Florida Statutes 381.915 – Casey DeSantis Cancer Research Program
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(1) This section may be cited as the “Casey DeSantis Cancer Research Act.”
(2) The Casey DeSantis Cancer Research Program is established to enhance the quality and competitiveness of cancer care in this state, further a statewide biomedical research strategy directly responsive to the health needs of Florida’s citizens, capitalize on the potential educational opportunities available to its students, and promote the provision of high-quality, innovative health care for persons undergoing cancer treatment in this state. The department shall:
(a) Make payments to cancer centers recognized by the National Cancer Institute (NCI) at the National Institutes of Health as NCI-designated cancer centers or NCI-designated comprehensive cancer centers, and cancer centers working toward achieving NCI designation. The department shall distribute funds to participating cancer centers on a quarterly basis during each fiscal year for which an appropriation is made.
Terms Used In Florida Statutes 381.915
- Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
- Ex officio: Literally, by virtue of one's office.
- Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
- Quorum: The number of legislators that must be present to do business.
(b) Make cancer innovation grant funding available through the Cancer Innovation Fund under subsection (9) to health care providers and facilities that demonstrate excellence in patient-centered cancer treatment or research.
(3) On or before September 15 of each year, the department shall calculate an allocation fraction to be used for distributing funds to participating cancer centers. On or before the final business day of each quarter of the state fiscal year, the department shall distribute to each participating cancer center one-fourth of that cancer center’s annual allocation calculated under subsection (6). The allocation fraction for each participating cancer center is based on the cancer center’s tier-designated weight under subsection (4) multiplied by each of the following allocation factors based on activities in this state: number of reportable cases, peer-review costs, and biomedical education and training. As used in this section, the term:
(a) “Biomedical education and training” means instruction that is offered to a student who is enrolled in a biomedical research program at an affiliated university as a medical student or a student in a master’s or doctoral degree program, or who is a resident physician trainee or postdoctoral trainee in such program. An affiliated university biomedical research program must be accredited or approved by a nationally recognized agency and offered through an institution accredited by an accrediting agency or association recognized by the database created and maintained by the United States Department of Education. Full-time equivalency for trainees shall be prorated for training received in oncologic sciences and oncologic medicine.
(b) “Cancer center” means a comprehensive center with at least one geographic site in the state, a freestanding center located in the state, a center situated within an academic institution, or a Florida-based formal research-based consortium under centralized leadership that has achieved NCI designation or is prepared to achieve NCI designation by June 30, 2024.
(c) “Florida-based” means that a cancer center’s actual or sought designated status is or would be recognized by the NCI as primarily located in Florida and not in another state.
(d) “Peer-review costs” means the total annual direct costs for peer-reviewed cancer-related research projects, consistent with reporting guidelines provided by the NCI, for the most recent annual reporting period available.
(e) “Reportable cases” means cases of cancer in which a cancer center is involved in the diagnosis, evaluation of the diagnosis, evaluation of the extent of cancer spread at the time of diagnosis, or administration of all or any part of the first course of therapy for the most recent annual reporting period available. Cases relating to patients enrolled in institutional or investigator-initiated interventional clinical trials shall be weighted at 1.2 relative to other cases weighted at 1.0. Determination of institutional or investigator-initiated interventional clinical trials must be consistent with reporting guidelines provided by the NCI.
(4) Tier designations and corresponding weights within the Casey DeSantis Cancer Research Program are as follows:
(a) Tier 1: NCI-designated comprehensive cancer centers, which shall be weighted at 1.5.
(b) Tier 2: NCI-designated cancer centers, which shall be weighted at 1.25.
(c) Tier 3: Cancer centers seeking designation as either a NCI-designated cancer center or NCI-designated comprehensive cancer center, which shall be weighted at 1.0.
1. A cancer center shall meet the following minimum criteria to be considered eligible for Tier 3 designation in any given fiscal year:
a. Conducting cancer-related basic scientific research and cancer-related population scientific research;
b. Offering and providing the full range of diagnostic and treatment services on site, as determined by the Commission on Cancer of the American College of Surgeons;
c. Hosting or conducting cancer-related interventional clinical trials that are registered with the NCI’s Clinical Trials Reporting Program;
d. Offering degree-granting programs or affiliating with universities through degree-granting programs accredited or approved by a nationally recognized agency and offered through the center or through the center in conjunction with another institution accredited by an accrediting agency or association recognized by the database created and maintained by the United States Department of Education;
e. Providing training to clinical trainees, medical trainees accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, and postdoctoral fellows recently awarded a doctorate degree; and
f. Having more than $5 million in annual direct costs associated with their total NCI peer-reviewed grant funding.
