House Staff Analysis: PCS for CS/HB 1013, Protection from Discrimination Based on Health Care Choices
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- 2023 3220 Commerce Committee Proposed Committee Bill Analyses Fn Pcs1013 Com
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- 2023 3220 Commerce Committee Proposed Committee Bill Analyses Fn Pcs1013 Com
Summary
A House of Representatives staff analysis of the PCS for CS/HB 1013, Protection from Discrimination Based on Health Care Choices, sponsored by the Commerce Committee and dated April 23, 2023. It summarizes current Florida law barring vaccination requirements and describes how the bill would prohibit businesses, governmental entities and educational institutions from requiring COVID-19 tests, facial coverings or vaccination documentation. The analysis says the bill requires express informed patient consent for COVID-19 treatment alternatives, moves enforcement to the Department of Legal Affairs, and grants pharmacists licensure discipline immunity. Background sections cover mRNA vaccines and FDA approvals and emergency use authorizations for COVID-19 drugs. The analysis states the bill is effective June 1, 2023 and has no impact on local government.
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“House Staff Analysis: PCS for CS/HB 1013, Protection from Discrimination Based on Health Care Choices.”
Original at www.flhouse.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2023-3220-commerce-committee-proposed-committee-bill-analyses-fn-pcs1013-com/
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HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: PCS for CS/HB 1013 Protection from Discrimination Based on Health Care Choices
SPONSOR(S): Commerce Committee
TIED BILLS: IDEN./SIM. BILLS:
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
Orig. Comm.: Commerce Committee Lloyd Hamon
SUMMARY ANALYSIS
The COVID-19 pandemic caused millions of deaths around the world, including over 1.1 million in the U.S.
Currently, hospitalizations and deaths from COVID-19 remain relatively low nationwide. In response, the federal
government issued Emergency Use Authorizations (EUAs) and full approvals, for vaccines and treatments. The
federal government also required vaccination and other preventive measures in certain settings. The pandemic led
to a worldwide debate on the role of government and private employers in su ch public health emergencies.
Current Florida law prohibits: businesses and governments from requiring employees to be vaccinated; businesses,
governments and educational institutions from requiring proof of vaccination or post -infection recovery; and schools
from requiring students to wear masks or be vaccinated. Enforcement is by the Department of Legal Affairs (DLA)
within the Office of the Attorney General, by the Department of Health (DOH), or by private court action, depending
on the provision.
The BILL amends current prohibitions and creates additional prohibitions. The bill:
Prohibits businesses, governmental entities, and educational institutions from requiring a person to take a
COVID-19 test, wear a facial covering to gain access to or use their services or document vaccination status
for any COVID-19 vaccine, mRNA vaccine, or EUA vaccine.
Prohibits businesses, governmental entities, and educational institutions from discriminating against a
person for refusing to comply with a requirement prohibited by the bill, or current law, and specifically
prohibits employment discrimination by businesses and governmental entities.
Requires businesses, governmental entities, and educational institutions to provide exemptions and
reasonable accommodations related to other (non-COVID-19, non-EUA and non-mRNA) vaccines.
Prohibits business, governmental entities, and educational institutions from using polices of international
public health organizations, unless expressly authorized by state government.
Prohibits the use of facial coverings in health care settings, except in compliance with emergency rules
required by the bill to be adopted by DOH and the Agency for Health Care Administration (AHCA) .
The bill requires DLA to enforce the provisions against businesses and governmental entities, and moves
enforcement of the current prohibitions against documentation requirements related to vaccination status or post-
infection recovery from DOH to DLA. Similarly, the bill requires DOH to enforce the provisions against educational
institutions, and repeals the current authority for parents and adult students to pursue declaratory and injunctive
relief to enforce the current prohibitions against requiring documentation of COVID-19 vaccination or post-infection
recovery.
The bill requires express informed patient consent for the use of COVID-19 treatment alternatives. Practitioners
must consider treatment alternatives approved or authorized by the U.S. Food an d Drug Administration, and explain
the risks and benefits. It prohibits hospitals from interfering with the patient’s right to choose treatment alternatives,
under certain circumstances. Finally, the bill grants pharmacists licensure discipline immunity for dispensing a
prescribed COVID-19 treatment alternative.
The bill has a significant, negative fiscal impact on DLA and DOH, and no impact on local government.
The bill is effective June 1, 2023.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
STORAGE NAME: pcs1013.COM
DATE: 4/23/2023
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
mRNA Vaccines
Vaccines help prevent infection by preparing the body to fight foreign bacteria, viruses, or other
pathogens. All vaccines introduce a harmless piece of a particular bacteria or virus into the body,
triggering an immune response.1
Messenger ribonucleic acid (mRNA) is a molecule that contains instructions directing cells in the human
body to make a certain protein. To enter cells smoothly, mRNA travels within a protective bubble called
a lipid nanoparticle. mRNA vaccines introduce a piece of mRNA that corresponds to a viral protein,
usually a small piece of a protein found on the virus’s outer membrane. By using this mRNA instruction,
cells can build the protein, which matches parts of the pathogen called antigens. 2 Once cells finish
making this protein, they quickly break down the mRNA. mRNA from a vaccine does not enter the
nucleus and does not alter DNA.3
The immune system sees these foreign antigens as invaders, dispatching defenders called antibodies
and T-cells, and training the immune system for potential future attacks. If the real virus attacks the
body, the body’s cells should recognize it, alerting the defender cells.
