By Bradford E. Adatto, JD, ByrdAdatto

Intravenous (IV) therapy services have been a growing rage in the elective medicine space for the past few years. Existing medical spas and wellness centers have moved to add the services, and there has been an explosion of standalone IV bars opening around the country. Like most elective services in the space, ByrdAdatto has noted that IV therapy falls within the practice of medicine, and medical providers must place themselves in a compliant position to reduce the potential risks that come along with offering this therapy.

Historically, IV therapy has been like the wild west from a compliance perspective. Practitioners with different backgrounds and significant training on placing IVs have resisted the idea that IV therapy services would be treated as the practice of medicine. Alabama first issued a definite ruling that sought to provide the clarity needed in this space in November 2022. The ruling clarified different practitioners’ roles in administering IV therapy. Additionally, the ruling addressed core health care compliance issues associated with IV therapy that purportedly concerned the Alabama Board of Medical Examiners (BME). While once an outlier, Alabama’s ruling is now one of many, as more states have taken steps to provide clarity to the compliance issues surrounding IV therapy.

Alabama

On July 21, 2022, the Alabama BME issued a declaratory ruling to address the growing business of retail IV therapy. The BME conducted a statewide investigation on retail IV therapy businesses and found that a substantial number of these businesses were not compliant with Alabama law. The BME found that medically unqualified or underqualified individuals were administering IV treatments without the proper oversight of a physician. This declaratory ruling clarified the regulations on the administration of IV therapy and addressed whether providing IV therapy constitutes the practice of medicine under Alabama law.

The ruling answered the following questions:

Does administration of IV therapy constitute the practice of medicine in Alabama? Yes. Under Alabama law, the diagnosis of a patient’s condition and the recommendation of IV therapy constitutes the practice of medicine.

Who can diagnose IV therapy in Alabama? Only a licensed physician or a physician assistant (PA), certified registered nurse practitioner (CRNP) or certified nurse-midwife (CNM) legally practicing with a physician may diagnose a patient, assess their symptoms and recommend an IV for the treatment of the patient’s condition. Often, this is called the good faith exam (GFE) in the medical industry.

Can a registered nurse (RN) diagnose IV therapy? No. Medical diagnosing is outside the scope of practice for an RN. The issuance of “standing orders” by the physician for the RN to follow does not satisfy the physician’s legal duties to the patient.

Can an RN administer IV therapy? Yes, an RN can administer IV therapy after the GFE has been conducted by the appropriate medical provider.

What steps must retail IV therapy businesses take to be in compliance? To comply with Alabama law, retail IV therapy businesses must:

1. Perform the GFE (this may occur in person or utilizing telemedicine);
2. Create a medical record for the patient; and
3. Issue a prescription* prior to administering IV therapy.

*Assuming that the physician, PA, CRNP or CNM diagnosed the patient and is prescribing IV, they have determined it will benefit the patient.

Since this ruling was issued, other states—such as Mississippi, South Carolina, North Carolina, South Dakota, Oklahoma and Florida—felt the need to address this growing issue as well.

Mississippi

Following Alabama’s lead and addressing its concern with the “proliferation of retail IV hydration therapy,” the Mississippi State Board of Medical Licensure issued its guidance concerning IV hydration therapy. The board clarified that IV hydration therapy is undoubtedly considered the practice of medicine in Mississippi and IV fluids are legend drugs that must be purchased using a practitioner’s DEA number. The board also stated that a practitioner with prescriptive authority must establish a valid practitioner/patient relationship before prescribing IV fluids. The guidance specifically reminded medical directors of their role: to ensure that each task is completed by a qualified person. Attempting to circumvent this requirement using standing orders is undeniably grounds for discipline.

This guidance was in direct response to the recent numerous inquiries concerning the legal requirements and limits for IV hydration spas and clinics. The board further stated, “the number of inquiries received is concerning, because this is NOT a complex issue.”

