facebook

Regulation of Unlicensed Activity by the Florida Department of Health

In the State of Florida, the Department of Health regulates the unlicensed practices of health care professionals. Florida Statute § 456.065 states that any practice, performance, or delivery of health care services by an individual without a valid and active license to practice that profession is strictly prohibited. 

Not only can practicing without a valid license accumulate hefty fines for an offender, but it can also impose criminal penalties and/or sentences. The Unlicensed Activity Unit works with law enforcement and the state attorney’s offices to prosecute any individuals practicing without a license.

Among the list of regulated healthcare professions that require licensure, some include:

  • Massage Therapists;
  • Physicians;
  • Tattoo Artists;
  • Nurses;
  • Occupational Therapists;
  • Pharmacists;
  • Dietitians/Nutritionists;

Cease and Desist Notices

Once the Department of Health has probable cause to believe someone is practicing without an appropriate license, the department may issue a notice to the violator or any person who has aided and abetted the unlicensed person through employment, to cease and desist from the violation. If the cease-and-desist notice is violated, the department may seek an injunction or a writ of mandamus in the court to further enforce it. For each day that the unlicensed person continues to practice after the cease-and-desist notice is issued, it creates a separate violation.

Citations

In addition to cease-and-desist notices, the suspected violator may receive a citation of a minimum of $500 and up to $5,000 per incident. Subsequent costs the department is entitled to recover could include the cost of the investigation, prosecution, and attorney’s fees and costs if the department was required to seek enforcement for the cease-and-desist notice. Once the citation is served, the respondent has 30 days to dispute the matter, otherwise the citation becomes a final order.

Within 30 days of the finalized agency action, the affected party has a right to seek judicial review under Florida Statute § 120.68. Pursuant to the Florida Rule of Appellate Procedure 9.110(c), the proceedings are initiated by filing a notice of appeal with the Agency Clerk of the Department of Health, filing a second copy, and paying the filing fees required.

The reviewing court may decide any of the following:

  • Order agency action required by the law;
  • Order agency exercise of discretion;
  • Set aside agency action;
  • Remand the case;
  • Decide the issue between the parties.

In addition to one of the options stated above, the court may also order such ancillary relief that the court deems necessary to redress the effects of official actions that were wrongfully taken or withheld.

Criminal Penalties

Florida differentiates between practicing without a license for up to 12 months or more than 12 months. The severity of penalties may also increase if any activities performed while practicing unlicensed leads to serious bodily harm or injury.

Practicing without a valid license for a period of more than 12 months is a third-degree felony that is punishable with a minimum fine of $1,000 and a minimum mandatory period of incarceration for 1 year. This third-degree felony also includes individuals who apply for a position requiring a license without notifying the employer they do not have an active license and those who purport themselves as able to provide a healthcare service for which they are not properly licensed. 

Those who are practicing unlicensed for a period of up to 12 months can be convicted of a misdemeanor of the first degree and subject to a minimum of 30 days in prison and a $500 fine.

For individuals who practice without a valid license and subsequently cause bodily injury, it is a felony of the second degree. Serious bodily injury can mean a multitude of situations including death, brain damage, spinal damage, disfigurement, fracture of bones, dislocations of joints, limited sensory functions, or a condition that requires surgical repair following the unlicensed treatment. The minimum penalty is a fine of $1,000 and a minimum mandatory period of incarceration of 1 year.

The Takeaways

The unlicensed practice of health care can have serious impositions on the administrative side and criminal side. An individual practicing without a valid license may be delivered a cease-and-desist notice to halt their practice which can have further implications if the notice is not abided by. Furthermore, individuals practicing unlicensed may be subject to citations and criminal proceedings that include fines and imprisonment.  

*****************************************************

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.

What are Work Relative Value Units (wRVUs) in Physician Employment Agreements?

When a physician provides a service, the reimbursement amount for that work is often measured through a metric referred to as work relative value units (wRVU). Although not every physician may be subject to wRVUs, such as physicians who have their own private practice, many physicians who work in large healthcare organizations may be required to meet a minimum amount of wRVUs.

