The Florida Senate BILL ANALYSIS AND FISCAL IMPACT STATEMENT (This document is based on the provisions contained in the legislation as of the latest date listed below.) Prepared By: The Professional Staff of the Appropriations Committee on Health and Human Services BILL: CS/CS/SB 1736 INTRODUCER: Appropriations Committee on Health and Human Services; Children, Families, and Elder Affairs Committee; and Senators Grall and Sharief SUBJECT: Insulin Administration by Direct-support Professionals and Relatives DATE: April 14, 2025 ANALYST STAFF DIRECTOR REFERENCE ACTION 1. Rao Tuszynski CF Fav/CS 2. Howard McKnight AHS Fav/CS 3. RC Please see Section IX. for Additional Information: COMMITTEE SUBSTITUTE - Substantial Changes I. Summary: CS/CS/SB 1736 creates s. 393.504, F.S., to allow direct-support professionals or a client’s relative to administer insulin in an Agency for Persons with Disabilities licensed group home facility to a client with a developmental disability. The bill defines the term “direct-support professional” to refer to an individual paid to provide services directly to a client with developmental disabilities that receives home and community- based services. The bill allows direct-support professionals or relatives to administer insulin in group home facilities if the group home facility provides training, and adopts policies and procedures governing the administration of insulin by direct-support professionals or relatives. The bill provides immunity from civil liability to group home facilities that are compliant with the requirements for the administration of insulin. The bill also provides civil and criminal immunity to direct-support professionals or relatives arising out of the administration of insulin in group home facilities, so long as the direct-support professional or relative were compliant with the requirements of administration. The bill provides that the administration of insulin by a direct-support professional or relative in a group home facility includes sliding scale insulin therapy. REVISED: BILL: CS/CS/SB 1736 Page 2 The bill adds subcutaneous administration of insulin and epinephrine by self-administration devices to existing law that allows an unlicensed direct service provider to supervise the self- administration of medication. The bill is expected to have an insignificant, negative fiscal impact on state expenditures. See Section V., Fiscal Impact Statement. The bill takes effect July 1, 2025. II. Present Situation: Agency for Persons with Disabilities — Generally Chapter 393, F.S., identifies the need to provide community-based services and programs for individuals with developmental disabilities that enable individuals to achieve their greatest potential for independent living while reducing the number of individuals in unnecessary institutional placements. 1 The Agency for Persons with Disabilities (APD) provides services to individuals with developmental disabilities and manages Medicaid waivers that provide federally approved services for individuals with developmental disabilities. 2 In addition to central headquarters in Tallahassee, the APD operates a total of six regional offices and 14 field offices throughout the state, as detailed below: 3 1 Section 393.062, F.S. 2 Section 20.197, F.S. 3 Agency for Persons with Disabilities, Regional Offices, available at: https://apd.myflorida.com/region/ (last visited March 11, 2025). Regions Counties Northwest Bay, Calhoun, Escambia, Franklin, Gadsen, Gulf, Holmes, Jackson, Jefferson, Leon, Liberty, Okaloosa, Santa Rosa, Wakulla, Walton, and Washington – Fields 1 and 2. Northeast Alachua, Baker, Bradford, Clay, Columbia, Dixie, Duval, Flagler, Gilchrist, Hamilton, Lafayette, Levy, Madison, Nassau, Putnam, St. Johns, Suwannee, Taylor, Union, and Volusia – Fields 3, 4, and 12. Central Brevard, Citrus, Hardee, Hernando, Highlands, Lake, Marion, Orange, Osceola, Polk, Seminole, and Sumter – Fields 7, 13, and 14 Suncoast Charlotte, Collier, DeSoto, Glades, Hendry, Hillsborough, Lee, Manatee, Pasco, Pinellas, and Sarasota – Suncoast Field (23) and Field 8 Southeast Broward, Indian River, Martin, Okeechobee, Palm Beach, and St. Lucie – Fiels 9 and 10 Southern Dade and Monroe – Field 11 BILL: CS/CS/SB 1736 Page 3 Agency for Persons with Disability - Licensed Placement Array The APD is required to license facilities and adult day training programs for individuals with developmental disabilities. 4 The APD licenses the following facilities, which provide an array of services for individuals with developmental disabilities: 5 Licensed Placements for Individuals with Developmental Disabilities Facility Description Foster Care Facility A residential facility licensed under ch. 393, F.S. that provides a family living environment including supervision and care necessary to meet the physical, emotional, and social needs of its residents. The capacity of such a facility may not be more than three residents. 6 Group Home Facility A residential facility licensed under ch. 393, F.S. which provides a family living environment including supervision and care necessary to meet the physical, emotional, and social needs of its residents. The capacity of such a facility must be at least 4 but not more than 15 residents. 