Catastrophic Medical Injury

On July 1, 2025, the following laws were enacted and may affect health care providers in Florida. These legislative changes introduce updates to regulatory compliance, patient care protocols and provider responsibilities. This overview highlights key provisions and their practical implications for providers across the state.

HB 519 — Administration of Controlled Substances by Paramedics
The Florida Comprehensive Drug Abuse Prevention and Control Act (Chapter 893, Fla. Stat.) allowed for specific licensed practitioners to authorize the administration of a controlled substance by a licensed nurse or an intern practitioner. It did not expressly include paramedics. Under federal law, the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEMA) created specific rules relevant to the EMS setting, allowing for a paramedic to administer controlled substances outside the physical presence of a medical director if the EMS agency was authorized to do so by state law, was registered with the DEA, and had a standing order or verbal order from a medical director.

What the changes mean:
A licensed practitioner may now authorize a certified paramedic to administer controlled substances in the course of providing emergency services.

HB 647 —Advanced Practice Registered Nurse Services (APRN)
Advanced practice registered nurses were not authorized to file a death certificate or complete a medical certification of cause of death, unless they were registered for autonomous practice.

What the changes mean:
An advanced practice registered nurse providing hospice care may certify the cause of death and file the certificate of death.

SB 958 — Type 1 Diabetes Early Detection Program
This bill created § 381.992, Fla. Stat., and requires the Department of Health, in collaboration with school districts throughout the state, to develop Type 1 diabetes information material related to early detection for the parents and guardians of students. The material must include a description of Type 1 diabetes, the risk factors and warning signs associated with Type 1 diabetes, the process for screening students using a blood autoantibody test, and recommendations for further evaluation for students displaying warning signs or positive early detection screening results.

What the new law means:
Medical providers may see an increase in concerned parents wanting to discuss Type 1 diabetes. However, some parents may not be able to seek medical care due to financial and insurance reasons.

It may be beneficial for pediatricians to reach out to their local school districts and assist with providing additional education and/or workshops for parents.

HB 791 - Surrendered Infants
Section 383.50, Fla. Stat., allows parents to safely surrender infants up to 30 days of life at an emergency medical services station, fire station, or hospital without civil or criminal liability. Existing provisions related to the presumption that the parent intended to surrender the infant, consented to appropriate medical treatment and care, and to the termination of parental rights; the care and custodial processing of an infant upon lawful surrender; and the parent’s anonymity upon surrender remain in effect.

New additions to the law:
The new law extends the previous law to include the surrender of an infant using an infant safety device. An infant safety device is a device that is installed in a supporting wall of a hospital, an emergency medical services station, or a fire station and that has an exterior point of access allowing an individual to place an infant inside and an interior point of access allowing individuals inside the building to safely retrieve the infant.

The infant safety device must be:

• Physically part of the hospital, emergency medical services station, or fire station and be in a conspicuous and visible area to employees;
• Temperature controlled and ventilated;
• Equipped with a dual alarm system which automatically triggers an alarm inside the building when an infant is placed in the device, and the alarm must be tested at least once a week;
• Equipped with a surveillance system that allows for monitoring the inside of the device 24 hours a day; and 
• Physically checked at least twice a day.

If the infant safety device is located at an emergency medical services station or fire station, the alarm must also immediately alert 911, and dispatch must send the nearest first responder to retrieve the infant.

HB 1089 — Newborn Screenings
Newborn screening is a preventive public health service provided in every state to identify, diagnose and manage newborns at risk for selected disorders that, without detection and treatment, can lead to permanent development and physical damage or death. The Florida Newborn Screening Program serves to promote the screening of all newborns for metabolic, hereditary and congenital disorders known to result in significant impairment of health or intellect. The program currently screens for 37 core conditions and 23 secondary conditions, nearly all of which are screened for through the collection and testing of blood spots. Hearing screening, critical congenital heart disease and targeted testing for congenital cytomegalovirus are completed at the birthing facility through point of care testing.

What the changes mean:
Duchenne Muscular Dystrophy (DMD) will be added to the Newborn Screening beginning January 1, 2027. DMD is a rare genetic condition, but it is also the most common childhood-onset form of muscular dystrophy. It affects approximately one in every 3,300—5,000 live male births. DMD is an X-linked inherited neuromuscular disorder that can be carried by females, but typically only presents symptomatically in boys. DMD is considered a lethal condition for which there is no curative treatment. However, early diagnoses and a multidisciplinary approach can slow the progression of the disease, prolong the survival rate and maintain a quality of life.

SB 1156 — Home Health Aide for Medically Fragile Children Program
The Home Health Aide for Medically Fragile Children (HHAMFC) Program was created in 2023 in response to the national health care provider shortage and its impact on medically fragile children and their family caregivers to provide an opportunity for family caregivers to receive training and gainful employment. Other Medicaid programs exist that pay a family member to provide home health services to a Medicaid enrollee, but the HHAMFC Program is the only one that pays a family member who is not a licensed nurse for the provision of home health services to a medically fragile child. The program allows a family caregiver to be reimbursed by Medicaid as an HHAMFC once they have completed an approved training program or graduated from an accredited pre-licensure nursing education program and are waiting to take the state licensing exam.

What the changes mean:
The HHAMFC must complete an approved training program, and the employing home health agency must provide validation of the HHAMFC prior to the aide providing services to an eligible relative. The employing home health agency must also provide training on HIV/AIDS and ensure that the HHAMFC holds and maintains a CPR certification.

The training program must consist of at least 76 total hours of training with at least 40 hours of home health aide training, 20 hours of skills training tailored to the needs of the child, 16 hours of clinical training related to the child’s needs, and training on HIV infections and CPR.