Though many people first became aware of mRNA technology because of COVID-19 vaccines, the
technology is not new to the scientific community. For decades, scientists have studied mRNA, looking
for ways to unlock its potential to prevent and treat disease. While the mechanism of action for mRNA
technology is relatively simple, researchers have worked for years to develop technologies to allow
mRNA to work in practical applications in the real world.4
mRNA vaccines have been used successfully to attain strong immunity in animals against influenza
virus, Zika virus, rabies virus and others.5 Current research is ongoing for human mRNA vaccines for
various infectious diseases, including HIV, Hepatitis C, Influenza, Malaria, and Tuberculosis.
Additionally, researchers are working on mRNA vaccines for cancer and genetic diseases as well as
treatments for food-based and environmental allergies.6
COVID-19
Beginning in late 2019, a coronavirus, identified as SARS-CoV-2, caused a pandemic of respiratory
illness, called COVID-19, to spread worldwide. COVID-19 can be severe, and has caused millions of
deaths around the world, including over 1.1 million deaths in the United States (US). It can be spread
from person to person and has caused lasting health problems in some.
COVID-19 Vaccines
1 National Library of Medicine, Medline Plus, “What are mRNA vaccines and how do they work?”
https://medlineplus.gov/genetics/understanding/therapy/mrnavaccines/#:~:text=mRNA%20vaccines%20work%20by%20in
troducing,the%20virus%20by%20t he%20vaccine
2 Pfizer, Harnessing the Potential of mRNA, available at https://www.pfizer.com/science/innovation/mrna-technology, (last
visited April 22, 2023).
3 Id. at note 1.
4 Id. at note 2
5 Pardi, N., Hogan, M., Porter, F. et al. mRNA Vaccines — a New Era in Vaccinology, Nat Rev Drug Discov 17, 261–279,
April 2018, available at https://www.nature.com/articles/nrd.2017.243#citeas (last visited April 22, 2023),
6 Penn Medicine, The Future of mRNA Vaccines, available at https://www.pennmedicine.org/mrna, (last vi sited April 22,
2023).
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In 2020, the federal Food and Drug Administration (FDA) issued an Emergency Use Authorization
(EUA)7 for COVID-19 vaccines by Pfizer/BioNTech and Moderna;8 the EUA for the J&J/Janssen
vaccine was issued in 2021.9 The FDA issued full approval for the Pfizer vaccine in August 2021,10 and
for the Moderna vaccine in January 2022.11
In the U.S., approximately 69 percent of the population have completed a primary series; approximately
70 percent of Floridians have completed a primary series. 12 It is estimated that 16.5 percent13 of
Florida’s population and 16.5 percent of the U.S. population14 have had an updated (bivalent) booster
dose.
COVID-19 Treatments
The U.S. Food and Drug Administration (FDA) approves medications for use following a review of
clinical data on safety and effectiveness. In instances of public health emergency, the FDA also issues
EUAs for the use of medical countermeasures; both new drugs not fully approved by the FDA, or
existing drugs not approved by the FDA for this specific purpose. 15
Since 2020, the FDA issued both approvals and EUAs for medications to treat COVID-19, listed in the
table below.16
Drug FDA Action Use
Actemra (Tocilizumab) is approved for the treatment of COVID-19 in hospitalized
Actemra adults who are receiving systemic corticosteroids and require supplemental oxygen,
Approved
(Tocilizumab) non-invasive or invasive mechanical ventilation, or extracorporeal membrane
oxygenation (ECMO).
Veklury (Remdesivir) is approved for the treatment of COVID-19 in adults and pediatric
patients (28 days of age and older and weighing at least 3 kilograms) with positive
Veklury
Approved results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized
(Remdesivir)
and have mild-to-moderate COVID-19 and are at high risk for progression to severe
COVID-19, including hospitalization or death.
Olumiant (baricitinib) is approved for the treatment of COVID-19 in hospitalized adults
Olumiant
Approved requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or
(baricitinib)
extracorporeal membrane oxygenation (ECMO).
Paxlovid
Emergency Use
(nirmatrelvir & An ti vi ra l uses
Authorization
ritonavir)
7 U.S. Food and Drug Administration, Emergency Use Authorization, https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Nov. 8, 2021). Medical
countermeasures are FDA-regulated products (biologics, drugs, and devices) that may be used in the event of a public h ealth
emergency. A determination that a public health emergency exists is insufficient to enable the FDA to issue EUAs ; See 21 U.S.C. §
360bbb-3; EUA allows the FDA to facilitate the availability and use of medical countermeasures during public health emer gencies.
8 U.S. Centers for Disease Control and Prevention, How CDC Is Making COVID-19 Vaccine Recommendations | CDC (last visited Nov.
11, 2021)
9 U.S. Food and Drug Administration, Janssen COVID-19 Vaccine | FDA (last visited April 5, 2023).
10
U.S. Food and Drug Administration, FDA Approves First COVID-19 Vaccine | FDA (last visited April 5, 2023).
11 Moderna COVID-19 Vaccines, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-
19/moderna-covid-19-vaccines, (last visited April 5, 2023).
12 U.S. Centers for Disease Control and Prevention, COVID Data Tracker, Daily Update for the United States,
https://covid.cdc.gov/covid-data-tracker/#datatracker-home, (last visited April 5, 2023); See also COVID-19 Integrated County View,
Vaccinations in Florida, https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=Florida&data-type=CommunityLevels ,
(last visited April 5, 2023).
13 Id.
14 U.S. Centers for Disease Control and Prevention, COVID Data Tracker, COVID-19 Vaccinations in the United States,
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-total
15 U.S. Food and Drug Administration, Emergency Use Authorization, https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited April 5, 2023). Medical
countermeasures are FDA-regulated products (biologics, drugs, and devices) that may be used in the event of a public health
emergency. A determination that a public health emergency exists is insufficient to enable the FDA to issue EUAs ; See 21 U.S.C. §
360bbb-3; EUA allows the FDA to facilitate the availability and use of medical countermeasures during public health emergencies.
