Bill Text: FL S1736 | 2011 | Regular Session | Comm Sub
Bill Title: Health Care
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2011-05-06 - Placed on Special Order Calendar, 05/06/11 [S1736 Detail]
Download: Florida-2011-S1736-Comm_Sub.html
Florida Senate - 2011 CS for SB 1736 By the Committee on Health Regulation; and Senator Latvala 588-02834A-11 20111736c1 1 A bill to be entitled 2 An act relating to health care; amending s. 83.42, 3 F.S., relating to exclusions from part II of ch. 83, 4 F.S., the Florida Residential Landlord and Tenant Act; 5 clarifying that the procedures in s. 400.0255, F.S., 6 for transfers and discharges are exclusive to 7 residents of a nursing home licensed under part II of 8 ch. 400, F.S.; amending s. 112.0455, F.S., relating to 9 the Drug-Free Workplace Act; deleting an obsolete 10 provision; deleting a provision that requires a 11 laboratory to submit to the Agency for Health Care 12 Administration a monthly report containing statistical 13 information regarding the testing of employees and job 14 applicants; repealing s. 383.325, F.S., relating to 15 confidentiality of inspection reports of licensed 16 birth center facilities; amending s. 395.002, F.S.; 17 revising and deleting definitions applicable to 18 regulation of hospitals and other licensed facilities; 19 conforming a cross-reference; amending s. 395.003, 20 F.S.; deleting an obsolete provision; conforming a 21 cross-reference; amending s. 395.0161, F.S.; deleting 22 a requirement that facilities licensed under part I of 23 ch. 395, F.S., pay licensing fees at the time of 24 inspection; amending s. 395.0193, F.S.; requiring a 25 licensed facility to report certain peer review 26 information and final disciplinary actions to the 27 Division of Medical Quality Assurance of the 28 Department of Health rather than the Division of 29 Health Quality Assurance of the Agency for Health Care 30 Administration; amending s. 395.1023, F.S.; providing 31 for the Department of Children and Family Services 32 rather than the Department of Health to perform 33 certain functions with respect to child protection 34 cases; requiring certain hospitals to notify the 35 Department of Children and Family Services of 36 compliance; amending s. 395.1041, F.S., relating to 37 hospital emergency services and care; deleting 38 obsolete provisions; repealing s. 395.1046, F.S., 39 relating to complaint investigation procedures; 40 amending s. 395.1055, F.S.; requiring licensed 41 facility beds to conform to standards specified by the 42 Agency for Health Care Administration, the Florida 43 Building Code, and the Florida Fire Prevention Code; 44 amending s. 395.10972, F.S.; revising a reference to 45 the Florida Society of Healthcare Risk Management to 46 conform to the current designation; amending s. 47 395.2050, F.S.; revising a reference to the federal 48 Health Care Financing Administration to conform to the 49 current designation; amending s. 395.3036, F.S.; 50 correcting a reference; repealing s. 395.3037, F.S., 51 relating to redundant definitions; amending ss. 52 154.11, 394.741, 395.3038, 400.925, 400.9935, 408.05, 53 440.13, 627.645, 627.668, 627.669, 627.736, 641.495, 54 and 766.1015, F.S.; revising references to the Joint 55 Commission on Accreditation of Healthcare 56 Organizations, the Commission on Accreditation of 57 Rehabilitation Facilities, and the Council on 58 Accreditation to conform to their current 59 designations; amending s. 395.602, F.S.; revising the 60 definition of the term “rural hospital” to delete an 61 obsolete provision; amending s. 400.021, F.S.; 62 revising the definition of the terms “geriatric 63 outpatient clinic” and “resident care plan”; amending 64 s. 400.0234, F.S.; conforming provisions to changes 65 made by the act; amending s. 400.0255, F.S.; 66 correcting an obsolete cross-reference to 67 administrative rules; amending s. 400.063, F.S.; 68 deleting an obsolete provision; amending ss. 400.071 69 and 400.0712, F.S.; revising applicability of general 70 licensure requirements under part II of ch. 408, F.S., 71 to applications for nursing home licensure; revising 72 provisions governing inactive licenses; amending s. 73 400.111, F.S.; providing for disclosure of controlling 74 interest of a nursing home facility upon request by 75 the Agency for Health Care Administration; amending s. 76 400.1183, F.S.; revising grievance record maintenance 77 and reporting requirements for nursing homes; amending 78 s. 400.141, F.S.; providing criteria for the provision 79 of respite services by nursing homes; requiring a 80 written plan of care; requiring a contract for 81 services; requiring resident release to caregivers to 82 be designated in writing; providing an exemption to 83 the application of discharge planning rules; providing 84 for residents’ rights; providing for use of personal 85 medications; providing terms of respite stay; 86 providing for communication of patient information; 87 requiring a physician’s order for care and proof of a 88 physical examination; providing for services for 89 respite patients and duties of facilities with respect 90 to such patients; conforming a cross-reference; 91 requiring facilities to maintain clinical records that 92 meet specified standards; providing a fine relating to 93 an admissions moratorium; deleting requirement for 94 facilities to submit certain information related to 95 management companies to the agency; deleting a 96 requirement for facilities to notify the agency of 97 certain bankruptcy filings to conform to changes made 98 by the act; authorizing a facility to charge a fee to 99 copy a resident’s records; amending s. 400.142, F.S.; 100 deleting language relating to agency adoption of 101 rules; repealing s. 400.145, F.S., relating 102 requirements for furnishing the records of residents 103 in a licensed nursing home to certain specified 104 parties; amending 400.147, F.S.; revising reporting 105 requirements for licensed nursing home facilities 106 relating to adverse incidents; repealing s. 400.148, 107 F.S., relating to the Medicaid “Up-or-Out” Quality of 108 Care Contract Management Program; amending s. 400.179, 109 F.S.; deleting an obsolete provision; amending s. 110 400.19, F.S.; revising inspection requirements; 111 amending s. 400.23, F.S.; deleting an obsolete 112 provision; correcting a reference; deleting a 113 requirement that the rules for minimum standards of 114 care for persons under 21 years of age include a 115 certain methodology; directing the agency to adopt 116 rules for minimum staffing standards in nursing homes 117 that serve persons under 21 years of age; providing 118 minimum staffing standards; amending s. 400.275, F.S.; 119 revising agency duties with regard to training nursing 120 home surveyor teams; revising requirements for team 121 members; amending s. 400.462, F.S.; redefining the 122 term “remuneration” for purposes of the Home Health 123 Services Act; amending s. 400.484, F.S.; revising the 124 schedule of home health agency inspection violations; 125 amending s. 400.506, F.S.; providing that a nurse 126 registry is exempt from certain license penalties and 127 fines otherwise imposed by the Agency for Health Care 128 Administration on a nurse registry under certain 129 circumstances; authorizing an administrator to manage 130 up to five nurse registries under certain 131 circumstances; requiring an administrator to 132 designate, in writing, for each licensed entity, a 133 qualified alternate administrator to serve during the 134 administrator’s absence; amending s. 400.509, F.S.; 135 providing that organizations that provide companion 136 services only to persons with developmental 137 disabilities, under contract with the Agency for 138 Persons with Disabilities, are exempt from 139 registration with the Agency for Health Care 140 Administration; reenacting ss. 400.464(5)(b) and 141 400.506(6)(a), F.S., relating to home health agencies 142 and licensure of nurse registries, respectively, to 143 incorporate the amendment made to s. 400.509, F.S., in 144 references thereto; amending s. 400.606, F.S.; 145 revising the content requirements of the plan 146 accompanying an initial or change-of-ownership 147 application for licensure of a hospice; revising 148 requirements relating to certificates of need for 149 certain hospice facilities; amending s. 400.607, F.S.; 150 revising grounds for agency action against a hospice; 151 amending s. 400.915, F.S.; correcting an obsolete 152 cross-reference to administrative rules; amending s. 153 400.931, F.S.; requiring each applicant for initial 154 licensure, change of ownership, or renewal to operate 155 a licensed home medical equipment provider at a 156 location outside the state to submit documentation of 157 accreditation, or an application for accreditation, 158 from an accrediting organization that is recognized by 159 the Agency for Health Care Administration; requiring 160 an applicant that has applied for accreditation to 161 provide proof of accreditation within a specified 162 time; deleting a requirement that an applicant for a 163 home medical equipment provider license submit a 164 surety bond to the agency; amending s. 400.932, F.S.; 165 revising grounds for the imposition of administrative 166 penalties for certain violations by an employee of a 167 home medical equipment provider; amending s. 400.967, 168 F.S.; revising the schedule of inspection violations 169 for intermediate care facilities for the 170 developmentally disabled; providing a penalty for 171 certain violations; amending s. 400.9905, F.S.; 172 revising the definitions of the terms “clinic” and 173 “portable equipment provider”; providing that part X 174 of ch. 400, F.S., the Health Care Clinic Act, does not 175 apply to certain clinical facilities, an entity owned 176 by a corporation with a specified amount of annual 177 sales of health care services under certain 178 circumstances, an entity owned or controlled by a 179 publicly traded entity with a specified amount of 180 annual revenues, or an entity that employs at least a 181 certain number of health care practitioners and bills 182 for medical services under a single corporate tax 183 identification number; amending s. 400.991, F.S.; 184 conforming terminology; revising application 185 requirements relating to documentation of financial 186 ability to operate a mobile clinic; amending s. 187 408.033, F.S.; providing that fees assessed on 188 selected health care facilities and organizations may 189 be collected prospectively at the time of licensure 190 renewal and prorated for the licensing period; 191 amending s. 408.034, F.S.; revising agency authority 192 relating to licensing of intermediate care facilities 193 for the developmentally disabled; amending s. 408.036, 194 F.S.; deleting an exemption from certain certificate 195 of-need review requirements for a hospice or a hospice 196 inpatient facility; deleting a requirement that the 197 agency submit a report to the Legislature providing 198 information concerning the number of requests it 199 receives for an exemption from certificate-of-need 200 review; amending s. 408.037, F.S.; revising 201 requirements for the financial information to be 202 included in an application for a certificate of need; 203 amending s. 408.043, F.S.; revising requirements for 204 certain freestanding inpatient hospice care facilities 205 to obtain a certificate of need; amending s. 408.061, 206 F.S.; revising health care facility data reporting 207 requirements; amending s. 408.10, F.S.; removing 208 agency authority to investigate certain consumer 209 complaints; amending s. 408.802, F.S.; removing 210 applicability of part II of ch. 408, F.S., relating to 211 general licensure requirements, to private review 212 agents; amending s. 408.804, F.S.; providing penalties 213 for altering, defacing, or falsifying a license 214 certificate issued by the agency or displaying such an 215 altered, defaced, or falsified certificate; amending 216 s. 408.806, F.S.; revising agency responsibilities for 217 notification of licensees of impending expiration of a 218 license; requiring payment of a late fee for a license 219 application to be considered complete under certain 220 circumstances; amending s. 408.8065, F.S.; revising 221 the requirements for becoming licensed as a home 222 health agency, home medical equipment provider, or 223 health care clinic; amending s. 408.809, F.S.; 224 revising provisions to include a schedule for 225 background rescreenings of certain employees; amending 226 s. 408.813, F.S.; authorizing the agency to impose 227 fines for unclassified violations of part II of ch. 228 408, F.S.; amending s. 408.815, F.S.; authorizing the 229 agency to extend a license expiration date under 230 certain circumstances; amending s. 409.91196, F.S.; 231 conforming a cross-reference; amending s. 409.912, 232 F.S.; revising procedures for implementation of a 233 Medicaid prescribed-drug spending-control program; 234 amending s. 429.07, F.S.; deleting the requirement for 235 an assisted living facility to obtain an additional 236 license in order to provide limited nursing services; 237 deleting the requirement for the agency to conduct 238 quarterly monitoring visits of facilities that hold a 239 license to provide extended congregate care services; 240 deleting the requirement for the department to report 241 annually on the status of and recommendations related 242 to extended congregate care; deleting the requirement 243 for the agency to conduct monitoring visits at least 244 twice a year to facilities providing limited nursing 245 services; increasing the additional licensing fee per 246 resident based on the total licensed resident capacity 247 of the facility; eliminating the license fee for the 248 limited nursing services license; transferring from 249 another provision of law the requirement that a 250 biennial survey of an assisted living facility include 251 specific actions to determine whether the facility is 252 adequately protecting residents’ rights; providing 253 that under specified conditions an assisted living 254 facility that has a class I or class II violation is 255 subject to periodic unannounced monitoring; requiring 256 a registered nurse to participate in certain 257 monitoring visits; amending s. 429.11, F.S.; revising 258 licensure application requirements for assisted living 259 facilities to eliminate provisional licenses; amending 260 s. 429.12, F.S.; deleting a requirement that a 261 transferor of an assisted living facility advise the 262 transferee to submit a plan for correction of certain 263 deficiencies to the Agency for Health Care 264 Administration before ownership of the facility is 265 transferred; amending s. 429.17, F.S.; deleting 266 provisions relating to the limited nursing services 267 license; revising agency responsibilities regarding 268 the issuance of conditional licenses; amending s. 269 429.195, F.S.; prohibiting an assisted living facility 270 from contracting or promising to pay or receive any 271 commission, bonus, kickback, or rebate or engage in 272 any split-fee arrangement with any health care 273 provider or health care facility; providing 274 exceptions; amending s. 429.23, F.S.; deleting 275 reporting requirements for assisted living facilities 276 relating to liability claims; amending s. 429.255, 277 F.S.; eliminating provisions authorizing the use of 278 volunteers to provide certain health-care-related 279 services in assisted living facilities; authorizing 280 assisted living facilities to provide limited nursing 281 services; requiring an assisted living facility to be 282 responsible for certain recordkeeping and staff to be 283 trained to monitor residents receiving certain health 284 care-related services; amending s. 429.28, F.S.; 285 deleting a requirement for a biennial survey of an 286 assisted living facility, to conform to changes made 287 by the act; conforming a cross-reference; amending s. 288 429.294, F.S.; conforming provisions to changes made 289 by the act; amending s. 429.41, F.S., relating to 290 rulemaking; conforming provisions to changes made by 291 the act; deleting the requirement for the Department 292 of Elderly Affairs to submit to the Legislature a copy 293 of proposed rules regarding the quality of resident 294 care in an assisted living facility; amending s. 295 429.53, F.S.; revising provisions relating to 296 consultation by the agency; revising a definition; 297 amending s. 429.54, F.S.; requiring licensed assisted 298 living facilities to electronically report certain 299 data semiannually to the agency in accordance with 300 rules adopted by the department; amending s. 429.71, 301 F.S.; revising schedule of inspection violations for 302 adult family-care homes; amending s. 429.915, F.S.; 303 revising agency responsibilities regarding the 304 issuance of conditional licenses; repealing s. 305 440.102(9)(d), F.S., relating to a laboratory’s 306 requirement to submit to the Agency for Health Care 307 Administration a monthly report containing statistical 308 information regarding the testing of employees and job 309 applicants; amending s. 483.035, F.S.; providing for a 310 clinical laboratory to be operated by certain nurses; 311 amending s. 483.051, F.S.; requiring the Agency for 312 Health Care Administration to provide for biennial 313 licensure of all nonwaived laboratories that meet 314 certain requirements; requiring the agency to 315 prescribe qualifications for such licensure; defining 316 nonwaived laboratories as laboratories that do not 317 have a certificate of waiver from the Centers for 318 Medicare and Medicaid Services; deleting requirements 319 for the registration of an alternate site testing 320 location when the clinical laboratory applies to renew 321 its license; amending s. 483.294, F.S.; revising 322 frequency of agency inspections of multiphasic health 323 testing centers; amending s. 626.9541, F.S.; 324 authorizing an insurer offering a group or individual 325 health benefit plan to offer a wellness program; 326 authorizing rewards or incentives; providing for 327 verification of a member’s inability to participate 328 for medical reasons; providing that such rewards or 329 incentives are not insurance benefits; amending s. 330 766.202, F.S.; adding persons licensed under part XIV 331 of ch. 468, F.S., to the definition of “health care 332 provider”; amending ss. 394.4787, 400.0239, 408.07, 333 430.80, and 651.118, F.S.; conforming terminology and 334 references to changes made by the act; revising a 335 reference; amending s. 817.505, F.S.; providing that 336 it is not patient brokering for an assisted living 337 facility to offer payment under certain circumstances; 338 amending s. 381.06014, F.S.; redefining the term 339 “blood establishment” and defining the term “volunteer 340 donor”; prohibiting local governments from restricting 341 access to public facilities or infrastructure for 342 certain activities based on whether a blood 343 establishment is operating as a for-profit 344 organization or not-for-profit organization; 345 prohibiting a blood establishment from considering 346 whether certain customers are operating as for-profit 347 organizations or not-for-profit organizations when 348 determining service fees for selling blood or blood 349 components; requiring that certain blood 350 establishments disclose specified information on the 351 Internet; authorizing the Department of Legal Affairs 352 to assess a civil penalty against a blood 353 establishment that fails to disclose specified 354 information on the Internet; providing that the civil 355 penalty accrues to the state and requiring that it be 356 deposited as received into the General Revenue Fund; 357 amending s. 499.003, F.S.; redefining the term “health 358 care entity” to clarify that a blood establishment is 359 a health care entity that may engage in certain 360 activities; amending s. 499.005, F.S.; clarifying 361 provisions that prohibit the unauthorized wholesale 362 distribution of a prescription drug that was purchased 363 by a hospital or other health care entity or donated 364 or supplied at a reduced price to a charitable 365 organization, to conform to changes made by the act; 366 amending s. 499.01, F.S.; exempting certain blood 367 establishments from the requirements to be permitted 368 as a prescription drug manufacturer and register 369 products; requiring that certain blood establishments 370 obtain a restricted prescription drug distributor 371 permit under specified conditions; limiting the 372 prescription drugs that a blood establishment may 373 distribute under a restricted prescription drug 374 distributor permit; authorizing the Department of 375 Health to adopt rules regarding the distribution of 376 prescription drugs by blood establishments; providing 377 an effective date. 378 379 Be It Enacted by the Legislature of the State of Florida: 380 381 Section 1. Subsection (1) of section 83.42, Florida 382 Statutes, is amended to read: 383 83.42 Exclusions from application of part.—This part does 384 not apply to: 385 (1) Residency or detention in a facility, whether public or 386 private, when residence or detention is incidental to the 387 provision of medical, geriatric, educational, counseling, 388 religious, or similar services. The procedures for all transfers 389 and discharges as provided in s. 400.0255 apply only to 390 residents of a facility licensed under part II of chapter 400. 391 Section 2. Present paragraphs (f) through (k) of subsection 392 (10) of section 112.0455, Florida Statutes, are redesignated as 393 paragraphs (e) through (j), respectively, and present paragraph 394 (e) of subsection (10), subsection (12), and paragraph (e) of 395 subsection (14) of that section are amended to read: 396 112.0455 Drug-Free Workplace Act.— 397 (10) EMPLOYER PROTECTION.— 398(e) Nothing in this section shall be construed to operate399retroactively, and nothing in this section shall abrogate the400right of an employer under state law to conduct drug tests prior401to January 1, 1990. A drug test conducted by an employer prior402to January 1, 1990, is not subject to this section.403 (12) DRUG-TESTING STANDARDS; LABORATORIES.— 404 (a) The requirements of part II of chapter 408 apply to the 405 provision of services that require licensure pursuant to this 406 section and part II of chapter 408 and to entities licensed by 407 or applying for such licensure from the Agency for Health Care 408 Administration pursuant to this section. A license issued by the 409 agency is required in order to operate a laboratory. 410 (b) A laboratory may analyze initial or confirmation drug 411 specimens only if: 412 1. The laboratory is licensed and approved by the Agency 413 for Health Care Administration using criteria established by the 414 United States Department of Health and Human Services as general 415 guidelines for modeling the state drug testing program and in 416 accordance with part II of chapter 408. Each applicant for 417 licensure and licensee must comply with all requirements of part 418 II of chapter 408. 419 2. The laboratory has written procedures to ensure chain of 420 custody. 421 3. The laboratory follows proper quality control 422 procedures, including, but not limited to: 423 a. The use of internal quality controls including the use 424 of samples of known concentrations which are used to check the 425 performance and calibration of testing equipment, and periodic 426 use of blind samples for overall accuracy. 427 b. An internal review and certification process for drug 428 test results, conducted by a person qualified to perform that 429 function in the testing laboratory. 430 c. Security measures implemented by the testing laboratory 431 to preclude adulteration of specimens and drug test results. 432 d. Other necessary and proper actions taken to ensure 433 reliable and accurate drug test results. 434 (c) A laboratory shall disclose to the employer a written 435 test result report within 7 working days after receipt of the 436 sample. All laboratory reports of a drug test result shall, at a 437 minimum, state: 438 1. The name and address of the laboratory which performed 439 the test and the positive identification of the person tested. 440 2. Positive results on confirmation tests only, or negative 441 results, as applicable. 442 3. A list of the drugs for which the drug analyses were 443 conducted. 444 4. The type of tests conducted for both initial and 445 confirmation tests and the minimum cutoff levels of the tests. 446 5. Any correlation between medication reported by the 447 employee or job applicant pursuant to subparagraph (8)(b)2. and 448 a positive confirmed drug test result. 449 450 No report shall disclose the presence or absence of any drug 451 other than a specific drug and its metabolites listed pursuant 452 to this section. 453(d) The laboratory shall submit to the Agency for Health454Care Administration a monthly report with statistical455information regarding the testing of employees and job456applicants. The reports shall include information on the methods457of analyses conducted, the drugs tested for, the number of458positive and negative results for both initial and confirmation459tests, and any other information deemed appropriate by the460Agency for Health Care Administration. No monthly report shall461identify specific employees or job applicants.462 (d)(e)Laboratories shall provide technical assistance to 463 the employer, employee, or job applicant for the purpose of 464 interpreting any positive confirmed test results which could 465 have been caused by prescription or nonprescription medication 466 taken by the employee or job applicant. 467 (14) DISCIPLINE REMEDIES.— 468 (e) Upon resolving an appeal filed pursuant to paragraph 469 (c), and finding a violation of this section, the commission may 470 order the following relief: 471 1. Rescind the disciplinary action, expunge related records 472 from the personnel file of the employee or job applicant and 473 reinstate the employee. 474 2. Order compliance with paragraph (10)(f)(g). 475 3. Award back pay and benefits. 476 4. Award the prevailing employee or job applicant the 477 necessary costs of the appeal, reasonable attorney’s fees, and 478 expert witness fees. 479 Section 3. Paragraph (n) of subsection (1) of section 480 154.11, Florida Statutes, is amended to read: 481 154.11 Powers of board of trustees.— 482 (1) The board of trustees of each public health trust shall 483 be deemed to exercise a public and essential governmental 484 function of both the state and the county and in furtherance 485 thereof it shall, subject to limitation by the governing body of 486 the county in which such board is located, have all of the 487 powers necessary or convenient to carry out the operation and 488 governance of designated health care facilities, including, but 489 without limiting the generality of, the foregoing: 490 (n) To appoint originally the staff of physicians to 491 practice in any designated facility owned or operated by the 492 board and to approve the bylaws and rules to be adopted by the 493 medical staff of any designated facility owned and operated by 494 the board, such governing regulations to be in accordance with 495 the standards of the Joint Commissionon the Accreditation of496Hospitalswhich provide, among other things, for the method of 497 appointing additional staff members and for the removal of staff 498 members. 499 Section 4. Section 383.325, Florida Statutes, is repealed. 500 Section 5. Subsection (7) of section 394.4787, Florida 501 Statutes, is amended to read: 502 394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and 503 394.4789.—As used in this section and ss. 394.4786, 394.4788, 504 and 394.4789: 505 (7) “Specialty psychiatric hospital” means a hospital 506 licensed by the agency pursuant to s. 395.002(26)(28)and part 507 II of chapter 408 as a specialty psychiatric hospital. 508 Section 6. Subsection (2) of section 394.741, Florida 509 Statutes, is amended to read: 510 394.741 Accreditation requirements for providers of 511 behavioral health care services.— 512 (2) Notwithstanding any provision of law to the contrary, 513 accreditation shall be accepted by the agency and department in 514 lieu of the agency’s and department’s facility licensure onsite 515 review requirements and shall be accepted as a substitute for 516 the department’s administrative and program monitoring 517 requirements, except as required by subsections (3) and (4), 518 for: 519 (a) Any organization from which the department purchases 520 behavioral health care services that is accredited by the Joint 521 Commissionon Accreditation of Healthcare Organizationsor the 522 Council on Accreditationfor Children and Family Services, or 523 has those services that are being purchased by the department 524 accredited by the Commission on Accreditation of Rehabilitation 525 FacilitiesCARF—the Rehabilitation Accreditation Commission. 526 (b) Any mental health facility licensed by the agency or 527 any substance abuse component licensed by the department that is 528 accredited by the Joint Commissionon Accreditation of529Healthcare Organizations, the Commission on Accreditation of 530 Rehabilitation FacilitiesCARF—the Rehabilitation Accreditation531Commission, or the Council on Accreditationof Children and532Family Services. 533 (c) Any network of providers from which the department or 534 the agency purchases behavioral health care services accredited 535 by the Joint Commissionon Accreditation of Healthcare536Organizations, the Commission on Accreditation of Rehabilitation 537 FacilitiesCARF—the Rehabilitation Accreditation Commission, the 538 Council on Accreditationof Children and Family Services, or the 539 National Committee for Quality Assurance. A provider 540 organization, which is part of an accredited network, is 541 afforded the same rights under this part. 542 Section 7. Present subsections (15) through (32) of section 543 395.002, Florida Statutes, are renumbered as subsections (14) 544 through (28), respectively, and present subsections (1), (14), 545 (24), (30), and (31) and paragraph (c) of present subsection 546 (28) of that section are amended to read: 547 395.002 Definitions.