2. The General Appropriations Act or accompanying legislation may limit the number of cancer centers which shall receive Tier 3 designations or provide additional criteria for such designation.
3. A cancer center’s participation in Tier 3 may not extend beyond June 30, 2024.
4. A cancer center that qualifies as a designated Tier 3 center under the criteria provided in subparagraph 1. by July 1, 2014, is authorized to pursue NCI designation as a cancer center or a comprehensive cancer center until June 30, 2024.
(5) The department shall use the following formula to calculate a participating cancer center’s allocation fraction:
CAF = [0.4 x (CRC÷TCRC)]+[0.3 x (CPC÷TCPC)]+[0.3 x (CBE÷TCBE)]
Where:
CAF = A cancer center’s allocation fraction.
CRC = A cancer center’s tier-weighted reportable cases.
TCRC = The total tier-weighted reportable cases for all cancer centers.
CPC = A cancer center’s tier-weighted peer-review costs.
TCPC = The total tier-weighted peer-review costs for all cancer centers.
CBE = A cancer center’s tier-weighted biomedical education and training.
TCBE = The total tier-weighted biomedical education and training for all cancer centers.
(6) A cancer center’s annual allocation shall be calculated by multiplying the funds appropriated for the Casey DeSantis Cancer Research Program in the General Appropriations Act by that cancer center’s allocation fraction. If the calculation results in an annual allocation that is less than $16 million, that cancer center’s annual allocation shall be increased to a sum equaling $16 million, with the additional funds being provided proportionally from the annual allocations calculated for the other participating cancer centers.
(7) The amount of $37,771,257 from the total funds appropriated in the General Appropriations Act for the Casey DeSantis Cancer Research Program shall be excluded from the annual allocation fraction calculation under subsection (5). The excluded amount shall be distributed to participating cancer centers in the same proportion as determined by the allocation fraction calculation.
(8) The Cancer Connect Collaborative, a council as defined in s. 20.03, is created within the department to advise the department and the Legislature on developing a holistic approach to the state’s efforts to fund cancer research, cancer facilities, and treatments for cancer patients. The collaborative may make recommendations on proposed legislation, proposed rules, best practices, data collection and reporting, issuance of grant funds, and other proposals for state policy relating to cancer research or treatment.
(a) The Surgeon General shall serve as an ex officio, nonvoting member and shall serve as the chair.
(b) The collaborative shall be composed of the following voting members, to be appointed by September 1, 2024:
1. Two members appointed by the Governor, one member appointed by the President of the Senate, and one member appointed by the Speaker of the House of Representatives, based on the criteria of this subparagraph. The appointing officers shall make their appointments prioritizing members who have the following experience or expertise:
a. The practice of a health care profession specializing in oncology clinical care or research;
b. The development of preventive and therapeutic treatments to control cancer;
c. The development of innovative research into the causes of cancer, the development of effective treatments for persons with cancer, or cures for cancer; or
d. Management-level experience with a cancer center licensed under chapter 395.
2. One member who is a resident of this state who can represent the interests of cancer patients in this state, appointed by the Governor.
(c) The terms of appointees under paragraph (b) shall be for 2 years unless otherwise specified. However, to achieve staggered terms, the initial appointees under that paragraph shall serve 3 years for their first term. These appointees may be reappointed for no more than four consecutive terms.
(d) Any vacancy occurring on the collaborative must be filled in the same manner as the original appointment. Any member who is appointed to fill a vacancy occurring because of death, resignation, or ineligibility for membership shall serve only for the unexpired term of the member’s predecessor.
(e) Members whose terms have expired may continue to serve until replaced or reappointed, but for no more than 6 months after the expiration of their terms.
(f) Members shall serve without compensation but are entitled to reimbursement for per diem and travel expenses pursuant to s. 112.061.
(g) The collaborative shall meet as necessary, but at least quarterly, at the call of the chair. A majority of the members of the collaborative constitutes a quorum, and a meeting may not be held with less than a quorum present. In order to establish a quorum, the collaborative may conduct its meetings through teleconference or other electronic means. The affirmative vote of a majority of the members of the collaborative present is necessary for any official action by the collaborative.
(h) The collaborative shall develop a long-range comprehensive plan for the Casey DeSantis Cancer Research Program. In the development of the plan, the collaborative must solicit input from cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers. The collaborative shall submit the plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives no later than December 1, 2024. The plan must include, but need not be limited to, all of the following components:
1. Expansion of grant fund opportunities to include a broader pool of Florida-based cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers to receive funding through the Cancer Innovation Fund.
