HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 1013 Protection from Discrimination Based on Health Care Choices
SPONSOR(S): Commerce Committee, Health & Human Services Committee, Griffitts
TIED BILLS: CS/CS/HB 1015 IDEN./SIM. BILLS: CS/SB 252
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Health & Human Services Committee 12 Y, 5 N, As CS Calamas Calamas
2) Commerce Committee 11 Y, 4 N, As CS 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 such 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 discriminat ing 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 (A HCA).
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 requir ing 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 and 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: h1013a.COM
DATE: 4/24/2023
 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 visited 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 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.
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 i