—As used in this chapter: 548 (1) “Accrediting organizations” means nationally recognized 549 or approved accrediting organizations whose standards 550 incorporate comparable licensure requirements as determined by 551 the agencythe Joint Commission on Accreditation of Healthcare552Organizations, the American Osteopathic Association, the553Commission on Accreditation of Rehabilitation Facilities, and554the Accreditation Association for Ambulatory Health Care, Inc. 555(14) “Initial denial determination” means a determination556by a private review agent that the health care services557furnished or proposed to be furnished to a patient are558inappropriate, not medically necessary, or not reasonable.559(24) “Private review agent” means any person or entity560which performs utilization review services for third-party561payors on a contractual basis for outpatient or inpatient562services. However, the term shall not include full-time563employees, personnel, or staff of health insurers, health564maintenance organizations, or hospitals, or wholly owned565subsidiaries thereof or affiliates under common ownership, when566performing utilization review for their respective hospitals,567health maintenance organizations, or insureds of the same568insurance group. For this purpose, health insurers, health569maintenance organizations, and hospitals, or wholly owned570subsidiaries thereof or affiliates under common ownership,571include such entities engaged as administrators of self572insurance as defined in s.624.031.573 (26)(28)“Specialty hospital” means any facility which 574 meets the provisions of subsection (12), and which regularly 575 makes available either: 576 (c) Intensive residential treatment programs for children 577 and adolescents as defined in subsection (14)(15). 578(30) “Utilization review” means a system for reviewing the579medical necessity or appropriateness in the allocation of health580care resources of hospital services given or proposed to be581given to a patient or group of patients.582(31) “Utilization review plan” means a description of the583policies and procedures governing utilization review activities584performed by a private review agent.585 Section 8. Paragraph (c) of subsection (1) and paragraph 586 (b) of subsection (2) of section 395.003, Florida Statutes, are 587 amended to read: 588 395.003 Licensure; denial, suspension, and revocation.— 589 (1) 590(c) Until July 1, 2006, additional emergency departments591located off the premises of licensed hospitals may not be592authorized by the agency.593 (2) 594 (b) The agency shall, at the request of a licensee that is 595 a teaching hospital as defined in s. 408.07(45), issue a single 596 license to a licensee for facilities that have been previously 597 licensed as separate premises, provided such separately licensed 598 facilities, taken together, constitute the same premises as 599 defined in s. 395.002(22)(23). Such license for the single 600 premises shall include all of the beds, services, and programs 601 that were previously included on the licenses for the separate 602 premises. The granting of a single license under this paragraph 603 shall not in any manner reduce the number of beds, services, or 604 programs operated by the licensee. 605 Section 9. Subsection (3) of section 395.0161, Florida 606 Statutes, is amended to read: 607 395.0161 Licensure inspection.— 608 (3) In accordance with s. 408.805, an applicant or licensee 609 shall pay a fee for each license application submitted under 610 this part, part II of chapter 408, and applicable rules. With 611 the exception of state-operated licensed facilities, each 612 facility licensed under this part shall pay to the agency, at613the time of inspection,the following fees: 614 (a) Inspection for licensure.—A fee shall be paid which is 615 not less than $8 per hospital bed, nor more than $12 per 616 hospital bed, except that the minimum fee shall be $400 per 617 facility. 618 (b) Inspection for lifesafety only.—A fee shall be paid 619 which is not less than 75 cents per hospital bed, nor more than 620 $1.50 per hospital bed, except that the minimum fee shall be $40 621 per facility. 622 Section 10. Paragraph (e) of subsection (2) and subsection 623 (4) of section 395.0193, Florida Statutes, are amended to read: 624 395.0193 Licensed facilities; peer review; disciplinary 625 powers; agency or partnership with physicians.— 626 (2) Each licensed facility, as a condition of licensure, 627 shall provide for peer review of physicians who deliver health 628 care services at the facility. Each licensed facility shall 629 develop written, binding procedures by which such peer review 630 shall be conducted. Such procedures shall include: 631 (e) Recording of agendas and minutes which do not contain 632 confidential material, for review by the Division of Medical 633 Quality Assurance of the departmentHealth Quality Assurance of634the agency. 635 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary 636 actions taken under subsection (3) shall be reported in writing 637 to the Division of Medical Quality Assurance of the department 638Health Quality Assurance of the agencywithin 30 working days 639 after its initial occurrence, regardless of the pendency of 640 appeals to the governing board of the hospital. The notification 641 shall identify the disciplined practitioner, the action taken, 642 and the reason for such action. All final disciplinary actions 643 taken under subsection (3), if different from those which were 644 reported to the departmentagencywithin 30 days after the 645 initial occurrence, shall be reported within 10 working days to 646 the Division of Medical Quality Assurance of the department 647Health Quality Assurance of the agencyin writing and shall 648 specify the disciplinary action taken and the specific grounds 649 therefor. The division shall review each report and determine 650 whether it potentially involved conduct by the licensee that is 651 subject to disciplinary action, in which case s. 456.073 shall 652 apply. The reports are not subject to inspection under s. 653 119.07(1) even if the division’s investigation results in a 654 finding of probable cause. 655 Section 11. Section 395.1023, Florida Statutes, is amended 656 to read: 657 395.1023 Child abuse and neglect cases; duties.—Each 658 licensed facility shall adopt a protocol that, at a minimum, 659 requires the facility to: 660 (1) Incorporate a facility policy that every staff member 661 has an affirmative duty to report, pursuant to chapter 39, any 662 actual or suspected case of child abuse, abandonment, or 663 neglect; and 664 (2) In any case involving suspected child abuse, 665 abandonment, or neglect, designate, at the request of the 666 Department of Children and Family Services, a staff physician to 667 act as a liaison between the hospital and the Department of 668 Children and Family Services office which is investigating the 669 suspected abuse, abandonment, or neglect, and the child 670 protection team, as defined in s. 39.01, when the case is 671 referred to such a team. 672 673 Each general hospital and appropriate specialty hospital shall 674 comply with the provisions of this section and shall notify the 675 agency and the Department of Children and Family Services of its 676 compliance by sending a copy of its policy to the agency and the 677 Department of Children and Family Services as required by rule. 678 The failure by a general hospital or appropriate specialty 679 hospital to comply shall be punished by a fine not exceeding 680 $1,000, to be fixed, imposed, and collected by the agency. Each 681 day in violation is considered a separate offense. 682 Section 12. Subsection (2) and paragraph (d) of subsection 683 (3) of section 395.1041, Florida Statutes, are amended to read: 684 395.1041 Access to emergency services and care.— 685 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency 686 shall establish and maintain an inventory of hospitals with 687 emergency services. The inventory shall list all services within 688 the service capability of the hospital, and such services shall 689 appear on the face of the hospital license. Each hospital having 690 emergency services shall notify the agency of its service 691 capability in the manner and form prescribed by the agency. The 692 agency shall use the inventory to assist emergency medical 693 services providers and others in locating appropriate emergency 694 medical care. The inventory shall also be made available to the 695 general public.On or before August 1, 1992, the agency shall696request that each hospital identify the services which are697within its service capability. On or before November 1, 1992,698the agency shall notify each hospital of the service capability699to be included in the inventory. The hospital has 15 days from700the date of receipt to respond to the notice. By December 1,7011992, the agency shall publish a final inventory.Each hospital 702 shall reaffirm its service capability when its license is 703 renewed and shall notify the agency of the addition of a new 704 service or the termination of a service prior to a change in its 705 service capability. 706 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF 707 FACILITY OR HEALTH CARE PERSONNEL.— 708 (d)1. Every hospital shall ensure the provision of services 709 within the service capability of the hospital, at all times, 710 either directly or indirectly through an arrangement with 711 another hospital, through an arrangement with one or more 712 physicians, or as otherwise made through prior arrangements. A 713 hospital may enter into an agreement with another hospital for 714 purposes of meeting its service capability requirement, and 715 appropriate compensation or other reasonable conditions may be 716 negotiated for these backup services. 717 2. If any arrangement requires the provision of emergency 718 medical transportation, such arrangement must be made in 719 consultation with the applicable provider and may not require 720 the emergency medical service provider to provide transportation 721 that is outside the routine service area of that provider or in 722 a manner that impairs the ability of the emergency medical 723 service provider to timely respond to prehospital emergency 724 calls. 725 3. A hospital shall not be required to ensure service 726 capability at all times as required in subparagraph 1. if, prior 727 to the receiving of any patient needing such service capability, 728 such hospital has demonstrated to the agency that it lacks the 729 ability to ensure such capability and it has exhausted all 730 reasonable efforts to ensure such capability through backup 731 arrangements. In reviewing a hospital’s demonstration of lack of 732 ability to ensure service capability, the agency shall consider 733 factors relevant to the particular case, including the 734 following: 735 a. Number and proximity of hospitals with the same service 736 capability. 737 b. Number, type, credentials, and privileges of 738 specialists. 739 c. Frequency of procedures. 740 d. Size of hospital. 741 4. The agency shall publishproposedrules implementing a 742 reasonable exemption procedureby November 1, 1992.Subparagraph7431. shall become effective upon the effective date of said rules744or January 31, 1993, whichever is earlier. For a period not to745exceed 1 year from the effective date of subparagraph 1., a746hospital requesting an exemption shall be deemed to be exempt747from offering the service until the agency initially acts to748deny or grant the original request.The agency has 45 days after 749fromthe date of receipt of the request to approve or deny the 750 request.After the first year from the effective date of751subparagraph 1.,If the agency fails to initially act within 752 thatthetime period, the hospital is deemed to be exempt from 753 offering the service until the agency initially acts to deny the 754 request. 755 Section 13. Section 395.1046, Florida Statutes, is 756 repealed. 757 Section 14. Paragraph (e) of subsection (1) of section 758 395.1055, Florida Statutes, is amended to read: 759 395.1055 Rules and enforcement.— 760 (1) The agency shall adopt rules pursuant to ss. 120.536(1) 761 and 120.54 to implement the provisions of this part, which shall 762 include reasonable and fair minimum standards for ensuring that: 763 (e) Licensed facility beds conform to minimum space, 764 equipment, and furnishings standards as specified by the agency, 765 the Florida Building Code, and the Florida Fire Prevention Code 766department. 767 Section 15. Subsection (1) of section 395.10972, Florida 768 Statutes, is amended to read: 769 395.10972 Health Care Risk Manager Advisory Council.—The 770 Secretary of Health Care Administration may appoint a seven 771 member advisory council to advise the agency on matters 772 pertaining to health care risk managers. The members of the 773 council shall serve at the pleasure of the secretary. The 774 council shall designate a chair. The council shall meet at the 775 call of the secretary or at those times as may be required by 776 rule of the agency. The members of the advisory council shall 777 receive no compensation for their services, but shall be 778 reimbursed for travel expenses as provided in s. 112.061. The 779 council shall consist of individuals representing the following 780 areas: 781 (1) Two shall be active health care risk managers, 782 including one risk manager who is recommended by and a member of 783 the Florida Society forofHealthcare Risk Management and 784 Patient Safety. 785 Section 16. Subsection (3) of section 395.2050, Florida 786 Statutes, is amended to read: 787 395.2050 Routine inquiry for organ and tissue donation; 788 certification for procurement activities; death records review.— 789 (3) Each organ procurement organization designated by the 790 federal Centers for Medicare and Medicaid ServicesHealth Care791Financing Administrationand licensed by the state shall conduct 792 an annual death records review in the organ procurement 793 organization’s affiliated donor hospitals. The organ procurement 794 organization shall enlist the services of every Florida licensed 795 tissue bank and eye bank affiliated with or providing service to 796 the donor hospital and operating in the same service area to 797 participate in the death records review. 798 Section 17. Subsection (2) of section 395.3036, Florida 799 Statutes, is amended to read: 800 395.3036 Confidentiality of records and meetings of 801 corporations that lease public hospitals or other public health 802 care facilities.—The records of a private corporation that 803 leases a public hospital or other public health care facility 804 are confidential and exempt from the provisions of s. 119.07(1) 805 and s. 24(a), Art. I of the State Constitution, and the meetings 806 of the governing board of a private corporation are exempt from 807 s. 286.011 and s. 24(b), Art. I of the State Constitution when 808 the public lessor complies with the public finance 809 accountability provisions of s. 155.40(5) with respect to the 810 transfer of any public funds to the private lessee and when the 811 private lessee meets at least three of the five following 812 criteria: 813 (2) The public lessor and the private lessee do not 814 commingle any of their funds in any account maintained by either 815 of them, other than the payment of the rent and administrative 816 fees or the transfer of funds pursuant to s. 155.40subsection817(2). 818 Section 18. Section 395.3037, Florida Statutes, is 819 repealed. 820 Section 19. Subsections (1), (4), and (5) of section 821 395.3038, Florida Statutes, are amended to read: 822 395.3038 State-listed primary stroke centers and 823 comprehensive stroke centers; notification of hospitals.— 824 (1) The agency shall make available on its website and to 825 the department a list of the name and address of each hospital 826 that meets the criteria for a primary stroke center and the name 827 and address of each hospital that meets the criteria for a 828 comprehensive stroke center. The list of primary and 829 comprehensive stroke centers shall include only those hospitals 830 that attest in an affidavit submitted to the agency that the 831 hospital meets the named criteria, or those hospitals that 832 attest in an affidavit submitted to the agency that the hospital 833 is certified as a primary or a comprehensive stroke center by 834 the Joint Commissionon Accreditation of Healthcare835Organizations. 836 (4) The agency shall adopt by rule criteria for a primary 837 stroke center which are substantially similar to the 838 certification standards for primary stroke centers of the Joint 839 Commissionon Accreditation of Healthcare Organizations. 840 (5) The agency shall adopt by rule criteria for a 841 comprehensive stroke center. However, if the Joint Commissionon842Accreditation of Healthcare Organizationsestablishes criteria 843 for a comprehensive stroke center, the agency shall establish 844 criteria for a comprehensive stroke center which are 845 substantially similar to those criteria established by the Joint 846 Commissionon Accreditation of Healthcare Organizations. 847 Section 20. Paragraph (e) of subsection (2) of section 848 395.602, Florida Statutes, is amended to read: 849 395.602 Rural hospitals.— 850 (2) DEFINITIONS.—As used in this part: 851 (e) “Rural hospital” means an acute care hospital licensed 852 under this chapter, having 100 or fewer licensed beds and an 853 emergency room, which is: 854 1. The sole provider within a county with a population 855 density of no greater than 100 persons per square mile; 856 2. An acute care hospital, in a county with a population 857 density of no greater than 100 persons per square mile, which is 858 at least 30 minutes of travel time, on normally traveled roads 859 under normal traffic conditions, from any other acute care 860 hospital within the same county; 861 3. A hospital supported by a tax district or subdistrict 862 whose boundaries encompass a population of 100 persons or fewer 863 per square mile; 8644. A hospital in a constitutional charter county with a865population of over 1 million persons that has imposed a local866option health service tax pursuant to law and in an area that867was directly impacted by a catastrophic event on August 24,8681992, for which the Governor of Florida declared a state of869emergency pursuant to chapter 125, and has 120 beds or less that870serves an agricultural community with an emergency room871utilization of no less than 20,000 visits and a Medicaid872inpatient utilization rate greater than 15 percent;873 4.5.A hospital with a service area that has a population 874 of 100 persons or fewer per square mile. As used in this 875 subparagraph, the term “service area” means the fewest number of 876 zip codes that account for 75 percent of the hospital’s 877 discharges for the most recent 5-year period, based on 878 information available from the hospital inpatient discharge 879 database in the Florida Center for Health Information and Policy 880 Analysis at the Agency for Health Care Administration; or 881 5.6.A hospital designated as a critical access hospital, 882 as defined in s. 408.07(15). 883 884 Population densities used in this paragraph must be based upon 885 the most recently completed United States census. A hospital 886 that received funds under s. 409.9116 for a quarter beginning no 887 later than July 1, 2002, is deemed to have been and shall 888 continue to be a rural hospital from that date through June 30, 889 2015, if the hospital continues to have 100 or fewer licensed 890 beds and an emergency room, or meets the criteria of891subparagraph 4. An acute care hospital that has not previously 892 been designated as a rural hospital and that meets the criteria 893 of this paragraph shall be granted such designation upon 894 application, including supporting documentation to the Agency 895 for Health Care Administration. 896 Section 21. Subsections (8) and (16) of section 400.021, 897 Florida Statutes, are amended to read: 898 400.021 Definitions.—When used in this part, unless the 899 context otherwise requires, the term: 900 (8) “Geriatric outpatient clinic” means a site for 901 providing outpatient health care to persons 60 years of age or 902 older, which is staffed by a registered nurse or a physician 903 assistant, or a licensed practical nurse under the direct 904 supervision of a registered nurse, advanced registered nurse 905 practitioner, or physician. 906 (16) “Resident care plan” means a written plan developed, 907 maintained, and reviewed not less than quarterly by a registered 908 nurse, with participation from other facility staff and the 909 resident or his or her designee or legal representative, which 910 includes a comprehensive assessment of the needs of an 911 individual resident; the type and frequency of services required 912 to provide the necessary care for the resident to attain or 913 maintain the highest practicable physical, mental, and 914 psychosocial well-being; a listing of services provided within 915 or outside the facility to meet those needs; and an explanation 916 of service goals.The resident care plan must be signed by the917director of nursing or another registered nurse employed by the918facility to whom institutional responsibilities have been919delegated and by the resident, the resident’s designee, or the920resident’s legal representative. The facility may not use an921agency or temporary registered nurse to satisfy the foregoing922requirement and must document the institutional responsibilities923that have been delegated to the registered nurse.924 Section 22. Subsection (1) of section 400.0234, Florida 925 Statutes, is amended to read: 926 400.0234 Availability of facility records for investigation 927 of resident’s rights violations and defenses; penalty.— 928 (1) Failure to provide complete copies of a resident’s 929 records, including, but not limited to, all medical records and 930 the resident’s chart, within the control or possession of the 931 facility constitutesin accordance with s.400.145shall932constituteevidence of failure of that party to comply with good 933 faith discovery requirements and waivesshall waivethe good 934 faith certificate and presuit notice requirements under this 935 part by the requesting party. 936 Section 23. Paragraph (g) of subsection (2) of section 937 400.0239, Florida Statutes, is amended to read: 938 400.0239 Quality of Long-Term Care Facility Improvement 939 Trust Fund.— 940 (2) Expenditures from the trust fund shall be allowable for 941 direct support of the following: 942 (g) Other initiatives authorized by the Centers for 943 Medicare and Medicaid Services for the use of federal civil 944 monetary penalties, including projects recommended through the945Medicaid “Up-or-Out” Quality of Care Contract Management Program946pursuant to s.400.148. 947 Section 24. Subsection (15) of section 400.0255, Florida 948 Statutes, is amended to read 949 400.0255 Resident transfer or discharge; requirements and 950 procedures; hearings.— 951 (15)(a) The department’s Office of Appeals Hearings shall 952 conduct hearings under this section. The office shall notify the 953 facility of a resident’s request for a hearing. 954 (b) The department shall, by rule, establish procedures to 955 be used for fair hearings requested by residents. These 956 procedures shall be equivalent to the procedures used for fair 957 hearings for other Medicaid cases appearing in s. 409.285 and 958 applicable rules, chapter 10-2, part VI, Florida Administrative959Code. The burden of proof must be clear and convincing evidence. 960 A hearing decision must be rendered within 90 days after receipt 961 of the request for hearing. 962 (c) If the hearing decision is favorable to the resident 963 who has been transferred or discharged, the resident must be 964 readmitted to the facility’s first available bed. 965 (d) The decision of the hearing officer shall be final. Any 966 aggrieved party may appeal the decision to the district court of 967 appeal in the appellate district where the facility is located. 968 Review procedures shall be conducted in accordance with the 969 Florida Rules of Appellate Procedure. 970 Section 25. Subsection (2) of section 400.063, Florida 971 Statutes, is amended to read: 972 400.063 Resident protection.— 973 (2) The agency is authorized to establish for each 974 facility, subject to intervention by the agency, a separate bank 975 account for the deposit to the credit of the agency of any 976 moneys received from the Health Care Trust Fund or any other 977 moneys received for the maintenance and care of residents in the 978 facility, and the agency is authorized to disburse moneys from 979 such account to pay obligations incurred for the purposes of 980 this section. The agency is authorized to requisition moneys 981 from the Health Care Trust Fund in advance of an actual need for 982 cash on the basis of an estimate by the agency of moneys to be 983 spent under the authority of this section. Any bank account 984 established under this section need not be approved in advance 985 of its creation as required by s. 17.58, but shall be secured by 986 depository insurance equal to or greater than the balance of 987 such account or by the pledge of collateral securityin988conformance with criteria established in s.18.11. The agency 989 shall notify the Chief Financial Officer of any such account so 990 established and shall make a quarterly accounting to the Chief 991 Financial Officer for all moneys deposited in such account. 992 Section 26. Subsections (1) and (5) of section 400.071, 993 Florida Statutes, are amended to read: 994 400.071 Application for license.— 995 (1) In addition to the requirements of part II of chapter 996 408, the application for a license shall be under oath and must 997 contain the following: 998 (a) The location of the facility for which a license is 999 sought and an indication, as in the original application, that 1000 such location conforms to the local zoning ordinances. 1001(b) A signed affidavit disclosing any financial or1002ownership interest that a controlling interest as defined in1003part II of chapter 408 has held in the last 5 years in any1004entity licensed by this state or any other state to provide1005health or residential care which has closed voluntarily or1006involuntarily; has filed for bankruptcy; has had a receiver1007appointed; has had a license denied, suspended, or revoked; or1008has had an injunction issued against it which was initiated by a1009regulatory agency. The affidavit must disclose the reason any1010such entity was closed, whether voluntarily or involuntarily.1011(c) The total number of beds and the total number of1012Medicare and Medicaid certified beds.1013 (b)(d)Information relating to the applicant and employees 1014 which the agency requires by rule. The applicant must 1015 demonstrate that sufficient numbers of qualified staff, by 1016 training or experience, will be employed to properly care for 1017 the type and number of residents who will reside in the 1018 facility. 1019(e) Copies of any civil verdict or judgment involving the1020applicant rendered within the 10 years preceding the1021application, relating to medical negligence, violation of1022residents’ rights, or wrongful death. As a condition of1023licensure, the licensee agrees to provide to the agency copies1024of any new verdict or judgment involving the applicant, relating1025to such matters, within 30 days after filing with the clerk of1026the court. The information required in this paragraph shall be1027maintained in the facility’s licensure file and in an agency1028database which is available as a public record.1029 (5) As a condition of licensure, each facility must 1030 establishand submit with its applicationa plan for quality 1031 assurance and for conducting risk management. 1032 Section 27. Section 400.0712, Florida Statutes, is amended 1033 to read: 1034 400.0712 Application for inactive license.— 1035(1) As specified in this section, the agency may issue an1036inactive license to a nursing home facility for all or a portion1037of its beds. Any request by a licensee that a nursing home or1038portion of a nursing home become inactive must be submitted to1039the agency in the approved format. The facility may not initiate1040any suspension of services, notify residents, or initiate1041inactivity before receiving approval from the agency; and a1042licensee that violates this provision may not be issued an1043inactive license.1044 (1)(2)In addition to the powers granted under part II of 1045 chapter 408, the agency may issue an inactive license for a 1046 portion of the total beds to a nursing home that chooses to use 1047 an unoccupied contiguous portion of the facility for an 1048 alternative use to meet the needs of elderly persons through the 1049 use of less restrictive, less institutional services. 1050 (a) An inactive license issued under this subsection may be 1051 granted for a period not to exceed the current licensure 1052 expiration date but may be renewed by the agency at the time of 1053 licensure renewal. 1054 (b) A request to extend the inactive license must be 1055 submitted to the agency in the approved format and approved by 1056 the agency in writing. 1057 (c) Nursing homes that receive an inactive license to 1058 provide alternative services shall not receive preference for 1059 participation in the Assisted Living for the Elderly Medicaid 1060 waiver. 1061 (2)(3)The agency shall adopt rules pursuant to ss. 1062 120.536(1) and 120.54 necessary to implement this section. 1063 Section 28. Section 400.111, Florida Statutes, is amended 1064 to read: 1065 400.111 Disclosure of controlling interest.