This document does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h7087z.DOCX DATE: 3/5/2024 HOUSE OF REPRESENTATIVES STAFF FINAL BILL ANALYSIS BILL #: HB 7087 PCB HHS -24-03 Cancer Funding SPONSOR(S): Health & Human Services Committee, Borrero TIED BILLS: IDEN./SIM. BILLS: CS/SB 7072 FINAL HOUSE FLOOR ACTION: 115 Y’s 0 N’s GOVERNOR’S ACTION: Pending SUMMARY ANALYSIS HB 7087 passed the House on March 6, 2024, as CS/SB 7072. Cancer is the general term for a group of more than 100 diseases characterized by the uncontrolled growth and spread of abnormal cells. Cancer is the second most common cause of death in the United States, exceeded only by heart disease. Cancer is the second leading cause of death in Florida and Florida has the second-highest number of newly-diagnosed cancer cases in the U.S. The Casey DeSantis Cancer Research Program’s (Program) goal is to 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 the potential educational opportunities available to students. Florida-based cancer centers are eligible to join if they are recognized by the National Cancer Institute. The bill revises the purpose of the Program to include promoting the provision of high-quality, innovative health care for persons undergoing cancer treatment in Florida. The Florida Cancer Control Research Advisory Council (council) is an advisory body appointed to make recommendations on solutions and policy alternatives to the Board of Governors and the State Surgeon General. The bill increases the membership requirements and adjusts the quorum of the council. In 2023, the Office of the Governor in partnership with the Department of Health (DOH) and the Agency for Health Care Administration created the Florida Cancer Connect Collaborative (collaborative). 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. Established in 2023, the Florida Cancer Innovation Fund funds cancer research and innovation. The Fund’s mission is to encourage collaboration between oncologists, researchers, and cancer facilities. The bill codifies the collaborative in Florida statute to advise DOH 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 tasked with administering the Cancer Innovation Fund; the collaborative will review all submitted grant application and make recommendations to DOH for awarding grants to support innovative cancer research and treatment models. The bill requires DOH to make cancer innovation grant funding available to health care providers and facilities demonstrating excellence in patient-centered cancer treatment or research. The bill has an insignificant, negative fiscal impact on DOH, which current resources are adequate to absorb, and no fiscal impact on state or local government. Subject to the Governor’s veto powers, the bill is effective July 1, 2024. STORAGE NAME: h7087z.DOCX PAGE: 2 DATE: 3/5/2024 I. SUBSTANTIVE INFORMATION A. EFFECT OF CHANGES: Background Cancer Cancer is the general term for a group of more than 100 diseases. Cancers start because abnormal cells grow out of control. Untreated cancers can cause serious illness and death. Cancer affects one in three people in the United States. 1 About 2,001,140 new cancer cases are expected to be diagnosed in the United States in 2024, with approximately 160,680 of those occurring in Florida. 2 In 2024, around 611,720 Americans are expected to die of cancer, with approximately 48,110 of those occurring in Florida. 3 Cancer is the second most common cause of death in the United States, exceeded only by heart disease. 4 Cancer is the second leading cause of death in Florida. 5 Florida also has the second-highest number of newly-diagnosed cancer cases in the U.S., despite being the third-largest state in terms of population. 6 The National Cancer Institute The National Cancer Institute (NCI) is the federal government’s principal agency for cancer research and training. 7 One function of the NCI is to designate cancer centers by recognizing an institution for the type and breadth of research conducted in addition to the leadership and resources that the cancer center offers. Such designation is nationally recognized as a marker of high-quality cancer care and research. The NCI designates institutions as: 8 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. Currently there are two NCI-designed Comprehensive Cancer Centers in Florida: Mayo Clinic Cancer Center Jacksonville, Florida, (in addition to facilities in Arizona and Minnesota); and, H. Lee Moffitt Cancer Center. The University of Miami Sylvester Comprehensive Cancer Center and the University of Florida Health Cancer Center are NCI- designated Cancer Centers. 