HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 1373 Rare Disease Advisory Council
SPONSOR(S): Professions & Public Health Subcommittee, DuBose and others
TIED BILLS: IDEN./SIM. BILLS: CS/CS/SB/272
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Professions & Public Health Subcommittee 18 Y, 0 N, As CS Rahming McElroy
2) Health Care Appropriations Subcommittee 13 Y, 0 N Mielke Clark
3) Health & Human Services Committee 20 Y, 0 N Rahming Calamas
SUMMARY ANALYSIS
In the United States, a rare disease is any condition that nationally affects fewer than 200,000 people. As
many as 7,000 rare diseases affect the lives of 25-30 million Americans and their families. This estimate has
been used by the rare disease community for several decades to highlight that while individual diseases may
be rare, the total number of people with a rare disease is large.
The National Organization for Rare Disorders, a non-profit patient advocacy organization dedicated to
individuals with rare diseases and the organizations that serve them, is working to establish a Rare Disease
Advisory Council (RDAC) in every state. Currently, 16 states have established RDACs.
CS/HB 1373 creates the Rare Disease Advisory Council (Council) adjunct to the Department of Health (DOH).
The bill establishes the membership of the Council as well as the length of the members’ terms. The Council
must:
Consult with experts on rare diseases and solicit public comment to assist in developing
recommendations on improving the treatment of rare diseases in this state.
Develop recommended strategies for academic research institutions in this state to facilitate
continued research on rare diseases.
Develop recommended strategies for health care providers to be informed on how to more
efficiently recognize and diagnose rare diseases in order to effectively treat patients.
Provide written input and feedback to the DOH, the Medicaid program, and other state agencies on
specified matters.
CS/HB 1373 requires the Council to first meet by October 1, 2021, and provide its recommendations to the
Governor and the State Surgeon General by July 1 of each year, beginning in 2022.
The bill has a significant, negative fiscal impact on the DOH, which current resources are adequate to absorb,
and no fiscal impact on local governments.
The bill provides an effective date of July 1, 2021.
This document does not reflect the intent or official position of the bill sponsor or House of Representatives .
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FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Rare Disease
In the United States, a rare disease is any condition that nationally affects fewer than 200,000 people.
There may be as many as 7,000 rare diseases impacting the lives of 25-30 million Americans and their
families. This estimate has been used by the rare disease community for several decades to highlight
that while individual diseases may be rare, the total number of people with a rare disease is large.
Nationally, only a few types of rare diseases are tracked when a person is diagnosed. These include
certain infectious diseases, birth defects, and cancers. It also includes the diseases on state newborn
screening tests. Because most rare diseases are not tracked, it is difficult to determine the exact
number of rare diseases or how many people are affected. Researchers have made progress in
learning how to diagnose, treat, and even prevent a variety of rare diseases, however, most rare
diseases have no treatments.1
The National Institutes of Health (NIH) supports research to improve the health of people with rare
diseases. Many of the 27 Institutes and Centers at the NIH fund medical research for rare diseases,
such as the National Center for Advancing Translational Sciences (NCATS), which focuses on getting
new cures and treatments to all patients more quickly. NCATS supports research through collaborative
projects to study common themes and causes of related diseases. This approach aims to speed the
development of treatments that will eventually serve both rare and common diseases.
Efforts to improve and bring to market treatments for rare diseases are coordinated by the Food and
Drug Administration. The Office of Orphan Products Development (OOPD) provides incentives for drug
companies to develop treatments for rare diseases. Between 1973 and 1983, fewer than 10 treatments
for rare diseases were approved. Since 1983, the OOPD program has helped develop and bring to
market more than 400 drugs and biologic products for rare diseases.2
Rare Disease Advisory Council
The National Organization for Rare Disorders (NORD), a non-profit patient advocacy organization
dedicated to individuals with rare diseases and the organizations that serve them, is working to
establish a Rare Disease Advisory Council (RDAC) in every state. An RDAC is an advisory body
providing a platform for the rare disease community to have a stronger voice in state government.3
According to NORD, RDACs address the needs of affected patients and families by giving stakeholders
an opportunity to make recommendations to state leaders on critical issues including the need for
increased awareness, diagnostic tools, and access to affordable treatments and cures.4 These
councils are housed by a variety of organizations including departments of health, outside nonprofits,
universities, or grantees from departments of health. The types of RDACs include councils, task forces,
advisory commissions and work groups.