16 U.S. Food and Drug Administration, Coronavirus (COVID-19) Drugs, available at https://www.fda.gov/drugs/emergency-
preparedness-drugs/coronavirus-covid-19-
drugs#:~:text=Veklury%20(Remdesivir)%20is%20approved%20for,are%20at%20high%20risk%20for (last viewed April 1, 2023).
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Lagevrio Emergency Use
An ti vi ra l uses
(molnupiravir) Authorization
Ki n e ret Kineret (anakinra) is authorized for the treatment of COVID-19 in hospitalized adults
(a n a kinra) Emergency Use with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at
(Im mu ne Authorization risk of progressing to severe respiratory failure and likely to have an elevated plasma
Mo d u l a to r) soluble urokinase plasminogen activator receptor (suPAR).
Olumiant
Olumiant (baricitinib) is authorized for the treatment of COVID-19 in pediatric patients 2
(baricitinib) Emergency Use
to less than 18 years of age requiring supplemental oxygen, invasive mechanical
(Im mu ne Authorization
ventilation, or extracorporeal membrane oxygen (ECMO).
Mo d u l a to r)
Actemra Actemra (tocilizumab) is authorized for the treatment of COVID-19 in hospitalized
(tocilizumab) Emergency Use pediatric patients 2 to less than 18 years of age who are receiving systemic
(Im mu ne Authorization corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical
m o d ula to r) ventilation, or extracorporeal membrane oxygenation (ECMO).
ARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced
antibodies that can help the immune system's attack on SARS-COV-2. These mAbs
REGEN-COV
block entry into human cells, thus neutralizing the virus like other infectious organisms,
(casirivimab &
SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of
imdevimab)
Emergency Use circulating viral strains. Some variants can cause resistance to one or more of the mAb
SAR S-C OV-2 -
Authorization therapies authorized to treat COVID-19. Due to the high frequency of variants
ta rg e ting
circulating within the United States that are not susceptible to the following mAbs, this
Mo n o cl ona l
product is not currently authorized in any U.S. region until further notice by FDA and
An ti b o di es
may not be administered for the pre-exposure prophylaxis for prevention or the
treatment of COVID-19 under the EUA.
ARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced
antibodies that can help the immune system's attack on SARS-COV-2. These mAbs
block entry into human cells, thus neutralizing the virus like other infectious organisms,
Sotrovimab
SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of
SAR S-C OV-2 -
Emergency Use circulating viral strains. Some variants can cause resistance to one or more of the mAb
ta rg e ting
Authorization therapies authorized to treat COVID-19. Due to the high frequency of variants
Mo n o cl ona l
circulating within the United States that are not susceptible to the following mAbs, this
An ti b o di es
product is not currently authorized in any U.S. region until further notice by FDA and
may not be administered for the pre-exposure prophylaxis for prevention or the
treatment of COVID-19 under the EUA.
ARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced
antibodies that can help the immune system's attack on SARS-COV-2. These mAbs
Bamlanivimab &
block entry into human cells, thus neutralizing the virus like other infectious organisms,
Etesevimab
SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of
SAR S-C OV-2 -
Emergency Use circulating viral strains. Some variants can cause resistance to one or more of the mAb
ta rg e ting
Authorization therapies authorized to treat COVID-19. Due to the high frequency of variants
Mo n o cl ona l circulating within the United States that are not susceptible to the following mAbs, this
An ti b o di es
product is not currently authorized in any U.S. region until further notice by FDA and
may not be administered for the pre-exposure prophylaxis for prevention or the
treatment of COVID-19 under the EUA.
ARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced
antibodies that can help the immune system's attack on SARS-COV-2. These mAbs
block entry into human cells, thus neutralizing the virus like other infectious organisms,
Bebtelovimab
SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of
SAR S-C OV-2 - Emergency Use circulating viral strains. Some variants can cause resistance to one or more of the mAb
ta rg e ting
Authorization therapies authorized to treat COVID-19. Due to the high frequency of variants
Mo n o cl ona l
circulating within the United States that are not susceptible to the following mAbs, this
An ti b o di es
product is not currently authorized in any U.S. region until further notice by FDA and
may not be administered for the pre-exposure prophylaxis for prevention or the
treatment of COVID-19 under the EUA.
ARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced
Evusheld antibodies that can help the immune system's attack on SARS-COV-2. These mAbs
(tixagevimab co- block entry into human cells, thus neutralizing the virus like other infectious organisms,
packaged with SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of
cilgavimab) Emergency Use circulating viral strains. Some variants can cause resistance to one or more of the mAb
SAR S-C OV-2 - Authorization therapies authorized to treat COVID-19. Due to the high frequency of variants
ta rg e ting circulating within the United States that are not susceptible to the following mAbs, this
Mo n o cl ona l product is not currently authorized in any U.S. region until further notice by FDA and
An ti b o di es may not be administered for the pre-exposure prophylaxis for prevention or the
treatment of COVID-19 under the EUA.
Propofol-Lipuro Emergency Use Maintains sedation, generally via continuous intravenous infusion, in patients who are
1%
Authorization intubated and require mechanical ventilation in an intensive care unit (ICU) setting.
(Sedative)
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Regiocit Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a
(R e n al Emergency Use machine treatment that filters and purifies the blood when a patient’s kidneys are
re p l acement Authorization damaged or are not functioning normally. CRRT is used for patients with kidney injury
th e ra py) in acute care settings.
