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A bill to be entitled |
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An act relating to health care; amending s. 395.002, F.S.; |
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providing definitions applicable to provisions regulating |
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hospitals and other licensed facilities; conforming cross |
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references; amending s. 395.003, F.S.; specifying that |
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only the applicant is entitled to an administrative |
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hearing on its application; conforming a cross reference; |
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creating s. 395.0095, F.S.; establishing licensing |
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criteria for cardiac programs; requiring reporting; |
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amending s. 408.034, F.S.; providing a nursing-home-bed |
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need methodology that has a goal of maintaining a |
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specified district average occupancy rate; amending s. |
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408.036, F.S., relating to health-care-related projects |
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subject to review for a certificate of need; deleting |
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hospice inpatient facilities from the projects subject to |
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review; deleting shared services contracts or projects |
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from expedited review; modifying circumstances requiring |
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transfer of a certificate of need; providing expedited |
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review for replacement of a nursing home and for |
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relocation of a portion of a nursing home's beds; adding |
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or revising exemptions for addition of acute care beds, |
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hospital-based distinct part skilled nursing unit beds, |
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comprehensive medical rehabilitation beds, Level II or |
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Level III neonatal intensive care beds, mental health |
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services beds, and nursing home beds; adding exemptions |
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for conversion of mental health services beds, replacement |
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of a statutory rural hospital, establishment of a Level II |
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neonatal intensive care unit, replacement of a licensed |
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nursing home, consolidation or combination of nursing |
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homes or transfer of beds between nursing homes by |
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providers that operate multiple nursing homes, and |
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establishment of certain adult open-heart programs; |
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deleting exemptions relating to establishment of certain |
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specialty hospitals and a satellite facility for new |
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medical technologies; amending s. 408.037, F.S.; allowing |
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a consolidated audit of a parent company; providing that |
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the acquisition of a licensed hospital includes |
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acquisition of any pending certificate-of-need |
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application; amending s. 408.038, F.S.; increasing fees to |
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fund the activities of the certificate-of-need program; |
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amending s. 408.039, F.S.; eliminating the right of |
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existing health care facilities to initiate or intervene |
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in an administrative hearing pertaining to the issuance or |
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denial of a certificate of need; providing that without |
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agency action within a specified time period the |
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recommended order of the Division of Administrative |
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Hearings becomes the final order; removing the requirement |
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that the court must find a complete absence of a |
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judiciable issue of law or fact prior to awarding |
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attorney's fees and costs; requiring a hospital that is |
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the losing party in a judicial review to pay the |
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reasonable attorney's fees and costs of the prevailing |
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hospital; amending s. 408.043, F.S.; deleting a provision |
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requiring a certificate of need for a hospice inpatient |
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facility, to conform to changes made by the act; amending |
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s. 408.05, F.S.; providing quality outcome measure |
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reporting requirements and standards for cardiac programs; |
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amending s. 52, ch. 2001-45, Laws of Florida; establishing |
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criteria for which the imposed moratorium on certificates |
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of need for nursing homes does not apply; amending ss. |
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383.50, 394.4787, 395.602, 395.701, 400.051, 409.905, |
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468.505, 766.316, and 812.014, F.S.; conforming cross |
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references; providing a grandfather clause for cardiac |
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programs; amending s. 408.043, F.S.; including the |
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additional beds at certain acute care hospitals in high |
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growth counties in the inventory of hospital beds used in |
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the calculation of the fixed-bed-need pool for acute care |
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hospitals; providing an effective date. |
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Be It Enacted by the Legislature of the State of Florida: |
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Section 1. Section 395.002, Florida Statutes, is amended |
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to read: |
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395.002 Definitions.--As used in this chapter: |
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(1) "Accrediting organizations" means the Joint Commission |
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on Accreditation of Healthcare Organizations, the American |
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Osteopathic Association, the Commission on Accreditation of |
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Rehabilitation Facilities, and the Accreditation Association for |
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Ambulatory Health Care, Inc. |
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(2) "Adult" mean a person who is 18 years of age or older.
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(3)(2)"Agency" means the Agency for Health Care |
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Administration. |
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(4)(3)"Ambulatory surgical center" or "mobile surgical |
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facility" means a facility the primary purpose of which is to |
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provide elective surgical care, in which the patient is admitted |
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to and discharged from such facility within the same working day |
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and is not permitted to stay overnight, and which is not part of |
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a hospital. However, a facility existing for the primary purpose |
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of performing terminations of pregnancy, an office maintained by |
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a physician for the practice of medicine, or an office |
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maintained for the practice of dentistry shall not be construed |
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to be an ambulatory surgical center, provided that any facility |
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or office which is certified or seeks certification as a |
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Medicare ambulatory surgical center shall be licensed as an |
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ambulatory surgical center pursuant to s. 395.003. Any structure |
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or vehicle in which a physician maintains an office and |
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practices surgery, and which can appear to the public to be a |
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mobile office because the structure or vehicle operates at more |
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than one address, shall be construed to be a mobile surgical |
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facility. |
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(5)(4)"Applicant" means an individual applicant, or any |
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officer, director, or agent, or any partner or shareholder |
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having an ownership interest equal to a 5-percent or greater |
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interest in the corporation, partnership, or other business |
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entity. |
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(6)(5)"Biomedical waste" means any solid or liquid waste |
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as defined in s. 381.0098(2)(a). |
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(7) "Cardiac surgery program" means a health service that |
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is provided by or on behalf of a health care facility in which |
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surgical procedures occur that treat conditions such as |
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congenital heart defects and heart and coronary artery diseases, |
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including replacement of heart valves, cardiac vascularization, |
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and cardiac trauma. One cardiac surgery operation equals one |
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patient admission to the hospital during which one or more |
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cardiac surgeries are performed. Cardiac surgery operations are |
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classified under the following Medicare diagnostic-related |
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groups: 104, 105, 106, 107, 108, and 109.
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(8)(6)"Clinical privileges" means the privileges granted |
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to a physician or other licensed health care practitioner to |
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render patient care services in a hospital, but does not include |
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the privilege of admitting patients. |
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(9)(7)"Department" means the Department of Health. |
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(10) "Diagnostic cardiac catheterization program" means a |
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health service that is provided by or on behalf of a health care |
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facility, that consists of one or more laboratories comprised of |
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a room or suite of rooms, and that has the equipment and staff |
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required to perform diagnostic cardiac catheterization serving |
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inpatients and outpatients.
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(11)(8)"Director" means any member of the official board |
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of directors as reported in the organization's annual corporate |
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report to the Florida Department of State, or, if no such report |
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is made, any member of the operating board of directors. The |
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term excludes members of separate, restricted boards that serve |
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only in an advisory capacity to the operating board. |
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(12) "Elective percutaneous coronary care program" means a |
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health service that is provided by or on behalf of a health care |
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facility for cardiac patients with procedures involving the use |
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of a coronary artery catheter that is for more than diagnostic |
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purposes. Such procedures include, but are not limited to, |
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rotational atherectomy, directional atherectomy, extraction of |
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atherectomy, laser angioplasty, ablation, and implementation of |
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intracoronary stents. Each elective percutaneous coronary care |
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program shall have a formal agreement for offsite surgical |
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backup.
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(13)(9)"Emergency medical condition" means: |
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(a) A medical condition manifesting itself by acute |
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symptoms of sufficient severity, which may include severe pain, |
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such that the absence of immediate medical attention could |
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reasonably be expected to result in any of the following: |
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1. Serious jeopardy to patient health, including a |
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pregnant woman or fetus. |
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2. Serious impairment to bodily functions. |
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3. Serious dysfunction of any bodily organ or part. |
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(b) With respect to a pregnant woman: |
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1. That there is inadequate time to effect safe transfer |
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to another hospital prior to delivery; |
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2. That a transfer may pose a threat to the health and |
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safety of the patient or fetus; or |
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3. That there is evidence of the onset and persistence of |
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uterine contractions or rupture of the membranes. |
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(14) "Emergency/primary percutaneous coronary intervention |
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program" means a health service that is provided by or on behalf |
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of a health care facility providing cardiac care, which includes |
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procedures involving the use of a coronary artery catheter that |
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is for more than diagnostic purposes, and that is applicable |
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only to patients presenting with an acute myocardial infarction |
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or similar condition in an emergency department. Such procedures |
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include, but are not limited to, rotational atherectomy, |
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directional atherectomy, extraction of atherectomy, laser |
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angioplasty, ablation, and implementation of intracoronary stents |
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for patients with an emergency condition. Each emergency/primary |
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percutaneous coronary intervention program shall have in place a |
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transfer agreement to a facility with a licensed cardiac surgery |
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program.
