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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.

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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.

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

Jamaal Jones Attends Match Madness with BBBS

On Saturday, March 15, Jamaal R. Jones, Esq. participated in a “Match Madness” event which was organized by Big Brothers Big Sisters of Miami. Big Brothers practiced basketball drills and exercises with their Little Brothers and then participated in a basketball game.

Mr. Jones has been a Big Brother for over four years and is very active in volunteering for this wonderful organization.

Can a Non-Dentist Own a Dental Practice in Florida?

At Jones Health Law, we receive a lot of inquiries from non-dentists who are looking to own and operate dental practices. Dental offices that are placed in high-traffic areas with good management, a diverse patient population, talented healthcare professionals, and robust marketing and advertising efforts can generate significant revenue even with declining reimbursement rates from insurers. According to the American Dental Association, the average gross billings per dentist for owner dentists in 2017 was $718,790 for a general practitioner and $1,058,630 for a specialist. With numbers like that you can see why a non-dentist might want to open a practice comprised of several dentists and dental hygienists. However, non-dentists must be very cautious about structuring their relationships with the dentists.

Under Florida law, no person other than a Florida licensed dentist, nor any entity other than a professional corporation or limited liability company composed of dentists may:

  1. Employ a dentist or dental hygienist in the operation of a dental office.
  2. Control the use of any dental equipment or material while such equipment or material is being used for the provision of dental services, whether those services are provided by a dentist, a dental hygienist, or a dental assistant.
  3. Direct, control, or interfere with a dentist’s clinical judgment.

As per statute, a non-dentist must not directly employ a dentist (i.e. W-2 employee) but they may work with the dentist as a 1099 independent contractor. The non-dentist cannot pay a dentist a salary or commission. The dentist may create their own wholly owned professional corporation while the non-dentist may provide their services through an LLC or other taxable organization. No employment contract may exist between the dentist and the operator but an independent contractor agreement may be necessary. Any dentist who is employed by a non-dentist may face disciplinary action.

The non-dentist who is providing the office space and equipment cannot control the use of dental equipment while such equipment or material is being used for the provision of dental services (emphasis added). This means that while the dentist is operating dental equipment the non-dentist cannot barge in and place restrictions on how the equipment or material is being used once a patient is being treated. For example, if a dentist is treating a patient and that treatment was expected to last 30 minutes but is now at the 45-minute mark the non-dentist cannot physically manipulate any dental equipment or tell the dentist that she has to finish within the next 5 minutes because another dentist needs to use it. However, a lease agreement can place general restrictions on the operation and use of the equipment that is being leased to the dentist.

Most importantly, a non-dentist cannot interfere with a dentist’s clinical judgment by instructing them on a course of treatment to provide to a patient. All clinical decisions must be left to the discretion of the dentist. The purpose of this law is to prevent non-dentists from influencing or interfering with the exercise of a dentist’s independent professional judgment.

The relationship between the non-dentist and dentist will be a network of lease, rental, marketing, practice management and administrative agreements. Any dental equipment lease agreement between a non-dentist and dentist must contain a provision stating that the dentist expressly maintains complete care, custody, and control of the equipment or practice. Further, an agreement is void if the non-dentist exercises control over the following:

  1. The selection of a course of treatment for a patient, the procedures or materials to be used as part of such course of treatment, and the manner in which such course of treatment is carried out by the dentist;
  2. The patient records of a dentist;
  3. Policies and decisions relating to pricing, credit, refunds, warranties, and advertising; and
  4. Decisions relating to office personnel and hours of practice.

A non-dentist may enter into a management contract with the dentist’s professional corporation to provide administrative services, which may include maintenance of patients’ medical records but the control and ownership of those records do not belong to the management company. The dentist must have unfettered access to those medical records as needed.

While a non-dentist cannot dictate the dentist’s hours of practice the medical office space lease agreement may include office access hours. For example, a lease agreement may grant the dentist access to the medical office space between the hours of 8 a.m. to 8 p.m. but the dentist would set their hours of practice between 9 a.m. to 3 p.m. Further, only the dentist has control over the hiring and termination of office licensed personnel such as dental associates, hygienists, technicians, and assistants.

A dentist may enter into an agreement with a non-dentist to receive “Practice Management Services.” The term “Practice management Services” is defined to include consultation or other activities or services offered by someone other than a Florida licensed dentist regarding one or more of the following types of products or services:

  1. The suitability of dental office space, furnishings and equipment;
  2. Staff necessary to operate a dental practice;
  3. Regulatory compliance expertise and services;
  4. Methods to increase productivity of a dental practice;
  5. Inventory and supplies required to operate a dental practice;
  6. Information systems designed to produce financial and operational data on the dental practice;
  7. Marketing plans or advertising to increase productivity of a dental practice;
  8. Site selection, relocation, design or physical layout of a dental practice, or
  9. Financial services such as accounting, bookkeeping, monitoring and payment of accounts receivable, payment of leases and subleases, payroll or benefits administration, billing and collection for patient services, payment of federal or state income tax, personal property or intangible taxes, administration of interest expense or indebtedness incurred to finance the operation of the dental practice, or malpractice insurance expenses.

Non-dentist management fee must be for fair market value and directly related to the goods and services provided without taking into account patient referrals. The dentists should not pay a percentage or portion of ifs gross or net profits to the non-dentist corporation.

Finally, dentists are prohibited from entering into non-compete agreements for the provision of dental services with any entity which is not itself a licensed dentist, or which is not licensed or otherwise permitted by law to provide the services which are the subject of the agreement not to compete.

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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 of the 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.

