An IV or intravenous infusion hydration business offers hydration, vitamins, minerals and medications to patients. Particularly important for patients who cannot take in hydration or nutrients orally, such as some cancer patients, IV infusion hydration businesses also flourish in warm climates like Arizona and are popular among professional athletes and the wellness-minded.
An IV infusion hydration business provides a necessary service and can be a lucrative business opportunity for a qualified and interested party. However, for those interested in the opportunity, there are numerous legal and regulatory requirements that must be met, including ensuring appropriate business structure, licensing, medical oversight, and the necessary qualifications of staff ordering and administering IV hydration services.
Latest Updates to Arizona Laws Regarding IV Infusion Hydration Businesses
The Arizona State Board of Nursing issued an advisory opinion in September 2023 which states that an advanced practice registered nurse (APRN), registered nurse (RN), or licensed practical nurse (LPN) must demonstrate the necessary education, knowledge, judgment, skills, and licensure/certification, where applicable, to administer IV hydration, nutrient therapies, and medications. Moreover, the administration of such substances by IV must be pursuant to the valid order of a licensed provider with prescriptive authority and acting within their scope of practice (e.g. APRN, physician assistant, or medical doctor).
Orders for IV hydration must be individualized, and based upon the patient-specific needs with a medical rationale for the order. The Arizona State Board of Nursing also advised that the issuance of standing orders for elective IV therapies, including hydration, nutrients, or medications, by an APRN does not satisfy an APRN’s duties to a patient.
Compounded solutions (i.e. solutions which are a mixture of two or more drugs) may be administered by RNs, LPNs, and APRNs in Arizona, but cannot be compounded by them.
Legal Requirements and Regulations in Arizona
There are many legal considerations when it comes to opening up an IV hydration business in Arizona. From important licensing considerations to necessary compliance protocols, you need to ensure your business follows all legal requirements.
Licensing and Permits
IV hydration is a medical service and therefore a business that offers such services must obtain a health care institution license from the Arizona Department of Health Services. The only exemption from licensure is if IV hydration services are offered through the private office or clinic of a licensed healthcare professional. Otherwise, a health care institution license is required. Moreover, in most cases, those wishing to operate a mobile IV hydration business will be required to obtain a health care institution license from the Arizona Department of Health Services.
State Health Department Regulations
An IV hydration business will be required to follow all regulatory requirements of the Arizona Department of Health Services and applicable professional licensing boards (e.g. Arizona State Board of Nursing, Arizona Medical Board). Per the Arizona State Board of Nursing, a valid order from a licensed professional (e.g. a physician’s assistant, APRN, or medical doctor) is necessary for an APRN, RN or LPN to administer IV hydration. While a licensed professional may be able to issue this order via telehealth, all legal requirements for the evaluation, assessment and treatment of patients via telehealth must be met. In addition, an IV hydration infusion business that is not operated through the private office or clinic of a licensed health care provider must have a licensed medical professional on their staff as its medical director.
Local Health Department Permits
In order to operate an IV hydration infusion business, you may also be required to obtain a permit from your city’s local health department in Arizona.
Compliance with Medical Practice Laws in Arizona
After attaining all the necessary licenses and permits to operate an IV hydration business, there are important steps you need to follow to remain in compliance with Arizona laws.
1. Supervision by Medical Professional
A licensed professional with prescriptive authority acting within their scope of practice must issue a valid order for IV hydration therapies to be administered. The licensed professional also must also be available for consultation during the delivery of IV hydration therapies, though in some circumstances consultation via telehealth may be permissible.
2. Scope of Services
IV hydration therapies may only be administered pursuant to a valid order from a licensed professional. Orders must be individualized, and based upon the patient-specific needs with a medical rationale for the order. While some patients might need only hydration, others might be in need of compounded solutions that are fortified with vitamins, minerals, etc. It is important that a condition specific, individualized examination be conducted of any patient before IV hydration therapies are ordered. While nurses (APRNs, RNs, LPNs, etc.) are able to administer compounded solutions intravenously, they are not able to compound the solution itself.
Ownership & Choice of Business Entity
Anyone can own an IV hydration infusion business in Arizona, but they must have a licensed medical professional on staff as their medical director. There are different business types and ownership structures available including corporations, professional corporations, limited liability companies (LLCs), and professional limited liability companies (PLLCs).
There are significant differences between corporations and LLCs. To determine which type is right for you, it is recommended that you consult with a qualified professional such as an attorney or accountant.
In general, corporations are owned by its shareholders and they are managed by its officers and directors. LLCs are owned by its members and they are managed by a manager(s) or its members. There are extensive tax and liability differences between the two entity types.
Typically, licensed professionals, such as doctors, form professional corporations or PLLCs. You should check with the agency or board that licenses your profession to see if it requires you to form a professional corporation or PLLC, or if it prohibits you from forming a professional corporation or PLLC.
In addition, in Arizona, there are legal restrictions on who can own and control professional corporations and PLLCs. You should always consult with an attorney to ensure that your professional corporation or PLLC complies with legal ownership and control requirements.
Further Requirements for Owning an IV Hydration Infusion Business
IV hydration therapies are becoming an increasingly popular business model, but before you open one of your own, there are important requirements to keep in mind.
Medical Professional Requirements
All IV hydration infusion businesses must have a licensed professional with prescriptive authority on staff to assess and evaluate patients and issue valid orders for treatment. IV hydration must be administered by personnel with necessary education, knowledge, judgment, skills, and licensure/certification, where applicable.
That being said, so long as a licensed medical professional is on staff as a medical director of your IV hydration infusion business, anyone may own one.
Documentation and Record-Keeping for the State of Arizona
In order to stay compliant, it’s very important to maintain adequate documentation and record keeping. Because IV hydration is a medical service, a patient medical record must be maintained for each patient who receives services. In addition, it is crucial that appropriate informed consent be obtained before IV hydration services are administered. Patient records must be kept confidential as they fall under HIPAA regulations. Records must be maintained for at least six years from the last date an adult patient received medical services per Arizona law.
Maintaining proper business and compliance documentation is also important to help protect you and your IV hydration infusion business. It is important to keep organizational records, such as corporate bylaws, operating agreements, meeting minutes and resolutions. In addition, policies and procedures related to delivery of services, personnel requirements, standards for equipment and supplies, and safety and emergency standards must be maintained.
Emergency Preparedness
Emergency preparation is a vital and important part of any health care business. All IV infusion hydration practices must have appropriate medications, supplies and equipment on hand to counteract any of the potential adverse reactions that may occur when administering IV infusion hydration therapy. Additionally, there must be documented protocols in case of emergency and a medical professional available to respond to in the event of an emergency.
Staffing and Training
Every IV infusion hydration business in Arizona must have a medical director, as well as licensed medical practitioners who have the proper training to administer IV infusions. Non-medical staff can also receive training in hydration services.
We Can Help
While there are many moving parts to starting an IV infusion hydration business in Arizona, with a comprehensive business plan and experienced legal counsel, there is ample profit to be made in this trending new industry. Ensuring you have the proper organizational structure, including medical oversight, personnel, and policies and procedures will set you up for success in your new business venture.
Because this is a new industry, staying up to date on the latest regulatory decisions in Arizona is also of utmost importance.
Goldberg Law Group offers a team of highly experienced health care lawyers that can guide you through every step of your IV infusion hydration business. For more information about how Goldberg Law Group can assist with your IV infusion hydration business, use our contact form linked below.