The goal of the wRVU model is for physicians’ compensation to be directly correlated to the amount of work they perform, regardless of the patient’s insurance plan or the revenue generated during the services. Focusing on the amount of work performed has proven to be more effective than the previous method of tracking a physician’s productivity by the number of patients seen and number of services performed. Additionally, calculating reimbursement simply off the amount charged to the patient can be ineffective as well because the amount does not necessarily reflect the underlying value of the work provided. As such, the current wRVU model is the standard compensation model that many physicians and employers use in the healthcare industry.

How wRVUs Operate

The calculation of wRVUs considers a multitude of factors such as:

  • the work the physician is performing;
  • the costs associated with the necessary equipment;
  • the skill required;
  • the costs of liability insurance and;
  • the time associated with the procedure.

The total work that is involved in a physician performing a service typically includes the preservice work provided before the service (i.e., reviewing medical records, surgery prep), the work provided during the service (i.e., medical examination, surgery), and the work provided after the service has been performed (i.e., post-operative care, further documentation).

Typically, each service performed by a physician has an associated number called a CPT code. Each CPT code receives a wRVU that is combined with the previously mentioned factors to create a total RVU. From there, the total RVU is multiplied by the Medicare conversion factor (currently placed at $32.74 in 2024) to determine the reimbursement amount of the service. The Medicare conversation rate is determined by the Medicare Economic Index, however, it is important to note that private insurance companies and Medicaid may have a different conversion rate for wRVU to dollars.

Benefits of the wRVU Model

One of the most common benefits of the wRVU model is the transparency associated with it. The wRVU’s and the conversion factor are standard. This makes it easier for a hospital to administer and prevents one doctor from getting paid more than another while performing the same work. Despite wRVUs leveling the playing field by standardizing the compensation for each service performed, the implementation of wRVUs can create healthy competition among physicians as well. The wRVU system encourages physicians to maintain a steady stream of patients. As a result, the hospital has the possibility to flourish as physicians compete to acquire new patients.

The steady stream of patients not only helps the hospital in acquiring new patients but also in retaining already existing patients. The wRVU model may encourage physicians to follow up with their patients more often, as post-operative care and other post-procedure services are included in the compensation model.

Downsides to be Aware of

Though the wRVU can provide many benefits to employers such as easy implementation of the system and healthy competition in the work environment which increases physician productivity and patient numbers, the wRVU model can also have some cons.

Since the wRVU model relies on CPT codes in their final calculations for reimbursement, services performed by physicians that do not have an associated CPT code, such as tasks performed outside of patient care do not get compensated. In an effort to reach the amount of wRVU’s physicians need, those tasks not associated with a CPT code may lose priority to tasks that will be compensated instead. This can also encourage physicians to focus on the quantity of the work they perform, rather than the quality.

While healthy competition in a work environment can be a good thing, especially for employers, for physicians it may create a challenging work environment. In a hospital, peers often collaborate to discuss the best route for a patient’s treatment. In a competitive environment, it may discourage that collaboration, harming not only the physician’s productivity but the patient as well.

As a result of these effects the wRVU model may have on physicians, it can lead to burnout which then can impact the physician, patient, and the employer.

Negotiating wRVUs

Some physicians may have the ability to negotiate their wRVUs. The process for negotiations may be more limited for physicians in larger organizations but may be possible for those in private practices or smaller groups. Understanding the terms of the contract can help a physician negotiate wRVUs with insurance companies or a hospital administration. It is important to note, however, that reimbursement rates provided by Medicare and Medicaid are determined by the government and not open for negotiation.

*****************************************************

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.

Guidelines for Closing or Relocating a Florida Medical Practice

By Ashley Lockett

Throughout the career of a healthcare practitioner, there may arise a multitude of reasons that can prompt the closing or relocation of their healthcare practice. These reasons may vary from retiring, moving, deciding to pursue another opportunity, or illness/death of the practitioner. Despite the various reasons one may have for closing or relocating a medical practice, there are guidelines that dictate the proper procedures to follow for a smooth process.