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(15)(10)"Emergency services and care" means medical |
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screening, examination, and evaluation by a physician, or, to |
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the extent permitted by applicable law, by other appropriate |
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personnel under the supervision of a physician, to determine if |
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an emergency medical condition exists and, if it does, the care, |
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treatment, or surgery by a physician necessary to relieve or |
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eliminate the emergency medical condition, within the service |
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capability of the facility. |
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(16)(11)"General hospital" means any facility which meets |
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the provisions of subsection (18)(13)and which regularly makes |
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its facilities and services available to the general population. |
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(17)(12)"Governmental unit" means the state or any |
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county, municipality, or other political subdivision, or any |
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department, division, board, or other agency of any of the |
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foregoing. |
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(18)(13)"Hospital" means any establishment that: |
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(a) Offers services more intensive than those required for |
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room, board, personal services, and general nursing care, and |
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offers facilities and beds for use beyond 24 hours by |
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individuals requiring diagnosis, treatment, or care for illness, |
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injury, deformity, infirmity, abnormality, disease, or |
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pregnancy; and |
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(b) Regularly makes available at least clinical laboratory |
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services, diagnostic X-ray services, and treatment facilities |
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for surgery or obstetrical care, or other definitive medical |
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treatment of similar extent. |
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However, the provisions of this chapter do not apply to any |
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institution conducted by or for the adherents of any well- |
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recognized church or religious denomination that depends |
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exclusively upon prayer or spiritual means to heal, care for, or |
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treat any person. For purposes of local zoning matters, the term |
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"hospital" includes a medical office building located on the |
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same premises as a hospital facility, provided the land on which |
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the medical office building is constructed is zoned for use as a |
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hospital; provided the premises were zoned for hospital purposes |
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on January 1, 1992. |
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(19)(14)"Hospital bed" means a hospital accommodation |
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which is ready for immediate occupancy, or is capable of being |
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made ready for occupancy within 48 hours, excluding provision of |
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staffing, and which conforms to minimum space, equipment, and |
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furnishings standards as specified by rule of the agency for the |
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provision of services specified in this section to a single |
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patient. |
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(20)(15)"Initial denial determination" means a |
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determination by a private review agent that the health care |
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services furnished or proposed to be furnished to a patient are |
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inappropriate, not medically necessary, or not reasonable. |
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(21)(16)"Intensive residential treatment programs for |
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children and adolescents" means a specialty hospital accredited |
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by the Joint Commission on Accreditation of Healthcare |
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Organizations which provides 24-hour care and which has the |
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primary functions of diagnosis and treatment of patients under |
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the age of 18 having psychiatric disorders in order to restore |
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such patients to an optimal level of functioning. |
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(22)(17)"Licensed facility" means a hospital, ambulatory |
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surgical center, or mobile surgical facility licensed in |
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accordance with this chapter. |
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(23)(18)"Lifesafety" means the control and prevention of |
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fire and other life-threatening conditions on a premises for the |
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purpose of preserving human life. |
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(24)(19)"Managing employee" means the administrator or |
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other similarly titled individual who is responsible for the |
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daily operation of the facility. |
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(25)(20)"Medical staff" means physicians licensed under |
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chapter 458 or chapter 459 with privileges in a licensed |
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facility, as well as other licensed health care practitioners |
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with clinical privileges as approved by a licensed facility's |
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governing board. |
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(26)(21)"Medically necessary transfer" means a transfer |
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made necessary because the patient is in immediate need of |
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treatment for an emergency medical condition for which the |
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facility lacks service capability or is at service capacity. |
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(27)(22)"Mobile surgical facility" is a mobile facility |
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in which licensed health care professionals provide elective |
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surgical care under contract with the Department of Corrections |
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or a private correctional facility operating pursuant to chapter |
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957 and in which inmate patients are admitted to and discharged |
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from said facility within the same working day and are not |
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permitted to stay overnight. However, mobile surgical facilities |
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may only provide health care services to the inmate patients of |
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the Department of Corrections, or inmate patients of a private |
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correctional facility operating pursuant to chapter 957, and not |
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to the general public. |
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(28) "Pediatric patient" means a patient who is under 18 |
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years of age.
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(29) "Percutaneous coronary intervention" means any |
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procedure involving the use of a coronary artery catheter that is |
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for more than diagnostic purposes. Such procedures include, but |
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are not limited to, rotational atherectomy, directional |
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atherectomy, extraction of atherectomy, laser angioplasty, |
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ablation, and implementation of intracoronary stents.
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(30)(23)"Person" means any individual, partnership, |
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corporation, association, or governmental unit. |
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(31)(24)"Premises" means those buildings, beds, and |
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equipment located at the address of the licensed facility and |
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all other buildings, beds, and equipment for the provision of |
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hospital, ambulatory surgical, or mobile surgical care located |
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in such reasonable proximity to the address of the licensed |
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facility as to appear to the public to be under the dominion and |
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control of the licensee. For any licensee that is a teaching |
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hospital as defined in s. 408.07(44), reasonable proximity |
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includes any buildings, beds, services, programs, and equipment |
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under the dominion and control of the licensee that are located |
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at a site with a main address that is within 1 mile of the main |
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address of the licensed facility; and all such buildings, beds, |
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and equipment may, at the request of a licensee or applicant, be |
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included on the facility license as a single premises. |
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(32)(25)"Private review agent" means any person or entity |
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which performs utilization review services for third-party |
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payors on a contractual basis for outpatient or inpatient |
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services. However, the term shall not include full-time |
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employees, personnel, or staff of health insurers, health |
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maintenance organizations, or hospitals, or wholly owned |
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subsidiaries thereof or affiliates under common ownership, when |
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performing utilization review for their respective hospitals, |
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health maintenance organizations, or insureds of the same |
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insurance group. For this purpose, health insurers, health |
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maintenance organizations, and hospitals, or wholly owned |
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subsidiaries thereof or affiliates under common ownership, |
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include such entities engaged as administrators of self- |
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insurance as defined in s. 624.031. |
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(33)(26)"Service capability" means all services offered |
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by the facility where identification of services offered is |
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evidenced by the appearance of the service in a patient's |
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medical record or itemized bill. |
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(34)(27)"At service capacity" means the temporary |
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inability of a hospital to provide a service which is within the |
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service capability of the hospital, due to maximum use of the |
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service at the time of the request for the service. |
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(35)(28)"Specialty bed" means a bed, other than a general |
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bed, designated on the face of the hospital license for a |
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dedicated use. |
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(36)(29)"Specialty hospital" means any facility which |
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meets the provisions of subsection (18)(13), and which |
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regularly makes available either: |
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(a) The range of medical services offered by general |
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hospitals, but restricted to a defined age or gender group of |
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the population; |
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(b) A restricted range of services appropriate to the |
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diagnosis, care, and treatment of patients with specific |
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categories of medical or psychiatric illnesses or disorders; or |
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(c) Intensive residential treatment programs for children |
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and adolescents as defined in subsection (21)(16). |
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(37)(30)"Stabilized" means, with respect to an emergency |
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medical condition, that no material deterioration of the |
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condition is likely, within reasonable medical probability, to |
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result from the transfer of the patient from a hospital. |
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(38) "Tertiary health service" means a health service |
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which, due to its high level of intensity, complexity, |
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specialized or limited applicability, and cost, should be limited |
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to, and concentrated in, a limited number of hospitals to ensure |
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the quality, availability, and cost-effectiveness of such |
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service. Such services include, and are limited to, organ |
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transplantation, specialty burn units, neonatal intensive care |
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units, comprehensive rehabilitation, and cardiac surgery.
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(39)(31)"Utilization review" means a system for reviewing |
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the medical necessity or appropriateness in the allocation of |
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health care resources of hospital services given or proposed to |
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be given to a patient or group of patients. |
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(40)(32)"Utilization review plan" means a description of |
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the policies and procedures governing utilization review |
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activities performed by a private review agent. |
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(41)(33)"Validation inspection" means an inspection of |
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the premises of a licensed facility by the agency to assess |
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whether a review by an accrediting organization has adequately |
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evaluated the licensed facility according to minimum state |
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standards. |
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Section 2. Paragraph (e) of subsection (2) of section |
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395.003, Florida Statutes, is amended, and subsection (9) is |
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added to said section, to read: |
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395.003 Licensure; issuance, renewal, denial, |
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modification, suspension, and revocation.-- |
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(2) |
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(e) The agency shall, at the request of a licensee that is |
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a teaching hospital as defined in s. 408.07(44), issue a single |
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license to a licensee for facilities that have been previously |
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licensed as separate premises, provided such separately licensed |
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facilities, taken together, constitute the same premises as |
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defined in s. 395.002(31)(24). Such license for the single |
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355
|
premises shall include all of the beds, services, and programs |
|
356
|
that were previously included on the licenses for the separate |
|
357
|
premises. The granting of a single license under this paragraph |
|
358
|
shall not in any manner reduce the number of beds, services, or |
|
359
|
programs operated by the licensee. |
|
360
|
(9) In administrative proceedings on an application to |
|
361
|
license any health care facility or program or to provide any |
|
362
|
service or take any other action requiring health care facility |
|
363
|
licensure authority, only the applicant is entitled to an |
|
364
|
administrative hearing on its application. No other person may |
|
365
|
initiate or intervene in any action to determine whether such an |
|
366
|
application should be approved or denied.
|
|
367
|
Section 3. Section 395.0095, Florida Statutes, is created |
|
368
|
to read: |
|
369
|
395.0095 Licensed cardiac programs.--
|
|
370
|
(1) LICENSED CARDIAC PROGRAMS.--The following inpatient |
|
371
|
services when provided by a hospital licensed under this chapter |
|
372
|
shall be subject to the requirements as specified in this |
|
373
|
section and in ss. 395.003 and 408.05 and shall be separately |
|
374
|
listed on the hospital license and specify whether the service |
|
375
|
is for adults or pediatric patients for:
|
|
376
|
(a) Diagnostic cardiac catheterization programs.
|
|
377
|
(b) Emergency/primary percutaneous coronary intervention |
|
378
|
programs.