—In addition to 1066 the requirements of part II of chapter 408, when requested by 1067 the agency, the licensee shall submit a signed affidavit 1068 disclosing any financial or ownership interest that a 1069 controlling interest has held within the last 5 years in any 1070 entity licensed by the state or any other state to provide 1071 health or residential care which entity has closed voluntarily 1072 or involuntarily; has filed for bankruptcy; has had a receiver 1073 appointed; has had a license denied, suspended, or revoked; or 1074 has had an injunction issued against it which was initiated by a 1075 regulatory agency. The affidavit must disclose the reason such 1076 entity was closed, whether voluntarily or involuntarily. 1077 Section 29. Subsection (2) of section 400.1183, Florida 1078 Statutes, is amended to read: 1079 400.1183 Resident grievance procedures.— 1080 (2) Each facility shall maintain records of all grievances 1081 and shall retain a log for agency inspection ofreport to the1082agency at the time of relicensurethe total number of grievances 1083 handledduring the prior licensure period, a categorization of 1084 the cases underlying the grievances, and the final disposition 1085 of the grievances. 1086 Section 30. Paragraphs (o) through (w) of subsection (1) of 1087 section 400.141, Florida Statutes, are redesignated as 1088 paragraphs (n) through (u), respectively, present paragraphs 1089 (f), (g), (j), (n), (o), and (r) of that subsection are amended, 1090 and subsection (3) is added to that section, to read: 1091 400.141 Administration and management of nursing home 1092 facilities.— 1093 (1) Every licensed facility shall comply with all 1094 applicable standards and rules of the agency and shall: 1095 (f) Be allowed and encouraged by the agency to provide 1096 other needed services under certain conditions. If the facility 1097 has a standard licensure status, and has had no class I or class1098II deficiencies during the past 2 yearsor has been awarded a1099Gold Seal under the program established in s.400.235, it maybe1100encouraged by the agency toprovide services, including, but not 1101 limited to, respite and adult day services, which enable 1102 individuals to move in and out of the facility. A facility is 1103 not subject to any additional licensure requirements for 1104 providing these services, under the following conditions:.1105 1. Respite care may be offered to persons in need of short 1106 term or temporary nursing home services. For each person 1107 admitted under the respite care program, the facility licensee 1108 must: 1109 a. Have a written abbreviated plan of care that, at a 1110 minimum, includes nutritional requirements, medication orders, 1111 physician orders, nursing assessments, and dietary preferences. 1112 The nursing or physician assessments may take the place of all 1113 other assessments required for full-time residents. 1114 b. Have a contract that, at a minimum, specifies the 1115 services to be provided to the respite resident, including 1116 charges for services, activities, equipment, emergency medical 1117 services, and the administration of medications. If multiple 1118 respite admissions for a single person are anticipated, the 1119 original contract is valid for 1 year after the date of 1120 execution. 1121 c. Ensure that each resident is released to his or her 1122 caregiver or an individual designated in writing by the 1123 caregiver. 1124 2. A person admitted under the respite care program is: 1125 a. Exempt from requirements in rule related to discharge 1126 planning. 1127 b. Covered by the residents’ rights set forth in s. 1128 400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident 1129 shall not be considered trust funds subject to the requirements 1130 of s. 400.022(1)(h) until the resident has been in the facility 1131 for more than 14 consecutive days. 1132 c. Allowed to use his or her personal medications for the 1133 respite stay if permitted by facility policy. The facility must 1134 obtain a physician’s order for the medications. The caregiver 1135 may provide information regarding the medications as part of the 1136 nursing assessment and that information must agree with the 1137 physician’s order. Medications shall be released with the 1138 resident upon discharge in accordance with current physician’s 1139 orders. 1140 3. A person receiving respite care is entitled to reside in 1141 the facility for a total of 60 days within a contract year or 1142 within a calendar year if the contract is for less than 12 1143 months. However, each single stay may not exceed 14 days. If a 1144 stay exceeds 14 consecutive days, the facility must comply with 1145 all assessment and care planning requirements applicable to 1146 nursing home residents. 1147 4. A person receiving respite care must reside in a 1148 licensed nursing home bed. 1149 5. A prospective respite resident must provide medical 1150 information from a physician, a physician assistant, or a nurse 1151 practitioner and other information from the primary caregiver as 1152 may be required by the facility prior to or at the time of 1153 admission to receive respite care. The medical information must 1154 include a physician’s order for respite care and proof of a 1155 physical examination by a licensed physician, physician 1156 assistant, or nurse practitioner. The physician’s order and 1157 physical examination may be used to provide intermittent respite 1158 care for up to 12 months after the date the order is written. 1159 6. The facility must assume the duties of the primary 1160 caregiver. To ensure continuity of care and services, the 1161 resident is entitled to retain his or her personal physician and 1162 must have access to medically necessary services such as 1163 physical therapy, occupational therapy, or speech therapy, as 1164 needed. The facility must arrange for transportation to these 1165 services if necessary.Respite care must be provided in1166accordance with this part and rules adopted by the agency.1167However, the agency shall, by rule, adopt modified requirements1168for resident assessment, resident care plans, resident1169contracts, physician orders, and other provisions, as1170appropriate, for short-term or temporary nursing home services.1171 7. The agency shall allow for shared programming and staff 1172 in a facility which meets minimum standards and offers services 1173 pursuant to this paragraph, but, if the facility is cited for 1174 deficiencies in patient care, may require additional staff and 1175 programs appropriate to the needs of service recipients. A 1176 person who receives respite care may not be counted as a 1177 resident of the facility for purposes of the facility’s licensed 1178 capacity unless that person receives 24-hour respite care. A 1179 person receiving either respite care for 24 hours or longer or 1180 adult day services must be included when calculating minimum 1181 staffing for the facility. Any costs and revenues generated by a 1182 nursing home facility from nonresidential programs or services 1183 shall be excluded from the calculations of Medicaid per diems 1184 for nursing home institutional care reimbursement. 1185 (g) If the facility has a standard licenseor is a Gold1186Seal facility, exceeds the minimum required hours of licensed 1187 nursing and certified nursing assistant direct care per resident 1188 per day, and is part of a continuing care facility licensed 1189 under chapter 651 or a retirement community that offers other 1190 services pursuant to part III of this chapter or part I or part 1191 III of chapter 429 on a single campus, be allowed to share 1192 programming and staff. At the time of inspectionand in the1193semiannual report required pursuant to paragraph (o), a 1194 continuing care facility or retirement community that uses this 1195 option must demonstrate through staffing records that minimum 1196 staffing requirements for the facility were met. Licensed nurses 1197 and certified nursing assistants who work in the nursing home 1198 facility may be used to provide services elsewhere on campus if 1199 the facility exceeds the minimum number of direct care hours 1200 required per resident per day and the total number of residents 1201 receiving direct care services from a licensed nurse or a 1202 certified nursing assistant does not cause the facility to 1203 violate the staffing ratios required under s. 400.23(3)(a). 1204 Compliance with the minimum staffing ratios shall be based on 1205 total number of residents receiving direct care services, 1206 regardless of where they reside on campus. If the facility 1207 receives a conditional license, it may not share staff until the 1208 conditional license status ends. This paragraph does not 1209 restrict the agency’s authority under federal or state law to 1210 require additional staff if a facility is cited for deficiencies 1211 in care which are caused by an insufficient number of certified 1212 nursing assistants or licensed nurses. The agency may adopt 1213 rules for the documentation necessary to determine compliance 1214 with this provision. 1215 (j) Keep full records of resident admissions and 1216 discharges; medical and general health status, including medical 1217 records, personal and social history, and identity and address 1218 of next of kin or other persons who may have responsibility for 1219 the affairs of the residents; and individual resident care plans 1220 including, but not limited to, prescribed services, service 1221 frequency and duration, and service goals. The records shall be 1222 open to inspection by the agency. The facility must maintain 1223 clinical records on each resident in accordance with accepted 1224 professional standards and practices that are complete, 1225 accurately documented, readily accessible, and systematically 1226 organized. 1227(n) Submit to the agency the information specified in s.1228400.071(1)(b) for a management company within 30 days after the1229effective date of the management agreement.1230 (n)(o)1.Submit semiannually to the agency, or more1231frequently if requested by the agency, information regarding1232facility staff-to-resident ratios, staff turnover, and staff1233stability, including information regarding certified nursing1234assistants, licensed nurses, the director of nursing, and the1235facility administrator. For purposes of this reporting:1236a. Staff-to-resident ratios must be reported in the1237categories specified in s.400.23(3)(a) and applicable rules.1238The ratio must be reported as an average for the most recent1239calendar quarter.1240b. Staff turnover must be reported for the most recent 121241month period ending on the last workday of the most recent1242calendar quarter prior to the date the information is submitted.1243The turnover rate must be computed quarterly, with the annual1244rate being the cumulative sum of the quarterly rates. The1245turnover rate is the total number of terminations or separations1246experienced during the quarter, excluding any employee1247terminated during a probationary period of 3 months or less,1248divided by the total number of staff employed at the end of the1249period for which the rate is computed, and expressed as a1250percentage.1251c. The formula for determining staff stability is the total1252number of employees that have been employed for more than 121253months, divided by the total number of employees employed at the1254end of the most recent calendar quarter, and expressed as a1255percentage.1256d.A nursing facility that has failed to comply with state 1257 minimum-staffing requirements for 2 consecutive days is 1258 prohibited from accepting new admissions until the facility has 1259 achieved the minimum-staffing requirements for a period of 6 1260 consecutive days. For the purposes of this sub-subparagraph, any 1261 person who was a resident of the facility and was absent from 1262 the facility for the purpose of receiving medical care at a 1263 separate location or was on a leave of absence is not considered 1264 a new admission. Failure to impose such an admissions moratorium 1265 is subject to a $1,000 fineconstitutes a class II deficiency. 1266 2.e.A nursing facility which does not have a conditional 1267 license may be cited for failure to comply with the standards in 1268 s. 400.23(3)(a)1.b. and c. only if it has failed to meet those 1269 standards on 2 consecutive days or if it has failed to meet at 1270 least 97 percent of those standards on any one day. 1271 3.f.A facility which has a conditional license must be in 1272 compliance with the standards in s. 400.23(3)(a) at all times. 1273 (r)2.This subsectionparagraphdoes not limit the agency’s 1274 ability to impose a deficiency or take other actions if a 1275 facility does not have enough staff to meet the residents’ 1276 needs. 1277(r) Report to the agency any filing for bankruptcy1278protection by the facility or its parent corporation,1279divestiture or spin-off of its assets, or corporate1280reorganization within 30 days after the completion of such1281activity.1282 (3) A facility may charge a reasonable fee for copying a 1283 resident’s records. Such fee may not exceed $1 per page for the 1284 first 25 pages and 25 cents per page for each page in excess of 1285 25 pages. 1286 Section 31. Subsection (3) of section 400.142, Florida 1287 Statutes, is amended to read: 1288 400.142 Emergency medication kits; orders not to 1289 resuscitate.— 1290 (3) Facility staff may withhold or withdraw cardiopulmonary 1291 resuscitation if presented with an order not to resuscitate 1292 executed pursuant to s. 401.45.The agency shall adopt rules1293providing for the implementation of such orders.Facility staff 1294 and facilities shall not be subject to criminal prosecution or 1295 civil liability, nor be considered to have engaged in negligent 1296 or unprofessional conduct, for withholding or withdrawing 1297 cardiopulmonary resuscitation pursuant to such an order and 1298 rules adopted by the agency. The absence of an order not to 1299 resuscitate executed pursuant to s. 401.45 does not preclude a 1300 physician from withholding or withdrawing cardiopulmonary 1301 resuscitation as otherwise permitted by law. 1302 Section 32. Section 400.145, Florida Statutes, is repealed. 1303 Section 33. Present subsections (9), (11), (12), (13), 1304 (14), and (15) of section 400.147, Florida Statutes, are 1305 renumbered as subsections (8), (9), (10), (11), (12), and (13), 1306 respectively, and present subsections (7), (8), and (10) of that 1307 section are amended to read: 1308 400.147 Internal risk management and quality assurance 1309 program.— 1310 (7) The facility shall initiate an investigationand shall1311notify the agencywithin 1 business day after the risk manager 1312 or his or her designee has received a report pursuant to 1313 paragraph (1)(d). Each facility shall complete the investigation 1314 and submit a report to the agency within 15 calendar days if the 1315 incident is determined to be an adverse incident as defined in 1316 subsection (5).The notification must be made in writing and be1317provided electronically, by facsimile device or overnight mail1318delivery.The agency shall develop a form for reporting this 1319 information, and the notification must include the name of the 1320 risk manager of the facility, information regarding the identity 1321 of the affected resident, the type of adverse incident, the 1322 initiation of an investigation by the facility, and whether the 1323 events causing or resulting in the adverse incident represent a 1324 potential risk to any other resident. The notification is 1325 confidential as provided by law and is not discoverable or 1326 admissible in any civil or administrative action, except in 1327 disciplinary proceedings by the agency or the appropriate 1328 regulatory board. The agency may investigate, as it deems 1329 appropriate, any such incident and prescribe measures that must 1330 or may be taken in response to the incident. The agency shall 1331 review each reportincidentand determine whether it potentially 1332 involved conduct by the health care professional who is subject 1333 to disciplinary action, in which case the provisions of s. 1334 456.073 shall apply. 1335(8)(a) Each facility shall complete the investigation and1336submit an adverse incident report to the agency for each adverse1337incident within 15 calendar days after its occurrence. If, after1338a complete investigation, the risk manager determines that the1339incident was not an adverse incident as defined in subsection1340(5), the facility shall include this information in the report.1341The agency shall develop a form for reporting this information.1342(b) The information reported to the agency pursuant to1343paragraph (a) which relates to persons licensed under chapter1344458, chapter 459, chapter 461, or chapter 466 shall be reviewed1345by the agency. The agency shall determine whether any of the1346incidents potentially involved conduct by a health care1347professional who is subject to disciplinary action, in which1348case the provisions of s.456.073shall apply.1349(c) The report submitted to the agency must also contain1350the name of the risk manager of the facility.1351(d) The adverse incident report is confidential as provided1352by law and is not discoverable or admissible in any civil or1353administrative action, except in disciplinary proceedings by the1354agency or the appropriate regulatory board.1355(10) By the 10th of each month, each facility subject to1356this section shall report any notice received pursuant to s.1357400.0233(2) and each initial complaint that was filed with the1358clerk of the court and served on the facility during the1359previous month by a resident or a resident’s family member,1360guardian, conservator, or personal legal representative. The1361report must include the name of the resident, the resident’s1362date of birth and social security number, the Medicaid1363identification number for Medicaid-eligible persons, the date or1364dates of the incident leading to the claim or dates of1365residency, if applicable, and the type of injury or violation of1366rights alleged to have occurred. Each facility shall also submit1367a copy of the notices received pursuant to s.400.0233(2) and1368complaints filed with the clerk of the court. This report is1369confidential as provided by law and is not discoverable or1370admissible in any civil or administrative action, except in such1371actions brought by the agency to enforce the provisions of this1372part.1373 Section 34. Section 400.148, Florida Statutes, is repealed. 1374 Section 35. Paragraph (e) of subsection (2) of section 1375 400.179, Florida Statutes, is amended to read: 1376 400.179 Liability for Medicaid underpayments and 1377 overpayments.— 1378 (2) Because any transfer of a nursing facility may expose 1379 the fact that Medicaid may have underpaid or overpaid the 1380 transferor, and because in most instances, any such underpayment 1381 or overpayment can only be determined following a formal field 1382 audit, the liabilities for any such underpayments or 1383 overpayments shall be as follows: 1384(e) For the 2009-2010 fiscal year only, the provisions of1385paragraph (d) shall not apply. This paragraph expires July 1,13862010.1387 Section 36. Subsection (3) of section 400.19, Florida 1388 Statutes, is amended to read: 1389 400.19 Right of entry and inspection.— 1390 (3) The agency shall every 15 months conduct at least one 1391 unannounced inspection to determine compliance by the licensee 1392 with statutes, and with rules promulgated under the provisions 1393 of those statutes, governing minimum standards of construction, 1394 quality and adequacy of care, and rights of residents. The 1395 survey shall be conducted every 6 months for the next 2-year 1396 period if the facility has been cited for a class I deficiency, 1397 has been cited for two or more class II deficiencies arising 1398 from separate surveys or investigations within a 60-day period, 1399 or has had three or more substantiated complaints within a 6 1400 month period, each resulting in at least one class I or class II 1401 deficiency. In addition to any other fees or fines in this part, 1402 the agency shall assess a fine for each facility that is subject 1403 to the 6-month survey cycle. The fine for the 2-year period 1404 shall be $6,000, one-half to be paid at the completion of each 1405 survey. The agency may adjust this fine by the change in the 1406 Consumer Price Index, based on the 12 months immediately 1407 preceding the increase, to cover the cost of the additional 1408 surveys. The agency shall verify through subsequent inspection 1409 that any deficiency identified during inspection is corrected. 1410 However, the agency may verify the correction of a class III or 1411 class IV deficiencyunrelated to resident rights or resident1412carewithout reinspecting the facility if adequate written 1413 documentation has been received from the facility, which 1414 provides assurance that the deficiency has been corrected. The 1415 giving or causing to be given of advance notice of such 1416 unannounced inspections by an employee of the agency to any 1417 unauthorized person shall constitute cause for suspension of not 1418 fewer than 5 working days according to the provisions of chapter 1419 110. 1420 Section 37. Subsection (5) of section 400.23, Florida 1421 Statutes, is amended to read: 1422 400.23 Rules; evaluation and deficiencies; licensure 1423 status.— 1424 (5)(a) The agency, in collaboration with the Division of 1425 Children’s Medical Services Network of the Department of Health, 1426 must, no later than December 31, 1993,adopt rules for minimum 1427 standards of care for persons under 21 years of age who reside 1428 in nursing home facilities.The rules must include a methodology1429for reviewing a nursing home facility under ss.408.031-408.0451430which serves only persons under 21 years of age.A facility may 1431 be exempt from these standards for specific persons between 18 1432 and 21 years of age, if the person’s physician agrees that 1433 minimum standards of care based on age are not necessary. 1434 (b) The agency, in collaboration with the Division of 1435 Children’s Medical Services Network, shall adopt rules for 1436 minimum staffing requirements for nursing home facilities that 1437 serve persons under 21 years of age, which shall apply in lieu 1438 of the standards contained in subsection (3). 1439 1. For persons under 21 years of age who require skilled 1440 care, the requirements shall include a minimum combined average 1441 of licensed nurses, respiratory therapists, respiratory care 1442 practitioners, and certified nursing assistants of 3.9 hours of 1443 direct care per resident per day for each nursing home facility. 1444 2. For persons under 21 years of age who are fragile, the 1445 requirements shall include a minimum combined average of 1446 licensed nurses, respiratory therapists, respiratory care 1447 practitioners, and certified nursing assistants of 5 hours of 1448 direct care per resident per day for each nursing home facility. 1449 Section 38. Subsection (1) of section 400.275, Florida 1450 Statutes, is amended to read: 1451 400.275 Agency duties.— 1452 (1)The agency shall ensure that each newly hired nursing1453home surveyor, as a part of basic training, is assigned full1454time to a licensed nursing home for at least 2 days within a 71455day period to observe facility operations outside of the survey1456process before the surveyor begins survey responsibilities. Such1457observations may not be the sole basis of a deficiency citation1458against the facility.The agency may not assign an individual to 1459 be a member of a survey team for purposes of a survey, 1460 evaluation, or consultation visit at a nursing home facility in 1461 which the surveyor was an employee within the preceding 251462 years. 1463 Section 39. Subsection (27) of section 400.462, Florida 1464 Statutes, is amended to read: 1465 400.462 Definitions.—As used in this part, the term: 1466 (27) “Remuneration” means any payment or other benefit made 1467 directly or indirectly, overtly or covertly, in cash or in kind. 1468 However, when the term is used in any provision of law relating 1469 to health care providers, such term does not mean an item that 1470 has an individual value of up to $10, including, but not limited 1471 to, a plaque, a certificate, a trophy, or a novelty item that is 1472 intended solely for presentation or is customarily given away 1473 solely for promotional, recognition, or advertising purposes. 1474 Section 40. Subsection (2) of section 400.484, Florida 1475 Statutes, is amended to read: 1476 400.484 Right of inspection; violationsdeficiencies; 1477 fines.— 1478 (2) The agency shall impose fines for various classes of 1479 violationsdeficienciesin accordance with the following 1480 schedule: 1481 (a) Class I violations are defined in s. 408.813.A class I1482deficiency is any act, omission, or practice that results in a1483patient’s death, disablement, or permanent injury, or places a1484patient at imminent risk of death, disablement, or permanent1485injury.Upon finding a class I violationdeficiency, the agency 1486 shall impose an administrative fine in the amount of $15,000 for 1487 each occurrence and each day that the violationdeficiency1488 exists. 1489 (b) Class II violations are defined in s. 408.813.A class1490II deficiency is any act, omission, or practice that has a1491direct adverse effect on the health, safety, or security of a1492patient.Upon finding a class II violationdeficiency, the 1493 agency shall impose an administrative fine in the amount of 1494 $5,000 for each occurrence and each day that the violation 1495deficiencyexists. 1496 (c) Class III violations are defined in s. 408.813.A class1497III deficiency is any act, omission, or practice that has an1498indirect, adverse effect on the health, safety, or security of a1499patient.Upon finding an uncorrected or repeated class III 1500 violationdeficiency, the agency shall impose an administrative 1501 fine not to exceed $1,000 for each occurrence and each day that 1502 the uncorrected or repeated violationdeficiencyexists. 1503 (d) Class IV violations are defined in s. 408.813.A class1504IV deficiency is any act, omission, or practice related to1505required reports, forms, or documents which does not have the1506potential of negatively affecting patients. These violations are1507of a type that the agency determines do not threaten the health,1508safety, or security of patients.Upon finding an uncorrected or 1509 repeated class IV violationdeficiency, the agency shall impose 1510 an administrative fine not to exceed $500 for each occurrence 1511 and each day that the uncorrected or repeated violation 1512deficiencyexists. 1513 Section 41. Paragraph (a) of section (15) of section 1514 400.506, Florida Statutes, is amended, present subsection (17) 1515 of that section is renumbered as subsection (18), and a new 1516 subsection (17) is added to that section, to read: 1517 400.506 Licensure of nurse registries; requirements; 1518 penalties.— 1519 (15)(a) The agency may deny, suspend, or revoke the license 1520 of a nurse registry and shall impose a fine of $5,000 against a 1521 nurse registry that: 1522 1. Provides services to residents in an assisted living 1523 facility for which the nurse registry does not receive fair 1524 market value remuneration. 1525 2. Provides staffing to an assisted living facility for 1526 which the nurse registry does not receive fair market value 1527 remuneration. 1528 3. Fails to provide the agency, upon request, with copies 1529 of all contracts with assisted living facilities which were 1530 executed within the last 5 years. 1531 4. Gives remuneration to a case manager, discharge planner, 1532 facility-based staff member, or third-party vendor who is 1533 involved in the discharge planning process of a facility 1534 licensed under chapter 395 or this chapter and from whom the 1535 nurse registry receives referrals. A nurse registry is exempt 1536 from this subparagraph if it does not billtheFlorida Medicaid1537program orthe Medicare program or share a controlling interest 1538 with any entity licensed, registered, or certified under part II 1539 of chapter 408 that billsthe Florida Medicaid programorthe 1540 Medicare program. 1541 5. Gives remuneration to a physician, a member of the 1542 physician’s office staff, or an immediate family member of the 1543 physician, and the nurse registry received a patient referral in 1544 the last 12 months from that physician or the physician’s office 1545 staff. A nurse registry is exempt from this subparagraph if it 1546 does not billthe Florida Medicaid program orthe Medicare 1547 program or share a controlling interest with any entity 1548 licensed, registered, or certified under part II of chapter 408 1549 that billsthe Florida Medicaid program orthe Medicare program. 1550 (17) An administrator may manage only one nurse registry. 1551 However, an administrator may manage up to five nurse registries 1552 if all five registries have identical controlling interests, as 1553 defined in s. 408.803, and are located within one agency 1554 geographic service area or within an immediately contiguous 1555 county. An administrator shall designate, in writing, for each 1556 licensed entity, a qualified alternate administrator to serve 1557 during the administrator’s absence. 1558 Section 42. Subsection (1) of section 400.509, Florida 1559 Statutes, is amended to read: 1560 400.509 Registration of particular service providers exempt 1561 from licensure; certificate of registration; regulation of 1562 registrants.— 1563 (1) Any organization that provides companion services or 1564 homemaker services and does not provide a home health service to 1565 a person is exempt from licensure under this part. However, any 1566 organization that provides companion services or homemaker 1567 services must register with the agency. Organizations that 1568 provide companion services only for persons with developmental 1569 disabilities, as defined in s. 393.063, under contract with the 1570 Agency for Persons with Disabilities, are exempt from 1571 registration with the agency. 