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Regulation of IV Hydration Therapyis on the Rise

In Florida, physicians and non-physicians are permitted to own a medical entity, which includes intravenous hydration businesses. Also in Florida, licensed medical doctors, osteopathic doctors, physician assistants, advanced nurse practitioners, registered nurses and arguably paramedics are permitted to administer IV therapy to patients.

Physician supervision requirements come into play when any midlevel professionals (anyone other than an MD or DO)is the one administering IV therapy to patients. It is crucial that owners develop, and all staff members attest to policies and procedures that govern the administration of IV therapy, including the documentation of what level of supervision is required for different types of professionals who administer different variations of IV’s, how compliance with the requisite supervision will be internally documented, as well as the implementation of emergency protocols in emergency situations.

The failure to do so not only places patients at risk, but also creates major issues for providers from a compliance standpoint, which can result in professional discipline, as well as potential administrative and civilliability.
A Texas physician recently failed to properly supervise a non-physician owner of a MedSpa (and an unlicensed individual) during the administration of IV therapy, which included prescription pharmaceutical solutionsthat resulted in complications in which the MedSpa staff was not trained or prepared to manage.

This resulted in not only the patient’s death, but the temporary suspension of the professional license of the physicianwho was responsible for supervising the unlicensed owner.Accordingto the TemporarySuspension Order, the MedSpa did not have any protocols, policies or procedures pertaining to the administration of IV Therapy in place.

Invoices from a pharmaceutical company listed the physician as the regulatory license for the facility, which enabled the MedSpa to order prescription solutions using (the physician’s) credentials.However, there was a lack of documentation with respect to compliance with state regulations that govern IV therapy and who is permitted to administer them nor were there emergency protocols in place to address such a situation.
Regulation of IV hydration is on the rise across the US.

Providers either need to define and implement “quality,” or it will be defined FOR them by regulators with little or no experience addressing the industry. Clinicians working in IV hydration may be relieved of the intense regulatory pressures of former employment venues (e.g., hospitals, SNFs and ALFs), but the clock is ticking now for clinics to self-regulate in a very specific way, ideally under attorney-client confidentiality.