What to know about providing IV therapy
Intravenous (or “IV”) therapy may have begun as a trend, but this service is now well-grounded within wellness culture and is here to stay. In most city centers, drip bars have become ubiquitous alongside medical spas and wellness clinics, offering various “cocktails” to boost hydration, energy, and immunity. Along with IV therapy come new questions about compliance and regulations.
While IVs are not at all new to medicine, offering them on menus as an “elective” treatment is a recent phenomenon that has exposed gray areas of the law. Therefore, state and federal regulators have begun to issue warnings and advisory opinions about IV therapy in rapid fashion.
In this article, we offer insight into some of these legal gray areas and frequently asked questions about IV therapy.
Everything you need to know about IV therapy and compliance:
Is IV therapy considered the practice of medicine?
Should IV therapy be treated differently than other procedures at medical spas?
Can providers offer IV therapy on a menu?
What do I need to know about compounding (mixing the bag)?
How are state and federal regulators cracking down?
What protocols should practices offering IV therapy have in place?
Is IV therapy considered the practice of medicine?
Yes. IV therapy is considered the practice of medicine in every state. Therefore, any provider offering IV therapy will need to abide by their state’s corporation practice of medicine (“CPOM”) and scope of practice laws. Every state’s CPOM position will impact who is allowed to own the clinical entity offering IV therapy. Here’s an example from the Medical Board of California:
“Because the operation of a medical spa or mobile IV hydration infusion therapy business in California is the practice of medicine, a Professional Medical Corporation must be formed. Under California law, a physician must either own [at least 51% of] the practice, or must be employed or contracted by a physician-owned practice or a medical corporation.”
In addition, a state’s scope of practice regulations will dictate which providers can make a diagnosis and recommendation for IV treatment. The Alabama Board of Medical Examiners recently stated:
“[T]he diagnosis of the patient's condition and recommendation of IV therapy constitutes the practice of medicine. Only a licensed physician, or a PA, CRNP, or CNM legally practicing with a physician, may diagnose a patient, assess their symptoms, and recommend an IV for the treatment of a patient's condition.”
Should IV therapy be treated differently than elective procedures?
Regulators are concerned that retail hydration therapy businesses have been operating without understanding that IV therapy constitutes the aforementioned practice of medicine. Rather, some practices are offering IV therapy as a retail, elective procedure that patients can order without the recommendation of a physician.
According to the Mississippi Board of Medical Licensure, some IV practices lack the “qualified staff legally authorized to perform the necessary tasks and satisfy minimum statutory and regulatory requirements.” Often, physicians associated with the practices are not located near the premises, nor have they established the proper provider-patient relationship as part of the Good Faith Exam (or “GFE”) process.
In Texas, IV therapy is not considered an elective procedure and is excluded from a list of elective medical cosmetic procedures. In the Lone Star State, a physician has to ensure it’s “beneficial” or “necessary” to the patient. Positions like this one emphasize the importance of a healthcare provider’s input in the process of diagnosing and treating with IV therapy.
To that end, here are a few important reminders for practices offering IV therapy:
Establish a Provider-Patient Relationship through a Good Faith Exam: State and federal regulators emphasize the importance of creating a provider-patient relationship prior to treating a patient with IV therapy. That means it is essential to conduct a GFE prior to recommending an IV to a patient. The GFE and patient-physician relationship should also dictate the patient’s recommended mixture. You should not rely solely on a patient’s choice from a menu. (We’ll cover that later in this article.)
Ensure Only Properly-Licensed Providers Administer IVs: After a prescribing provider has recommended the appropriate treatment, medical providers including PAs, NPs, RNs, and in some states an LPN or LVN, can administer the IV. Be sure to thoroughly review your specific state’s guidelines.
Can I offer IV therapy treatments through a menu?
It is not unusual for IV lounges and clinics to offer patients a menu of various IV cocktails. Patients can choose from fat burners, hangover cures, immunity boosters, and more. And while this might be a great way to showcase your offerings, ordering an IV is not exactly like ordering a smoothie. Certainly not in the eyes of regulators.
For practices who do choose to offer IV menus, we urge you to make sure you have the proper protocols in place to keep your patients safe and practice compliant. That includes (once again) a Good Faith Exam to understand a patient’s medical history and other medications to identify potential risks and contraindications. A qualified healthcare provider should always have the final say on whether or not a patient qualifies for treatment. In addition, we always recommend thoroughly documenting a patient’s informed consent. A patient requesting a treatment does not release a provider from responsibility, nor will it suffice as a defense in a board action against a provider’s license.
