Bill Text: FL S1884 | 2012 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Health Regulation by the Agency for Health Care Administration
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Introduced - Dead) 2012-03-09 - Died on Calendar, companion bill(s) passed, see CS/HB 517 (Ch. [S1884 Detail]
Download: Florida-2012-S1884-Comm_Sub.html
Bill Title: Health Regulation by the Agency for Health Care Administration
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Introduced - Dead) 2012-03-09 - Died on Calendar, companion bill(s) passed, see CS/HB 517 (Ch. [S1884 Detail]
Download: Florida-2012-S1884-Comm_Sub.html
Florida Senate - 2012 CS for SB 1884 By the Committee on Health Regulation; and Senator Garcia 588-02736A-12 20121884c1 1 A bill to be entitled 2 An act relating to health regulation by the Agency for 3 Health Care Administration; amending s. 83.42, F.S., 4 relating to exclusions from part II of ch. 83, F.S., 5 the Florida Residential Landlord and Tenant Act; 6 clarifying that the procedures in s. 400.0255, F.S., 7 for transfers and discharges are exclusive to 8 residents of a nursing home licensed under part II of 9 ch. 400, F.S.; amending s. 112.0455, F.S., relating to 10 the Drug-Free Workplace Act; deleting a provision 11 regarding retroactivity of the act; deleting a 12 provision specifying that the act does not abrogate 13 the right of an employer under state law to conduct 14 drug tests before a certain date; deleting a provision 15 that requires a laboratory to submit to the Agency for 16 Health Care Administration a monthly report containing 17 statistical information regarding the testing of 18 employees and job applicants; amending s. 318.21, 19 F.S.; providing that a portion of the additional fines 20 assessed for traffic violations within an enhanced 21 penalty zone be remitted to the Department of Revenue 22 and deposited into the Brain and Spinal Cord Injury 23 Trust Fund of the Department of Health to serve 24 certain Medicaid recipients; repealing s. 383.325, 25 F.S., relating to confidentiality of inspection 26 reports of licensed birth center facilities; creating 27 s. 385.2031, F.S.; designating the Florida 28 Hospital/Sandford-Burnham Translational Research 29 Institute for Metabolism and Diabetes as a resource 30 for research in the prevention and treatment of 31 diabetes; amending s. 395.002, F.S.; redefining the 32 term “accrediting organizations” as it applies to the 33 regulation of hospitals and other licensed facilities; 34 conforming a cross-reference; amending s. 395.003, 35 F.S.; deleting an obsolete provision; authorizing a 36 specialty–licensed children’s hospital that has at 37 least a specified number of licensed neonatal 38 intensive care unit beds to provide obstetrical 39 services that are restricted to the diagnosis, care, 40 and treatment of certain pregnant women; authorizing 41 the Agency for Health Care Administration to adopt 42 rules; amending s. 395.0161, F.S.; deleting a 43 requirement that facilities licensed under part I of 44 ch. 395, F.S., pay licensing fees at the time of 45 inspection; amending s. 395.0193, F.S.; requiring a 46 licensed facility to report certain peer review 47 information and final disciplinary actions to the 48 Division of Medical Quality Assurance of the 49 Department of Health rather than the Division of 50 Health Quality Assurance of the Agency for Health Care 51 Administration; amending s. 395.1023, F.S.; providing 52 for the Department of Children and Family Services 53 rather than the Department of Health to perform 54 certain functions with respect to child protection 55 cases; requiring certain hospitals to notify the 56 Department of Children and Family Services of 57 compliance; amending s. 395.1041, F.S., relating to 58 hospital emergency services and care; deleting 59 obsolete provisions; repealing s. 395.1046, F.S., 60 relating to complaint investigation procedures; 61 amending s. 395.1055, F.S.; requiring that licensed 62 facility beds conform to standards specified by the 63 Agency for Health Care Administration, the Florida 64 Building Code, and the Florida Fire Prevention Code; 65 amending s. 395.3025, F.S.; authorizing the disclosure 66 of patient records to the Department of Health rather 67 than the Agency for Health Care Administration in 68 accordance with an issued subpoena; requiring the 69 department, rather than the agency, to make available, 70 upon written request by a practitioner against whom 71 probable cause has been found, any patient records 72 that form the basis of the determination of probable 73 cause; amending s. 395.3036, F.S.; correcting a cross 74 reference; repealing s. 395.3037, F.S., relating to 75 redundant definitions for the Department of Health and 76 the Agency for Health Care Administration; amending s. 77 395.602, F.S.; revising the definition of the term 78 “rural hospital” to delete an obsolete provision; 79 amending s. 400.021, F.S.; revising the definitions of 80 the terms “geriatric outpatient clinic” and “resident 81 care plan”; amending s. 400.275, F.S.; revising agency 82 duties with regard to training nursing home surveyor 83 teams; revising requirements for team members; 84 amending s. 400.474, F.S.; revising the requirements 85 for a quarterly report submitted to the Agency for 86 Health Care Administration by each home health agency; 87 amending s. 400.484, F.S.; revising the classification 88 of violations by a home health agency for which the 89 agency imposes an administrative fine; amending and 90 reenacting s. 400.506, F.S., relating to licensure of 91 nurse registries, to incorporate the amendment made to 92 s. 400.509, F.S., in a reference thereto; authorizing 93 an administrator to manage up to five nurse registries 94 under certain circumstances; requiring an 95 administrator to designate, in writing, for each 96 licensed entity, a qualified alternate administrator 97 to serve during the administrator’s absence; amending 98 s. 400.509, F.S.; providing that organizations that 99 provide companion services only to persons with 100 developmental disabilities, under contract with the 101 Agency for Persons with Disabilities, are exempt from 102 registration with the Agency for Health Care 103 Administration; amending s. 400.601, F.S.; redefining 104 the term “hospice” to include a limited liability 105 company as it relates to nursing homes and related 106 health care facilities; amending s. 400.606, F.S.; 107 revising the content requirements of the plan 108 accompanying an initial or change-of-ownership 109 application for licensure of a hospice; revising 110 requirements relating to certificates of need for 111 certain hospice facilities; amending s. 400.915, F.S.; 112 correcting an obsolete cross-reference to 113 administrative rules; amending s. 400.931, F.S.; 114 requiring each applicant for initial licensure, change 115 of ownership, or license renewal to operate a licensed 116 home medical equipment provider at a location outside 117 the state to submit documentation of accreditation, or 118 an application for accreditation, from an accrediting 119 organization that is recognized by the Agency for 120 Health Care Administration; requiring an applicant 121 that has applied for accreditation to provide proof of 122 accreditation within a specified time; deleting a 123 requirement that an applicant for a home medical 124 equipment provider license submit a surety bond to the 125 agency; amending s. 400.967, F.S.; revising the 126 classification of violations by intermediate care 127 facilities for the developmentally disabled; providing 128 a penalty for certain violations; amending s. 129 400.9905, F.S.; revising the definitions of the terms 130 “clinic” and “portable equipment provider”; 131 authorizing the Agency for Health Care Administration 132 to deny or revoke an exemption from licensure based on 133 certain criteria if a health care clinic receives 134 payment for health care services under personal injury 135 protection insurance coverage; including health 136 services provided at multiple