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Florida House Bill 725 Introduces New Requirements for Administering IV Hydration Therapy under the Stephanie Balais Act

IV Hydration Vitamin treatments have taken the world by storm in recent years. This alternative medicine practice has gained popularity since the COVID-19 pandemic. It promises to boost the immune system in a post-pandemic world where everyone has developed elevated attentiveness to their bodies and wellness. Certain IV therapies are widely promoted to treat conditions such as fatigue, dehydration, fibromyalgia, asthma, migraines, and more. The ‘Myers Cocktail’ has been coined as one of the most popular mixtures claiming to “heal” patients from many ailments such as those listed above. It was named after the pioneer of IV Hydration, John Myers, who founded IV Hydration treatments in the 1960s. This cocktail is only one of countless mixes used for IV Hydration treatments.

Although popularity has spiked in IV Hydration recently, not much progress has been made to regulate procedures and care for those seeking these treatments. These IV treatments are executed in various settings (i.e. home or place of residence) by various providers (e.g. RNs, LPNs, APRNs, M.D.s, etc.). While there are definitive rules about who can administer an IV therapy treatment, there are not many protocols on emergency care. As with any wellness or medical treatment, there is always some level of risk to be considered beforehand. These risks include but are not limited to vitamin toxicity, infection, and nutritional imbalances.

After the unfortunate death of a young, aspiring nursing student in South Florida (Ms. Stephanie Balais) Florida Representatives filed House Bill 725. It is cited as the “Stephanie Balais Act”. In the products liability case of Stephanie Balais it is noted that her untimely passing was due to a Selenium treatment she received in 2018. It is unclear whether the fault lie with the manufacturer and the batch of products; the individual administering the product; or the lack of established procedures in the event of an emergency.  Liability was never determined in this case, and the case was settled out of court. However, this case prompted the introduction of House Bill 725.

The Act defines Intravenous Hydration Therapy as “a procedure in which high concentrations of vitamins and minerals are administered directly into the person’s bloodstream, allowing rapid absorption of higher doses of the vitamins and minerals than if received through food or supplements”. The prospective rule seeks to require the Board of Nursing to clearly define procedures to: (1) safely administer such treatments; (2) educate those administering treatments; and (3) create protocols for emergency situations. The Act also requires the following:

  • Completion of a Florida Department of Health self-screening risk assessment questionnaire from a patient prior to administering IV Hydration treatments;
  • Notifications to the patient’s designated physicians that an IV Hydration treatment has been administered and documentation regarding the process;
  • Enhanced emergency care plans for the facilities offering treatments, which must be written and kept at the location offering IV Hydration treatments;
  • Patients are also to be provided instructions detailing when to seek medical attention and information on the risks and side effects associated with the treatment being performed; and
  • Patients must receive a visit summary.

The purpose of the Act is to ensure the safety of patients considering IV Hydration treatments. Due to the rise in popularity and frequency of these treatments, it has become necessary to create safety guidelines to eliminate or at the very least minimize risks for the healthcare and wellness community. This is why any written emergency plan must at a minimum include: (1) the name and address of the hospital closest to the location where the IV Hydration Treatment is being performed; (2) reasons why an emergency transfer may be obligatory; and (3) the medical services that must be utilized in the event of a medical emergency. Additionally, if a health care provider, upon review of the completed self-screening risk assessment questionnaire determines that a patient can’t safely receive an IV Hydration Treatment the provider must decline administering the treatment to that individual.

We will have to wait to see how the IV Hydration business will be impacted moving forward. Violation of this Act will result in disciplinary action for the physicians and nurses who are providing IV Hydration Treatments to their patients. The act was set to become effective on July 1, 2023 but died in Congress. This Bill is not effective and the proposed requirements do not have to enforced by healthcare practitioners.

For more information on IV Hydration, please read our previous article,  Establishing A Mobile IV Therapy Clinic in Florida. 

