This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h0783d.HHS DATE: 4/16/2023 HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: CS/HB 783 Emergency Opioid Antagonists SPONSOR(S): Healthcare Regulation Subcommittee, Caruso TIED BILLS: IDEN./SIM. BILLS: SB 704 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Healthcare Regulation Subcommittee 14 Y, 0 N, As CS Osborne McElroy 2) Health Care Appropriations Subcommittee 13 Y, 0 N Fontaine Clark 3) Health & Human Services Committee Osborne Calamas SUMMARY ANALYSIS Opioids are psychoactive substances which are highly effective pain relievers. Opioids are commonly prescribed to treat acute and chronic pain; however, while highly effective, they are also highly addictive and an overabundance of opioids in the body can lead to a fatal overdose. More than 106,000 Americans died from drug-involved overdose in 2021, including illicit drugs and prescription opioids. In 2021, there were 6,442 opioid overdose deaths reported in Florida, a 22% increase from 2019. Opioid antagonists are used to treat opioid overdoses to counteract the life-threatening depression of the central nervous system and respiratory system that results from an opioid overdose. Under current law, a pharmacist is authorized to order and dispense an emergency opioid antagonist to a patient or caregiver without a prescription or a non-patient-specific standing order being in place. Emergency responders, crime laboratory personnel, and personnel of a law enforcement agency or another agency who, if they are likely to come in contact with a controlled substance or persons at risk of an overdose, are authorized to possess, store, and administer emergency opioid antagonists. In September 2022, the Department of Health (DOH) issued a statewide Standing Order for Naloxone, an emergency opioid antagonist. The Standing Order authorizes pharmacists to dispense certain naloxone formulations to emergency responders for administration to persons exhibiting signs of opioid overdose. Under the Standing Order, emergency responders, including law enforcement, firefighters, paramedics, and emergency medical technicians, can go to a pharmacy or community-based program for training on opioid antagonist administration and receive an opioid antagonist without a patient-specific prescription. CS/HB 783 expands the authority of pharmacies, pharmacists, pharmacy technicians, and first responders to possess, dispense, and administer emergency opioid antagonists. The bill also expands civil immunity for those who receive, store, possess or dispense emergency opioid antagonists. The bill creates the Statewide Council on Opioid Abatement within the Department of Children and Families for the purpose of enhancing the development and coordination of state and local efforts to abate the opioid epidemic and to support the victims of the opioid crisis. The bill has an indeterminate, negative fiscal impact on the Department of Children and Families and the Department of Legal Affairs. The bill also has an insignificant, negative fiscal impact on DOH that can be absorbed within existing resources. The bill has no fiscal impact on local government. See Fiscal Comments. The bill provides an effective date of July 1, 2023. STORAGE NAME: h0783d.HHS PAGE: 2 DATE: 4/16/2023 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Background Opioids are psychoactive substances derived from the opium poppy, or their synthetic analogues. 1 Opioids are highly effective pain relievers, and as such are commonly used to treat acute and chronic pain. An individual experiences pain because of a series of electrical and chemical exchanges across the individual’s peripheral nerves, spinal cord, and brain. 2 Opioid receptors occur naturally and are distributed widely throughout the central nervous system and in peripheral sensory and autonomic nerves and modulate the body’s perception of pain. 3 Opioids bind to specific opioid receptors, disrupt the transmission of pain signals through the central nervous system and reduce the perception of pain. 4 Opioids include prescription medications used to treat pain, as well as illegal drugs. Opioids include: 5 Buprenorphine (Subutex, Suboxone), Codeine, Fentanyl (Duragesic, Fentora), Heroin, Hydrocodone (Vicodin, Lortab, Norco), Hydromorphone (Dilaudid, Exalgo), Meperidine, Methadone, Morphine, Oxycodone (OxyContin, Percodan, Percocet), Oxymorphone, Tramadol, and U-47700. Opioids can create a euphoric feeling because they affect the regions of the brain involved with pleasure and reward, which can lead to abuse. 