Fr es enius Medical
multiFiltr ate/multi Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a
Bic /multiPlus Emergency Use machine treatment that filters and purifies the blood when a patient’s kidneys are
(R e n al Authorization damaged or are not functioning normally. CRRT is used for patients with kidney injury
re p l acement in acute care settings.
th e ra py)
Some practitioners and patients advocate for the use of other drug and non-drug remedies to treat
COVID-19, with or without the use of the above FDA-approved or -authorized drugs, including, for
example:
Hydroxychloroquine17
Ivermectin18
Methanol
Herbal medicines
Vitamins
Minerals
Probiotics
Nasal saline irrigation and gargling
Ultraviolet light
Green tea
Elderberry syrup
Ginger
Federal COVID-19 Vaccination and Prevention Requirements
In addition to approving vaccines and treatments, the federal government adopted policies to require
vaccination and other preventive measures for businesses and health care facilities.
OSHA COVID-19 Emergency Temporary Standards
On November 4, 2021, the federal Occupational Safety and Health Administration (OSHA) issued
“COVID-19 Vaccination and Testing; Emergency Temporary Standards” (OSHA ETS), along with a
number of Fact Sheets, FAQs, and templates for a mandatory vaccination policy, and a vaccination,
testing, and face covering policy. The OSHA ETS was published in the Federal Register on November
5, 2021. 19
In summary, the OSHA ETS required all employers with 100 or more employees to ensure their
workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative
test result at least weekly and wear a mask. These employers are also required to provide paid time off
to workers who decide to be vaccinated so they can recover in the event of experiencing any short-term
side effects from the vaccination. The OSHA ETS provides penalties of up to $14,000 per violation.
According to the Administration, the requirement was expected to impact over 80 million workers in
private sector businesses with 100 or more employees. 20
17 See, U.S. Food and Drug Administration, “FDA cautions against use of hydroxychloroquine or chloroquine for COVID -19 outside of
the hospital setting or a clinical trial due to risk of heart rhythm problems”, Jan. 12, 2022, available at https://www.fda.gov/drugs/fda-
drug-safety-podcasts/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or (last viewed
April 1, 2023).
18 See, U.S. Food and Drug Administration, “FAQ: COVID-19 and Ivermectin Intended for Animals”, current as of March 10, 2023,
available at https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-
animals#:~:text=A%3A%20No.,acquired%20from%20a%20legitimate%20source (last viewed April 1, 2023).
19 COVID–19 Vaccination and Testing; Emergency Temporary Standard, 86 Fed. Reg. 61402, https://www.federalregister.gov/d/2021-
23643
20 The White House, Path Out of the Pandemic: President Biden’s COVID-19 Action Plan, (Sep. 2021), https://www.vsba.org/wp-
content/uploads/2021/09/Path-out-of-the-Pandemic-POTUS-COVID-19-Action-Plan.pdf (last visited April 5, 2023).
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Challenges to the new OSHA ETS and applications for a stay on its enforcement were brought in
almost every federal circuit in the US. On November 6, 2021, a panel of the US Court of Appeal for the
Fifth Circuit granted a nationwide stay of the OSHA ETS pending further action of that court, because
the “petitions give cause to believe there are grave statutory and constitutional issues with the
mandate.” On November 12th, the Fifth Circuit reaffirmed the initial stay finding that the OSHA ETS was
“overbroad” and “flawed,” and determined that it exceeded OSHA’s statutory authority. 21
All the cases were consolidated and transferred to the Sixth Circuit Court of Appeal,22 which has the
authority to modify, rescind, or leave in place the stay issued by the Fifth Circuit. 23 As of April, 2023,
OSHA has withdrawn the vaccination and testing ETS as an enforceable emergency temporary
standard and suspended enforcement and implementation activities regarding the ETS pending further
development in the litigation.24
CMS Vaccination Rule
On November 5, 2021, CMS issued a new regulation (CMS Rule) 25 governing Medicare certification
and Medicaid provider enrollment. As a condition of receiving Medicare and Medicaid funds, health
care providers must establish and implement policies that will ensure that all workers are fully
vaccinated26 against COVID-19.27 In 2022, CMS revised its guidance and survey procedures for all
provider types related to assessing and maintaining compliance with the staff vaccination
regulatory requirements. The revisions address frequency of review of the staff vaccination
requirements to ensure that deficiency citations recognize good faith efforts by providers/suppliers. 28
CMS estimated the rule would apply to 13,050,000 health care staff in the first year, nationwide. 29
State survey agencies conduct provider surveys to ensure compliance with CMS regulations; in Florida,
federal enforcement surveys are conducted by the Agency for Health Care Administration.
On November 10, 2021, ten states 30 filed a lawsuit in federal court challenging the CMS rule. The
states argue the rule violates the federal Administrative Procedure Act, is not authorized by Congress,
and violates Medicare laws requiring consultation with state officials prior to issuing certain types of
rules. The states also make constitutional claims related to spending powers, the anti-commandeering
doctrine and the Tenth Amendment, and requested declaratory and injunctive relief. 31 The court
granted the plaintiffs’ request for expedited briefing, but a hearing date on the preliminary injunction has
not yet been set.
21 National Law Review, Fifth Circuit Hits Pause on OSHA COVID-19 Vaccine or Testing Emergency Standard,
https://www.natlawreview.com/article/fifth-circuit-hits-pause-osha-covid-19-vaccine-or-testing-emergency-standard
22 The 6 th Circuit hears cases from federal district courts in Kentucky, Michigan, Ohio, and Tennessee.
23 Consolidation Order, In Re: Occupational Safety and Health Agency, Interim Final Rule: COVID-19 Vaccination and Testing;
Emergency Temporary Standard, 86 Fed. Reg. 61402, Issued On November 4, 2021 , MCP No. 165, J.P.M.L. (November 16, 2021).