IV Hydration Masterclass: Legal Requirements of Starting an IV Hydration Business

 

 

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Establishing A Mobile IV Therapy Clinic in Florida

Recently, I’ve received several inquiries from doctors, nurses and healthcare entrepreneurs who are considering opening mobile intravenous therapy clinics throughout Florida but have some legal concerns. In the past, there weren’t many Florida laws enacted to significantly regulate IV therapy clinics whether mobile or not and not much has changed over the years. Florida doesn’t have corporate practice of medicine limitations which is attractive for many of these individuals.

What is Intravenous Therapy?

The administration of intravenous (“IV”) therapy is defined as the therapeutic infusion and/or injection of substances (i.e. supplements, vitamins and minerals) through the venous peripheral system, consisting of activity which includes observing, initiating, monitoring, discontinuing, maintaining, regulating, adjusting, documenting, planning, interviewing and evaluating. It involves the administration of medication through a needle or catheter. It is believed by some that delivering medication directly into the bloodstream can help to quickly manage a patient’s pain or symptoms. In addition to treating illnesses, IV therapy proponents claim that it may also increase athletic performance, reduce jet lag, build immunity or help with dehydration by using vitamins and minerals. According to several practitioners, IV therapy should be customized for each patient’s needs to maximize results.

What is a Mobile IV Therapy Clinic?

A license issued by the Agency for Healthcare Administration (“Agency”) is required to operate a clinic in Florida. Each clinic location must be licensed separately regardless of whether the clinic is operated under the same business name or management as another clinic. In Florida, a clinic is an entity where health care services are provided to individuals and which tenders charges for reimbursement for those services, including a mobile clinic and a portable equipment provider. A mobile clinic means a movable or detached self-contained health care unit within or from which direct health care services are provided to individuals. Each mobile clinic must obtain a separate healthcare clinic license and must provide to the Agency, at least quarterly, its projected street location to enable the agency to locate and inspect the clinic.

Additionally, a home infusion therapy provider must be licensed as a home health agency or nurse registry. Nurse registries can refer nurses to patients to provide home infusion therapy. “Home infusion therapy provider” means an organization that employs, contracts with, or refers a licensed professional who has received advanced training and experience in intravenous infusion therapy and who administers infusion therapy to a patient in the patient’s home or place of residence. “Home infusion therapy” means the administration of intravenous pharmacological or nutritional products to a patient in his or her home.

A healthcare professional licensed as an acupuncturist, medical doctor, osteopathic doctor, nurse, midwife, speech pathologist, occupational therapist, physical therapist and others, whether or not incorporated, are exempt from the licensure requirements of Florida Statute 400.464 if they are acting alone within the scope of his or her professional license to provide care to patients in their homes.

The application for a healthcare clinic license must include information pertaining to the name, residence and business address, phone number, social security number and license number of the medical or clinic director of the licensed medical providers employed or under contract with the clinic.

Who Can Provide IV Therapy?

Most Florida licensed medical doctors, osteopathic doctors, dentists, registered nurses, medical assistants, and licensed practical nurses may provide iv therapy to patients if they possess the appropriate certifications and training. Several of these practitioners must complete a required 30-hour IV certification course. Regardless of who you hire to provide IV therapy they should have several years of experience with administering IVs.

1. Emergency Medical Technicians and Paramedics

Some have inquired about the appropriateness of hiring an emergency medical technician (“EMT”) or a paramedic to administer IV therapy to the clinic’s patients. Florida law makes a clear distinction between what types of services an EMT and paramedic may provide. An EMT is defined as a person who is certified by the Department of Health to perform “basic life support”. A paramedic is defined as someone who is certified by the DOH to provide basic and advanced life support. Paramedics hold a certificate of successful completion in “advanced cardiac life support” from the American Heart Association (“AHA”) or its equivalent, whereas EMTs are only required to hold a current AHA cardiopulmonary resuscitation course card. This distinction between basic and advanced life support is important. Florida law states that Advanced life support means assessment or treatment by an appropriately qualified individual to use techniques such as endotracheal intubation, the administration of drugs or intravenous fluids, cardiac monitoring and cardiac defibrillation. Basic life support means the assessment or treatment by a person qualified to use techniques as described in the EMT-Basic National Standard Curriculum or the National EMS Education Standards of the USDOT, which includes the administration of oxygen and other techniques. The DOH has taken action against several IV clinics, which were identified as posing a potential health threat to Florida’s residents and visitors. DOH investigators have issued several cease and desist notices to paramedics and EMTs for operating outside their scope of practice for practicing medicine without the proper license.