locations within the 137 definition of the term “portable health service or 138 equipment provider”; amending s. 400.991, F.S.; 139 conforming terminology; revising application 140 requirements relating to documentation of financial 141 ability to operate a mobile clinic; amending s. 142 408.033, F.S.; providing that fees assessed on 143 selected health care facilities and organizations may 144 be collected prospectively at the time of licensure 145 renewal and prorated for the licensing period; 146 amending s. 408.034, F.S.; revising agency authority 147 relating to licensing of intermediate care facilities 148 for the developmentally disabled; amending s. 408.036, 149 F.S.; deleting an exemption from certain certificate 150 of-need review requirements for a hospice or a hospice 151 inpatient facility; amending s. 408.037, F.S.; 152 revising requirements for the financial information to 153 be included in an application for a certificate of 154 need; amending s. 408.043, F.S.; revising requirements 155 for certain freestanding inpatient hospice care 156 facilities to obtain a certificate of need; amending 157 s. 408.061, F.S.; revising data reporting requirements 158 for health care facilities; amending s. 408.07, F.S.; 159 deleting a cross-reference; amending s. 408.10, F.S.; 160 removing agency authority to investigate certain 161 consumer complaints; amending s. 408.7056, F.S.; 162 providing that the Subscriber Assistance Program 163 applies to health plans that meet certain 164 requirements; repealing s. 408.802(11), F.S.; removing 165 applicability of part II of ch. 408, F.S., relating to 166 general licensure requirements, to private review 167 agents; amending s. 408.804, F.S.; providing penalties 168 for altering, defacing, or falsifying a license 169 certificate issued by the agency or displaying such an 170 altered, defaced, or falsified certificate; amending 171 s. 408.806, F.S.; revising agency responsibilities for 172 notification of licensees of impending expiration of a 173 license; requiring payment of a late fee for a license 174 application to be considered complete under certain 175 circumstances; amending s. 408.8065, F.S.; revising 176 the requirements for becoming licensed as a home 177 health agency, home medical equipment provider, or 178 health care clinic; amending s. 408.809, F.S.; 179 revising provisions to include a schedule for 180 background rescreenings of certain employees; amending 181 s. 408.810, F.S.; requiring that the controlling 182 interest of a health care licensee notify the agency 183 of certain court proceedings; providing a penalty; 184 amending s. 408.813, F.S.; authorizing the agency to 185 impose fines for unclassified violations of part II of 186 ch. 408, F.S.; amending s. 409.912, F.S.; revising the 187 components of the Medicaid prescribed-drug spending 188 control program; amending s. 409.91195, F.S.; revising 189 the membership of the Medicaid Pharmaceutical and 190 Therapeutics Committee; providing the requirements for 191 the members; providing terms of membership; requiring 192 the Agency for Health Care Administration to serve as 193 staff for the committee and assist the committee with 194 its duties; providing additional requirements for 195 presenting public testimony to include a product on a 196 preferred drug list; requiring that the committee be 197 informed in writing of the agency’s action when the 198 agency does not follow the recommendation of the 199 committee; amending s. 409.975, F.S.; providing that 200 an essential provider and a hospital that is necessary 201 for a managed care plan to demonstrate an adequate 202 network as determined by the Agency for Health Care 203 Administration is part of that managed care plan’s 204 network for purposes of the provider’s or hospital’s 205 application for enrollment or expansion in the 206 Medicaid program; requiring that a managed care plan’s 207 payment under this provision to an essential provider 208 be made in accordance with s. 409.975, F.S., regarding 209 managed care plan accountability; repealing s. 210 429.11(6), F.S., relating to provisional licenses for 211 assisted living facilities; amending s. 429.294, F.S.; 212 revising a cross-reference; amending s. 429.71, F.S.; 213 revising the classification of violations; amending s. 214 429.915, F.S.; revising agency responsibilities 215 regarding the issuance of conditional licenses; 216 amending ss. 430.80 and 430.81, F.S.; conforming 217 cross-references; repealing s. 440.102(9)(d), F.S., 218 relating to a requirement that laboratories submit to 219 the Agency for Health Care Administration a monthly 220 report containing statistical information regarding 221 the testing of employees and job applicants; amending 222 s. 483.035, F.S.; providing for a clinical laboratory 223 to be operated by certain nurses; amending s. 483.051, 224 F.S.; requiring the Agency for Health Care 225 Administration to provide for biennial licensure of 226 all nonwaived laboratories that meet certain 227 requirements; requiring the agency to prescribe 228 qualifications for such licensure; defining nonwaived 229 laboratories as laboratories that do not have a 230 certificate of waiver from the Centers for Medicare 231 and Medicaid Services; deleting requirements for the 232 registration of an alternate site testing location 233 when the clinical laboratory applies to renew its 234 license; amending s. 483.245, F.S.; prohibiting a 235 clinical laboratory from placing a specimen collector 236 or other personnel in any physician’s office, unless 237 the clinical lab and the physician’s office are owned 238 and operated by the same entity; authorizing a person 239 who is aggrieved by a violation to bring a civil 240 action for appropriate relief; amending s. 483.294, 241 F.S.; revising the frequency of agency inspections of 242 multiphasic health testing centers; amending s. 243 499.003, F.S.; redefining the term “wholesale 244 distribution” with regard to the Florida Drug and 245 Cosmetic Act to remove certain requirements governing 246 prescription drug inventories; amending and creating, 247 respectively, ss. 627.602 and 627.6513, F.S.; 248 providing that the Uniform Health Carrier External 249 Review Model Act and the Employee Retirement Income 250 Security Act apply to individual and group health 251 insurance policies except those subject to the 252 Subscriber Assistance Program under s. 408.7056, F.S.; 253 creating s. 641.312, F.S.; requiring the Office of 254 Insurance Regulation within the Department of 255 Financial Services to administer the National 256 Association of Insurance Commissioners’ Uniform Health 257 Carrier External Review Model Act; providing that the 258 Uniform Health Carrier External Review Model Act does 259 not apply to a health maintenance contract that is 260 subject to the Subscriber Assistance Program under s. 261 408.7056, F.S.; amending s. 651.118, F.S.; conforming 262 a cross-reference; providing a directive to the 263 Division of Statutory Revision; providing effective 264 dates. 265 266 Be It Enacted by the Legislature of the State of Florida: 267 268 Section 1. Subsection (1) of section 83.42, Florida 269 Statutes, is amended to read: 270 83.42 Exclusions from application of part.—This part does 271 not apply to: 272 (1) Residency or detention in a facility, whether public or 273 private, when residence or detention is incidental to the 274 provision of medical, geriatric, educational, counseling, 275 religious, or similar services. For residents of a facility 276 licensed under part II of chapter 400, the provisions of s. 277 400.0255 are the exclusive procedures for all transfers and 278 discharges. 279 Section 2. Present paragraphs (f) through (k) of subsection 280 (10) of section 112.0455, Florida Statutes, are redesignated as 281 paragraphs (e) through (j), respectively, and present paragraph 282 (e) of subsection (10), subsection (12), and paragraph (e) of 283 subsection (14) of that section are amended to read: 284 112.0455 Drug-Free Workplace Act.— 285 (10) EMPLOYER PROTECTION.