The Florida Senate BILL ANALYSIS AND FISCAL IMPACT STATEMENT (This document is based on the provisions contained in the legislation as of the latest date listed below.) Prepared By: The Professional Staff of the Committee on Fiscal Policy BILL: CS/SB 7072 INTRODUCER: Fiscal Policy Committee and Appropriations Committee on Health and Human Services Committee SUBJECT: Cancer Funding DATE: February 26, 2024 ANALYST STAFF DIRECTOR REFERENCE ACTION Gerbrandt McKnight AHS Submitted as Comm. Bill/Fav 1. Gerbrandt Yeatman FP Fav/CS Please see Section IX. for Additional Information: COMMITTEE SUBSTITUTE - Substantial Changes I. Summary: CS/SB 7072 bill revises s. 381.915, F.S., relating to the Casey DeSantis Cancer Research Program (Casey DeSantis Program). The bill provides that the Casey DeSantis Program is established, in addition to current law’s existing provisions for the program’s establishment, to promote the provision of high-quality, innovative health care for persons undergoing cancer treatment in Florida. The bill requires the Florida Department of Health (DOH) to make cancer innovation grant funding available to health care providers and facilities that demonstrate excellence in patient- centered cancer treatment or research. The bill codifies the Cancer Connect Collaborative in statute by providing that the Collaborative is created within the DOH 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 is authorized under the bill to 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. REVISED: BILL: CS/SB 7072 Page 2 The bill requires the Collaborative to develop a long-range comprehensive plan for the Casey DeSantis Program. The Collaborative must solicit input from cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers. The Collaborative must advise the department on the awarding of grants issued through the Cancer Innovation Fund. During any fiscal year for which funds are appropriated the Collaborative must recommend to the DOH the awarding of 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 Collaborative is directed to give priority to applications seeking to expand the reach of innovative cancer treatment models into underserved areas of the state. The Collaborative must review all grant applications and make grant funding recommendations to the DOH, and the DOH is directed under the bill to make final grant allocation awards. Beginning July 1, 2024, the bill requires each allocation agreement issued by the DOH relating to cancer center payments made under current law 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, must include specified requirements. The bill may have an indeterminate fiscal impact to the DOH. See Section V., Fiscal Impact Statement. The bill provides an effective date of July 1, 2024. II. Present Situation: Florida Cancer Research Programs The Legislature funds cancer research in Florida through four main programs: William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program (Bankhead-Coley program), the Casey DeSantis Cancer Research Program, Live Like Bella Initiative - Pediatric Cancer Research Program, and the Cancer Innovation Fund. Currently, $160.5 million is appropriated annually for these research programs as follows: 1 Bankhead-Coley Program - $10 million Biomedical Trust Fund Casey DeSantis Cancer Research Program - $127.5 million ($111.1 General Revenue; $16.4 Trust Fund) Live Like Bella Initiative - Pediatric Cancer Research - $3 million Biomedical Trust Fund Florida Cancer Innovation Fund - $20 million General Revenue 1 Chapter 2023-239, Laws of Fla., see specific appropriations 462, 464, 467, and 465 respectively. BILL: CS/SB 7072 Page 3 William G. "Bill" Bankhead, Jr., and David Coley Cancer Research Program In 2006, the Legislature created the William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program (Bankhead-Coley Program) to advance progress toward cures for cancer through grants awarded through a peer-reviewed, competitive process. 2 The program provides grants for cancer research to further the search for cures for cancer, by pursuing the following goals: 3 Significantly expand cancer research capacity in Florida. Improve both research and treatment through greater pediatric and adult participation in clinical trials networks. Reduce the impact of cancer on disproportionately impacted individuals. Currently, the Bankhead-Coley Program is funded at $10 million annually. 4 The Casey DeSantis Cancer Research Program In 2014, the Legislature created the Florida Consortium of National Cancer Institute Centers Program, which was renamed as the Casey DeSantis Cancer Research Program (Casey DeSantis Program) in 2022. The Casey DeSantis Program was established to: 5 Enhance the quality and competitiveness of cancer care in Florida; Further a statewide biomedical research strategy directly responsive to the health needs of Florida’s citizens; and Capitalize on potential educational opportunities available to students. The Florida Department of Health (DOH) is required to make payments to cancer centers recognized by the NCI as NCI-designated comprehensive cancer centers, cancer centers, and cancer centers working toward achieving NCI designation. 6 The NCI designates institutions as: 7 Comprehensive Cancer Centers – focused on substantial transdisciplinary research that bridges all cancer-related research areas; Cancer Centers – focused on one research area such as clinical, prevention, cancer control or population science research; or Basic Laboratory Cancer Centers – focused on laboratory research and work collaboratively with other institutions. A participating center's annual allocation of funds is determined by a statutory tier-weighted formula that factors in a cancer center’s reportable cancer cases; peer-review costs; and 2 Section 381.922(1), F.S. 3 Section 381.922(2), F.S. 4 Chapter 2023-239, Laws of Fla., see specific appropriation 462. 