9 1 American Cancer Society, What is Cancer, available at https://www.cancer.org/cancer/understanding-cancer/what-is-cancer.html (last visited March 7, 2024). 2 American Cancer Society, Cancer Facts and Figures 2024, available at https://www.cancer.org/content/dam/cancer- org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf (last visited March 7, 2024). 3 Id. 4 Id. 5 Florida Department of Health, Cancer, available at https://www.floridahealth.gov/diseases-and- conditions/cancer/index.html#:~:text=Since%202014%2C%20cancer%20has%20been,one%20disease%20but%20many%20diseases . (last visited March 7, 2024). 6 Florida Department of Health, The Florida Breast Cancer Early Detection and Treatment Referral Program Report, available at https://www.floridahealth.gov/diseases-and-conditions/cancer/breast cancer/_documents/2020FloridaBreastCancerEarlyDetectionandTreatmentReferralProgram.pdf (last visited March 7, 2024). 7 National Cancer Institute, National Cancer Institute Overview and Mission, available at https://www.cancer.gov/about-nci/overview (last visited March 7, 2024). 8 National Cancer Institute, NCI-Designated Cancer Centers, available at https://www.cancer.gov/research/infrastructure/cancer-centers (last visited March 7, 2024). 9 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 March 7, 2024). STORAGE NAME: h7087z.DOCX PAGE: 3 DATE: 3/5/2024 Florida Cancer Research Programs The Legislature funds cancer research in Florida through various programs including the James and Esther King Biomedical Research Program 10 , William G. “Bill” Bankhead, Jr. and David Coley Cancer Research Program 11 ,the Casey DeSantis Cancer Research Program 12 , and the Cancer Innovation Fund. Currently, approximately $160 million is appropriated annually for these programs. 13 The James and Esther King Biomedical Research Program The James and Esther King Program within the Department of Health (DOH) provides an annual and perpetual source of funding in order to support research initiatives that address the health care problems in Floridians in the areas of tobacco-related cancer, cardiovascular disease, stroke, and pulmonary disease. 14 The William G. “Bill” Bankhead, Jr. and David Coley Research Program The William G. “Bill” Bankhead, Jr. and David Coley Research Program within DOH advances progress towards cures for cancer through grants awarded through a peer-reviewed, competitive process. Emphasis is given to efforts that significantly expand cancer research capacity in the state. 15 The Casey DeSantis Cancer Research Program In 2014, the Legislature created the Florida Consortium of National Cancer Institute Centers Program, renamed the Casey DeSantis Cancer Research Program (Program) in 2022. 16 The Program was established to: 17 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, Funding Allocation The Program funds Florida-based, 18 NCI- designated cancer centers according to a statutory formula. 19 A participating cancer center’s annual allocation is determined by multiplying the funds appropriated for the Program in the General Appropriations Act by an allocation fraction calculation determined by DOH. 20 DOH must calculate a participating cancer center’s allocation fraction by September 15 each year using a specific statutory formula, but each center receives a minimum of $16 million. 21 In an instance when the statutory formula would allocate less than $16 million, the difference is made up using funds proportionally redistributed from other participating cancer centers’ allocations. 22 10 S. 215.5602, F.S. 11 S. 381.922, F.S. 12 S. 381.915, F.S. 13 Conference Report on SB 2500, General Appropriations Act for Fiscal Year 2023-2024, Items 461, 462, 464, and 465. 14 S. 215.5602(1), F.S. 15 S. 381.922(2), F.S. 16 S. 381.915, F.S. 17 S. 381.915(2), F.S. 18 “Florida-based” means that a cancer center’s actual or sought designation status is, or would be recognized by the NCI as, primarily located in Florida and not in another state. S. 381.915(3)(c), F.S. 19 S. 381.915(6), F.S. Distributions pursuant to the program are subject to annual appropriation by the Legislature. 20 Id. 21 S. 381.915(3), F.S. 22 Supra, note 19. STORAGE NAME: h7087z.DOCX PAGE: 4 DATE: 3/5/2024 A participating cancer center’s allocation fraction calculation is determined by DOH using a tier- weighted formula that factors in a cancer center’s reportable cancer cases; peer-review costs; and biomedical education and training. 