| 1 | The Committee on Health Care recommends the following: |
| 2 |
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| 3 | Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to certificates of need; amending s. |
| 7 | 395.003, F.S.; providing certain restrictions on the |
| 8 | licensure of hospitals; providing exceptions; authorizing |
| 9 | rulemaking; amending s. 408.032, F.S.; revising |
| 10 | definitions; amending s. 408.033, F.S.; revising |
| 11 | provisions relating to local health councils; deleting |
| 12 | provisions relating to regional areas; revising funding |
| 13 | provisions; making the Agency for Health Care |
| 14 | Administration solely responsible for coordinated planning |
| 15 | of health care services; transferring certain duties from |
| 16 | the agency to the Department of Health; amending ss. |
| 17 | 408.034 and 408.035, F.S., to conform; amending s. |
| 18 | 408.036, F.S.; revising the list of projects subject to |
| 19 | review; including beds in community nursing homes and |
| 20 | intermediate care facilities for the developmentally |
| 21 | disabled in project review requirements; including |
| 22 | conversion from a general hospital to another form of |
| 23 | hospital in project review requirements; revising the list |
| 24 | of projects subject to expedited review; revising the list |
| 25 | of projects subject to exemption from review; specifying |
| 26 | certain facility or provider notice requirements; amending |
| 27 | s. 408.0361, F.S.; requiring the agency to adopt rules to |
| 28 | develop licensing standards for cardiology services and |
| 29 | burn units; providing criteria for such rules; requiring |
| 30 | certain providers to comply with such rules; requiring the |
| 31 | agency to include certain provisions in establishing the |
| 32 | rules; requiring the agency to establish a technical |
| 33 | advisory panel and adopt rules based on the panel's |
| 34 | recommendations; requiring the secretary of the agency to |
| 35 | appoint an advisory group; providing membership criteria |
| 36 | for such group; requiring the group to make certain |
| 37 | recommendations; requiring the secretary to appoint a |
| 38 | workgroup; providing the components of such workgroup's |
| 39 | assessment; requiring a report; amending s. 408.038, F.S.; |
| 40 | providing for a higher application fee; amending s. |
| 41 | 408.039, F.S.; specifying an annual review cycle; amending |
| 42 | s. 408.040, F.S.; providing that failure to report |
| 43 | compliance constitutes noncompliance; amending s. 408.043, |
| 44 | F.S.; deleting special provisions relating to sole acute |
| 45 | care hospitals in high-growth counties; amending s. |
| 46 | 408.0455, F.S.; deleting an obsolete judicial or |
| 47 | administrative abatement provision; providing an effective |
| 48 | date. |
| 49 |
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| 50 | WHEREAS, the Legislature finds that it is essential for the |
| 51 | public health and safety of this state that general hospitals |
| 52 | providing emergency services be available in our communities, |
| 53 | and |
| 54 | WHEREAS, the Legislature finds that a substantial number of |
| 55 | hospitals have closed in this state and is concerned that more |
| 56 | hospitals may close, and |
| 57 | WHEREAS, the Legislature finds the creation of hospitals |
| 58 | with limited services will serve only paying patients and may |
| 59 | cause harm to the existence of general hospitals serving broad |
| 60 | populations, including the medically indigent of this state, and |
| 61 | WHEREAS, the Legislature finds that the creation of |
| 62 | hospitals with limited services may limit or eliminate |
| 63 | competitive alternatives in the health care service market, may |
| 64 | result in overutilization of certain high-cost health care |
| 65 | services such as cardiac, orthopedic, surgical, and oncology |
| 66 | services, may increase costs to the health care system, and may |
| 67 | adversely affect the quality of health care, NOW, THEREFORE, |
| 68 |
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| 69 | Be It Enacted by the Legislature of the State of Florida: |
| 70 |
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| 71 | Section 1. Subsections (9), (10), and (11) are added to |
| 72 | section 395.003, Florida Statutes, to read: |
| 73 | 395.003 Licensure; issuance, renewal, denial, |
| 74 | modification, suspension, and revocation.-- |
| 75 | (9) A hospital shall not be licensed or relicensed if: |
| 76 | (a) The diagnostic-related groups for 65 percent or more |
| 77 | of the discharges from the hospital, in the most recent year for |
| 78 | which data is available to the Agency for Health Care |
| 79 | Administration pursuant to s. 408.061, are for diagnosis, care, |
| 80 | and treatment of patients with: |
| 81 | 1. Cardiac-related diseases and disorders classified as |
| 82 | diagnostic-related groups 103-145, 478-479, 514-518, or 525-527; |
| 83 | 2. Orthopedic-related diseases and disorders classified as |
| 84 | diagnostic-related groups 209-256, 471, 491, 496-503, or 519- |
| 85 | 520; |
| 86 | 3. Cancer-related diseases and disorders classified as |
| 87 | diagnostic-related groups 64, 82, 172, 173, 199, 200, 203, 257- |
| 88 | 260, 274, 275, 303, 306, 307, 318, 319, 338, 344, 346, 347, 363, |
| 89 | 366, 367, 400-414, 473, or 492; or |
| 90 | 4. Any combination of the above discharges. |
| 91 | (b) The hospital restricts its medical and surgical |
| 92 | services to primarily or exclusively cardiac, orthopedic, |
| 93 | surgical, or oncology specialties. |
| 94 | (10) A hospital licensed as of June 1, 2004, shall be |
| 95 | exempt from the requirements in subsection (9) so long as the |
| 96 | hospital maintains the same ownership, facility street address, |
| 97 | and range of services that were in existence on June 1, 2004. |
| 98 | Any transfer of beds, or other agreements that result in the |
| 99 | establishment of a hospital or hospital services within the |
| 100 | intent of this section, shall be subject to these provisions. |
| 101 | Unless otherwise exempt under subsection (9), the agency shall |
| 102 | deny or revoke a license if a hospital violates any of the |
| 103 | criteria under subsection (9). |
| 104 | (11) The agency may adopt rules implementing the licensure |
| 105 | requirements set forth in subsection (9). Within 14 days after |
| 106 | rendering its decision on a license application or revocation, |
| 107 | the agency shall publish its proposed decision in the Florida |
| 108 | Administrative Weekly. Within 21 days after publication of the |
| 109 | agency's decision, any authorized person may file a request for |
| 110 | an administrative hearing. In administrative proceedings |
| 111 | challenging the approval, denial, or revocation of a license |
| 112 | pursuant to subsection (9), the hearing will be based on the |
| 113 | facts and law existing at the time of the agency's proposed |
| 114 | agency action. Existing hospitals may initiate or intervene in |
| 115 | an administrative hearing to approve, deny, or revoke licensure |
| 116 | under subsection (9) based upon a showing that an established |
| 117 | program will be substantially affected by the issuance or |
| 118 | renewal of a license to a hospital within the same district or |
| 119 | service area. |
| 120 | Section 2. Subsections (9), (13), (17), and (18) of |
| 121 | section 408.032, Florida Statutes, are amended to read: |
| 122 | 408.032 Definitions relating to Health Facility and |
| 123 | Services Development Act.--As used in ss. 408.031-408.045, the |
| 124 | term: |
| 125 | (9) "Health services" means inpatient diagnostic, |
| 126 | curative, or comprehensive medical rehabilitative services and |
| 127 | includes mental health services. Obstetric services are not |
| 128 | health services for purposes of ss. 408.031-408.045. |
| 129 | (13) "Long-term care hospital" means a hospital licensed |
| 130 | under chapter 395 which meets the requirements of 42 C.F.R. s. |
| 131 | 412.23(e) and seeks exclusion from the acute care Medicare |
| 132 | prospective payment system for inpatient hospital services. |
| 133 | (17) "Tertiary health service" means a health service |
| 134 | which, due to its high level of intensity, complexity, |
| 135 | specialized or limited applicability, and cost, should be |
| 136 | limited to, and concentrated in, a limited number of hospitals |
| 137 | to ensure the quality, availability, and cost-effectiveness of |
| 138 | such service. Examples of such service include, but are not |
| 139 | limited to, pediatric cardiac catheterization, pediatric open- |
| 140 | heart surgery, organ transplantation, specialty burn units, |
| 141 | neonatal intensive care units, comprehensive rehabilitation, and |
| 142 | medical or surgical services which are experimental or |
| 143 | developmental in nature to the extent that the provision of such |
| 144 | services is not yet contemplated within the commonly accepted |
| 145 | course of diagnosis or treatment for the condition addressed by |
| 146 | a given service. The agency shall establish by rule a list of |
| 147 | all tertiary health services. |
| 148 | (18) "Regional area" means any of those regional health |
| 149 | planning areas established by the agency to which local and |
| 150 | district health planning funds are directed to local health |
| 151 | councils through the General Appropriations Act. |
| 152 | Section 3. Section 408.033, Florida Statutes, is amended |
| 153 | to read: |
