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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.

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.

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

Jamaal Jones

jrj@joneshealthlaw.com

This post was authored by Jamaal R. Jones, Esquire (Partner) of Jones Health Law, P.A. where we provide "On-Call Legal Services to Healthcare Professionals". For more information contact us at (305) 877-5054; email us at JRJ@JonesHealthLaw.com, or visit our website at www.JonesHealthLaw.com

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sasha ikramelahai
sasha ikramelahai
4 years ago

So can. Emt open an iv mobile infusion business?

Amanda
Amanda
3 years ago

I am confused as well I am a registered medical assistant trained in emergency medicine and iv’s can I open one?

sasha ikramelahai
sasha ikramelahai
4 years ago

Can a Emt open a iv infusion center

Burgos
Burgos
3 years ago

I am looking to start my own business as well. I am however looking for a partner. I am a Family Nurse Practitioner. If you’re interested in possible starting it together- contact me and maybe we can use Jones as our lawyer burgosfamily07@gmail.com

Flobrenne Joseph-Spaulding
Flobrenne Joseph-Spaulding
3 years ago
Reply to  Burgos

Hi, I’m looking to partner up with a practitioner to open a IV hydration clinic. I would love to talk to you more about this.

Brenda Ramirez
Brenda Ramirez
3 years ago
Reply to  Burgos

What part of Florida are you in?

Faith Baker
Faith Baker
3 years ago

Can a nurse Practitiner be the medical director/clinical director?

Christina Bennett
Christina Bennett
2 years ago

Now that statue 464 gives qualifying Primary care NPs autonomous practice, would that not allow autonomous NPs the ability to be medical/clinical directors for IV therapy?

James
James
3 years ago

Your distinction between Paramedics and EMT’s needs to be reviewed. All properly certified Paramedics including both the EMT-P designation from the state and the NRP certification from the National Registry have a scope of practice that qualifies them to initiate IV therapy, administer pharmacological interventions, and monitor patients for therapeutic response.

EMTs cannot, Paramedics can.

Lisa
Lisa
3 years ago

Jamal: out of curiosity, are you saying RNs can prescribe and administer infusions without a provider (MD, DO, PA, NP) order?

Russ
Russ
1 year ago
Reply to  Lisa

If the infusion is vitamins and saline, I don’t see why not. I don’t think they are going to be able to call the pharmacy and order Vancomycin or other IV administered drugs. (not a lawyer)

LEE
LEE
1 year ago
Reply to  James

I read that Paramedics can only work under medical direction for emergency services. They can’t provide Infusions for a private clinic. All this information is provided I believe under the Florida Department of Health. So, Paramedics would be in violation if performing outside of FDOH statues. This is unfair but they make the rules.

Alexis
Alexis
3 years ago

I am a registered nurse and I am looking to open a mobile IV hydration business. I have a physician who has agreed to partner with me. I want to make the business an LLC. My question is does the physician have to be a part business owner to be covered by my business insurance I obtain? If he is my medical director but not a business owner, would the business insurance still cover him from liability or would he have to be covered separately?

Cynthia
Cynthia
3 years ago

Hi
I’m a physician assistant looking into opening a mobile infusion business. Am I allowed to provide the IVs or can I get an RN to do them? Does she need a special certification?
I’m assuming I still need a medical supervisor . Does he have to be co-owner?

Miranda
Miranda
3 years ago

Hi I’m Looking to start Mobile IV and looking to partner up with A practitioner in the Tampa FL area. I have been doing IVs for a while now and wanting to branch out on my own contact me if interested 🙂 mirandaklenja@icloud.com

Ola Thomas
Ola Thomas
1 year ago
Reply to  Miranda

I am a registered nurse interested to start iv dehydration clinic and looking for someone to partner. I lived in orlando

Rose Jonka
Rose Jonka
1 year ago
Reply to  Ola Thomas

Hi looking to partner with someone if only you was in Port st Lucie

Beth S.
Beth S.
1 year ago
Reply to  Rose Jonka

I am in PSL ,just found this do u still need a partner ?

McCaela
McCaela
1 year ago
Reply to  Beth S.

I am just north in Satellite Beach. Are you a practitioner? I am an RN and am interested in finding a partner.

Mallissa
Mallissa
11 months ago
Reply to  Ola Thomas

I’m an LPN who’s also located in Orlando. I’m looking to partner up to start an IV hydration clinic. Please let me know if you’re interested in teaming up. You may reach me at “MALLISSAFAUSTIN@yahoo.com”

Cynthia Remy
Cynthia Remy
2 years ago

Hi So I am a license Nurse Practitioner so I wanted to know if I was able to start a mobile IV hydration service?

