395.003 Licensure; denial, suspension, and revocation.—
(1)(a) The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to ss. 395.001-395.1065 and part II of chapter 408 and to entities licensed by or applying for such licensure from the Agency for Health Care Administration pursuant to ss. 395.001-395.1065. A license issued by the agency is required in order to operate a hospital or ambulatory surgical center in this state.
(b)1. It is unlawful for a person to use or advertise to the public, in any way or by any medium whatsoever, any facility as a “hospital” or “ambulatory surgical center” unless such facility has first secured a license under this part.
2. This part does not apply to veterinary hospitals or to commercial business establishments using the word “hospital” or “ambulatory surgical center” as a part of a trade name if no treatment of human beings is performed on the premises of such establishments.
(2)(a) In addition to the requirements in part II of chapter 408, the agency shall, at the request of a licensee, issue a single license to a licensee for facilities located on separate premises. Such a license shall specifically state the location of the facilities, the services, and the licensed beds available on each separate premises. If a licensee requests a single license, the licensee shall designate which facility or office is responsible for receipt of information, payment of fees, service of process, and all other activities necessary for the agency to carry out the provisions of this part.
(b) The agency shall, at the request of a licensee that is a teaching hospital as defined in s. 408.07, issue a single license to a licensee for facilities that have been previously licensed as separate premises, provided such separately licensed facilities, taken together, constitute the same premises as defined in s. 395.002. Such license for the single premises shall include all of the beds, services, and programs that were previously included on the licenses for the separate premises. The granting of a single license under this paragraph may not in any manner reduce the number of beds, services, or programs operated by the licensee.
(c) Intensive residential treatment programs for children and adolescents which have received accreditation from an accrediting organization as defined in s. 395.002(1) and which meet the minimum standards developed by rule of the agency for such programs shall be licensed by the agency under this part.
(3) In addition to the requirements of s. 408.807, after a change of ownership has been approved by the agency, the transferee shall be liable for any liability to the state, regardless of when identified, resulting from changes to allowable costs affecting provider reimbursement for Medicaid participation or Public Medical Assistance Trust Fund Assessments, and related administrative fines.
(4) The agency shall issue a license that specifies the service categories and the number of hospital beds in each bed category for which a license is received. Such information shall be listed on the face of the license. A licensed facility shall not operate a number of hospital beds greater than the number indicated by the agency on the face of the license without approval from the agency under conditions established by rule.
(5)(a) Adherence to patient rights, standards of care, and examination and placement procedures provided under part I of chapter 394 shall be a condition of licensure for hospitals providing voluntary or involuntary medical or psychiatric observation, evaluation, diagnosis, or treatment.
(b) Any hospital that provides psychiatric treatment to persons under 18 years of age who have emotional disturbances shall comply with the procedures pertaining to the rights of patients prescribed in part I of chapter 394.
(c) A hospital that provides birthing services shall affirm in writing as part of the application for a new, provisional, or renewal license that the hospital shall comply with s. 382.013(2)(c), which includes assisting unmarried parents who request assistance in executing a voluntary acknowledgment of paternity. No fine or other sanction under s. 395.1065 may be imposed on a hospital for noncompliance with s. 382.013(2)(c).
(d) A hospital, an ambulatory surgical center, a specialty hospital, or an urgent care center shall comply with ss. 627.64194 and 641.513 as a condition of licensure.
(6)(a) A specialty hospital may not provide any service or regularly serve any population group beyond those services or groups specified in its license. A specialty-licensed children’s hospital that is authorized to provide pediatric cardiac catheterization and pediatric open-heart surgery services may provide cardiovascular service to adults who, as children, were previously served by the hospital for congenital heart disease, or to those patients who are referred for a specialized procedure only for congenital heart disease by an adult hospital, without obtaining additional licensure as a provider of adult cardiovascular services. The agency may request documentation as needed to support patient selection and treatment. This subsection does not apply to a specialty-licensed children’s hospital that is already licensed to provide adult cardiovascular services.
