Justin Marti, attorney and principal at Marti Law Group, explains why offering IVs on a menu as an elective treatment has exposed grey areas of the law.
Intravenous (or “IV”) therapy may have started as a trend, but this service is now well-grounded within wellness culture. 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.
In order to ensure compliance at your drip bar, IV lounge, or medical spa, make sure to put these protocols in place for your IV treatments:
- Abide by your state’s CPOM and scope of practice laws.
- Establish a patient-provider relationship through a Good Faith Exam.
- Let a provider (not a menu) determine if a patient qualifies for treatment.
- Practice safe and compliant compounding.
- Have standardized operating procedures for administration of IVs.
Abide by your state’s CPOM and Scope of Practice Laws
IV therapy is considered the practice of medicine in every state. Therefore, any provider offering IV therapy will need to abide by their respective state’s corporation practice of medicine regulations (“CPOM”) and scope of practice laws. Every state’s CPOM position will impact who is allowed to own the clinical entity offering IV therapy. In addition, a state’s scope of practice regulations will dictate which providers can make a diagnosis and recommendation for IV treatment. Here’s an example from the Alabama Board of Medical Examiners:
“[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.”
Both ownership and diagnosis are huge issues for providers wanting to offer IV therapy. It is imperative to understand how your state’s CPOM and scope of practice laws will influence potential exposure to liability of your business.
Establish a provider-patient relationship through a Good Faith Exam
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.
It is essential for providers to establish a provider-patient relationship through a Good Faith Exam (or “GFE”) prior to recommending an IV to a patient. Providers should have a thorough understanding of a patient’s medical history, and patients should understand potential risks. The GFE and patient-physician relationship should also dictate the patient’s recommended mixture.
Let a provider (not a menu) determine if a patient qualifies for treatment
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.
Here’s the bottom line: a qualified healthcare provider should always have the final say on whether or not a patient qualifies for treatment. 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.
Practice safe and compliant compounding
Compounding is a grey area of IV therapy regulation. Some practices have taken this lack of clarity into their own hands, compounding various 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?
As attorneys like to say: it depends.
- 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.
How can you compound?
We recommend providers work with a state-authorized pharmacy and that they properly ensure compounds are created in sterile environments. The FDA issued a warning about the risks of compounding under insanitary conditions after reports of fungal infections, septic shock, and multi-organ failure.
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.
Have standardized operating procedures for the administration of IVs
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. Lack of clear regulation, however, should not lead to a lack of clear protocols. We recommend your practice has standard operating procedures for:
- Conducting a Good Faith Exam
- Making recommendations for appropriate treatment
- Documenting a patient’s informed consent
- Compounding
- Administering the IV
We believe more state regulators will continue to weigh in with detailed guidance for providers and business owners. Some, like the Mississippi Board of Licensure, have already laid out clearer ground rules for IV therapy.