— 286(e) Nothing in this section shall be construed to operate287retroactively, and nothing in this section shall abrogate the288right of an employer under state law to conduct drug tests prior289to January 1, 1990. A drug test conducted by an employer prior290to January 1, 1990, is not subject to this section.291 (12) DRUG-TESTING STANDARDS; LABORATORIES.— 292 (a) The requirements of part II of chapter 408 apply to the 293 provision of services that require licensure pursuant to this 294 section and part II of chapter 408 and to entities licensed by 295 or applying for such licensure from the Agency for Health Care 296 Administration pursuant to this section. A license issued by the 297 agency is required in order to operate a laboratory. 298 (b) A laboratory may analyze initial or confirmation drug 299 specimens only if: 300 1. The laboratory is licensed and approved by the Agency 301 for Health Care Administration using criteria established by the 302 United States Department of Health and Human Services as general 303 guidelines for modeling the state drug testing program and in 304 accordance with part II of chapter 408. Each applicant for 305 licensure and licensee must comply with all requirements of part 306 II of chapter 408. 307 2. The laboratory has written procedures to ensure chain of 308 custody. 309 3. The laboratory follows proper quality control 310 procedures, including, but not limited to: 311 a. The use of internal quality controls including the use 312 of samples of known concentrations which are used to check the 313 performance and calibration of testing equipment, and periodic 314 use of blind samples for overall accuracy. 315 b. An internal review and certification process for drug 316 test results, conducted by a person qualified to perform that 317 function in the testing laboratory. 318 c. Security measures implemented by the testing laboratory 319 to preclude adulteration of specimens and drug test results. 320 d. Other necessary and proper actions taken to ensure 321 reliable and accurate drug test results. 322 (c) A laboratory shall disclose to the employer a written 323 test result report within 7 working days after receipt of the 324 sample. All laboratory reports of a drug test result shall, at a 325 minimum, state: 326 1. The name and address of the laboratory which performed 327 the test and the positive identification of the person tested. 328 2. Positive results on confirmation tests only, or negative 329 results, as applicable. 330 3. A list of the drugs for which the drug analyses were 331 conducted. 332 4. The type of tests conducted for both initial and 333 confirmation tests and the minimum cutoff levels of the tests. 334 5. Any correlation between medication reported by the 335 employee or job applicant pursuant to subparagraph (8)(b)2. and 336 a positive confirmed drug test result. 337 338 ANoreport may notshalldisclose the presence or absence of 339 any drug other than a specific drug and its metabolites listed 340 pursuant to this section. 341(d) The laboratory shall submit to the Agency for Health342Care Administration a monthly report with statistical343information regarding the testing of employees and job344applicants. The reports shall include information on the methods345of analyses conducted, the drugs tested for, the number of346positive and negative results for both initial and confirmation347tests, and any other information deemed appropriate by the348Agency for Health Care Administration. No monthly report shall349identify specific employees or job applicants.350 (d)(e)Laboratories shall provide technical assistance to 351 the employer, employee, or job applicant for the purpose of 352 interpreting any positive confirmed test results which could 353 have been caused by prescription or nonprescription medication 354 taken by the employee or job applicant. 355 (14) DISCIPLINE REMEDIES.— 356 (e) Upon resolving an appeal filed pursuant to paragraph 357 (c), and finding a violation of this section, the commission may 358 order the following relief: 359 1. Rescind the disciplinary action, expunge related records 360 from the personnel file of the employee or job applicant and 361 reinstate the employee. 362 2. Order compliance with paragraph (10)(f)(10)(g). 363 3. Award back pay and benefits. 364 4. Award the prevailing employee or job applicant the 365 necessary costs of the appeal, reasonable attorney’s fees, and 366 expert witness fees. 367 Section 3. Subsection (15) of section 318.21, Florida 368 Statutes, is amended to read: 369 318.21 Disposition of civil penalties by county courts.—All 370 civil penalties received by a county court pursuant to the 371 provisions of this chapter shall be distributed and paid monthly 372 as follows: 373 (15) Of the additional fine assessed under s. 318.18(3)(e) 374 for a violation of s. 316.1893, 50 percent of the moneys 375 received from the fines shall be remitted to the Department of 376 Revenue and deposited into the Brain and Spinal Cord Injury 377 Trust Fund of Department of Health and appropriated to the 378 Department of HealthAgency for Health Care Administrationas 379 general revenue toprovide an enhanced Medicaid payment to380nursing homes thatserve Medicaid recipients who havewithbrain 381 and spinal cord injuries that are medically complex and who are 382 technologically and respiratory dependent. The remaining 50 383 percent of the moneys received from the enhanced fine imposed 384 under s. 318.18(3)(e) shall be remitted to the Department of 385 Revenue and deposited into the Department of Health Emergency 386 Medical Services Trust Fund to provide financial support to 387 certified trauma centers in the counties where enhanced penalty 388 zones are established to ensure the availability and 389 accessibility of trauma services. Funds deposited into the 390 Emergency Medical Services Trust Fund under this subsection 391 shall be allocated as follows: 392 (a) Fifty percent shall be allocated equally among all 393 Level I, Level II, and pediatric trauma centers in recognition 394 of readiness costs for maintaining trauma services. 395 (b) Fifty percent shall be allocated among Level I, Level 396 II, and pediatric trauma centers based on each center’s relative 397 volume of trauma cases as reported in the Department of Health 398 Trauma Registry. 399 Section 4. Section 383.325, Florida Statutes, is repealed. 400 Section 5. Section 385.2031, Florida Statutes, is created 401 to read: 402 385.2031 Resource for research in the prevention and 403 treatment of diabetes.—The Florida Hospital/Sanford-Burnham 404 Translational Research Institute for Metabolism and Diabetes is 405 designated as a resource in this state for research in the 406 prevention and treatment of diabetes. 407 Section 6. Subsection (1) of section 395.002, Florida 408 Statutes, is amended to read: 409 395.002 Definitions.—As used in this chapter: 410 (1) “Accrediting organizations” means national 411 accreditation organizations that are approved by the Centers for 412 Medicare and Medicaid Services and whose standards incorporate 413 comparable licensure regulations required by the statethe Joint414Commission on Accreditation of Healthcare Organizations, the415American Osteopathic Association, the Commission on416Accreditation of Rehabilitation Facilities, and the417Accreditation Association for Ambulatory Health Care, Inc. 418 Section 7. Paragraph (c) of subsection (1) and subsection 419 (6) of section 395.003, Florida Statutes, are amended to read: 420 395.003 Licensure; denial, suspension, and revocation.