24
U.S. Dept. of Labor, OSHA, COVID-19 Vaccination and Testing ETS, January 25, 2022, https://www.osha.gov/coronavirus/ets2, (last
visited April 5, 2023); See Also, JDSupra, Navigating the Uncertainties of the ETS: What Employers Should Do Now,
https://www.jdsupra.com/legalnews/navigating-the-uncertainties-of-the-ets-4266782/ (last visited April 5, 2023).
25 The regulation was issued as an Interim Final Rule. Under Medicare law, Interim Final Rules expire three years after issuance,
unless finalized. The Interim Final Rule was effective on the day of publication in the Federal Register (Nov. 5, 2021). See, Social
Security Act § 1871(a)(3) (42 U.S.C. § 1395hh(a)(3)).
26 “Fully vaccinated” means a person 14 days after receipt of either a single-dose vaccine or the second of a two-dose vaccinations
sequence. Receiving a booster is not required to be considered “fully vaccinated.” 61563, citing Centers for Disease Control and
Prevention, Frequently Asked Questions ab out COVID-19 Vaccination, , Mar. 29, 2023, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/faq.html, (lastvisited April 5, 2023).
27 Medicare and Medicaid Programs; Om nibus COVID-19 Health Care Staff Vaccination, 86 Fed. Reg. 61555 to 61627 (Nov. 5, 2021)
(to be codified at 42 C.F.R. pts. 416, 418, 441, 460, 482-486, 491, and 494), available at 2021-23831.pdf (govinfo.gov) (last visited April
5, 2023).
28 Centers for Medicare & Medicaid Services, Memorandum, Revised Guidance for Staff Vaccination Requirements,
https://www.cms.gov/files/document/qs0-23-02-all.pdf, Oct. 26, 2022, (last visited April 5, 2023).
29 Health Care Staff Vaccination, 86 Fed. Reg. 61603, Table 6.
30 Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, New Hampshire.
31 Missouri, et al, v. Joseph Biden, Jr., et al, No. 21-01329, (E.D. Missouri filed on Nov. 10, 2021).
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On November 18, 2021, the State of Florida filed a lawsuit in the Northern District of Florida challenging
the CMS Rule.32 The state argues the CMS action:
Exceeds its authority under federal law;
Was issued without consulting the states as required under law; 33
Was issued without the notice and comment period required by law;
Is arbitrary and capricious; and
Is a condition of receiving federal funds which violates the Spending Clause of the U.S.
Constitution.34
Florida requested the court issue a temporary restraining order and preliminary and permanent
injunctive relief prohibiting defendants from enforcing the mandate which was denied for failure to make
a showing of irreparable harm to justify such an order.35
On January 13, 2022, the U.S. Supreme Court upheld the validity of the CMS rule. 36 Thereafter, Florida
moved to dismiss its appeal, and the case was terminated.37
In response to these federal actions, the Florida Legislature, in Special Session 2021-B, adopted
legislation to regulate businesses, government entities and educational institutions related to
requirements for vaccination, proof of vaccination or infection recovery, and the use of face masks.
(See below.)
COVID-19 Vaccination Mandates in Florida
Private Businesses
Section 381.00317, F.S., generally prohibits businesses from requiring any employee or contracted
worker to be vaccinated for COVID-19. This prohibition applies to any form of corporation, partnership,
association, cooperative, joint venture, business trust, or sole proprietorship that conducts business in
this state, and any charitable organization.
Businesses can require employee vaccination, if they allow the employees to opt out of vaccination for
these or any other reasons:
for medical or religious reasons;
based on immunity to COVID-19 (as determined by testing methods set by DOH rule);
if the employee agrees to periodic testing; or
if the employee uses employer-provided personal protective equipment (PPE).
The statute lays out specific criteria for claiming each of the above exemptions, and requires employer
to use DOH forms for employees to submit statements of exemption.
This prohibition is enforced by the Department of Legal Affairs (DLA) within the Office of the Attorney
General. Employees may file complaints with DLA, which investigates them. DLA must offer the
employer the opportunity to comply with the law. However, DLA is required to fine an employer who
violates this prohibition and terminates an employee due to a vaccination mandate: up to $10,000 per
violation for employers with under 100 employees; and up to $50,000 per violation for employers with
100 or more employees. The statute authorizes the Attorney General to consider various factors and
mitigating circumstances when determining the amount of the fine.
32 Florida v. Dep’t. of Health and Human Srvcs., et al., No. 21-2722 (N.D. Fla. filed on November 17, 2021).
33 42 U.S.C. s. 1395z
34 U.S. Const. art. I, s. 8
35 Florida v. Dep’t. of Health and Human Srvcs., et al., No. 21-2722 (N.D. Fla.) (See Order denying Motion for Preliminary Injunction,
November 20, 2021).
36 Biden. v. Missouri, 142 S.Ct. 647 (2022).
37 Florida v. Dep’t. of Health and Human Srvcs., et al. No. 21- 2722 (N.D. Fla.) (See Notice of Voluntary Dismissal by State of Florida,
February 4, 2022).
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An employer can avoid fines by reinstating employee back pay, if accomplished prior to the issuance of
a final order.