|
|
379
|
(c) Elective percutaneous coronary intervention programs.
|
|
380
|
(d) Cardiac surgery programs.
|
|
381
|
(2) REQUIRMENTS FOR LICENSED CARDIAC PROGRAMS.--Each |
|
382
|
hospital providing diagnostic cardiac catheterization, |
|
383
|
emergency/primary percutaneous coronary interventions, elective |
|
384
|
percutaneous interventions, or cardiac surgery shall be subject |
|
385
|
to the following provisions:
|
|
386
|
(a) The hospital shall document for each program it |
|
387
|
provides that sufficient numbers of properly trained personnel |
|
388
|
shall be available for the specific service offered to ensure |
|
389
|
quality of care and patient safety, providing services 24 hours |
|
390
|
a day, 7 days a week, in accordance with the guidelines |
|
391
|
established by the American College of Cardiology and the |
|
392
|
American Heart Association.
|
|
393
|
(b) The hospital shall be fully accredited by the Joint |
|
394
|
Commission on Accreditation of Health Care Organizations in |
|
395
|
accordance with evidence-based standards and core measures for |
|
396
|
cardiac programs.
|
|
397
|
(c) The hospital shall ensure that each program it |
|
398
|
provides shall possess the capability for emergency services, |
|
399
|
which includes rapid mobilization of the surgical and medical |
|
400
|
support teams for emergency cases, 24 hours a day, 7 days a |
|
401
|
week.
|
|
402
|
(3) MINIMUM STANDARDS FOR QUALITY OUTCOME MEASURES AND |
|
403
|
PUBLIC REPORTING.--Beginning January 1, 2004, each hospital with |
|
404
|
a cardiac program as defined in this section shall submit the |
|
405
|
data elements required by s. 408.05(9). As of July 1, 2005, each |
|
406
|
hospital with a cardiac program as defined in this section shall |
|
407
|
be subject to the quality outcome standards established pursuant |
|
408
|
to s. 408.05(9).
|
|
409
|
(a) After July 1, 2006, and before December 30, 2006, all |
|
410
|
hospitals with cardiac programs shall be notified by the |
|
411
|
department of their standing in the various quality measures. |
|
412
|
(b) Any hospital whose service or services fail to achieve |
|
413
|
an acceptable rating pursuant to s. 408.05, when adjusted for, |
|
414
|
but not limited to, age, sex, and severity of patients, shall be |
|
415
|
directed by the agency, within 30 days after its receipt of the |
|
416
|
hospital's quality outcome scores, to submit a plan for quality |
|
417
|
improvements within 60 days.
|
|
418
|
(4) REQUIREMENTS FOR DIAGNOSTIC CARDIAC CATHETERIZATION |
|
419
|
PROGRAMS.--
|
|
420
|
(a) Each diagnostic cardiac catheterization program shall:
|
|
421
|
1. Have the capability of providing immediate endocardiac |
|
422
|
catheter pacemaking, in case of cardiac arrest or heart failure, |
|
423
|
and pressure recording for monitoring and evaluating valvular |
|
424
|
disease.
|
|
425
|
2. Provide a full range of noninvasive cardiac or |
|
426
|
circulatory diagnostic services within the hospital itself.
|
|
427
|
3. Have the capability of rapid mobilization of the study |
|
428
|
team within 30 minutes after emergency procedures, 24 hours a |
|
429
|
day, 7 days a week.
|
|
430
|
4. Provide a minimum of 500 catheterizations annually.
|
|
431
|
(b) Diagnostic cardiac catheterization programs licensed |
|
432
|
in a facility not licensed for a cardiac surgery program must |
|
433
|
submit, as part of their licensure application, a written |
|
434
|
protocol for the transfer of emergency patients to a hospital |
|
435
|
providing cardiac surgery that is within 30 minutes' travel time |
|
436
|
via air or ground transportation vehicle under average travel |
|
437
|
conditions.
|
|
438
|
(c) Pediatric cardiac catheterization programs must be |
|
439
|
located in a hospital in which pediatric cardiac surgery is |
|
440
|
being performed.
|
|
441
|
(5) REQUIRMENTS FOR EMERGENCY/PRIMARY PERCUTANEOUS |
|
442
|
CORONARY INTERVENTION PROGRAMS.--
|
|
443
|
(a) Each hospital providing emergency/primary percutaneous |
|
444
|
coronary intervention for patients presenting with emergency |
|
445
|
myocardial infarctions in a hospital without an operational |
|
446
|
cardiac surgery program must comply with the following:
|
|
447
|
1. Provide a cardiologist or cardiovascular surgeon who is |
|
448
|
an experienced interventionalist who has performed a minimum of |
|
449
|
75 interventions within the previous 12 months.
|
|
450
|
2. Provide a minimum of 36 emergency interventions |
|
451
|
annually, in order to continue to provide the service.
|
|
452
|
3. Provide nursing and technical staff who have |
|
453
|
demonstrated experience in handling acutely ill patients |
|
454
|
requiring intervention based on previous experience in dedicated |
|
455
|
interventional laboratories or surgical centers and cardiac care |
|
456
|
nursing staff who are adept in hemodynamic monitoring and Intra |
|
457
|
Aortic Balloon Pump (IABP) management.
|
|
458
|
4. Provide formalized written transfer agreements, |
|
459
|
developed with a hospital with an adult cardiac surgery program, |
|
460
|
and put in place written transport protocols to ensure safe and |
|
461
|
efficient transfer of a patient within 60 minutes. Transfer and |
|
462
|
transport agreements must be reviewed and tested, with |
|
463
|
appropriate documentation maintained at least every 3 months.
|
|
464
|
5. Certify that the facility implementing the service |
|
465
|
undertook a 3-month to 6-month training program that includes |
|
466
|
establishing standards, testing logistics, providing quality |
|
467
|
assessment and error management practices, and formalizing |
|
468
|
patient selection criteria.
|
|
469
|
6. Certify that it will utilize at all times at hospitals |
|
470
|
without adult cardiac surgery programs the patient selection |
|
471
|
criteria for the performance of primary angioplasty issued by |
|
472
|
the American College of Cardiology and the American Heart |
|
473
|
Association.
|
|
474
|
(b) The applicant must agree to submit a quarterly report |
|
475
|
to the agency detailing patient characteristics and treatment |
|
476
|
and outcomes for all patients receiving emergency/primary |
|
477
|
percutaneous coronary interventions pursuant to this licensure |
|
478
|
category. The specialty license provided by this subsection |
|
479
|
shall not apply unless the agency determines that the hospital |
|
480
|
has taken all necessary steps to comply with the requirements of |
|
481
|
this subsection, including the training program required |
|
482
|
pursuant to subparagraph (a)5.
|
|
483
|
(6) REQUIRMENTS FOR ELECTIVE PERCUTANEOUS CORONARY |
|
484
|
INTERVENTION PROGRAMS.--
|
|
485
|
(a) Each hospital providing elective percutaneous coronary |
|
486
|
intervention for patients in a hospital without an operational |
|
487
|
adult cardiac surgery program must comply with the following:
|
|
488
|
1. Provide a cardiologist or cardiovascular surgeon who is |
|
489
|
an experienced interventionalist who has performed a minimum of |
|
490
|
150 interventions within the previous 12 months.
|
|
491
|
2. Provide a minimum of 400 elective interventions |
|
492
|
annually, in order to continue to provide the service.
|
|
493
|
3. Provide nursing and technical staff who have |
|
494
|
demonstrated experience in handling acutely ill patients |
|
495
|
requiring intervention based on previous experience in dedicated |
|
496
|
interventional laboratories or surgical centers and cardiac care |
|
497
|
nursing staff who are adept in hemodynamic monitoring and Intra- |
|
498
|
aortic Balloon Pump (IABP) management.
|
|
499
|
4. Provide formalized written transfer agreements, |
|
500
|
developed with a hospital with an adult cardiac surgery program, |
|
501
|
and put in place written transport protocols to ensure safe and |
|
502
|
efficient transfer of a patient within 30 minutes. Transfer and |
|
503
|
transport agreements must be reviewed and tested, with |
|
504
|
appropriate documentation maintained at least every 3 months.
|
|
505
|
5. Certify that the facility implementing the service |
|
506
|
undertook a 3-month to 6-month training program that includes |
|
507
|
establishing standards, testing logistics, providing quality |
|
508
|
assessment and error management practices, and formalizing |
|
509
|
patient selection criteria.
|
|
510
|
6. Certify that it will utilize at all times at hospitals |
|
511
|
without adult cardiac surgery programs the patient selection |
|
512
|
criteria for the performance of primary angioplasty issued by |
|
513
|
the American College of Cardiology and the American Heart |
|
514
|
Association.
|
|
515
|
(b) The applicant must agree to submit a quarterly report |
|
516
|
to the agency detailing patient characteristics and treatment |
|
517
|
and outcomes for all patients receiving elective percutaneous |
|
518
|
coronary interventions pursuant to this licensure category. This |
|
519
|
report must be submitted within 45 days after the close of each |
|
520
|
calendar quarter. The specialty license provided by this |
|
521
|
subsection shall not apply unless the agency determines that the |
|
522
|
hospital has taken all necessary steps to comply with the |
|
523
|
requirements of this subsection, including the training program |
|
524
|
required pursuant to subparagraph (a)5.