— 421 (1) 422(c) Until July 1, 2006, additional emergency departments423located off the premises of licensed hospitals may not be424authorized by the agency.425 (6) A specialty hospital may not provide any service or 426 regularly serve any population group beyond those services or 427 groups specified in its license. A specialty-licensed children’s 428 hospital that is authorized to provide pediatric cardiac 429 catheterization and pediatric open-heart surgery services may 430 provide cardiovascular service to adults who, as children, were 431 previously served by the hospital for congenital heart disease, 432 or to those patients who are referred for a specialized 433 procedure only for congenital heart disease by an adult 434 hospital, without obtaining additional licensure as a provider 435 of adult cardiovascular services. The agency may request 436 documentation as needed to support patient selection and 437 treatment. This subsection does not apply to a specialty 438 licensed children’s hospital that is already licensed to provide 439 adult cardiovascular services. A specialty–licensed children’s 440 hospital that has at least 50 licensed neonatal intensive care 441 unit beds may provide obstetrical services, including labor and 442 delivery, which are restricted to the diagnosis, care, and 443 treatment of pregnant women of any age who have: 444 (a) At least one maternal or fetal characteristic or 445 condition that would characterize the pregnancy or delivery as 446 high-risk; or 447 (b) Received medical advice or a diagnosis indicating their 448 fetus will require at least one perinatal intervention. 449 450 The agency shall adopt rules that establish standards and 451 guidelines for admission to any program that qualifies under 452 this subsection. 453 Section 8. Subsection (3) of section 395.0161, Florida 454 Statutes, is amended to read: 455 395.0161 Licensure inspection.— 456 (3) In accordance with s. 408.805, an applicant or licensee 457 shall pay a fee for each license application submitted under 458 this part, part II of chapter 408, and applicable rules. With 459 the exception of state-operated licensed facilities, each 460 facility licensed under this part shall pay to the agency, at461the time of inspection,the following fees: 462 (a) Inspection for licensure.—A fee shall be paid which is 463 not less than $8 per hospital bed, nor more than $12 per 464 hospital bed, except that the minimum fee shall be $400 per 465 facility. 466 (b) Inspection for lifesafety only.—A fee shall be paid 467 which is not less than 75 cents per hospital bed, nor more than 468 $1.50 per hospital bed, except that the minimum fee shall be $40 469 per facility. 470 Section 9. Subsections (2) and (4) of section 395.0193, 471 Florida Statutes, are amended to read: 472 395.0193 Licensed facilities; peer review; disciplinary 473 powers; agency or partnership with physicians.— 474 (2) Each licensed facility, as a condition of licensure, 475 shall provide for peer review of physicians who deliver health 476 care services at the facility. Each licensed facility shall 477 develop written, binding procedures by which such peer review 478 shall be conducted. Such procedures mustshallinclude: 479 (a) Mechanism for choosing the membership of the body or 480 bodies that conduct peer review. 481 (b) Adoption of rules of order for the peer review process. 482 (c) Fair review of the case with the physician involved. 483 (d) Mechanism to identify and avoid conflict of interest on 484 the part of the peer review panel members. 485 (e) Recording of agendas and minutes which do not contain 486 confidential material, for review by the Division of Medical 487 Quality Assurance of the departmentHealth Quality Assurance of488the agency. 489 (f) Review, at least annually, of the peer review 490 procedures by the governing board of the licensed facility. 491 (g) Focus of the peer review process on review of 492 professional practices at the facility to reduce morbidity and 493 mortality and to improve patient care. 494 (4) Pursuant to ss. 458.337 and 459.016, any disciplinary 495 actions taken under subsection (3) shall be reported in writing 496 to the Division of Medical Quality Assurance of the department 497Health Quality Assurance of the agencywithin 30 working days 498 after its initial occurrence, regardless of the pendency of 499 appeals to the governing board of the hospital. The notification 500 shall identify the disciplined practitioner, the action taken, 501 and the reason for such action. All final disciplinary actions 502 taken under subsection (3), if different from those which were 503 reported to the departmentagencywithin 30 days after the 504 initial occurrence, shall be reported within 10 working days to 505 the Division of Medical Quality Assurance of the department 506Health Quality Assurance of the agencyin writing and shall 507 specify the disciplinary action taken and the specific grounds 508 therefor. The division shall review each report and determine 509 whether it potentially involved conduct by the licensee that is 510 subject to disciplinary action, in which case s. 456.073 shall 511 apply. The reports are not subject to inspection under s. 512 119.07(1) even if the division’s investigation results in a 513 finding of probable cause. 514 Section 10. Section 395.1023, Florida Statutes, is amended 515 to read: 516 395.1023 Child abuse and neglect cases; duties.—Each 517 licensed facility shall adopt a protocol that, at a minimum, 518 requires the facility to: 519 (1) Incorporate a facility policy that every staff member 520 has an affirmative duty to report, pursuant to chapter 39, any 521 actual or suspected case of child abuse, abandonment, or 522 neglect; and 523 (2) In any case involving suspected child abuse, 524 abandonment, or neglect, designate, at the request of the 525 Department of Children and Family Services, a staff physician to 526 act as a liaison between the hospital and the Department of 527 Children and Family Services office which is investigating the 528 suspected abuse, abandonment, or neglect, and the child 529 protection team, as defined in s. 39.01, when the case is 530 referred to such a team. 531 532 Each general hospital and appropriate specialty hospital shall 533 comply with the provisions of this section and shall notify the 534 agency and the Department of Children and Family Services of its 535 compliance by sending a copy of its policy to the agency and the 536 Department of Children and Family Services as required by rule. 537 The failure by a general hospital or appropriate specialty 538 hospital to comply shall be punished by a fine not exceeding 539 $1,000, to be fixed, imposed, and collected by the agency. Each 540 day in violation is considered a separate offense. 541 Section 11. Subsection (2) and paragraph (d) of subsection 542 (3) of section 395.1041, Florida Statutes, are amended to read: 543 395.1041 Access to emergency services and care.— 544 (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency 545 shall establish and maintain an inventory of hospitals with 546 emergency services. The inventory shall list all services within 547 the service capability of the hospital, and such services shall 548 appear on the face of the hospital license. Each hospital having 549 emergency services shall notify the agency of its service 550 capability in the manner and form prescribed by the agency. The 551 agency shall use the inventory to assist emergency medical 552 services providers and others in locating appropriate emergency 553 medical care. The inventory shall also be made available to the 554 general public.On or before August 1, 1992, the agency shall555request that each hospital identify the services which are556within its service capability. On or before November 1, 1992,557the agency shall notify each hospital of the service capability558to be included in the inventory. The hospital has 15 days from559the date of receipt to respond to the notice. By December 1,5601992, the agency shall publish a final inventory.Each hospital 561 shall reaffirm its service capability when its license is 562 renewed and shall notify the agency of the addition of a new 563 service or the termination of a service prior to a change in its 564 service capability. 565 (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF 566 FACILITY OR HEALTH CARE PERSONNEL.