Anna Marie Di Santi
Anna Marie Di Santi
2 years ago

I am an RN. Do the clients need a presciption for the IV solution in order for me to deliver it? If so then do they need a brief history and physical from an MD or NP to get the prescription? Please advise.

Rhonda
Rhonda
2 years ago

Hi
I’m a Registered Nurse in NYS and would like to relocate and partner up to open a business. Anyone interested reach out at knkliv@gmail.com

Christie Kennedy
Christie Kennedy
2 years ago

Does a Nurse Practitioner with autonomous practice need a collaborative MD to run their own mobile or office IV hydration business?

Eve
Eve
2 years ago

I didn’t see anything mentioning Respiratory Therapist. Why not?

Las Vegas Mobile IV Therapy
Las Vegas Mobile IV Therapy
2 years ago

It is so important to know and follow the applicable state and federal laws that apply to the IV therapy industry. Thanks for posting this. Maybe i will do the same for my state. You are a good influence on the industry!

Jheanelle
Jheanelle
2 years ago

Jamaal,
On ACHA’s website do I obtain license for home health agency or nurse registry. Also, is this the very first step?

Thanks

Marin Mobile IV Therapy
Marin Mobile IV Therapy
2 years ago

Thank you for providing this thorough article on the benefits of iv infusions. We just opened up our own practice in Marin, CA, and are currently hiring RN nurses to provide services to our clients in their homes.

Yoe Estevez
Yoe Estevez
2 years ago

Please I’m a Registered Nurse in Florida. I will like to operate a home IV therapy business. Please advise on steps and requirements needed.

richard eckert
richard eckert
2 years ago

Hi Jamal! Could you kindly contact me directly so as to discuss the terms/cost of your assistance in setting up my IVT biz in Miami? suenoanesthesia@gmail.com

Tommy
Tommy
1 year ago

Good day Mr. Jones. what are the steps to follow to open a mobile IV clinic in FL? I am a paramedic with a LLC already opened and have an MD standing by, thanks

Indira Ponce
Indira Ponce
1 year ago

Can an autonomous Nurse Practitioner be the medical director of an IV mobile hydration business in Florida ?

Fabiola Baptiste
Fabiola Baptiste
1 year ago

Can a nurse practitioner with a family practice clinic add IV hydration to the practice without a medical director? I do have a collaborative physician buy will be autonomous soon.

Jorge Vazquez
Jorge Vazquez
1 year ago

Hi jones
I am a RN for the state of Florida and I have a Serenity day spa in New Smyrna, Fl. I would like to know if I am aloud to give iv hydration therapy to my clients. And what are the rules or permits that I need? You can email me at asdspa@yahoo.com
Thank you.

Ariel
Ariel
1 year ago

Nurse Practitioner looking for partner for IV therapy in Florida. Ariel9313@gmail.com

Robin G
Robin G
1 year ago
Reply to  Ariel

Where in Florida are you? I’m an RN

Alya
Alya
11 months ago
Reply to  Robin G

Hi! I am a pharmacist looking to get into IV business. Please contact if any interest

Amber RN
Amber RN
1 year ago

Hello, thank you so much for educating us all on the IV Hydration ViVe situation. I was wondering, I have a family member in California that holds an active chiropractic physician license, But she be able to be my medical Director here in Florida it’s a business has been around here?

Crystal FLOWERS
Crystal FLOWERS
1 year ago

Can Phlebotomist do iv

Chrizzi
Chrizzi
1 year ago

This was an amazing read! I learned so much! Thank you! I will be saving it💕

Ryan
Ryan
1 year ago

If you are already licensed to perform IVs in a clinic / mobile setting and have all appropriate business licenses etc, are there any regulations for performing them in a booth at an outdoor festival?

Thanks for the info!

Lori Lenhart
Lori Lenhart
10 months ago

Can a licensed salon or hair salon offer IV therapy from a contractor or mobile IV therapy service? Or do we need to hold a Medispa business license or some other license to have this offered in our salon if it’s coming from a mobile IV therapy business?

Nicole Paiz
Nicole Paiz
8 months ago

Can a registered dental hygienist, in the state of Florida, perform IV infusions? We have degrees and licensures, as well as license for local anesthetic injections (much more than a medical assistant). You would think so… i’ m unsure..?

Alicia Rech
Alicia Rech
3 months ago

Great article! 🙂

Jasmyne
Jasmyne
1 month ago

What would qualify if a health care profession , like a nurse, is “acting alone”?

Satesh Raju
Satesh Raju
1 month ago

Thank you for this helpful article

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