7 Residential Habilitation Center A community residential facility licensed under ch. 393, F.S. which provides habilitation services. The capacity of such a facility may not be fewer than nine residents. After October 1, 1989, new residential habilitation centers may not be licensed and the licensed capacity for any existing residential habilitation center may not be increased 8 Adult Day Training Program A program of services which takes place in a nonresidential setting, separate from the home or facility in which the client resides, and is intended to support the participation of clients in meaningful and valued routines of the community. These services include, but are not limited to, the acquisition, retention, or improvement of self-help, socialization, and adaptive skills. 9 The APD is required to adopt license application procedures, provider qualifications, facility and client care standards, requirements for client records, requirements for staff qualifications and training, and requirements for monitoring the licensed placements. 10 The APD is required to adopt rules relating to the oversight and accountability of such placements. 11 If the licensee fails to comply with licensure or statutory requirements, Florida law authorizes the APD to take disciplinary action against the licensee, such as the revocation or suspension of a licensing, or the imposition of administrative fines. 12 Administration of Medication in APD Licensed Facilities Florida law allows an unlicensed direct service provider to supervise the self-administration of medication or to administer oral, transdermal, ophthalmic, otic, rectal, inhaled, enteral, or topical prescription medications to a client, provided the unlicensed direct service providers meets 4 Section 393.067, F.S. 5 See generally 65G-2, F.A.C. 6 Section 393.063(17), F.S. 7 Section 393.063(18), F.S. 8 Section 393.063(34), F.S. 9 Section 393.063(1), F.S. 10 Section 393.067, F.S. 11 Section 393.067, F.S. 12 Section 393.0673, F.S. BILL: CS/CS/SB 1736 Page 4 statutory requirements. 13 Unlicensed direct service providers who have completed an APD- approved training course and have current validation to provide clients with medication administration or assist clients with self-administration of medication are referred to as Medication Assistance Providers under administrative rule. 14 Medical Case Managers 15 teach Basic Medication Administration Courses to unlicensed direct service providers. 16 Currently, administrative rule does not reference medication administration by non-paid family members. 17 Medication Assistance Providers are not allowed to prepare syringes for a client’s use during the self-administration of medication via a subcutaneous, intra-dermal, intra-muscular, or intravenous route. 18 Syringes, insulin pens, and insulin pumps administer insulin subcutaneously. 19 Currently, licensed nurses are the only individuals who are allowed to administer insulin in APD facilities. 20 Upon a medication error, the Medical Assistance Provider or facility administrator is required to document the incident in a procedure identified in administrative rule. 21 There is no reference to insulin administration in 65G-7, F.A.C., which establishes the requirements for Medication Administration in APD facilities. 22 Diabetes Diabetes occurs when an individual’s blood glucose, or blood sugar, is too high. 23 High blood glucose may lead to negative effects on an individual’s heart, nerve, eye, and kidney function. 24 An individual receives blood glucose through the food he or she eats, and the hormone insulin, produced by the pancreas, assists blood glucose absorption into the cells to produce energy. 25 13 Section 393.506, F.S. 14 65G-7.001, F.A.C. 15 “Medical Case Managers” refer to a registered nurse or Advanced Practice Nurse Practitioner employed by the Agency to provide nursing consultation and technical assistance to an Area office regarding the medical care of Agency clients. See 65G-7.001, F.A.C. 16 Florida Agency for Persons with Disabilities, 2025 Agency Analysis, pg. 2, on file with the Senate Committee on Children, Families, and Elder Affairs. 17 Id. 18 65G-7.005, F.A.C. 19 Shah, Rima B. et al. “Insulin delivery methods: Past, Present, and Future.” International Journal of Pharmaceutical Investigation vol. 6, 1 (2016): 1-9. doi: 10.4103/2230-973X.176456. 20 Supra, Note 16. 21 65G-7.006, F.A.C. 22 65G-7.001, F.A.C. 23 National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Statistics, available at: https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics (last visited March 14, 2025). 24 Id. 25 National Institute of Diabetes and Digestive and Kidney Diseases, Type 2 Diabetes, available at: https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes (last visited March 14, 2025). BILL: CS/CS/SB 1736 Page 5 An individual with diabetes may have trouble producing the insulin necessary to help glucose absorption. The most common types of diabetes are type 1, type 2, and gestational diabetes, which affects individuals during pregnancy. 26 Type 1 diabetes typically occurs when an individual’s immune system attacks and destroys the cells in the pancreas responsible for producing insulin, causing the pancreas to cease insulin production. 27 This causes abnormal levels of blood glucose, as the glucose cannot absorb into the cells and remains in an individual’s blood. 