|
|
525
|
(c) Pediatric percutaneous coronary intervention programs |
|
526
|
must be located in a hospital in which pediatric cardiac surgery |
|
527
|
is being performed.
|
|
528
|
(7) REQUIRMENTS FOR CARDIAC SURGERY PROGRAMS.--
|
|
529
|
(a) Each hospital providing a cardiac surgery program must |
|
530
|
have the capability to provide a full range of cardiac surgery |
|
531
|
operations, including, at a minimum:
|
|
532
|
1. Repair or replacement of heart valves.
|
|
533
|
2. Repair of congenital heart defects.
|
|
534
|
3. Cardiac revascularization.
|
|
535
|
4. Repair or reconstruction of intrathoracic vessels.
|
|
536
|
5. Treatment of cardiac trauma.
|
|
537
|
(b) Each cardiac surgery program must document its ability |
|
538
|
to implement and apply circulatory assist devices such as intra- |
|
539
|
aortic balloon assist and prolonged cardiopulmonary partial |
|
540
|
bypass.
|
|
541
|
(c) Each hospital with a cardiac surgery program shall |
|
542
|
provide the following services:
|
|
543
|
1. Cardiology, gastroenterology, hematology, nephrology, |
|
544
|
pulmonary medicine, general surgery, and treatment of infectious |
|
545
|
diseases.
|
|
546
|
2. Pathology, including anatomical, clinical, blood bank, |
|
547
|
and coagulation laboratory services.
|
|
548
|
3. Anesthesiology, including respiratory therapy.
|
|
549
|
4. Radiology, including diagnostic nuclear medicine.
|
|
550
|
5. Neurology.
|
|
551
|
6. Inpatient cardiac catheterization.
|
|
552
|
7. Noninvasive cardiographics, including |
|
553
|
electrocardiography, exercise stress testing, and |
|
554
|
echocardiography.
|
|
555
|
8. Intensive care.
|
|
556
|
9. Emergency care available 24 hours a day, 7 days a week, |
|
557
|
for cardiac emergencies.
|
|
558
|
(d) For emergency services:
|
|
559
|
1. Each cardiac surgery program shall be available for |
|
560
|
elective cardiac operations 8 hours a day, 5 days a week. Each |
|
561
|
cardiac surgery program shall possess the capability for rapid |
|
562
|
mobilization of the surgical and medical support teams for |
|
563
|
emergency cases, 24 hours a day, 7 days a week.
|
|
564
|
2. Cardiac surgery shall routinely be available for |
|
565
|
emergency cardiac surgery operations within a maximum waiting |
|
566
|
period of 2 hours.
|
|
567
|
(e) Each cardiac surgery program shall provide a minimum |
|
568
|
of 300 cardiac surgeries within the first 3 years of operation |
|
569
|
and annually thereafter.
|
|
570
|
(f) Each hospital applying for licensure of a cardiac |
|
571
|
surgery program must be a licensed general acute care hospital |
|
572
|
that is in operation for 3 years or more. This section shall not |
|
573
|
be construed as allowing single-service hospitals to apply for |
|
574
|
licensure.
|
|
575
|
(g) Each cardiac surgery program shall provide nursing and |
|
576
|
technical staff who have demonstrated experience in handling |
|
577
|
acutely ill patients requiring intervention based on previous |
|
578
|
experience in dedicated interventional laboratories or surgical |
|
579
|
centers and cardiac care nursing staff who are adept in |
|
580
|
hemodynamic monitoring and Intra Aortic Balloon Pump (IABP) |
|
581
|
management.
|
|
582
|
Section 4. Subsection (5) of section 408.034, Florida |
|
583
|
Statutes, is amended to read: |
|
584
|
408.034 Duties and responsibilities of agency; rules.-- |
|
585
|
(5) The agency shall establish by rule a nursing-home-bed- |
|
586
|
need methodology that has a goal of maintaining a district |
|
587
|
average occupancy rate of 94 percent andthat reduces the |
|
588
|
community nursing home bed need for the areas of the state where |
|
589
|
the agency establishes pilot community diversion programs |
|
590
|
through the Title XIX aging waiver program. |
|
591
|
Section 5. Section 408.036, Florida Statutes, is amended |
|
592
|
to read: |
|
593
|
408.036 Projects subject to review; exemptions.-- |
|
594
|
(1) APPLICABILITY.--Unless exempt under subsection (3), |
|
595
|
all health-care-related projects, as described in paragraphs |
|
596
|
(a)-(h), are subject to review and must file an application for |
|
597
|
a certificate of need with the agency. The agency is exclusively |
|
598
|
responsible for determining whether a health-care-related |
|
599
|
project is subject to review under ss. 408.031-408.045. |
|
600
|
(a) The addition of beds by new construction or |
|
601
|
alteration. |
|
602
|
(b) The new construction or establishment of additional |
|
603
|
health care facilities, including a replacement health care |
|
604
|
facility when the proposed project site is not located on the |
|
605
|
same site as the existing health care facility. |
|
606
|
(c) The conversion from one type of health care facility |
|
607
|
to another. |
|
608
|
(d) An increase in the total licensed bed capacity of a |
|
609
|
health care facility. |
|
610
|
(e) The establishment of a hospice or hospice inpatient |
|
611
|
facility, except as provided in s. 408.043. |
|
612
|
(f) The establishment of inpatient health services by a |
|
613
|
health care facility, or a substantial change in such services. |
|
614
|
(g) An increase in the number of beds for acute care, |
|
615
|
nursing home care beds, specialty burn units, neonatal intensive |
|
616
|
care units, comprehensive rehabilitation, mental health |
|
617
|
services, or hospital-based distinct part skilled nursing units, |
|
618
|
or at a long-term care hospital. |
|
619
|
(h) The establishment of tertiary health services. |
|
620
|
(2) PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless exempt |
|
621
|
pursuant to subsection (3), projects subject to an expedited |
|
622
|
review shall include, but not be limited to: |
|
623
|
(a) Research, education, and training programs. |
|
624
|
(b) Shared services contracts or projects.
|
|
625
|
(b)(c) A transfer of a certificate of need, except that |
|
626
|
when an existing hospital is acquired by a purchaser, all |
|
627
|
certificates of need issued to the hospital which are not yet |
|
628
|
operational shall be acquired by the purchaser without the need |
|
629
|
for a transfer. |
|
630
|
(c)(d)A 50-percent increase in nursing home beds for a |
|
631
|
facility incorporated and operating in this state for at least |
|
632
|
60 years on or before July 1, 1988, which has a licensed nursing |
|
633
|
home facility located on a campus providing a variety of |
|
634
|
residential settings and supportive services. The increased |
|
635
|
nursing home beds shall be for the exclusive use of the campus |
|
636
|
residents. Any application on behalf of an applicant meeting |
|
637
|
this requirement shall be subject to the base fee of $5,000 |
|
638
|
provided in s. 408.038. |
|
639
|
(d)(e)Replacement of a health care facility when the |
|
640
|
proposed project site is located in the same district and within |
|
641
|
a 1-mile radius of the replaced health care facility. |
|
642
|
(e)(f)The conversion of mental health services beds |
|
643
|
licensed under chapter 395 or hospital-based distinct part |
|
644
|
skilled nursing unit beds to general acute care beds; the |
|
645
|
conversion of mental health services beds between or among the |
|
646
|
licensed bed categories defined as beds for mental health |
|
647
|
services;or the conversion of general acute care beds to beds |
|
648
|
for mental health services. |
|
649
|
1. Conversion under this paragraph shall not establish a |
|
650
|
new licensed bed category at the hospital but shall apply only |
|
651
|
to categories of beds licensed at that hospital. |
|
652
|
2. Beds converted under this paragraph must be licensed |
|
653
|
and operational for at least 12 months before the hospital may |
|
654
|
apply for additional conversion affecting beds of the same type. |
|
655
|
(f) Replacement of a nursing home within the same |
|
656
|
district, provided the proposed project site is located within a |
|
657
|
geographic area that contains at least 65 percent of the |
|
658
|
facility's current residents and is within a 30-mile radius of |
|
659
|
the replaced nursing home.
|
|
660
|
(g) Relocation of a portion of a nursing home's licensed |
|
661
|
beds to a replacement facility within the same district, |
|
662
|
provided the relocation is within a 30-mile radius of the |
|
663
|
existing facility and the total number of nursing home beds in |
|
664
|
the district does not increase.