6 In 2019, an estimated 62 million people used opioids for non-medical reasons worldwide. 7 Opioids are commonly misused, with an estimated 36.3 million people worldwide suffering from drug use disorders. 8 Continued use of opioids can lead to the development of tolerance and psychological and physical dependence. 9 This dependence is characterized by a strong desire to take opioids, impaired control over opioid use, persistent opioid use 1 World Health Organization, Opioid Overdose, available at https://www.who.int/news-room/fact-sheets/detail/opioid-overdose (last visited March 20, 2023). 2 Medical News Today, What is pain, and how do you treat it? (Sept. 7, 2020), available at https://www.medicalnewstoday.com/articles/145750#:~:text=People%20feel%20pain%20when%20specific,immediate%20contraction% 20of%20the%20muscles (last visited March 20, 2023). 3 Gjermund Henriksen, Frode Willoch, Imaging of Opioid Receptors in the Central Nervous System, Brain (2008) 131 (5): 1171-1196. 4 Id. 5 U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, SAMHSA Opioid Overdose Toolkit: Facts for Community Members (2018), available at https://store.samhsa.gov/sites/default/files/d7/priv/sma18- 4742.pdf (last visited March 20, 2023). 6 National Institute on Drug Abuse, How Do Opioids Affect the Brain and Body?, (June 2020), available at http://www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids/how-do-opioids-affect-brain-body (last visited March 20, 2023). 7 Florida Department of Law Enforcement, Drugs Identified in Deceased Persons by Florida Medical Examiners 2019 Report, (Nov. 2020), available at https://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-in-Deceased-Persons/2019-Annual- Drug-Report.aspx#:~:text=%E2%9C%93%20The%20most%20frequently%20occurring,)%20and%20oxycodone%20(1%2C181 ) (last visited March 20, 2023). 8 United Nations Office on Drugs and Crime, World Drug Report 2021, Global Overview: Drug Demand and Drug Supply (Jun. 2021), available at https://www.unodc.org/res/wdr2021/field/WDR21_Booklet_2.pdf (last visited March 20, 2023). 9 Supra, note 4. STORAGE NAME: h0783d.HHS PAGE: 3 DATE: 4/16/2023 despite harmful consequences, a higher priority given to opioid use than to other activities and obligations, and a physical withdrawal reaction when opioids are discontinued. 10 Opioid Overdose An overabundance of opioids in the body can lead to a fatal overdose. The opioid receptors that are located in major pain pathways, thus enabling opioids to alleviate the sensation of pain, are also found in the respiratory control centers of the brain. 11 Opioids disrupt the transmission of signals for respiration in the identical manner as they disrupt the transmission of pain signals. This leads to a reduction, and possible cessation, of an individual’s respiration. Oxygen starvation will eventually stop vital organs like the heart and brain and can lead to unconsciousness, coma, and possible death. 12 Within 3-5 minutes without oxygen, brain damage starts to occur, soon followed by death. 13 However, a person’s breathing will commonly slow gradually over time and breathing may not stop until minutes to hours after the drug or drugs were used. 14 An opioid overdose can be identified by a combination of three signs and symptoms referred to as the “opioid overdose triad”: 15 Pinpoint pupils; Unconsciousness; and Respiratory depression. More than 106,000 Americans died from drug-involved overdose in 2021, including illicit drugs and prescription opioids. 16 Opioid-involved overdose deaths increased from 21,088 in 2010 to 47,600 in 2017; the rate of such deaths remained relatively consistent for the next two years with 49,860 opioid- involved overdose deaths in 2019. 17 This was followed by a sharp increase in opioid-involved overdose deaths associated with the COVID-19 pandemic beginning in 2020. 18 Nationally, there were 63,630 reported opioid-involved overdose deaths in 2020 and 80,411 in 2021. 19 The graph below demonstrates the total number of U.S. overdose deaths involving any opioid 20 from 1999 to 2021. 21 10 Supra, note 1. 11 Pattinson, K.T.S., Opioids and the Control of Respiration, BJA, Vol. 100, Issue 6, Pages 747-758, available at https://doi.org/10.1093/bja/aen094. 12 Harm Reduction Coalition, Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects, (Aug. 31, 2020), available at http://harmreduction.org/our-work/overdose-prevention/ (last visited March 20, 2023). 13 Id. 14 Id. 15 Supra, note 1. 