Regulations around compounding, cocktails, and mixing the bag
As we spoke about in the context of medical weight loss drugs, compounding is another gray area related to IV therapy. Who is authorized to mix an IV cocktail, a compound of saline, various vitamins, peptides, and other ingredients? Some practices have taken this lack of clarity into their own hands, compounding cocktails within the four walls of their practice. We urge practices to proceed with extreme caution, as there are many legal and health risks associated with compounding.
Because there is so much variation from state to state, we recommend consulting with your attorney for more specific guidance for your practice. Your state’s Board of Pharmacy will be the authority on compounding, however you will have to reconcile those regulations with that of the Board of Medicine and Board of Nursing (yes, that’s a lot of Boards!).
Below is a high level overview to provide insight for providers and practice owners in all states.
Who can compound?
Well as we like to say…it depends. See below:
Some states require all compounding to take place in compounding pharmacies.
In Louisiana, RNs and APRNs are prohibited from compounding IV solutions in all non-emergency circumstances.
In Maryland, while the Board of Pharmacy states that a compounding pharmacist must mix IV compounds under a hood and in a sterile environment, nursing regulations allow nurses to add medications to an intravenous solution, given the proper training. It is unclear how these two laws interact, adding to the frustration of providers seeking to remain compliant.
We recommend providers work with a state-authorized pharmacy and that they properly ensure compounds are created in sterile environments. For those states that allow for in-office compounding, it is once again critical to familiarize yourself with your respective state’s Board of Pharmacy and Board of Medicine (and/or Nursing) regulations.
FDA’s Warning on Compounding Under Insanitary Conditions
In 2021, the FDA issued a statement regarding the organization’s concerns about compounding of drug products by medical offices and clinics under “insanitary” conditions. The warning came after reports of adverse effects to patients and multiple case examples, from fungal infections to septic shock and multi-organ failure.
The FDA’s warning acknowledges that the organization does not know the extent to which drugs are being compounded at IV hydration clinics, but warns that there is a risk of product contamination when drugs are compounded, packed, or held under such conditions. The FDA concludes, “[s]terile compounding activities being performed by business entities such as IV hydration clinics present risk and require continued evaluation.”
Are state and federal regulators cracking down on IV therapy?
As IV therapy becomes mainstream, it is becoming apparent that there has been a lack of regulation in the space. This is concerning for providers, patients, and regulators alike–who all hope to create a safe treatment plan for patients.
When a woman in Texas died after receiving IV therapy, the Texas Medical Board cited a lack of protocols and supervision before restricting the Medical Director’s license. It brought even more awareness to the under-regulated space of retail IV therapy. We believe more state regulators will continue to weigh in with detailed guidance for providers and business owners with statements such as this from the Mississippi Board of Licensure:
To be clear and avoid any possible basis for misunderstandings:
(1) IV hydration therapy constitutes the practice of medicine.
(2) IV fluids are legend drugs that must be purchased using a practitioner's DEA number.
(3) Just as with any other medication, to satisfy legal and regulatory requirements, a practitioner with prescriptive authority must establish a valid practitioner/patient relationship, take an appropriate history, make a diagnosis necessitating IV therapy, develop a plan, and prescribe IV fluids for a specific patient.
(4) After such a lawful prescription has been issued, qualified personnel such as Registered Nurses may administer IV fluids and monitor a patient for potential side effects.
(5) Any IV hydration therapy practice or business model that does not satisfy these requirements is unlawful.
(6) Licensees of this Board must at all times remain mindful that neither a business nor business owner can lawfully exercise control over the manner in which a physician provides medical services, nor interfere with the independent exercise of a physician's medical judgment.
What protocols should businesses offering IV therapy have in place?
Ensure you understand your state’s position on Corporate Practice of Medicine and how that impacts who can own the IV therapy business, conduct a Good Faith Exam, and recommend treatment to patients.
Create standard protocols for your Good Faith Exam to which every provider in your practice must adhere. Develop a provider-patient relationship, and do not recommend IV treatment unless advised by a supervising physician.
Pay close attention to your state’s regulations on compounding and ensure that all “cocktails” are mixed in safe and sterile environments by authorized providers
Have a standardized operating procedures for the administration of IVs, policies, and protocols
Work closely with a legal team to stay up-to-date on state and federal regulation
Reach out to Marti Law Group for clear, state-specific legal guidance as you roll out IV hydration services. Our team of legal experts has conducted countless hours of research on this topic, and we’d love to protect your practice from potential risk.