|
|
665
|
|
|
666
|
The agency shall develop rules to implement the provisions for |
|
667
|
expedited review, including time schedule, application content |
|
668
|
which may be reduced from the full requirements of s. |
|
669
|
408.037(1), and application processing. |
|
670
|
(3) EXEMPTIONS.--Upon request, the following projects are |
|
671
|
subject to exemption from the provisions of subsection (1): |
|
672
|
(a) For replacement of a licensed health care facility on |
|
673
|
the same site, provided that the number of beds in each licensed |
|
674
|
bed category will not increase. |
|
675
|
(b) For hospice services or for swing beds in a rural |
|
676
|
hospital, as defined in s. 395.602, in a number that does not |
|
677
|
exceed one-half of its licensed beds. |
|
678
|
(c) For the conversion of licensed acute care hospital |
|
679
|
beds to Medicare and Medicaid certified skilled nursing beds in |
|
680
|
a rural hospital, as defined in s. 395.602, so long as the |
|
681
|
conversion of the beds does not involve the construction of new |
|
682
|
facilities. The total number of skilled nursing beds, including |
|
683
|
swing beds, may not exceed one-half of the total number of |
|
684
|
licensed beds in the rural hospital as of July 1, 1993. |
|
685
|
Certified skilled nursing beds designated under this paragraph, |
|
686
|
excluding swing beds, shall be included in the community nursing |
|
687
|
home bed inventory. A rural hospital which subsequently |
|
688
|
decertifies any acute care beds exempted under this paragraph |
|
689
|
shall notify the agency of the decertification, and the agency |
|
690
|
shall adjust the community nursing home bed inventory |
|
691
|
accordingly. |
|
692
|
(d) For the addition of nursing home beds at a skilled |
|
693
|
nursing facility that is part of a retirement community that |
|
694
|
provides a variety of residential settings and supportive |
|
695
|
services and that has been incorporated and operated in this |
|
696
|
state for at least 65 years on or before July 1, 1994. All |
|
697
|
nursing home beds must not be available to the public but must |
|
698
|
be for the exclusive use of the community residents. |
|
699
|
(e) For an increase in the bed capacity of a nursing |
|
700
|
facility licensed for at least 50 beds as of January 1, 1994, |
|
701
|
under part II of chapter 400 which is not part of a continuing |
|
702
|
care facility if, after the increase, the total licensed bed |
|
703
|
capacity of that facility is not more than 60 beds and if the |
|
704
|
facility has been continuously licensed since 1950 and has |
|
705
|
received a superior rating on each of its two most recent |
|
706
|
licensure surveys. |
|
707
|
(f) For an inmate health care facility built by or for the |
|
708
|
exclusive use of the Department of Corrections as provided in |
|
709
|
chapter 945. This exemption expires when such facility is |
|
710
|
converted to other uses. |
|
711
|
(g) For the termination of an inpatient health care |
|
712
|
service, upon 30 days' written notice to the agency. |
|
713
|
(h) For the delicensure of beds, upon 30 days' written |
|
714
|
notice to the agency. A request for exemption submitted under |
|
715
|
this paragraph must identify the number, the category of beds, |
|
716
|
and the name of the facility in which the beds to be delicensed |
|
717
|
are located. |
|
718
|
(i) For the provision of adult inpatient diagnostic |
|
719
|
cardiac catheterization services in a hospital. |
|
720
|
1. In addition to any other documentation otherwise |
|
721
|
required by the agency, a request for an exemption submitted |
|
722
|
under this paragraph must comply with the following criteria: |
|
723
|
a. The applicant must certify it will not provide |
|
724
|
therapeutic cardiac catheterization pursuant to the grant of the |
|
725
|
exemption. |
|
726
|
b. The applicant must certify it will meet and |
|
727
|
continuously maintain the minimum licensure requirements adopted |
|
728
|
by the agency governing such programs pursuant to subparagraph |
|
729
|
2. |
|
730
|
c. The applicant must certify it will provide a minimum of |
|
731
|
2 percent of its services to charity and Medicaid patients. |
|
732
|
2. The agency shall adopt licensure requirements by rule |
|
733
|
which govern the operation of adult inpatient diagnostic cardiac |
|
734
|
catheterization programs established pursuant to the exemption |
|
735
|
provided in this paragraph. The rules shall ensure that such |
|
736
|
programs: |
|
737
|
a. Perform only adult inpatient diagnostic cardiac |
|
738
|
catheterization services authorized by the exemption and will |
|
739
|
not provide therapeutic cardiac catheterization or any other |
|
740
|
services not authorized by the exemption. |
|
741
|
b. Maintain sufficient appropriate equipment and health |
|
742
|
personnel to ensure quality and safety. |
|
743
|
c. Maintain appropriate times of operation and protocols |
|
744
|
to ensure availability and appropriate referrals in the event of |
|
745
|
emergencies. |
|
746
|
d. Maintain appropriate program volumes to ensure quality |
|
747
|
and safety. |
|
748
|
e. Provide a minimum of 2 percent of its services to |
|
749
|
charity and Medicaid patients each year. |
|
750
|
3.a. The exemption provided by this paragraph shall not |
|
751
|
apply unless the agency determines that the program is in |
|
752
|
compliance with the requirements of subparagraph 1. and that the |
|
753
|
program will, after beginning operation, continuously comply |
|
754
|
with the rules adopted pursuant to subparagraph 2. The agency |
|
755
|
shall monitor such programs to ensure compliance with the |
|
756
|
requirements of subparagraph 2. |
|
757
|
b.(I) The exemption for a program shall expire immediately |
|
758
|
when the program fails to comply with the rules adopted pursuant |
|
759
|
to sub-subparagraphs 2.a., b., and c. |
|
760
|
(II) Beginning 18 months after a program first begins |
|
761
|
treating patients, the exemption for a program shall expire when |
|
762
|
the program fails to comply with the rules adopted pursuant to |
|
763
|
sub-subparagraphs 2.d. and e. |
|
764
|
(III) If the exemption for a program expires pursuant to |
|
765
|
sub-sub-subparagraph (I) or sub-sub-subparagraph (II), the |
|
766
|
agency shall not grant an exemption pursuant to this paragraph |
|
767
|
for an adult inpatient diagnostic cardiac catheterization |
|
768
|
program located at the same hospital until 2 years following the |
|
769
|
date of the determination by the agency that the program failed |
|
770
|
to comply with the rules adopted pursuant to subparagraph 2. |
|
771
|
(j) For mobile surgical facilities and related health care |
|
772
|
services provided under contract with the Department of |
|
773
|
Corrections or a private correctional facility operating |
|
774
|
pursuant to chapter 957. |
|
775
|
(k) For state veterans' nursing homes operated by or on |
|
776
|
behalf of the Florida Department of Veterans' Affairs in |
|
777
|
accordance with part II of chapter 296 for which at least 50 |
|
778
|
percent of the construction cost is federally funded and for |
|
779
|
which the Federal Government pays a per diem rate not to exceed |
|
780
|
one-half of the cost of the veterans' care in such state nursing |
|
781
|
homes. These beds shall not be included in the nursing home bed |
|
782
|
inventory. |
|
783
|
(l) For combination within one nursing home facility of |
|
784
|
the beds or services authorized by two or more certificates of |
|
785
|
need issued in the same planning subdistrict. An exemption |
|
786
|
granted under this paragraph shall extend the validity period of |
|
787
|
the certificates of need to be consolidated by the length of the |
|
788
|
period beginning upon submission of the exemption request and |
|
789
|
ending with issuance of the exemption. The longest validity |
|
790
|
period among the certificates shall be applicable to each of the |
|
791
|
combined certificates. |
|
792
|
(m) For division into two or more nursing home facilities |
|
793
|
of beds or services authorized by one certificate of need issued |
|
794
|
in the same planning subdistrict. An exemption granted under |
|
795
|
this paragraph shall extend the validity period of the |
|
796
|
certificate of need to be divided by the length of the period |
|
797
|
beginning upon submission of the exemption request and ending |
|
798
|
with issuance of the exemption. |
|
799
|
(n) For the addition of hospital beds licensed under |
|
800
|
chapter 395.
|
|
801
|
1. Beds in the following licensed categories may be |
|
802
|
increased under this paragraph:
|
|
803
|
a.for Acute care beds, mental health services, or a |
|
804
|
hospital-based distinct part skilled nursing unitin a number |
|
805
|
that may not exceed 3010total beds or 10 percent of the |
|
806
|
licensed capacity of acute care bedsthe bed category being |
|
807
|
expanded, whichever is greater;
|
|
808
|
b. Hospital-based distinct part skilled nursing unit beds, |
|
809
|
in a number that may not exceed 10 total beds or 10 percent of |
|
810
|
the licensed capacity of skilled nursing unit beds, whichever is |
|
811
|
greater;
|
|
812
|
c. Comprehensive medical rehabilitation beds in a number |
|
813
|
that may not exceed 8 total beds or 10 percent of the licensed |
|
814
|
capacity of comprehensive medical rehabilitation beds, whichever |
|
815
|
is greater;
|
|
816
|
d. Level II or Level III neonatal intensive care beds, in |
|
817
|
a number that may not exceed 6 total beds or 10 percent of the |
|
818
|
licensed capacity of Level II or Level III neonatal intensive |
|
819
|
care beds, whichever is greater; or
|
|
820
|
e. Mental health services beds, in a number that may not |
|
821
|
exceed 10 total beds or 10 percent of the licensed capacity of |
|
822
|
mental health services beds, whichever is greater. |
|
823
|
2. Beds for specialty burn units, neonatal intensive care |
|
824
|
units, or comprehensive rehabilitation,or at a long-term care |
|
825
|
hospital,may not be increased under this paragraph. |
|
826
|
3.1.In addition to any other documentation otherwise |
|
827
|
required by the agency, a request for exemption submitted under |
|
828
|
this paragraph must: |
|
829
|
a. Certify that the prior 12-month average occupancy rate |
|
830
|
is at least 75 percent for acute care beds, at least 96 percent |
|
831
|
for the category of licensed beds being expanded at the facility |
|
832
|
meets or exceeds 80 percent or, for ahospital-based distinct |
|
833
|
part skilled nursing unit beds, at least 90 percent for |
|
834
|
comprehensive medical rehabilitation beds, or at least 75 percent |
|
835
|
for the level of neonatal intensive care beds being expandedthe |
|
836
|
prior 12-month average occupancy rate meets or exceeds 96 |
|
837
|
percent. |
|
838
|
b. Certify that any beds of the same type authorized for |
|
839
|
the facility under this paragraph before the date of the current |
|
840
|
request for an exemption have been licensed and operational for |
|
841
|
at least 12 months. |
|
842
|
4.2.The timeframes and monitoring process specified in s. |
|
843
|
408.040(2)(a)-(c) apply to any exemption issued under this |
|
844
|
paragraph. |
|
845
|
5.3.The agency shall count beds authorized under this |
|
846
|
paragraph as approved beds in the published inventory of |
|
847
|
hospital beds until the beds are licensed. |
|
848
|
(o) For the addition of acute care beds, as authorized by |
|
849
|
rule consistent with s. 395.003(4), in a number that may not |
|
850
|
exceed 3010total beds or 10 percent of licensed bed capacity, |
|
851
|
whichever is greater, for temporary beds in a hospital that has |
|
852
|
experienced high seasonal occupancy within the prior 12-month |
|
853
|
period or in a hospital that must respond to emergency |
|
854
|
circumstances. |
|
855
|
(p) For the addition of nursing home beds licensed under |
|
856
|
chapter 400 in a number not exceeding 10 total beds or 10 |
|
857
|
percent of the number of beds licensed in the facility being |
|
858
|
expanded, whichever is greater. |
|
859
|
1. In addition to any other documentation required by the |
|
860
|
agency, a request for exemption submitted under this paragraph |
|
861
|
must: |
|
862
|
a. Effective until June 30, 2001,Certify that the |
|
863
|
facility has not had any class I or class II deficiencies within |
|
864
|
the 30 months preceding the request for addition. |
|
865
|
b. Effective on July 1, 2001, certify that the facility |
|
866
|
has been designated as a Gold Seal nursing home under s. |
|
867
|
400.235.