5 Section 381.915(2), F.S. 6 Id. 7 National Cancer Institute, NCI-Designated Cancer Centers, available at: https://www.cancer.gov/research/infrastructure/cancer-centers (last visited Feb. 16, 2024). BILL: CS/SB 7072 Page 4 biomedical education and training. 8 The tier designations are weighted based on the participating cancer center’s NCI-designation status. The program’s three-tier designations are: 9 Tier 1: NCI-designated comprehensive cancer centers; Tier 2: NCI-designated cancer centers; and Tier 3: Cancer centers seeking NCI designation and meeting additional criteria related to their research and biomedical education. Currently, there are two NCI-designed comprehensive cancer centers and two NCI-designated cancer centers in Florida: 10 H. Lee Moffitt Cancer Center – Comprehensive Cancer Center Mayo Clinic Cancer Center – Comprehensive Cancer Center The University of Florida (UF) Health Shands Cancer Hospital – Cancer Center University of Miami (UM) Sylvester Cancer Center – Cancer Center See chart below for the funding history of the Casey DeSantis Program: 11 FY 19-20 FY 20-21 FY 21-22 FY 22-23 FY 23-24 H. Lee Moffitt $ 25,300,898 $ 24,911,553 $ 23,313,325 $ 39,368,392 $ 38,060,795 Mayo Clinic N/A N/A N/A N/A $ 23,314,286 UF Health Shands Cancer Hospital $ 19,551,236 $ 20,722,858 $ 22,321,087 $ 30,721,560 $ 37,135,352 UM Sylvester Cancer Center $ 17,376,609 $ 16,594,331 $ 16,595,331 $ 29,910,047 $ 28,989,567 Total $ 62,228,743 $ 62,228,742 $ 62,229,743 $ 99,999,999 $ 127,500,000 Every three years, the DOH, in conjunction with participating cancer centers, must provide a report to the Cancer Control and Research Advisory Council (CCRAB) by July 1. The report must include the following: 12 An analysis of trending age-adjusted cancer mortality rates in the state by age group, geographic region, and type of cancer. Identification of trends in overall federal funding, broken down by institutional source, for cancer-related research in the state. A list and narrative description of collaborative grants and interinstitutional collaboration among participating cancer centers, a comparison of collaborative 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. 8 Section 381.915(3), F.S. 9 Section 381.915(4), F.S. 10 National Cancer Institute, NCI-Designated Cancer Centers, “Find a Cancer Centers” directory, available at: https://www.cancer.gov/research/infrastructure/cancer-centers/find (last visited Feb. 16, 2024). 11 Email from Ty Gentle, DOH Budget Director (Dec. 8, 2023), Final NCI Cancer Allocation Spreadsheet, (on file with the Appropriations Committee on Health and Human Services). 12 Section 381.915(8), FS. BILL: CS/SB 7072 Page 5 Live Like Bella Initiative – Pediatric Cancer Research The Live Like Bella Pediatric Cancer Research Initiative was established to advance progress toward curing pediatric cancer through grants awarded through a peer-reviewed, competitive process. 13 The Initiative will provide grants for research to further the search for cures for pediatric cancer, by pursuing the following goals to: 14 Significantly expand pediatric cancer research capacity in Florida. Improve both research and treatment through greater pediatric enrollment in clinical trial networks. Reduce the impact of pediatric cancer on disproportionately impacted individuals. Currently, the Live Like Bella Initiative is funded with $3 million annually. 15 Florida Cancer Innovation Fund The Florida Cancer Innovation Fund was established in Fiscal Year 2023-24 to fund projects focused on innovative research in cancer care and treatment. The funding aims to provide opportunities to break down longstanding silos between researchers, cancer facilities, and medical providers to improve cancer research and treatment through innovative approaches to data infrastructure and best practices. 16 Funding is limited to Florida-based institutions. The projects funded through grant awards are required to focus on at least one of three goal areas below: 17 Data – to identify the reasons data is slow to move or hard to access and ways to dismantle those barriers. Best Practices – to streamline, encourage, and incentivize the sharing of treatment best practices among public and private entities. Innovation – to make advancements in cutting-edge technology and clinical treatments. Currently, the Florida Cancer Innovation Fund is funded with $20 million annually. 18 Florida Cancer Control and Research Advisory Council (CCRAB) The Florida Cancer Control Research Advisory Council was established by the Legislature as an advisory body appointed to function on a continuing basis for the study of cancer and to make recommendations on solutions and policy alternatives to the Board of Governors and the State Surgeon General. 19 The CCRAB closely monitors Florida’s cancer burden and recommends 13 Section 381.922(2), F.S. 14 Department of Health, Biomedical Research Program Funding Announcement, Fiscal Year 2023-24, available at: https://www.floridahealth.gov/provider-and-partner-resources/research/funding-opportunity- announcements/BRACFOAApprovedFINAL.pdf (last visited Feb. 16, 2024). 15 Chapter 2023-239, Laws of Fla., see specific appropriations 467. 