— 567 (d)1. Every hospital shall ensure the provision of services 568 within the service capability of the hospital, at all times, 569 either directly or indirectly through an arrangement with 570 another hospital, through an arrangement with one or more 571 physicians, or as otherwise made through prior arrangements. A 572 hospital may enter into an agreement with another hospital for 573 purposes of meeting its service capability requirement, and 574 appropriate compensation or other reasonable conditions may be 575 negotiated for these backup services. 576 2. If any arrangement requires the provision of emergency 577 medical transportation, such arrangement must be made in 578 consultation with the applicable provider and may not require 579 the emergency medical service provider to provide transportation 580 that is outside the routine service area of that provider or in 581 a manner that impairs the ability of the emergency medical 582 service provider to timely respond to prehospital emergency 583 calls. 584 3. A hospital isshallnotberequired to ensure service 585 capability at all times as required in subparagraph 1. if, prior 586 to the receiving of any patient needing such service capability, 587 such hospital has demonstrated to the agency that it lacks the 588 ability to ensure such capability and it has exhausted all 589 reasonable efforts to ensure such capability through backup 590 arrangements. In reviewing a hospital’s demonstration of lack of 591 ability to ensure service capability, the agency shall consider 592 factors relevant to the particular case, including the 593 following: 594 a. Number and proximity of hospitals with the same service 595 capability. 596 b. Number, type, credentials, and privileges of 597 specialists. 598 c. Frequency of procedures. 599 d. Size of hospital. 600 4. The agency shall publishproposedrules implementing a 601 reasonable exemption procedureby November 1, 1992.Subparagraph6021. shall become effective upon the effective date of said rules603or January 31, 1993, whichever is earlier. For a period not to604exceed 1 year from the effective date of subparagraph 1., a605hospital requesting an exemption shall be deemed to be exempt606from offering the service until the agency initially acts to607deny or grant the original request.The agency has 45 days after 608fromthe date of receipt of the request to approve or deny the 609 request.After the first year from the effective date of610subparagraph 1.,If the agency fails to initially act within 611 thatthetime period, the hospital is deemed to be exempt from 612 offering the service until the agency initially acts to deny the 613 request. 614 Section 12. Section 395.1046, Florida Statutes, is 615 repealed. 616 Section 13. Paragraph (e) of subsection (1) of section 617 395.1055, Florida Statutes, is amended to read: 618 395.1055 Rules and enforcement.— 619 (1) The agency shall adopt rules pursuant to ss. 120.536(1) 620 and 120.54 to implement the provisions of this part, which shall 621 include reasonable and fair minimum standards for ensuring that: 622 (e) Licensed facility beds conform to minimum space, 623 equipment, and furnishings standards as specified by the agency, 624 the Florida Building Code, and the Florida Fire Prevention Code 625department. 626 Section 14. Paragraph (e) of subsection (4) of section 627 395.3025, Florida Statutes, is amended to read: 628 395.3025 Patient and personnel records; copies; 629 examination.— 630 (4) Patient records are confidential and must not be 631 disclosed without the consent of the patient or his or her legal 632 representative, but appropriate disclosure may be made without 633 such consent to: 634 (e) The departmentagencyupon subpoena issued pursuant to 635 s. 456.071., butThe records obtained thereby must be used 636 solely for the purpose of the agency, the department, and the 637 appropriate professional board in anitsinvestigation, 638 prosecution, and appeal of disciplinary proceedings. If the 639 departmentagencyrequests copies of the records, the facility 640 shall charge a fee pursuant to this sectionno more than its641actual copying costs, including reasonable staff time. The 642 records must be sealed and must not be available to the public 643 pursuant to s. 119.07(1) or any other statute providing access 644 to records, nor may they be available to the public as part of 645 the record of investigation for and prosecution in disciplinary 646 proceedings made available to the public by the agency, the 647 department, or the appropriate regulatory board. However, the 648 departmentagencymust make available, upon written request by a 649 practitioner against whom probable cause has been found, any 650 such records that form the basis of the determination of 651 probable cause. 652 Section 15. Subsection (2) of section 395.3036, Florida 653 Statutes, is amended to read: 654 395.3036 Confidentiality of records and meetings of 655 corporations that lease public hospitals or other public health 656 care facilities.—The records of a private corporation that 657 leases a public hospital or other public health care facility 658 are confidential and exempt from the provisions of s. 119.07(1) 659 and s. 24(a), Art. I of the State Constitution, and the meetings 660 of the governing board of a private corporation are exempt from 661 s. 286.011 and s. 24(b), Art. I of the State Constitution when 662 the public lessor complies with the public finance 663 accountability provisions of s. 155.40(5) with respect to the 664 transfer of any public funds to the private lessee and when the 665 private lessee meets at least three of the five following 666 criteria: 667 (2) The public lessor and the private lessee do not 668 commingle any of their funds in any account maintained by either 669 of them, other than the payment of the rent and administrative 670 fees or the transfer of funds pursuant to s. 155.40subsection671(2). 672 Section 16. Section 395.3037, Florida Statutes, is 673 repealed. 674 Section 17. Paragraph (e) of subsection (2) of section 675 395.602, Florida Statutes, is amended to read: 676 395.602 Rural hospitals.— 677 (2) DEFINITIONS.—As used in this part: 678 (e) “Rural hospital” means an acute care hospital licensed 679 under this chapter, having 100 or fewer licensed beds and an 680 emergency room, which is: 681 1. The sole provider within a county with a population 682 density of no greater than 100 persons per square mile; 683 2. An acute care hospital, in a county with a population 684 density of no greater than 100 persons per square mile, which is 685 at least 30 minutes of travel time, on normally traveled roads 686 under normal traffic conditions, from any other acute care 687 hospital within the same county; 688 3. A hospital supported by a tax district or subdistrict 689 whose boundaries encompass a population of 100 persons or fewer 690 per square mile; 6914. A hospital in a constitutional charter county with a692population of over 1 million persons that has imposed a local693option health service tax pursuant to law and in an area that694was directly impacted by a catastrophic event on August 24,6951992, for which the Governor of Florida declared a state of696emergency pursuant to chapter 125, and has 120 beds or less that697serves an agricultural community with an emergency room698utilization of no less than 20,000 visits and a Medicaid699inpatient utilization rate greater than 15 percent;700 4.5.A hospital with a service area that has a population 701 of 100 persons or fewer per square mile. As used in this 702 subparagraph, the term “service area” means the fewest number of 703 zip codes that account for 75 percent of the hospital’s 704 discharges for the most recent 5-year period, based on 705 information available from the hospital inpatient discharge 706 database in the Florida Center for Health Information and Policy 707 Analysis at the Agency for Health Care Administration; or 708 5.6.A hospital designated as a critical access hospital, 709 as defined in s. 408.07(15). 