| 154 | 408.033 Local and state health planning.-- |
| 155 | (1) LOCAL HEALTH COUNCILS.-- |
| 156 | (a) Local health councils are hereby established as public |
| 157 | or private nonprofit agencies serving the counties of a district |
| 158 | or regional area of the agency. The members of each council |
| 159 | shall be appointed in an equitable manner by the county |
| 160 | commissions having jurisdiction in the respective district. Each |
| 161 | council shall be composed of a number of persons equal to 11/2 |
| 162 | times the number of counties which compose the district or 12 |
| 163 | members, whichever is greater. Each county in a district shall |
| 164 | be entitled to at least one member on the council. The balance |
| 165 | of the membership of the council shall be allocated among the |
| 166 | counties of the district on the basis of population rounded to |
| 167 | the nearest whole number; except that in a district composed of |
| 168 | only two counties, no county shall have fewer than four members. |
| 169 | The appointees shall be representatives of health care |
| 170 | providers, health care purchasers, and nongovernmental health |
| 171 | care consumers, but not excluding elected government officials. |
| 172 | The members of the consumer group shall include a representative |
| 173 | number of persons over 60 years of age. A majority of council |
| 174 | members shall consist of health care purchasers and health care |
| 175 | consumers. The local health council shall provide each county |
| 176 | commission a schedule for appointing council members to ensure |
| 177 | that council membership complies with the requirements of this |
| 178 | paragraph. The members of the local health council shall elect a |
| 179 | chair. Members shall serve for terms of 2 years and may be |
| 180 | eligible for reappointment. |
| 181 | (b) Each local health council may: |
| 182 | 1. Develop a district or regional area health plan that |
| 183 | permits each local health council to develop strategies and set |
| 184 | priorities for implementation based on its unique local health |
| 185 | needs. The district or regional area health plan must contain |
| 186 | preferences for the development of health services and |
| 187 | facilities, which may be considered by the agency in its review |
| 188 | of certificate-of-need applications. The district health plan |
| 189 | shall be submitted to the agency and updated periodically. The |
| 190 | district health plans shall use a uniform format and be |
| 191 | submitted to the agency according to a schedule developed by the |
| 192 | agency in conjunction with the local health councils. The |
| 193 | schedule must provide for the development of district health |
| 194 | plans by major sections over a multiyear period. The elements of |
| 195 | a district plan which are necessary to the review of |
| 196 | certificate-of-need applications for proposed projects within |
| 197 | the district may be adopted by the agency as a part of its |
| 198 | rules. |
| 199 | 2. Advise the agency on health care issues and resource |
| 200 | allocations. |
| 201 | 3. Promote public awareness of community health needs, |
| 202 | emphasizing health promotion and cost-effective health service |
| 203 | selection. |
| 204 | 4. Collect data and conduct analyses and studies related |
| 205 | to health care needs of the district, including the needs of |
| 206 | medically indigent persons, and assist the agency and other |
| 207 | state agencies in carrying out data collection activities that |
| 208 | relate to the functions in this subsection. |
| 209 | 5. Monitor the onsite construction progress, if any, of |
| 210 | certificate-of-need approved projects and report council |
| 211 | findings to the agency on forms provided by the agency. |
| 212 | 6. Advise and assist any regional planning councils within |
| 213 | each district that have elected to address health issues in |
| 214 | their strategic regional policy plans with the development of |
| 215 | the health element of the plans to address the health goals and |
| 216 | policies in the State Comprehensive Plan. |
| 217 | 7. Advise and assist local governments within each |
| 218 | district on the development of an optional health plan element |
| 219 | of the comprehensive plan provided in chapter 163, to assure |
| 220 | compatibility with the health goals and policies in the State |
| 221 | Comprehensive Plan and district health plan. To facilitate the |
| 222 | implementation of this section, the local health council shall |
| 223 | annually provide the local governments in its service area, upon |
| 224 | request, with: |
| 225 | a. A copy and appropriate updates of the district health |
| 226 | plan; |
| 227 | b. A report of hospital and nursing home utilization |
| 228 | statistics for facilities within the local government |
| 229 | jurisdiction; and |
| 230 | c. Applicable agency rules and calculated need |
| 231 | methodologies for health facilities and services regulated under |
| 232 | s. 408.034 for the district served by the local health council. |
| 233 | 8. Monitor and evaluate the adequacy, appropriateness, and |
| 234 | effectiveness, within the district, of local, state, federal, |
| 235 | and private funds distributed to meet the needs of the medically |
| 236 | indigent and other underserved population groups. |
| 237 | 9. In conjunction with the Department of Health Agency for |
| 238 | Health Care Administration, plan for services at the local level |
| 239 | for persons infected with the human immunodeficiency virus. |
| 240 | 10. Provide technical assistance to encourage and support |
| 241 | activities by providers, purchasers, consumers, and local, |
| 242 | regional, and state agencies in meeting the health care goals, |
| 243 | objectives, and policies adopted by the local health council. |
| 244 | 11. Provide the agency with data required by rule for the |
| 245 | review of certificate-of-need applications and the projection of |
| 246 | need for health services and facilities in the district. |
| 247 | (c) Local health councils may conduct public hearings |
| 248 | pursuant to s. 408.039(3)(b). |
| 249 | (d) Each local health council shall enter into a |
| 250 | memorandum of agreement with each regional planning council in |
| 251 | its district that elects to address health issues in its |
| 252 | strategic regional policy plan. In addition, each local health |
| 253 | council shall enter into a memorandum of agreement with each |
| 254 | local government that includes an optional health element in its |
| 255 | comprehensive plan. Each memorandum of agreement must specify |
| 256 | the manner in which each local government, regional planning |
| 257 | council, and local health council will coordinate its activities |
| 258 | to ensure a unified approach to health planning and |
| 259 | implementation efforts. |
| 260 | (e) Local health councils may employ personnel or contract |
| 261 | for staffing services with persons who possess appropriate |
| 262 | qualifications to carry out the councils' purposes. However, |
| 263 | such personnel are not state employees. |
| 264 | (f) Personnel of the local health councils shall provide |
| 265 | an annual orientation to council members about council member |
| 266 | responsibilities. The orientation shall include presentations |
| 267 | and participation by agency staff. |
| 268 | (g) Each local health council is authorized to accept and |
| 269 | receive, in furtherance of its health planning functions, funds, |
| 270 | grants, and services from governmental agencies and from private |
| 271 | or civic sources and to perform studies related to local health |
| 272 | planning in exchange for such funds, grants, or services. Each |
| 273 | local health council shall, no later than January 30 of each |
| 274 | year, render an accounting of the receipt and disbursement of |
| 275 | such funds received by it to the Department of Health agency. |
| 276 | The department agency shall consolidate all such reports and |
| 277 | submit such consolidated report to the Legislature no later than |
| 278 | March 1 of each year. Funds received by a local health council |
| 279 | pursuant to this paragraph shall not be deemed to be a |
| 280 | substitute for, or an offset against, any funding provided |
| 281 | pursuant to subsection (2). |
| 282 | (2) FUNDING.-- |
| 283 | (a) The Legislature intends that the cost of local health |
| 284 | councils be borne by application fees for certificates of need |
| 285 | and by assessments on selected health care facilities subject to |
| 286 | facility licensure by the Agency for Health Care Administration, |
| 287 | including abortion clinics, assisted living facilities, |
| 288 | ambulatory surgical centers, birthing centers, clinical |
| 289 | laboratories except community nonprofit blood banks and clinical |
| 290 | laboratories operated by practitioners for exclusive use |
| 291 | regulated under s. 483.035, home health agencies, hospices, |
| 292 | hospitals, intermediate care facilities for the developmentally |
| 293 | disabled, nursing homes, and multiphasic testing centers and by |
| 294 | assessments on organizations subject to certification by the |
| 295 | agency pursuant to chapter 641, part III, including health |
| 296 | maintenance organizations and prepaid health clinics. |
| 297 | (b)1. A hospital licensed under chapter 395, a nursing |
| 298 | home licensed under chapter 400, and an assisted living facility |