16 Department of Health, Funding Opportunity Announcement, The Florida Cancer Innovation Fund, available at https://www.floridahealth.gov/provider-and-partner-resources/research/florida-cancer-innovation-fund/index.html (last visited Feb. 16, 2024). 17 Id. 18 Chapter 2023-239, Laws of Fla., see specific appropriation 465. 19 Section 1004.435, F.S. BILL: CS/SB 7072 Page 6 changes in policies, systems, and environments that lead to improved prevention, early detection, high-quality treatment, and increased cancer serval rates. 20 The Council consists of 15 members: 21 The State Surgeon General or his or her designee within the DOH; A representative of the H. Lee Moffitt Cancer Center and Research Institute, Inc.; A representative of the Sylvester Comprehensive Cancer Center of the University of Miami; A representative of the University of Florida Shands Cancer Center; A representative of the American Cancer Society; A representative of the Association of Community Cancer Centers; A member of the Florida Hospital Association who specializes in the field of oncology; A member of the Florida Medical Association who specializes in the field of oncology; A representative of the Florida Nurses Association who specializes in the field of oncology; A representative of the Florida Osteopathic Medical Association who specializes in the field of oncology; A specialist in pediatric oncology research or clinical care appointed by the Governor; A specialist in oncology clinical care or research appointed by the President of the Senate; A current or former cancer patient or a current or former caregiver to a cancer patient appointed by the Speaker of the House of Representatives; A member of the House of Representatives appointed by the Speaker of the House of Representatives; and A member of the Senate appointed by the President of the Senate. CCRAB members serve four year terms. 22 Florida Cancer Connect Collaborative Established in 2023, the Florida Cancer Connect Collaborative 23 (Collaborative) is an initiative created by First Lady Casey DeSantis in partnership with the DOH and the Agency for Health Care Administration. The Collaborative is a team made up of medical professionals and government officials who analyze Florida’s approach to combatting cancer. The goal of the Collaborative is to break down long-standing silos between researchers, cancer facilities, and medical providers to improve cancer research and treatment. According to the Governor and First Lady, the Collaborative has five main objectives: 24 Data – The Collaborative will seek to identify the reasons data is slow to move or hard to access and dismantle those barriers. 20 Florida Cancer Control and Research Advisory Council, CCRAB Annual Report 2024, The State of Cancer in Florida, available at: https://www.ccrab.org/_cache/files/c/3/c388cd5a-94e1-4342-b946- d21f872724cc/72B5F6981BBF2571E5C3B73AF0DC1169.2024ccrab-annualreport-final.pdf (last visited Feb. 19, 2024). 21 Section 1004.435(4), F.S. 22 Section 1004.435(4), F.S. 23 The Cancer Connect Collaborative is an expansion of Cancer Connect, an initiative launched by First Lady Casey DeSantis in August 2022 to provide cancer information and survivor stories. 24 Florida Governor Ron DeSantis, First Lady Casey DeSantis Announces the Cancer Connect Collaborative to Explore Innovative Strategies for Cancer Treatment and Care, available at: https://www.flgov.com/2023/02/23/first-lady-casey- DeSantis-announces-the-cancer-connect-collaborative-to-explore-innovative-strategies-for-cancer-treatment-and-care/ (last visited Feb. 16, 2024). BILL: CS/SB 7072 Page 7 Best practices – The Collaborative will seek to streamline, encourage and incentivize the sharing of treatment best practices among public and private entities so that everyone is treated with the most effective treatment possible. Innovation – The Collaborative will identify the reasons that technology gets held up — whether it be special interests, over-litigiousness or bureaucratic red tape — and recommend ways to eliminate these barriers. Funding – The Collaborative will provide recommendations for the implementation of the Governor’s proposed $170 million in funding to improve the pace of cancer research and novel technologies. Honesty – The Collaborative will be tasked with identifying the ways to ensure cancer causes, treatment, prevention, and diagnosis information is available and easy to access. III. Effect of Proposed Changes: Section 1 revises s. 381.915, F.S., relating to the Casey DeSantis Cancer Research Program (Casey DeSantis Program). The bill provides that the Casey DeSantis Program is established, in addition to current law’s existing provisions for the program’s establishment, to promote the provision of high-quality, innovative health care for persons undergoing cancer treatment in Florida. The bill requires the Florida Department of Health (DOH) to make cancer innovation grant funding available through the Cancer Innovation Fund to health care providers and facilities that demonstrate excellence in patient-centered cancer treatment or research. The bill codifies the Collaborative in statute by providing that the Collaborative is a council 25 as defined in s. 20.03, F.S., created within the DOH 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 is authorized under the bill to 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. The bill provides for membership of the Collaborative, to be chaired by the State Surgeon General who will serve as an ex officio, non-voting member. The remaining membership of the