Increased the Medicaid utilization cap from eight hours per day to 12 hours per day.

Requires the home health agency to report an adverse incident within 48 hours of the incident.

HB 1195 — Fentanyl Testing
The bill created § 395.1042, Fla. Stat., and requires a hospital or hospital-based off-campus emergency department treating patients for possible drug overdose or poisoning to include testing for fentanyl in the urine drug screening. If the urine test is positive for fentanyl, a second analytical confirmation test must be performed. The results of the urine drug test and confirmation test must be retained as part of the patient’s medical record for the period of time required by the hospital’s current practice.

What the new law means:
Providers must include testing for fentanyl when a patient is suspected of a possible drug overdose or poisoning.

The addition of testing for fentanyl should not be limited to patients who are suspected of a possible drug overdose or poisoning. As fentanyl overdoses are becoming more common in patients who unknowingly take a substance that contains fentanyl, emergency medical providers should include testing for fentanyl when ordering any urine drug screening, including for patients who are disoriented or unconscious for unknown reasons.

HB 1353 — Home Health Care Services
What the changes mean:
An administrator may now manage up to five home health agencies that have the same controlling interest, regardless of where they are located in the state.

The initial admission visit, all service evaluation visits, and the discharge visit that a home health agency must provide may now be performed by a registered nurse who is contracted but not a direct employee of the home health agency.

HB 1421 — Improving Screening for and Treatment of Blood Clots
This bill aims to improve the screening for and treatment of venous thromboembolism or deep vein thrombosis (blood clots).

New additions to the law:
Every hospital with an emergency department and every ambulatory surgical center must develop and implement policies and procedures for the rendering of appropriate medical attention for patients at risk of forming blood clots.

All non-physician personnel must be trained on the policies and procedures annually. A certified nursing assistant (CNA) employed by a nursing home must undergo in-service training which includes recognizing the signs and symptoms of a blood clot and techniques for providing an emergency response.

A CNA wishing to administer medication, as delegated by a registered nurse, must complete training on identifying signs and symptoms of a blood clot and response protocols to assist a patient with a blood clot as part of the 34-hour training course on medication administration.

Assisted living facilities must provide a pamphlet to residents upon admission which contains information about risk factors for, and recognizing signs and symptoms of, a blood clot.

SB 1768 - Stem Cell Therapy
The new law, §§ 458.3245 and 459.0127, Fla. Stat., authorizes physicians to perform stem cell therapies that have not been approved by the FDA when used for orthopedic conditions, wound care or pain management. It sets forth standards for the retrieval, manufacture, storage and use of stem cells, ensuring the stem cells used are obtained from facilities that meet rigorous regulatory and accreditation requirements. Before administering any stem cell therapy, a physician must provide written notice to the patient that the therapy is not approved by the FDA and must obtain signed informed consent clearly informing the patient of the nature and purpose of the proposed treatment prior to initiation of therapy. Any advertisements must include clearly legible writing indicating the stem cell therapy is not approved by the FDA.

Who does the law not apply to:
Physicians who have obtained FDA approval for an investigational new drug or device for the use of human cells, tissues, or cellular or tissue-based products.

Physicians who perform stem cell therapy under an employment or other contract on behalf of an institution that is certified to perform stem cell therapy or has expertise in stem cell therapy as determined by the Department of Health.

Violations of the law:
A violation may subject the physician to disciplinary action by their regulating board.

A physician who willfully performs, or actively participates in, treatment or research using human cells or tissues derived from a fetus or embryo after abortion commits a felony of the third degree.

A physician who willfully performs, or actively participates in, the sale, manufacture or distribution of computer products created using human cells, tissues or cellular tissue-based products commits a felony of the third degree.

SB 1808 — Refund of Overpayments Made by Patients
This bill requires anyone who accepts payment from a patient’s insurance for services rendered by a health care practitioner and determines that a patient has overpaid for said services to refund the overpayment within 30 days. If a health care practitioner fails to timely refund the overpayment, the failure will constitute grounds for disciplinary action. If a facility or provider licensed by the Agency for Health Care Administration fails to timely refund an overpayment, the agency may impose an administrative penalty of up to $500 on the license.

HB 597 — Diabetes Management in Schools
Public schools may acquire and maintain a supply of undesignated glucagon for use on students with diabetes experiencing hypoglycemic emergencies. Public schools are authorized to obtain the glucagon through a prescription from a county health department or authorized healthcare practitioner, or through arrangements with manufacturers or suppliers. This will help decrease the delay in treatment as students with diabetes experiencing a hypoglycemic emergency can now be treated with glucagon even if they don’t have their own medication at school.

SB 1514 —Anaphylaxis in Public and Charter Schools
Schools may maintain a supply of epinephrine auto-injectors (epi-pens), accessible to trained school personnel or authorized students. They must adopt a physician-developed protocol for school personnel, medical and non-medical, who are trained to recognize an anaphylactic reaction and to administer an injection of epinephrine via auto-injection during emergencies. This will help decrease the delay in treatment as students who are experiencing an anaphylactic emergency can receive an injection of epinephrine via an auto-injector by a school nurse or other trained school employee, even if they don’t have their own epi-pen with them. 

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_{The Quarterly Dose – August 2025, has been prepared for our readers by Marshall Dennehey. It is solely intended to provide information on recent legal developments and is not intended to provide legal advice for a specific situation or to create an attorney-client relationship. We welcome the opportunity to provide such legal assistance as you require on this and other subjects. If you receive the alerts in error, please send a note to tamontemuro@mdwcg.com. ATTORNEY ADVERTISING pursuant to New York RPC 7.1. © 2025 Marshall Dennehey. All Rights Reserved.}