2. An evaluation to determine metrics that focus on patient outcomes, quality of care, and efficacy of treatment.
3. A compilation of best practices relating to cancer research or treatment.
(i) The department shall provide reasonable and necessary support staff and materials to assist the collaborative in the performance of its duties.
(j)1. As used in this paragraph, the term “proprietary business information” means information that:
a. Is owned or controlled by the applicant;
b. Is intended to be private and is treated by the applicant as private;
c. Has not been disclosed except as required by law or a private agreement that provides that the information will not be released to the public;
d. Is not readily available or ascertainable through proper means from another source in the same configuration as received by the collaborative;
e. Affects competitive interests, and the disclosure of such information would impair the competitive advantage of the applicant; and
f. Is explicitly identified or clearly marked as proprietary business information.
2. Proprietary business information held by the department or the collaborative is confidential and exempt from s. 119.07(1) and Fla. Const. Art. I, § 24(a). This exemption does not apply to information contained in final recommendations of the collaborative.
3. Portions of a meeting of the collaborative during which confidential and exempt proprietary business information is discussed are exempt from s. 286.011 and Fla. Const. Art. I, § 24(b). The closed portion of a meeting must be recorded, and the recording must be maintained by the collaborative. The recording is confidential and exempt from s. 119.07(1) and Fla. Const. Art. I, § 24(a).
4.a. Proprietary business information made confidential and exempt under subparagraph 2. may be disclosed with the express written consent of the applicant to whom the information pertains, or the applicant’s legally authorized representative, or pursuant to a court order upon a showing of good cause.
b. Recordings of those portions of exempt meetings which are made confidential and exempt under subparagraph 3. may be disclosed to the department or pursuant to a court order upon a showing of good cause.
5. This paragraph is subject to the Open Government Sunset Review Act in accordance with s. 119.15 and shall stand repealed on October 2, 2029, unless reviewed and saved from repeal through reenactment by the Legislature.
(9) The collaborative shall advise the department on the awarding of grants issued through the Cancer Innovation Fund. During any fiscal year for which funds are appropriated to the fund, the collaborative shall review all submitted grant applications and make recommendations to the department for awarding grants to support innovative cancer research and treatment models, including emerging research and treatment trends and promising treatments that may serve as catalysts for further research and treatments. The department shall make the final grant allocation awards. The collaborative shall give priority to applications seeking to expand the reach of innovative cancer treatment models into underserved areas of this state.
(10) Beginning July 1, 2025, and each year thereafter, the department, in conjunction with participating cancer centers, shall submit a report to the Cancer Control and Research Advisory Council and the collaborative on specific metrics relating to cancer mortality and external funding for cancer-related research in this state. If a cancer center does not endorse this report or produce an equivalent independent report, the cancer center is ineligible to receive program funding for 1 year. The department must submit this annual report, and any equivalent independent reports, to the Governor, the President of the Senate, and the Speaker of the House of Representatives no later than September 15 of each year the report or reports are submitted by the department. The report must include:
(a) An analysis of trending age-adjusted cancer mortality rates in the state, which must include, at a minimum, overall age-adjusted mortality rates for cancer statewide and age-adjusted mortality rates by age group, geographic region, and type of cancer, which must include, at a minimum:
1. Lung cancer.
2. Pancreatic cancer.
3. Sarcoma.
4. Melanoma.
5. Leukemia and myelodysplastic syndromes.
6. Brain cancer.
7. Breast cancer.
(b) Identification of trends in overall federal funding, broken down by institutional source, for cancer-related research in the state.
(c) A list and narrative description of interinstitutional collaboration among participating cancer centers, which may include grants received by participating cancer centers in collaboration, a comparison of such grants in proportion to the grant totals for each cancer center, a catalog of retreats and progress seed grants using state funds, and targets for collaboration in the future and reports on progress regarding such targets where appropriate.
(11) Beginning July 1, 2024, each allocation agreement issued by the department relating to cancer center payments under subsection (2) must include all of the following:
(a) A line-item budget narrative documenting the annual allocation of funds to a cancer center.
(b) A cap on the annual award of 15 percent for administrative expenses.
(c) A requirement for the cancer center to submit quarterly reports of all expenditures made by the cancer center with funds received through the Casey DeSantis Cancer Research Program.
(d) A provision to allow the department and other state auditing bodies to audit all financial records, supporting documents, statistical records, and any other documents pertinent to the allocation agreement.
(e) A provision requiring the annual reporting of outcome data and protocols used in achieving those outcomes.
(12) This section is subject to annual appropriation by the Legislature.
(13) The department may adopt rules to administer this section.