1572 Section 43. For the purpose of incorporating the amendment 1573 made by this act to section 400.509, Florida Statutes, in a 1574 reference thereto, paragraph (b) of subsection (5) of section 1575 400.464, Florida Statutes, is reenacted to read: 1576 400.464 Home health agencies to be licensed; expiration of 1577 license; exemptions; unlawful acts; penalties.— 1578 (5) The following are exempt from the licensure 1579 requirements of this part: 1580 (b) Home health services provided by a state agency, either 1581 directly or through a contractor with: 1582 1. The Department of Elderly Affairs. 1583 2. The Department of Health, a community health center, or 1584 a rural health network that furnishes home visits for the 1585 purpose of providing environmental assessments, case management, 1586 health education, personal care services, family planning, or 1587 followup treatment, or for the purpose of monitoring and 1588 tracking disease. 1589 3. Services provided to persons with developmental 1590 disabilities, as defined in s. 393.063. 1591 4. Companion and sitter organizations that were registered 1592 under s. 400.509(1) on January 1, 1999, and were authorized to 1593 provide personal services under a developmental services 1594 provider certificate on January 1, 1999, may continue to provide 1595 such services to past, present, and future clients of the 1596 organization who need such services, notwithstanding the 1597 provisions of this act. 1598 5. The Department of Children and Family Services. 1599 Section 44. For the purpose of incorporating the amendment 1600 made by this act to section 400.509, Florida Statutes, in a 1601 reference thereto, paragraph (a) of subsection (6) of section 1602 400.506, Florida Statutes, is reenacted to read: 1603 400.506 Licensure of nurse registries; requirements; 1604 penalties.— 1605 (6)(a) A nurse registry may refer for contract in private 1606 residences registered nurses and licensed practical nurses 1607 registered and licensed under part I of chapter 464, certified 1608 nursing assistants certified under part II of chapter 464, home 1609 health aides who present documented proof of successful 1610 completion of the training required by rule of the agency, and 1611 companions or homemakers for the purposes of providing those 1612 services authorized under s. 400.509(1). A licensed nurse 1613 registry shall ensure that each certified nursing assistant 1614 referred for contract by the nurse registry and each home health 1615 aide referred for contract by the nurse registry is adequately 1616 trained to perform the tasks of a home health aide in the home 1617 setting. Each person referred by a nurse registry must provide 1618 current documentation that he or she is free from communicable 1619 diseases. 1620 Section 45. Paragraph (i) of subsection (1) and subsection 1621 (4) of section 400.606, Florida Statutes, are amended to read: 1622 400.606 License; application; renewal; conditional license 1623 or permit; certificate of need.— 1624 (1) In addition to the requirements of part II of chapter 1625 408, the initial application and change of ownership application 1626 must be accompanied by a plan for the delivery of home, 1627 residential, and homelike inpatient hospice services to 1628 terminally ill persons and their families. Such plan must 1629 contain, but need not be limited to: 1630(i) The projected annual operating cost of the hospice.1631 1632 If the applicant is an existing licensed health care provider, 1633 the application must be accompanied by a copy of the most recent 1634 profit-loss statement and, if applicable, the most recent 1635 licensure inspection report. 1636 (4) A freestanding hospice facility that isprimarily1637 engaged in providing inpatient and related services and that is 1638 not otherwise licensed as a health care facility shall be 1639 required to obtain a certificate of need. However, a 1640 freestanding hospice facility with six or fewer beds shall not 1641 be required to comply with institutional standards such as, but 1642 not limited to, standards requiring sprinkler systems, emergency 1643 electrical systems, or special lavatory devices. 1644 Section 46. Subsection (2) of section 400.607, Florida 1645 Statutes, is amended to read: 1646 400.607 Denial, suspension, revocation of license; 1647 emergency actions; imposition of administrative fine; grounds.— 1648 (2) A violation of this part, part II of chapter 408, or 1649 applicable rulesAny of the following actionsby a licensed 1650 hospice or any of its employees shall be grounds for 1651 administrative action by the agency against a hospice.:1652(a) A violation of the provisions of this part, part II of1653chapter 408, or applicable rules.1654(b) An intentional or negligent act materially affecting1655the health or safety of a patient.1656 Section 47. Section 400.915, Florida Statutes, is amended 1657 to read: 1658 400.915 Construction and renovation; requirements.—The 1659 requirements for the construction or renovation of a PPEC center 1660 shall comply with: 1661 (1) The provisions of chapter 553, which pertain to 1662 building construction standards, including plumbing, electrical 1663 code, glass, manufactured buildings, accessibility for the 1664 physically disabled; 1665 (2) The provisions of s. 633.022 and applicable rules 1666 pertaining to physicalminimumstandards for nonresidential 1667 child carephysicalfacilitiesin rule 10M-12.003, Florida1668Administrative Code, Child Care Standards; and 1669 (3) The standards or rules adopted pursuant to this part 1670 and part II of chapter 408. 1671 Section 48. Subsection (1) of section 400.925, Florida 1672 Statutes, is amended to read: 1673 400.925 Definitions.—As used in this part, the term: 1674 (1) “Accrediting organizations” means the Joint Commission 1675on Accreditation of Healthcare Organizationsor other national 1676 accreditation agencies whose standards for accreditation are 1677 comparable to those required by this part for licensure. 1678 Section 49. Section 400.931, Florida Statutes, is amended 1679 to read: 1680 400.931 Application for license; documentation of 1681 accreditation; fee; provisional license; temporary permit.— 1682 (1) In addition to the requirements of part II of chapter 1683 408, the applicant must file with the application satisfactory 1684 proof that the home medical equipment provider is in compliance 1685 with this part and applicable rules, including: 1686 (a) A report, by category, of the equipment to be provided, 1687 indicating those offered either directly by the applicant or 1688 through contractual arrangements with existing providers. 1689 Categories of equipment include: 1690 1. Respiratory modalities. 1691 2. Ambulation aids. 1692 3. Mobility aids. 1693 4. Sickroom setup. 1694 5. Disposables. 1695 (b) A report, by category, of the services to be provided, 1696 indicating those offered either directly by the applicant or 1697 through contractual arrangements with existing providers. 1698 Categories of services include: 1699 1. Intake. 1700 2. Equipment selection. 1701 3. Delivery. 1702 4. Setup and installation. 1703 5. Patient training. 1704 6. Ongoing service and maintenance. 1705 7. Retrieval. 1706 (c) A listing of those with whom the applicant contracts, 1707 both the providers the applicant uses to provide equipment or 1708 services to its consumers and the providers for whom the 1709 applicant provides services or equipment. 1710 (2) An applicant for initial licensure, change of 1711 ownership, or renewal to operate a licensed home medical 1712 equipment provider at a location outside the state of Florida 1713 must submit documentation of accreditation, or an application 1714 for accreditation, from an accrediting organization that is 1715 recognized by the agency. An applicant that has applied for 1716 accreditation must provide proof of accreditation that is not 1717 conditional or provisional within 120 days after the date of the 1718 agency’s receipt of the application for licensure or the 1719 application shall be withdrawn from further consideration. Such 1720 accreditation must be maintained by the home medical equipment 1721 provider in order to maintain licensure.As an alternative to1722submitting proof of financial ability to operate as required in1723s.408.810(8), the applicant may submit a $50,000 surety bond to1724the agency.1725 (3) As specified in part II of chapter 408, the home 1726 medical equipment provider must also obtain and maintain 1727 professional and commercial liability insurance. Proof of 1728 liability insurance, as defined in s. 624.605, must be submitted 1729 with the application. The agency shall set the required amounts 1730 of liability insurance by rule, but the required amount must not 1731 be less than $250,000 per claim. In the case of contracted 1732 services, it is required that the contractor have liability 1733 insurance not less than $250,000 per claim. 1734 (4) When a change of the general manager of a home medical 1735 equipment provider occurs, the licensee must notify the agency 1736 of the change within 45 days. 1737 (5) In accordance with s. 408.805, an applicant or a 1738 licensee shall pay a fee for each license application submitted 1739 under this part, part II of chapter 408, and applicable rules. 1740 The amount of the fee shall be established by rule and may not 1741 exceed $300 per biennium. The agency shall set the fees in an 1742 amount that is sufficient to cover its costs in carrying out its 1743 responsibilities under this part. However, state, county, or 1744 municipal governments applying for licenses under this part are 1745 exempt from the payment of license fees. 1746 (6) An applicant for initial licensure, renewal, or change 1747 of ownership shall also pay an inspection fee not to exceed 1748 $400, which shall be paid by all applicants except those not 1749 subject to licensure inspection by the agency as described in s. 1750 400.933. 1751 Section 50. Subsection (2) of section 400.932, Florida 1752 Statutes, is amended to read: 1753 400.932 Administrative penalties.— 1754 (2) A violation of this part, part II of chapter 408, or 1755 applicable rulesAny of the following actionsby an employee of 1756 a home medical equipment provider shall bearegrounds for 1757 administrative action or penalties by the agency.:1758(a) Violation of this part, part II of chapter 408, or1759applicable rules.1760(b) An intentional, reckless, or negligent act that1761materially affects the health or safety of a patient.1762 Section 51. Subsection (3) of section 400.967, Florida 1763 Statutes, is amended to read: 1764 400.967 Rules and classification of violations 1765deficiencies.— 1766 (3) The agency shall adopt rules to provide that, when the 1767 criteria established under this part and part II of chapter 408 1768 are not met, such violationsdeficienciesshall be classified 1769 according to the nature of the violationdeficiency. The agency 1770 shall indicate the classification on the face of the notice of 1771 deficiencies as follows: 1772 (a) Class I violationsdeficienciesare defined in s. 1773 408.813those which the agency determines present an imminent1774danger to the residents or guests of the facility or a1775substantial probability that death or serious physical harm1776would result therefrom.The condition or practice constituting a1777class I violation must be abated or eliminated immediately,1778unless a fixed period of time, as determined by the agency, is1779required for correction.A class I violationdeficiencyis 1780 subject to a civil penalty in an amount not less than $5,000 and 1781 not exceeding $10,000 for each violationdeficiency. A fine may 1782 be levied notwithstanding the correction of the violation 1783deficiency. 1784 (b) Class II violationsdeficienciesare defined in s. 1785 408.813those which the agency determines have a direct or1786immediate relationship to the health, safety, or security of the1787facility residents, other than class I deficiencies. A class II 1788 violationdeficiencyis subject to a civil penalty in an amount 1789 not less than $1,000 and not exceeding $5,000 for each violation 1790deficiency. A citation for a class II violationdeficiencyshall 1791 specify the time within which the violationdeficiencymust be 1792 corrected. If a class II violationdeficiencyis corrected 1793 within the time specified, no civil penalty shall be imposed, 1794 unless it is a repeated offense. 1795 (c) Class III violationsdeficienciesare defined in s. 1796 408.813those which the agency determines to have an indirect or1797potential relationship to the health, safety, or security of the1798facility residents, other than class I or class II deficiencies. 1799 A class III violationdeficiencyis subject to a civil penalty 1800 of not less than $500 and not exceeding $1,000 for each 1801 deficiency. A citation for a class III violationdeficiency1802 shall specify the time within which the violationdeficiency1803 must be corrected. If a class III violationdeficiencyis 1804 corrected within the time specified, no civil penalty shall be 1805 imposed, unless it is a repeated offense. 1806 (d) Class IV violations are defined in s. 408.813. Upon 1807 finding an uncorrected or repeated class IV violation, the 1808 agency shall impose an administrative fine not to exceed $500 1809 for each occurrence and each day that the uncorrected or 1810 repeated violation exists. 1811 Section 52. Subsections (4) and (7) of section 400.9905, 1812 Florida Statutes, are amended to read: 1813 400.9905 Definitions.— 1814 (4) “Clinic” means an entity at which health care services 1815 are provided to individuals and which tenders charges for 1816 reimbursement for such services, including a mobile clinic and a 1817 portable health service or equipment provider. For purposes of 1818 this part, the term does not include and the licensure 1819 requirements of this part do not apply to: 1820 (a) Entities licensed or registered by the state under 1821 chapter 395; or entities licensed or registered by the state and 1822 providing only health care services within the scope of services 1823 authorized under their respective licenses granted under ss. 1824 383.30-383.335, chapter 390, chapter 394, chapter 397, this 1825 chapter except part X, chapter 429, chapter 463, chapter 465, 1826 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 1827 chapter 651; end-stage renal disease providers authorized under 1828 42 C.F.R. part 405, subpart U; or providers certified under 42 1829 C.F.R. part 485, subpart B or subpart H; or any entity that 1830 provides neonatal or pediatric hospital-based health care 1831 services or other health care services by licensed practitioners 1832 solely within a hospital licensed under chapter 395. 1833 (b) Entities that own, directly or indirectly, entities 1834 licensed or registered by the state pursuant to chapter 395; or 1835 entities that own, directly or indirectly, entities licensed or 1836 registered by the state and providing only health care services 1837 within the scope of services authorized pursuant to their 1838 respective licenses granted under ss. 383.30-383.335, chapter 1839 390, chapter 394, chapter 397, this chapter except part X, 1840 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 1841 part I of chapter 483, chapter 484, chapter 651; end-stage renal 1842 disease providers authorized under 42 C.F.R. part 405, subpart 1843 U; or providers certified under 42 C.F.R. part 485, subpart B or 1844 subpart H; or any entity that provides neonatal or pediatric 1845 hospital-based health care services by licensed practitioners 1846 solely within a hospital licensed under chapter 395. 1847 (c) Entities that are owned, directly or indirectly, by an 1848 entity licensed or registered by the state pursuant to chapter 1849 395; or entities that are owned, directly or indirectly, by an 1850 entity licensed or registered by the state and providing only 1851 health care services within the scope of services authorized 1852 pursuant to their respective licenses granted under ss. 383.30 1853 383.335, chapter 390, chapter 394, chapter 397, this chapter 1854 except part X, chapter 429, chapter 463, chapter 465, chapter 1855 466, chapter 478, part I of chapter 483, chapter 484, or chapter 1856 651; end-stage renal disease providers authorized under 42 1857 C.F.R. part 405, subpart U; or providers certified under 42 1858 C.F.R. part 485, subpart B or subpart H; or any entity that 1859 provides neonatal or pediatric hospital-based health care 1860 services by licensed practitioners solely within a hospital 1861 under chapter 395. 1862 (d) Entities that are under common ownership, directly or 1863 indirectly, with an entity licensed or registered by the state 1864 pursuant to chapter 395; or entities that are under common 1865 ownership, directly or indirectly, with an entity licensed or 1866 registered by the state and providing only health care services 1867 within the scope of services authorized pursuant to their 1868 respective licenses granted under ss. 383.30-383.335, chapter 1869 390, chapter 394, chapter 397, this chapter except part X, 1870 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 1871 part I of chapter 483, chapter 484, or chapter 651; end-stage 1872 renal disease providers authorized under 42 C.F.R. part 405, 1873 subpart U; or providers certified under 42 C.F.R. part 485, 1874 subpart B or subpart H; or any entity that provides neonatal or 1875 pediatric hospital-based health care services by licensed 1876 practitioners solely within a hospital licensed under chapter 1877 395. 1878 (e) An entity that is exempt from federal taxation under 26 1879 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 1880 under 26 U.S.C. s. 409 that has a board of trustees not less 1881 than two-thirds of which are Florida-licensed health care 1882 practitioners and provides only physical therapy services under 1883 physician orders, any community college or university clinic, 1884 and any entity owned or operated by the federal or state 1885 government, including agencies, subdivisions, or municipalities 1886 thereof. 1887 (f) A sole proprietorship, group practice, partnership, or 1888 corporation that provides health care services by physicians 1889 covered by s. 627.419, that is directly supervised by one or 1890 more of such physicians, and that is wholly owned by one or more 1891 of those physicians or by a physician and the spouse, parent, 1892 child, or sibling of that physician. 1893 (g) A sole proprietorship, group practice, partnership, or 1894 corporation that provides health care services by licensed 1895 health care practitioners under chapter 457, chapter 458, 1896 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 1897 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 1898 chapter 490, chapter 491, or part I, part III, part X, part 1899 XIII, or part XIV of chapter 468, or s. 464.012, which are 1900 wholly owned by one or more licensed health care practitioners, 1901 or the licensed health care practitioners set forth in this 1902 paragraph and the spouse, parent, child, or sibling of a 1903 licensed health care practitioner, so long as one of the owners 1904 who is a licensed health care practitioner is supervising the 1905 business activities and is legally responsible for the entity’s 1906 compliance with all federal and state laws. However, a health 1907 care practitioner may not supervise services beyond the scope of 1908 the practitioner’s license, except that, for the purposes of 1909 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 1910 provides only services authorized pursuant to s. 456.053(3)(b) 1911 may be supervised by a licensee specified in s. 456.053(3)(b). 1912 (h) Clinical facilities affiliated with an accredited 1913 medical school at which training is provided for medical 1914 students, residents, or fellows. 1915 (i) Entities that provide only oncology or radiation 1916 therapy services by physicians licensed under chapter 458 or 1917 chapter 459 or entities that provide oncology or radiation 1918 therapy services by physicians licensed under chapter 458 or 1919 chapter 459 which are owned by a corporation whose shares are 1920 publicly traded on a recognized stock exchange. 1921 (j) Clinical facilities affiliated with a college of 1922 chiropractic accredited by the Council on Chiropractic Education 1923 at which training is provided for chiropractic students. 1924 (k) Entities that provide licensed practitioners to staff 1925 emergency departments or to deliver anesthesia services in 1926 facilities licensed under chapter 395 and that derive at least 1927 90 percent of their gross annual revenues from the provision of 1928 such services. Entities claiming an exemption from licensure 1929 under this paragraph must provide documentation demonstrating 1930 compliance. 1931 (l) Orthotic,orprosthetic, pediatric cardiology, or 1932 perinatology clinical facilities that are a publicly traded 1933 corporation or that are wholly owned, directly or indirectly, by 1934 a publicly traded corporation. As used in this paragraph, a 1935 publicly traded corporation is a corporation that issues 1936 securities traded on an exchange registered with the United 1937 States Securities and Exchange Commission as a national 1938 securities exchange. 1939 (m) Entities that are owned by a corporation that has $250 1940 million or more in total annual sales of health care services 1941 provided by licensed health care practitioners if one or more of 1942 the owners of the entity is a health care practitioner who is 1943 licensed in this state, is responsible for supervising the 1944 business activities of the entity, and is legally responsible 1945 for the entity’s compliance with state law for purposes of this 1946 section. 1947 (n) Entities that are owned or controlled, directly or 1948 indirectly, by a publicly traded entity with $100 million or 1949 more, in the aggregate, in total annual revenues derived from 1950 providing health care services by licensed health care 1951 practitioners that are employed or contracted by an entity 1952 described in this paragraph. 1953 (o) Entities that employ 50 or more health care 1954 practitioners who are licensed under chapter 458 or chapter 459 1955 if the billing for medical services is under a single corporate 1956 tax identification number. The application for exemption under 1957 this paragraph must contain information that includes the name, 1958 residence address, business address, and telephone number of the 1959 entity that owns the practice; a complete list of the names and 1960 contact information of all the officers and directors of the 1961 entity; the name, residence address, business address, and 1962 medical license number of each health care practitioner who is 1963 licensed to practice in this state and employed by the entity; 1964 the corporate tax identification number of the entity seeking an 1965 exemption; a listing of health care services to be provided by 1966 the entity at the health care clinics owned or operated by the 1967 entity; and a certified statement prepared by an independent 1968 certified public accountant which states that the entity and the 1969 health care clinics owned or operated by the entity have not 1970 received payment for health care services under insurance 1971 coverage for personal injury protection for the preceding year. 1972 If the agency determines that an entity that is exempt under 1973 this paragraph has received payments for medical services for 1974 insurance coverage for personal injury protection, the agency 1975 may deny or revoke the exemption from licensure under this 1976 paragraph. 1977 (7) “Portable health service or equipment provider” means 1978 an entity that contracts with or employs persons to provide 1979 portable health services or equipment to multiple locations 1980performing treatment or diagnostic testing of individuals, that 1981 bills third-party payors for those services, and that otherwise 1982 meets the definition of a clinic in subsection (4). 1983 Section 53. Paragraph (b) of subsection (1) and paragraph 1984 (c) of subsection (4) of section 400.991, Florida Statutes, are 1985 amended to read: 1986 400.991 License requirements; background screenings; 1987 prohibitions.— 1988 (1) 1989 (b) Each mobile clinic must obtain a separate health care 1990 clinic license and must provide to the agency, at least 1991 quarterly, its projected street location to enable the agency to 1992 locate and inspect such clinic. A portable health service or 1993 equipment provider must obtain a health care clinic license for 1994 a single administrative office and is not required to submit 1995 quarterly projected street locations. 1996 (4) In addition to the requirements of part II of chapter 1997 408, the applicant must file with the application satisfactory 1998 proof that the clinic is in compliance with this part and 1999 applicable rules, including: 2000 (c) Proof of financial ability to operate as required under 2001 ss.s.408.810(8) and 408.8065.As an alternative to submitting2002proof of financial ability to operate as required under s.2003408.810(8), the applicant may file a surety bond of at least2004$500,000 which guarantees that the clinic will act in full2005conformity with all legal requirements for operating a clinic,2006payable to the agency. The agency may adopt rules to specify2007related requirements for such surety bond.2008 Section 54. Paragraph (g) of subsection (1) and paragraph 2009 (a) of subsection (7) of section 400.9935, Florida Statutes, are 2010 amended to read: 2011 400.9935 Clinic responsibilities.— 2012 (1) Each clinic shall appoint a medical director or clinic 2013 director who shall agree in writing to accept legal 2014 responsibility for the following activities on behalf of the 2015 clinic. The medical director or the clinic director shall: 2016 (g) Conduct systematic reviews of clinic billings to ensure 2017 that the billings are not fraudulent or unlawful. Upon discovery 2018 of an unlawful charge, the medical director or clinic director 2019 shall take immediate corrective action. If the clinic performs 2020 only the technical component of magnetic resonance imaging, 2021 static radiographs, computed tomography, or positron emission 2022 tomography, and provides the professional interpretation of such 2023 services, in a fixed facility that is accredited by the Joint 2024 Commissionon Accreditation of Healthcare Organizationsor the 2025 Accreditation Association for Ambulatory Health Care, and the 2026 American College of Radiology; and if, in the preceding quarter, 2027 the percentage of scans performed by that clinic which was 2028 billed to all personal injury protection insurance carriers was 2029 less than 15 percent, the chief financial officer of the clinic 2030 may, in a written acknowledgment provided to the agency, assume 2031 the responsibility for the conduct of the systematic reviews of 2032 clinic billings to ensure that the billings are not fraudulent 2033 or unlawful. 2034 (7)(a) Each clinic engaged in magnetic resonance imaging 2035 services must be accredited by the Joint Commissionon2036Accreditation of Healthcare Organizations, the American College 2037 of Radiology, or the Accreditation Association for Ambulatory 2038 Health Care, within 1 year after licensure. A clinic that is 2039 accredited by the American College of Radiology or is within the 2040 original 1-year period after licensure and replaces its core 2041 magnetic resonance imaging equipment shall be given 1 year after 2042 the date on which the equipment is replaced to attain 2043 accreditation. However, a clinic may request a single, 6-month 2044 extension if it provides evidence to the agency establishing 2045 that, for good cause shown, such clinic cannot be accredited 2046 within 1 year after licensure, and that such accreditation will 2047 be completed within the 6-month extension. After obtaining 2048 accreditation as required by this subsection, each such clinic 2049 must maintain accreditation as a condition of renewal of its 2050 license. A clinic that files a change of ownership application 2051 must comply with the original accreditation timeframe 2052 requirements of the transferor. The agency shall deny a change 2053 of ownership application if the clinic is not in compliance with 2054 the accreditation requirements. When a clinic adds, replaces, or 2055 modifies magnetic resonance imaging equipment and the 2056 accreditation agency requires new accreditation, the clinic must 2057 be accredited within 1 year after the date of the addition, 2058 replacement, or modification but may request a single, 6-month 2059 extension if the clinic provides evidence of good cause to the 2060 agency. 2061 Section 55. Paragraph (a) of subsection (2) of section 2062 408.033, Florida Statutes, is amended to read: 2063 408.033 Local and state health planning.— 2064 (2) FUNDING.— 2065 (a) The Legislature intends that the cost of local health 2066 councils be borne by assessments on selected health care 2067 facilities subject to facility licensure by the Agency for 2068 Health Care Administration, including abortion clinics, assisted 2069 living facilities, ambulatory surgical centers, birthing 2070 centers, clinical laboratories except community nonprofit blood 2071 banks and clinical laboratories operated by practitioners for 2072 exclusive use regulated under s. 483.035, home health agencies, 2073 hospices, hospitals, intermediate care facilities for the 2074 developmentally disabled, nursing homes, health care clinics, 2075 and multiphasic testing centers and by assessments on 2076 organizations subject to certification by the agency pursuant to 2077 chapter 641, part III, including health maintenance 2078 organizations and prepaid health clinics. Any fee that is 2079 assessed may be collected prospectively at the time a facility’s 2080 license is renewed and prorated for the licensing period. 2081 Section 56. Subsection (2) of section 408.034, Florida 2082 Statutes, is amended to read: 2083 408.034 Duties and responsibilities of agency; rules.