| 299 | licensed under chapter 400 shall be assessed an annual fee based |
| 300 | on number of beds. |
| 301 | 2. All other facilities and organizations listed in |
| 302 | paragraph (a) shall each be assessed an annual fee of $150. |
| 303 | 3. Facilities operated by the Department of Children and |
| 304 | Family Services, the Department of Health, or the Department of |
| 305 | Corrections and any hospital which meets the definition of rural |
| 306 | hospital pursuant to s. 395.602 are exempt from the assessment |
| 307 | required in this subsection. |
| 308 | (c)1. The agency shall, by rule, establish fees for |
| 309 | hospitals and nursing homes based on an assessment of $2 per |
| 310 | bed. However, no such facility shall be assessed more than a |
| 311 | total of $500 under this subsection. |
| 312 | 2. The agency shall, by rule, establish fees for assisted |
| 313 | living facilities based on an assessment of $1 per bed. However, |
| 314 | no such facility shall be assessed more than a total of $150 |
| 315 | under this subsection. |
| 316 | 3. The agency shall, by rule, establish an annual fee of |
| 317 | $150 for all other facilities and organizations listed in |
| 318 | paragraph (a). |
| 319 | (d) The agency shall, by rule, establish a facility |
| 320 | billing and collection process for the billing and collection of |
| 321 | the health facility fees authorized by this subsection. |
| 322 | (e) A health facility which is assessed a fee under this |
| 323 | subsection is subject to a fine of $100 per day for each day in |
| 324 | which the facility is late in submitting its annual fee up to |
| 325 | maximum of the annual fee owed by the facility. A facility which |
| 326 | refuses to pay the fee or fine is subject to the forfeiture of |
| 327 | its license. |
| 328 | (f) The agency shall deposit in the Health Care Trust Fund |
| 329 | all health care facility assessments that are assessed under |
| 330 | this subsection and proceeds from the certificate-of-need |
| 331 | application fees. The agency shall transfer such funds to the |
| 332 | Department of Health an amount sufficient to maintain the |
| 333 | aggregate for funding of level for the local health councils as |
| 334 | specified in the General Appropriations Act. The remaining |
| 335 | certificate-of-need application fees shall be used only for the |
| 336 | purpose of administering the certificate-of-need program Health |
| 337 | Facility and Services Development Act. |
| 338 | (3) DUTIES AND RESPONSIBILITIES OF THE AGENCY.-- |
| 339 | (a) The agency, in conjunction with the local health |
| 340 | councils, is responsible for the coordinated planning of health |
| 341 | care services in the state. |
| 342 | (b) The agency shall develop and maintain a comprehensive |
| 343 | health care database for the purpose of health planning and for |
| 344 | certificate-of-need determinations. The agency or its contractor |
| 345 | is authorized to require the submission of information from |
| 346 | health facilities, health service providers, and licensed health |
| 347 | professionals which is determined by the agency, through rule, |
| 348 | to be necessary for meeting the agency's responsibilities as |
| 349 | established in this section. |
| 350 | (c) The agency shall assist personnel of the local health |
| 351 | councils in providing an annual orientation to council members |
| 352 | about council member responsibilities. |
| 353 | (c)(d) The Department of Health agency shall contract with |
| 354 | the local health councils for the services specified in |
| 355 | subsection (1). All contract funds shall be distributed |
| 356 | according to an allocation plan developed by the department |
| 357 | agency that provides for a minimum and equal funding base for |
| 358 | each local health council. Any remaining funds shall be |
| 359 | distributed based on adjustments for workload. The agency may |
| 360 | also make grants to or reimburse local health councils from |
| 361 | federal funds provided to the state for activities related to |
| 362 | those functions set forth in this section. The department agency |
| 363 | may withhold funds from a local health council or cancel its |
| 364 | contract with a local health council which does not meet |
| 365 | performance standards agreed upon by the department agency and |
| 366 | local health councils. |
| 367 | Section 4. Subsections (1) and (2) of section 408.034, |
| 368 | Florida Statutes, are amended to read: |
| 369 | 408.034 Duties and responsibilities of agency; rules.-- |
| 370 | (1) The agency is designated as the single state agency to |
| 371 | issue, revoke, or deny certificates of need and to issue, |
| 372 | revoke, or deny exemptions from certificate-of-need review in |
| 373 | accordance with the district plans and present and future |
| 374 | federal and state statutes. The agency is designated as the |
| 375 | state health planning agency for purposes of federal law. |
| 376 | (2) In the exercise of its authority to issue licenses to |
| 377 | health care facilities and health service providers, as provided |
| 378 | under chapters 393, 395, and parts II and VI of chapter 400, the |
| 379 | agency may not issue a license to any health care facility or, |
| 380 | health service provider, hospice, or part of a health care |
| 381 | facility which fails to receive a certificate of need or an |
| 382 | exemption for the licensed facility or service. |
| 383 | Section 5. Section 408.035, Florida Statutes, is amended |
| 384 | to read: |
| 385 | 408.035 Review criteria.--The agency shall determine the |
| 386 | reviewability of applications and shall review applications for |
| 387 | certificate-of-need determinations for health care facilities |
| 388 | and health services in context with the following criteria: |
| 389 | (1) The need for the health care facilities and health |
| 390 | services being proposed in relation to the applicable district |
| 391 | health plan. |
| 392 | (2) The availability, quality of care, accessibility, and |
| 393 | extent of utilization of existing health care facilities and |
| 394 | health services in the service district of the applicant. |
| 395 | (3) The ability of the applicant to provide quality of |
| 396 | care and the applicant's record of providing quality of care. |
| 397 | (4) The need in the service district of the applicant for |
| 398 | special health care services that are not reasonably and |
| 399 | economically accessible in adjoining areas. |
| 400 | (5) The needs of research and educational facilities, |
| 401 | including, but not limited to, facilities with institutional |
| 402 | training programs and community training programs for health |
| 403 | care practitioners and for doctors of osteopathic medicine and |
| 404 | medicine at the student, internship, and residency training |
| 405 | levels. |
| 406 | (4)(6) The availability of resources, including health |
| 407 | personnel, management personnel, and funds for capital and |
| 408 | operating expenditures, for project accomplishment and |
| 409 | operation. |
| 410 | (5)(7) The extent to which the proposed services will |
| 411 | enhance access to health care for residents of the service |
| 412 | district. |
| 413 | (6)(8) The immediate and long-term financial feasibility |
| 414 | of the proposal. |
| 415 | (7)(9) The extent to which the proposal will foster |
| 416 | competition that promotes quality and cost-effectiveness. |
| 417 | (8)(10) The costs and methods of the proposed |
| 418 | construction, including the costs and methods of energy |
| 419 | provision and the availability of alternative, less costly, or |
| 420 | more effective methods of construction. |
| 421 | (9)(11) The applicant's past and proposed provision of |
| 422 | health care services to Medicaid patients and the medically |
| 423 | indigent. |
| 424 | (10)(12) The applicant's designation as a Gold Seal |
| 425 | Program nursing facility pursuant to s. 400.235, when the |
| 426 | applicant is requesting additional nursing home beds at that |
| 427 | facility. |
| 428 | Section 6. Section 408.036, Florida Statutes, is amended |
| 429 | to read: |
| 430 | 408.036 Projects subject to review; exemptions.-- |
| 431 | (1) APPLICABILITY.--Unless exempt under subsection (3), |
| 432 | all health-care-related projects, as described in paragraphs |
| 433 | (a)-(e) (a)-(h), are subject to review and must file an |
| 434 | application for a certificate of need with the agency. The |
| 435 | agency is exclusively responsible for determining whether a |
| 436 | health-care-related project is subject to review under ss. |
| 437 | 408.031-408.045. |
| 438 | (a) The addition of beds in community nursing homes or |
| 439 | intermediate care facilities for the developmentally disabled by |
| 440 | new construction or alteration. |
| 441 | (b) The new construction or establishment of additional |
| 442 | health care facilities, including a replacement health care |
| 443 | facility when the proposed project site is not located on the |
| 444 | same site as or within 1 mile of the existing health care |
| 445 | facility provided that the number of beds in each licensed bed |
| 446 | category will not increase. |
| 447 | (c) The conversion from one type of health care facility |
| 448 | to another, including the conversion from a general hospital, a |
| 449 | specialty hospital, or a long-term care hospital. |
| 450 | (d) An increase in the total licensed bed capacity of a |
| 451 | health care facility. |
| 452 | (d)(e) The establishment of a hospice or hospice inpatient |