28 An individual with type 1 diabetes will take synthetic insulin every day to facilitate the absorption of blood glucose into an individual’s cells. 29 Type 2 diabetes occurs when an individual’s pancreas does not produce enough insulin or does not utilize insulin well. 30 Insulin Types and Administration There are a variety of insulin types an individual may take to manage their diabetes. 31 The following chart shows different types of insulin 32 Insulin Types Insulin Type Onset Peak Time Duration Method Rapid acting 15 minutes 1 hour 2 to 4 hours Usually taken right before a meal. Often used with longer-acting insulin. Rapid-acting inhaled 10 to 15 minutes 30 minutes 3 hours Usually taken right before a meal. Often used with injectable long-acting insulin. Regular/short acting 30 minutes 2 to 3 hours 3 to 6 hours Usually taken 30 to 60 minutes before a meal. Intermediate acting 2 to 4 hours 4 to 12 hours 12 to 18 hours Covers insulin needs for half a day or overnight. Often used with rapid- or short-acting insulin. Long acting 2 hours Does not peak Up to 24 hours Covers insulin needs for about a full day. Often used, when needed, with rapid- or short-acting insulin. Ultra-long acting 6 hours Does not peak 36 hours or longer Provides steady insulin for long periods. Premixed 5 to 60 minutes Peaks vary 10 to 16 hours Combines intermediate- and short-acting insulin. Usually taken 10 to 30 minutes before breakfast and dinner. 26 National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Statistics, available at: https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics (last visited March 14, 2025). 27 National Institute of Diabetes and Digestive and Kidney Diseases, Type 1 Diabetes, available at: https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-1-diabetes (last visited March 14, 2025). 28 Id. 29 Id. 30 National Institute of Diabetes and Digestive and Kidney Diseases, Type 2 Diabetes, available at: https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes (last visited March 14, 2025). 31 Center for Disease Control Diabetes, Types of Insulin, available at: https://www.cdc.gov/diabetes/about/how-to-use- insulin.html (last visited March 14, 2025). 32 Center for Disease Control Diabetes, Types of Insulin, available at: https://www.cdc.gov/diabetes/about/how-to-use- insulin.html (last visited March 14, 2025). BILL: CS/CS/SB 1736 Page 6 Source: Center for Disease Control Individuals often take insulin differently depending on the type of insulin they use and what method they are most comfortable with when administering insulin. The following chart displays common methods for administering insulin: 33 Insulin Administration Methods Method Description Syringe This method delivers insulin through a needle. This is often referred to as “sliding-scale” administration as the amount needed (the bolus) is calculated based on the current blood glucose level and drawn from a container into a syringe and then administered subcutaneously. Insulin Pen Cartridges may be inserted into an insulin pen for insulin administration. Some insulin pens are pre-filled and single use. The insulin is injected through a needle. Insulin Pump Insulin pumps give an individual a dose of short- or rapid-acting insulin per hour. An individual calculates the insulin dosage, and the insulin in the pump delivers the bolus (short- or rapid-acting insulin take at or before mealtimes). The pump delivers insulin through a thin plastic tube placed in the fatty layer under an individual’s skin. Insulin Inhaler An individual uses an oral inhaler to deliver ultra-rapid-acting insulin at the beginning of meals. Inhaled insulin is used with an injectable long-acting insulin. Auto-Injectors for Medication Administration In recent years, there has been an increased interest in auto injectors for the self-administration of medication in the medical community. 34 Generally, auto injectors are prefilled with an individual’s required dosage of medication (such as insulin or epinephrine) and the individual presses a button or pushes against the injection site to deliver the dosage subcutaneously. 35 Auto injectors have been found to provide an individual more autonomy and flexibility when self- administering their medication. 36 Additionally, auto injectors have been associated with less painful medication administration. 37 III. Effect of Proposed Changes: Section 1 amends s. 393.063, F.S., to define the term “direct-support professional” to mean a person who is paid to provide services directly to a client with developmental disabilities that receives home and community-based services to address activities of daily living or instrumental 33 Center for Disease Control Diabetes, 4 Ways to Take Insulin, available at: https://www.cdc.gov/diabetes/about/4-ways-to- take-insulin.html (last visited March 14, 2025). 34 Schneider, et al. (2023). Autoinjectors for large-volume subcutaneous drug delivery: a review of current research and future directions. Expert Opinion on Drug Delivery, 20(6), 815-830. https://doi.org/10.1080/17425247.2023.2219891 35 Id. 36 Berteau, et al. (2010) Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers, Patient Preference and Adherence, 4, 379-288, https://doi.org/10.2147/ppa.s13132. 