710 711 Population densities used in this paragraph must be based upon 712 the most recently completed United States census. A hospital 713 that received funds under s. 409.9116 for a quarter beginning no 714 later than July 1, 2002, is deemed to have been and shall 715 continue to be a rural hospital from that date through June 30, 716 2015, if the hospital continues to have 100 or fewer licensed 717 beds and an emergency room, or meets the criteria of718subparagraph 4. An acute care hospital that has not previously 719 been designated as a rural hospital and that meets the criteria 720 of this paragraph shall be granted such designation upon 721 application, including supporting documentation to the Agency 722 for Health Care Administration. 723 Section 18. Subsections (8) and (16) of section 400.021, 724 Florida Statutes, are amended to read: 725 400.021 Definitions.—When used in this part, unless the 726 context otherwise requires, the term: 727 (8) “Geriatric outpatient clinic” means a site for 728 providing outpatient health care to persons 60 years of age or 729 older, which is staffed by a registered nurse or a physician 730 assistant, or by a licensed practical nurse who is under the 731 direct supervision of a registered nurse, an advanced registered 732 nurse practitioner, a physician assistant, or a physician. 733 (16) “Resident care plan” means a written plan developed, 734 maintained, and reviewed not less than quarterly by a registered 735 nurse, with participation from other facility staff and the 736 resident or his or her designee or legal representative, which 737 includes a comprehensive assessment of the needs of an 738 individual resident; the type and frequency of services required 739 to provide the necessary care for the resident to attain or 740 maintain the highest practicable physical, mental, and 741 psychosocial well-being; a listing of services provided within 742 or outside the facility to meet those needs; and an explanation 743 of service goals.The resident care plan must be signed by the744director of nursing or another registered nurse employed by the745facility to whom institutional responsibilities have been746delegated and by the resident, the resident’s designee, or the747resident’s legal representative. The facility may not use an748agency or temporary registered nurse to satisfy the foregoing749requirement and must document the institutional responsibilities750that have been delegated to the registered nurse.751 Section 19. Subsection (1) of section 400.275, Florida 752 Statutes, is amended to read: 753 400.275 Agency duties.— 754 (1)The agency shall ensure that each newly hired nursing755home surveyor, as a part of basic training, is assigned full756time to a licensed nursing home for at least 2 days within a 7757day period to observe facility operations outside of the survey758process before the surveyor begins survey responsibilities. Such759observations may not be the sole basis of a deficiency citation760against the facility.The agency may not assign an individual to 761 be a member of a survey team for purposes of a survey, 762 evaluation, or consultation visit at a nursing home facility in 763 which the surveyor was an employee within the preceding 25764 years. 765 Section 20. Subsection (6) of section 400.474, Florida 766 Statutes, is amended, present subsection (7) is redesignated as 767 subsection (8), and a new subsection (7) is added to that 768 section, to read: 769 400.474 Administrative penalties.— 770 (6) The agency may deny, revoke, or suspend the license of 771 a home health agency and shall impose a fine of $5,000 against a 772 home health agency that: 773 (a) Gives remuneration for staffing services to: 774 1. Another home health agency with which it has formal or 775 informal patient-referral transactions or arrangements; or 776 2. A health services pool with which it has formal or 777 informal patient-referral transactions or arrangements, 778 779 unless the home health agency has activated its comprehensive 780 emergency management plan in accordance with s. 400.492. This 781 paragraph does not apply to a Medicare-certified home health 782 agency that provides fair market value remuneration for staffing 783 services to a non-Medicare-certified home health agency that is 784 part of a continuing care facility licensed under chapter 651 785 for providing services to its own residents if each resident 786 receiving home health services pursuant to this arrangement 787 attests in writing that he or she made a decision without 788 influence from staff of the facility to select, from a list of 789 Medicare-certified home health agencies provided by the 790 facility, that Medicare-certified home health agency to provide 791 the services. 792 (b) Provides services to residents in an assisted living 793 facility for which the home health agency does not receive fair 794 market value remuneration. 795 (c) Provides staffing to an assisted living facility for 796 which the home health agency does not receive fair market value 797 remuneration. 798 (d) Fails to provide the agency, upon request, with copies 799 of all contracts with assisted living facilities which were 800 executed within 5 years before the request. 801 (e) Gives remuneration to a case manager, discharge 802 planner, facility-based staff member, or third-party vendor who 803 is involved in the discharge planning process of a facility 804 licensed under chapter 395, chapter 429, or this chapter from 805 whom the home health agency receives referrals. 806(f) Fails to submit to the agency, within 15 days after the807end of each calendar quarter, a written report that includes the808following data based on data as it existed on the last day of809the quarter:8101. The number of insulin-dependent diabetic patients811receiving insulin-injection services from the home health812agency;8132. The number of patients receiving both home health814services from the home health agency and hospice services;8153. The number of patients receiving home health services816from that home health agency; and8174. The names and license numbers of nurses whose primary818job responsibility is to provide home health services to819patients and who received remuneration from the home health820agency in excess of $25,000 during the calendar quarter.821 (f)(g)Gives cash, or its equivalent, to a Medicare or 822 Medicaid beneficiary. 823 (g)(h)Has more than one medical director contract in 824 effect at one time or more than one medical director contract 825 and one contract with a physician-specialist whose services are 826 mandated for the home health agency in order to qualify to 827 participate in a federal or state health care program at one 828 time. 829 (h)(i)Gives remuneration to a physician without a medical 830 director contract being in effect. The contract must: 831 1. Be in writing and signed by both parties; 832 2. Provide for remuneration that is at fair market value 833 for an hourly rate, which must be supported by invoices 834 submitted by the medical director describing the work performed, 835 the dates on which that work was performed, and the duration of 836 that work; and 837 3. Be for a term of at least 1 year. 838 839 The hourly rate specified in the contract may not be increased 840 during the term of the contract. The home health agency may not 841 execute a subsequent contract with that physician which has an 842 increased hourly rate and covers any portion of the term that 843 was in the original contract. 844 (i)(j)Gives remuneration to: 845 1. A physician, and the home health agency is in violation 846 of paragraph (g)(h)or paragraph (h)(i); 847 2. A member of the physician’s office staff; or 848 3. An immediate family member of the physician, 849 850 if the home health agency has received a patient referral in the 851 preceding 12 months from that physician or physician’s office 852 staff. 853 (j)(k)Fails to provide to the agency, upon request, copies 854 of all contracts with a medical director which were executed 855 within 5 years before the request. 856 (k)(l)Demonstrates a pattern of billing the Medicaid 857 program for services to Medicaid recipients which are medically 858 unnecessary as determined by a final order. A pattern may be 859 demonstrated by a showing of at least two such medically 860 unnecessary services within one Medicaid program integrity audit 861 period. 