23 The tier designations that weight DOH’s annual allocation calculation are based on the participating cancer center’s NCI-designation status. The Program’s three tier designations are: 24 Tier 1: Florida-based NCI-designated Comprehensive Cancer Centers; Tier 2: Florida-based NCI-designated Cancer Centers; and Tier 3: Florida-based cancer centers seeking NCI-designation as well as meeting additional criteria related to their research and biomedical education. Currently, three cancer centers participate in the Program: H. Lee Moffitt Cancer Center, which is an NCI-designated Comprehensive Cancer Center; Sylvester Comprehensive Cancer Center at the University of Miami, which is an NCI- designated Cancer Center; and The University of Florida Health Cancer Center, which is an NCI- designated Cancer Center. Department of Health Report Participating cancer centers are required to work with DOH to prepare and submit a report to the Cancer Control and Research Advisory Council (council) every three years which includes specific metrics relating to cancer mortality and external funding for cancer-related research in the state. 25 If a participating cancer center does not endorse this report or produce an equivalent independent report, the cancer center shall be suspended from the Program for one year. 26 Among other elements, the report must include an analysis of specific trending age-adjusted cancer mortality rates in the state for: lung cancer; pancreatic cancer; sarcoma; melanoma; leukemia and myelodysplastic syndromes; brain cancer; and, breast cancer. 27 Cancer Innovation Fund Established by the Legislature in 2023, the Cancer Innovation Fund funds cancer research and innovation. 28 The Cancer Innovation Fund’s mission is to encourage collaboration between oncologists, researchers, and cancer facilities. The fund is administered by DOH. In Fiscal Year 2023-2024, the Legislature appropriated $20 million for the fund. 29 The 2024-2025 General Appropriations Act appropriates $60 million to the fund. 30 Florida Cancer Control and Research Advisory Council The 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. 31 The council closely monitors Florida’s cancer burden and recommends changes in policies, systems, and environments that lead to improved prevention, early detection, high-quality treatment, and increased cancer survival 23 S. 381.915(5), F.S. 24 S. 381.915(4), F.S. 25 S. 381.915(8), F.S. 26 Id. 27 S. 381.915(8)(a), F.S. 28 Florida Department of Health, Florida Cancer Innovation Fund, available at https://www.floridahealth.gov/provider-and-partner- resources/research/florida-cancer-innovation-fund/index.html (last visited March 7, 2024). 29 Conference Report on SB 2500, General Appropriations Act for Fiscal Year 2023-2024, Item 465. 30 Conference Report on HB 5001, General Appropriations Act for Fiscal Year 2024-2025, Item 457B. 31 S. 1004.435, F.S. STORAGE NAME: h7087z.DOCX PAGE: 5 DATE: 3/5/2024 rates. 32 The council consists of 15 members: 33 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. Council members serve four-year terms. Eight members constitute a quorum for the purpose of exercising all of the powers of the council. 34 Florida Cancer Connect Collaborative The Florida Cancer Connect Collaborative 35 (collaborative) is an initiative established in 2023 by the Office of the Governor in partnership with 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. 36 The collaborative meets to discuss the availability of cancer treatment data, processes for sharing treatment best practices, innovative cancer technologies, and funding recommendations. 37 The collaborative is not codified in Florida law, and has no statutory relationship to the cancer research initiatives established in law, or the council. Effect of the Bill The Casey DeSantis Cancer Research Program The bill revises the purpose of the Program to include promoting the provision of high-quality, innovative health care for persons undergoing cancer treatment in Florida. 32 Florida Cancer Control and Research Advisory Council, CCRAB Annual Report 2024, The State of Cancer in Florida, available at https://www.ccrab.org/?a=Files.Serve&File_id=C388CD5A-94E1-4342-B946-D21F872724CC (last visited March 6, 2024). 33 S. 1004.435(4), F.S. 34 S. 1004.435(4), F.S. 35 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. 36 Florida Cancer Connect, Cancer Connect Collaborative, available at https://flcancerconnect.com/collaborative/ (last visited March 7, 2024). 