|
|
868
|
b.c.Certify that the prior 12-month average occupancy |
|
869
|
rate for the nursing home beds at the facility meets or exceeds |
|
870
|
96 percent. |
|
871
|
c.d.Certify that any beds authorized for the facility |
|
872
|
under this paragraph before the date of the current request for |
|
873
|
an exemption have been licensed and operational for at least 12 |
|
874
|
months. |
|
875
|
2. The timeframes and monitoring process specified in s. |
|
876
|
408.040(2)(a)-(c) apply to any exemption issued under this |
|
877
|
paragraph. |
|
878
|
3. The agency shall count beds authorized under this |
|
879
|
paragraph as approved beds in the published inventory of nursing |
|
880
|
home beds until the beds are licensed. |
|
881
|
(q) For establishment of a specialty hospital offering a |
|
882
|
range of medical service restricted to a defined age or gender |
|
883
|
group of the population or a restricted range of services |
|
884
|
appropriate to the diagnosis, care, and treatment of patients |
|
885
|
with specific categories of medical illnesses or disorders, |
|
886
|
through the transfer of beds and services from an existing |
|
887
|
hospital in the same county.
|
|
888
|
(q)(r)For the conversion of hospital-based Medicare and |
|
889
|
Medicaid certified skilled nursing beds to acute care beds, if |
|
890
|
the conversion does not involve the construction of new |
|
891
|
facilities. |
|
892
|
(r) For the conversion of mental health services beds |
|
893
|
between or among the licensed bed categories defined as beds for |
|
894
|
mental health services, provided that conversion under this |
|
895
|
paragraph shall not establish a new licensed bed category at the |
|
896
|
hospital but shall apply only to categories of beds licensed at |
|
897
|
that hospital.
|
|
898
|
(s) For the replacement of a statutory rural hospital |
|
899
|
within the same district, provided the proposed project site is |
|
900
|
within 10 miles of the existing facility and is within the |
|
901
|
current primary service area, defined as the least number of zip |
|
902
|
codes comprising 75 percent of the hospital's inpatient |
|
903
|
admissions.
|
|
904
|
(t) For the establishment of a Level II neonatal intensive |
|
905
|
care unit with at least 10 beds, upon documentation to the |
|
906
|
agency that the applicant hospital had a minimum of 1,500 births |
|
907
|
during the previous 12 months.
|
|
908
|
(u) For replacement of a licensed nursing home on the same |
|
909
|
site, or within 3 miles of the same site, provided the number of |
|
910
|
licensed beds does not increase.
|
|
911
|
(v) For consolidation or combination of licensed nursing |
|
912
|
homes or transfer of beds between licensed nursing homes within |
|
913
|
the same district, by providers that operate multiple nursing |
|
914
|
homes within that district, provided there is no increase in the |
|
915
|
district total of nursing home beds and the relocation does not |
|
916
|
exceed 30 miles from the original location.
|
|
917
|
(w) For the establishment of an adult open-heart program |
|
918
|
in a facility located in a municipality without an open-heart |
|
919
|
program which has a population of 225,000 or more.
|
|
920
|
(s) For fiscal year 2001-2002 only, for transfer by a |
|
921
|
health care system of existing services and not more than 100 |
|
922
|
licensed and approved beds from a hospital in district 1, |
|
923
|
subdistrict 1, to another location within the same subdistrict |
|
924
|
in order to establish a satellite facility that will improve |
|
925
|
access to outpatient and inpatient care for residents of the |
|
926
|
district and subdistrict and that will use new medical |
|
927
|
technologies, including advanced diagnostics, computer assisted |
|
928
|
imaging, and telemedicine to improve care. This paragraph is |
|
929
|
repealed on July 1, 2002.
|
|
930
|
(4) A request for exemption under subsection (3) may be |
|
931
|
made at any time and is not subject to the batching requirements |
|
932
|
of this section. The request shall be supported by such |
|
933
|
documentation as the agency requires by rule. The agency shall |
|
934
|
assess a fee of $250 for each request for exemption submitted |
|
935
|
under subsection (3). |
|
936
|
Section 6. Paragraph (c) of subsection (1) and subsection |
|
937
|
(2) of section 408.037, Florida Statutes, are amended to read: |
|
938
|
408.037 Application content.-- |
|
939
|
(1) An application for a certificate of need must contain: |
|
940
|
(c) An audited financial statement of the applicant; or, |
|
941
|
if the applicant is included in a parent company's consolidated |
|
942
|
audit which details each entity separately, an audited financial |
|
943
|
statement of the parent company. In an application submitted by |
|
944
|
an existing health care facility, health maintenance |
|
945
|
organization, or hospice, financial condition documentation must |
|
946
|
include, but need not be limited to, a balance sheet and a |
|
947
|
profit-and-loss statement of the 2 previous fiscal years' |
|
948
|
operation. |
|
949
|
(2) The applicant must certify that it will license and |
|
950
|
operate the health care facility. For an existing health care |
|
951
|
facility, the applicant must be the licenseholder of the |
|
952
|
facility. However, acquisition of a licensed hospital prior to |
|
953
|
final agency action on its application for a certificate of need |
|
954
|
shall transfer the application to the new owner and |
|
955
|
licenseholder. |
|
956
|
Section 7. Section 408.038, Florida Statutes, is amended |
|
957
|
to read: |
|
958
|
408.038 Fees.-- |
|
959
|
(1)The agency shall assess fees on certificate-of-need |
|
960
|
applications. Such fees shall be for the purpose of funding the |
|
961
|
functions of the local health councils andthe activities of the |
|
962
|
agency. Except as otherwise provided in subsection (2), such |
|
963
|
feesandshall be allocated as provided in s. 408.033. The fee |
|
964
|
shall be determined as follows: |
|
965
|
(a)(1) A minimum base fee of $10,000$5,000. |
|
966
|
(b)(2) In addition to the base fee of $10,000$5,000, |
|
967
|
0.015 of each dollar of proposed expenditure, except that a fee |
|
968
|
may not exceed $50,000$22,000. |
|
969
|
(2) The proceeds from half of each minimum base fee under |
|
970
|
paragraph (1)(a) and the proceeds from each additional amount |
|
971
|
assessed under paragraph (1)(b) which is in excess of $22,000 |
|
972
|
shall be used to fund activities of the certificate-of-need |
|
973
|
program.