In addition, an employee terminated for failure to comply with an employer vaccination mandate is
eligible for reemployment assistance under ch. 443, F.S., and that refusal to comply does not disqualify
the employee based on misconduct.38
Section 381.00318, F.S., provides a public records exemption for information related to vaccination
mandate investigation of a private business. All such information is both confidential and exempt from
disclosure during an active investigation, and remains so when the investigation is no longer active if
the disclosure, as determined by the Attorney General, would jeopardize another, active, investigation,
or result in certain harms to the complaining employee.
Since enactment, DLA has received 927 complaints, the majority of which were closed due to lack of a
statutory violation. DLA found probable cause for nine complaints, and filed a single administrative
complaint against an employer.39
Government Entities and Educational Institutions
Section 112.0441 prohibits governmental entities and educational institutions from requiring any
employee or contracted worker to be vaccinated for COVID-19. This prohibition applies to the state and
any political subdivision of the state, including local governments, boards and commissions; and to
schools governed by school districts, charter schools, state universities, state college system
institutions, developmental research schools, the Florida Virtual School and the Florida School for the
Deaf and Blind.
The Department of Health (DOH) enforces this prohibition: current law authorizes DOH to impose a fine
up to $5,000 per violation. In addition, an employee terminated for failure to comply with an employer
vaccination mandate is eligible for reemployment assistance under ch. 443, F.S.
Similarly, s. 381.00319, F.S., prohibits educational institutions from requiring students to be vaccinated.
Unlike the other vaccination mandate prohibitions, this prohibition is not enforced by any state agency.
Instead, the law establishes a cause of action for adult students, or parents of minor students, to obtain
injunctive relief against the educational institution. If the parent or student prevails, the law requires the
court to award attorney fees and court costs to the plaintiff.
Sections 381.00317, 112.0441 and 381.00319, F.S., expire on June 1, 2023, unless saved by the
Legislature, thereby ending these prohibitions on COVID-19 vaccination mandates by private
businesses, governmental entities and educational institutions.
Documentation of Vaccination or Post-Infection Recovery
Private Businesses, Government Entities and Educational Institutions
38 The Federal-State Unemployment Insurance Program provides unemployment benefits to eligible workers unemployed through no
fault of their own, as determined by state law. The program is administered as a partnership between the federal government a nd the
states. Florida’s program, administered by the Department of Economic Opportunity (DEO) under ch. 443, F.S., requires claimants to
meet certain eligibility criteria. Applications may be disqualified if the employee:
Voluntarily left work without good cause attributable to his or her employer;
Has been discharged by his or her employer for misconduct;
Is unemployed due to a suspension for misconduct connected to his or her work;
Is unemployed due to a leave of absence initiated by the individual; or
Is discharged for misconduct connected with the individual’s work, consisting of drug use , confirmed by a positive drug test
Failed without good cause to apply for available suitable work, accept suitable work when offered to him or her, or return to his or
her customary self-employment when directed by DEO.
39 Department of Legal Affairs, email to committee staff from Libby Guzzo, Legislative Affairs Director, Feb. 7, 2023 (on file with
committee staff).
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Section 381.00316, F.S., prohibits private businesses, government entities and educational institutions
from requiring people to provide documentation certifying COVID-19 vaccination or post-infection
recovery to access the business, governmental operations or school attendance or enrollment, or to
access the institution and its services.
Current law does not prohibit the use of screening protocols, and expressly states that it should not be
construed to restrict businesses, governments and educational institutions from using protocols, if used
in a manner consistent with “authoritative or controlling” government guidance.
DOH enforces this prohibition: current law authorizes DOH to impose a fine up to $5,000 per violation.
DOH received a combined total of 4,396 notifications of potential violations since enactment of the
prohibitions on vaccination mandates and requirements for documentation of vaccination or post-
infection recovery, as follows:
Business Entities – 3,216
Governmental Entities – 174
Educational Institutions – 231
Other (not specific) – 775
DOH issued 14 warning letters and 5 Notices of Violation, resulting in collection of two fines.40
Masks and Quarantine or Isolation
Schools
Section 1002.20(2)(n), F.S., prohibits K-12 public schools from requiring students to wear face masks
or other facial coverings at school, other than when necessary for occupational or laboratory safety.
Students are allowed to wear face masks if their parents allow it.
Current law also prohibits K-12 public schools from requiring students and employees to stay home from
school if exposed to COVID-19, if they are asymptomatic and have not tested positive for COVID-19.
As with the student vaccination law, this prohibition is enforced by civil litigation, rather than by a state
agency. Parents and adult students may bring an action for declaratory and injunctive relief against the
school district for violations; and, if they prevail, will be awarded attorney fees and costs.
Section 1002.20(2)(n), F.S., expires on June 1, 2023, unless saved by the Legislature, thereby ending
this prohibition on mask requirements and COVID-19 quarantine requirements by private businesses,
public K-12 schools.
Private Businesses and Government Entities
Current law does not address mask or quarantine requirements by other (non-educational) government
entities, or by private businesses.
Effect of the Bill
The bill significantly expands regulation of COVID-19-related policies, and other vaccine-related
policies, for private businesses, governmental entities and educational institutions.
Facial Coverings, Vaccination Status, and COVID-19 Tests and Post-Infection Recovery Status
Businesses and Governments
40 Department of Health, email from Gangul Gabadage, April 5, 2023, on file with committee staff.
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The bill amends s. 381.0016, F.S., to add prohibitions for private businesses and government entities
on requiring any person to take a COVID-19 test to gain entry to, or services from, the business or
government entity, or as a condition of contracting with, employing, or promoting, anyone. The bill
expands these COVID-19-related prohibitions to include business-imposed, and government-imposed,
mandates related to any EUA or mRNA vaccine; not just those related to COVID-19. Under the bill, the
provisions related to mRNA vaccines will sunset July 1, 2025, unless reenacted by the Legislature.