The Guidelines

Record Keeping

Fla. Stat. §456.057(13) of the Florida statutes states that “records owners shall notify the appropriate board office when they are terminating practice, retiring, or relocating, and no longer available to patients, specifying who the new records owner is and where medical records can be found.”

As defined in the statute, a records owner means:

  • Any health care practitioner who administers treatment, dispenses drugs, or generates a medical record after making a physical or mental examination of any person.
  • A health care practitioner to whom records are transferred by a previous record’s owner.
  • Any health care practitioner’s employer provided that the agreement designates the practitioner’s employer as the records owner.

Notification of Changes

In addition to notifying the appropriate board office when retiring, closing, or relocating their practice, a record’s owner must also place an advertisement in the local newspaper or notify the patients in writing of the change, pursuant to Fla. Stat. §456.057(12). The patients of the practitioner must have the opportunity to request a copy of their medical record. According to Fla. Stat. §456.057(14), when a new records owner has been appointed, the new owner is responsible for providing a copy of the complete medical record to a patient or a patient’s legal representative who has requested the record.

Outside of notifying the appropriate board office and patients, practitioners may need to notify the Centers for Medicare & Medicaid Services and the U.S. Drug Enforcement Agency to comply with the appropriate disposal of the drugs within the practice. If the practitioner holds a license from the Department of Health for their use of medical equipment, they must notify the department and keep a record of the transfer or disposal of the equipment. Other establishments that may need to be notified include the Florida Agency for Health Care Administration, the hospital where the practitioner worked if applicable, other vendors whom the practitioner may have received supplies or equipment from, and the practitioner’s medical malpractice insurance carrier.

Failure to Follow the Guidelines

Under Fla. Stat. §456.057(15), a licensee shall be subject to discipline by the appropriate licensing authority if they are found to be in violation of the guidelines set. A healthcare practitioner is among those who are deemed a licensee.

Among those unlicensed, Fla. Stat. §456.057 states that “the Attorney General is authorized to enforce the provisions of this section for records owners not otherwise licensed by the state, through injunctive relief and fines not to exceed $5,000 per violation.”

Non-Compete Agreements

For individuals who plan to continue practicing after closing or relocating their practice, any non-compete agreements that may have been signed when initially onboarding are important to keep in mind. Non-compete agreements are restrictive covenants that restrict an employee from competing with their employer after the employment period has ended. Although terms of non-compete agreements vary depending on the employer, restrictive covenants are required to be reasonable in regard to “time, area, and line of business,” under Fla. Stat. §542.335(1).

A restrictive covenant is not enforceable unless it is in writing and signed by the individual whom the enforcement is seeking to effect. Furthermore, the person seeking enforcement must prove the existence of a legitimate business interest that justifies the need for the restrictive covenant.

Legitimate business interests are defined under Fla. Stat. §542.335 as:

  • Trade secrets.
  • Valuable confidential business or professional information.
  • Substantial relationships with specific prospective or existing customers, patients, or clients.
  • Customer, patient, or client goodwill associated with:
    1. An ongoing business or professional practice, by way of trade name, trademark, service mark, or “trade dress”;
    2. A specific geographic location; or
    3. A specific marketing or trade area.
  • Extraordinary or specialized training.

When an employee enters a valid non-compete agreement, it is crucial to thoroughly understand the terms of the conditions or serious consequences for violating it can occur. In Alonso-Llamazares v. Int’l Dermatology Rsch., Inc., a former employee was sued after violating their non-compete agreement. The non-compete agreement listed several stipulations that prohibited the employee from competing with the company during the time of their employment and two years after the expiration of it. Although the agreement listed the employment as ending on December 31, 2017, the employee worked for the company until November 1, 2019. Thereafter, the employee began working elsewhere on January 2, 2020. Despite the employee arguing that the agreement ended in 2017, the court found that the language of the agreement intended for the covenant to survive the expiration or termination of the agreement.  

