Texas regulations. Specifically, TMB President Dr. Sherif Zaafran, M.D., FASA, cited facilities offering intravenous (IV) vitamin therapy or hydration.
Dr. Zaafran advised physicians to seek legal guidance before engaging in these new models, or any form of medical intervention in the state.
IV Therapy Is the Practice of Medicine
In his “friendly reminder”, Dr. Zaafran 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.”
“Because these are medical procedures or treatments,” Dr. Zaafran continued, “they must be administered by a Texas licensed physician or properly delegated to qualified non-physicians to provide such services while under the physician’s delegation and supervision.”
Practicing medicine is defined as 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 either:
- Publicly professes to be a physician or surgeon; or
- Directly or indirectly charges money or other compensation for those services.
Physicians participating in IV hydration services should remain vigilant that these medical treatments are diagnosed and documented as therapeutically beneficial or necessary for the patient's treatment.
Can My Business Offer IV Treatments Through a Menu?
“Medical treatments must be provided pursuant to medical standards,” wrote Dr. Zaafran in his October 2023 President’s Message, “and not based on the patient choosing a treatment from a menu without an appropriate assessment of the patient by a qualified individual.”
It is not enough to screen for contraindications. Texas Medical Board Rule 169.3 states that a physician may “administer those drugs to his or her patients, which are, in the physician's medical judgment, therapeutically beneficial or necessary for the patient's treatment.”
Under Rule 190.8(2)(J), the provision of medically unnecessary services qualifies as an act of unprofessional and dishonorable conduct that is likely to deceive, defraud, or injure the public within the meaning of the Medical Practice Act.
When a patient requests treatment for any real or perceived condition, a qualified healthcare practitioner must first examine the patient, perform appropriate diagnostic tests, and develop a diagnosis before prescribing drug therapies. Ordering prescription drugs without determining medical necessity may be a violation of the Medical Practice Act and Texas Medical Board Rules.
TMB Regulations Limit the Scope of Standing Delegation Orders
The Texas Medical Board has strict guidelines for standing delegation orders and standing medical orders, including the types of medicines that may be provided.
TMB rules define a standing delegation order as “written instructions, orders, rules, regulations, or procedures prepared by a physician and designed for a patient population with specific diseases, disorders, health problems, or sets of symptoms.”
The scope of standing delegation orders are limited to “the administration or providing of drugs ordered by direct personal or voice communication by the authorizing physician who shall assume responsibility for the patient's welfare, providing such administration or provision of drugs shall be in compliance with other state or federal law.”
Pre-signed prescriptions may be utilized under certain conditions, including the condition that “the prescription shall be for one of the following classes or types of drugs:
- Oral contraceptives;
- Diaphragms and contraceptive creams and jellies;
- Topical anti-infectives for vaginal use;
- Oral anti-parasitic drugs for treatment of pinworms;
- Topical anti-parasitic drugs; or
- Antibiotic drugs for treatment of venereal disease.”
Physicians are encouraged to review existing TMB regulation, Chapter 193 – Standing Delegation Orders, for full guidance on the Texas Medical Board’s rules related to delegation and supervision requirements and responsibilities.
For more compliance shortfalls widespread among IV hydration business models, read our October 2023 blog article, “Physicians: Diagnose & Document Therapeutic Necessity For IV Hydration Treatments”.
Beware of Illegal IV Hydration Franchise Models
Whether starting on your own or investing in a franchise, beware of business models that offer IV hydration as a menu offering.
IV hydration is not the same as elective cosmetic procedures and is specifically excluded from Rule 193.17 Nonsurgical Medical Cosmetic Procedures. Cosmetic procedures are elective; IV hydration is intended to treat a diagnosed illness or condition. This means that prior to authorizing IV hydration, a physician is responsible for ensuring that it is therapeutically beneficial or necessary for the patient. It is not enough to screen for contraindications.
Have you invested in a medical franchise with an illegal business model? Contact our healthcare attorneys to discuss your options.
Is Your IV Hydration Business Compliant?
Physicians are ultimately responsible for protecting the welfare of their patients by only ordering medically necessary treatments, and by ensuring that all delegated medical acts are safely and properly provided.
If you have concerns about the compliance of an IV hydration business in which you participate, please contact the healthcare attorneys at Hendershot Cowart P.C. for a consultation. Our attorneys routinely review existing practices for compliance and set up new practices in compliance with Texas and federal regulations.