862 863 Nothing in paragraph (e) or paragraph (i)(j)shall be 864 interpreted as applying to or precluding any discount, 865 compensation, waiver of payment, or payment practice permitted 866 by 42 U.S.C. s. 1320a-7(b) or regulations adopted thereunder, 867 including 42 C.F.R. s. 1001.952 or s. 1395nn or regulations 868 adopted thereunder. 869 (7) Each home health agency shall submit to the agency, 870 within 15 days after the end of each calendar quarter, a written 871 report that includes the following data as it existed on the 872 last day of the quarter: 873 (a) The number of insulin-dependent diabetic patients 874 receiving insulin-injection services from the home health 875 agency. 876 (b) The number of patients receiving home health services 877 from the home health agency who are also receiving hospice 878 services. 879 (c) The number of patients receiving home health services 880 from the home health agency. 881 (d) The names and license numbers of nurses whose primary 882 job responsibility is to provide home health services to 883 patients and who received remuneration from the home health 884 agency in excess of $25,000 during the calendar quarter. 885 (e) The number of physicians who were paid by the home 886 health agency for professional services of any kind during the 887 calendar quarter, the amount paid to each physician, and the 888 number of hours each physician spent performing those services. 889 890 If the quarterly report is not received by the agency on or 891 before the deadline, the agency shall impose a fine in the 892 amount of $200 for each day that the report is late, which may 893 not exceed $5,000 per quarter. 894 Section 21. Section 400.484, Florida Statutes, is amended 895 to read: 896 400.484 Right of inspection; violationsdeficiencies; 897 fines.— 898 (1) In addition to the requirements of s. 408.811, the 899 agency may make such inspections and investigations as are 900 necessary in order to determine the state of compliance with 901 this part, part II of chapter 408, and applicable rules. 902 (2) The agency shall impose fines for various classes of 903 violationsdeficienciesin accordance with the following 904 schedule: 905 (a) A class I violation is defined in s. 408.813deficiency906is any act, omission, or practice that results in a patient’s907death, disablement, or permanent injury, or places a patient at908imminent risk of death, disablement, or permanent injury. Upon 909 finding a class I violationdeficiency, the agency shall impose 910 an administrative fine in the amount of $15,000 for each 911 occurrence and each day that the violationdeficiencyexists. 912 (b) A class II violation is defined in s. 408.813 913deficiency is any act, omission, or practice that has a direct914adverse effect on the health, safety, or security of a patient. 915 Upon finding a class II violationdeficiency, the agency shall 916 impose an administrative fine in the amount of $5,000 for each 917 occurrence and each day that the violationdeficiencyexists. 918 (c) A class III violation is defined in s. 408.813 919deficiency is any act, omission, or practice that has an920indirect, adverse effect on the health, safety, or security of a921patient. Upon finding an uncorrected or repeated class III 922 violationdeficiency, the agency shall impose an administrative 923 fine not to exceed $1,000 for each occurrence and each day that 924 the uncorrected or repeated violationdeficiencyexists. 925 (d) A class IV violation is defined in s. 408.813 926deficiency is any act, omission, or practice related to required927reports, forms, or documents which does not have the potential928of negatively affecting patients. These violations are of a type 929 that the agency determines do not threaten the health, safety, 930 or security of patients. Upon finding an uncorrected or repeated 931 class IV violationdeficiency, the agency shall impose an 932 administrative fine not to exceed $500 for each occurrence and 933 each day that the uncorrected or repeated violationdeficiency934 exists. 935 (3) In addition to any other penalties imposed pursuant to 936 this section or part, the agency may assess costs related to an 937 investigation that results in a successful prosecution, 938 excluding costs associated with an attorney’s time. 939 Section 22. For the purpose of incorporating the amendment 940 made by this act to section 400.509, Florida Statutes, in a 941 reference thereto, paragraph (a) of subsection (6) of section 942 400.506 is reenacted, present subsection (17) of that section is 943 renumbered as subsection (18), and a new subsection (17) is 944 added to that section, to read: 945 400.506 Licensure of nurse registries; requirements; 946 penalties.— 947 (6)(a) A nurse registry may refer for contract in private 948 residences registered nurses and licensed practical nurses 949 registered and licensed under part I of chapter 464, certified 950 nursing assistants certified under part II of chapter 464, home 951 health aides who present documented proof of successful 952 completion of the training required by rule of the agency, and 953 companions or homemakers for the purposes of providing those 954 services authorized under s. 400.509(1). A licensed nurse 955 registry shall ensure that each certified nursing assistant 956 referred for contract by the nurse registry and each home health 957 aide referred for contract by the nurse registry is adequately 958 trained to perform the tasks of a home health aide in the home 959 setting. Each person referred by a nurse registry must provide 960 current documentation that he or she is free from communicable 961 diseases. 962 (17) An administrator may manage only one nurse registry, 963 except that an administrator may manage up to five registries if 964 all five registries have identical controlling interests as 965 defined in s. 408.803 and are located within one agency 966 geographic service area or within an immediately contiguous 967 county. An administrator shall designate, in writing, for each 968 licensed entity, a qualified alternate administrator to serve 969 during the administrator’s absence. 970 Section 23. Subsection (1) of section 400.509, Florida 971 Statutes, is amended to read: 972 400.509 Registration of particular service providers exempt 973 from licensure; certificate of registration; regulation of 974 registrants.— 975 (1) Any organization that provides companion services or 976 homemaker services and does not provide a home health service to 977 a person is exempt from licensure under this part. However, any 978 organization that provides companion services or homemaker 979 services must register with the agency. An organization under 980 contract with the Agency for Persons with Disabilities which 981 provides companion services only for persons with a 982 developmental disability, as defined in s. 393.063, is exempt 983 from registration. 984 Section 24. Subsection (3) of section 400.601, Florida 985 Statutes, is amended to read: 986 400.601 Definitions.—As used in this part, the term: 987 (3) “Hospice” means a centrally administered corporation or 988 a limited liability company that providesprovidinga continuum 989 of palliative and supportive care for the terminally ill patient 990 and his or her family. 991 Section 25. Paragraph (i) of subsection (1) and subsection 992 (4) of section 400.606, Florida Statutes, are amended to read: 993 400.606 License; application; renewal; conditional license 994 or permit; certificate of need.— 995 (1) In addition to the requirements of part II of chapter 996 408, the initial application and change of ownership application 997 must be accompanied by a plan for the delivery of home, 998 residential, and homelike inpatient hospice services to 999 terminally ill persons and their families. Such plan must 1000 contain, but need not be limited to: 1001(i) The projected annual operating cost of the hospice.1002 1003 If the applicant is an existing licensed health care provider, 1004 the application must be accompanied by a copy of the most recent 1005 profit-loss statement and, if applicable, the most recent 1006 licensure inspection report. 