— 2084 (2) In the exercise of its authority to issue licenses to 2085 health care facilities and health service providers, as provided 2086 under chapters 393 and 395 and parts II,andIV, and VIII of 2087 chapter 400, the agency may not issue a license to any health 2088 care facility or health service provider that fails to receive a 2089 certificate of need or an exemption for the licensed facility or 2090 service. 2091 Section 57. Paragraph (d) of subsection (1) and paragraph 2092 (m) of subsection (3) of section 408.036, Florida Statutes, are 2093 amended to read: 2094 408.036 Projects subject to review; exemptions.— 2095 (1) APPLICABILITY.—Unless exempt under subsection (3), all 2096 health-care-related projects, as described in paragraphs (a) 2097 (g), are subject to review and must file an application for a 2098 certificate of need with the agency. The agency is exclusively 2099 responsible for determining whether a health-care-related 2100 project is subject to review under ss. 408.031-408.045. 2101 (d) The establishment of a hospice or hospice inpatient 2102 facility, except as provided in s.408.043. 2103 (3) EXEMPTIONS.—Upon request, the following projects are 2104 subject to exemption from the provisions of subsection (1): 2105 (m)1. For the provision of adult open-heart services in a 2106 hospital located within the boundaries of a health service 2107 planning district, as defined in s. 408.032(5), which has 2108 experienced an annual net out-migration of at least 600 open 2109 heart-surgery cases for 3 consecutive years according to the 2110 most recent data reported to the agency, and the district’s 2111 population per licensed and operational open-heart programs 2112 exceeds the state average of population per licensed and 2113 operational open-heart programs by at least 25 percent. All 2114 hospitals within a health service planning district which meet 2115 the criteria reference in sub-subparagraphs 2.a.-h. shall be 2116 eligible for this exemption on July 1, 2004, and shall receive 2117 the exemption upon filing for it and subject to the following: 2118 a. A hospital that has received a notice of intent to grant 2119 a certificate of need or a final order of the agency granting a 2120 certificate of need for the establishment of an open-heart 2121 surgery program is entitled to receive a letter of exemption for 2122 the establishment of an adult open-heart-surgery program upon 2123 filing a request for exemption and complying with the criteria 2124 enumerated in sub-subparagraphs 2.a.-h., and is entitled to 2125 immediately commence operation of the program. 2126 b. An otherwise eligible hospital that has not received a 2127 notice of intent to grant a certificate of need or a final order 2128 of the agency granting a certificate of need for the 2129 establishment of an open-heart-surgery program is entitled to 2130 immediately receive a letter of exemption for the establishment 2131 of an adult open-heart-surgery program upon filing a request for 2132 exemption and complying with the criteria enumerated in sub 2133 subparagraphs 2.a.-h., but is not entitled to commence operation 2134 of its program until December 31, 2006. 2135 2. A hospital shall be exempt from the certificate-of-need 2136 review for the establishment of an open-heart-surgery program 2137 when the application for exemption submitted under this 2138 paragraph complies with the following criteria: 2139 a. The applicant must certify that it will meet and 2140 continuously maintain the minimum licensure requirements adopted 2141 by the agency governing adult open-heart programs, including the 2142 most current guidelines of the American College of Cardiology 2143 and American Heart Association Guidelines for Adult Open Heart 2144 Programs. 2145 b. The applicant must certify that it will maintain 2146 sufficient appropriate equipment and health personnel to ensure 2147 quality and safety. 2148 c. The applicant must certify that it will maintain 2149 appropriate times of operation and protocols to ensure 2150 availability and appropriate referrals in the event of 2151 emergencies. 2152 d. The applicant can demonstrate that it has discharged at 2153 least 300 inpatients with a principal diagnosis of ischemic 2154 heart disease for the most recent 12-month period as reported to 2155 the agency. 2156 e. The applicant is a general acute care hospital that is 2157 in operation for 3 years or more. 2158 f. The applicant is performing more than 300 diagnostic 2159 cardiac catheterization procedures per year, combined inpatient 2160 and outpatient. 2161 g. The applicant’s payor mix at a minimum reflects the 2162 community average for Medicaid, charity care, and self-pay 2163 patients or the applicant must certify that it will provide a 2164 minimum of 5 percent of Medicaid, charity care, and self-pay to 2165 open-heart-surgery patients. 2166 h. If the applicant fails to meet the established criteria 2167 for open-heart programs or fails to reach 300 surgeries per year 2168 by the end of its third year of operation, it must show cause 2169 why its exemption should not be revoked. 21703. By December 31, 2004, and annually thereafter, the2171agency shall submit a report to the Legislature providing2172information concerning the number of requests for exemption it2173has received under this paragraph during the calendar year and2174the number of exemptions it has granted or denied during the2175calendar year.2176 Section 58. Paragraph (c) of subsection (1) of section 2177 408.037, Florida Statutes, is amended to read: 2178 408.037 Application content.— 2179 (1) Except as provided in subsection (2) for a general 2180 hospital, an application for a certificate of need must contain: 2181 (c) An audited financial statement of the applicant or of 2182 the applicant’s parent corporation if audited financial 2183 statements of the applicant do not exist. In an application 2184 submitted by an existing health care facility, health 2185 maintenance organization, or hospice, financial condition 2186 documentation must include, but need not be limited to, a 2187 balance sheet and a profit-and-loss statement of the 2 previous 2188 fiscal years’ operation. 2189 Section 59. Subsection (2) of section 408.043, Florida 2190 Statutes, is amended to read: 2191 408.043 Special provisions.— 2192 (2) HOSPICES.—When an application is made for a certificate 2193 of need to establish or to expand a hospice, the need for such 2194 hospice shall be determined on the basis of the need for and 2195 availability of hospice services in the community. The formula 2196 on which the certificate of need is based shall discourage 2197 regional monopolies and promote competition. The inpatient 2198 hospice care component of a hospice which is a freestanding 2199 facility, or a part of a facility,which is primarily engaged in2200providing inpatient care and related servicesand is not 2201 licensed as a health care facility shall also be required to 2202 obtain a certificate of need. Provision of hospice care by any 2203 current provider of health care is a significant change in 2204 service and therefore requires a certificate of need for such 2205 services. 2206 Section 60. Paragraph (k) of subsection (3) of section 2207 408.05, Florida Statutes, is amended to read: 2208 408.05 Florida Center for Health Information and Policy 2209 Analysis.— 2210 (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to 2211 produce comparable and uniform health information and statistics 2212 for the development of policy recommendations, the agency shall 2213 perform the following functions: 2214 (k) Develop, in conjunction with the State Consumer Health 2215 Information and Policy Advisory Council, and implement a long 2216 range plan for making available health care quality measures and 2217 financial data that will allow consumers to compare health care 2218 services. The health care quality measures and financial data 2219 the agency must make available shall include, but is not limited 2220 to, pharmaceuticals, physicians, health care facilities, and 2221 health plans and managed care entities. The agency shall update 2222 the plan and report on the status of its implementation 2223 annually. The agency shall also make the plan and status report 2224 available to the public on its Internet website. As part of the 2225 plan, the agency shall identify the process and timeframes for 2226 implementation, any barriers to implementation, and 2227 recommendations of changes in the law that may be enacted by the 2228 Legislature to eliminate the barriers. As preliminary elements 2229 of the plan, the agency shall: 2230 1. Make available patient-safety indicators, inpatient 2231 quality indicators, and performance outcome and patient charge 2232 data collected from health care facilities pursuant to s. 2233 408.061(1)(a) and (2). The terms “patient-safety indicators” and 2234 “inpatient quality indicators” shall be as defined by the 2235 Centers for Medicare and Medicaid Services, the National Quality 2236 Forum, the Joint Commissionon Accreditation of Healthcare2237Organizations, the Agency for Healthcare Research and Quality, 2238 the Centers for Disease Control and Prevention, or a similar 2239 national entity that establishes standards to measure the 2240 performance of health care providers, or by other states. The 2241 agency shall determine which conditions, procedures, health care 2242 quality measures, and patient charge data to disclose based upon 2243 input from the council. When determining which conditions and 2244 procedures are to be disclosed, the council and the agency shall 2245 consider variation in costs, variation in outcomes, and 2246 magnitude of variations and other relevant information. When 2247 determining which health care quality measures to disclose, the 2248 agency: 2249 a. Shall consider such factors as volume of cases; average 2250 patient charges; average length of stay; complication rates; 2251 mortality rates; and infection rates, among others, which shall 2252 be adjusted for case mix and severity, if applicable. 2253 b. May consider such additional measures that are adopted 2254 by the Centers for Medicare and Medicaid Studies, National 2255 Quality Forum, the Joint Commissionon Accreditation of2256Healthcare Organizations, the Agency for Healthcare Research and 2257 Quality, Centers for Disease Control and Prevention, or a 2258 similar national entity that establishes standards to measure 2259 the performance of health care providers, or by other states. 2260 2261 When determining which patient charge data to disclose, the 2262 agency shall include such measures as the average of 2263 undiscounted charges on frequently performed procedures and 2264 preventive diagnostic procedures, the range of procedure charges 2265 from highest to lowest, average net revenue per adjusted patient 2266 day, average cost per adjusted patient day, and average cost per 2267 admission, among others. 2268 2. Make available performance measures, benefit design, and 2269 premium cost data from health plans licensed pursuant to chapter 2270 627 or chapter 641. The agency shall determine which health care 2271 quality measures and member and subscriber cost data to 2272 disclose, based upon input from the council. When determining 2273 which data to disclose, the agency shall consider information 2274 that may be required by either individual or group purchasers to 2275 assess the value of the product, which may include membership 2276 satisfaction, quality of care, current enrollment or membership, 2277 coverage areas, accreditation status, premium costs, plan costs, 2278 premium increases, range of benefits, copayments and 2279 deductibles, accuracy and speed of claims payment, credentials 2280 of physicians, number of providers, names of network providers, 2281 and hospitals in the network. Health plans shall make available 2282 to the agency any such data or information that is not currently 2283 reported to the agency or the office. 2284 3. Determine the method and format for public disclosure of 2285 data reported pursuant to this paragraph. The agency shall make 2286 its determination based upon input from the State Consumer 2287 Health Information and Policy Advisory Council. At a minimum, 2288 the data shall be made available on the agency’s Internet 2289 website in a manner that allows consumers to conduct an 2290 interactive search that allows them to view and compare the 2291 information for specific providers. The website must include 2292 such additional information as is determined necessary to ensure 2293 that the website enhances informed decisionmaking among 2294 consumers and health care purchasers, which shall include, at a 2295 minimum, appropriate guidance on how to use the data and an 2296 explanation of why the data may vary from provider to provider. 2297 4. Publish on its website undiscounted charges for no fewer 2298 than 150 of the most commonly performed adult and pediatric 2299 procedures, including outpatient, inpatient, diagnostic, and 2300 preventative procedures. 2301 Section 61. Paragraph (a) of subsection (1) of section 2302 408.061, Florida Statutes, is amended to read: 2303 408.061 Data collection; uniform systems of financial 2304 reporting; information relating to physician charges; 2305 confidential information; immunity.— 2306 (1) The agency shall require the submission by health care 2307 facilities, health care providers, and health insurers of data 2308 necessary to carry out the agency’s duties. Specifications for 2309 data to be collected under this section shall be developed by 2310 the agency with the assistance of technical advisory panels 2311 including representatives of affected entities, consumers, 2312 purchasers, and such other interested parties as may be 2313 determined by the agency. 2314 (a) Data submitted by health care facilities, including the 2315 facilities as defined in chapter 395, shall include, but are not 2316 limited to: case-mix data, patient admission and discharge data, 2317 hospital emergency department data which shall include the 2318 number of patients treated in the emergency department of a 2319 licensed hospital reported by patient acuity level, data on 2320 hospital-acquired infections as specified by rule, data on 2321 complications as specified by rule, data on readmissions as 2322 specified by rule, with patient and provider-specific 2323 identifiers included, actual charge data by diagnostic groups, 2324 financial data, accounting data, operating expenses, expenses 2325 incurred for rendering services to patients who cannot or do not 2326 pay, interest charges, depreciation expenses based on the 2327 expected useful life of the property and equipment involved, and 2328 demographic data. The agency shall adopt nationally recognized 2329 risk adjustment methodologies or software consistent with the 2330 standards of the Agency for Healthcare Research and Quality and 2331 as selected by the agency for all data submitted as required by 2332 this section. Data may be obtained from documents such as, but 2333 not limited to: leases, contracts, debt instruments, itemized 2334 patient bills, medical record abstracts, and related diagnostic 2335 information. Reported data elements shall be reported 2336 electronically andin accordance with rule 59E-7.012, Florida2337Administrative Code. Data submitted shall becertified by the 2338 chief executive officer or an appropriate and duly authorized 2339 representative or employee of the licensed facility that the 2340 information submitted is true and accurate. 2341 Section 62. Subsection (43) of section 408.07, Florida 2342 Statutes, is amended to read: 2343 408.07 Definitions.—As used in this chapter, with the 2344 exception of ss. 408.031-408.045, the term: 2345 (43) “Rural hospital” means an acute care hospital licensed 2346 under chapter 395, having 100 or fewer licensed beds and an 2347 emergency room, and which is: 2348 (a) The sole provider within a county with a population 2349 density of no greater than 100 persons per square mile; 2350 (b) An acute care hospital, in a county with a population 2351 density of no greater than 100 persons per square mile, which is 2352 at least 30 minutes of travel time, on normally traveled roads 2353 under normal traffic conditions, from another acute care 2354 hospital within the same county; 2355 (c) A hospital supported by a tax district or subdistrict 2356 whose boundaries encompass a population of 100 persons or fewer 2357 per square mile; 2358 (d) A hospital with a service area that has a population of 2359 100 persons or fewer per square mile. As used in this paragraph, 2360 the term “service area” means the fewest number of zip codes 2361 that account for 75 percent of the hospital’s discharges for the 2362 most recent 5-year period, based on information available from 2363 the hospital inpatient discharge database in the Florida Center 2364 for Health Information and Policy Analysis at the Agency for 2365 Health Care Administration; or 2366 (e) A critical access hospital. 2367 2368 Population densities used in this subsection must be based upon 2369 the most recently completed United States census. A hospital 2370 that received funds under s. 409.9116 for a quarter beginning no 2371 later than July 1, 2002, is deemed to have been and shall 2372 continue to be a rural hospital from that date through June 30, 2373 2015, if the hospital continues to have 100 or fewer licensed 2374 beds and an emergency room, or meets the criteria of s.2375395.602(2)(e)4. An acute care hospital that has not previously 2376 been designated as a rural hospital and that meets the criteria 2377 of this subsection shall be granted such designation upon 2378 application, including supporting documentation, to the Agency 2379 for Health Care Administration. 2380 Section 63. Section 408.10, Florida Statutes, is amended to 2381 read: 2382 408.10 Consumer complaints.—The agency shall:2383(1)publish and make available to the public a toll-free 2384 telephone number for the purpose of handling consumer complaints 2385 and shall serve as a liaison between consumer entities and other 2386 private entities and governmental entities for the disposition 2387 of problems identified by consumers of health care. 2388(2) Be empowered to investigate consumer complaints2389relating to problems with health care facilities’ billing2390practices and issue reports to be made public in any cases where2391the agency determines the health care facility has engaged in2392billing practices which are unreasonable and unfair to the2393consumer.2394 Section 64. Subsections (12) through (30) of section 2395 408.802, Florida Statutes, are renumbered as subsections (11) 2396 through (29), respectively, and present subsection (11) of that 2397 section is amended to read: 2398 408.802 Applicability.—The provisions of this part apply to 2399 the provision of services that require licensure as defined in 2400 this part and to the following entities licensed, registered, or 2401 certified by the agency, as described in chapters 112, 383, 390, 2402 394, 395, 400, 429, 440, 483, and 765: 2403(11) Private review agents, as provided under part I of2404chapter 395.2405 Section 65. Subsection (3) is added to section 408.804, 2406 Florida Statutes, to read: 2407 408.804 License required; display.— 2408 (3) Any person who knowingly alters, defaces, or falsifies 2409 a license certificate issued by the agency, or causes or 2410 procures any person to commit such an offense, commits a 2411 misdemeanor of the second degree, punishable as provided in s. 2412 775.082 or s 775.083. Any licensee or provider who displays an 2413 altered, defaced, or falsified license certificate is subject to 2414 the penalties set forth in s. 408.815 and an administrative fine 2415 of $1,000 for each day of illegal display. 2416 Section 66. Paragraph (d) of subsection (2) of section 2417 408.806, Florida Statutes, is amended, to read: 2418 408.806 License application process.— 2419 (2) 2420 (d)The agency shall notify the licensee by mail or2421electronically at least 90 days before the expiration of a2422license that a renewal license is necessary to continue2423operation.The licensee’s failure to timely filesubmita 2424 renewal application and license application fee with the agency 2425 shall result in a $50 per day late fee charged to the licensee 2426 by the agency; however, the aggregate amount of the late fee may 2427 not exceed 50 percent of the licensure fee or $500, whichever is 2428 less. The agency shall provide a courtesy notice to the licensee 2429 by United States mail, electronically, or by any other manner at 2430 its address of record or mailing address, if provided, at least 2431 90 days prior to the expiration of a license informing the 2432 licensee of the expiration of the license. If the licensee does 2433 not receive the courtesy notice, the licensee continues to be 2434 legally obligated to timely file the renewal application and 2435 license application fee with the agency and is not excused from 2436 the payment of a late fee. If an application is received after 2437 the required filing date and exhibits a hand-canceled postmark 2438 obtained from a United States post office dated on or before the 2439 required filing date, no fine will be levied. Payment of the 2440 late fee is required in order for a late application to be 2441 considered complete, and failure to pay the late fee is 2442 considered an omission from the application. 2443 Section 67. Paragraph (b) of subsection (1) of section 2444 408.8065, Florida Statutes, is amended to read: 2445 408.8065 Additional licensure requirements for home health 2446 agencies, home medical equipment providers, and health care 2447 clinics.— 2448 (1) An applicant for initial licensure, or initial 2449 licensure due to a change of ownership, as a home health agency, 2450 home medical equipment provider, or health care clinic shall: 2451 (b) Submit projectedpro formafinancial statements, 2452 including a balance sheet, income and expense statement, and a 2453 statement of cash flows for the first 2 years of operation which 2454 provide evidence that the applicant has sufficient assets, 2455 credit, and projected revenues to cover liabilities and 2456 expenses. 2457 2458 All documents required under this subsection must be prepared in 2459 accordance with generally accepted accounting principles and may 2460 be in a compilation form. The financial statements must be 2461 signed by a certified public accountant. 2462 Section 68. Subsections (4) through (8) of section 408.809, 2463 Florida Statutes, are amended to read: 2464 408.809 Background screening; prohibited offenses.— 2465 (4) In addition to the offenses listed in s. 435.04, all 2466 persons required to undergo background screening pursuant to 2467 this part or authorizing statutes must not have an arrest 2468 awaiting final disposition for, must not have been found guilty 2469 of, regardless of adjudication, or entered a plea of nolo 2470 contendere or guilty to, and must not have been adjudicated 2471 delinquent and the record not have been sealed or expunged for 2472 any of the following offenses or any similar offense of another 2473 jurisdiction: 2474 (a) Any authorizing statutes, if the offense was a felony. 2475 (b) This chapter, if the offense was a felony. 2476 (c) Section 409.920, relating to Medicaid provider fraud. 2477 (d) Section 409.9201, relating to Medicaid fraud. 2478 (e) Section 741.28, relating to domestic violence. 2479 (f) Section 817.034, relating to fraudulent acts through 2480 mail, wire, radio, electromagnetic, photoelectronic, or 2481 photooptical systems. 2482 (g) Section 817.234, relating to false and fraudulent 2483 insurance claims. 2484 (h) Section 817.505, relating to patient brokering. 2485 (i) Section 817.568, relating to criminal use of personal 2486 identification information. 2487 (j) Section 817.60, relating to obtaining a credit card 2488 through fraudulent means. 2489 (k) Section 817.61, relating to fraudulent use of credit 2490 cards, if the offense was a felony. 2491 (l) Section 831.01, relating to forgery. 2492 (m) Section 831.02, relating to uttering forged 2493 instruments. 2494 (n) Section 831.07, relating to forging bank bills, checks, 2495 drafts, or promissory notes. 2496 (o) Section 831.09, relating to uttering forged bank bills, 2497 checks, drafts, or promissory notes. 2498 (p) Section 831.30, relating to fraud in obtaining 2499 medicinal drugs. 2500 (q) Section 831.31, relating to the sale, manufacture, 2501 delivery, or possession with the intent to sell, manufacture, or 2502 deliver any counterfeit controlled substance, if the offense was 2503 a felony. 2504 (5) A person who serves as a controlling interest of, is 2505 employed by, or contracts with a licensee on July 31, 2010, who 2506 has been screened and qualified according to standards specified 2507 in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015, 2508 in accordance with the schedule provided in this subsection.The2509agency may adopt rules to establish a schedule to stagger the2510implementation of the required rescreening over the 5-year2511period, beginning July 31, 2010, through July 31, 2015.If, upon 2512 rescreening, such person has a disqualifying offense that was 2513 not a disqualifying offense at the time of the last screening, 2514 but is a current disqualifying offense and was committed before 2515 the last screening, he or she may apply for an exemption from 2516 the appropriate licensing agency and, if agreed to by the 2517 employer, may continue to perform his or her duties until the 2518 licensing agency renders a decision on the application for 2519 exemption if the person is eligible to apply for an exemption 2520 and the exemption request is received by the agency within 30 2521 days after receipt of the rescreening results by the person. The 2522 rescreening schedule is as follows: 2523 (a) An individual whose last screening was conducted before 2524 December 31, 2003, must be rescreened by July 31, 2013; 2525 (b) An individual whose last screening was conducted 2526 between January 1, 2004, and December 31, 2007, must be 2527 rescreened by July 31, 2014; and 2528 (c) An individual whose last screening was conducted 2529 between January 1, 2008, and July 31, 2010, must be rescreened 2530 by July 31, 2015. 2531 (6)(5)The costs associated with obtaining the required 2532 screening must be borne by the licensee or the person subject to 2533 screening. Licensees may reimburse persons for these costs. The 2534 Department of Law Enforcement shall charge the agency for 2535 screening pursuant to s. 943.053(3). The agency shall establish 2536 a schedule of fees to cover the costs of screening. 2537 (7)(6)(a) As provided in chapter 435, the agency may grant 2538 an exemption from disqualification to a person who is subject to 2539 this section and who: 2540 1. Does not have an active professional license or 2541 certification from the Department of Health; or 2542 2. Has an active professional license or certification from 2543 the Department of Health but is not providing a service within 2544 the scope of that license or certification. 2545 (b) As provided in chapter 435, the appropriate regulatory 2546 board within the Department of Health, or the department itself 2547 if there is no board, may grant an exemption from 2548 disqualification to a person who is subject to this section and 2549 who has received a professional license or certification from 2550 the Department of Health or a regulatory board within that 2551 department and that person is providing a service within the 2552 scope of his or her licensed or certified practice. 2553 (8)(7)The agency and the Department of Health may adopt 2554 rules pursuant to ss. 120.536(1) and 120.54 to implement this 2555 section, chapter 435, and authorizing statutes requiring 2556 background screening and to implement and adopt criteria 2557 relating to retaining fingerprints pursuant to s. 943.05(2). 2558 (9)(8)There is no unemployment compensation or other 2559 monetary liability on the part of, and no cause of action for 2560 damages arising against, an employer that, upon notice of a 2561 disqualifying offense listed under chapter 435 or this section, 2562 terminates the person against whom the report was issued, 2563 whether or not that person has filed for an exemption with the 2564 Department of Health or the agency. 2565 Section 69. Subsection (3) is added to section 408.813, 2566 Florida Statutes, to read: 2567 408.813 Administrative fines; violations.—As a penalty for 2568 any violation of this part, authorizing statutes, or applicable 2569 rules, the agency may impose an administrative fine. 2570 (3) The agency may impose an administrative fine for a 2571 violation that is not designated as a class I, class II, class 2572 III, or class IV violation. Unless otherwise specified by law, 2573 the amount of the fine shall not exceed $500 for each violation. 2574 Unclassified violations may include: 2575 (a) Violating any term or condition of a license. 2576 (b) Violating any provision of this part, authorizing 2577 statutes, or applicable rules. 2578 (c) Exceeding licensed capacity. 2579 (d) Providing services beyond the scope of the license. 2580 (e) Violating a moratorium imposed pursuant to s. 408.814. 2581 Section 70. Subsection (5) is added to section 408.815, 2582 Florida Statutes, to read: 2583 408.815 License or application denial; revocation.— 2584 (5) In order to ensure the health, safety, and welfare of 2585 clients when a license has been denied, revoked, or is set to 2586 terminate, the agency may extend the license expiration date for 2587 a period of up to 30 days for the sole purpose of allowing the 2588 safe and orderly discharge of clients. The agency may impose 2589 conditions on the extension, including, but not limited to, 2590 prohibiting or limiting admissions, expedited discharge 2591 planning, required status reports, and mandatory monitoring by 2592 the agency or third parties. When imposing these conditions, the 2593 agency shall take into consideration the nature and number of 2594 clients, the availability and location of acceptable alternative 2595 placements, and the ability of the licensee to continue 2596 providing care to the clients. The agency may terminate the 2597 extension or modify the conditions at any time. This authority 2598 is in addition to any other authority granted to the agency 2599 under chapter 120, this part, and authorizing statutes but 2600 creates no right or entitlement to an extension of a license 2601 expiration date. 2602 Section 71. Subsection (1) of section 409.91196, Florida 2603 Statutes, is amended to read: 2604 409.91196 Supplemental rebate agreements; public records 2605 and public meetings exemption.