Intravenous (“IV”) therapy has been used to provide nutrition and for rehydration in hospitals and medical practices for decades. However, in this new day-in-age, IV therapy is also utilized to treat things such as hangovers, fatigue, flu symptoms, and jet lag. In July 2017, ByrdAdatto released an article titled “123s of IV Therapy Providers,” which discussed the growing business of IV therapy bars and major considerations when providing such services. This update revisits one of the major considerations, the corporate practice of medicine (“CPOM”), and expands upon compliance issues with the administration of IV services.
Corporate Practice Of Medicine
While this new innovation certainly has its benefits, businesses offering IV services must still be aware of the potential risks that come along with offering this therapy. First and foremost, one must understand that in most states the piercing of the outermost layer of the skin or the epidermis, and the rendering of fluids and vitamins via a compound, is the practice of medicine. As a result, when practicing medicine, a business must comply with its state CPOM position.
The CPOM doctrine is a legal doctrine, which generally prohibits corporations, entities or non-physicians from practicing medicine. Expanded, it prohibits lay people from owning medical clinics and employing physicians. Each state has its own position with respect to this doctrine where some can be strict, meaning only physicians can own the medical clinic, non-existent, allowing anyone to own a medical practice (although there is still an interference prohibition), or in between allowing for joint ownership by other healthcare providers or non-professionals. For example, in California if providing IV therapy, it must be rendered through a medical corporation, and at least 51% must be owned by a licensed physician(s) and the other 49% may be owned by one or more allied health professionals. These “allied health professionals” may be either a, physician assistant (“PA”), nurse practitioner (“NP”), registered nurse (“RN”), or other practitioners specified. However, the number of non-physicians cannot exceed the number of physicians. In New York, an entity rendering IV services, must be 100% owned by a physician, or a group of physicians.
Not all states have adopted these same ownership restrictions or recognize the CPOM prohibition. For example, in Florida, both physicians and non-physicians may own a medical entity. However, in order to preserve the physician-patient relationship in an entity that is owned by non-physicians, Florida requires the employment of a physician as the medical director. Additionally, the medical services must be rendered only by licensed practitioners and non-physicians cannot interfere with the professional judgment of the physician.
To add to the complexity, in some states a NP has independent autonomy, which can be confusing as to how this impacts the professional medical services rendered in the state (Please see the following articles for more information on NP independent autonomy – California Temporarily Amends NP Supervision Requirements to Address COVID-19 Pandemic; Massachusetts Removes Barrier for MedSpa Ownership By Nurse Practitioners; and Illinois Adopts final rules for Full Practice Authority for Advanced Practice Registered Nurses).
Besides CPOM, another critical compliance issue is the chain of care of the patient that must be consistent with the diagnoses and treatment requirements of the particular procedure because the practice of medicine is occurring. Once an entity has been established in accordance with the applicable state laws, to render IV services, the next part of the equation is to determine if the patient (or customer) is a good candidate for the services. As such a “good faith exam” or initial evaluation must be conducted prior to rendering of any services. In most states, a physician, PA, or NP (note – both the PA and NP may be subject to applicable supervision and delegation rules) may perform the good faith exam. After the good faith exam is conducted, either the physician, PA, or NP will prescribe a course of treatment and will have the ability to delegate the performance of the treatment to a non-physician provider.
The non-physician provider can be the PA, NP, RN, and in some states a licensed practical nurse (“LPN”) or a licensed vocational nurse (“LVN”). Only a few states allow the administration of IV fluids by a person other than those listed, such as emergency medical technicians or paramedics, in a medical clinic.
Once delegated to the non-physician provider, the prescribing provider must meet the applicable supervision rules. These rules can vary from the prescribing provider being on site, to the prescribing provider being immediately available in case of emergency.
For example, in California, a RN may administer the IV therapy under the supervision of either a physician, PA, or NP. A LVN will be considered competent to start and superimpose IV fluids via a primary or secondary line if they have completed either a nursing board approved intravenous therapy course, or submitted certification to prove that the LVN has the knowledge, skills, and abilities to safely administer IV services.
In New York, it is similar to California, but a LPN must be under the direct supervision of a physician, PA, NP, or RN. Further, in order for a LPN to administer IV services, they must have taken the appropriate IV therapy course training.
In Florida, there are similar restrictions as New York and California for the administration of IV therapy.
One of the most important takeaways from these rules and regulations is to remember that just because a provider may be qualified to administer IV services, this by itself does not mean the provider can form and own an IV bar or business performing IV therapy. Each state has its own rules and regulations outlining who may do what and who may own what. Be sure to check your states requirements before you start.
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