Florida Senate - 2025                   (Proposed Bill) SPB 7028
       
       
        
       FOR CONSIDERATION By the Committee on Health Policy
       
       
       
       
       
       588-02667A-25                                         20257028pb
    1                        A bill to be entitled                      
    2         An act relating to cancer; amending s. 381.915, F.S.;
    3         revising the definitions of the terms “cancer center”
    4         and “Florida-based”; defining the term “Cancer Connect
    5         Collaborative” or “collaborative”; making clarifying
    6         changes; deleting an obsolete date; revising the
    7         composition of the collaborative; deleting obsolete
    8         provisions; requiring the collaborative to review all
    9         submitted Cancer Innovation Fund grant applications
   10         using certain parameters; requiring the collaborative
   11         to give priority to certain applications; requiring
   12         licensed or certified health care providers,
   13         facilities, or entities to meet certain criteria to be
   14         eligible for specified grant funding; specifying such
   15         criteria; requiring the Department of Health to
   16         appoint peer review panels for a specified purpose;
   17         requiring that priority scores be forwarded to the
   18         collaborative and be considered in determining which
   19         proposals the collaborative recommends for certain
   20         grant funding; requiring the collaborative and peer
   21         review panels to establish and follow certain
   22         guidelines and adhere to a certain policy; prohibiting
   23         a member of the collaborative or a panel from
   24         participating in certain discussions or decisions
   25         under certain circumstances; requiring, beginning on a
   26         specified date and annually thereafter, the
   27         collaborative to prepare and submit a specified report
   28         to the Governor and the Legislature; requiring that
   29         the report include certain information; revising the
   30         requirements for a specified report by the department;
   31         requiring, beginning on a specified date, that certain
   32         allocation agreements include certain information;
   33         providing legislative findings; creating the Cancer
   34         Connect Collaborative Research Incubator within the
   35         department, and overseen by the collaborative, to
   36         provide funding for a specified purpose over a
   37         specified timeframe; specifying the incubator’s
   38         targeted area of cancer research for the first
   39         specified timeframe; providing that grants issued
   40         through the incubator are contingent upon the
   41         appropriation of funds and must be awarded through a
   42         specified process; requiring that priority be given to
   43         certain applicants; authorizing the prioritization of
   44         certain grant proposals; providing that applications
   45         for incubator funding may be submitted by specified
   46         hospitals; requiring that all qualified applicants
   47         have equal access and opportunity to compete for
   48         research funding; requiring that incubator grants be
   49         recommended by the collaborative and awarded by the
   50         department in a certain manner; requiring the
   51         department to appoint peer review panels for a
   52         specified purpose; requiring that priority scores be
   53         forwarded to the collaborative and be considered in
   54         determining which proposals the collaborative
   55         recommends for funding; requiring the collaborative
   56         and peer review panels to establish and follow certain
   57         guidelines and adhere to a certain policy; prohibiting
   58         a member of the collaborative or a panel from
   59         participating in certain discussions or decisions;
   60         requiring recipients of incubator grant funds to enter
   61         into an allocation agreement with the department;
   62         specifying requirements for such allocation
   63         agreements; requiring, beginning on a specified date
   64         and annually until a specified date, the collaborative
   65         to prepare and submit a specified report to the
   66         Governor and the Legislature; requiring the
   67         collaborative to make a certain recommendation under
   68         certain circumstances; requiring that a specified
   69         report include certain information; amending s.
   70         381.922, F.S.; establishing the Bascom Palmer Eye
   71         Institute VisionGen Initiative within the William G.
   72         “Bill” Bankhead, Jr., and David Coley Cancer Research
   73         Program; providing the purpose of the initiative;
   74         providing that funding for the initiative is subject
   75         to annual appropriation; providing an effective date.
