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 Committee on Fiscal Policy
BILL:           CS/SB 704
INTRODUCER:     Fiscal Policy Committee and Senator Boyd
SUBJECT:        Substance Abuse Prevention
DATE:           April 21, 2023                  REVISED:
           ANALYST                    STAFF DIRECTOR                 REFERENCE                                 ACTION
1. Looke                            Brown                                HP               Favorable
2. Sneed                            Money                                AHS              Favorable
3. Looke                            Yeatman                               FP              Fav/CS
                     Please see Section IX. for Additional Information:
                                   COMMITTEE SUBSTITUTE - Substantial Changes
  I.    Summary:
        CS/SB 704 creates the Statewide Council on Opioid Abatement (Council) within the Department
        of Children and Families (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.
        The bill amends two definitions in s. 381.887, F.S., to clarify that caregivers need not to have
        recurring contact with persons at risk of an opioid overdose to meet the definition and to include
        health care practitioners who dispense drugs in the definition of “authorized health care
        practitioner.” The bill allows pharmacists to prescribe as well as dispense emergency opioid
        antagonists within the constraints of that section of statute. Additionally, the bill adds emergency
        opioid antagonists that are delivered through a prefilled injection device delivery system to the
        types of opioid antagonists that may be prescribed, dispensed, and administered under the
        section.
        The bill will have an indeterminate, yet insignificant negative fiscal impact on state government.
        See Section V. of this analysis.
        The bill is effective upon becoming law.
BILL:     CS/SB 704                                                                                           Page 2
    II.    Present Situation:
           History of the Opioid Crisis in Florida
           According to the National Institute on Drug Abuse:1
            “In the late 1990s, pharmaceutical companies reassured the medical community that patients
              would not become addicted to prescription opioid pain relievers, and health care providers
              began to prescribe them at greater rates”; and
            “This subsequently led to widespread diversion and misuse of these medications before it
              became clear that these medications could indeed be highly addictive.”
           Between the early 2000s and the early 2010s, Florida was infamous as the “pill mill capital” of
           the nation. At the peak of the pill mill crisis, doctors in Florida bought 89 percent of all the
           oxycodone sold in the country.2
           Between 2009 and 2011, the Legislature enacted a series of reforms to combat prescription drug
           abuse. These reforms included strict regulation of pain management clinics; creating the
           Prescription Drug Monitoring Program (PDMP); and stricter regulation on selling, distributing,
           and dispensing controlled substances.3 “In 2016, the opioid prescription rate was 75 prescriptions
           for every 100 persons in Florida. This rate was down from a high of 83 prescriptions for every
           100 persons. ” 4
           As reported at the time by the Florida Attorney General’s Opioid Working Group:
                  Drug overdose is now the leading cause of non-injury related deaths in the
                  United States. Since 2000, drug overdose death rates increased by 137
                  percent, including a 200 percent increase in the rate of overdose deaths
                  involving opioids. In 2015, over 52,000 deaths in the U.S. were attributed
                  to drug poisoning, and over 33,000 (63 percent) involved an opioid. In 2015,
                  3,535 deaths occurred in Florida where at least one drug was identified as
                  the cause of death. More specifically, 2,535 deaths were caused by at least
                  one opioid in 2015. Stated differently, seven lives per day were lost to
                  opioids in Florida in 2015. Overall, the state had a rate of opioid-caused
                  deaths of 13 per 100,000. The three counties with the highest opioid death
                  rate were Manatee County (37 per 100,000), Dixie County (30 per 100,000),
                  and Palm Beach County (22 per 100,000).5
1
  Center on Positive Behavioral Interventions and Supports, Opioid Crisis and Substance Misuse, available at:
https://www.pbis.org/topics/opioid-crisis-and-substance-misuse (last visited March 17, 2023).
2
  Lizette Alvarez, Florida Shutting ‘Pill Mill’ Clinics, The New York Times (Aug. 31, 2011), available at
http://www.nytimes.com/2011/09/01/us/01drugs.html (last visited March 17, 2023).
3
  See Chapters 2009-198, 2010-211, and 2011-141, Laws of Fla.
4
  Attorney General’s Opioid Working Group, Florida’s Opioid Epidemic: Recommendations and Best Practices, 7 (Mar. 1,
2019), available at https://myfloridalegal.com/webfiles.nsf/WF/TDGT-
B9UTV9/$file/AG+Opioid+Working+Group+Report+Final+2-28-2019.pdf (last visited March 17, 2023).