Mr. Jones Attends Health Law Executive Council Meeting in Sarasota

On January 17, 2019, Jamaal R. Jones attended the Florida Bar Health Law Section’s Executive Council Meeting in his capacity as Executive Council member and Chair of the Communications and Technology Committee.

Many things were discussed during the meeting including updates the Health Law Section’s website, updates to the Health Law Section’s Bylaws, legislative updates and more.

The meeting was held at the Hyatt Regency Sarasota and Chart House Longboat Key.

AHCA Application for Exemption from Disqualification

If you are reading this article it means that you have probably received a letter from the Agency for Healthcare Administration (“AHCA”) stating that they have uncovered criminal offenses that disqualify you from working for a health care provider. AHCA may have uncovered this offense a result of background screening submitted as part of the employment process for a health care provider and/or participation as a Medicaid provider. This applies to clinical staff as well as facility owners, administrators and chief financial officers and those seeking enrollment as a provider in the Florida Medicaid program. Fear not, because you may be eligible to file an Exemption from Disqualification if you meet certain criteria.

Am I Eligible for Exemption?

Our firm can assist you with demonstrating to AHCA by clear and convincing evidence that an exemption from disqualification should be granted. The application will only be reviewed once all relevant supporting documents are received by AHCA. You are only eligible for Exemption from Disqualification if:

  1. You have been lawfully released from confinement, supervision or other nonmonetary condition imposed by the court for a disqualifying misdemeanor criminal offense;
  2. At least 3 years after you have been lawfully released from confinement, supervision, or other nonmonetary condition imposed by the court for a disqualifying felony criminal offense;
  3. You have completed any court-ordered fee, fine, fund, lien, civil judgment, application, costs of prosecution, trust, or restitution as part of the judgment and sentence for any disqualifying felony or misdemeanor in full; and
  4. If you have been designated as a sexual predator, sexual offender or career offender you are not eligible for an exemption from Disqualification.

 

Filing the Application

Filling out the application can be a bit tricky, so you should definitely hire a health law attorney that has experience with doing so in order to prevent delays in processing your application. In addition to completing the Application for Exemption from Disqualification you will need to provide AHCA with the following:

  1. Current Level II Screening;
  2. Arrest Reports;
  3. Court Dispositions;
  4. Signed Statement (only if you cannot obtain the arrest report and/or court disposition);
  5. Probation and/or Parole records;
  6. Letters of Reference; and
  7. Documentation of Rehabilitation

It is important to note that when you apply for exemption you must provide all arrest reports, including those that were not specifically listed in the notice that you received from AHCA. You will also need to provide all court dispositions no matter the plea, judgment, verdict or even if it was sealed or expunged from your record. All of these documents will need to be neatly organized and AHCA must receive the documents within 30 days from receipt of its letter. It may take a little bit of legwork to retrieve these documents, so it is important to contact our firm as soon as possible so that we don’t miss the deadline. AHCA rarely grants extensions for filing the application.

Finally, if you are a certified or licensed healthcare professional you may also have to file an application for exemption with the Florida Department of Health (“DOH”). Florida Statute 408.809(7)(a) states that AHCA may grant an exemption from disqualification to a person who is subject to this section and who: (1) Does not have an active professional license or certification from the DOH; or (2) has an active professional license or certification from the DOH but is not providing a service within the scope of that license or certification.You may also have to submit a signed background screening privacy policy acknowledging receipt of the privacy policy. Once the DOH receives your application they will review it and make a decision as long as that person is working in the scope of their license or certification.

What Happens After Filing?

Once AHCA received the documents, it will be transferred to the Exemption Team and assigned to one of their analysts. As stated earlier, the analyst is looking for clear and convincing evidence that the employee should not be disqualified from employment. The Agency will consider the following:

  • The circumstances surrounding the criminal incident(s) for which an exemption is sought;
  • The time period that has elapsed since the incident(s);
  • The nature of the harm caused to the victim;
  • The history of the employee since the incident(s);
  • Any other evidence or circumstances indicating that the employee will not present a danger if employed or continued employment is allowed; and
  • Whether the applicant has been arrested for or convicted of another crime, even if that crime is not a disqualifying offense.

Once you’ve submitted your application it takes approximately 30 days for AHCA to render its decision to you. Exemptions granted by one agency will be considered by other agencies, but it is not binding on subsequent agencies. It is possible for AHCA and DOH to deny your application even though you feel you meet the criteria for an exemption. In those instances, our firm will represent you before AHCA and DOH Boards if you chose to contest the Agency decision. You have 21 days from the date you sign for the certified letter to request an appeal. The administrative law judge will only decide whether the agency’s intended action is an abuse of discretion.

Job Status

Are you allowed to continue to work for your employer after you’ve submitted the application for Exemption from Disqualification? It depends on the circumstances. If you were screened and hired by your current employer on or before June 30, 2014 and this disqualification was due to a rescreening by the same employer, you may continue work if you meet all of the following criteria:

  1. You are eligible to apply for exemption;
  2. Your disqualifying offense was not disqualifying at the time of your last screening, but is now disqualifying and was committed before the date of your last screening;
  3. Your employer agrees that you may continue working; and
  4. You submit your application timely.

According to Florida Statute, 408.809(4) an employee may continue to perform her duties and her employer may continue to allow her to have contact with any vulnerable person (i.e. physical therapy patients) that would place employee in a role that requires background screening while her application for exemption from disqualification by the agency is being processed and under review. You also must make sure that your license stays active if you are a licensed healthcare provider, which means that you should submit any renewal forms and correct any omissions to prevent your license from expiring.

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

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