Key Points

Whether a practitioner plans on retiring or chooses to work elsewhere, the requirements for closing or relocating the practice are important to abide by. Consulting with an attorney on the necessary steps may provide ample support in the process. For practitioners choosing to work elsewhere, the exit of a medical practice may mean the start of a non-compete agreement.

*****************************************************

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.

How Does The Corporate Transparency Act Impact My Business?

The United States Department of Treasury’s Financial Crimes Enforcement Network (FinCEN) is required through the Corporate Transparency Act to prevent and protect the community from fraud and illicit activities involving U.S. companies. In 2021, the Corporate Transparency Act was enacted and took effect on January 1, 2024.

Background

The National Defense Authorization Act (NDAA) is a series of federal laws specifying the annual budget and expenditures of the United States Department of Defense.  In 2021, the NDAA incorporated substantial modifications to its Anti-Money Laundering management.  These modifications began with the enactment of the Anti-Money Laundering Act (AMLA). The purpose of AMLA is to promote regulatory reform and engagement and to update federal laws to prevent money laundering. Through the Corporate Transparency Act, the AMLA requires FinCEN to identify risks of fraud by those posing as business owners in shell companies and to collect information to provide feedback to Congress in an attempt to reduce the amount of illicit activities, including money laundering and financial terrorism in the United States. The Corporate Transparency Act was enacted to comply with required reporting instructions to Congress. Congress argues that the lack of state laws requiring beneficial owners to be identified has allowed for the exploitation of business entities to be used for conducting criminal activities. FinCEN is required to maintain a national registry of beneficial owners of business entities deemed to be reporting companies. A Beneficial Ownership Information (BOI) Report is required to be filed by all Beneficial Owners.

Who Is Required To Report?

Beneficial Owners of any U.S. reporting company are required to file a report. Beneficial Owner is defined by the Corporate Transparency Act as any individual who, “directly or indirectly, (1) exercises substantial control over the entity or (2) owns or controls not less than 25 percent equity in the entity.”

There are listed individuals who are expressly excluded from this definition. These individuals include minors; any individual whose only interest in the reporting company is through inheritance; a person whose control derives strictly from employment in the company; an individual acting as an intermediary for the company, etc.

There are 23 entity types that are exempt from the reporting requirements set out by FinCEN. A complete list and compliance guide are available on the FinCEN Q&A website (https://www.fincen.gov/boi-faqs#B_2).

Third party entities or individuals, such as those listed as registered agents (i.e. accountants, attorneys, and any other intermediary companies) are not required to report as beneficial owners unless they exercise substantial control over a company or hold ownership interest in the company. Substantial control is defined in detail by FinCEN’s Small Entity Compliance Guide but generally applies to individuals of a company that hold decision making authority (such as CEO, CFO, general counsel) and individuals who hold authority to appoint or remove officers.

There are two types of reporting companies. A domestic reporting company is defined as a corporation, an LLC, and other entity created by the filing of a document to a state’s Secretary of State or any similar office in the United States. A foreign reporting company is defined as an entity formed under the law of another country that is registered to do business in the United States. Further clarifications to these definitions are sure to come.  

What Is Included In The Report To FinCEN?

 A qualified reporting company must provide each beneficial owner’s name, date of birth, residential or business address, and a unique identifying number from an acceptable identification document (such as a state driver’s license or passport).

When Must The Report Be Filed?

FinCEN has begun accepting reports since January 1, 2024. Companies established before January 1, 2024 have until January 1, 2025 to file. Companies formed after January 1, 2024 have ninety (90) days after the company becomes effective to submit a report. There is no fee required to file this report.

Beneficial Ownership Information Reports can be filed using the BOI E-Filing System at: https://boiefiling.fincen.gov/

*****************************************************

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.