   76          
   77  Be It Enacted by the Legislature of the State of Florida:
   78  
   79         Section 1. Present paragraphs (c), (d), and (e) of
   80  subsection (3) and present subsections (12) and (13) of section
   81  381.915, Florida Statutes, are redesignated as paragraphs (d),
   82  (e), and (f) of subsection (3) and subsections (13) and (14),
   83  respectively, a new paragraph (c) is added to subsection (3),
   84  paragraph (d) is added to subsection (10), a new subsection (12)
   85  is added to that section, and paragraph (b) and present
   86  paragraph (c) of subsection (3), paragraphs (a), (b), (e), (f),
   87  and (h) of subsection (8), and subsections (9) and (11) of that
   88  section are amended, to read:
   89         381.915 Casey DeSantis Cancer Research Program.—
   90         (3) On or before September 15 of each year, the department
   91  shall calculate an allocation fraction to be used for
   92  distributing funds to participating cancer centers. On or before
   93  the final business day of each quarter of the state fiscal year,
   94  the department shall distribute to each participating cancer
   95  center one-fourth of that cancer center’s annual allocation
   96  calculated under subsection (6). The allocation fraction for
   97  each participating cancer center is based on the cancer center’s
   98  tier-designated weight under subsection (4) multiplied by each
   99  of the following allocation factors based on activities in this
  100  state: number of reportable cases, peer-review costs, and
  101  biomedical education and training. As used in this section, the
  102  term:
  103         (b) “Cancer center” means a comprehensive center with at
  104  least one geographic site in the state, a freestanding center
  105  located in the state, a center situated within an academic
  106  institution, or a Florida-based formal research-based consortium
  107  under centralized leadership that has achieved NCI designation
  108  or is prepared to achieve NCI designation by June 30, 2024.
  109         (c) “Cancer Connect Collaborative” or “collaborative” means
  110  the council created under subsection (8).
  111         (d)(c) “Florida-based” means that a cancer center’s actual
  112  or sought designated status is or would be recognized by the NCI
  113  as primarily located in Florida and not in another state, or
  114  that a health care provider or facility is physically located in
  115  Florida and provides services in Florida.
  116         (8) The Cancer Connect Collaborative, a council as defined
  117  in s. 20.03, is created within the department to advise the
  118  department and the Legislature on developing a holistic approach
  119  to the state’s efforts to fund cancer research, cancer
  120  facilities, and treatments for cancer patients. The
  121  collaborative may make recommendations on proposed legislation,
  122  proposed rules, best practices, data collection and reporting,
  123  issuance of grant funds, and other proposals for state policy
  124  relating to cancer research or treatment.
  125         (a) The Surgeon General shall serve as an ex officio,
  126  nonvoting member of the collaborative and shall serve as the
  127  chair.
  128         (b) The collaborative shall be composed of the following
  129  voting members, to be appointed by September 1, 2024:
  130         1. Two members appointed by the Governor, three members one
  131  member appointed by the President of the Senate, and three
  132  members one member appointed by the Speaker of the House of
  133  Representatives, based on the criteria of this subparagraph. The
  134  appointing officers shall make their appointments prioritizing
  135  members who have the following experience or expertise:
  136         a. The practice of a health care profession specializing in
  137  oncology clinical care or research;
  138         b. The development of preventive and therapeutic treatments
  139  to control cancer;
  140         c. The development of innovative research into the causes
  141  of cancer, the development of effective treatments for persons
  142  with cancer, or cures for cancer; or
  143         d. Management-level experience with a cancer center
  144  licensed under chapter 395.
  145         2. One member who is a resident of this state who can
  146  represent the interests of cancer patients in this state,
  147  appointed by the Governor.
  148         (e) Members of the collaborative whose terms have expired
  149  may continue to serve until replaced or reappointed, but for no
  150  more than 6 months after the expiration of their terms.
  151         (f) Members of the collaborative shall serve without
  152  compensation but are entitled to reimbursement for per diem and
  153  travel expenses pursuant to s. 112.061.