|
|
974
|
Section 8. Paragraphs (c) and (e) of subsection (5) and |
|
975
|
paragraph (c) of subsection (6) of section 408.039, Florida |
|
976
|
Statutes, are amended to read: |
|
977
|
408.039 Review process.--The review process for |
|
978
|
certificates of need shall be as follows: |
|
979
|
(5) ADMINISTRATIVE HEARINGS.-- |
|
980
|
(c) In administrative proceedings challenging the issuance |
|
981
|
or denial of a certificate of need, only applicants considered |
|
982
|
by the agency in the same batching cycle are entitled to a |
|
983
|
comparative hearing on their applications. Existing health care |
|
984
|
facilities may initiate or intervene in an administrative |
|
985
|
hearing upon a showing that an established program will be |
|
986
|
substantially affected by the issuance of any certificate of |
|
987
|
need, whether reviewed under s. 408.036(1) or (2), to a |
|
988
|
competing proposed facility or program within the same district. |
|
989
|
(e) The agency shall issue its final order within 45 days |
|
990
|
after receipt of the recommended order. If the agency fails to |
|
991
|
take action within 45 days, the recommended order of the |
|
992
|
Division of Administrative Hearings becomes the agency's final |
|
993
|
ordersuch time, or as otherwise agreed to by the applicant and |
|
994
|
the agency, the applicant may take appropriate legal action to |
|
995
|
compel the agency to act. When making a determination on an |
|
996
|
application for a certificate of need, the agency is |
|
997
|
specifically exempt from the time limitations provided in s. |
|
998
|
120.60(1). |
|
999
|
(6) JUDICIAL REVIEW.-- |
|
1000
|
(c) The court, in its discretion, may award reasonable |
|
1001
|
attorney's fees and costs to the prevailing party. If the losing |
|
1002
|
party is a hospital, the court shall order it to pay the |
|
1003
|
reasonable attorney's fees and costs of the prevailing hospital |
|
1004
|
party, which shall include fees and costs incurred as a result |
|
1005
|
of the administrative hearing and the judicial appealif the |
|
1006
|
court finds that there was a complete absence of a justiciable |
|
1007
|
issue of law or fact raised by the losing party. |
|
1008
|
Section 9. Subsection (2) of section 408.043, Florida |
|
1009
|
Statutes, is amended to read: |
|
1010
|
408.043 Special provisions.-- |
|
1011
|
(2) HOSPICES.--When an application is made for a |
|
1012
|
certificate of need to establish or to expand a hospice, the |
|
1013
|
need for such hospice shall be determined on the basis of the |
|
1014
|
need for and availability of hospice services in the community. |
|
1015
|
The formula on which the certificate of need is based shall |
|
1016
|
discourage regional monopolies and promote competition. The |
|
1017
|
inpatient hospice care component of a hospice which is a |
|
1018
|
freestanding facility, or a part of a facility, which is |
|
1019
|
primarily engaged in providing inpatient care and related |
|
1020
|
services and is not licensed as a health care facility shall |
|
1021
|
also be required to obtain a certificate of need.Provision of |
|
1022
|
hospice care by any current provider of health care is a |
|
1023
|
significant change in service and therefore requires a |
|
1024
|
certificate of need for such services. |
|
1025
|
Section 10. Subsection (9) of section 408.05, Florida |
|
1026
|
Statutes, is renumbered as subsection (10) and amended, and a |
|
1027
|
new subsection (9) is added to said section, to read: |
|
1028
|
408.05 State Center for Health Statistics.-- |
|
1029
|
(9) OUTCOME MEASURES.--The agency shall establish, |
|
1030
|
implement, and evaluate scientifically sound and clinically |
|
1031
|
relevant quality outcome measures for cardiac programs in order |
|
1032
|
to reduce unwarranted variation in the delivery of cardiac care, |
|
1033
|
improve the quality of cardiac care, and promote the appropriate |
|
1034
|
utilization of cardiac services.
|
|
1035
|
(a) The agency, in conjunction with the Florida Hospital |
|
1036
|
Association, the Florida Society of Thoracic and Cardiovascular |
|
1037
|
Surgeons, the Florida Chapter of the American College of |
|
1038
|
Cardiology, and the Florida Chapter of the American Heart |
|
1039
|
Association shall develop and adopt by rule state quality |
|
1040
|
outcome measures based on data received pursuant to this |
|
1041
|
subsection, as well as on nationally developed quality outcome |
|
1042
|
measures.
|
|
1043
|
(b) The outcome measures shall be based on the data |
|
1044
|
elements reported by hospitals licensed under s. 395.0095, |
|
1045
|
simultaneously to the Society of Thoracic Surgeons' data base |
|
1046
|
and the agency. The data shall be aggregated to establish |
|
1047
|
statewide norms for cardiac programs and cardiac surgery. The |
|
1048
|
data shall be adjusted by risk and used to determine morbidity |
|
1049
|
and mortality rates for operative categories by surgical |
|
1050
|
urgency. Other measures shall include, but not be limited to, |
|
1051
|
infection rates, nonfatal myocardial infarctions, lengths of |
|
1052
|
stay, postoperative bleeds, and returns to surgery for operative |
|
1053
|
categories by surgical urgency. Where appropriate, the rates |
|
1054
|
shall be adjusted for age.
|
|
1055
|
(c) Every hospital with a licensed cardiac program, in |
|
1056
|
conjunction with the hospital medical staff, shall produce |
|
1057
|
quality outcome data pursuant to the criteria developed in this |
|
1058
|
subsection. The hospital shall forward such data to the agency |
|
1059
|
in a manner consistent with s. 408.061 on a quarterly basis |
|
1060
|
beginning July 1, 2003. As used in this subsection, "hospital" |
|
1061
|
means an acute care hospital licensed under chapter 395.
|
|
1062
|
(d) The agency shall summarize the quality outcome |
|
1063
|
measures for cardiac procedures by hospital, by district, by |
|
1064
|
region, and across the state. The agency shall make the report |
|
1065
|
available to the public and all hospitals throughout the state |
|
1066
|
on an annual basis beginning December 31, 2006. The agency shall |
|
1067
|
also make detail data submitted pursuant to this subsection |
|
1068
|
available for analysis by others, subject to protection of |
|
1069
|
confidentiality pursuant to s. 408.061.
|
|
1070
|
(e) Parameters developed pursuant to this subsection shall |
|
1071
|
be made available to the public, all hospitals, and health |
|
1072
|
professionals by publication on the agency's website or in |
|
1073
|
writing upon written request.
|
|
1074
|
(f) Procedures shall be instituted which provide for the |
|
1075
|
periodic review and revision of quality outcome measures based |
|
1076
|
on the latest outcome data, research findings, technological |
|
1077
|
advancements, and clinical experiences, at least once every 2 |
|
1078
|
years.
|
|
1079
|
(10)(9)SECTION NOT LIMITING.--Nothing in this section |
|
1080
|
shall limit, restrict, affect, or control the collection, |
|
1081
|
analysis, release, or publication of data by any state agency |
|
1082
|
pursuant to its statutory authority, duties, or |
|
1083
|
responsibilities. |
|
1084
|
Section 11. Section 52 of chapter 2001-45, Laws of |
|
1085
|
Florida, is amended to read: |
|
1086
|
Section 52. (1)Notwithstanding the establishment of need |
|
1087
|
as provided for in chapter 408, Florida Statutes, no certificate |
|
1088
|
of need for additional community nursing home beds shall be |
|
1089
|
approved by the agency until July 1, 2006. |
|
1090
|
(2)The Legislature finds that the continued growth in the |
|
1091
|
Medicaid budget for nursing home care has constrained the |
|
1092
|
ability of the state to meet the needs of its elderly residents |
|
1093
|
through the use of less restrictive and less institutional |
|
1094
|
methods of long-term care. It is therefore the intent of the |
|
1095
|
Legislature to limit the increase in Medicaid nursing home |
|
1096
|
expenditures in order to provide funds to invest in long-term |
|
1097
|
care that is community-based and provides supportive services in |
|
1098
|
a manner that is both more cost-effective and more in keeping |
|
1099
|
with the wishes of the elderly residents of this state. |
|
1100
|
(3)This moratorium on certificates of need shall not |
|
1101
|
apply to sheltered nursing home beds in a continuing care |
|
1102
|
retirement community certified by the Department of Insurance |
|
1103
|
pursuant to chapter 651, Florida Statutes. |
|
1104
|
(4)(a) This moratorium on certificates of need shall not |
|
1105
|
apply, and a certificate of need for additional community nursing |
|
1106
|
home beds may be approved, for a county that meets the following |
|
1107
|
circumstances:
|
|
1108
|
1. The county has no community nursing home beds.
|
|
1109
|
2. The lack of community nursing home beds occurs because |
|
1110
|
all nursing home beds in the county that were licensed on July |
|
1111
|
1, 2001, have subsequently closed.
|
|
1112
|
(b) The certificate-of-need review for such circumstances |
|
1113
|
shall be subject to the comparative review process consistent |
|
1114
|
with the provisions of s. 408.039, Florida Statutes, and the |
|
1115
|
number of beds may not exceed the number of beds lost by the |
|
1116
|
county after July 1, 2001.