The Legal Significance of IV Hydration Documents

The healthcare industry is heavily regulated and IV Hydration Clinics have their own set of regulatory compliance requirements that they must strictly adhere to or else they risk disciplinary action (i.e. fines and penalties) taken against them by various federal and state agencies. These regulations aim at protecting patient privacy, worker safety, preventing fraud, waste, and abuse while improving operational efficiency. Ultimately regulatory compliance enhances patient outcomes by promoting adherence to best practices across the sector.

 

Proprietors of IV Hydration Clinics must utilize legally compliant Agreements and documents in addition to obtaining the necessary permits and licenses for operating their business. It is important to understand the legal significance of the IV Hydration documents that you will utilize in your clinic as we will discuss below.

 

IV Therapy Informed Consent

IV Hydration Clinics must receive informed consent from clients. Consent can be oral or written but it must be complete to comply with Florida law. This document is intended to serve as confirmation of the client’s agreement to receive IV Hydration treatment by a duly licensed Florida healthcare practitioner. In Florida, the informed consent law requires that the client be advised of three things: 1) the nature of the treatment; 2) the substantial risks and hazards of the treatment; and 3) the reasonable alternatives to the treatment (including, when appropriate, the option of not receiving the treatment). After learning these things, if a client consents to the IV Hydration treatment, then informed consent has taken place. Failure to obtain informed consent in accordance with Florida Statute 766.103, can result in discipline against your license and a medical malpractice action filed against your IV Hydration Clinic. If you are engaging Independent Contractors to provide IV Hydration services on behalf of your clinic you must ensure that they obtain the appropriate consent prior to providing the treatment.

 

Intake Form with Medical History Questionnaire

This form is critical because it provides insight into the client’s past medical history and present medical condition(s). The form collects basic information such as the client’s name, date of birth, sex, contact information, and emergency contact. It also collects information about medical history, current health status, and any medications that the client is currently taking. Certain conditions may render a client ineligible to receive IV Hydration treatments due to pre-existing conditions, medications that they are taking, and other factors. Failure to do a proper assessment may result in patient harm that could have otherwise been avoided if the Intake Form had been completed by the patient. It is the client’s responsibility to accurately complete the Intake Form. If the patient harm can be linked to the IV Hydration treatment that the client received then a potential lawsuit for damages may be filed by the client, assuming that the client properly disclosed relevant medical history information. Liability may attach to the clinic if the IV Hydration Clinic knew or had reason to discover that the patient had certain medical conditions that rendered the client ineligible for the treatment. To reduce exposure to potential lawsuits relating to patient harm, an intake form should be completed by all clients before providing treatment.

 

Medical Director Agreement

A Medical Director Agreement is a legally binding agreement outlining the terms, duties, and responsibilities of the Medical Director role within the IV Hydration Clinic. IV Hydration Clinic’s may not operate or be maintained without the day-to-day supervision of a single medical or clinic director. Failure by a clinic to employ a qualified medical director may result in disciplinary action against the IV Hydration Clinic. Medical Directors that are supervising the services provided at an IV Hydration Clinic must notify the Florida Department of Health. Medical Directors of IV Hydration Clinics should endeavor to comply with the requirements set forth in Florida Statutes 400.9935 and 59A-33.008, F.A.C. The Agreement will also determine whether the IV Hydration Clinic or Medial Director will provide professional liability insurance for the services provided as well as the coverage limits, in accordance with Florida law. The Agreement should also address indemnification requirements for any liability arising out of, incident to, or attributable to the performance or nonperformance of any duty or responsibility under this Agreement by the Medical Director.

