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2016 Florida Statutes
385.101 Short title.
385.102 Legislative intent.
385.103 Community intervention programs.
385.202 Statewide cancer registry.
385.203 Diabetes Advisory Council; creation; function; membership.
385.204 Insulin; purchase, distribution; penalty for fraudulent application for and obtaining of insulin.
385.206 Hematology-oncology care center program.
385.207 Care and assistance of persons with epilepsy; establishment of programs in epilepsy control.
385.211 Refractory and intractable epilepsy treatment and research at recognized medical centers.
385.212 Powers and duties of the Department of Health; Office of Compassionate Use.
385.101 Short title.—Sections 385.101-385.103 may be cited as the “Chronic Diseases Act.”
History.—s. 92, ch. 86-220.
385.102 Legislative intent.—It is the finding of the Legislature that:
(1) Chronic diseases exist in high proportions among the people of this state. These chronic diseases include, but are not limited to, heart disease, hypertension, diabetes, renal disease, cancer, and chronic obstructive lung disease. These diseases are often interrelated, and they directly and indirectly account for a high rate of death and illness.
(2) Advances in medical knowledge and technology have assisted in the prevention of chronic diseases. Comprehensive approaches stressing application of current treatment, continuing research, professional training, and patient education should be encouraged.
(3) A comprehensive program dealing with the early detection and prevention of chronic diseases is required to make knowledge and therapy available to all people of this state. The mobilization of scientific, medical, and educational resources under one comprehensive chronic disease act will facilitate the prevention and treatment of these diseases and their symptoms and result in a decline in death and illness among the people of this state.
History.—s. 93, ch. 86-220.
385.103 Community intervention programs.—
(1) DEFINITIONS.—As used in this section, the term:
(a) “Chronic disease prevention and control program” means a program including a combination of the following elements:
1. Health screening;
2. Risk factor detection;
3. Appropriate intervention to enable and encourage changes in behaviors that create health risks; and
4. Counseling in nutrition, physical activity, the effects of tobacco use, hypertension, blood pressure control, and diabetes control and the provision of other clinical prevention services.
(b) “Community health education program” means a program involving the planned and coordinated use of the educational resources available in a community in an effort to:
1. Motivate and assist citizens to adopt and maintain healthful practices and lifestyles;
2. Make available learning opportunities which will increase the ability of people to make informed decisions affecting their personal, family, and community well-being and which are designed to facilitate voluntary adoption of behavior which will improve or maintain health;
3. Reduce, through coordination among appropriate agencies, duplication of health education efforts; and
4. Facilitate collaboration among appropriate agencies for efficient use of scarce resources.
(c) “Community intervention program” means a program combining the required elements of a chronic disease prevention and control program and a community health education program into a unified program over which a single administrative entity has authority and responsibility.
(d) “Department” means the Department of Health.
(e) “Risk factor” means a factor identified during the course of an epidemiological study of a disease, which factor appears to be statistically associated with a high incidence of that disease.
(2) OPERATION OF COMMUNITY INTERVENTION PROGRAMS.—
(a) The department shall assist the county health departments in developing and operating community intervention programs throughout the state. At a minimum, the community intervention programs shall address one to three of the following chronic diseases: cancer, diabetes, heart disease, stroke, hypertension, renal disease, and chronic obstructive lung disease.
(b) Existing community resources, when available, shall be used to support the programs. The department shall seek funding for the programs from federal and state financial assistance programs which presently exist or which may be hereafter created. Additional services, as appropriate, may be incorporated into a program to the extent that resources are available. The department may accept gifts and grants in order to carry out a program.
(c) Volunteers shall be used to the maximum extent possible in carrying out the programs. The department shall contract for the necessary insurance coverage to protect volunteers from personal liability while acting within the scope of their volunteer assignments under a program.
(d) The department may contract for the provision of all or any portion of the services required by a program, and shall so contract whenever the services so provided are more cost-efficient than those provided by the department.