  154         (h) The collaborative shall develop a long-range
  155  comprehensive plan for the Casey DeSantis Cancer Research
  156  Program. In the development of the plan, the collaborative must
  157  solicit input from cancer centers, research institutions,
  158  biomedical education institutions, hospitals, and medical
  159  providers. The collaborative shall submit the plan to the
  160  Governor, the President of the Senate, and the Speaker of the
  161  House of Representatives no later than December 1, 2024. The
  162  plan must include, but need not be limited to, all of the
  163  following components:
  164         1. Expansion of grant fund opportunities to include a
  165  broader pool of Florida-based cancer centers, research
  166  institutions, biomedical education institutions, hospitals, and
  167  medical providers to receive funding through the Cancer
  168  Innovation Fund.
  169         2. An evaluation to determine metrics that focus on patient
  170  outcomes, quality of care, and efficacy of treatment.
  171         3. A compilation of best practices relating to cancer
  172  research or treatment.
  173         (9)(a) The collaborative shall advise the department on the
  174  awarding of grants issued through the Cancer Innovation Fund.
  175  During any fiscal year for which funds are appropriated to the
  176  fund, the collaborative shall review all submitted grant
  177  applications using the parameters provided in paragraph (c) and
  178  make recommendations to the department for awarding grants to
  179  support innovative cancer research and treatment models,
  180  including emerging research and treatment trends and promising
  181  treatments that may serve as catalysts for further research and
  182  treatments. The department shall make the final grant allocation
  183  awards. The collaborative shall give priority to applications
  184  seeking to expand the reach of cancer screening efforts and
  185  innovative cancer treatment models into underserved areas of
  186  this state.
  187         (b) To be eligible for grant funding under this section, a
  188  licensed or certified health care provider, facility, or entity
  189  must meet at least one of the following criteria:
  190         1. Operates as a licensed hospital that has a minimum of 30
  191  percent of its current cancer patients residing in rural or
  192  underserved areas.
  193         2. Operates as a licensed health care clinic or facility
  194  that employs or contracts with at least one physician licensed
  195  under chapter 458 or chapter 459 who is board certified in
  196  oncology and that administers chemotherapy treatments for
  197  cancer.
  198         3. Operates as a licensed facility that employs or
  199  contracts with at least one physician licensed under chapter 458
  200  or chapter 459 who is board certified in oncology and that
  201  administers radiation therapy treatments for cancer.
  202         4. Operates as a licensed health care clinic or facility
  203  that provides cancer screening services at no cost or a minimal
  204  cost to patients.
  205         5. Operates as a rural hospital as defined in s.
  206  395.602(2)(b).
  207         6. Operates as a critical access hospital as defined in s.
  208  408.07(14).
  209         7. Operates as a specialty hospital as defined in s.
  210  395.002(28)(a) which provides cancer treatment for patients from
  211  birth to 18 years of age.
  212         8. Engages in biomedical research intended to develop
  213  therapies, medical pharmaceuticals, treatment protocols, or
  214  medical procedures intended to cure cancer or improve the
  215  quality of life of cancer patients.
  216         9. Educates or trains students, postdoctoral fellows, or
  217  licensed or certified health care practitioners in the
  218  screening, diagnosis, or treatment of cancer.
  219         (c) To ensure that all proposals for grant funding issued
  220  through the Cancer Innovation Fund are appropriate and are
  221  evaluated fairly on the basis of scientific merit, the
  222  department shall appoint peer review panels of independent,
  223  scientifically qualified individuals to review the scientific
  224  merit of each proposal and establish its priority score. The
  225  priority scores must be forwarded to the collaborative and must
  226  be considered in determining which proposals the collaborative
  227  recommends for grant funding through the Cancer Innovation Fund.
  228         (d) The collaborative and the peer review panels shall
  229  establish and follow rigorous guidelines for ethical conduct and
  230  adhere to a strict policy with regard to conflicts of interest
  231  regarding the assessment of Cancer Innovation Fund grant
  232  applications. A member of the collaborative or a panel may not
  233  participate in any discussion or decision of the collaborative
  234  or a panel with respect to a research proposal by any firm,
  235  entity, or agency with which the member is associated as a
  236  member of the governing body or as an employee or with which the
  237  member has entered into a contractual arrangement.