16 National Institute on Drug Abuse, Overdose Death Rates, available at https://www.drugabuse.gov/drug-topics/trends- statistics/overdose-death-rates (last visited March 20, 2023). 17 Id. 18 Ghose, R., Forati, A.M. & Mantsch, J.R. Impact of the COVID-19 Pandemic on Opioid Overdose Deaths: A Spatiotemporal Analysis. J Urban Health 99, 316–327 (2022), available at https://doi.org/10.1007/s11524-022-00610-0 (last visited March 27, 2023). 19 Supra, note 16. 20 Any opioid includes prescription opioids (natural and semi-synthetic opioids and methadone), heroin and synthetic opioids other than methadone (primarily fentanyl). 21 Supra, note 16. STORAGE NAME: h0783d.HHS PAGE: 4 DATE: 4/16/2023 Opioid Deaths in the United States, 1999-2021 22 Prior to the COVID-19 pandemic, the increase in opioid overdose deaths can be outlined in three distinct waves: The first wave began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids increasing since at least 1999. The second wave began in 2010, with rapid increase in overdose deaths involving heroin. The third wave began in 2013, with significant increases in overdose deaths involving synthetic opioids, particularly those involving illicitly manufactured fentanyl. The market for illicitly manufactured fentanyl continues to change, and the drug can be found in combination with heroin, counterfeit pills, and cocaine. 23 In 2021, there were 6,442 opioid overdose deaths reported in Florida, a 22% increase from 2019. 24 There were an additional 50,803 all-drug, non-fatal overdoses resulting in an emergency department visit in 2021. 25 Additionally, fentanyl, an extremely potent opioid drug, is the leading cause of overdose deaths in Florida, and the incidence of fentanyl overdose deaths increased by 38 percent from 2,348 in 2019 to 3,244 in 2020. 26 Opioid Antagonists An opioid antagonist, such as Narcan or Naloxone, is a drug that blocks the effects of exogenously administered opioids. Opioid antagonists are used in opioid overdoses to counteract life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. 27 This occurs because opioid antagonists create a stronger bond with opioid 22 Supra, note 16. 23 Centers for Disease Control and Prevention, Understanding the Opioid Overdose Epidemic, available at https://www.cdc.gov/opioids/basics/epidemic.html (last visited March 20, 2023). 24 Florida Department of Health, FL Health Charts: Substance Use Dashboard, available at https://www.flhealthcharts.gov/ChartsDashboards/rdPage.aspx?rdReport=SubstanceUse.Overdose (last visited March 20, 2023). 25 Id. 26 Project Opioid, A Pandemic Fueling an Epidemic in Florida in 2020, available at https://projectopioid.org/wp- content/uploads/2020/12/PO-2020-Data-Study-Final_New-Section.pdf (last visited March 20, 2023). 27 Harm Reduction Coalition, Understanding Naloxone, (Sept. 8, 2020), available at http://harmreduction.org/issues/overdose- prevention/overview/overdose-basics/understanding-naloxone/ (last visited March 20, 2023). STORAGE NAME: h0783d.HHS PAGE: 5 DATE: 4/16/2023 receptors than opioids. This forces the opioids from the opioid receptors and allows the transmission of signals for respiration to resume. 28 This effect lasts only for a short period of time, 29 with the narcotic effect of the opioids returning if still present in large quantities in the body. In this scenario, additional doses of an opioid antagonist would be required, which is why it is generally recommended that anyone who has experienced an overdose seek medical attention. Opioid antagonists, such as naloxone, have no potential for abuse 30 and will not cause harm if mistakenly administered to a person who is not overdosing on an opioid. 31 Pharmacists Dispensing Opioid Antagonists Chapter 465, F.S., regulates the permitting and licensure of pharmacies, pharmacists, and pharmacy technicians. Pharmacies are facilities permitted under the Department of Health (DOH) where medicinal drugs may be compounded, dispensed, stored, or sold. 32 A pharmacy may only operate with a licensed pharmacist present and on duty. 33 Pharmacy technicians assist, and work under the supervision of, licensed pharmacists, but do not dispense medications or provide medical advice. 34 Under current law, dispensing a drug includes the assessment of the prescription for potential adverse effects and counseling the patient regarding the drug; this is an act conducted exclusively by a pharmacist. 35 Neither the actual sales transaction and delivery of a drug nor the administration 36 of such drug are considered dispensing. 