37 Id. STORAGE NAME: h7087z.DOCX PAGE: 6 DATE: 3/5/2024 Funding Allocation The bill requires each allocation agreement issued by DOH relating to cancer center payments to include: 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 Cancer Research Program. A provision to allow DOH and other state auditing bodies to audit all financial records, supporting documents, statistical records, and any other documents pertinent to the allocation agreement. A provision requiring the annual reporting of outcome data and protocols used in achieving those outcomes. Department of Health Report The bill revises the requirements under current law for the DOH report. Beginning July 1, 2025, the report must be issued every year to the council and also the collaborative, instead of every three years. DOH must also submit the report to the Governor, the President of the Senate, and the Speaker of the House of Representatives by September 15 of each year. Florida Cancer Control and Research Advisory Council The bill increases the membership of the council from 15 to 16 people, adding a representative of the Mayo Clinic in Jacksonville, and adjusts the quorum to nine members. Cancer Connect Collaborative Council The bill codifies the collaborative in statute as a council, created within DOH. The bill makes the council’s structure and administration function subject to the standards in ch. 20, F.S. 38 The bill requires the collaborative to advise DOH 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, 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 also establishes meeting and membership requirements for the collaborative. The collaborative must meet as necessary, but at least quarterly, at the call of the chair. The members include the Surgeon General, serving as a nonvoting member and as the chair and the following voting members: 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. The appointments should prioritize members with experience in: o A health care profession specializing in oncology care or research; o The development of preventive and therapeutic treatments to control cancer; o The development of innovative research into the causes of cancer, effective treatments, or cures for cancer; or 38 S. 20.052, F.S. provides that a council must be established, evaluated, or maintained in accordance with certain provisions. For example, a council may be created only when necessary and beneficial and must be terminated by the Legislature when it ceases to be essential to the furtherance of a public purpose. Under ch. 20, the members of a council serve 4-year terms, are not compensated, and must be appointed by the Governor, the head of the department, the executive director of the department, or a Cabinet officer. Ch. 20 requires councils to keep the Legislature and the public informed of the numbers, purposes, memberships, activities, and expenses of a council, and requires all meetings to be held in public unless an exemption is provided by law. STORAGE NAME: h7087z.DOCX PAGE: 7 DATE: 3/5/2024 o Management of a cancer center licensed under chapter 395. One member who is a resident of Florida who can represent the interests of the cancer patients. The bill requires the collaborative to develop a long-range comprehensive plan for the Program. The collaborative must request input from cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers to develop the plan. The collaborative must submit the plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives by December 1, 2024. The plan must include, but need not be limited to, all of the following components: 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. 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. Cancer Innovation Fund The bill also tasks the collaborative with administering the Cancer Innovation Fund. The collaborative will review all submitted grant application and make recommendations to DOH for awarding grants to support innovative cancer research and treatment models. The bill requires the collaborative to prioritize applications seeking to expand the reach of innovative cancer treatment models into underserved areas in the state. The bill requires DOH to make cancer innovation grant funding available through the Cancer Innovation Fund to health care providers and facilities demonstrating excellence in patient-centered cancer treatment or research. The bill provides an effective date of July 1, 2024. II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 1. Revenues: None. 2. Expenditures: The cost of the administrative functions of the collaborative, and the additional DOH report, can be absorbed by DOH within existing resources. B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: None. STORAGE NAME: h7087z.DOCX PAGE: 8 DATE: 3/5/2024 C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: None. D. FISCAL COMMENTS: None.