  238         (e) Beginning December 1, 2025, and annually thereafter,
  239  the collaborative shall prepare and submit a report to the
  240  Governor, the President of the Senate, and the Speaker of the
  241  House of Representatives which identifies and evaluates the
  242  performance and the impact of grants issued through the Cancer
  243  Innovation Fund on cancer treatment, research, screening,
  244  diagnosis, prevention, practitioner training, workforce
  245  education, and cancer patient survivorship. The report must
  246  include all of the following:
  247         1. Amounts of grant funds awarded to each recipient.
  248         2. Descriptions of each recipient’s research or project
  249  which include, but need not be limited to, the following:
  250         a.Goals or projected outcomes.
  251         b.Population to be served.
  252         c.Research methods or project implementation plan.
  253         3.An assessment of grant recipients which evaluates their
  254  progress toward achieving objectives specified in each
  255  recipient’s grant application.
  256         4.Recommendations for best practices that may be
  257  implemented by health care providers in this state who diagnose,
  258  treat, and screen for cancer, based on the outcomes of projects
  259  funded through the Cancer Innovation Fund.
  260         (10) Beginning July 1, 2025, and each year thereafter, the
  261  department, in conjunction with participating cancer centers,
  262  shall submit a report to the Cancer Control and Research
  263  Advisory Council and the collaborative on specific metrics
  264  relating to cancer mortality and external funding for cancer
  265  related research in this state. If a cancer center does not
  266  endorse this report or produce an equivalent independent report,
  267  the cancer center is ineligible to receive program funding for 1
  268  year. The department must submit this annual report, and any
  269  equivalent independent reports, to the Governor, the President
  270  of the Senate, and the Speaker of the House of Representatives
  271  no later than September 15 of each year the report or reports
  272  are submitted by the department. The report must include:
  273         (d) A description of the numbers and types of cancer cases
  274  treated annually at each participating cancer center, including
  275  reportable and nonreportable cases.
  276         (11) Beginning July 1, 2025 2024, each allocation agreement
  277  issued by the department relating to cancer center payments
  278  under paragraph (2)(a) subsection (2) must include all of the
  279  following:
  280         (a) A line-item budget narrative documenting the annual
  281  allocation of funds to a cancer center.
  282         (b) A cap on the annual award of 15 percent for
  283  administrative expenses.
  284         (c) A requirement for the cancer center to submit quarterly
  285  reports of all expenditures made by the cancer center with funds
  286  received through the Casey DeSantis Cancer Research Program.
  287         (d) A provision to allow the department and other state
  288  auditing bodies to audit all financial records, supporting
  289  documents, statistical records, and any other documents
  290  pertinent to the allocation agreement.
  291         (e) A provision requiring the annual reporting of outcome
  292  data and protocols used in achieving those outcomes.
  293         (12)(a)The Legislature finds that targeted areas of cancer
  294  research require increased resources and that Florida should
  295  become a leader in promoting research opportunities for these
  296  targeted areas. Floridians should not have to leave the state to
  297  receive the most advanced cancer care and treatment. To meet
  298  this need, the Cancer Connect Collaborative Research Incubator,
  299  or “incubator” as used in this subsection, is created within the
  300  department, to be overseen by the collaborative, to provide
  301  funding for a targeted area of cancer research over a 5-year
  302  period. For the 5-year period beginning July 1, 2025, the
  303  incubator’s targeted area of cancer research is pediatric
  304  cancer.
  305         (b)Contingent upon the appropriation of funds by the
  306  Legislature, grants issued through the incubator must be awarded
  307  through a peer-reviewed, competitive process. Priority must be
  308  given to applicants that focus on enhancing both research and
  309  treatment by increasing participation in clinical trials related
  310  to the targeted area of cancer research, including all of the
  311  following:
  312         1. Identifying strategies to increase enrollment in cancer
  313  clinical trials.
  314         2. Supporting public and private professional education
  315  programs to raise awareness and knowledge about cancer clinical
  316  trials.
  317         3. Providing tools for cancer patients and community-based
  318  oncologists to help identify available cancer clinical trials in
  319  this state.
  320         4. Creating opportunities for the state’s academic cancer
  321  centers to collaborate with community-based oncologists in
  322  cancer clinical trial networks.