37 Under current law, a pharmacist is authorized to order and dispense an emergency opioid antagonist to a patient or caregiver without a prescription or a non-patient specific standing order being in place. 38 In September 2022, DOH issued a statewide Standing Order for Naloxone. 39 The Standing Order authorizes pharmacists to dispense certain naloxone formulations to emergency responders for administration to persons exhibiting signs of opioid overdose. Under the Standing Order, emergency responders, including law enforcement, firefighters, paramedics, and emergency medical technicians, can go to a pharmacy or community-based program for training on opioid antagonist administration and receive an opioid antagonist without a patient-specific prescription. 40 Under current law, emergency responders, crime laboratory personnel, and personnel of a law enforcement agency or another agency who are likely to come in contact with a controlled substance or persons at risk of an overdose, are authorized to possess, store, and administer emergency opioid antagonists. Such individuals are immune from civil liability for administering an emergency opioid antagonist in accordance with the Good Samaritans Act. 41 Multistate Opioid Lawsuit and Settlement 28 Supra, note 11. 29 The half-life for a common opioid antagonist in adults ranged from 30 to 81 minutes. Acute opiate withdrawal is a potential side-effect of naloxone; however, this would be time limited to the half-life of naloxone. 30 Supra, note 27. 31 Centers for Disease Control and Prevention, 5 Things to Know About Naloxone, (Oct. 25, 2022), available at https://www.cdc.gov/drugoverdose/featured- topics/naloxone.html#:~:text=Naloxone%20is%20safe.,Small%2C%20constricted%20%E2%80%9Cpinpoint%20pupils%E2%80%9D (last visited March 20, 2023). 32 S. 465.003(20)(a), F.S. 33 S. 465.003(20)(b), F.S. 34 S. 465.014, F.S. 35 S. 465.003(13), F.S. 36 See s. 465.003(2), F.S. “Administration” means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. 37 Id. 38 S. 381.887, F.S. 39 Florida Department of Health, Statewide Standing Order for Naloxone, (Sep. 30, 2022), available at https://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf (last visited March 20, 2023). 40 Id. 41 S. 381.887(5), F.S.; see also s. 768.13, F.S. STORAGE NAME: h0783d.HHS PAGE: 6 DATE: 4/16/2023 In 2018, Attorney General Pam Bondi filed a lawsuit against multiple opioid manufacturers and distributors. The suit was later expanded to include the pharmacies CVS and Walgreens. 42 The complaint alleged that the defendants caused the opioid crisis by, among other things: 43 Engaging in a campaign of misrepresentations and omissions about opioid use designed to increase opioid prescriptions and opioid use, despite the risks. Funding ostensibly neutral and independent “front” organizations to publish information touting the benefits of opioids for chronic pain while omitting the information about the risks of opioid treatment. Paying ostensibly neutral medical experts called “key opinion leaders” who were really manufacturer “mouthpieces” to publish articles promoting the use of opioids to treat pain while omitting information regarding the risks. In 2021, McKesson, Cardinal Health, and AmerisourceBergen, the nation’s three largest pharmaceutical distributors, as well as manufacturer Janssen Pharmaceuticals, Inc., agreed to a national settlement in which the distributors agreed to pay $21 billion over 18 years and Janssen agreed to pay $5 billion over nine years. 44 Of the $26 billion available, approximately $22.7 billion is earmarked for use by states that participated in the lawsuit, including Florida. 45 Florida has additionally negotiated individual settlements with multiple other companies including: 46 $65 million settlement with Endo Health Solutions; $440 million settlement with CVS Pharmacy, Inc.; $177,114,999 settlement with Teva Pharmaceuticals Industries, Ltd.; $122 million settlement with Allergan Finance, LLC.; $620 million settlement with Walgreens Boots Alliance, Inc. and Walgreens Co.; and $215 million settlement with Walmart. These settlements will pay out over a period of time ranging from 10 to 18 years. The monies from the settlements in general must be used for the purpose of opioid abatement, including prevention efforts, treatment, and recovery services, and to pay fees and costs incurred by the state, cities, and counties. 47 Additionally, Teva Pharmaceuticals has agreed to provide the state with a supply of Naloxone Hydrochloride, an opioid antagonist, valued at $84 million. 