(e) If the department determines that it is necessary for clients to help pay for services provided by a program, the department may require clients to make contribution therefor in either money or personal services. The amount of money or value of the personal services shall be fixed according to a fee schedule established by the department or by the entity developing the program. In establishing the fee schedule, the department or the entity developing the program shall take into account the expenses and resources of a client and his or her overall ability to pay for the services.
History.—ss. 1, 2, ch. 78-331; s. 5, ch. 82-213; ss. 7, 94, ch. 86-220; s. 3, ch. 92-174; s. 7, ch. 93-200; s. 4, ch. 93-267; s. 70, ch. 95-143; s. 683, ch. 95-148; s. 68, ch. 97-101; s. 24, ch. 2000-367; s. 51, ch. 2004-350.
Note.—Former s. 381.605.
385.202 Statewide cancer registry.—
(1) Each facility licensed under chapter 395 and each freestanding radiation therapy center as defined in s. 408.07 shall report to the Department of Health such information, specified by the department, by rule, which indicates diagnosis, stage of disease, medical history, laboratory data, tissue diagnosis, and radiation, surgical, or other methods of diagnosis or treatment for each cancer diagnosed or treated by the facility or center. Failure to comply with this requirement may be cause for registration or licensure suspension or revocation.
(2) The department shall establish, or cause to have established, by contract with a recognized medical organization in this state and its affiliated institutions, a statewide cancer registry program to ensure that cancer reports required under this section shall be maintained and available for use in the course of any study for the purpose of reducing morbidity or mortality; and no liability of any kind or character for damages or other relief shall arise or be enforced against any hospital by reason of having provided such information or material to the department.
(3) The department or a contractual designee operating the statewide cancer registry program required by this section shall use or publish said material only for the purpose of advancing medical research or medical education in the interest of reducing morbidity or mortality, except that a summary of such studies may be released for general publication. Information which discloses or could lead to the disclosure of the identity of any person whose condition or treatment has been reported and studied shall be confidential and exempt from the provisions of s. 119.07(1), except that:
(a) Release may be made with the written consent of all persons to whom the information applies;
(b) The department or a contractual designee may contact individuals for the purpose of epidemiologic investigation and monitoring, provided information that is confidential under this section is not further disclosed; or
(c) The department may exchange personal data with any other governmental agency or a contractual designee for the purpose of medical or scientific research, provided such governmental agency or contractual designee shall not further disclose information that is confidential under this section.
(4) Funds appropriated for this section shall be used for establishing, administering, compiling, processing, and providing biometric and statistical analyses to the reporting facilities. Funds may also be used to ensure the quality and accuracy of the information reported and to provide management information to the reporting facilities.
(5) The department may, by rule, classify facilities for purposes of reports made to the cancer registry and specify the content and frequency of the reports. In classifying facilities, the department shall exempt certain facilities from reporting cancer information that was previously reported to the department or retrieved from existing state reports made to the department or the Agency for Health Care Administration. The provisions of this section shall not apply to any facility whose primary function is to provide psychiatric care to its patients.
History.—ss. 2, 3, 4, 9, ch. 78-171; s. 5, ch. 82-213; s. 2, ch. 83-234; s. 96, ch. 86-220; s. 1, ch. 90-6; s. 3, ch. 95-188; s. 201, ch. 96-406; s. 190, ch. 97-101; s. 31, ch. 97-237; s. 24, ch. 99-397.
Note.—Former s. 381.3812.
385.203 Diabetes Advisory Council; creation; function; membership.—
(1) To guide a statewide comprehensive approach to diabetes prevention, diagnosis, education, care, treatment, impact, and costs thereof, there is created a Diabetes Advisory Council that serves as the advisory unit to the Department of Health, other governmental agencies, professional and other organizations, and the general public. The council shall:
(a) Provide statewide leadership to continuously improve the lives of Floridians with diabetes and reduce the burden of diabetes.
(b) Serve as a forum for the discussion and study of issues related to the public health approach for the delivery of health care services to persons with diabetes.
(c) In conjunction with the department, the Agency for Health Care Administration, and the Department of Management Services, by January 10 of each odd-numbered year, submit to the Governor, the President of the Senate, and the Speaker of the House of Representatives a report containing the following information:
1. The public health consequences and financial impact on the state of all types of diabetes and resulting health complications, including the number of persons with diabetes covered by Medicaid, the number of persons with diabetes who are insured by the Division of State Group Insurance, and the number of persons with diabetes who are impacted by state agency diabetes programs and activities.