5
  Id.
BILL:   CS/SB 704                                                                                                  Page 3
         Early in 2017, the federal Centers for Disease Control and Prevention (CDC) declared the opioid
         crisis an epidemic.6 Shortly thereafter, on May 3, 2017, Governor Rick Scott signed Executive
         Order 17-146, declaring the opioid epidemic a public health emergency in Florida.7
         House Bill 21 (2018)
         In 2018, the Florida Legislature passed CS/CS/HB 21 (Chapter 2018-13, Laws of Florida) to
         combat the opioid crisis. CS/CS/HB 21:
          Required additional training for practitioners on the safe and effective prescribing of
             controlled substances;
          Restricted the duration of prescriptions for Schedule II opioid medications to three days or up
             to seven days if medically necessary;
          Reworked the PDMP statute to require that prescribing practitioners check the PDMP prior
             to prescribing a controlled substance and to allow the integration of PDMP data with
             electronic health records and the sharing of PDMP data between Florida and other states; and
          Provided for additional funding for treatment and other issues related to opioid abuse.
         Status of the Opioid Crisis after HB 21
         There is evidence that the passage of HB 21 reduced opioid use in Florida. For example, one
         study that reviewed pharmacy prescriptions claims for a health plan serving more than 45,000
         Floridians found that, on average, the number of enrollees per month that began opioid use
         between April of 2019 and August of 2019 dropped from 5.5 per 1,000 patients to 4.6 per 1,000
         patients.8
         However, with the onset of the COVID-19 pandemic, the incidence of opioid use disorder and
         resulting overdose deaths has once again risen. A report from Project Opioid details provisional
         data from the Department of Health (DOH) showing that deaths from drug overdoses have
         increased by 43 percent between 2019 and 2020, from 56 deaths per 100,000 in 2019 to 94
         deaths per 100,000 in 2020. 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 2020.9 From the start of 2020 through
         the end of 2021, non-fatal opioid related emergency room visits and hospitalizations have
         increased from 4,992 to 5,913 and 1,940 to 2,130, respectively.10 Fatal opioid related overdoses
         during that time period have also trended upward with 6,089 occurring in 2020 and 6,442
         occurring in 2021.11
6
  See Exec. Order No. 17-146, available at https://www.flgov.com/wp-content/uploads/2017/05/17146.pdf. (last visited
March 17, 2023).
7
  Id.
8
  Juan M. Hincapie-Castillo, et al., Changes in Opioid Use After Florida’s Restriction Law for Acute Pain Prescriptions,
JAMA Netw Open. 2020 Feb; 3(2): e200234, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049083/, (last
visited March 17, 2023).
9
  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 17, 2023).
10
   Q1 of 2020 compared to Q4 of 2021, Florida Health Charts, Substance Abuse Dashboard, available at
https://www.flhealthcharts.gov/ChartsDashboards/rdPage.aspx?rdReport=SubstanceUse.Overdose, (last visited March 17,
2023)
11
   Id.
BILL:   CS/SB 704                                                                                                   Page 4
         Multistate Opioid Lawsuit and Settlement
         In 2018, Attorney General Pam Bondi filed suit against multiple opioid manufacturers and
         distributors. The suit was later expanded to include the pharmacies CVS and Walgreens.12 The
         complaint alleged that the defendants caused the opioid crisis by, among other things:
          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.13
         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.14 Of the $26 billion available, approximately $22.7
         billion is earmarked for use by states that participated in the lawsuit, including Florida.15 In
         addition, Florida has negotiated individual settlements with multiple other companies including:
          A $65 million settlement with Endo Health Solutions;
          A $440 million settlement with CVS Pharmacy, Inc.;
          A $177,114,999 settlement with Teva Pharmaceuticals Industries, Ltd.;
          A $122 million settlement with Allergan Finance, LLC.;
          A $620 million settlement with Walgreens Boots Alliance, Inc. and Walgreens Co.; and
          A $215 million settlement with Walmart.16
         These settlements will pay out over a period of time ranging from 10 years to 18 years. The
         monies from the settlements in general must be used on opioid abatement, including prevention
         efforts, treatment or recovery services,17 and to pay fees and costs incurred by the state, cities,
         and counties. Additionally, Teva Pharmaceuticals has agreed to provide the state with $84
         million worth of Naloxone Hydrochloride, which is an opioid overdose reversal medication.18
12
   See Florida Sues Walgreens, CVS for Alleged Role in Opioid Crisis, (November 19, 2018) available at
https://www.npr.org/2018/11/19/669146432/florida-sues-walgreens-cvs-for-alleged-role-in-opioid-crisis (last visited on
March 17, 2023).