48 Florida’s Good Samaritan Act The Good Samaritan Act (the Act) is established under s. 768.13, F.S. The Act provides civil immunity to any person, including those licensed to practice medicine, who gratuitously and in good faith renders emergency care or treatment in direct response to an emergency situation. 49 Under the Act, a person may not be held liable for any civil damages resulting from such care or treatment, or failure to act in providing further medical treatment where the person acted as a reasonable person would. 42 Sullivan, E., NPR, Florida Sues Walgreens, CVS for Alleged Role in Opioid Crisis, (Nov. 2018), available at https://www.npr.org/2018/11/19/669146432/florida-sues-walgreens-cvs-for-alleged-role-in-opioid-crisis (last visited March 20, 2023). 43 Florida Attorney General, Florida’s Opioid Lawsuit, available at http://myfloridalegal.com/webfiles.nsf/WF/MNOS- AYSNED/$file/Complaint+summary.pdf (last visited March 20, 2023). 44 National Opioid Settlement, Executive Summary of National Opioid Settlements, (Feb. 2023), available at https://nationalopioidsettlement.com/executive- summary/#:~:text=In%20all%2C%20the%20Distributors%20will,additional%20manufacturers%E2%80%94Allergan%20and%20Teva (last visited March 20, 2023). 45 Office of the Attorney General, Attorney General Moody Secures Relief for Opioid Crisis, available at https://myfloridalegal.com/opioidsettlement (last visited March 20, 2023). 46 Id. 47 Id. 48 Id. 49 S. 768.13(2)(a) and (b), F.S., in this context, an emergency situation includes those arising out of a public health emergency declared pursuant to s. 381.00315, a state of emergency which has been declared pursuant to s. 252.36 or at the scene of an emergency outside of a medical facility. STORAGE NAME: h0783d.HHS PAGE: 7 DATE: 4/16/2023 The Act expressly provides civil immunity to health care practitioners 50 in a hospital attending to patients or for personal reasons who voluntarily provide care necessitated by a sudden or unexpected situation or by an occurrence that demands immediate medical attention. The Act also provides civil immunity to any person participating in emergency response activities under the direction of or in connection with a community emergency response team, local emergency management agencies, the Division of Emergency Management, or the Federal Emergency Management Agency. 51 Effect of Proposed Changes Opioid Antagonists CS/HB 783 expressly authorizes emergency responders to receive, store, and possess approved emergency opioid antagonists. The bill also authorizes emergency responders to administer the emergency opioid antagonist in an emergency situation when a physician is not immediately available. The bill expressly authorizes a pharmacy or pharmacist to receive, store, possess, and dispense emergency opioid antagonists delivered by a manufacturer related to an agreement reached with the Division of Legal Affairs (DLA) for the purpose of dispensing emergency opioid antagonists to emergency responders pursuant to a standing order issued by the Surgeon General. These provisions appear to be duplicative and unnecessary. Current law authorizes a pharmacist to dispense an opioid pursuant to a nonpatient-specific standing order. 52 Current law also authorizes “any person” to receive, store, possess and administer approved emergency opioid antagonists. 53 “Person” includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. 54 Emergency responders, pharmacies and pharmacists are included within the definition of “person” and thus entitled to all rights and protections in current law. The bill authorizes a pharmacy technician to dispense an emergency opioid antagonist pursuant to a standing order issued by the Surgeon General. Pharmacy technicians are not authorized to dispense medications under their current scope of practice. It is unclear if the intent of the bill is to expand the scope of practice for pharmacy technicians. Florida’s Good Samaritan Act The bill amends the Good Samaritan Act to expressly provide that any licensed pharmacy, pharmacist, or pharmacy technician who receives, stores, possesses, or dispenses an emergency opioid antagonist to a first responder in compliance with a standing order by the Surgeon General may not be held liable for any damages, penalties, fines, or costs related to such actions. This provision appears to be duplicative and unnecessary. Current law provides good Samaritan protections to “any person” to receive, store, possess and administer approved emergency opioid antagonists. Pharmacies, pharmacists and pharmacy technicians are included within the definition of “person” and thus entitled to good Samaritan protections under current law. 50 See s. 456.001, F.S., “Health care practitioner” means any person licensed under chapter 457; chapter 458; chapter 459; chapter 460; chapter 461; chapter 462; chapter 463; chapter 464; chapter 465; chapter 466; chapter 467; part I, part II, part III, part V, part X, part XIII, or part XIV of chapter 468; chapter 478; chapter 480; part I, part II, or part III of chapter 483; chapter 484; chapter 486; chapter 490; or chapter 491. 