| 453 | facility, except as provided in s. 408.043. |
| 454 | (f) The establishment of inpatient health services by a |
| 455 | health care facility, or a substantial change in such services. |
| 456 | (g) An increase in the number of beds for acute care, |
| 457 | nursing home care beds, specialty burn units, neonatal intensive |
| 458 | care units, comprehensive rehabilitation, mental health |
| 459 | services, or hospital-based distinct part skilled nursing units, |
| 460 | or at a long-term care hospital. |
| 461 | (e)(h) The establishment of tertiary health services. |
| 462 | (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless exempt |
| 463 | pursuant to subsection (3), projects subject to an expedited |
| 464 | review shall include, but not be limited to: |
| 465 | (a) Research, education, and training programs. |
| 466 | (b) Shared services contracts or projects. |
| 467 | (a)(c) A transfer of a certificate of need, except that |
| 468 | when an existing hospital is acquired by a purchaser, all |
| 469 | certificates of need issued to the hospital which are not yet |
| 470 | operational shall be acquired by the purchaser, without need for |
| 471 | a transfer. |
| 472 | (b) Replacement of a community nursing home or |
| 473 | intermediate care facility for the developmentally disabled when |
| 474 | the proposed project site is located within the same district |
| 475 | and within the same planning area of the replaced health care |
| 476 | facility provided the number of licensed beds is the same as |
| 477 | that of the facility being replaced. |
| 478 | (d) A 50-percent increase in nursing home beds for a |
| 479 | facility incorporated and operating in this state for at least |
| 480 | 60 years on or before July 1, 1988, which has a licensed nursing |
| 481 | home facility located on a campus providing a variety of |
| 482 | residential settings and supportive services. The increased |
| 483 | nursing home beds shall be for the exclusive use of the campus |
| 484 | residents. Any application on behalf of an applicant meeting |
| 485 | this requirement shall be subject to the base fee of $5,000 |
| 486 | provided in s. 408.038. |
| 487 | (e) Replacement of a health care facility when the |
| 488 | proposed project site is located in the same district and within |
| 489 | a 1-mile radius of the replaced health care facility. |
| 490 | (f) The conversion of mental health services beds licensed |
| 491 | under chapter 395 or hospital-based distinct part skilled |
| 492 | nursing unit beds to general acute care beds; the conversion of |
| 493 | mental health services beds between or among the licensed bed |
| 494 | categories defined as beds for mental health services; or the |
| 495 | conversion of general acute care beds to beds for mental health |
| 496 | services. |
| 497 | 1. Conversion under this paragraph shall not establish a |
| 498 | new licensed bed category at the hospital but shall apply only |
| 499 | to categories of beds licensed at that hospital. |
| 500 | 2. Beds converted under this paragraph must be licensed |
| 501 | and operational for at least 12 months before the hospital may |
| 502 | apply for additional conversion affecting beds of the same type. |
| 503 |
|
| 504 | The agency shall develop rules to implement the provisions for |
| 505 | expedited review, including time schedule, application content |
| 506 | which may be reduced from the full requirements of s. |
| 507 | 408.037(1), and application processing. |
| 508 | (3) EXEMPTIONS.--Upon request, the following projects are |
| 509 | subject to exemption from the provisions of subsection (1): |
| 510 | (a) For replacement of a licensed health care facility on |
| 511 | the same site, provided that the number of beds in each licensed |
| 512 | bed category will not increase. |
| 513 | (a)(b) For hospice services or for swing beds in a rural |
| 514 | hospital, as defined in s. 395.602, in a number that does not |
| 515 | exceed one-half of its licensed beds. |
| 516 | (b)(c) For the conversion of licensed acute care hospital |
| 517 | beds to Medicare and Medicaid certified skilled nursing beds in |
| 518 | a rural hospital, as defined in s. 395.602, so long as the |
| 519 | conversion of the beds does not involve the construction of new |
| 520 | facilities. The total number of skilled nursing beds, including |
| 521 | swing beds, may not exceed one-half of the total number of |
| 522 | licensed beds in the rural hospital as of July 1, 1993. |
| 523 | Certified skilled nursing beds designated under this paragraph, |
| 524 | excluding swing beds, shall be included in the community nursing |
| 525 | home bed inventory. A rural hospital which subsequently |
| 526 | decertifies any acute care beds exempted under this paragraph |
| 527 | shall notify the agency of the decertification, and the agency |
| 528 | shall adjust the community nursing home bed inventory |
| 529 | accordingly. |
| 530 | (c)(d) For the addition of nursing home beds at a skilled |
| 531 | nursing facility that is part of a retirement community that |
| 532 | provides a variety of residential settings and supportive |
| 533 | services and that has been incorporated and operated in this |
| 534 | state for at least 65 years on or before July 1, 1994. All |
| 535 | nursing home beds must not be available to the public but must |
| 536 | be for the exclusive use of the community residents. |
| 537 | (e) For an increase in the bed capacity of a nursing |
| 538 | facility licensed for at least 50 beds as of January 1, 1994, |
| 539 | under part II of chapter 400 which is not part of a continuing |
| 540 | care facility if, after the increase, the total licensed bed |
| 541 | capacity of that facility is not more than 60 beds and if the |
| 542 | facility has been continuously licensed since 1950 and has |
| 543 | received a superior rating on each of its two most recent |
| 544 | licensure surveys. |
| 545 | (d)(f) For an inmate health care facility built by or for |
| 546 | the exclusive use of the Department of Corrections as provided |
| 547 | in chapter 945. This exemption expires when such facility is |
| 548 | converted to other uses. |
| 549 | (g) For the termination of an inpatient health care |
| 550 | service, upon 30 days' written notice to the agency. |
| 551 | (h) For the delicensure of beds, upon 30 days' written |
| 552 | notice to the agency. A request for exemption submitted under |
| 553 | this paragraph must identify the number, the category of beds, |
| 554 | and the name of the facility in which the beds to be delicensed |
| 555 | are located. |
| 556 | (i) For the provision of adult inpatient diagnostic |
| 557 | cardiac catheterization services in a hospital. |
| 558 | 1. In addition to any other documentation otherwise |
| 559 | required by the agency, a request for an exemption submitted |
| 560 | under this paragraph must comply with the following criteria: |
| 561 | a. The applicant must certify it will not provide |
| 562 | therapeutic cardiac catheterization pursuant to the grant of the |
| 563 | exemption. |
| 564 | b. The applicant must certify it will meet and |
| 565 | continuously maintain the minimum licensure requirements adopted |
| 566 | by the agency governing such programs pursuant to subparagraph |
| 567 | 2. |
| 568 | c. The applicant must certify it will provide a minimum of |
| 569 | 2 percent of its services to charity and Medicaid patients. |
| 570 | 2. The agency shall adopt licensure requirements by rule |
| 571 | which govern the operation of adult inpatient diagnostic cardiac |
| 572 | catheterization programs established pursuant to the exemption |
| 573 | provided in this paragraph. The rules shall ensure that such |
| 574 | programs: |
| 575 | a. Perform only adult inpatient diagnostic cardiac |
| 576 | catheterization services authorized by the exemption and will |
| 577 | not provide therapeutic cardiac catheterization or any other |
| 578 | services not authorized by the exemption. |
| 579 | b. Maintain sufficient appropriate equipment and health |
| 580 | personnel to ensure quality and safety. |
| 581 | c. Maintain appropriate times of operation and protocols |
| 582 | to ensure availability and appropriate referrals in the event of |
| 583 | emergencies. |
| 584 | d. Maintain appropriate program volumes to ensure quality |
| 585 | and safety. |
| 586 | e. Provide a minimum of 2 percent of its services to |
| 587 | charity and Medicaid patients each year. |
| 588 | 3.a. The exemption provided by this paragraph shall not |
| 589 | apply unless the agency determines that the program is in |
| 590 | compliance with the requirements of subparagraph 1. and that the |
| 591 | program will, after beginning operation, continuously comply |
| 592 | with the rules adopted pursuant to subparagraph 2. The agency |
| 593 | shall monitor such programs to ensure compliance with the |
| 594 | requirements of subparagraph 2. |
| 595 | b.(I) The exemption for a program shall expire immediately |
| 596 | when the program fails to comply with the rules adopted pursuant |
| 597 | to sub-subparagraphs 2.a., b., and c. |
| 598 | (II) Beginning 18 months after a program first begins |
| 599 | treating patients, the exemption for a program shall expire when |
| 600 | the program fails to comply with the rules adopted pursuant to |
| 601 | sub-subparagraphs 2.d. and e. |
| 602 | (III) If the exemption for a program expires pursuant to |
| 603 | sub-sub-subparagraph (I) or sub-sub-subparagraph (II), the |