— 2606 (1) The rebate amount, percent of rebate, manufacturer’s 2607 pricing, and supplemental rebate, and other trade secrets as 2608 defined in s. 688.002 that the agency has identified for use in 2609 negotiations, held by the Agency for Health Care Administration 2610 under s. 409.912(39)(a)8.7.are confidential and exempt from s. 2611 119.07(1) and s. 24(a), Art. I of the State Constitution. 2612 Section 72. Paragraph (a) of subsection (39) of section 2613 409.912, Florida Statutes, is amended to read: 2614 409.912 Cost-effective purchasing of health care.—The 2615 agency shall purchase goods and services for Medicaid recipients 2616 in the most cost-effective manner consistent with the delivery 2617 of quality medical care. To ensure that medical services are 2618 effectively utilized, the agency may, in any case, require a 2619 confirmation or second physician’s opinion of the correct 2620 diagnosis for purposes of authorizing future services under the 2621 Medicaid program. This section does not restrict access to 2622 emergency services or poststabilization care services as defined 2623 in 42 C.F.R. part 438.114. Such confirmation or second opinion 2624 shall be rendered in a manner approved by the agency. The agency 2625 shall maximize the use of prepaid per capita and prepaid 2626 aggregate fixed-sum basis services when appropriate and other 2627 alternative service delivery and reimbursement methodologies, 2628 including competitive bidding pursuant to s. 287.057, designed 2629 to facilitate the cost-effective purchase of a case-managed 2630 continuum of care. The agency shall also require providers to 2631 minimize the exposure of recipients to the need for acute 2632 inpatient, custodial, and other institutional care and the 2633 inappropriate or unnecessary use of high-cost services. The 2634 agency shall contract with a vendor to monitor and evaluate the 2635 clinical practice patterns of providers in order to identify 2636 trends that are outside the normal practice patterns of a 2637 provider’s professional peers or the national guidelines of a 2638 provider’s professional association. The vendor must be able to 2639 provide information and counseling to a provider whose practice 2640 patterns are outside the norms, in consultation with the agency, 2641 to improve patient care and reduce inappropriate utilization. 2642 The agency may mandate prior authorization, drug therapy 2643 management, or disease management participation for certain 2644 populations of Medicaid beneficiaries, certain drug classes, or 2645 particular drugs to prevent fraud, abuse, overuse, and possible 2646 dangerous drug interactions. The Pharmaceutical and Therapeutics 2647 Committee shall make recommendations to the agency on drugs for 2648 which prior authorization is required. The agency shall inform 2649 the Pharmaceutical and Therapeutics Committee of its decisions 2650 regarding drugs subject to prior authorization. The agency is 2651 authorized to limit the entities it contracts with or enrolls as 2652 Medicaid providers by developing a provider network through 2653 provider credentialing. The agency may competitively bid single 2654 source-provider contracts if procurement of goods or services 2655 results in demonstrated cost savings to the state without 2656 limiting access to care. The agency may limit its network based 2657 on the assessment of beneficiary access to care, provider 2658 availability, provider quality standards, time and distance 2659 standards for access to care, the cultural competence of the 2660 provider network, demographic characteristics of Medicaid 2661 beneficiaries, practice and provider-to-beneficiary standards, 2662 appointment wait times, beneficiary use of services, provider 2663 turnover, provider profiling, provider licensure history, 2664 previous program integrity investigations and findings, peer 2665 review, provider Medicaid policy and billing compliance records, 2666 clinical and medical record audits, and other factors. Providers 2667 shall not be entitled to enrollment in the Medicaid provider 2668 network. The agency shall determine instances in which allowing 2669 Medicaid beneficiaries to purchase durable medical equipment and 2670 other goods is less expensive to the Medicaid program than long 2671 term rental of the equipment or goods. The agency may establish 2672 rules to facilitate purchases in lieu of long-term rentals in 2673 order to protect against fraud and abuse in the Medicaid program 2674 as defined in s. 409.913. The agency may seek federal waivers 2675 necessary to administer these policies. 2676 (39)(a) The agency shall implement a Medicaid prescribed 2677 drug spending-control program that includes the following 2678 components: 2679 1. A Medicaid preferred drug list, which shall be a listing 2680 of cost-effective therapeutic options recommended by the 2681 Medicaid Pharmacy and Therapeutics Committee established 2682 pursuant to s. 409.91195 and adopted by the agency for each 2683 therapeutic class on the preferred drug list. At the discretion 2684 of the committee, and when feasible, the preferred drug list 2685 should include at least two products in a therapeutic class. The 2686 agency may post the preferred drug list and updates to the 2687 preferred drug list on an Internet website without following the 2688 rulemaking procedures of chapter 120. Antiretroviral agents are 2689 excluded from the preferred drug list. The agency shall also 2690 limit the amount of a prescribed drug dispensed to no more than 2691 a 34-day supply unless the drug products’ smallest marketed 2692 package is greater than a 34-day supply, or the drug is 2693 determined by the agency to be a maintenance drug in which case 2694 a 100-day maximum supply may be authorized. The agency is 2695 authorized to seek any federal waivers necessary to implement 2696 these cost-control programs and to continue participation in the 2697 federal Medicaid rebate program, or alternatively to negotiate 2698 state-only manufacturer rebates. The agency may adopt rules to 2699 implement this subparagraph. The agency shall continue to 2700 provide unlimited contraceptive drugs and items. The agency must 2701 establish procedures to ensure that: 2702 a. There is a response to a request for prior consultation 2703 by telephone or other telecommunication device within 24 hours 2704 after receipt of a request for prior consultation; and 2705 b. A 72-hour supply of the drug prescribed is provided in 2706 an emergency or when the agency does not provide a response 2707 within 24 hours as required by sub-subparagraph a. 2708 2. Reimbursement to pharmacies for Medicaid prescribed 2709 drugs shall be set at the lesser of: the average wholesale price 2710 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC) 2711 plus 4.75 percent, the federal upper limit (FUL), the state 2712 maximum allowable cost (SMAC), or the usual and customary (UAC) 2713 charge billed by the provider. 2714 3. For a prescribed drug billed as a 340B prescribed 2715 medication, the claim must meet the requirements of the Deficit 2716 Reduction Act of 2005 and the federal 340B program, contain a 2717 national drug code, and be billed at the actual acquisition cost 2718 or payment shall be denied. 2719 4.3.The agency shall develop and implement a process for 2720 managing the drug therapies of Medicaid recipients who are using 2721 significant numbers of prescribed drugs each month. The 2722 management process may include, but is not limited to, 2723 comprehensive, physician-directed medical-record reviews, claims 2724 analyses, and case evaluations to determine the medical 2725 necessity and appropriateness of a patient’s treatment plan and 2726 drug therapies. The agency may contract with a private 2727 organization to provide drug-program-management services. The 2728 Medicaid drug benefit management program shall include 2729 initiatives to manage drug therapies for HIV/AIDS patients, 2730 patients using 20 or more unique prescriptions in a 180-day 2731 period, and the top 1,000 patients in annual spending. The 2732 agency shall enroll any Medicaid recipient in the drug benefit 2733 management program if he or she meets the specifications of this 2734 provision and is not enrolled in a Medicaid health maintenance 2735 organization. 2736 5.4.The agency may limit the size of its pharmacy network 2737 based on need, competitive bidding, price negotiations, 2738 credentialing, or similar criteria. The agency shall give 2739 special consideration to rural areas in determining the size and 2740 location of pharmacies included in the Medicaid pharmacy 2741 network. A pharmacy credentialing process may include criteria 2742 such as a pharmacy’s full-service status, location, size, 2743 patient educational programs, patient consultation, disease 2744 management services, and other characteristics. The agency may 2745 impose a moratorium on Medicaid pharmacy enrollment when it is 2746 determined that it has a sufficient number of Medicaid 2747 participating providers. The agency must allow dispensing 2748 practitioners to participate as a part of the Medicaid pharmacy 2749 network regardless of the practitioner’s proximity to any other 2750 entity that is dispensing prescription drugs under the Medicaid 2751 program. A dispensing practitioner must meet all credentialing 2752 requirements applicable to his or her practice, as determined by 2753 the agency. 2754 6.5.The agency shall develop and implement a program that 2755 requires Medicaid practitioners who prescribe drugs to use a 2756 counterfeit-proof prescription pad for Medicaid prescriptions. 2757 The agency shall require the use of standardized counterfeit 2758 proof prescription pads by Medicaid-participating prescribers or 2759 prescribers who write prescriptions for Medicaid recipients. The 2760 agency may implement the program in targeted geographic areas or 2761 statewide. 2762 7.6.The agency may enter into arrangements that require 2763 manufacturers of generic drugs prescribed to Medicaid recipients 2764 to provide rebates of at least 15.1 percent of the average 2765 manufacturer price for the manufacturer’s generic products. 2766 These arrangements shall require that if a generic-drug 2767 manufacturer pays federal rebates for Medicaid-reimbursed drugs 2768 at a level below 15.1 percent, the manufacturer must provide a 2769 supplemental rebate to the state in an amount necessary to 2770 achieve a 15.1-percent rebate level. 2771 8.7.The agency may establish a preferred drug list as 2772 described in this subsection, and, pursuant to the establishment 2773 of such preferred drug list, it is authorized to negotiate 2774 supplemental rebates from manufacturers that are in addition to 2775 those required by Title XIX of the Social Security Act and at no 2776 less than 14 percent of the average manufacturer price as 2777 defined in 42 U.S.C. s. 1936 on the last day of a quarter unless 2778 the federal or supplemental rebate, or both, equals or exceeds 2779 29 percent. There is no upper limit on the supplemental rebates 2780 the agency may negotiate. The agency may determine that specific 2781 products, brand-name or generic, are competitive at lower rebate 2782 percentages. Agreement to pay the minimum supplemental rebate 2783 percentage will guarantee a manufacturer that the Medicaid 2784 Pharmaceutical and Therapeutics Committee will consider a 2785 product for inclusion on the preferred drug list. However, a 2786 pharmaceutical manufacturer is not guaranteed placement on the 2787 preferred drug list by simply paying the minimum supplemental 2788 rebate. Agency decisions will be made on the clinical efficacy 2789 of a drug and recommendations of the Medicaid Pharmaceutical and 2790 Therapeutics Committee, as well as the price of competing 2791 products minus federal and state rebates. The agency is 2792 authorized to contract with an outside agency or contractor to 2793 conduct negotiations for supplemental rebates. For the purposes 2794 of this section, the term “supplemental rebates” means cash 2795 rebates. Effective July 1, 2004, value-added programs as a 2796 substitution for supplemental rebates are prohibited. The agency 2797 is authorized to seek any federal waivers to implement this 2798 initiative. 2799 9.8.The Agency for Health Care Administration shall expand 2800 home delivery of pharmacy products. To assist Medicaid patients 2801 in securing their prescriptions and reduce program costs, the 2802 agency shall expand its current mail-order-pharmacy diabetes 2803 supply program to include all generic and brand-name drugs used 2804 by Medicaid patients with diabetes. Medicaid recipients in the 2805 current program may obtain nondiabetes drugs on a voluntary 2806 basis. This initiative is limited to the geographic area covered 2807 by the current contract. The agency may seek and implement any 2808 federal waivers necessary to implement this subparagraph. 2809 10.9.The agency shall limit to one dose per month any drug 2810 prescribed to treat erectile dysfunction. 2811 11.10.a. The agency may implement a Medicaid behavioral 2812 drug management system. The agency may contract with a vendor 2813 that has experience in operating behavioral drug management 2814 systems to implement this program. The agency is authorized to 2815 seek federal waivers to implement this program. 2816 b. The agency, in conjunction with the Department of 2817 Children and Family Services, may implement the Medicaid 2818 behavioral drug management system that is designed to improve 2819 the quality of care and behavioral health prescribing practices 2820 based on best practice guidelines, improve patient adherence to 2821 medication plans, reduce clinical risk, and lower prescribed 2822 drug costs and the rate of inappropriate spending on Medicaid 2823 behavioral drugs. The program may include the following 2824 elements: 2825 (I) Provide for the development and adoption of best 2826 practice guidelines for behavioral health-related drugs such as 2827 antipsychotics, antidepressants, and medications for treating 2828 bipolar disorders and other behavioral conditions; translate 2829 them into practice; review behavioral health prescribers and 2830 compare their prescribing patterns to a number of indicators 2831 that are based on national standards; and determine deviations 2832 from best practice guidelines. 2833 (II) Implement processes for providing feedback to and 2834 educating prescribers using best practice educational materials 2835 and peer-to-peer consultation. 2836 (III) Assess Medicaid beneficiaries who are outliers in 2837 their use of behavioral health drugs with regard to the numbers 2838 and types of drugs taken, drug dosages, combination drug 2839 therapies, and other indicators of improper use of behavioral 2840 health drugs. 2841 (IV) Alert prescribers to patients who fail to refill 2842 prescriptions in a timely fashion, are prescribed multiple same 2843 class behavioral health drugs, and may have other potential 2844 medication problems. 2845 (V) Track spending trends for behavioral health drugs and 2846 deviation from best practice guidelines. 2847 (VI) Use educational and technological approaches to 2848 promote best practices, educate consumers, and train prescribers 2849 in the use of practice guidelines. 2850 (VII) Disseminate electronic and published materials. 2851 (VIII) Hold statewide and regional conferences. 2852 (IX) Implement a disease management program with a model 2853 quality-based medication component for severely mentally ill 2854 individuals and emotionally disturbed children who are high 2855 users of care. 2856 12.11.a. The agency shall implement a Medicaid prescription 2857 drug management system. The agency may contract with a vendor 2858 that has experience in operating prescription drug management 2859 systems in order to implement this system. Any management system 2860 that is implemented in accordance with this subparagraph must 2861 rely on cooperation between physicians and pharmacists to 2862 determine appropriate practice patterns and clinical guidelines 2863 to improve the prescribing, dispensing, and use of drugs in the 2864 Medicaid program. The agency may seek federal waivers to 2865 implement this program. 2866 b. The drug management system must be designed to improve 2867 the quality of care and prescribing practices based on best 2868 practice guidelines, improve patient adherence to medication 2869 plans, reduce clinical risk, and lower prescribed drug costs and 2870 the rate of inappropriate spending on Medicaid prescription 2871 drugs. The program must: 2872 (I) Provide for the development and adoption of best 2873 practice guidelines for the prescribing and use of drugs in the 2874 Medicaid program, including translating best practice guidelines 2875 into practice; reviewing prescriber patterns and comparing them 2876 to indicators that are based on national standards and practice 2877 patterns of clinical peers in their community, statewide, and 2878 nationally; and determine deviations from best practice 2879 guidelines. 2880 (II) Implement processes for providing feedback to and 2881 educating prescribers using best practice educational materials 2882 and peer-to-peer consultation. 2883 (III) Assess Medicaid recipients who are outliers in their 2884 use of a single or multiple prescription drugs with regard to 2885 the numbers and types of drugs taken, drug dosages, combination 2886 drug therapies, and other indicators of improper use of 2887 prescription drugs. 2888 (IV) Alert prescribers to patients who fail to refill 2889 prescriptions in a timely fashion, are prescribed multiple drugs 2890 that may be redundant or contraindicated, or may have other 2891 potential medication problems. 2892 (V) Track spending trends for prescription drugs and 2893 deviation from best practice guidelines. 2894 (VI) Use educational and technological approaches to 2895 promote best practices, educate consumers, and train prescribers 2896 in the use of practice guidelines. 2897 (VII) Disseminate electronic and published materials. 2898 (VIII) Hold statewide and regional conferences. 2899 (IX) Implement disease management programs in cooperation 2900 with physicians and pharmacists, along with a model quality 2901 based medication component for individuals having chronic 2902 medical conditions. 2903 13.12.The agency is authorized to contract for drug rebate 2904 administration, including, but not limited to, calculating 2905 rebate amounts, invoicing manufacturers, negotiating disputes 2906 with manufacturers, and maintaining a database of rebate 2907 collections. 2908 14.13.The agency may specify the preferred daily dosing 2909 form or strength for the purpose of promoting best practices 2910 with regard to the prescribing of certain drugs as specified in 2911 the General Appropriations Act and ensuring cost-effective 2912 prescribing practices. 2913 15.14.The agency may require prior authorization for 2914 Medicaid-covered prescribed drugs. The agency may, but is not 2915 required to, prior-authorize the use of a product: 2916 a. For an indication not approved in labeling; 2917 b. To comply with certain clinical guidelines; or 2918 c. If the product has the potential for overuse, misuse, or 2919 abuse. 2920 2921 The agency may require the prescribing professional to provide 2922 information about the rationale and supporting medical evidence 2923 for the use of a drug. The agency may post prior authorization 2924 criteria and protocol and updates to the list of drugs that are 2925 subject to prior authorization on an Internet website without 2926 amending its rule or engaging in additional rulemaking. 2927 16.15.The agency, in conjunction with the Pharmaceutical 2928 and Therapeutics Committee, may require age-related prior 2929 authorizations for certain prescribed drugs. The agency may 2930 preauthorize the use of a drug for a recipient who may not meet 2931 the age requirement or may exceed the length of therapy for use 2932 of this product as recommended by the manufacturer and approved 2933 by the Food and Drug Administration. Prior authorization may 2934 require the prescribing professional to provide information 2935 about the rationale and supporting medical evidence for the use 2936 of a drug. 2937 17.16.The agency shall implement a step-therapy prior 2938 authorization approval process for medications excluded from the 2939 preferred drug list. Medications listed on the preferred drug 2940 list must be used within the previous 12 months prior to the 2941 alternative medications that are not listed. The step-therapy 2942 prior authorization may require the prescriber to use the 2943 medications of a similar drug class or for a similar medical 2944 indication unless contraindicated in the Food and Drug 2945 Administration labeling. The trial period between the specified 2946 steps may vary according to the medical indication. The step 2947 therapy approval process shall be developed in accordance with 2948 the committee as stated in s. 409.91195(7) and (8). A drug 2949 product may be approved without meeting the step-therapy prior 2950 authorization criteria if the prescribing physician provides the 2951 agency with additional written medical or clinical documentation 2952 that the product is medically necessary because: 2953 a. There is not a drug on the preferred drug list to treat 2954 the disease or medical condition which is an acceptable clinical 2955 alternative; 2956 b. The alternatives have been ineffective in the treatment 2957 of the beneficiary’s disease; or 2958 c. Based on historic evidence and known characteristics of 2959 the patient and the drug, the drug is likely to be ineffective, 2960 or the number of doses have been ineffective. 2961 2962 The agency shall work with the physician to determine the best 2963 alternative for the patient. The agency may adopt rules waiving 2964 the requirements for written clinical documentation for specific 2965 drugs in limited clinical situations. 2966 18.17.The agency shall implement a return and reuse 2967 program for drugs dispensed by pharmacies to institutional 2968 recipients, which includes payment of a $5 restocking fee for 2969 the implementation and operation of the program. The return and 2970 reuse program shall be implemented electronically and in a 2971 manner that promotes efficiency. The program must permit a 2972 pharmacy to exclude drugs from the program if it is not 2973 practical or cost-effective for the drug to be included and must 2974 provide for the return to inventory of drugs that cannot be 2975 credited or returned in a cost-effective manner. The agency 2976 shall determine if the program has reduced the amount of 2977 Medicaid prescription drugs which are destroyed on an annual 2978 basis and if there are additional ways to ensure more 2979 prescription drugs are not destroyed which could safely be 2980 reused. The agency’s conclusion and recommendations shall be 2981 reported to the Legislature by December 1, 2005. 2982 Section 73. Subsections (3) and (4) of section 429.07, 2983 Florida Statutes, are amended, and subsections (6) and (7) are 2984 added to that section, to read: 2985 429.07 License required; fee; inspections.— 2986 (3) In addition to the requirements of s. 408.806, each 2987 license granted by the agency must state the type of care for 2988 which the license is granted. Licenses shall be issued for one 2989 or more of the following categories of care: standard, extended 2990 congregate care,limited nursing services,or limited mental 2991 health. 2992 (a) A standard license shall be issued to a facility 2993facilitiesproviding one or more of the personal services 2994 identified in s. 429.02. Such licenseefacilitiesmay also 2995 employ or contract with a personlicensed under part I of2996chapter 464toadminister medications andperform other tasks as 2997 specified in s. 429.255. 2998 (b) An extended congregate care license shall be issued to 2999 a licenseefacilitiesproviding, directly or through contract, 3000 services beyond those authorized in paragraph (a), including 3001 services performed by persons licensed under part I of chapter 3002 464 and supportive services, as defined by rule, to persons who 3003 would otherwise be disqualified from continued residence in a 3004 facility licensed under this part. 3005 1. In order for extended congregate care services to be 3006 provided, the agency must first determine that all requirements 3007 established in law and rule are met and must specifically 3008 designate, on thefacility’slicense, that such services may be 3009 provided and whether the designation applies to all or part of 3010 the facility. Such designation may be made at the time of 3011 initial licensure or relicensure, or upon request in writing by 3012 a licensee under this part and part II of chapter 408. The 3013 notification of approval or the denial of the request shall be 3014 made in accordance with part II of chapter 408. An existing 3015 licenseefacilitiesqualifying to provide extended congregate 3016 care services must have maintained a standard license andmay3017 nothavebeen subject to administrative sanctions during the 3018 previous 2 years, or since initial licensure ifthe facility has3019beenlicensed for less than 2 years, for any of the following 3020 reasons: 3021 a. A class I or class II violation; 3022 b. Three or more repeat or recurring class III violations 3023 of identical or similar resident care standards from which a 3024 pattern of noncompliance is found by the agency; 3025 c. Three or more class III violations that were not 3026 corrected in accordance with the corrective action plan approved 3027 by the agency; 3028 d. Violation of resident care standards which results in 3029 requiring the facility to employ the services of a consultant 3030 pharmacist or consultant dietitian; 3031 e. Denial, suspension, or revocation of a license for 3032 another facility licensed under this part in which the applicant 3033 for an extended congregate care license has at least 25 percent 3034 ownership interest; or 3035 f. Imposition of a moratorium pursuant to this part or part 3036 II of chapter 408 or initiation of injunctive proceedings. 3037 2. A facility that is licensed to provide extended 3038 congregate care services shall maintain a written progress 3039 report foroneach person who receives services which describes 3040 the type, amount, duration, scope, and outcome of services that 3041 are rendered and the general status of the resident’s health.A3042registered nurse, or appropriate designee, representing the3043agency shall visit the facility at least quarterly to monitor3044residents who are receiving extended congregate care services3045and to determine if the facility is in compliance with this3046part, part II of chapter 408, and relevant rules. One of the3047visits may be in conjunction with the regular survey. The3048monitoring visits may be provided through contractual3049arrangements with appropriate community agencies. A registered3050nurse shall serve as part of the team that inspects the3051facility. The agency may waive one of the required yearly3052monitoring visits for a facility that has been licensed for at3053least 24 months to provide extended congregate care services,3054if, during the inspection, the registered nurse determines that3055extended congregate care services are being provided3056appropriately, and if the facility has no class I or class II3057violations and no uncorrected class III violations. The agency3058must first consult with the long-term care ombudsman council for3059the area in which the facility is located to determine if any3060complaints have been made and substantiated about the quality of3061services or care. The agency may not waive one of the required3062yearly monitoring visits if complaints have been made and3063substantiated.3064 3. A facility that is licensed to provide extended 3065 congregate care services must: 3066 a. Demonstrate the capability to meet unanticipated 3067 resident service needs. 3068 b. Offer a physical environment that promotes a homelike 3069 setting, provides for resident privacy, promotes resident 3070 independence, and allows sufficient congregate space as defined 3071 by rule. 3072 c. Have sufficient staff available, taking into account the 3073 physical plant and firesafety features of the building, to 3074 assist with the evacuation of residents in an emergency. 3075 d. Adopt and follow policies and procedures that maximize 3076 resident independence, dignity, choice, and decisionmaking to 3077 permit residents to age in place, so that moves due to changes 3078 in functional status are minimized or avoided. 3079 e. Allow residents or, if applicable, a resident’s 3080 representative, designee, surrogate, guardian, or attorney in 3081 fact to make a variety of personal choices, participate in 3082 developing service plans, and share responsibility in 3083 decisionmaking. 3084 f. Implement the concept of managed risk. 3085 g. Provide, directly or through contract, the services of a 3086 person licensed under part I of chapter 464. 3087 h. In addition to the training mandated in s. 429.52, 3088 provide specialized training as defined by rule for facility 3089 staff. 3090 4. A facility that is licensed to provide extended 3091 congregate care services is exempt from the criteria for 3092 continued residency set forth in rules adopted under s. 429.41. 