51 S. 768.13(2)(c) and (d), F.S. 52 S. 381.77(3)(b), F.S. 53 S. 381.77, F.S. 54 S. 1.01(3), F.S. STORAGE NAME: h0783d.HHS PAGE: 8 DATE: 4/16/2023 This provision also appears to create a two-tier system of good Samaritan protections: protection for those dispensing under a nonspecific standing order under current law; and protection for those dispensing under the specific standing order in the bill. It can be reasonably inferred that the distinction creates varying levels of good Samaritan protections. It is unclear if it is the intent of the bill to create such a distinction. Statewide Council on Opioid Abatement The settlement agreement between the state and various opioid manufacturers requires the state to create an opioid abatement taskforce to advise state and local governments on the priorities that should be addressed with the settlement funds. The bill establishes the Statewide Council on Opioid Abatement (Council) within DCF for the purpose of enhancing the development and coordination of state and local efforts to abate the opioid epidemic and to support the victims of the opioid crisis and their families. Membership The bill requires that the Council be composed of 10 members as follows: The Attorney General, or a designee, who serves as chair; The Secretary of DCF, or a designee, who serves as vice-chair; A member appointed by the Governor; A member appointed by the President of the Senate; A member appointed by the Speaker of the House; Two members appointed by the Florida League of Cities who are commissioners or mayors of municipalities. At least one of such members must be from a municipality with a population of less than 50,000; Two members appointed by, or through, the Florida Association of Counties who are county commissioners or mayors. One of such members must represent a county with a population of more than 200,000; the other must represent a county with a population of fewer than 200,000; and One member who is appointed on a rotational basis by either the Florida Association of Counties or the Florida League of Cities. The bill specifies that members are appointed to two-year terms and may not receive a commission, fee, or financial benefit in connection with their service on the Council, but may be reimbursed for per diem and travel expenses in accordance with s. 112.061, F.S., 55 by the agency that the member represents, or by DCF if the member is not affiliated with a state agency. Organization and Support The bill requires that the first meeting of the Council be held by August 31, 2023. The Council is directed to meet quarterly thereafter, and upon the call of the chair or two other members. The bill allows for meetings of the Council to take place in person or virtually. The bill specifies that a majority of the members of the Council is necessary for a quorum. The bill requires that DCF and DLA provide the Council with staff as necessary for the performance of the Council’s duties. The bill authorizes the Council to apply for and accept funds, grants, gifts, and services from the state, the Federal Government and its agencies, or any other public or private source for the purposes of defraying costs or performing its duties. The bill specifies that Council members are required to adhere to all laws, rules, and regulations, including s. 112.311, F.S., relating to the disclosure of conflicts of interest and recusal. Duties of the Council 55 See S. 112.061, F.S., which sets rates for travel and per diem reimbursement. STORAGE NAME: h0783d.HHS PAGE: 9 DATE: 4/16/2023 The bill assigns the Council a series of duties associated with the monitoring of the abatement of the opioid epidemic in Florida and review of settlement fund expenditures associated with the opioid litigation. The duties of the Council include the following: Advising the state and local governments on resolving or abating the opioid epidemic and reviewing