Collaborative will be composed as follows, all of whom are to be voting members, with appointments to be made by September 1, 2024: 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, prioritizing their appointments on members who have the following experience or expertise: o The practice of a health care profession specializing in oncology clinical care or research; o The development of preventive and therapeutic treatments to control cancer; 25 Section 20.03, F.S., defines a “council” or an “advisory council” as an advisory body created by specific statutory enactment and 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. BILL: CS/SB 7072 Page 8 o The development of innovative research into the causes of cancer, the development of effective treatments for persons with cancer, or cures for cancer; or Management-level experience with a cancer center licensed under ch. 395, F.S. A Florida resident who can represent the interests of cancer patients in this state, appointed by the Governor. The bill provides for members to have staggered terms and for vacancies to be filled. The bill provides that members will serve without compensation but are entitled to reimbursement for per diem and travel expenses pursuant to s. 112.061, F.S. Under the bill, the Collaborative shall meet as necessary, but at least quarterly, at the call of the chair. A majority of the members of the Collaborative constitute a quorum, and a meeting may not be held with less than a quorum present. To establish a quorum, the Collaborative may conduct its meetings through teleconference or other electronic means. The bill requires the Collaborative to develop a long-range comprehensive plan for the Casey DeSantis Program. The Collaborative must solicit input from cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers. The plan must be submitted to the President of the Senate, the Speaker of the House of Representatives, and the Executive Office of the Governor no later than December 1, 2024. The plan must include, but need not be limited to, the following components: Expansion of grant funding 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. An evaluation to determine metrics that focus on patient outcomes, quality of care, and efficacy of treatment. A compilation of best practices relating to cancer research or treatment. The Collaborative must advise the DOH on the awarding of grants issued through the Cancer Innovation Fund. During any fiscal year for which funds are appropriated, the Collaborative must recommend to the DOH the awarding of 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 Collaborative is directed to give priority to applications seeking to expand the reach of innovative cancer treatment models into underserved areas of the state. The Collaborative must review all grant applications and make grant funding recommendations to the DOH, and the DOH is directed under the bill to make final grant allocation awards. The bill revises the requirements under current law for the DOH to issue a report every three years to the Florida Cancer Control & Research Advisory Council (CCRAB). Under the bill, beginning July 1, 2025, the report must be issued every year to the CCRAB and the Collaborative and requires the DOH to submit the report to the Governor and Legislative leadership no later than September 15 each year. Beginning July 1, 2024, the bill requires each allocation agreement issued by the DOH relating to cancer center payments made under current law to cancer centers recognized by the NCI at the National Institutes of Health as NCI-designated cancer centers or NCI-designated comprehensive BILL: CS/SB 7072 Page 9 cancer centers, and cancer centers working toward achieving NCI designation, must include the following: A line-item budget narrative documenting the annual allocation of funds to a cancer center; A cap on the annual award of 15 percent for administrative expenses; 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 Program; A provision to allow the DOH and other state of Florida auditing bodies to audit all financial records, supporting documents, statistical records, and any other documents pertinent to the allocation agreement; and A provision requiring the annual reporting of outcome data and protocols utilized in achieving those outcomes. Section 2 provides an effective date of July 1, 2024. IV. Constitutional Issues: A. Municipality/County Mandates Restrictions: None. B. Public Records/Open Meetings Issues: None. C. Trust Funds Restrictions: None. D. State Tax or Fee Increases: None. E. Other Constitutional Issues: None identified. V. Fiscal Impact Statement: A. Tax/Fee Issues: None. B. Private Sector Impact: None. BILL: CS/SB 7072 Page 10 C. Government Sector Impact: The Florida Department of Health (DOH) may experience operational and fiscal impacts from carrying out its duties under the bill. Such impacts are indeterminate. VI. Technical Deficiencies: None. VII. Related Issues: None. VIII. Statutes Affected: This bill substantially amends section 381.915 of the Florida Statutes. IX. Additional Information: A. Committee Substitute – Statement of Substantial Changes: (Summarizing differences between the Committee Substitute and the prior version of the bill.) CS by Fiscal Policy on February 22, 2024: The committee substitute removes the Cancer Connect Collaborative from the administration of the Cancer Innovation Fund and leaves the administration of the fund to the Department of Health. B. Amendments: None. This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.