3093 A licensed facility must adopt its own requirements within 3094 guidelines for continued residency set forth by rule. However, 3095 the facility may not serve residents who require 24-hour nursing 3096 supervision. A licensed facility that provides extended 3097 congregate care services must also provide each resident with a 3098 written copy of facility policies governing admission and 3099 retention. 3100 5. The primary purpose of extended congregate care services 3101 is to allow residents, as they become more impaired, the option 3102 of remaining in a familiar setting from which they would 3103 otherwise be disqualified for continued residency. A facility 3104 licensed to provide extended congregate care services may also 3105 admit an individual who exceeds the admission criteria for a 3106 facility with a standard license, if the individual is 3107 determined appropriate for admission to the extended congregate 3108 care facility. 3109 6. Before the admission of an individual to a facility 3110 licensed to provide extended congregate care services, the 3111 individual must undergo a medical examination as provided in s. 3112 429.26(4) and the facility must develop a preliminary service 3113 plan for the individual. 3114 7. When a licenseefacilitycan no longer provide or 3115 arrange for services in accordance with the resident’s service 3116 plan and needs and the licensee’sfacility’spolicy, the 3117 licenseefacilityshall make arrangements for relocating the 3118 person in accordance with s. 429.28(1)(k). 3119 8. Failure to provide extended congregate care services may 3120 result in denial of extended congregate care license renewal. 3121(c) A limited nursing services license shall be issued to a3122facility that provides services beyond those authorized in3123paragraph (a) and as specified in this paragraph.31241. In order for limited nursing services to be provided in3125a facility licensed under this part, the agency must first3126determine that all requirements established in law and rule are3127met and must specifically designate, on the facility’s license,3128that such services may be provided. Such designation may be made3129at the time of initial licensure or relicensure, or upon request3130in writing by a licensee under this part and part II of chapter3131408. Notification of approval or denial of such request shall be3132made in accordance with part II of chapter 408. Existing3133facilities qualifying to provide limited nursing services shall3134have maintained a standard license and may not have been subject3135to administrative sanctions that affect the health, safety, and3136welfare of residents for the previous 2 years or since initial3137licensure if the facility has been licensed for less than 23138years.31392. Facilities that are licensed to provide limited nursing3140services shall maintain a written progress report on each person3141who receives such nursing services, which report describes the3142type, amount, duration, scope, and outcome of services that are3143rendered and the general status of the resident’s health. A3144registered nurse representing the agency shall visit such3145facilities at least twice a year to monitor residents who are3146receiving limited nursing services and to determine if the3147facility is in compliance with applicable provisions of this3148part, part II of chapter 408, and related rules. The monitoring3149visits may be provided through contractual arrangements with3150appropriate community agencies. A registered nurse shall also3151serve as part of the team that inspects such facility.31523. A person who receives limited nursing services under3153this part must meet the admission criteria established by the3154agency for assisted living facilities. When a resident no longer3155meets the admission criteria for a facility licensed under this3156part, arrangements for relocating the person shall be made in3157accordance with s.429.28(1)(k), unless the facility is licensed3158to provide extended congregate care services.3159 (4) In accordance with s. 408.805, an applicant or licensee 3160 shall pay a fee for each license application submitted under 3161 this part, part II of chapter 408, and applicable rules. The 3162 amount of the fee shall be established by rule. 3163 (a) The biennial license fee required of a facility is $300 3164 per license, with an additional fee of $71$50per resident 3165 based on the total licensed resident capacity of the facility, 3166 except that no additional fee will be assessed for beds 3167 designated for recipients of optional state supplementation 3168 payments provided for in s. 409.212. The total fee may not 3169 exceed $10,000. 3170 (b) In addition to the total fee assessed under paragraph 3171 (a), the agency shall require facilities that are licensed to 3172 provide extended congregate care services under this part to pay 3173 an additional fee per licensed facility. The amount of the 3174 biennial fee shall be $400 per license, with an additional fee 3175 of $10 per resident based on the total licensed resident 3176 capacity of the facility. 3177(c) In addition to the total fee assessed under paragraph3178(a), the agency shall require facilities that are licensed to3179provide limited nursing services under this part to pay an3180additional fee per licensed facility. The amount of the biennial3181fee shall be $250 per license, with an additional fee of $10 per3182resident based on the total licensed resident capacity of the3183facility.3184 (6) In order to determine whether the facility is 3185 adequately protecting residents’ rights as provided in s. 3186 429.28, the agency’s standard license survey shall include 3187 private informal conversations with a sample of residents and 3188 consultation with the ombudsman council in the planning and 3189 service area in which the facility is located to discuss 3190 residents’ experiences within the facility. 3191 (7) An assisted living facility that has been cited within 3192 the previous 24-month period for a class I or class II 3193 violation, regardless of the status of any enforcement or 3194 disciplinary action, is subject to periodic unannounced 3195 monitoring to determine if the facility is in compliance with 3196 this part, part II of chapter 408, and applicable rules. 3197 Monitoring may occur through a desk review or an onsite 3198 assessment. If the class I or class II violation relates to 3199 providing or failing to provide nursing care, a registered nurse 3200 must participate in monitoring activities during the 12-month 3201 period following the violation. 3202 Section 74. Subsection (7) of section 429.11, Florida 3203 Statutes, is renumbered as subsection (6), and present 3204 subsection (6) of that section is amended to read: 3205 429.11 Initial application for license; provisional3206license.— 3207(6) In addition to the license categories available in s.3208408.808, a provisional license may be issued to an applicant3209making initial application for licensure or making application3210for a change of ownership. A provisional license shall be3211limited in duration to a specific period of time not to exceed 63212months, as determined by the agency.3213 Section 75. Section 429.12, Florida Statutes, is amended to 3214 read: 3215 429.12 Sale or transfer of ownership of a facility.—It is 3216 the intent of the Legislature to protect the rights of the 3217 residents of an assisted living facility when the facility is 3218 sold or the ownership thereof is transferred. Therefore, in 3219 addition to the requirements of part II of chapter 408, whenever 3220 a facility is sold or the ownership thereof is transferred, 3221 including leasing,:3222(1)the transferee shall notify the residents, in writing, 3223 of the change of ownership within 7 days after receipt of the 3224 new license. 3225(2) The transferor of a facility the license of which is3226denied pending an administrative hearing shall, as a part of the3227written change-of-ownership contract, advise the transferee that3228a plan of correction must be submitted by the transferee and3229approved by the agency at least 7 days before the change of3230ownership and that failure to correct the condition which3231resulted in the moratorium pursuant to part II of chapter 408 or3232denial of licensure is grounds for denial of the transferee’s3233license.3234 Section 76. Subsections (1), (4), and (5) of section 3235 429.17, Florida Statutes, are amended to read: 3236 429.17 Expiration of license; renewal; conditional 3237 license.— 3238 (1)Limited nursing,Extended congregate care,and limited 3239 mental health licenses shall expire at the same time as the 3240 facility’s standard license, regardless of when issued. 3241 (4) In addition to the license categories available in s. 3242 408.808, a conditional license may be issued to an applicant for 3243 license renewal if the applicant fails to meet all standards and 3244 requirements for licensure. A conditional license issued under 3245 this subsection shall be limited in duration to a specific 3246 period of time not to exceed 6 months, as determined by the 3247 agency, and shall be accompanied by an agency-approved plan of3248correction. 3249 (5) When an extended congregate careor limited nursing3250 license is requested during a facility’s biennial license 3251 period, the fee shall be prorated in order to permit the 3252 additional license to expire at the end of the biennial license 3253 period. The fee shall be calculated as of the date the 3254 additional license application is received by the agency. 3255 Section 77. Section 429.195, Florida Statutes, is amended 3256 to read: 3257 429.195 Rebates prohibited; penalties.— 3258 (1) It is unlawful for any assisted living facility 3259 licensed under this part to contract or promise to pay or 3260 receive any commission, bonus, kickback, or rebate or engage in 3261 any split-fee arrangement in any form whatsoever with any health 3262 care provider or health care facility under s. 817.505 3263physician, surgeon, organization, agency, or person, either3264directly or indirectly, for residents referred to an assisted3265living facility licensed under this part.A facility may employ3266or contract with persons to market the facility, provided the3267employee or contract provider clearly indicates that he or she3268represents the facility. A person or agency independent of the3269facility may provide placement or referral services for a fee to3270individuals seeking assistance in finding a suitable facility;3271however, any fee paid for placement or referral services must be3272paid by the individual looking for a facility, not by the3273facility.3274 (2) A violation of this section shall be considered patient 3275 brokering and is punishable as provided in s. 817.505. 3276 (3) This section does not apply to: 3277 (a) An individual with whom the facility employs or 3278 contracts with to market the facility if the individual clearly 3279 indicates that he or she works with or for the facility. 3280 (b) A referral service that provides information, 3281 consultation, or referrals to consumers to assist them in 3282 finding appropriate care or housing options for senior citizens 3283 or disabled adults if such referred consumers are not Medicaid 3284 recipients. 3285 (c) A resident of an assisted living facility who refers to 3286 the assisted living facility a friend, family member, or other 3287 individual with whom the resident has a personal relationship, 3288 and the assisted living facility is not prohibited from 3289 providing a monetary reward to the resident for making such a 3290 referral. 3291 Section 78. Subsections (6) through (10) of section 429.23, 3292 Florida Statutes, are renumbered as subsections (5) through (9), 3293 respectively, and present subsection (5) of that section is 3294 amended to read: 3295 429.23 Internal risk management and quality assurance 3296 program; adverse incidents and reporting requirements.— 3297(5) Each facility shall report monthly to the agency any3298liability claim filed against it. The report must include the3299name of the resident, the dates of the incident leading to the3300claim, if applicable, and the type of injury or violation of3301rights alleged to have occurred. This report is not discoverable3302in any civil or administrative action, except in such actions3303brought by the agency to enforce the provisions of this part.3304 Section 79. Paragraph (a) of subsection (1) and subsection 3305 (2) of section 429.255, Florida Statutes, are amended to read: 3306 429.255 Use of personnel; emergency care.— 3307 (1)(a) Persons under contract to the facility or,facility 3308 staff, or volunteers,who are licensed according to part I of 3309 chapter 464, or those persons exempt under s. 464.022(1), and 3310 others as defined by rule, may administer medications to 3311 residents, take residents’ vital signs, manage individual weekly 3312 pill organizers for residents who self-administer medication, 3313 give prepackaged enemas ordered by a physician, observe 3314 residents, document observations on the appropriate resident’s 3315 record, report observations to the resident’s physician, and 3316 contract or allow residents or a resident’s representative, 3317 designee, surrogate, guardian, or attorney in fact to contract 3318 with a third party, provided residents meet the criteria for 3319 appropriate placement as defined in s. 429.26. Persons under 3320 contract to the facility or facility staff who are licensed 3321 according to part I of chapter 464 may provide limited nursing 3322 services. Nursing assistants certified pursuant to part II of 3323 chapter 464 may take residents’ vital signs as directed by a 3324 licensed nurse or physician. The facility is responsible for 3325 maintaining documentation of services provided under this 3326 paragraph and as required by rule and ensuring that staff are 3327 adequately trained to monitor residents receiving these 3328 services. 3329 (2) In facilities licensed to provide extended congregate 3330 care, persons under contract to the facility or,facility staff,3331or volunteers,who are licensed according to part I of chapter 3332 464, or those persons exempt under s. 464.022(1), or those 3333 persons certified as nursing assistants pursuant to part II of 3334 chapter 464, may also perform all duties within the scope of 3335 their license or certification, as approved by the facility 3336 administrator and pursuant to this part. 3337 Section 80. Subsections (4), (5), (6), and (7) of section 3338 429.28, Florida Statutes, are renumbered as subsections (3), 3339 (4), (5), and (6), respectively, and present subsections (3) and 3340 (6) of that section are amended to read: 3341 429.28 Resident bill of rights.— 3342(3)(a) The agency shall conduct a survey to determine3343general compliance with facility standards and compliance with3344residents’ rights as a prerequisite to initial licensure or3345licensure renewal.3346(b) In order to determine whether the facility is3347adequately protecting residents’ rights, the biennial survey3348shall include private informal conversations with a sample of3349residents and consultation with the ombudsman council in the3350planning and service area in which the facility is located to3351discuss residents’ experiences within the facility.3352(c) During any calendar year in which no survey is3353conducted, the agency shall conduct at least one monitoring3354visit of each facility cited in the previous year for a class I3355or class II violation, or more than three uncorrected class III3356violations.3357(d) The agency may conduct periodic followup inspections as3358necessary to monitor the compliance of facilities with a history3359of any class I, class II, or class III violations that threaten3360the health, safety, or security of residents.3361(e) The agency may conduct complaint investigations as3362warranted to investigate any allegations of noncompliance with3363requirements required under this part or rules adopted under3364this part.3365 (5)(6)Any facility which terminates the residency of an 3366 individual who participated in activities specified in 3367 subsection (4)(5)shall show good cause in a court of competent 3368 jurisdiction. 3369 Section 81. Subsection (1) of section 429.294, Florida 3370 Statutes, is amended to read: 3371 429.294 Availability of facility records for investigation 3372 of resident’s rights violations and defenses; penalty.— 3373 (1) Failure to provide complete copies of a resident’s 3374 records, including, but not limited to, all medical records and 3375 the resident’s chart, within the control or possession of the 3376 facility within 10 days, constitutesin accordance with the3377provisions of s.400.145, shall constituteevidence of failure 3378 of that party to comply with good faith discovery requirements 3379 and waivesshall waivethe good faith certificate and presuit 3380 notice requirements under this part by the requesting party. 3381 Section 82. Paragraphs (i) and (j) of subsection (1) and 3382 subsection (3) of section 429.41, Florida Statutes, are amended, 3383 and present subsections (4) and (5) of that section are 3384 renumbered subsections (3) and (4), respectively, to read: 3385 429.41 Rules establishing standards.— 3386 (1) It is the intent of the Legislature that rules 3387 published and enforced pursuant to this section shall include 3388 criteria by which a reasonable and consistent quality of 3389 resident care and quality of life may be ensured and the results 3390 of such resident care may be demonstrated. Such rules shall also 3391 ensure a safe and sanitary environment that is residential and 3392 noninstitutional in design or nature. It is further intended 3393 that reasonable efforts be made to accommodate the needs and 3394 preferences of residents to enhance the quality of life in a 3395 facility. The agency, in consultation with the department, may 3396 adopt rules to administer the requirements of part II of chapter 3397 408. In order to provide safe and sanitary facilities and the 3398 highest quality of resident care accommodating the needs and 3399 preferences of residents, the department, in consultation with 3400 the agency, the Department of Children and Family Services, and 3401 the Department of Health, shall adopt rules, policies, and 3402 procedures to administer this part, which must include 3403 reasonable and fair minimum standards in relation to: 3404 (i) Facilities holding ana limited nursing,extended 3405 congregate care, or limited mental health license. 3406 (j) The establishment of specific criteria to define 3407 appropriateness of resident admission and continued residency in 3408 a facility holding a standard,limited nursing,extended 3409 congregate care, and limited mental health license. 3410(3) The department shall submit a copy of proposed rules to3411the Speaker of the House of Representatives, the President of3412the Senate, and appropriate committees of substance for review3413and comment prior to the promulgation thereof. Rules promulgated3414by the department shall encourage the development of homelike3415facilities which promote the dignity, individuality, personal3416strengths, and decisionmaking ability of residents.3417 Section 83. Subsections (1) and (2) of section 429.53, 3418 Florida Statutes, are amended to read: 3419 429.53 Consultation by the agency.— 3420 (1) Thearea offices of licensure and certification of the3421 agency shall provide consultation to the following upon request: 3422 (a) A licensee of a facility. 3423 (b) A person interested in obtaining a license to operate a 3424 facility under this part. 3425 (2) As used in this section, “consultation” includes: 3426 (a) An explanation of the requirements of this part and 3427 rules adopted pursuant thereto; 3428 (b) An explanation of the license application and renewal 3429 procedures; and 3430(c) The provision of a checklist of general local and state3431approvals required prior to constructing or developing a3432facility and a listing of the types of agencies responsible for3433such approvals;3434(d) An explanation of benefits and financial assistance3435available to a recipient of supplemental security income3436residing in a facility;3437 (c)(e)Any other information which the agency deems 3438 necessary to promote compliance with the requirements of this 3439 part; and3440(f) A preconstruction review of a facility to ensure3441compliance with agency rules and this part. 3442 Section 84. Subsections (1) and (2) of section 429.54, 3443 Florida Statutes, are renumbered as subsections (2) and (3), 3444 respectively, and a new subsection (1) is added to that section 3445 to read: 3446 429.54 Collection of information; local subsidy.— 3447 (1) A facility that is licensed under this part must report 3448 electronically to the agency semiannually data related to the 3449 facility, including, but not limited to, the total number of 3450 residents, the number of residents who are receiving limited 3451 mental health services, the number of residents who are 3452 receiving extended congregate care services, the number of 3453 residents who are receiving limited nursing services, and 3454 professional staffing employed by or under contract with the 3455 licensee to provide resident services. The department, in 3456 consultation with the agency, shall adopt rules to administer 3457 this subsection. 3458 Section 85. Subsections (1) and (5) of section 429.71, 3459 Florida Statutes, are amended to read: 3460 429.71 Classification of violationsdeficiencies; 3461 administrative fines.— 3462 (1) In addition to the requirements of part II of chapter 3463 408 and in addition to any other liability or penalty provided 3464 by law, the agency may impose an administrative fine on a 3465 provider according to the following classification: 3466 (a) Class I violations are defined in s. 408.813those3467conditions or practices related to the operation and maintenance3468of an adult family-care home or to the care of residents which3469the agency determines present an imminent danger to the3470residents or guests of the facility or a substantial probability3471that death or serious physical or emotional harm would result3472therefrom. The condition or practice that constitutes a class I3473violation must be abated or eliminated within 24 hours, unless a3474fixed period, as determined by the agency, is required for3475correction. A class I violationdeficiencyis subject to an 3476 administrative fine in an amount not less than $500 and not 3477 exceeding $1,000 for each violation.A fine may be levied3478notwithstanding the correction of the deficiency.3479 (b) Class II violations are defined in s. 408.813those3480conditions or practices related to the operation and maintenance3481of an adult family-care home or to the care of residents which3482the agency determines directly threaten the physical or3483emotional health, safety, or security of the residents, other3484than class I violations. A class II violation is subject to an 3485 administrative fine in an amount not less than $250 and not 3486 exceeding $500 for each violation.A citation for a class II3487violation must specify the time within which the violation is3488required to be corrected. If a class II violation is corrected3489within the time specified, no civil penalty shall be imposed,3490unless it is a repeated offense.3491 (c) Class III violations are defined in s. 408.813those3492conditions or practices related to the operation and maintenance3493of an adult family-care home or to the care of residents which3494the agency determines indirectly or potentially threaten the3495physical or emotional health, safety, or security of residents,3496other than class I or class II violations. A class III violation 3497 is subject to an administrative fine in an amount not less than 3498 $100 and not exceeding $250 for each violation.A citation for a3499class III violation shall specify the time within which the3500violation is required to be corrected.If a class III violation 3501 is corrected within the time specified, no civil penalty shall 3502 be imposed, unless it is a repeated violationoffense. 3503 (d) Class IV violations are defined in s. 408.813those3504conditions or occurrences related to the operation and3505maintenance of an adult family-care home, or related to the3506required reports, forms, or documents, which do not have the3507potential of negatively affecting the residents.A provider that3508does not correctA class IV violationwithin the time limit3509specified by the agencyis subject to an administrative fine in 3510 an amount not less than $50 and not exceeding $100 for each 3511 violation. Any class IV violation that is corrected during the 3512 time the agency survey is conducted will be identified as an 3513 agency finding and not as a violation, unless it is a repeat 3514 violation. 3515(5) As an alternative to or in conjunction with an3516administrative action against a provider, the agency may request3517a plan of corrective action that demonstrates a good faith3518effort to remedy each violation by a specific date, subject to3519the approval of the agency.3520 Section 86. Section 429.915, Florida Statutes, is amended 3521 to read: 3522 429.915 Conditional license.—In addition to the license 3523 categories available in part II of chapter 408, the agency may 3524 issue a conditional license to an applicant for license renewal 3525 or change of ownership if the applicant fails to meet all 3526 standards and requirements for licensure. A conditional license 3527 issued under this subsection must be limited to a specific 3528 period not exceeding 6 months, as determined by the agency, and3529must be accompanied by an approved plan of correction. 3530 Section 87. Paragraphs (b) and (g) of subsection (3) of 3531 section 430.80, Florida Statutes, are amended to read: 3532 430.80 Implementation of a teaching nursing home pilot 3533 project.— 3534 (3) To be designated as a teaching nursing home, a nursing 3535 home licensee must, at a minimum: 3536 (b) Participate in a nationally recognized accreditation 3537 program and hold a valid accreditation, such as the 3538 accreditation awarded by the Joint Commissionon Accreditation3539of Healthcare Organizations, or, at the time of initial 3540 designation, possess a Gold Seal Award as conferred by the state 3541 on its licensed nursing home; 3542 (g) Maintain insurance coverage pursuant to s. 3543 400.141(1)(q)(s)or proof of financial responsibility in a 3544 minimum amount of $750,000. Such proof of financial 3545 responsibility may include: 3546 1. Maintaining an escrow account consisting of cash or 3547 assets eligible for deposit in accordance with s. 625.52; or 3548 2. Obtaining and maintaining pursuant to chapter 675 an 3549 unexpired, irrevocable, nontransferable and nonassignable letter 3550 of credit issued by any bank or savings association organized 3551 and existing under the laws of this state or any bank or savings 3552 association organized under the laws of the United States that 3553 has its principal place of business in this state or has a 3554 branch office which is authorized to receive deposits in this 3555 state. The letter of credit shall be used to satisfy the 3556 obligation of the facility to the claimant upon presentment of a 3557 final judgment indicating liability and awarding damages to be 3558 paid by the facility or upon presentment of a settlement 3559 agreement signed by all parties to the agreement when such final 3560 judgment or settlement is a result of a liability claim against 3561 the facility. 3562 Section 88. Paragraph (d) of subsection (9) of section 3563 440.102, Florida Statutes, is repealed. 3564 Section 89. Paragraph (a) of subsection (2) of section 3565 440.13, Florida Statutes, is amended to read: 3566 440.13 Medical services and supplies; penalty for 3567 violations; limitations.— 3568 (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.— 3569 (a) Subject to the limitations specified elsewhere in this 3570 chapter, the employer shall furnish to the employee such 3571 medically necessary remedial treatment, care, and attendance for 3572 such period as the nature of the injury or the process of 3573 recovery may require, which is in accordance with established 3574 practice parameters and protocols of treatment as provided for 3575 in this chapter, including medicines, medical supplies, durable 3576 medical equipment, orthoses, prostheses, and other medically 3577 necessary apparatus. Remedial treatment, care, and attendance, 3578 including work-hardening programs or pain-management programs 3579 accredited by the Commission on Accreditation of Rehabilitation 3580 Facilities or the Joint Commissionon the Accreditation of3581Health Organizationsor pain-management programs affiliated with 3582 medical schools, shall be considered as covered treatment only 3583 when such care is given based on a referral by a physician as 3584 defined in this chapter. Medically necessary treatment, care, 3585 and attendance does not include chiropractic services in excess 3586 of 24 treatments or rendered 12 weeks beyond the date of the 3587 initial chiropractic treatment, whichever comes first, unless 3588 the carrier authorizes additional treatment or the employee is 3589 catastrophically injured. 3590 3591 Failure of the carrier to timely comply with this subsection 3592 shall be a violation of this chapter and the carrier shall be 3593 subject to penalties as provided for in s. 440.525. 3594 Section 90. Subsection (1) of section 483.035, Florida 3595 Statutes, is amended to read: 3596 483.035 Clinical laboratories operated by practitioners for 3597 exclusive use; licensure and regulation.