| 604 | agency shall not grant an exemption pursuant to this paragraph |
| 605 | for an adult inpatient diagnostic cardiac catheterization |
| 606 | program located at the same hospital until 2 years following the |
| 607 | date of the determination by the agency that the program failed |
| 608 | to comply with the rules adopted pursuant to subparagraph 2. |
| 609 | (e)(j) For mobile surgical facilities and related health |
| 610 | care services provided under contract with the Department of |
| 611 | Corrections or a private correctional facility operating |
| 612 | pursuant to chapter 957. |
| 613 | (f)(k) For state veterans' nursing homes operated by or on |
| 614 | behalf of the Florida Department of Veterans' Affairs in |
| 615 | accordance with part II of chapter 296 for which at least 50 |
| 616 | percent of the construction cost is federally funded and for |
| 617 | which the Federal Government pays a per diem rate not to exceed |
| 618 | one-half of the cost of the veterans' care in such state nursing |
| 619 | homes. These beds shall not be included in the nursing home bed |
| 620 | inventory. |
| 621 | (g)(l) For combination within one nursing home facility of |
| 622 | the beds or services authorized by two or more certificates of |
| 623 | need issued in the same planning subdistrict. An exemption |
| 624 | granted under this paragraph shall extend the validity period of |
| 625 | the certificates of need to be consolidated by the length of the |
| 626 | period beginning upon submission of the exemption request and |
| 627 | ending with issuance of the exemption. The longest validity |
| 628 | period among the certificates shall be applicable to each of the |
| 629 | combined certificates. |
| 630 | (h)(m) For division into two or more nursing home |
| 631 | facilities of beds or services authorized by one certificate of |
| 632 | need issued in the same planning subdistrict. An exemption |
| 633 | granted under this paragraph shall extend the validity period of |
| 634 | the certificate of need to be divided by the length of the |
| 635 | period beginning upon submission of the exemption request and |
| 636 | ending with issuance of the exemption. |
| 637 | (n) For the addition of hospital beds licensed under |
| 638 | chapter 395 for acute care, mental health services, or a |
| 639 | hospital-based distinct part skilled nursing unit in a number |
| 640 | that may not exceed 10 total beds or 10 percent of the licensed |
| 641 | capacity of the bed category being expanded, whichever is |
| 642 | greater. Beds for specialty burn units, neonatal intensive care |
| 643 | units, or comprehensive rehabilitation, or at a long-term care |
| 644 | hospital, may not be increased under this paragraph. |
| 645 | 1. In addition to any other documentation otherwise |
| 646 | required by the agency, a request for exemption submitted under |
| 647 | this paragraph must: |
| 648 | a. Certify that the prior 12-month average occupancy rate |
| 649 | for the category of licensed beds being expanded at the facility |
| 650 | meets or exceeds 80 percent or, for a hospital-based distinct |
| 651 | part skilled nursing unit, the prior 12-month average occupancy |
| 652 | rate meets or exceeds 96 percent. |
| 653 | b. Certify that any beds of the same type authorized for |
| 654 | the facility under this paragraph before the date of the current |
| 655 | request for an exemption have been licensed and operational for |
| 656 | at least 12 months. |
| 657 | 2. The timeframes and monitoring process specified in s. |
| 658 | 408.040(2)(a)-(c) apply to any exemption issued under this |
| 659 | paragraph. |
| 660 | 3. The agency shall count beds authorized under this |
| 661 | paragraph as approved beds in the published inventory of |
| 662 | hospital beds until the beds are licensed. |
| 663 | (o) For the addition of acute care beds, as authorized by |
| 664 | rule consistent with s. 395.003(4), in a number that may not |
| 665 | exceed 10 total beds or 10 percent of licensed bed capacity, |
| 666 | whichever is greater, for temporary beds in a hospital that has |
| 667 | experienced high seasonal occupancy within the prior 12-month |
| 668 | period or in a hospital that must respond to emergency |
| 669 | circumstances. |
| 670 | (i)(p) For the addition of nursing home beds licensed |
| 671 | under chapter 400 in a number not exceeding 10 total beds or 10 |
| 672 | percent of the number of beds licensed in the facility being |
| 673 | expanded, whichever is greater. |
| 674 | 1. In addition to any other documentation required by the |
| 675 | agency, a request for exemption submitted under this paragraph |
| 676 | must: |
| 677 | a. Effective until June 30, 2001, certify that the |
| 678 | facility has not had any class I or class II deficiencies within |
| 679 | the 30 months preceding the request for addition. |
| 680 | b. Effective on July 1, 2001, certify that the facility |
| 681 | has been designated as a Gold Seal nursing home under s. |
| 682 | 400.235. |
| 683 | c. Certify that the prior 12-month average occupancy rate |
| 684 | for the nursing home beds at the facility meets or exceeds 96 |
| 685 | percent. |
| 686 | d. Certify that any beds authorized for the facility under |
| 687 | this paragraph before the date of the current request for an |
| 688 | exemption have been licensed and operational for at least 12 |
| 689 | months. |
| 690 | 2. The timeframes and monitoring process specified in s. |
| 691 | 408.040(2)(a)-(c) apply to any exemption issued under this |
| 692 | paragraph. |
| 693 | 3. The agency shall count beds authorized under this |
| 694 | paragraph as approved beds in the published inventory of nursing |
| 695 | home beds until the beds are licensed. |
| 696 | (j) For the establishment of a Level II neonatal intensive |
| 697 | care unit with at least 10 beds, upon documentation to the |
| 698 | agency that the applicant hospital had a minimum of 1,500 births |
| 699 | during the previous 12 months; or the establishment of a Level |
| 700 | III neonatal intensive care unit with at least 15 beds, upon |
| 701 | documentation to the agency that the applicant hospital has a |
| 702 | Level II neonatal intensive care unit of at least 10 beds and |
| 703 | had a minimum of 3,500 births during the previous 12 months; |
| 704 | provided the applicant demonstrates that it meets the quality of |
| 705 | care, nurse staffing, physician staffing, physical plant, |
| 706 | equipment, emergency transportation, and data reporting |
| 707 | requirements as found in agency certificate-of-need rules for |
| 708 | Level II and Level III neonatal intensive care units and that |
| 709 | the applicant commits to the provision of services to Medicaid |
| 710 | and charity care patients at a level equal to or greater than |
| 711 | the district average. Such commitment shall be subject to the |
| 712 | provisions of s. 408.040. |
| 713 | (q) For establishment of a specialty hospital offering a |
| 714 | range of medical service restricted to a defined age or gender |
| 715 | group of the population or a restricted range of services |
| 716 | appropriate to the diagnosis, care, and treatment of patients |
| 717 | with specific categories of medical illnesses or disorders, |
| 718 | through the transfer of beds and services from an existing |
| 719 | hospital in the same county. |
| 720 | (r) For the conversion of hospital-based Medicare and |
| 721 | Medicaid certified skilled nursing beds to acute care beds, if |
| 722 | the conversion does not involve the construction of new |
| 723 | facilities. |
| 724 | (s)1. For an adult open-heart-surgery program to be |
| 725 | located in a new hospital provided the new hospital is being |
| 726 | established in the location of an existing hospital with an |
| 727 | adult open-heart-surgery program, the existing hospital and the |
| 728 | existing adult open-heart-surgery program are being relocated to |
| 729 | a replacement hospital, and the replacement hospital will |
| 730 | utilize a closed-staff model. A hospital is exempt from the |
| 731 | certificate-of-need review for the establishment of an open- |
| 732 | heart-surgery program if the application for exemption submitted |
| 733 | under this paragraph complies with the following criteria: |
| 734 | a. The applicant must certify that it will meet and |
| 735 | continuously maintain the minimum Florida Administrative Code |
| 736 | and any future licensure requirements governing adult open-heart |
| 737 | programs adopted by the agency, including the most current |
| 738 | guidelines of the American College of Cardiology and American |
| 739 | Heart Association Guidelines for Adult Open Heart Programs. |
| 740 | b. The applicant must certify that it will maintain |
| 741 | sufficient appropriate equipment and health personnel to ensure |
| 742 | quality and safety. |
| 743 | c. The applicant must certify that it will maintain |
| 744 | appropriate times of operation and protocols to ensure |
| 745 | availability and appropriate referrals in the event of |
| 746 | emergencies. |
| 747 | d. The applicant is a newly licensed hospital in a |
| 748 | physical location previously owned and licensed to a hospital |
| 749 | performing more than 300 open-heart procedures each year, |
| 750 | including heart transplants. |
| 751 | e. The applicant must certify that it can perform more |
| 752 | than 300 diagnostic cardiac catheterization procedures per year, |
| 753 | combined inpatient and outpatient, by the end of the third year |
| 754 | of its operation. |