2. Medical Assistants

Medical Assistants involved in the performance of IV therapy must receive training and certification in IV procedures. All IV therapy provided by a medical assistant must be done under direct supervision of a practitioner who is trained and has experience in the administration, potential side effect and complications related to IV therapy. If services are provided in an office setting (or mobile clinic) the experienced practitioner should always present in the office whenever a medical assistant is providing IV therapy to a patient. In a Florida Board of Medicine case, the Board held that medical assistants may lawfully perform IV infusion therapy as long as it is performed under the direct supervision and responsibility of a Florida licensed physician that is always present in the office whenever a medical assistant is providing the therapy to a patient.

3. Licensed Practical Nurses

Aspects of IV therapy may be outside the scope of practice of a licensed practical nurse (“LPN”) unless under the direct supervision of the registered professional nurse or physician and which shall not be performed or initiated by the LPN without direct supervision include the following:

          • Initiation of blood and blood products;
          • Initiation or administration of cancer chemotherapy;
          • Initiation of plasma expanders;
          • Initiation or administration of investigational drugs;
          • Mixing IV solution;
          • IV pushes, except heparin flushes and saline flushes.

With the exception of those aspects of IV therapy deemed outside the scope of practice of the LPN, and subject to the approval of the institution at which the LPN is employed, any LPN who meets the competency knowledge requirements is authorized to administer intravenous therapy under the direction of a registered professional nurse. “Under the direction of a registered professional nurse” means that the registered professional nurse has delegated IV therapy functions to a qualified LPN. The registered professional nurse does not in all instances have to be on the premises in order for the licensed practical nurse to perform the delegated functions. Direct supervision means on the premises and immediately physically available. Only license practical nurses that have met the education and competency requirement in state nursing rules can provide infusion therapy.

Who Pays for IV Therapy?

The overwhelming majority of mobile IV therapy patients will be self-pay. Medicare, Medicaid and commercial payors typically won’t cover the costs for these treatments. However, I have seen reports where commercial payors may utilize specific per diem codes to pay certain infusion providers for services, supplies and equipment. Medicare has limited coverage for home infused drugs under the Part B and Part D benefit when it is medically justified.

Other Considerations

As a medical provider you must anticipate that medical emergencies may emerge even during the most routine situations. Providers should have adequate insurance coverage for claims arising out of injury to or death of a patient and damage to the property of others resulting from any cause for which the owner of the mobile IV clinic would be liable. In lieu of malpractice insurance, a provider may furnish a certificate of self-insurance as evidence that the provider has established adequate self-insurance to cover these types of risks.

Because IV injection involves direct access into the patient’s circulatory system, sterile equipment and sterile technique must be used to avoid the introduction of any pathogens into a patient’s bloodstream. The practitioner must inspect vials for signs of contamination such as particulate matter, cloudiness, or inappropriate color. The practitioner must use a sterile alcohol wipe to cleanse the top of the vial and withdraw the fluid form the vial using a sterile needle and a sterile syringe. Practitioners must follow Universal Precautions, as described by the Occupational Safety and Health Standards (“OSHA”). To ensure safe and proper administration of infusion drugs you should consider providing some of the following services:

      • Patient Assessment
      • Drug interaction monitoring
      • Patient education
      • Patient monitoring
      • Car planning
      • Maintenance of storage, preparation, dispensing and quality control of all infusion medications and equipment.

I would advise against treating individuals under the influence of alcohol, suffering from congestive heart failure, history of aneurysms, kidney or renal disease and high blood pressure. Patients should also be 18 or older and valid written consent forms should be signed by every patient.

You must have a medical director who is employed or contracted by the clinic licensee and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training. Additionally, a health care practitioner may not serve as the clinic director if the services provided at the clinic are beyond the scope of that practitioner’s license.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

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