 

HIPAA Notice of Privacy Practice

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) is a federal law that required the creation of national standards to protect sensitive protected health information (“PHI”) from being disclosed without the patient’s consent or knowledge. The US Department of Health and Human Services (“HHS”) issued the HIPAA Privacy Rule to implement the requirements of HIPAA. The HIPAA Security Rule requires IV Hydration Clinics to implement appropriate technical, physical, and administrative safeguard to protect PHI. This Notice of Privacy Practices informs the IV Hydration client of: (1) how their PHI may be used and disclosed; (2) the IV Hydration Clinic duties to protect the privacy and confidentiality of the client’s PHI; (3) explain the client’s privacy rights, including their right to complain to HHS and to the IV Hydration Clinic if the client believes that their privacy rights have been violated; and (4) how to contact the IV Hydration Clinic for additional information and how to file a complaint. The Law requires healthcare providers to obtain a signed writing that confirms that you have received the Notice of Privacy Practices. The Notice is typically provided at the client’s first appointment and is also posted to the IV Hydration Clinic’s website with reminders issued to clients every three years. It should be noted that in addition to HIPAA, IV Hydration Clincs must comply with the Florida Information Protection Act of 2014.

 

IV Therapy Independent Contractor Agreement

An Independent Contractor Agreement (1099) is a contract that lists the terms and conditions of the contractor’s work for the IV Hydration Clinic. The Agreement is meant to protect all parties involved and clarifies the relationship between the IV Hydration Clinic and contractor. Specifically, it outlines the contractor’s classification, compensation, compliance requirements, qualifications of contractor, restrictive covenants, tax obligations, insurance and indemnification requirements, liability, and other miscellaneous terms. It is important that the Agreement is compliant with the IRS’s definition of an independent contractor, which is determined in part by the contractor’s ability to make its own independent decisions regarding the scope of the services and when and how they will be performed. The more control the IV Hydration Clinic has over the contractor and its decision making the less it appears to be an independent contractor relationship.

 

Patient Media Release

A patient media release form is a legally binding document that is signed by an IV Hydration client and authorizes the IV Hydration Clinic to utilize that client’s image, likeness, and voice in its marketing materials, which may include videos, pictures, prints, and recordings. Many IV Hydration Clinics utilize social media and other forms of advertising to promote their goods and services. Oftentimes, IV Hydration Clinics post videos or pictures of their clients receiving IV Hydration treatments to their social media accounts. Due to the sensitive nature of the content that is being posted to social media it is important to receive permission from your clients prior to doing so. The patient media release form ensures that the client understands how their media will be used and authorizes the clinic to utilize the media without fear of liability for privacy or copyright infringement.

*****************************************************

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.

Can a Licensed Practical Nurse (LPN) administer I.V. Hydration Treatments in Florida?

As the booming world of I.V. Hydration continues to flourish, it has proven to become a reliable source of revenue for many in the healthcare industry. While these therapies were offered well before 2019, the pandemic has skyrocketed their popularity. Many celebrities have since been known to promote the efficacy and benefits to receiving vitamins intravenously.  I.V. Hydration treatments allow vitamins to be delivered directly into the veins. This can deliver almost immediate results and is a quick outpatient procedure. Because of these benefits and the increasing convenience, the world of intravenous drip therapies has grown in popularity. The world is now debatably much more health conscious and pro-active when it comes to individualized care.

Who Can Administer Intravenous Therapies?

There are various I.V. Hydration clinics opening statewide run by medical professional and non-medical professionals alike. There is guidance on who can run these clinics, and who can and cannot administer these such treatments or if specific medical professionals in the nursing field can administer these treatments under limited supervisions. As for licensed practical nurses, Florida law distinguishes their scope of practice when it comes to intravenous procedures. According to Chapter 464, Section 003, subsection (14) a licensed practical nurse is defined as any person licensed in this state or holding an active multistate license under s. 464.0095 to practice practical nursing. Florida Administrative Code 64B9-12.004 states that with the exception of aspects deemed outside of the scope of practice, a licensed practical nurse who meets competency requirements is authorized to administer intravenous therapy under the direction of a registered nurse or other healthcare provider.

What is Considered “Outside of the Scope of Practice”?

Florida’s Administrative Code Rule 64B9-12.003 says that an IV certified LPN should not perform the initiation of administration of cancer chemotherapy, plasma expanders, administration of investigational drugs, or blood and blood products. Although LPN’s are not to perform these duties without direct supervision of a registered nurse or a health care practitioner, they can however, care for patients who have received these procedures under proper care.

What are the ‘Competency Requirements’ to be Met?