In addition, the bill prohibits businesses and governments from discriminating against employees or
applicants for employment, or otherwise discriminate against any person, based COVID-19 vaccination,
post-infection recovery status, failure to take a COVID-19 test, or vaccination status related to any EUA
or mRNA vaccine.
Facial Coverings
Similarly, the bill adds prohibitions for private businesses and government entities on requirements to
wear a facial covering, including a cloth or surgical face mask, a face shield, or any other device that
covers the mouth and nose. This prohibition does not apply to health care providers and practitioners, if
they are in compliance with facial covering prohibitions and regulations elsewhere in the bill (see
below).
Other Vaccines
The bill also addresses business and government policies related to vaccines other than COVID-19,
EUA and mRNA vaccines: it requires businesses and governments to provide for exemptions and
accommodations for religious and medical reasons, in accordance with federal law. 41
Enforcement
The bill requires DLA to enforce these new prohibitions, and enforce the current prohibition on requiring
documentation of COVID-19 vaccination or post-infection recovery (which is currently enforced by
DOH). The DLA may impose an administrative fine up to $5,000 for each violation, which revenues
must be deposited into the General Revenue Fund, consistent with the enforcement provisions in
current law. The bill authorizes DLA to take certain administrative actions when investigating a
complaint of a violation of these provisions, such as administering oaths, taking depositions, conducting
inspections, issuing subpoenas, etc.
Consistent with current law, the bill authorizes reemployment assistance under ch. 443, F.S., for an
employee terminated for failure to comply with prohibited mandates.
Educational Institutions
The bill amends s. 381.0016, F.S., to add prohibitions for educational institutions on requiring any
person to take a COVID-19 test to gain access to, or services from, the educational institution. The bill
expands these COVID-19-related prohibitions to include vaccination mandates imposed by educational
institutions related to any EUA or mRNA vaccine; not just those related to COVID-19. Under the bill, the
provisions related to mRNA vaccines will sunset July 1, 2025, unless reenacted by the Legislature.
The bill prohibits educational institutions from discriminating against any person based on COVID-19
vaccination, post-infection recovery status, failure to take a COVID-19 test or wear a facial covering, or
vaccination status related to any EUA or mRNA vaccine.
41 See, e.g., the federal Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, Title VII of the Civil
Rights Act of 1964, the Pregnancy Discrimination Act and the Genetic Information Nondiscrimination Act of 2008. This
group of federal laws contain various protections from discrimination on the basis of disability, medical condition, sex,
race, age, pregnancy, and religion. Employers are required to provide reasonable accommodation when requested, and
are authorized to make sufficient inquiry about the nature and justification of the request to make a determination, within
parameters that protect the worker from discrimination.
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Facial Coverings
Similarly, the bill adds a prohibition on requirements to wear a facial covering, including a cloth or
surgical face mask, a face shield, or any other device that covers the mouth and nose. This prohibition
does not apply to facial covering requirements necessary for classes with occupational or laboratory
safety requirements.
Other Vaccines
The bill also addresses educational institution policies related to vaccines other than COVID-19, EUA
and mRNA vaccines: it requires such institutions to provide for exemptions and accommodations for
religious and medical reasons, in accordance with federal law. 42
Enforcement
The bill requires DOH to enforce these new prohibitions, and enforce the current prohibition on
requiring documentation of COVID-19 vaccination or post-infection recovery, consistent with the
enforcement provision in current law. The DOH may impose an administrative fine up to $5,000 for
each violation, which revenues must be deposited into the General Revenue Fund, consistent with the
enforcement provisions in current law. The bill authorizes DOH to take certain administrative actions
when investigating a complaint of a violation of these provisions, such as administering oaths, taking
depositions, conducting inspections, issuing subpoenas, etc.
The bill repeals the current enforcement provision for violations of the COVID-19 vaccination or post-
infection recovery documentation prohibition. Under the bill, parents (and adult children) will no longer
be expressly authorized to bring an action against the educational institution for declaratory and
injunctive relief.
The bill does not save s. 381.00317, F.S., or s. 112.0441, F.S., from repeal on June 1, 2023, so the
current law prohibitions against private businesses and government entities requiring employee
vaccination will terminate on that date.
Facial Coverings and Health Care Facilities
The bill creates s. 408.833, F.S., to address facial covering requirements in health care facilities.
First, it requires the Agency for Health Care Administration (AHCA) and DOH to jointly develop
standards for facial coverings for infection control in health care settings, and adopt them in the form of
emergency rules by July 1, 2023, and publish the standards on their websites. The bill exempts the
agencies from current law making emergency rules effective for only 90 days, and provides that the
emergency rules will remain in effect until the agencies adopt rules under the non-emergency
procedures of ch. 120.
Second, the bill prohibits health care providers and practitioners from requiring facial coverings
inconsistent with the AHCA/DOH standards. This applies to all health care practitioners and health care
settings regulated by DOH and its boards, to facilities licensed by AHCA, certain AHCA-regulated
health care clinics exempt from regulation, and certain providers regulated by the Agency for Persons
with Disabilities.
Instead, the bill requires health care providers and practitioners to adopt facial covering policies and
procedures based on the AHCA/DOH standards by August 1, 2023, publish them online, and post them
in their offices or facilities.
42 See, Id.
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The bill makes violations of this provision grounds for licensure discipline under the applicable practice
acts or facility licensure acts.
COVID-19 Treatment Alternatives
The bill creates s. 456.62, F.S., to regulate interactions between practitioners and patients diagnosed
with COVID-19 related to treatment medication decisions.