— 3598 (1) A clinical laboratory operated by one or more 3599 practitioners licensed under chapter 458, chapter 459, chapter 3600 460, chapter 461, chapter 462, part I of chapter 464, or chapter 3601 466, exclusively in connection with the diagnosis and treatment 3602 of their own patients, must be licensed under this part and must 3603 comply with the provisions of this part, except that the agency 3604 shall adopt rules for staffing, for personnel, including 3605 education and training of personnel, for proficiency testing, 3606 and for construction standards relating to the licensure and 3607 operation of the laboratory based upon and not exceeding the 3608 same standards contained in the federal Clinical Laboratory 3609 Improvement Amendments of 1988 and the federal regulations 3610 adopted thereunder. 3611 Section 91. Subsections (1) and (9) of section 483.051, 3612 Florida Statutes, are amended to read: 3613 483.051 Powers and duties of the agency.—The agency shall 3614 adopt rules to implement this part, which rules must include, 3615 but are not limited to, the following: 3616 (1) LICENSING; QUALIFICATIONS.—The agency shall provide for 3617 biennial licensure of all nonwaived clinical laboratories 3618 meeting the requirements of this part and shall prescribe the 3619 qualifications necessary for such licensure, including, but not 3620 limited to, an application for or proof of a certificate under 3621 Clinical Laboratory Improvement Amendments of 1988. A nonwaived 3622 laboratory is a laboratory that has not been granted a 3623 certificate of waiver by the Centers for Medicare and Medicaid 3624 Services under the Clinical Laboratory Improvement Amendments of 3625 1988 and the federal rules adopted thereunder. 3626 (9) ALTERNATE-SITE TESTING.—The agency, in consultation 3627 with the Board of Clinical Laboratory Personnel, shall adopt, by 3628 rule, the criteria for alternate-site testing to be performed 3629 under the supervision of a clinical laboratory director. The 3630 elements to be addressed in the rule include, but are not 3631 limited to: a hospital internal needs assessment; a protocol of 3632 implementation including tests to be performed and who will 3633 perform the tests; criteria to be used in selecting the method 3634 of testing to be used for alternate-site testing; minimum 3635 training and education requirements for those who will perform 3636 alternate-site testing, such as documented training, licensure, 3637 certification, or other medical professional background not 3638 limited to laboratory professionals; documented inservice 3639 training as well as initial and ongoing competency validation; 3640 an appropriate internal and external quality control protocol; 3641 an internal mechanism for identifying and tracking alternate 3642 site testing by the central laboratory; and recordkeeping 3643 requirements.Alternate-site testing locations must register3644when the clinical laboratory applies to renew its license.For 3645 purposes of this subsection, the term “alternate-site testing” 3646 means any laboratory testing done under the administrative 3647 control of a hospital, but performed out of the physical or 3648 administrative confines of the central laboratory. 3649 Section 92. Section 483.294, Florida Statutes, is amended 3650 to read: 3651 483.294 Inspection of centers.—In accordance with s. 3652 408.811, the agency shall biennially, at least once annually,3653 inspect the premises and operations of all centers subject to 3654 licensure under this part. 3655 Section 93. Subsection (4) is added to section 626.9541, 3656 Florida Statutes, to read: 3657 626.9541 Unfair methods of competition and unfair or 3658 deceptive acts or practices defined; alternative rates of 3659 payment; wellness programs.— 3660 (4) WELLNESS PROGRAMS.—An insurer issuing a group or 3661 individual health benefit plan may offer a voluntary wellness or 3662 health-improvement program that allows for rewards or 3663 incentives, including, but not limited to, merchandise, gift 3664 cards, debit cards, premium discounts or rebates, contributions 3665 towards a member’s health savings account, modifications to 3666 copayment, deductible, or coinsurance amounts, or any 3667 combination of these incentives, to encourage or reward 3668 participation in the program. The health plan member may be 3669 required to provide verification, such as a statement from his 3670 or her physician, that a medical condition makes it unreasonably 3671 difficult or medically inadvisable for the individual to 3672 participate in the wellness program. Any reward or incentive 3673 established under this subsection is not an insurance benefit 3674 and does not violate this section. This subsection does not 3675 prohibit an insurer from offering incentives or rewards to 3676 members for adherence to wellness or health improvement programs 3677 if otherwise allowed by state or federal law. Notwithstanding 3678 any provision of this subsection, no insurer, nor its agent, may 3679 use any incentive authorized by this subsection for the purpose 3680 of redirecting patients from one health care insurance plan to 3681 another. 3682 Section 94. Subsection (1) of section 627.645, Florida 3683 Statutes, is amended to read: 3684 627.645 Denial of health insurance claims restricted.— 3685 (1) No claim for payment under a health insurance policy or 3686 self-insured program of health benefits for treatment, care, or 3687 services in a licensed hospital which is accredited by the Joint 3688 Commissionon the Accreditation of Hospitals, the American 3689 Osteopathic Association, or the Commission on the Accreditation 3690 of Rehabilitative Facilities shall be denied because such 3691 hospital lacks major surgical facilities and is primarily of a 3692 rehabilitative nature, if such rehabilitation is specifically 3693 for treatment of physical disability. 3694 Section 95. Paragraph (c) of subsection (2) of section 3695 627.668, Florida Statutes, is amended to read: 3696 627.668 Optional coverage for mental and nervous disorders 3697 required; exception.— 3698 (2) Under group policies or contracts, inpatient hospital 3699 benefits, partial hospitalization benefits, and outpatient 3700 benefits consisting of durational limits, dollar amounts, 3701 deductibles, and coinsurance factors shall not be less favorable 3702 than for physical illness generally, except that: 3703 (c) Partial hospitalization benefits shall be provided 3704 under the direction of a licensed physician. For purposes of 3705 this part, the term “partial hospitalization services” is 3706 defined as those services offered by a program accredited by the 3707 Joint Commissionon Accreditation of Hospitals (JCAH)or in 3708 compliance with equivalent standards. Alcohol rehabilitation 3709 programs accredited by the Joint Commissionon Accreditation of3710Hospitalsor approved by the state and licensed drug abuse 3711 rehabilitation programs shall also be qualified providers under 3712 this section. In any benefit year, if partial hospitalization 3713 services or a combination of inpatient and partial 3714 hospitalization are utilized, the total benefits paid for all 3715 such services shall not exceed the cost of 30 days of inpatient 3716 hospitalization for psychiatric services, including physician 3717 fees, which prevail in the community in which the partial 3718 hospitalization services are rendered. If partial 3719 hospitalization services benefits are provided beyond the limits 3720 set forth in this paragraph, the durational limits, dollar 3721 amounts, and coinsurance factors thereof need not be the same as 3722 those applicable to physical illness generally. 3723 Section 96. Subsection (3) of section 627.669, Florida 3724 Statutes, is amended to read: 3725 627.669 Optional coverage required for substance abuse 3726 impaired persons; exception.— 3727 (3) The benefits provided under this section shall be 3728 applicable only if treatment is provided by, or under the 3729 supervision of, or is prescribed by, a licensed physician or 3730 licensed psychologist and if services are provided in a program 3731 accredited by the Joint Commissionon Accreditation of Hospitals3732 or approved by the state. 3733 Section 97. Paragraph (a) of subsection (1) of section 3734 627.736, Florida Statutes, is amended to read: 3735 627.736 Required personal injury protection benefits; 3736 exclusions; priority; claims.— 3737 (1) REQUIRED BENEFITS.—Every insurance policy complying 3738 with the security requirements of s. 627.733 shall provide 3739 personal injury protection to the named insured, relatives 3740 residing in the same household, persons operating the insured 3741 motor vehicle, passengers in such motor vehicle, and other 3742 persons struck by such motor vehicle and suffering bodily injury 3743 while not an occupant of a self-propelled vehicle, subject to 3744 the provisions of subsection (2) and paragraph (4)(e), to a 3745 limit of $10,000 for loss sustained by any such person as a 3746 result of bodily injury, sickness, disease, or death arising out 3747 of the ownership, maintenance, or use of a motor vehicle as 3748 follows: 3749 (a) Medical benefits.—Eighty percent of all reasonable 3750 expenses for medically necessary medical, surgical, X-ray, 3751 dental, and rehabilitative services, including prosthetic 3752 devices, and medically necessary ambulance, hospital, and 3753 nursing services. However, the medical benefits shall provide 3754 reimbursement only for such services and care that are lawfully 3755 provided, supervised, ordered, or prescribed by a physician 3756 licensed under chapter 458 or chapter 459, a dentist licensed 3757 under chapter 466, or a chiropractic physician licensed under 3758 chapter 460 or that are provided by any of the following persons 3759 or entities: 3760 1. A hospital or ambulatory surgical center licensed under 3761 chapter 395. 3762 2. A person or entity licensed under ss. 401.2101-401.45 3763 that provides emergency transportation and treatment. 3764 3. An entity wholly owned by one or more physicians 3765 licensed under chapter 458 or chapter 459, chiropractic 3766 physicians licensed under chapter 460, or dentists licensed 3767 under chapter 466 or by such practitioner or practitioners and 3768 the spouse, parent, child, or sibling of that practitioner or 3769 those practitioners. 3770 4. An entity wholly owned, directly or indirectly, by a 3771 hospital or hospitals. 3772 5. A health care clinic licensed under ss. 400.990-400.995 3773 that is: 3774 a. Accredited by the Joint Commissionon Accreditation of3775Healthcare Organizations, the American Osteopathic Association, 3776 the Commission on Accreditation of Rehabilitation Facilities, or 3777 the Accreditation Association for Ambulatory Health Care, Inc.; 3778 or 3779 b. A health care clinic that: 3780 (I) Has a medical director licensed under chapter 458, 3781 chapter 459, or chapter 460; 3782 (II) Has been continuously licensed for more than 3 years 3783 or is a publicly traded corporation that issues securities 3784 traded on an exchange registered with the United States 3785 Securities and Exchange Commission as a national securities 3786 exchange; and 3787 (III) Provides at least four of the following medical 3788 specialties: 3789 (A) General medicine. 3790 (B) Radiography. 3791 (C) Orthopedic medicine. 3792 (D) Physical medicine. 3793 (E) Physical therapy. 3794 (F) Physical rehabilitation. 3795 (G) Prescribing or dispensing outpatient prescription 3796 medication. 3797 (H) Laboratory services. 3798 3799 The Financial Services Commission shall adopt by rule the form 3800 that must be used by an insurer and a health care provider 3801 specified in subparagraph 3., subparagraph 4., or subparagraph 3802 5. to document that the health care provider meets the criteria 3803 of this paragraph, which rule must include a requirement for a 3804 sworn statement or affidavit. 3805 3806 Only insurers writing motor vehicle liability insurance in this 3807 state may provide the required benefits of this section, and no 3808 such insurer shall require the purchase of any other motor 3809 vehicle coverage other than the purchase of property damage 3810 liability coverage as required by s. 627.7275 as a condition for 3811 providing such required benefits. Insurers may not require that 3812 property damage liability insurance in an amount greater than 3813 $10,000 be purchased in conjunction with personal injury 3814 protection. Such insurers shall make benefits and required 3815 property damage liability insurance coverage available through 3816 normal marketing channels. Any insurer writing motor vehicle 3817 liability insurance in this state who fails to comply with such 3818 availability requirement as a general business practice shall be 3819 deemed to have violated part IX of chapter 626, and such 3820 violation shall constitute an unfair method of competition or an 3821 unfair or deceptive act or practice involving the business of 3822 insurance; and any such insurer committing such violation shall 3823 be subject to the penalties afforded in such part, as well as 3824 those which may be afforded elsewhere in the insurance code. 3825 Section 98. Subsection (12) of section 641.495, Florida 3826 Statutes, is amended to read: 3827 641.495 Requirements for issuance and maintenance of 3828 certificate.— 3829 (12) The provisions of part I of chapter 395 do not apply 3830 to a health maintenance organization that, on or before January 3831 1, 1991, provides not more than 10 outpatient holding beds for 3832 short-term and hospice-type patients in an ambulatory care 3833 facility for its members, provided that such health maintenance 3834 organization maintains current accreditation by the Joint 3835 Commissionon Accreditation of Health Care Organizations, the 3836 Accreditation Association for Ambulatory Health Care, or the 3837 National Committee for Quality Assurance. 3838 Section 99. Subsection (13) of section 651.118, Florida 3839 Statutes, is amended to read: 3840 651.118 Agency for Health Care Administration; certificates 3841 of need; sheltered beds; community beds.— 3842 (13) Residents, as defined in this chapter, are not 3843 considered new admissions for the purpose of s. 3844 400.141(1)(n)(o)1.d. 3845 Section 100. Subsection (2) of section 766.1015, Florida 3846 Statutes, is amended to read: 3847 766.1015 Civil immunity for members of or consultants to 3848 certain boards, committees, or other entities.— 3849 (2) Such committee, board, group, commission, or other 3850 entity must be established in accordance with state law or in 3851 accordance with requirements of the Joint Commissionon3852Accreditation of Healthcare Organizations, established and duly 3853 constituted by one or more public or licensed private hospitals 3854 or behavioral health agencies, or established by a governmental 3855 agency. To be protected by this section, the act, decision, 3856 omission, or utterance may not be made or done in bad faith or 3857 with malicious intent. 3858 Section 101. Subsection (4) of section 766.202, Florida 3859 Statutes, is amended to read: 3860 766.202 Definitions; ss. 766.201-766.212.—As used in ss. 3861 766.201-766.212, the term: 3862 (4) “Health care provider” means any hospital, ambulatory 3863 surgical center, or mobile surgical facility as defined and 3864 licensed under chapter 395; a birth center licensed under 3865 chapter 383; any person licensed under chapter 458, chapter 459, 3866 chapter 460, chapter 461, chapter 462, chapter 463, part I of 3867 chapter 464, chapter 466, chapter 467, part XIV of chapter 468, 3868 or chapter 486; a clinical lab licensed under chapter 483; a 3869 health maintenance organization certificated under part I of 3870 chapter 641; a blood bank; a plasma center; an industrial 3871 clinic; a renal dialysis facility; or a professional association 3872 partnership, corporation, joint venture, or other association 3873 for professional activity by health care providers. 3874 Section 102. Paragraph (j) is added to subsection (3) of 3875 section 817.505, Florida Statutes, to read: 3876 817.505 Patient brokering prohibited; exceptions; 3877 penalties.— 3878 (3) This section shall not apply to: 3879 (j) Any payment by an assisted living facility, as defined 3880 in s. 429.02, which is permitted under s. 429.195(3). 3881 Section 103. Section 381.06014, Florida Statutes, is 3882 amended to read: 3883 381.06014 Blood establishments.— 3884 (1) As used in this section, the term: 3885 (a) “Blood establishment” means any person, entity, or 3886 organization, operating within the state, which examines an 3887 individual for the purpose of blood donation or which collects, 3888 processes, stores, tests, or distributes blood or blood 3889 components collected from the human body for the purpose of 3890 transfusion, for any other medical purpose, or for the 3891 production of any biological product. A person, entity, or 3892 organization that uses a mobile unit to conduct such activities 3893 within the state is also a blood establishment. 3894 (b) “Volunteer donor” means a person who does not receive 3895 remuneration, other than an incentive, for a blood donation 3896 intended for transfusion, and the product container of the 3897 donation from the person qualifies for labeling with the 3898 statement “volunteer donor” under 21 C.F.R. s. 606.121. 3899 (2) Any blood establishment operating in the state may not 3900 conduct any activity defined in paragraph (1)(a)subsection (1)3901 unless that blood establishment is operated in a manner 3902 consistent with the provisions of Title 21 C.F.R. parts 211 and 3903 600-640, Code of Federal Regulations. 3904 (3) Any blood establishment determined to be operating in 3905 the state in a manner not consistent with the provisions of 3906 Title 21 C.F.R. parts 211 and 600-640, Code of Federal3907Regulations,and in a manner that constitutes a danger to the 3908 health or well-being of donors or recipients as evidenced by the 3909 federal Food and Drug Administration’s inspection reports and 3910 the revocation of the blood establishment’s license or 3911 registration isshall bein violation of this chapter and must 3912shallimmediately cease all operations in the state. 3913 (4) The operation of a blood establishment in a manner not 3914 consistent with the provisions of Title 21 C.F.R. parts 211 and 3915 600-640, Code of Federal Regulations,and in a manner that 3916 constitutes a danger to the health or well-being of blood donors 3917 or recipients as evidenced by the federal Food and Drug 3918 Administration’s inspection process is declared a nuisance and 3919 inimical to the public health, welfare, and safety. The Agency 3920 for Health Care Administration or any state attorney may bring 3921 an action for an injunction to restrain such operations or 3922 enjoin the future operation of the blood establishment. 3923 (5) A local government may not restrict the access to or 3924 use of any public facility or infrastructure for the collection 3925 of blood or blood components from volunteer donors based on 3926 whether the blood establishment is operating as a for-profit 3927 organization or not-for-profit organization. 3928 (6) In determining the service fee of blood or blood 3929 components received from volunteer donors and sold to hospitals 3930 or other health care providers, a blood establishment may not 3931 base the service fee of the blood or blood component solely on 3932 whether the purchasing entity is a for-profit organization or 3933 not-for-profit organization. 3934 (7) A blood establishment that collects blood or blood 3935 components from volunteer donors must disclose on the Internet 3936 the information required under this subsection to educate and 3937 inform donors and the public about the blood establishment’s 3938 activities. A hospital that collects blood or blood components 3939 to be used only by that hospital’s licensed facilities or by a 3940 health care provider that is a part of the hospital’s business 3941 entity is exempt from the disclosure requirements in this 3942 subsection. The information required to be disclosed under this 3943 subsection may be cumulative for all blood establishments within 3944 a business entity. A blood establishment must disclose on its 3945 website all of the following information: 3946 (a) A description of the steps involved in collecting, 3947 processing, and distributing volunteer donations. 3948 (b) By March 1 of each year, the number of units of blood 3949 components which were: 3950 1. Produced by the blood establishment during the preceding 3951 calendar year; 3952 2. Obtained from other sources during the preceding 3953 calendar year; 3954 3. Distributed during the preceding calendar year to health 3955 care providers located outside this state. However, if the blood 3956 establishment collects donations in a county outside this state, 3957 distributions to health care providers in that county shall be 3958 excluded. Such information shall be reported in the aggregate 3959 for health care providers located within the United States and 3960 its territories or outside the United States and its 3961 territories; and 3962 4. Distributed during the preceding calendar year to 3963 entities that are not health care providers. Such information 3964 shall be reported in the aggregate for purchasers located within 3965 the United States and its territories or outside the United 3966 States and its territories. 3967 (c) The blood establishment’s conflict-of-interest policy, 3968 policy concerning related-party transactions, whistleblower 3969 policy, and policy for determining executive compensation. If a 3970 change occurs to any of these documents, the revised document 3971 must be available on the blood establishment’s website by the 3972 following March 1. 3973 (d) Except for a hospital that collects blood or blood 3974 components from volunteer donors: 3975 1. The most recent 3 years of the Return of Organization 3976 Exempt from Income Tax, Internal Revenue Service Form 990, if 3977 the business entity for the blood establishment is eligible to 3978 file such return. The Form 990 must be available on the blood 3979 establishment’s website within 60 calendar days after it is 3980 filed with the Internal Revenue Service; or 3981 2. If the business entity for the blood establishment is 3982 not eligible to file the Form 990 return, a balance sheet, 3983 income statement, and statement of changes in cash flow, along 3984 with the expression of an opinion thereon by an independent 3985 certified public accountant who audited or reviewed such 3986 financial statements. Such documents must be available on the 3987 blood establishment’s website within 120 days after the end of 3988 the blood establishment’s fiscal year and must remain on the 3989 blood establishment’s website for at least 36 months. 3990 (8) A blood establishment is liable for a civil penalty for 3991 failing to make the disclosures required under subsection (7). 3992 The Department of Legal Affairs may assess the civil penalty 3993 against the blood establishment for each day that it fails to 3994 make such required disclosures, but the penalty may not exceed 3995 $10,000 per year. If multiple blood establishments operated by a 3996 single business entity fail to meet such disclosure 3997 requirements, the civil penalty may be assessed against only one 3998 of the business entity’s blood establishments. The Department of 3999 Legal Affairs may terminate an action if the blood establishment 4000 agrees to pay a stipulated civil penalty. A civil penalty so 4001 collected accrues to the state and shall be deposited as 4002 received into the General Revenue Fund unallocated. The 4003 Department of Legal Affairs may terminate the action and waive 4004 the civil penalty upon a showing of good cause by the blood 4005 establishment as to why the required disclosures were not made. 4006 Section 104. Subsection (23) of section 499.003, Florida 4007 Statutes, is amended to read: 4008 499.003 Definitions of terms used in this part.—As used in 4009 this part, the term: 4010 (23) “Health care entity” means a closed pharmacy or any 4011 person, organization, or business entity that provides 4012 diagnostic, medical, surgical, or dental treatment or care, or 4013 chronic or rehabilitative care, but does not include any 4014 wholesale distributor or retail pharmacy licensed under state 4015 law to deal in prescription drugs. However, a blood 4016 establishment is a health care entity that may engage in the 4017 wholesale distribution of prescription drugs under s. 4018 499.01(2)(g)1.c. 4019 Section 105. Subsection (21) of section 499.005, Florida 4020 Statutes, is amended to read: 4021 499.005 Prohibited acts.—It is unlawful for a person to 4022 perform or cause the performance of any of the following acts in 4023 this state: 4024 (21) The wholesale distribution of any prescription drug 4025 that was: 4026 (a) Purchased by a public or private hospital or other 4027 health care entity; or 4028 (b) Donated or supplied at a reduced price to a charitable 4029 organization, 4030 4031 unless the wholesale distribution of the prescription drug is 4032 authorized in s. 499.01(2)(g)1.c. 4033 Section 106. Paragraphs (a) and (g) of subsection (2) of 4034 section 499.01, Florida Statutes, are amended to read: 4035 499.01 Permits.— 4036 (2) The following permits are established: 4037 (a) Prescription drug manufacturer permit.—A prescription 4038 drug manufacturer permit is required for any person that is a 4039 manufacturer of a prescription drug and that manufactures or 4040 distributes such prescription drugs in this state. 4041 1. A person that operates an establishment permitted as a 4042 prescription drug manufacturer may engage in wholesale 4043 distribution of prescription drugs manufactured at that 4044 establishment and must comply with all of the provisions of this 4045 part, except s. 499.01212, and the rules adopted under this 4046 part, except s. 499.01212, whichthatapply to a wholesale 4047 distributor. 4048 2. A prescription drug manufacturer must comply with all 4049 appropriate state and federal good manufacturing practices. 4050 3. A blood establishment, as defined in s. 381.06014, 4051 operating in a manner consistent with the provisions of Title 21 4052 C.F.R. parts 211 and 600-640, and manufacturing only the 4053 prescription drugs described in s. 499.003(54)(d) is not 4054 required to be permitted as a prescription drug manufacturer 4055 under this paragraph or to register products under s. 499.015. 4056 (g) Restricted prescription drug distributor permit.— 4057 1. A restricted prescription drug distributor permit is 4058 required for: 4059 a. Any person located in this state that engages in the 4060 distribution of a prescription drug, which distribution is not 4061 considered “wholesale distribution” under s. 499.003(54)(a). 4062 b.1.AnyAperson located in this state who engages in the 4063 receipt or distribution of a prescription drug in this state for 4064 the purpose of processing its return or its destructionmust4065obtain a permit as a restricted prescription drug distributorif 4066 such person is not the person initiating the return, the 4067 prescription drug wholesale supplier of the person initiating 4068 the return, or the manufacturer of the drug. 4069 c. A blood establishment located in this state which 4070 collects blood and blood components only from volunteer donors 4071 as defined in s. 381.06014 or pursuant to an authorized 4072 practitioner’s order for medical treatment or therapy and 4073 engages in the wholesale distribution of a prescription drug not 4074 described in s. 499.003(54)(d) to a health care entity. The 4075 health care entity receiving a prescription drug distributed 4076 under this sub-subparagraph must be licensed as a closed 4077 pharmacy or provide health care services at that establishment. 4078 The blood establishment must operate in accordance with s. 4079 381.06014 and may distribute only: 4080 (I) Prescription drugs indicated for a bleeding or clotting 4081 disorder or anemia; 4082 (II) Blood-collection containers approved under s. 505 of 4083 the federal act; 4084 (III) Drugs that are blood derivatives, or a recombinant or 4085 synthetic form of a blood derivative; 4086 (IV) Prescription drugs that are identified in rules 4087 adopted by the department and that are essential to services 4088 performed or provided by blood establishments and authorized for 4089 distribution by blood establishments under federal law; or 4090 (V) To the extent authorized by federal law, drugs 4091 necessary to collect blood or blood components from volunteer 4092 blood donors; for blood establishment personnel to perform 4093 therapeutic procedures under the direction and supervision of a 4094 licensed physician; and to diagnose, treat, manage, and prevent 4095 any reaction of either a volunteer blood donor or a patient 4096 undergoing a therapeutic procedure performed under the direction 4097 and supervision of a licensed physician, 4098 4099 as long as all of the health care services provided by the blood 4100 establishment are related to its activities as a registered 4101 blood establishment or the health care services consist of 4102 collecting, processing, storing, or administering human 4103 hematopoietic stem cells or progenitor cells or performing 4104 diagnostic testing of specimens if such specimens are tested 4105 together with specimens undergoing routine donor testing. 4106 2. Storage, handling, and recordkeeping of these 4107 distributions by a person required to be permitted as a 4108 restricted prescription drug distributor must comply with the 4109 requirements for wholesale distributors under s. 499.0121, but 4110 not those set forth in s. 499.01212 if the distribution occurs 4111 pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b. 4112 3. A person who applies for a permit as a restricted 4113 prescription drug distributor, or for the renewal of such a 4114 permit, must provide to the department the information required 4115 under s. 499.012. 4116 4. The department may adopt rules regarding the 4117 distribution of prescription drugs by hospitals, health care 4118 entities, charitable organizations,orother persons not 4119 involved in wholesale distribution, and blood establishments, 4120 which rules are necessary for the protection of the public 4121 health, safety, and welfare. 4122 Section 107. This act shall take effect July 1, 2011.