  323         (c) Priority may be given to grant proposals that foster
  324  collaborations among institutions, researchers, and community
  325  practitioners to support the advancement of cures through basic
  326  or applied research, including clinical trials involving cancer
  327  patients and related networks.
  328         (d) Applications for incubator funding may be submitted by
  329  any Florida-based specialty hospital as defined in s.
  330  395.002(28)(a) which provides cancer treatment for patients from
  331  birth to 18 years of age. All qualified applicants must have
  332  equal access and opportunity to compete for research funding.
  333  Incubator grants must be recommended by the collaborative and
  334  awarded by the department on the basis of scientific merit, as
  335  determined by a competitively open and peer-reviewed process to
  336  ensure objectivity, consistency, and high quality.
  337         (e) To ensure that all proposals for research funding are
  338  appropriate and are evaluated fairly on the basis of scientific
  339  merit, the department shall appoint peer review panels of
  340  independent, scientifically qualified individuals to review the
  341  scientific merit of each proposal and establish its priority
  342  score. The priority scores must be forwarded to the
  343  collaborative and must be considered in determining which
  344  proposals the collaborative recommends for funding.
  345         (f) The collaborative and the peer review panels shall
  346  establish and follow rigorous guidelines for ethical conduct and
  347  adhere to a strict policy with regard to conflicts of interest
  348  regarding the assessment of incubator grant applications. A
  349  member of the collaborative or a panel may not participate in
  350  any discussion or decision of the collaborative or a panel
  351  regarding a research proposal from any firm, entity, or agency
  352  with which the member is associated as a governing body member,
  353  as an employee, or through a contractual arrangement.
  354         (g) Each recipient of incubator grant funds must enter into
  355  an allocation agreement with the department. Each such
  356  allocation agreement must include all of the following:
  357         1. A line-item budget narrative documenting the annual
  358  allocation of funds to a recipient.
  359         2. A cap on the annual award of 15 percent for
  360  administrative expenses.
  361         3. A requirement for the recipient to submit quarterly
  362  reports of all expenditures made by the recipient with funds
  363  received through the incubator.
  364         4. A provision to allow the department and other state
  365  auditing bodies to audit all financial records, supporting
  366  documents, statistical records, and any other documents
  367  pertinent to the allocation agreement.
  368         5. A provision requiring the annual reporting of outcome
  369  data and protocols used in achieving those outcomes.
  370         (h) Beginning December 1, 2026, and annually through
  371  December 1, 2030, the collaborative shall prepare and submit a
  372  report to the Governor, the President of the Senate, and the
  373  Speaker of the House of Representatives which evaluates research
  374  conducted through the incubator and provides details on outcomes
  375  and findings available through the end of the fiscal year
  376  immediately preceding each report. If the collaborative
  377  recommends that the incubator be extended beyond its 5-year
  378  lifespan, the collaborative shall make such recommendation in
  379  the report due December 1, 2029, and shall include a
  380  recommendation for the next targeted area of cancer research.
  381  The report due on December 1, 2030, must include all of the
  382  following:
  383         1.Details of all results of the research conducted with
  384  incubator funding which has been completed or the status of
  385  research in progress.
  386         2.An evaluation of all research conducted with incubator
  387  funding during the 5 fiscal years preceding the report.
  388         Section 2. Paragraph (d) is added to subsection (2) of
  389  section 381.922, Florida Statutes, to read:
  390         381.922 William G. “Bill” Bankhead, Jr., and David Coley
  391  Cancer Research Program.—
  392         (2) The program shall provide grants for cancer research to
  393  further the search for cures for cancer.
  394         (d) There is established within the program the Bascom
  395  Palmer Eye Institute VisionGen Initiative. The purpose of the
  396  initiative is to advance genetic and epigenetic research on
  397  inherited eye diseases and ocular oncology by awarding grants
  398  through the peer-reviewed, competitive process established under
  399  subsection (3). Funding for the initiative is subject to the
  400  annual appropriation of funds by the Legislature.
  401         Section 3. This act shall take effect July 1, 2025.