|
|
1117
|
Section 12. Subsection (4) of section 383.50, Florida |
|
1118
|
Statutes, is amended to read: |
|
1119
|
383.50 Treatment of abandoned newborn infant.-- |
|
1120
|
(4) Each hospital of this state subject to s. 395.1041 |
|
1121
|
shall, and any other hospital may, admit and provide all |
|
1122
|
necessary emergency services and care, as defined in s. |
|
1123
|
395.002(15)(10), to any newborn infant left with the hospital in |
|
1124
|
accordance with this section. The hospital or any of its |
|
1125
|
licensed health care professionals shall consider these actions |
|
1126
|
as implied consent for treatment, and a hospital accepting |
|
1127
|
physical custody of a newborn infant has implied consent to |
|
1128
|
perform all necessary emergency services and care. The hospital |
|
1129
|
or any of its licensed health care professionals is immune from |
|
1130
|
criminal or civil liability for acting in good faith in |
|
1131
|
accordance with this section. Nothing in this subsection limits |
|
1132
|
liability for negligence. |
|
1133
|
Section 13. Subsection (7) of section 394.4787, Florida |
|
1134
|
Statutes, is amended to read: |
|
1135
|
394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, |
|
1136
|
and 394.4789.--As used in this section and ss. 394.4786, |
|
1137
|
394.4788, and 394.4789: |
|
1138
|
(7) "Specialty psychiatric hospital" means a hospital |
|
1139
|
licensed by the agency pursuant to s. 395.002(36)(29)as a |
|
1140
|
specialty psychiatric hospital. |
|
1141
|
Section 14. Paragraph (c) of subsection (2) of section |
|
1142
|
395.602, Florida Statutes, is amended to read: |
|
1143
|
395.602 Rural hospitals.-- |
|
1144
|
(2) DEFINITIONS.--As used in this part: |
|
1145
|
(c) "Inactive rural hospital bed" means a licensed acute |
|
1146
|
care hospital bed, as defined in s. 395.002(19)(14), that is |
|
1147
|
inactive in that it cannot be occupied by acute care inpatients. |
|
1148
|
Section 15. Paragraph (c) of subsection (1) of section |
|
1149
|
395.701, Florida Statutes, is amended to read: |
|
1150
|
395.701 Annual assessments on net operating revenues for |
|
1151
|
inpatient and outpatient services to fund public medical |
|
1152
|
assistance; administrative fines for failure to pay assessments |
|
1153
|
when due; exemption.-- |
|
1154
|
(1) For the purposes of this section, the term: |
|
1155
|
(c) "Hospital" means a health care institution as defined |
|
1156
|
in s. 395.002(18)(13), but does not include any hospital |
|
1157
|
operated by the agency or the Department of Corrections. |
|
1158
|
Section 16. Paragraph (b) of subsection (1) of section |
|
1159
|
400.051, Florida Statutes, is amended to read: |
|
1160
|
400.051 Homes or institutions exempt from the provisions |
|
1161
|
of this part.-- |
|
1162
|
(1) The following shall be exempt from the provisions of |
|
1163
|
this part: |
|
1164
|
(b) Any hospital, as defined in s. 395.002(16)(11), that |
|
1165
|
is licensed under chapter 395. |
|
1166
|
Section 17. Subsection (8) of section 409.905, Florida |
|
1167
|
Statutes, is amended to read: |
|
1168
|
409.905 Mandatory Medicaid services.--The agency may make |
|
1169
|
payments for the following services, which are required of the |
|
1170
|
state by Title XIX of the Social Security Act, furnished by |
|
1171
|
Medicaid providers to recipients who are determined to be |
|
1172
|
eligible on the dates on which the services were provided. Any |
|
1173
|
service under this section shall be provided only when medically |
|
1174
|
necessary and in accordance with state and federal law. |
|
1175
|
Mandatory services rendered by providers in mobile units to |
|
1176
|
Medicaid recipients may be restricted by the agency. Nothing in |
|
1177
|
this section shall be construed to prevent or limit the agency |
|
1178
|
from adjusting fees, reimbursement rates, lengths of stay, |
|
1179
|
number of visits, number of services, or any other adjustments |
|
1180
|
necessary to comply with the availability of moneys and any |
|
1181
|
limitations or directions provided for in the General |
|
1182
|
Appropriations Act or chapter 216. |
|
1183
|
(8) NURSING FACILITY SERVICES.--The agency shall pay for |
|
1184
|
24-hour-a-day nursing and rehabilitative services for a |
|
1185
|
recipient in a nursing facility licensed under part II of |
|
1186
|
chapter 400 or in a rural hospital, as defined in s. 395.602, or |
|
1187
|
in a Medicare certified skilled nursing facility operated by a |
|
1188
|
hospital, as defined by s. 395.002(16)(11), that is licensed |
|
1189
|
under part I of chapter 395, and in accordance with provisions |
|
1190
|
set forth in s. 409.908(2)(a), which services are ordered by and |
|
1191
|
provided under the direction of a licensed physician. However, |
|
1192
|
if a nursing facility has been destroyed or otherwise made |
|
1193
|
uninhabitable by natural disaster or other emergency and another |
|
1194
|
nursing facility is not available, the agency must pay for |
|
1195
|
similar services temporarily in a hospital licensed under part I |
|
1196
|
of chapter 395 provided federal funding is approved and |
|
1197
|
available. |
|
1198
|
Section 18. Paragraph (l) of subsection (1) of section |
|
1199
|
468.505, Florida Statutes, is amended to read: |
|
1200
|
468.505 Exemptions; exceptions.-- |
|
1201
|
(1) Nothing in this part may be construed as prohibiting |
|
1202
|
or restricting the practice, services, or activities of: |
|
1203
|
(l) A person employed by a nursing facility exempt from |
|
1204
|
licensing under s. 395.002(18)(13), or a person exempt from |
|
1205
|
licensing under s. 464.022. |
|
1206
|
Section 19. Section 766.316, Florida Statutes, is amended |
|
1207
|
to read: |
|
1208
|
766.316 Notice to obstetrical patients of participation in |
|
1209
|
the plan.--Each hospital with a participating physician on its |
|
1210
|
staff and each participating physician, other than residents, |
|
1211
|
assistant residents, and interns deemed to be participating |
|
1212
|
physicians under s. 766.314(4)(c), under the Florida Birth- |
|
1213
|
Related Neurological Injury Compensation Plan shall provide |
|
1214
|
notice to the obstetrical patients as to the limited no-fault |
|
1215
|
alternative for birth-related neurological injuries. Such notice |
|
1216
|
shall be provided on forms furnished by the association and |
|
1217
|
shall include a clear and concise explanation of a patient's |
|
1218
|
rights and limitations under the plan. The hospital or the |
|
1219
|
participating physician may elect to have the patient sign a |
|
1220
|
form acknowledging receipt of the notice form. Signature of the |
|
1221
|
patient acknowledging receipt of the notice form raises a |
|
1222
|
rebuttable presumption that the notice requirements of this |
|
1223
|
section have been met. Notice need not be given to a patient |
|
1224
|
when the patient has an emergency medical condition as defined |
|
1225
|
in s. 395.002(13)(9)(b) or when notice is not practicable. |
|
1226
|
Section 20. Paragraph (b) of subsection (2) of section |
|
1227
|
812.014, Florida Statutes, is amended to read: |
|
1228
|
812.014 Theft.-- |
|
1229
|
(2) |
|
1230
|
(b)1. If the property stolen is valued at $20,000 or more, |
|
1231
|
but less than $100,000; |
|
1232
|
2. The property stolen is cargo valued at less than |
|
1233
|
$50,000 that has entered the stream of interstate or intrastate |
|
1234
|
commerce from the shipper's loading platform to the consignee's |
|
1235
|
receiving dock; or |
|
1236
|
3. The property stolen is emergency medical equipment, |
|
1237
|
valued at $300 or more, that is taken from a facility licensed |
|
1238
|
under chapter 395 or from an aircraft or vehicle permitted under |
|
1239
|
chapter 401, |
|
1240
|
|
|
1241
|
the offender commits grand theft in the second degree, |
|
1242
|
punishable as a felony of the second degree, as provided in s. |
|
1243
|
775.082, s. 775.083, or s. 775.084. Emergency medical equipment |
|
1244
|
means mechanical or electronic apparatus used to provide |
|
1245
|
emergency services and care as defined in s. 395.002(15)(10)or |
|
1246
|
to treat medical emergencies. |
|
1247
|
Section 21. (1) A facility authorized by the state to |
|
1248
|
provide services under any of the following authorized programs |
|
1249
|
pursuant to state authorization or a valid certificate of need |
|
1250
|
on June 30, 2003, shall continue to be licensed to provide such |
|
1251
|
service on and after the effective date of this act:
|
|
1252
|
(a) Diagnostic cardiac catheterization program.
|
|
1253
|
(b) Emergency percutaneous coronary intervention program.
|
|
1254
|
(c) Percutaneous coronary intervention program.
|
|
1255
|
(d) Cardiac surgery program.
|
|
1256
|
(2) Facilities applying for relicensure to provide such |
|
1257
|
services pursuant to the provisions of this act are authorized |
|
1258
|
to continue to operate until the Agency for Health Care |
|
1259
|
Administration takes final action on the licensure application.
|
|
1260
|
Section 22. Subsection (5) of section 408.043, Florida |
|
1261
|
Statutes, as created by section 1 of Senate Bill 1568, 2003 |
|
1262
|
Regular Session, is amended to read: |
|
1263
|
408.043 Special provisions.-- |
|
1264
|
(5) SOLE ACUTE CARE HOSPITALS IN HIGH GROWTH |
|
1265
|
COUNTIES.--Notwithstanding any other provision of law, an acute |
|
1266
|
care hospital licensed under chapter 395 may add up to 180 |
|
1267
|
additional beds without agency review if such hospital is |
|
1268
|
located in a county that has experienced at least a 60-percent |
|
1269
|
growth rate for the most recent 10-year period for which data |
|
1270
|
are available as determined by using the population statistics |
|
1271
|
published in the most recent edition of the Florida Statistical |
|
1272
|
Abstract, is the sole acute care hospital in the county, and is |
|
1273
|
the only acute care hospital within a 10-mile radius of another |
|
1274
|
hospital. A hospital shall provide written notice to the agency |
|
1275
|
that it qualifies under this subsection prior to the addition of |
|
1276
|
beds. Such projects shall not be subject to challenge under s. |
|
1277
|
408.039 or chapter 120. Acute care beds added under this |
|
1278
|
subsection shall notbe included in the inventory of hospital |
|
1279
|
beds used by the agency in the calculation of the fixed-bed-need |
|
1280
|
pool for acute care hospitals. |
|
1281
|
Section 23. This act shall take effect July 1, 2003. |