Heath care practitioners must obtain informed consent from the patient (or the patient’s legal
representative) before prescribing medication to treat COVID-19. The practitioner must explain the
“alternative medications” to treat COVID-19, including the benefits and risks, sufficiently to allow the
patient to make a “prudent” decision, taking into account the patient’s physical state and ability to
understand the information.
The bill does not define “alternative medications”; instead, it requires the practitioner to consider
medications currently authorized or approved by the federal Food and Drug Administration (see table
above, pp. 3-4). The practitioner must use best clinical judgment to identify, among those alternatives,
which would benefit the patient.
The bill creates s. 395.1057, F.S., to establish a patient right to choose COVID-19 treatment
alternatives in a hospital, and prohibits hospitals from interfering with that right, if the treatment is
recommended by a health care practitioner with privileges at that hospital. Interference with the
patient’s right is grounds for discipline under the hospital licensure act.
Current law related to pharmacy practice obligates pharmacies to exercise independent professional
judgment when dispensing a prescription. The bill grants license disciplinary immunity to a pharmacist
when properly dispensing a COVID-19 treatment alternative.
Policies of International Health Organizations
The bill prohibits businesses, governments and educational institutions from adopting, implementing,
and enforcing public health policies issued by international organizations as guides for their internal
policies. Businesses, governments and educational institutions may use such policies only if authorized
by the legislature in law, by an executive branch rule, or by a gubernatorial executive order issued
under a declared emergency under s. 252.36, F.S.
The bill provides an effective date of June 1, 2023.
B. SECTION DIRECTORY:
Section 1: Amending s. 381.00316, F.S., relating to discrimination based on health care choices;
prohibition.
Section 2: Amending s. 381.00319, F.S., relating to prohibition on mask mandates and vaccination
and testing mandates.
Section 3: Creating s. 381.00321, F.S., relating to international health organization policies.
Section 4: Creating s. 395.1057, F.S., relating to patients’ rights to choose COVID-19 treatment
alternatives.
Section 5: Creating s. 408.824, F.S. relating to facial covering requirements for health care
practitioners and health care providers.
Section 6: Creating s. 456.62, relating to communication of COVID-19 treatment alternatives.
Section 7: Amending s. 465.0266, F.S., relating to common database.
Section 8: Amending s. 1002.20, F.S., relating to K-12 student and parent rights.
Section 9: Creating an unnumbered section of law establishing a statutory sunset.
Section 10: Providing an effective date.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
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1. Revenues:
DOH and DLA may experience increased revenue from fines, which the bill requires to be
deposited into the General Revenue Fund.
2. Expenditures:
The Department of Legal Affairs (DLA) expended $519,758.77 in personnel costs to date enforcing
the current law prohibition against vaccine mandates by private employers. DLA received 927
complaints, the majority of which were closed due to lack of a statutory violation. DLA found
probable cause for nine complaints, and filed a single administrative complaint against an
employer.43 DLA estimates the need for an additional 6.2 FTE to implement the bill’s provisions,
totaling $275,080.99 in recurring general revenue, as indicated in the table below. 44
Class Position Working Title # Base Pay Fringe Total % time Estimated
Code FTE Benefits spent Cost
7747 Senior Assistant 1.2 $94,786.69 $33,175.34 $127,962.03 100% $153,554.44
Attorney General
OPS Paralegal Specialist 2 $41,600.00 $12,480.00 $54,080.00 100% $108,160.00
2117 Systems Programming 1 $88,181.17 $30,863.41 $119,044.58 9% $10,860.60
Administrator-SES
3128 Paralegal Specialist I 1 $38,000.04 $13,300.01 $51,300.05 1% $569.47
3126 Legal Assistant III 1 $33,721.74 $11,802.61 $45,524.35 4% $1,936.48
Annual Cost $275,080.99
As of April 11, DLA has 83 vacancies, so can address this need using existing positions. The Fiscal
Year 2023-2024 House and Senate budgets both provide $5 million in nonrecurring General
Revenue to DLA for COVID-related litigation, including the work required of DLA by this bill. 45
Due to the potential increase of notifications and based on the number of complaints received
during the implementation of the COVID-19 Vaccine Documentation Program, DOH projects a need
for two positions at a professional level. The Department can initiate budget amendment actions
during Fiscal Year 2023-2024 to address this need using existing positions. 46
The bill provisions related to AHCA enforcement of the patients’ right to choose COVID-19
treatment alternatives in hospitals has no fiscal impact on AHCA.
The bill provisions requiring AHCA and DOH to establish emergency rules has an insignificant
negative impact on those agencies, which can be absorbed within current resources .
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
43 Department of Legal Affairs, email to committee staff from Libby Guzzo, Legislative Affairs Dire ctor, Feb. 7, 2023 (on file with
committee staff).
44 Department of Legal Affairs, Agency Bill Analysis of HB 1013, March 7, 2023. Note that this fiscal impact estimate is based o n the bill
as originally filed, and may require adjustment to accurately esti mate the impact of the CS/HB content.
45 House Fiscal Year 2023-2024 GAA Section 82, reverting and appropriating the unexpended funds for Fiscal Year 2022 -2023 for
COVID-19 related litigation.
46 Department of Health, Agency Bill Analysis for HB 1013, April 5, 2023.
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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. This bill does not appear to require counties or municipalities to spend funds or take
action requiring the expenditures of funds; reduce the authority that counties or municipalities have
to raise revenues in the aggregate; or reduce the percentage of state tax shared with counties or
municipalities.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
The bill and current law provide DLA, DOH and AHCA sufficient rule-making authority to implement the
bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
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