South Carolina

In South Carolina, the concern surrounding IV hydration was not just that of the medical board—the South Carolina Board of Pharmacy, South Carolina Board of Nursing, and South Carolina Board of Medical Examiners collectively came together to issue a 10-page joint advisory opinion addressing the retail IV therapy business model and the various issues related to it, including the Medical Practice Act, the unlicensed practice of medicine and providing medical services outside of an RN’s scope of practice. Because this area is rapidly growing in South Carolina and across the country, all three boards aim to protect the residents of South Carolina from harm by issuing this opinion.

The opinion states that there is no question that the services being provided by IV retail clinics constitute the practice of medicine. Because IV therapy is the practice of medicine, scenarios where an RN is the only licensed health care professional interacting with the patient or present at the facility are “unacceptable and unlawful.” Furthermore, only a physician, PA or nurse practitioner (NP) is allowed to diagnose, treat, correct, advise or prescribe IV fluid to a person.

Additionally, a valid practitioner/patient relationship is absolutely required in South Carolina before prescribing an IV therapy treatment. The opinion states that “without an evaluation by a physician or practitioner to create a physician-patient relationship, the RN is dispensing medical supplies and medications to a person who is not the physician’s patient.” Failure of a physician, PA or NP constitutes unprofessional conduct and can result in disciplinary action.

The opinion also cautions practitioners that mixing substances for these IV therapy treatments can constitute compounding. Compounding is defined as the process by which a properly trained person combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Most states take the position that mixing IV therapy solutions constitutes compounding. Compounding is heavily regulated both on state and federal levels, and strict compliance by providers who wish to compound is required. The South Carolina boards state that compounding must result from a valid practitioner’s order in the course of professional practice, and not from a patient-driven menu “akin to a fast-food restaurant.”

North Carolina

In North Carolina, the Board of Nursing took a different approach to the recent uptick in IV therapy clinics by issuing a position statement reminding RNs and licensed practical nurses (LPNs) of their role in performing IV therapy. While the statement does not explicitly state that IV therapy qualifies as the practice of medicine, it does state that it is within the scope of practice for a RN and LPN to administer IV fluids, nutrition therapies and medications, but only as authorized by a valid order prescribed by a physician, NP, PA or other licensed health care practitioner with prescriptive authority acting within the legal scope of practice.

South Dakota

The South Dakota Board of Nursing also issued an opinion clarifying the role of RNs and LPNs in “Elective Infusion and Medication Therapy Guidelines.” In this opinion, the Board of Nursing did not address whether IV therapy was specifically the practice of medicine, but it did state both RNs and LPNs may administer IV therapy in certain situations and clearly lays out what is within an RN’s or LPN’s scope of practice.

Oklahoma

The Oklahoma Board of Nursing made clear an LPN’s role in administering IV therapy by revising their guidelines in November 2022. This guidance addressed the supervision and delegation requirements, training requirements, and policy and procedure requirements.

Florida

Florida weighed in on IV therapy by amending its rules to clearly define exactly what an LPN may and may not do. However, Florida avoided the larger questions, such as IV therapy constituting the practice of medicine and who may administer IV therapy other than LPNs.

A nationwide movement toward the regulation of IV therapy

Alabama’s BME statement in 2022 kicked off an industry movement toward clearly addressing compliance issues and concerns with respect to IV therapy. While some states have addressed a plethora of compliance issues that present with IV therapy, others focus on other issues.

Regardless, this movement signifies that statements from other states, in some form, are likely on the horizon. Yet, even in states without a stated opinion, the consistency of the recent opinions is instructive of the compliance issues at play and the way licensing boards view retail IV therapy.

Your compliance partner for IV therapy regulations in your state

ByrdAdatto is working hard to ensure its clients are apprised of constantly changing laws and well equipped for operating their business. If you have questions regarding IV therapy compliance in your state, schedule a consultation with ByrdAdatto at info@byrdadatto.com.

ByrdAdatto is grateful for the significant research and drafting contribution to this article from its Law Clerk, Clint Nuckolls, a third-year student at SMU Dedman School of Law who will be working for ByrdAdatto upon graduation.

Bradford E. Adatto, JD, has a background in regulatory, transactional and securities law. Having worked in health care law his entire career, he has an in-depth knowledge of the “dos and don’ts” of this heavily regulated industry. Adatto has worked with physicians, physician groups and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral and private securities laws.