13
   See http://myfloridalegal.com/webfiles.nsf/WF/MNOS-AYSNED/$file/Complaint+summary.pdf, (last visited on March
17, 2023).
14
   Executive Summary of National Opioid Settlements, Feb. 3, 2023, available at
https://nationalopioidsettlement.com/executive-
summary/#:~:text=In%20all%2C%20the%20Distributors%20will,additional%20manufacturers%E2%80%94Allergan%20an
d%20Teva., (last visited March 17, 2023).
15
   Opioid Settlements: Who’s in?, Florida DLA, available at https://myfloridalegal.com/opioidsettlement, (last visited March
17, 2023).
16
   Id.
17
   Id. A portion of these funds will go to the state while another portion will go directly to the cities and counties.
18
   Id.
BILL:   CS/SB 704                                                                                              Page 5
         As part of the settlement agreement, Florida agreed to establish an “Opioid Abatement Taskforce
         or Council.” The agreement lays out how the Council must be structured and the tasks the
         Council must perform. For a comparison of what is required of the Council in the settlement
         agreement with the language from CS/SB 704, see the chart below:
 Florida Opioid Allocation and                        CS/ SB 704 Council Provisions
 Statewide Response Agreement
 Create an “Opioid Abatement” Taskforce or            The Statewide Council on Opioid Abatement, an advisory
 Council.                                             council as defined in s. 20.03, [F.S.,] is created within the
                                                      department for the purpose of enhancing the development
                                                      and coordination of state and local efforts to abate the opioid
                                                      epidemic and to support the victims and families of the crisis.
 Council must advise the Governor, Legislature,       The council shall review data from local, state, and national
 DCF, and Local Governments on the priorities         agencies, both on a regional and a statewide basis, to advise
 that should be addressed by the expenditure of       state and local governments on the status, severity, and stage
 Opioid Funds.                                        of the opioid epidemic.
                                                      The council must advise the state and local governments on
                                                      resolving or abating the opioid epidemic.
                                                      The council shall work with and provide and receive
                                                      information from the Statewide Drug Policy Advisory
                                                      Council and make sure that its recommendations and actions
                                                      are consistent with the recommendations of that council to
                                                      the extent possible.
 Council must review how monies have been             The council…must review how settlement monies recovered
 spent and the results that have been achieved        from the opioid litigation brought by state and political
 with Opioid Funds.                                   subdivisions have been spent, and the results that have been
                                                      achieved from such expenditures.
                                                      The council shall review data from local governments, other
                                                      states, and national agencies regarding how moneys are being
                                                      spent to abate the opioid epidemic, the success of such
                                                      programs, and the appropriate metrics needed to assess the
                                                      epidemic and progress in abating it.
 Prior to July 1st of each year, the State and each   By June 30 of each year, each county, municipality,
 of the Local Governments shall provide               managing entity, or state agency that receives settlement
 information to the DCF about how they intend         funds from an opioid settlement shall provide information to
 to expend Opioid Funds in the upcoming fiscal        the council related to how it intends to use settlement funds
 year.                                                and how it intends to collect data regarding its use of funds.
 State and local governments shall report             By August 31 of each year, each county, municipality,
 expenditures to DCF no later than Aug. 31st for      managing entity, or state agency that receives settlement
 the previous fiscal year.                            funds from an opioid settlement must provide information to
                                                      the council related to its expenditure of settlement funds and
                                                      the results obtained from those expenditures.
BILL:   CS/SB 704                                                                                            Page 6
 Florida Opioid Allocation and                      CS/ SB 704 Council Provisions
 Statewide Response Agreement
 Council will set other data sets that need to be   The council shall develop and recommend metrics, measures,
 reported to DCF to demonstrate the                 or data sets to assess the progress and success of programs
 effectiveness of expenditures on Approved          funded by expenditures of opioid settlement funds. The
 Purposes. In setting those requirements the        council must attempt to keep such metrics, measures, or data
 Council shall consider the Reporting               sets consistent with those used by the state with managing
 Templates, Deliverables, Performance               entities as well as any metrics, measures, or data sets required
 Measures, and other already utilized and           by the Substance Abuse and Mental Health Services
 existing templates and forms required by DCF       Administration of the Un