1 U.S. Department of Health & Human Services, National Institutes of Health (NIH), FAQs About Rare Diseases,
https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-
diseases#:~:text=In%20the%20United%20States%2C%20only,on%20state%20newborn%20screening%20tests. (last visited Mar. 18,
2021).
2 National Organization for Rare Diseases (NORD), Rare Disease Advisory Councils (RDACs): Project RDAC,
https://rarediseases.org/rdac-overview/ (last visited Mar. 18, 2021).
3 National Organization for Rare Diseases (NORD), Rare Disease Advisory Councils (RDACs): Project RDAC,
https://rarediseases.org/rdac-overview/ (last visited Mar. 18, 2021).
4 Id.
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The first RDAC was created in 2015 in North Carolina.5 Currently, 16 states have RDACs.6
Advisory Councils in Florida
In Florida, a statutorily created advisory council is appointed to function on a continuing basis for the
study of the problems arising in a specified functional or program area of state government and to
provide recommendations and policy alternatives.7Section 20.052, F.S., governs advisory bodies and
their creation and requires an advisory council specifically created as an adjunct to an executive
agency to be created only after being found to be necessary and beneficial to the furtherance of a
public purpose and must be terminated by the Legislature when it is no longer necessary.8
Under current law, an advisory body may not be created unless:9
It meets a statutorily defined purpose;
Its powers and responsibilities conform with the definitions for specified governmental units;
Its members, unless expressly provided otherwise in the State Constitution, are appointed for
four-year staggered terms; and
Its members, unless expressly provided otherwise by specific statutory enactment, serve
without additional compensation or honorarium, and are authorized to receive only per diem and
reimbursement for travel expenses as provided in s. 112.061, F.S.
Private citizen members of an advisory body that is adjunct to an executive agency must be appointed
by the Governor, the head of the department, the executive director of the department, or a Cabinet
officer.10 Unless exempt under law, all advisory council meetings are open to the public under s.
286.011, F.S., and minutes, including a record of all votes cast, must be maintained for all meetings.11
If an advisory council adjunct to an executive agency is abolished, its records must be appropriately
stored, within 30 days after the effective date of its abolition, by the executive agency to which it was
adjunct, and any property assigned to it must be reclaimed by the executive agency.12 An advisory
council is prohibited from performing any activities after the effective date of its abolition.13
Florida currently does not have an RDAC. However, the Department of Health (DOH) administratively
supports existing councils to promote engagement with stakeholders regarding disabilities and
developmental delays:14
The Genetics and Newborn Screening Advisory Council: Includes a large array of expertise
ranging from pediatricians, audiologists, representatives from each of the four medical schools
in this state, pediatric hematologist, the Florida Hospital Association, as well as executive
representation from the DOH.
The Florida Interagency Coordinating Council for Infants and Toddlers: Advises and assists the
Early Steps program with its implementation of the Individuals with Disabilities Education Act,
Part C, and includes representation from public and private providers, the Agency for Health
Care Administration, the Department of Education, and parents.
The Information Clearinghouse on Developmental Disabilities Advisory Council: Provides
resources to parents with children with developmental disabilities via the Bright Expectations
website.
5 Id.
6 Alabama, Connecticut, Illinois, Kentucky, Minnesota, Missouri, Nevada, New Hampshire, New York, North Carolina, Ohio,
Pennsylvania, Tennessee, Utah, West Virginia, and Virginia. NORD, RDACs by State, https://rarediseases.org/rdac-overview/rdacs-by-
state/ (last visited Apr. 4, 2021).