37 Id. BILL: CS/CS/SB 1736 Page 7 activities of daily living, behavioral supports, employment supports, or other services to promote community integration of the client. Section 2 creates s. 393.504, F.S., to allow a direct-support professional (DSP) or a client’s relative to administer insulin to a client in a group home facility if the group home facility has established training procedures and has adopted policies and procedures governing the administration of insulin by DSP and relatives. The term “relative” is defined in s. 393.063(30), F.S., and refers to an individual who is connected by affinity or consanguinity to the client and who is 18 years of age or older. If a group home facility wants to allow a DSP or relative to administer insulin, the bill requires the group home facility to have an established procedure to provide training to the DSP or relative in the administration of insulin. This training must be provided by: • A registered nurse, a licensed practical nurse, or an advanced practice registered nurse licensed under ch. 464, F.S.; • A physician licensed under ch. 458, F.S., or ch. 459, F.S.; or • A physician assistant licensed under ch. 458, F.S., or ch. 459, F.S. The bill requires the group home facility to adopt policies and procedures governing the administration of insulin by direct-support professionals and relatives, which must include, but need not be limited to, the following: • Requirements to have the client’s prescribed dosage of insulin required for the client and proof of the direct-support professional’s or relative’s training on file. • Coordination procedures in place between the group home facility and direct-support professional or relative to avoid duplication in insulin administration. • Established emergency procedures related to the administration of insulin to clients. • Certifications for direct-support professionals or relatives to administer insulin if the individual is in compliance with requirements. • Requirements for the group home facility to immediately notify a direct-support professional or relative if he or she is not in compliance with these requirements and immediately cease to allow them to administer insulin. The bill provides compliant group home facilities with immunity from civil liability for damages arising out of the administration of insulin by a direct-support professional or a client’s relative. The bill provides compliant direct-support professionals or relatives with immunity from civil liability or criminal penalties arising out of the administration of insulin to the client. The bill clarifies that DSPs and relatives may administer insulin including sliding scale insulin therapy, to include the calculation of an insulin dose based on current blood glucose for administration of the dose subcutaneously with an insulin pen or a syringe filled with the calculated dose drawn from a vial of insulin. Section 3 amends s. 393.506, F.S., to include, but is not limited to, the subcutaneous administration of insulin and epinephrine through an insulin pen, epinephrine pen, or similar BILL: CS/CS/SB 1736 Page 8 device designed for self-administration to the administration of medication allowed by unlicensed direct service providers. Section 4 amends s. 1002.394, F.S., to make conforming cross-reference changes. Section 5 provides an effective date of July 1, 2025. IV. Constitutional Issues: A. Municipality/County Mandates Restrictions: None. B. Public Records/Open Meetings Issues: None. C. Trust Funds Restrictions: None. D. State Tax or Fee Increases: None. E. Other Constitutional Issues: None identified. V. Fiscal Impact Statement: A. Tax/Fee Issues: None. B. Private Sector Impact: None. C. Government Sector Impact: The Agency for Persons with Disabilities (APD) reports the bill will require enhancements to the iConnect system, the APD’s client data management and electronic visit verification system, and estimates a cost of $20,000 based on the number of hours it will take to make the necessary modifications to some of the impacted forms in the iConnect system. The APD can absorb these costs within existing resources. BILL: CS/CS/SB 1736 Page 9 VI. Technical Deficiencies: None. VII. Related Issues: None. VIII. Statutes Affected: This bill amends the following sections of the Florida Statutes: 393.063, 393.506, and 1002.394. This bill creates section 393.504 of the Florida Statutes. IX. Additional Information: A. Committee Substitute – Statement of Changes: (Summarizing differences between the Committee Substitute and the prior version of the bill.) CS/CS by Appropriations Committee on Health and Human Services on April 10, 2025: The committee substitute specifies that the inclusion of the subcutaneous administration of insulin and epinephrine through an insulin pen, epinephrine pen, or similar device designed for self-administration to the administration of medication allowed by unlicensed direct service providers is not the only administration of medication method allowed under the law. CS by Children, Families, and Elder Affairs on March 19, 2025: • Clarifies that the administration of insulin in a group home facility by a direct-support professional or relative includes sliding scale insulin therapy. • Includes the subcutaneous administration of insulin and epinephrine by a self- administration device in medications that may be self-administered. B. Amendments: None. This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.