2. A description and an assessment of the effectiveness of the diabetes programs and activities implemented by each state agency, the amount and source of funding for such programs and activities, and the cost savings realized as a result of the implementation of such programs and activities.
3. A description of the coordination among state agencies of their respective programs, activities, and communications designed to manage, treat, and prevent all types of diabetes.
4. The development of and revisions to a detailed action plan for reducing and controlling the number of new cases of diabetes and identification of proposed action steps to reduce the impact of all types of diabetes, identification of expected outcomes if the plan is implemented, and the establishment of benchmarks for preventing and controlling diabetes.
(d) By June 30 of each year, meet with the State Surgeon General or designee to make specific recommendations regarding the public health aspects of the prevention and control of diabetes.
(2) The members of the council shall be appointed by the Governor with advice from the State Surgeon General. Members shall serve 4-year terms or until their successors are appointed or qualified.
(3) The council shall be composed of 26 citizens of the state who have knowledge of, or work in, the area of diabetes mellitus as follows:
(a) Five interested citizens, three of whom are affected by diabetes.
(b) One member each from at least three of the medical schools in the state.
(c) Not more than 18 members and not more than one each from among the following areas: nursing with diabetes-educator certification; dietary with diabetes educator certification; podiatry; ophthalmology or optometry; psychology; pharmacy; adult endocrinology; pediatric endocrinology; the American Diabetes Association (ADA); the American Association of Diabetes Educators; the Juvenile Diabetes Foundation; the Florida Academy of Family Physicians; a community health center; a county health department; an ADA-recognized community education program; an osteopathic medical school; the insurance industry; a Children’s Medical Services diabetes regional program; and an employer.
(d) One or more representatives from the Department of Health, who shall serve on the council as ex officio members.
(4)(a) The council shall annually elect from its members a chair and vice chair. The council shall meet at the chair’s discretion; however, at least three meetings shall be held each year.
(b) In conducting its meetings, the council shall use accepted rules of procedure. A majority of the members of the council constitutes a quorum, and action by a majority of a quorum is necessary for the council to take any official action. The Department of Health shall keep a complete record of the proceedings of each meeting. The record shall show the names of the members present and the actions taken. The records shall be kept on file with the department, and these and other documents about matters within the jurisdiction of the council may be inspected by members of the council.
(5) Members of the council shall serve without remuneration but may be reimbursed for per diem and travel expenses as provided in s. 112.061, to the extent resources are available.
(6) The department shall serve as an intermediary for the council if the council coordinates, applies for, or accepts any grants, funds, gifts, or services made available to it by any agency or department of the Federal Government, or any private agency or individual, for assistance in the operation of the council.
History.—ss. 1, 2, 3, ch. 80-62; ss. 1, 4, ch. 82-46; s. 2, ch. 83-265; ss. 6, 97, ch. 86-220; ss. 3, 5, 6, ch. 89-93; s. 5, ch. 91-429; s. 684, ch. 95-148; s. 69, ch. 97-101; s. 32, ch. 97-237; s. 25, ch. 99-397; s. 42, ch. 2008-6; s. 1, ch. 2010-57; s. 1, ch. 2015-45.
Note.—Former s. 381.345.
385.204 Insulin; purchase, distribution; penalty for fraudulent application for and obtaining of insulin.—
(1) The Department of Health shall purchase and distribute insulin through its agents or other appropriate agent of the state or Federal Government in any county or municipality in the state to any bona fide resident of this state suffering from diabetes or a kindred disease requiring insulin in its treatment who makes application for insulin and furnishes proof of his or her financial inability to purchase in accordance with the rules promulgated by the department concerning the distribution of insulin.
(2) Any person who makes fraudulent application for and obtains insulin under the provisions of this chapter is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
History.—s. 2, ch. 29834, 1955; ss. 19, 35, ch. 69-106; s. 330, ch. 71-136; s. 79, ch. 77-147; s. 98, ch. 86-220; s. 55, ch. 91-221; s. 685, ch. 95-148; s. 70, ch. 97-101.