In order to meet the Knowledge and Competency requirements outlined by the Florida Administrative code governing IV Hydration, an LPN must take a course with no less than thirty (30) hours of post-graduation level IV Hydration training. The didactic course must contain specific materials listed in rule 64B9-12.005 such as aspects of policies and procedures, psychological preparation and support for patients, and many more. After the course, interested LPN’s must partake in supervised clinical practice to demonstrate capability and proficiency. For a licensed practical nurse to be able to perform intravenous therapy under the direction of a registered nurse or health care practitioner via central and PICC lines, four (4) hours of appropriate education on Central Venous Lines (CVL) and Peripherally Inserted Central Catheter Lines (PICC) should be included within the required thirty (30) post graduate hours.  It is important to note that this I.V. Hydration education must be sponsored by a provider of continuing education courses approved by the Florida Board of Nursing.

For more information on the rules and regulations for Licensed Practical Nurses and IV Hydration, see the full chapter from the Florida Department of State here:

https://www.flrules.org/gateway/ChapterHome.asp?Chapter=64B9-12

If you are interested in learning more about starting your own I.V. Hydration business, schedule a consultation with Jamaal R. Jones via our Calendly app: https://calendly.com/joneshealthlaw/iv-hydration-consultation or sign up for one of our comprehensive Webinars. For more information or direct assistance call our offices at (305) 877 – 5054.

*****************************************************

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.

*****************************************************

Board of Nursing Issues Declaratory Statement Regarding Botox Injections by RNs

The Scope of Practice for a Registered Nurse isn’t always clear. The Florida Nurse Practice Act (Florida Statute Ch. § 464) and the Rules of the Florida Board of Nursing (Florida Administrative Codes, Title 64B9) exist to establish regulations, authority, and guidance regarding the practice of nursing. The issue of whether a registered nurse can legally administer Botox has been clearly addressed under Florida law. Previous rulings set a precedent when a nurse was disciplined for performing Botox injections on a client without a physician’s direct orders (Department of Health v. Trisha Lorraine White, R.N. Case Number 2016-13884). However, this ruling seemed to leave more questions than answers. The ruling did not clearly state whether a nurse is allowed to perform Botox injections if acting pursuant to a physician’s orders. In White, the court held that even pursuant to a physician’s orders a registered nurse does not possess the requisite educational preparation to perform the procedure and that doing so would be practicing beyond the scope of a nursing license. Without clarification, this matter left unanswered questions for nurses, med spas, and clinics who could potentially benefit from having nurses perform Botox procedures.

Per the Board of Nursing, if a specific act is questionable, a declaratory statement may be requested to provide clarity. The Board of Nursing defines a declaratory statement as a means for resolving a controversy or answering questions or doubts concerning the applicability of statutory provisions, rules, or orders over which the board, or department when there is no board. On September 26, 2022, Jessica James, a registered nurse (R.N.) from Pensacola, Florida requested a declaratory statement on clarification for the task delegation of Botox Cosmetic. The case referenced Florida Statute § 464.003, specifically quoting, “The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments.” Jessica James’ request went on to identify some prerequisites in her case for Botox task delegation eligibility by stating that the physician would first examine the patient and write an order detailing the specific muscles to be injected as well as the units per injection site before delegating the task to a registered nurse.

The Board of Nursing concluded that it is within the scope of practice for this particular case to allow the task delegation of administering of Botox. It should be noted that the Board of Nursing mentioned the “Petitioner’s specific and particular education, training, and experience” when making this decision. In this particular case, Jessica James, stated that she had experience in this field because she had observed aesthetic injections for 4 years and had completed Method Aesthetics Academy Level I training. This finding opens the door to the possibility for other qualified nurses to administer Botox under the supervision of a physician with the appropriate trainings and education. At the very least, this finding displays more progressive thought than previous rulings and statements that disallowed nurses to partake and assist in Botox injections. While this matter remains open ended and subject to specific conditions, it most definitely provides some transparency for those concerned.