7 S. 20.03(7), F.S.
8 S. 20.052, F.S.
9 S. 20.052(4), F.S.
10 S. 20.052(5)(a), F.S.
11 S. 20.052(5)(c), F.S.
12 S. 20.052(5)(d), F.S.
13 Id.
14 Florida Department of Health (DOH), 2021 Agency Legislative Bill Analysis for House Bill 1373, p. 2 (Mar. 1, 2021).
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Effect of Proposed Changes
CS/HB 1373 creates s. 381.99, F.S., to establish the Rare Disease Advisory Council (Council). The
Council is created adjunct to the DOH for the purpose of providing recommendations on ways to
improve health outcomes for individuals with rare diseases, conditions that affect fewer than 200,000
people in the United States.
The bill requires the Governor to appoint members to the Council as follows:
A representative of the Department of Health.
A representative of the Agency for Health Care Administration.
A representative of the Office of Insurance Regulation.
A representative of the Department of Education.
One geneticist practicing in this state.
One registered nurse or advanced practice registered nurse who is licensed and practicing in
this state with experience treating rare diseases.
One hospital administrator from a hospital in this state which provides care to individuals
diagnosed with rare diseases.
A pharmacist who is licensed and practicing in this state who has experience with drugs that are
used to treat rare diseases.
A representative of the biotechnology industry.
A representative of health insurance companies.
The bill requires the President of the Senate to appoint the following members to the Council:
A representative from an academic research institution in this state which receives any grant
funding for research regarding rare diseases.
A physician who is licensed under ch. 458 or ch. 459, practices in Florida, and has experience
treating rare diseases.
An individual who is 18 years of age or older who have a rare disease.
An individual who is a caregiver of an individual with a rare disease.
A representative of an organization operating in this state which provides care or other support
for individuals with rare diseases.
The bill requires the Speaker of the House of Representatives to appoint the following members to the
Council:
A representative from an academic research institution in this state which receives any grant
funding for research regarding rare diseases.
A physician who is licensed under ch. 458 or ch. 459, practices in Florida, and has experience
treating rare diseases.
An individual who is 18 years of age or older who have a rare disease.
An individual who is a caregiver of an individual with a rare disease.
A representative of an organization operating in this state which provides care or other support
for individuals with rare diseases.
Members of the Council must be appointed by September 1, 2021, and are appointed for four-year
terms except that specified members are initially appointed to two-year terms to stagger the
appointments. The Council is required to hold its initial meeting by October 1, 2021, and may meet
upon the call of the chair or upon the request of the majority of its members thereafter. The Council is
authorized to meet electronically.
The bill requires the Council to:
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Consult with experts on rare diseases and solicit public comment to assist in developing
recommendations on improving the treatment of rare diseases in this state.
Develop recommended strategies for academic research institutions in this state to facilitate
continued research on rare diseases.
Develop recommended strategies for health care providers to be informed on how to more
efficiently recognize and diagnose rare diseases in order to effectively treat patients. The
advisory council shall provide such strategies to the DOH for publication on the department’s
website.
Provide written input and feedback to the DOH, the Medicaid program, and other state agencies
on specified matters.
The DOH must provide staff and administrative support to the Council. The Council is required to
submit a report to the DOH and the State Surgeon General by July 1 of each year, beginning in 2022,
which describes the activities of the Council in the most recent year and its findings and
recommendations regarding rare disease research and care.
The bill provides an effective date of July 1, 2021.
B. SECTION DIRECTORY:
Section 1: Creates s. 381.99, F.S., relating to the Rare Disease Advisory Council.
Section 2: Provides an effective date of July 1, 2021.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The DOH will incur costs associated with staffing and supporting the Rare Disease Advisory
Council. The DOH estimates one FTE will be required and requests $75,569 in recurring funds and
$4,429 in nonrecurring funds for Fiscal Year 2021-2022. Additionally, the DOH requests $47,120 in
recurring funds to support travel expenses for Council members to attend an estimated four
meetings per year. 15 However, the department has sufficient vacancies which can be filled to
support the Council.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.
D. FISCAL COMMENTS:
None.
15 DOH, supra note 14, at 5.
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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:
Not applicable. The bill does not require rulemaking.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/ COMMITTEE SUBSTITUTE CHANGES
On March 23, 2021, the Professions & Public Health Subcommittee adopted an amendment to HB 1373
and reported the b