facebook

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

My DEA Number Was Stolen by an Employee and Used to Self-Prescribe Controlled Substances

Most doctors have various licenses that provide them with unique identification numbers. If any of these identification numbers find their way into the wrong hands it can be detrimental to the healthcare provider’s practice, their patients, and the public. Doctors hire support staff to run their practice efficiently by perform tasks that they don’t have time to do or don’t have the training to perform. This employer-employee relationship requires a certain level of trust from both parties because a bad act by either party can have a negative impact on the other party’s license, privileges, or reimbursement for services. Some of the support staff working in a doctor’s office may have access to HIPAA-protected information and a doctor’s unique identification numbers, such as his NPI and DEA numbers. What should you do if one of your employees steals your DEA number and uses it to self-prescribe controlled substance through e-prescribing or traditional prescription pads? What if they use your DEA number to order controlled substances for the practice without your knowledge or consent? Doctors should also be concerned with their potential liability for the unauthorized use of their DEA number.

Reporting Requirement

According to Florida Statute §893.07(5)(b), if your DEA number has been stolen and used to divert controlled substances you must file a police report with the local sheriff of that county within 24 hours after discovery. A person who fails to report a theft or significant loss of a controlled substance commits a misdemeanor of the second degree. It is not required that you press charges against the perpetrator of the theft, but I always recommend that my clients do so for several reasons. First, it shows authorities that you were not complicit in the theft. Second, it becomes part of the employee’s record and prospective future employers will be able to see this information on their criminal history during background checks. Third, as punishment for the emotional despair you will endure, negative impact on your practice, and the cost to hire an attorney to represent you in this matter.

You must also notify the Drug Enforcement Agency (“DEA”) within one business day upon discovery of a theft or significant loss of controlled substances. “Upon discovery” means that a report should be filed once the doctor has made a good-faith effort to determine whether a theft has in fact occurred. To determine whether a loss is significant the DEA provided the following factors in 21 C.F.R. § 1301.74(c):

1) The actual quantity of controlled substances lost in relation to the type of business;
2) The specific controlled substances lost;
3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
5) Whether the specific controlled substances are likely candidates for diversion; and
6) Local trends and other indicators of the diversion potential of the missing controlled substance.

The six factors mentioned above are not exhaustive and should be taken into account with other factors where appropriate.

According to 21 C.F.R. § 1301.76(b), the DEA’s implementing regulations for the Controlled Substance Act, all DEA registrants must complete DEA Form 106 and submit it to the DEA electronically or by mail. Once submitted, the DEA will begin the investigatory process and contact you to obtain additional information.

Additionally, you should contact the board or association that grants you your license to practice (i.e. Florida Board of Osteopathic Medicine) to see what reporting requirements they may have. For example, although I could not find a clearly defined rule requiring so, the Florida Board of Osteopathic Medicine (“FDOM”) strongly suggests that the doctor file a complaint with the Florida Department of Health (“DOH”) against the perpetrator of the crime so that they may conduct their own investigation into the matter. The complaint should be sent to the Consumer Services Section of the DOH. You will typically receive a response from the DOH within ten business days at which point in time they may schedule a phone call or an in person meeting as part of their ongoing investigation. This investigation may include interviewing parties in your practice about the perpetrator or the crime and facts and events that gave rise to the incident.

During all stages of the investigation, whether talking to the DEA, local police authorities, or the DOH you must be candid with the investigating authorities so that there isn’t any indication of impropriety on your part.

Steps To Prevent A Theft From Occurring Again

To limit the occurrence of future thefts or significant loss, providers should do the following:

  • Conduct employee background checks for all employees, including those employees with access to controlled substances. This background check should be performed in any local, state jurisdiction where the employee has worked and resided. Federal background checks should also be performed.
  • Schedule I and II drugs must be stored separately from other drugs in an approved safe. Schedule III and IV drugs must also be kept under lock and key but the security measures are more relaxed than their counterparts.
  • Utilize tracking software that records specific employee’s removal of controlled substances from locked cabinets together with an associated patient identifier. The software is designed to flag and alert the doctor of suspicious or unusual employee activity.
  • Providers should also conduct periodic internal audits to ensure that the inventory of controlled substances is accurate.
  • Providers may also want to consider a adopting a policy into their practice which requires employees to be periodically drug tested and suspicion-based drug testing. Drug testing should be performed prior to employment; the offer of employment should be conditional on a clean drug test.
  • Sparingly share you DEA number and e-prescribing log-in information only with trusted employees.
  • Make sure that your prescription pads are locked up in a secure area. Utilize watermarks on your prescription pads because it makes it more difficult to replicate.
  • Monitor remittance advice, claims and reimbursements to verify billed services match your income.
  • Observe and takes notes of erratic or unusual behavior by an employee (i.e. lying and mood swings) and physical abnormalities, such as “track marks”, excessive sweating, pale skin, red face with red eyes, etc.
  • Implement a training program to educate staff on controlled substance diversion.

 

Conclusion

If you are unable to determine whether a theft of controlled substances did in fact occur within one business day, you should err on the side of caution and file a report with the DEA and other appropriate authorities. It may also be necessary to notify the Center for Medicare and Medicaid Services If you fail to timely report a theft or significant loss you may face penalties and fines or any other remedial actions that the authorities deem are necessary. If any patients were affected by the theft you must determine how to appropriately notify your patients. Make sure to gather any documents or evidence that can be useful for authorities during their investigation. Any theft of prescribing pads should be reported to the Board of Pharmacy.

****

This post was authored by Jamaal R. Jones, Esquire of Jones Health Law, P.A. for more information contact me at (305) 877-5054; email us at JRJ@JonesHealthLaw.com, or visit our website at www.JonesHealthLaw.com.

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 information listed above.

All of the information and references made to laws, 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.

 

Join Us for a LIVE Masterclass


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

This will close in 35 seconds