| 755 | f. The applicant's payor mix at a minimum reflects the |
| 756 | community average for Medicaid, charity care, and self-pay |
| 757 | patients or the applicant must certify that it will provide a |
| 758 | minimum of 5 percent of Medicaid, charity care, and self-pay to |
| 759 | open-heart-surgery patients. |
| 760 | g. If the applicant fails to meet the established criteria |
| 761 | for open-heart programs or fails to reach 300 surgeries per year |
| 762 | by the end of its third year of operation, it must show cause |
| 763 | why its exemption should not be revoked. |
| 764 | h. In order to ensure continuity of available services, |
| 765 | the applicant of the newly licensed hospital may apply for this |
| 766 | certificate-of-need before taking possession of the physical |
| 767 | facilities. The effective date of the certificate-of-need will |
| 768 | be concurrent with the effective date of the newly issued |
| 769 | hospital license. |
| 770 | 2. By December 31, 2004, and annually thereafter, the |
| 771 | agency shall submit a report to the Legislature providing |
| 772 | information concerning the number of requests for exemption |
| 773 | received under this paragraph and the number of exemptions |
| 774 | granted or denied. |
| 775 | 3. This paragraph is repealed effective January 1, 2008. |
| 776 | (t)1. For the provision of adult open-heart services in a |
| 777 | hospital located within the boundaries of Palm Beach, Polk, |
| 778 | Martin, St. Lucie, and Indian River Counties if the following |
| 779 | conditions are met: The exemption must be based upon objective |
| 780 | criteria and address and solve the twin problems of geographic |
| 781 | and temporal access. A hospital shall be exempt from the |
| 782 | certificate-of-need review for the establishment of an open- |
| 783 | heart-surgery program when the application for exemption |
| 784 | submitted under this paragraph complies with the following |
| 785 | criteria: |
| 786 | a. The applicant must certify that it will meet and |
| 787 | continuously maintain the minimum licensure requirements adopted |
| 788 | by the agency governing adult open-heart programs, including the |
| 789 | most current guidelines of the American College of Cardiology |
| 790 | and American Heart Association Guidelines for Adult Open Heart |
| 791 | Programs. |
| 792 | b. The applicant must certify that it will maintain |
| 793 | sufficient appropriate equipment and health personnel to ensure |
| 794 | quality and safety. |
| 795 | c. The applicant must certify that it will maintain |
| 796 | appropriate times of operation and protocols to ensure |
| 797 | availability and appropriate referrals in the event of |
| 798 | emergencies. |
| 799 | d. The applicant can demonstrate that it is referring 300 |
| 800 | or more patients per year from the hospital, including the |
| 801 | emergency room, for cardiac services at a hospital with cardiac |
| 802 | services, or that the average wait for transfer for 50 percent |
| 803 | or more of the cardiac patients exceeds 4 hours. |
| 804 | e. The applicant is a general acute care hospital that is |
| 805 | in operation for 3 years or more. |
| 806 | f. The applicant is performing more than 300 diagnostic |
| 807 | cardiac catheterization procedures per year, combined inpatient |
| 808 | and outpatient. |
| 809 | g. The applicant's payor mix at a minimum reflects the |
| 810 | community average for Medicaid, charity care, and self-pay |
| 811 | patients or the applicant must certify that it will provide a |
| 812 | minimum of 5 percent of Medicaid, charity care, and self-pay to |
| 813 | open-heart-surgery patients. |
| 814 | h. If the applicant fails to meet the established criteria |
| 815 | for open-heart programs or fails to reach 300 surgeries per year |
| 816 | by the end of its third year of operation, it must show cause |
| 817 | why its exemption should not be revoked. |
| 818 | 2. By December 31, 2004, and annually thereafter, the |
| 819 | Agency for Health Care Administration shall submit a report to |
| 820 | the Legislature providing information concerning the number of |
| 821 | requests for exemption received under this paragraph and the |
| 822 | number of exemptions granted or denied. |
| 823 | (k) For the addition of comprehensive medical |
| 824 | rehabilitation or mental health services or beds provided the |
| 825 | applicant commits to the provision of services to Medicaid or |
| 826 | charity care patients at a level equal to or greater than the |
| 827 | district average. Such commitment shall be subject to the |
| 828 | provisions of s. 408.040. |
| 829 | (4) REQUESTS FOR EXEMPTIONS.--A request for exemption |
| 830 | under subsection (3) may be made at any time and is not subject |
| 831 | to the batching requirements of this section. The request shall |
| 832 | be supported by such documentation as the agency requires by |
| 833 | rule. The agency shall assess a fee of $250 for each request for |
| 834 | exemption submitted under subsection (3). |
| 835 | (5) NOTIFICATION.--Health care facilities and providers |
| 836 | must provide notification to the agency of the following: |
| 837 | (a) Replacement of a health care facility when the |
| 838 | proposed project site is located in the same district and on the |
| 839 | existing site or within a 1-mile radius of the replaced health |
| 840 | care facility, provided that the number and type of beds do not |
| 841 | increase. |
| 842 | (b) For the termination of a health care service, upon 30 |
| 843 | days' written notice to the agency. |
| 844 | (c) For the addition or delicensure of beds. |
| 845 |
|
| 846 | Notification under this subsection may be made at any time, |
| 847 | prior to the action described, by electronic, facsimile, or |
| 848 | written means. |
| 849 | Section 7. Section 408.0361, Florida Statutes, is amended |
| 850 | to read: |
| 851 | 408.0361 Cardiology services and burn unit licensure |
| 852 | Diagnostic cardiac catheterization services providers; |
| 853 | compliance with guidelines and requirements.-- |
| 854 | (1) Each provider of diagnostic cardiac catheterization |
| 855 | services shall comply with the requirements of s. |
| 856 | 408.036(3)(i)2.a.-d., and rules adopted by of the agency that |
| 857 | establish licensure standards for Health Care Administration |
| 858 | governing the operation of adult inpatient diagnostic cardiac |
| 859 | catheterization programs. The rules shall ensure that such |
| 860 | programs: |
| 861 | (a) Comply with, including the most recent guidelines of |
| 862 | the American College of Cardiology and American Heart |
| 863 | Association Guidelines for Cardiac Catheterization and Cardiac |
| 864 | Catheterization Laboratories. |
| 865 | (b) Perform only adult inpatient diagnostic cardiac |
| 866 | catheterization services and will not provide therapeutic |
| 867 | cardiac catheterization or any other cardiology services. |
| 868 | (c) Maintain sufficient appropriate equipment and health |
| 869 | care personnel to ensure quality and safety. |
| 870 | (d) Maintain appropriate times of operation and protocols |
| 871 | to ensure availability and appropriate referrals in the event of |
| 872 | emergencies. |
| 873 | (e) Demonstrate a plan to provide services to Medicaid and |
| 874 | charity care patients. |
| 875 | (2) Each provider of adult interventional cardiology |
| 876 | services or operator of a burn unit shall comply with rules |
| 877 | adopted by the agency that establish licensure standards that |
| 878 | govern the provision of adult interventional cardiology services |
| 879 | or the operation of a burn unit. Such rules shall consider, at a |
| 880 | minimum, staffing, equipment, physical plant, operating |
| 881 | protocols, the provision of services to Medicaid and charity |
| 882 | care patients, accreditation, licensure period and fees, and |
| 883 | enforcement of minimum standards. The certificate-of-need rules |
| 884 | for adult interventional cardiology services and burn units in |
| 885 | effect on June 30, 2004, are authorized pursuant to this |
| 886 | subsection and shall remain in effect and shall be enforceable |
| 887 | by the agency until the licensure rules are adopted. Existing |
| 888 | providers and any provider with a notice of intent to grant a |
| 889 | certificate of need or a final order of the agency granting a |
| 890 | certificate of need for adult interventional cardiology services |
| 891 | or burn units shall be considered grandfathered and receive a |
| 892 | license for their programs effective on the effective date of |
| 893 | this act. The grandfathered licensure shall be for at least 2 |
| 894 | years or a period specified in the rule, whichever is longer, |
| 895 | but shall be required to meet licensure standards applicable to |
| 896 | existing programs for every subsequent licensure period. |
| 897 | (3) In establishing rules for adult interventional |
| 898 | cardiology services, the agency shall include provisions that |
| 899 | allow for: |
| 900 | (a) Establishment of two hospital program licensure |
| 901 | levels: a Level I program authorizing the performance of adult |
| 902 | percutaneous cardiac intervention without onsite cardiac surgery |
| 903 | and a Level II program authorizing the performance of |
| 904 | percutaneous cardiac intervention with onsite cardiac surgery. |
| 905 | (b) For a hospital seeking a Level I program, |
| 906 | demonstration that, for the most recent 12-month period as |