 

*****************************************************

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.

Who Enforces Health and Safety Law?

Health and Safety laws are regulated by various agency officials and theses are arguably the most crucial jobs in our community. Most people do not take the time to adequately research their healthcare providers prior to receiving healthcare services or medication. However, several agencies have been established to safeguard and regulate the health and safety of the healthcare services that consumers receive. These agencies can’t replace individual due diligence but they make every attempt to prevent patient harm and to eliminate fraudulent activity in the healthcare system.

Florida Department of Health

The Florida Department of Health (DOH) was the first accredited public health system in the United States. Their mission is to protect and improve on the health of all people in Florida by regulating healthcare practitioners and facilities. They offer programs and services for the Florida community, but they are also responsible for the licensing and regulation of various healthcare practitioners and facilities. Various healthcare professions must be licensed and are regulated via the Florida Department of Health such as: medical doctors, acupuncturist, optometrists, and many more. Certain facilities such as piercing salons and pharmacies are also regulated by the Department of Health. Complaints can be filed against any of the practitioners or facilities, which will then be investigated by an officer for violations. The complaint is referred over to the Probably Cause Panel, which will determine whether to file an Administrative Complaint against the healthcare provider based on the weight of the evidence that is provided by the complainant and the provider who under investigation. It is not uncommon for the DOH to place an emergency restriction on a provider’s license if they pose an imminent danger to patient safety. If a violation is found, the Department of Health will determine appropriate disciplinary action to enforce the regulations, which includes, probation, suspension, or even revocation of a healthcare provider’s license.

Agency for Health Care Administration

The Agency for Health Care Administration (“AHCA”) was established in Florida to regulate the Medicaid system and healthcare providers who offer services to Medicaid beneficiaries. AHCA administers background screening, compiles healthcare data, and monitors the quality of care and civil rights complaints within healthcare facilities. They also license various healthcare facilities throughout Florida such as assisted living facilities, health care clinics, home health agencies, and many more.

Department of Health and Human Services

The Department of Health and Human Services has a family of agencies to provide services on local levels through state and county agencies. Some of these agencies include:

  • Centers for Medicare and Medicaid Services (“CMS”) proposes and publishes regulations yearly for those programs under medicare.gov, healthcare.gov, and more. CMS also enforces compliance with clearinghouses and healthcare providers and conducts audits regularly. CM provides health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace. CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.
  • The Centers for Disease Control and Prevention (“CDC”) is one of the most widely known organizations within the Department of Health and Human Services. The mission statement of the CDC to protect the America people from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. The CDC conducts critical science and provides health information that protects America against expensive and dangerous health threats, and responds when these arise. This is a science based organization that works to protect communities from health threats. The U.S. Secretary for Human and Health Services has authorized the CDC to carry out and enforce functions for isolation and quarantine to prevent exposure to contagious diseases.
  • The Office of Inspector General (“OIG”) is another department within the Department of Health and Human Services that works to improve the efficiency of many health based programs. They are the largest office in the Federal Government. They investigate complaints based on fraud, waste, abuse, and misconduct. The majority of the agency’s resources go towards the oversight of Medicare and Medicaid — programs that represent a significant part of the Federal budget and that affect this country’s most vulnerable citizens. The OIG has the authority to exclude individuals and entities from Federally funded health care programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from Federal health care programs for any items or services they furnish, order, or prescribe. This includes those that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan).
  • The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA conducts research on various food and drug safety protocols. They create reports to share with the general public to spread accurate information. The FDA also works closely with drug manufacturers to ensure the production of safe and effective drugs. They are accountable for overseeing quality control, delays, and discontinuations of drugs and medications. The agency works closely to reduce or prevent shortages. The supervision and regulation of the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors is also a crucial role played by the FDA.

 

These are just a few of the hundreds of agencies established to protect our communities from safety and health emergencies. Each agency regulates their own sections within each community or program.

*****************************************************

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.

 

Join Us for a LIVE Masterclass


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

This will close in 35 seconds