(b) A specialty-licensed children’s hospital that has licensed neonatal intensive care unit beds and is located in District 5 or District 11, as defined in s. 408.032, as of January 1, 2018, may provide obstetrical services, in accordance with the pertinent guidelines promulgated by the American College of Obstetricians and Gynecologists and with verification of guidelines and compliance with internal safety standards by the Voluntary Review for Quality of Care Program of the American College of Obstetricians and Gynecologists and in compliance with the agency’s rules pertaining to the obstetrical department in a hospital and offer healthy mothers all necessary critical care equipment, services, and the capability of providing up to 10 beds for labor and delivery care, which services are restricted to the diagnosis, care, and treatment of pregnant women of any age who have documentation by an examining physician that includes information regarding:
1. At least one fetal characteristic or condition diagnosed intra-utero that would characterize the pregnancy or delivery as high risk including structural abnormalities of the digestive, central nervous, and cardiovascular systems and disorders of genetic malformations and skeletal dysplasia, acute metabolic emergencies, and babies of mothers with rheumatologic disorders; or
2. Medical advice or a diagnosis indicating that the fetus may require at least one perinatal intervention.
This paragraph shall not preclude a specialty-licensed children’s hospital from complying with s. 395.1041 or the Emergency Medical Treatment and Active Labor Act, 42 U.S.C. s. 1395dd.
(7) In addition to the requirements of part II of chapter 408, whenever the agency finds that there has been a substantial failure to comply with the requirements established under this part or in rules, the agency is authorized to deny, modify, suspend, and revoke:
(a) A license;
(b) That part of a license which is limited to a separate premises, as designated on the license; or
(c) Licensure approval limited to a facility, building, or portion thereof, or a service, within a given premises.
(8) A hospital may not be licensed or relicensed if:
(a) The diagnosis-related groups for 65 percent or more of the discharges from the hospital, in the most recent year for which data is available to the Agency for Health Care Administration pursuant to s. 408.061, are for diagnosis, care, and treatment of patients who have:
1. Cardiac-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 5;
2. Orthopedic-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 8;
3. Cancer-related diseases and disorders classified as discharges in which the principal diagnosis is neoplasm or carcinoma or is for an admission for radiotherapy or antineoplastic chemotherapy or immunotherapy; or
4. Any combination of the above discharges.
(b) The hospital restricts its medical and surgical services to primarily or exclusively cardiac, orthopedic, surgical, or oncology specialties.
(c) A hospital classified as an exempt cancer center hospital pursuant to 42 C.F.R. s. 412.23(f) as of December 31, 2005, is exempt from the licensure restrictions of this subsection.
(9) A hospital licensed as of June 1, 2004, shall be exempt from subsection (8) as long as the hospital maintains the same ownership, facility street address, and range of services that were in existence on June 1, 2004. Any transfer of beds, or other agreements that result in the establishment of a hospital or hospital services within the intent of this section, shall be subject to subsection (8). Unless the hospital is otherwise exempt under subsection (8), the agency shall deny or revoke the license of a hospital that violates any of the criteria set forth in that subsection.
(10) The agency may adopt rules implementing the licensure requirements set forth in subsection (8). Within 14 days after rendering its decision on a license application or revocation, the agency shall publish its proposed decision in the Florida Administrative Register. Within 21 days after publication of the agency’s decision, any authorized person may file a request for an administrative hearing. In administrative proceedings challenging the approval, denial, or revocation of a license pursuant to subsection (8), the hearing must be based on the facts and law existing at the time of the agency’s proposed agency action. Existing hospitals may initiate or intervene in an administrative hearing to approve, deny, or revoke licensure under subsection (8) based upon a showing that an established program will be substantially affected by the issuance or renewal of a license to a hospital within the same district or service area.
History.—ss. 26, 30, ch. 82-182; s. 47, ch. 83-218; s. 4, ch. 83-244; ss. 34, 40, ch. 87-92; ss. 4, 98, ch. 92-289; s. 29, ch. 96-169; s. 3, ch. 98-303; s. 5, ch. 2002-400; s. 23, ch. 2004-350; s. 1, ch. 2004-383; s. 21, ch. 2005-39; s. 2, ch. 2005-81; s. 1, ch. 2005-256; s. 38, ch. 2007-230; s. 1, ch. 2007-248; s. 4, ch. 2009-223; s. 5, ch. 2012-66; s. 40, ch. 2013-14; s. 6, ch. 2013-153; s. 5, ch. 2016-222; s. 25, ch. 2018-24; s. 3, ch. 2020-156; s. 2, ch. 2021-112.