Note.—Former ss. 381.341, 381.411(4).
385.206 Hematology-oncology care center program.—
(1) DEFINITIONS.—As used in this section:
(a) “Department” means the Department of Health.
(b) “Hematology” means the study, diagnosis, and treatment of blood and blood-forming tissues.
(c) “Oncology” means the study, diagnosis, and treatment of malignant neoplasms or cancer.
(d) “Hemophilia” or “other hemostatic disorder” means a bleeding disorder resulting from a genetic abnormality of mechanisms related to the control of bleeding.
(e) “Sickle-cell anemia or other hemoglobinopathy” means an hereditary, chronic disease caused by an abnormal type of hemoglobin.
(f) “Patient” means a person under the age of 21 who is in need of hematologic-oncologic services and who is declared medically and financially eligible by the department; or a person who received such services prior to age 21 and who requires long-term monitoring and evaluation to ascertain the sequelae and the effectiveness of treatment.
(g) “Center” means a facility designated by the department as having a program specifically designed to provide a full range of medical and specialty services to patients with hematologic and oncologic disorders.
(2) HEMATOLOGY-ONCOLOGY CARE CENTER PROGRAM; AUTHORITY.—The department is authorized to make grants and reimbursements to designated centers to establish and maintain programs for the care of patients with hematologic and oncologic disorders. Program administration costs shall be paid by the department from funds appropriated for this purpose.
(3) GRANT AGREEMENTS; CONDITIONS.—A grant made under this section shall be pursuant to a contractual agreement made between a center and the department. Each agreement shall provide that patients will receive specified types of treatment and care from the center without additional charge to the patients or their parents or guardians. Grants shall be disbursed in accordance with conditions set forth in the disbursement guidelines.
(4) GRANT DISBURSEMENTS AND SPECIAL DISBURSEMENTS FOR LOCAL PROGRAMS.—
(a) Grant disbursements may be made to centers which meet the following criteria:
1. The personnel shall include at least one board-certified pediatric hematologist-oncologist, at least one board-certified pediatric surgeon, at least one board-certified radiotherapist, and at least one board-certified pathologist.
2. As approved by the department, the center shall actively participate in a national children’s cancer study group, maintain a pediatric tumor registry, have a multidisciplinary pediatric tumor board, and meet other guidelines for development, including, but not limited to, guidelines from such organizations as the American Academy of Pediatrics and the American Pediatric Surgical Association.
(b) Programs shall also be established to provide care to hematology-oncology patients within each district of the department. The guidelines for local programs shall be formulated by the department. Special disbursements may be made by the program office to centers for educational programs designed for the districts of the department. These programs may include teaching total supportive care of the dying patient and his or her family, home therapy to hemophiliacs and patients with other hemostatic disorders, and screening and counseling for patients with sickle-cell anemia or other hemoglobinopathies.
(5) PROGRAM AND PEER REVIEW.—The department shall evaluate at least annually during the grant period the services rendered by the centers and the districts of the department. Data from the centers and other sources relating to pediatric cancer shall be reviewed annually by the Florida Association of Pediatric Tumor Programs, Inc.; and a written report with recommendations shall be made to the department. This database will be available to the department for formulation of its annual program and financial evaluation report. A portion of the funds appropriated for this section may be used to provide statewide consultation, supervision, and evaluation of the programs of the centers, as well as program office support personnel.
History.—ss. 1, 2, 3, 4, 5, ch. 81-31; s. 100, ch. 86-220; s. 686, ch. 95-148; s. 72, ch. 97-101.
Note.—Former s. 402.212.
385.207 Care and assistance of persons with epilepsy; establishment of programs in epilepsy control.—
(1) The Legislature finds and intends that epilepsy is recognized as a developmental disability and a handicapping condition. The Legislature further intends that persons with epilepsy are entitled to the protection and benefits available to all persons through the equal and nondiscriminatory application and implementation of statutes, rules, programs, and services.