| 907 | reported to the agency, it has provided a minimum of 300 adult |
| 908 | inpatient and outpatient diagnostic cardiac catheterizations or |
| 909 | transferred at least 300 inpatients with the principal diagnosis |
| 910 | of ischemic heart disease and that it has a formalized, written |
| 911 | transfer agreement with a hospital that has a Level II program, |
| 912 | including written transport protocols to ensure safe and |
| 913 | efficient transfer of a patient within 60 minutes. |
| 914 | (c) For a hospital seeking a Level II program, |
| 915 | demonstration that, for the most recent 12-month period as |
| 916 | reported to the agency, it has performed a minimum of 1,100 |
| 917 | adult inpatient and outpatient diagnostic cardiac |
| 918 | catheterizations, of which at least 400 must be therapeutic |
| 919 | catheterizations, or has discharged at least 800 patients with |
| 920 | the principal diagnosis of ischemic heart disease. |
| 921 | (d) Compliance with the most recent guidelines of the |
| 922 | American College of Cardiology and American Heart Association |
| 923 | guidelines for staffing, physician training and experience, |
| 924 | operating procedures, equipment, physical plant, and patient |
| 925 | selection criteria to ensure patient quality and safety. |
| 926 | (e) Establishment of appropriate hours of operation and |
| 927 | protocols to ensure availability and timely referral in the |
| 928 | event of emergencies. |
| 929 | (f) Demonstration of a plan to provide services to |
| 930 | Medicaid and charity care patients. |
| 931 | (4) The agency shall establish a technical advisory panel |
| 932 | to develop procedures and standards for measuring outcomes of |
| 933 | interventional cardiac programs. Members of the panel shall |
| 934 | include representatives of the Florida Hospital Association, the |
| 935 | Florida Society of Thoracic and Cardiovascular Surgeons, the |
| 936 | Florida Chapter of the American College of Cardiology, and the |
| 937 | Florida Chapter of the American Heart Association and others |
| 938 | with experience in statistics and outcome measurement. Based on |
| 939 | recommendations from the panel, the agency shall develop and |
| 940 | adopt rules for the interventional cardiac programs that include |
| 941 | at least the following: |
| 942 | (a) A standard data set consisting primarily of data |
| 943 | elements reported to the agency in accordance with s. 408.061. |
| 944 | (b) A risk adjustment procedure that accounts for the |
| 945 | variations in severity and case mix found in hospitals in this |
| 946 | state. |
| 947 | (c) Outcome standards specifying expected levels of |
| 948 | performance in Level I and Level II adult interventional |
| 949 | cardiology services. Such standards may include, but shall not |
| 950 | be limited to, in-hospital mortality, infection rates, nonfatal |
| 951 | myocardial infarctions, length of stay, postoperative bleeds, |
| 952 | and returns to surgery. |
| 953 | (d) Specific steps to be taken by the agency and licensed |
| 954 | hospitals that do not meet the outcome standards within |
| 955 | specified time periods, including time periods for detailed case |
| 956 | reviews and development and implementation of corrective action |
| 957 | plans. |
| 958 | (5) The Secretary of Health Care Administration shall |
| 959 | appoint an advisory group to study the issue of replacing |
| 960 | certificate-of-need review of organ transplant programs under |
| 961 | this chapter with licensure regulation of organ transplant |
| 962 | programs under chapter 395. The advisory group shall include |
| 963 | three representatives of organ transplant providers, one |
| 964 | representative of an organ procurement organization, one |
| 965 | representative of the Division of Health Quality Assurance, one |
| 966 | representative of Medicaid, and one organ transplant patient |
| 967 | advocate. The advisory group shall, at minimum, make |
| 968 | recommendations regarding access to organs, delivery of services |
| 969 | to Medicaid and charity care patients, staff training, and |
| 970 | resource requirements for organ transplant programs in a report |
| 971 | due to the secretary and the Legislature by July 1, 2005. |
| 972 | (6) The Secretary of Health Care Administration shall |
| 973 | appoint a workgroup to study certificate-of-need regulations and |
| 974 | changing market conditions related to the supply and |
| 975 | distribution of hospital beds. The assessment by the workgroup |
| 976 | shall include, but not be limited to, the following: |
| 977 | (a) The appropriateness of current certificate-of-need |
| 978 | methodologies and other criteria for evaluating proposals for |
| 979 | new hospitals and transfer of beds to new sites. |
| 980 | (b) Additional factors that should be considered, |
| 981 | including the viability of safety net services, the extent of |
| 982 | market competition, and the accessibility of hospital services. |
| 983 |
|
| 984 | The workgroup shall submit a report by January 1, 2005, to the |
| 985 | secretary and the Legislature identifying specific problem areas |
| 986 | and recommending needed changes in statutes or rules. |
| 987 | Section 8. Section 408.038, Florida Statutes, is amended |
| 988 | to read: |
| 989 | 408.038 Fees.--The agency shall assess fees on |
| 990 | certificate-of-need applications. Such fees shall be for the |
| 991 | purpose of funding the functions of the local health councils |
| 992 | and the activities of the agency and shall be allocated as |
| 993 | provided in s. 408.033. The fee shall be determined as follows: |
| 994 | (1) A minimum base fee of $10,000 $5,000. |
| 995 | (2) In addition to the base fee of $10,000 $5,000, 0.015 |
| 996 | of each dollar of proposed expenditure, except that a fee may |
| 997 | not exceed $50,000 $22,000. |
| 998 | Section 9. Subsection (1), paragraph (a) of subsection |
| 999 | (3), and paragraphs (a) and (b) of subsection (4) of section |
| 1000 | 408.039, Florida Statutes, are amended to read: |
| 1001 | 408.039 Review process.--The review process for |
| 1002 | certificates of need shall be as follows: |
| 1003 | (1) REVIEW CYCLES.--The agency by rule shall provide for |
| 1004 | applications to be submitted on a timetable or cycle basis; |
| 1005 | provide for review on a timely basis; and provide for all |
| 1006 | completed applications pertaining to similar types of services |
| 1007 | or facilities affecting the same service district to be |
| 1008 | considered in relation to each other no less often than annually |
| 1009 | two times a year. |
| 1010 | (3) APPLICATION PROCESSING.-- |
| 1011 | (a) An applicant shall file an application with the |
| 1012 | agency, and shall furnish a copy of the application to the local |
| 1013 | health council and the agency. Within 15 days after the |
| 1014 | applicable application filing deadline established by agency |
| 1015 | rule, the staff of the agency shall determine if the application |
| 1016 | is complete. If the application is incomplete, the staff shall |
| 1017 | request specific information from the applicant necessary for |
| 1018 | the application to be complete; however, the staff may make only |
| 1019 | one such request. If the requested information is not filed with |
| 1020 | the agency within 21 days after of the receipt of the staff's |
| 1021 | request, the application shall be deemed incomplete and deemed |
| 1022 | withdrawn from consideration. |
| 1023 | (4) STAFF RECOMMENDATIONS.-- |
| 1024 | (a) The agency's review of and final agency action on |
| 1025 | applications shall be in accordance with the district health |
| 1026 | plan, and statutory criteria, and the implementing |
| 1027 | administrative rules. In the application review process, the |
| 1028 | agency shall give a preference, as defined by rule of the |
| 1029 | agency, to an applicant which proposes to develop a nursing home |
| 1030 | in a nursing home geographically underserved area. |
| 1031 | (b) Within 60 days after all the applications in a review |
| 1032 | cycle are determined to be complete, the agency shall issue its |
| 1033 | State Agency Action Report and Notice of Intent to grant a |
| 1034 | certificate of need for the project in its entirety, to grant a |
| 1035 | certificate of need for identifiable portions of the project, or |
| 1036 | to deny a certificate of need. The State Agency Action Report |
| 1037 | shall set forth in writing its findings of fact and |
| 1038 | determinations upon which its decision is based. If a finding of |
| 1039 | fact or determination by the agency is counter to the district |
| 1040 | health plan of the local health council, the agency shall |
| 1041 | provide in writing its reason for its findings, item by item, to |
| 1042 | the local health council. If the agency intends to grant a |
| 1043 | certificate of need, the State Agency Action Report or the |
| 1044 | Notice of Intent shall also include any conditions which the |
| 1045 | agency intends to attach to the certificate of need. The agency |
| 1046 | shall designate by rule a senior staff person, other than the |
| 1047 | person who issues the final order, to issue State Agency Action |
| 1048 | Reports and Notices of Intent. |
| 1049 | Section 10. Section 408.040, Florida Statutes, is amended |
| 1050 | to read: |
| 1051 | 408.040 Conditions and monitoring.-- |
| 1052 | (1)(a) The agency may issue a certificate of need or an |
| 1053 | exemption predicated upon statements of intent expressed by an |