how settlement monies recovered from the opioid litigation brought by the state and its subdivisions have been spent and the results that have been achieved from those expenditures; Working with and exchanging information with the Statewide Drug Policy Advisory Council to ensure that the recommendations and actions of each are consistent to the extent possible; Reviewing data from local, state, and national agencies on a regional and statewide basis to advise the state and local governments on the status of the opioid epidemic; Reviewing data from local, state, and national agencies regarding how monies are being spent to abate the opioid epidemic, the success of such programs, and the appropriate metrics necessary for assessing the opioid epidemic; Developing and recommending metrics, measures, or data sets for the assessment of the progress and success of programs funded by expenditures of opioid settlement monies. The Council is directed to align its recommended metrics, measures, or data sets with those the state uses with its managing entities, as well as any required by the Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services in connection with grants received by the state; With the assistance and support of DCF, providing a system of documentation and reporting commensurate with the requirements of federal and other agencies providing funding to the state, including, but not limited to, auditing expenditures consistent with any requirements imposed by the Legislature; Publishing an annual report containing how settlement moneys were spent in the previous fiscal year by the state, managing entities, and each county and municipality. The report must also contain recommendations to the Governor, the Legislature, and local governments for how moneys should be prioritized and spent the coming fiscal year in response to the opioid epidemic. The first report is required to be published by December 1, 2023, and must be posted on the website of DCF and DLA. Each county, city, managing entity, or state agency which receives settlement monies from an opioid settlement is required to annually provide to the Council information regarding how it intends to use settlement funds and collect data on its use of funds and the expenditure of settlement moneys and the results of those expenditures. The Council may also request information relating to metrics, measures, or data sets from each county, city, managing entity, or agency. If a county, city, managing entity, or agency fails to provide information requested by the Council, the DLA, acting on behalf of the Council, may seek such information through civil investigative demand, subpoena, or by commencing an action seeking such information. B. SECTION DIRECTORY: Section 1: Amends s. 381.887, F.S., relating to emergency treatment for suspected opioid overdose. Section 2: Creates s. 397.335, F.S., relating to the Statewide Council on Opioid Abatement. Section 3: Amends s. 768.13, F.S., relating to the Good Samaritan Act; immunity from civil liability. Section 4: Provides an effective date of July 1, 2023. II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 1. Revenues: None. STORAGE NAME: h0783d.HHS PAGE: 10 DATE: 4/16/2023 2. Expenditures: The bill may have an indeterminate, negative fiscal impact on DCF and DLA associated with establishing and staffing the Council. However, the impact on each agency will likely be insignificant and can be absorbed within existing resources. DOH will experience a non-recurring increase in workload associated with the expanded authority granted to specific practitioners in the bill. Current resources are adequate to absorb this increase. B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: None. C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: None. D. FISCAL COMMENTS: None. III. COMMENTS A. CONSTITUTIONAL ISSUES: 1. Applicability of Municipality/County Mandates Provision: Not applicable. The bill does not appear to affect county or municipal governments. 2. Other: None. B. RULE-MAKING AUTHORITY: DOH has sufficient rulemaking authority to implement the bill’s provisions. C. DRAFTING ISSUES OR OTHER COMMENTS: None. IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES On March 22, 2023, the Healthcare Regulation Subcommittee adopted an amendment and reported the bill favorably as a committee substitute. The amendment removed legislative intent provisions from the bill. The analysis is drafted to the committee substitute as passed by the Healthcare Regulation Subcommittee.