(2) The Department of Health shall:
(a) Establish within the office of the Deputy State Health Officer a program for the care and assistance of persons with epilepsy and promote and assist in the continued development and expansion of programs for the case management, diagnosis, care, and treatment of such persons, including required pharmaceuticals, medical procedures, and techniques which will have a positive effect in the care and treatment of persons with epilepsy.
(b) Develop standards for determining eligibility for care and treatment under such program.
(c) Assist in the development of programs for the prevention of and early intervention in epilepsy.
(d) Assist in the establishment of screening programs and early diagnosis facilities.
(e) Institute and maintain an educational program among physicians, hospitals, county health departments, and the public concerning epilepsy, including the dissemination of information and the conducting of educational programs concerning the prevention of epilepsy and methods developed and used for the care and treatment of persons with epilepsy.
(f) Contract for the provision of care as outlined in paragraph (a).
(g) Continue current programs and develop cooperative programs and services designed to enhance the vocational rehabilitation of epilepsy clients, including the current jobs programs. The department shall keep and make available to the Governor and the Legislature information regarding the number of clients served, the outcome reached, and the expense incurred by such programs and services.
(h) Monitor participating facilities or agencies for program compliance with the terms contained in service contracts.
(3) Revenue for statewide implementation of programs for epilepsy prevention and education pursuant to this section shall be derived pursuant to the provisions of s. 318.21(6) and shall be deposited in the Epilepsy Services Trust Fund, which is hereby established to be administered by the Department of Health.
(4) The department shall adopt rules to administer this section. The rules may include requirements for the scope of service, criteria for eligibility, and requirements for reports and forms.
(5) Nothing in this section shall be construed to obligate the state to provide direct financial assistance to clients requiring epilepsy therapy.
(6) Funds in the Epilepsy Services Trust Fund may be appropriated for epilepsy case management services.
(7) The department shall limit total administrative expenditures from the Epilepsy Services Trust Fund to 5 percent of annual receipts.
History.—s. 3, ch. 88-398; s. 1, ch. 90-141; s. 73, ch. 97-101; s. 22, ch. 2000-242; s. 25, ch. 2000-367; ss. 18, 72, 73, ch. 2002-402; s. 406, ch. 2003-261; s. 25, ch. 2003-399; s. 7, ch. 2003-400; s. 4, ch. 2004-245; ss. 11, 76, ch. 2004-269.
385.211 Refractory and intractable epilepsy treatment and research at recognized medical centers.—
(1) As used in this section, the term “low-THC cannabis” means “low-THC cannabis” as defined in s. 381.986 that is dispensed only from a dispensing organization as defined in s. 381.986.
(2) Notwithstanding chapter 893, medical centers recognized pursuant to s. 381.925, or an academic medical research institution legally affiliated with a licensed children’s specialty hospital as defined in s. 395.002(28) that contracts with the Department of Health, may conduct research on cannabidiol and low-THC cannabis. This research may include, but is not limited to, the agricultural development, production, clinical research, and use of liquid medical derivatives of cannabidiol and low-THC cannabis for the treatment for refractory or intractable epilepsy. The authority for recognized medical centers to conduct this research is derived from 21 C.F.R. parts 312 and 316. Current state or privately obtained research funds may be used to support the activities described in this section.
History.—s. 3, ch. 2014-157; s. 1, ch. 2016-212.
385.212 Powers and duties of the Department of Health; Office of Compassionate Use.—
(1) The Department of Health shall establish an Office of Compassionate Use under the direction of the Deputy State Health Officer.
(2) The Office of Compassionate Use may enhance access to investigational new drugs for Florida patients through approved clinical treatment plans or studies. The Office of Compassionate Use may:
(a) Create a network of state universities and medical centers recognized pursuant to s. 381.925.
(b) Make any necessary application to the United States Food and Drug Administration or a pharmaceutical manufacturer to facilitate enhanced access to compassionate use for Florida patients.
(c) Enter into any agreements necessary to facilitate enhanced access to compassionate use for Florida patients.
(3) The department may adopt rules necessary to implement this section.
History.—s. 4, ch. 2014-157.