| 1054 | applicant in the application for a certificate of need or |
| 1055 | exemption. Any conditions imposed on a certificate of need or an |
| 1056 | exemption based on such statements of intent shall be stated on |
| 1057 | the face of the certificate of need or in the exemption |
| 1058 | approval. |
| 1059 | (b) The agency may consider, in addition to the other |
| 1060 | criteria specified in s. 408.035, a statement of intent by the |
| 1061 | applicant that a specified percentage of the annual patient days |
| 1062 | at the facility will be utilized by patients eligible for care |
| 1063 | under Title XIX of the Social Security Act. Any certificate of |
| 1064 | need issued to a nursing home in reliance upon an applicant's |
| 1065 | statements that a specified percentage of annual patient days |
| 1066 | will be utilized by residents eligible for care under Title XIX |
| 1067 | of the Social Security Act must include a statement that such |
| 1068 | certification is a condition of issuance of the certificate of |
| 1069 | need. The certificate-of-need program shall notify the Medicaid |
| 1070 | program office and the Department of Elderly Affairs when it |
| 1071 | imposes conditions as authorized in this paragraph in an area in |
| 1072 | which a community diversion pilot project is implemented. |
| 1073 | (c) A certificateholder or exemption holder may apply to |
| 1074 | the agency for a modification of conditions imposed under |
| 1075 | paragraph (a) or paragraph (b). If the holder of a certificate |
| 1076 | of need or exemption demonstrates good cause why the certificate |
| 1077 | or exemption should be modified, the agency shall reissue the |
| 1078 | certificate of need or exemption with such modifications as may |
| 1079 | be appropriate. The agency shall by rule define the factors |
| 1080 | constituting good cause for modification. |
| 1081 | (d) If the holder of a certificate of need or exemption |
| 1082 | fails to comply with a condition upon which the issuance of the |
| 1083 | certificate or exemption was predicated, the agency shall may |
| 1084 | assess an administrative fine against the certificate or |
| 1085 | exemption holder certificateholder in an amount not to exceed |
| 1086 | $1,000 per failure per day. Failure to annually report |
| 1087 | compliance with any condition upon which the issuance of the |
| 1088 | certificate or exemption was predicated constitutes |
| 1089 | noncompliance. In assessing the penalty, the agency shall take |
| 1090 | into account as mitigation the degree of noncompliance relative |
| 1091 | lack of severity of a particular failure. Proceeds of such |
| 1092 | penalties shall be deposited in the Public Medical Assistance |
| 1093 | Trust Fund. |
| 1094 | (2)(a) Unless the applicant has commenced construction, if |
| 1095 | the project provides for construction, unless the applicant has |
| 1096 | incurred an enforceable capital expenditure commitment for a |
| 1097 | project, if the project does not provide for construction, or |
| 1098 | unless subject to paragraph (b), a certificate of need shall |
| 1099 | terminate 18 months after the date of issuance. The agency shall |
| 1100 | monitor the progress of the holder of the certificate of need in |
| 1101 | meeting the timetable for project development specified in the |
| 1102 | application with the assistance of the local health council as |
| 1103 | specified in s. 408.033(1)(b)5., and may revoke the certificate |
| 1104 | of need, if the holder of the certificate is not meeting such |
| 1105 | timetable and is not making a good-faith effort, as defined by |
| 1106 | rule, to meet it. |
| 1107 | (b) A certificate of need issued to an applicant holding a |
| 1108 | provisional certificate of authority under chapter 651 shall |
| 1109 | terminate 1 year after the applicant receives a valid |
| 1110 | certificate of authority from the Office of Insurance Regulation |
| 1111 | of the Financial Services Commission. |
| 1112 | (c) The certificate-of-need validity period for a project |
| 1113 | shall be extended by the agency, to the extent that the |
| 1114 | applicant demonstrates to the satisfaction of the agency that |
| 1115 | good-faith commencement of the project is being delayed by |
| 1116 | litigation or by governmental action or inaction with respect to |
| 1117 | regulations or permitting precluding commencement of the |
| 1118 | project. |
| 1119 | (3) The agency shall require the submission of an executed |
| 1120 | architect's certification of final payment for each certificate- |
| 1121 | of-need project approved by the agency. Each project that |
| 1122 | involves construction shall submit such certification to the |
| 1123 | agency within 30 days following completion of construction. |
| 1124 | Section 11. Section 408.043, Florida Statutes, is amended |
| 1125 | to read: |
| 1126 | 408.043 Special provisions.-- |
| 1127 | (1) OSTEOPATHIC ACUTE CARE HOSPITALS.--When an application |
| 1128 | is made for a certificate of need to construct or to expand an |
| 1129 | osteopathic acute care hospital, the need for such hospital |
| 1130 | shall be determined on the basis of the need for and |
| 1131 | availability of osteopathic services and osteopathic acute care |
| 1132 | hospitals in the district. When a prior certificate of need to |
| 1133 | establish an osteopathic acute care hospital has been issued in |
| 1134 | a district, and the facility is no longer used for that purpose, |
| 1135 | the agency may continue to count such facility and beds as an |
| 1136 | existing osteopathic facility in any subsequent application for |
| 1137 | construction of an osteopathic acute care hospital. |
| 1138 | (2) HOSPICES.--When an application is made for a |
| 1139 | certificate of need to establish or to expand a hospice, the |
| 1140 | need for such hospice shall be determined on the basis of the |
| 1141 | need for and availability of hospice services in the community. |
| 1142 | The formula on which the certificate of need is based shall |
| 1143 | discourage regional monopolies and promote competition. The |
| 1144 | inpatient hospice care component of a hospice which is a |
| 1145 | freestanding facility, or a part of a facility, which is |
| 1146 | primarily engaged in providing inpatient care and related |
| 1147 | services and is not licensed as a health care facility shall |
| 1148 | also be required to obtain a certificate of need. Provision of |
| 1149 | hospice care by any current provider of health care is a |
| 1150 | significant change in service and therefore requires a |
| 1151 | certificate of need for such services. |
| 1152 | (3) RURAL HEALTH NETWORKS.--Preference shall be given in |
| 1153 | the award of a certificate of need to members of certified rural |
| 1154 | health networks, as provided for in s. 381.0406, subject to the |
| 1155 | following conditions: |
| 1156 | (a) Need must be shown pursuant to s. 408.035. |
| 1157 | (b) The proposed project must: |
| 1158 | 1. Strengthen health care services in rural areas through |
| 1159 | partnerships between rural care providers; or |
| 1160 | 2. Increase access to inpatient health care services for |
| 1161 | Medicaid recipients or other low-income persons who live in |
| 1162 | rural areas. |
| 1163 | (c) No preference shall be given under this section for |
| 1164 | the establishment of skilled nursing facility services by a |
| 1165 | hospital. |
| 1166 | (4) PRIVATE ACCREDITATION NOT REQUIRED.--Accreditation by |
| 1167 | any private organization may not be a requirement for the |
| 1168 | issuance or maintenance of a certificate of need under ss. |
| 1169 | 408.031-408.045. |
| 1170 | (5) SOLE ACUTE CARE HOSPITALS IN HIGH GROWTH |
| 1171 | COUNTIES.--Notwithstanding any other provision of law, an acute |
| 1172 | Notwithstanding any other provision of law, an acute care |
| 1173 | hospital licensed under chapter 395 may add up to 180 additional |
| 1174 | beds without agency review if such hospital is located in a |
| 1175 | county that has experienced at least a 60-percent growth rate |
| 1176 | for the most recent 10-year period for which data are available |
| 1177 | as determined by using the population statistics published in |
| 1178 | the most recent edition of the Florida Statistical Abstract, is |
| 1179 | the sole acute care hospital in the county, and is the only |
| 1180 | acute care hospital within a 10-mile radius of another hospital. |
| 1181 | A hospital shall provide written notice to the agency that it |
| 1182 | qualifies under this subsection prior to the addition of beds. |
| 1183 | Such projects shall not be subject to challenge under s. 408.039 |
| 1184 | or chapter 120. Acute care beds added under this subsection |
| 1185 | shall not be included in the inventory of hospital beds used by |
| 1186 | the agency in the calculation of the fixed-bed-need pool for |
| 1187 | acute care hospitals. |
| 1188 | Section 12. Section 408.0455, Florida Statutes, is amended |
| 1189 | to read: |
| 1190 | 408.0455 Rules; pending proceedings.--The rules of the |
| 1191 | agency in effect on June 30, 2004 1997, shall remain in effect |
| 1192 | and shall be enforceable by the agency with respect to ss. |
| 1193 | 408.031-408.045 until such rules are repealed or amended by the |
| 1194 | agency, and no judicial or administrative proceeding pending on |
| 1195 | July 1, 1997, shall be abated as a result of the provisions of |
| 1196 | ss. 408.031-408.043(1) and (2); s. 408.044; or s. 408.045. |
| 1197 | Section 13. This act shall take effect July 1, 2004. |