1007 (4) A freestanding hospice facility that isprimarily1008 engaged in providing inpatient and related services and that is 1009 not otherwise licensed as a health care facility shallbe1010required toobtain a certificate of need. However, a 1011 freestanding hospice facility that haswithsix or fewer beds is 1012shallnotberequired to comply with institutional standards 1013 such as, but not limited to, standards requiring sprinkler 1014 systems, emergency electrical systems, or special lavatory 1015 devices. 1016 Section 26. Section 400.915, Florida Statutes, is amended 1017 to read: 1018 400.915 Construction and renovation; requirements.—The 1019 requirements for the construction or renovation of a PPEC center 1020 shall comply with: 1021 (1) The provisions of chapter 553, which pertain to 1022 building construction standards, including plumbing, electrical 1023 code, glass, manufactured buildings, accessibility for the 1024 physically disabled; 1025 (2) The provisions of s. 633.022 and applicable rules 1026 pertaining to physicalminimumstandards for nonresidential 1027 child carephysicalfacilitiesin rule 10M-12.003, Florida1028Administrative Code, Child Care Standards; and 1029 (3) The standards or rules adopted pursuant to this part 1030 and part II of chapter 408. 1031 Section 27. Section 400.931, Florida Statutes, is amended 1032 to read: 1033 400.931 Application for license; fee;provisional license;1034temporary permit.— 1035 (1) In addition to the requirements of part II of chapter 1036 408, the applicant must file with the application satisfactory 1037 proof that the home medical equipment provider is in compliance 1038 with this part and applicable rules, including: 1039 (a) A report, by category, of the equipment to be provided, 1040 indicating those offered either directly by the applicant or 1041 through contractual arrangements with existing providers. 1042 Categories of equipment include: 1043 1. Respiratory modalities. 1044 2. Ambulation aids. 1045 3. Mobility aids. 1046 4. Sickroom setup. 1047 5. Disposables. 1048 (b) A report, by category, of the services to be provided, 1049 indicating those offered either directly by the applicant or 1050 through contractual arrangements with existing providers. 1051 Categories of services include: 1052 1. Intake. 1053 2. Equipment selection. 1054 3. Delivery. 1055 4. Setup and installation. 1056 5. Patient training. 1057 6. Ongoing service and maintenance. 1058 7. Retrieval. 1059 (c) A listing of those with whom the applicant contracts, 1060 both the providers the applicant uses to provide equipment or 1061 services to its consumers and the providers for whom the 1062 applicant provides services or equipment. 1063 (2) An applicant for initial licensure, change of 1064 ownership, or license renewal to operate a licensed home medical 1065 equipment provider at a location outside the state must submit 1066 documentation of accreditation or an application for 1067 accreditation from an accrediting organization that is 1068 recognized by the agency. An applicant that has applied for 1069 accreditation must provide proof of accreditation that is not 1070 conditional or provisional within 120 days after the date the 1071 agency receives the application for licensure or the application 1072 shall be withdrawn from further consideration. Such 1073 accreditation must be maintained by the home medical equipment 1074 provider in order to maintain licensure.As an alternative to1075submitting proof of financial ability to operate as required in1076s.408.810(8), the applicant may submit a $50,000 surety bond to1077the agency.1078 (3) As specified in part II of chapter 408, the home 1079 medical equipment provider must also obtain and maintain 1080 professional and commercial liability insurance. Proof of 1081 liability insurance, as defined in s. 624.605, must be submitted 1082 with the application. The agency shall set the required amounts 1083 of liability insurance by rule, but the required amount must not 1084 be less than $250,000 per claim. In the case of contracted 1085 services, it is required that the contractor have liability 1086 insurance not less than $250,000 per claim. 1087 (4) When a change of the general manager of a home medical 1088 equipment provider occurs, the licensee must notify the agency 1089 of the change within 45 days. 1090 (5) In accordance with s. 408.805, an applicant or a 1091 licensee shall pay a fee for each license application submitted 1092 under this part, part II of chapter 408, and applicable rules. 1093 The amount of the fee shall be established by rule and may not 1094 exceed $300 per biennium. The agency shall set the fees in an 1095 amount that is sufficient to cover its costs in carrying out its 1096 responsibilities under this part. However, state, county, or 1097 municipal governments applying for licenses under this part are 1098 exempt from the payment of license fees. 1099 (6) An applicant for initial licensure, renewal, or change 1100 of ownership shall also pay an inspection fee not to exceed 1101 $400, which shall be paid by all applicants except those not 1102 subject to licensure inspection by the agency as described in s. 1103 400.933. 1104 Section 28. Section 400.967, Florida Statutes, is amended 1105 to read: 1106 400.967 Rules and classification of violations 1107deficiencies.— 1108 (1) It is the intent of the Legislature that rules adopted 1109 and enforced under this part and part II of chapter 408 include 1110 criteria by which a reasonable and consistent quality of 1111 resident care may be ensured, the results of such resident care 1112 can be demonstrated, and safe and sanitary facilities can be 1113 provided. 1114 (2) Pursuant to the intention of the Legislature, the 1115 agency, in consultation with the Agency for Persons with 1116 Disabilities and the Department of Elderly Affairs, shall adopt 1117 and enforce rules to administer this part and part II of chapter 1118 408, which shall include reasonable and fair criteria governing: 1119 (a) The location and construction of the facility; 1120 including fire and life safety, plumbing, heating, cooling, 1121 lighting, ventilation, and other housing conditions that ensure 1122 the health, safety, and comfort of residents. The agency shall 1123 establish standards for facilities and equipment to increase the 1124 extent to which new facilities and a new wing or floor added to 1125 an existing facility after July 1, 2000, are structurally 1126 capable of serving as shelters only for residents, staff, and 1127 families of residents and staff, and equipped to be self 1128 supporting during and immediately following disasters. The 1129 agency shall update or revise the criteria as the need arises. 1130 All facilities must comply with those lifesafety code 1131 requirements and building code standards applicable at the time 1132 of approval of their construction plans. The agency may require 1133 alterations to a building if it determines that an existing 1134 condition constitutes a distinct hazard to life, health, or 1135 safety. The agency shall adopt fair and reasonable rules setting 1136 forth conditions under which existing facilities undergoing 1137 additions, alterations, conversions, renovations, or repairs are 1138 required to comply with the most recent updated or revised 1139 standards. 1140 (b) The number and qualifications of all personnel, 1141 including management, medical nursing, and other personnel, 1142 having responsibility for any part of the care given to 1143 residents. 1144 (c) All sanitary conditions within the facility and its 1145 surroundings, including water supply, sewage disposal, food 1146 handling, and general hygiene, which will ensure the health and 1147 comfort of residents. 1148 (d) The equipment essential to the health and welfare of 1149 the residents. 1150 (e) A uniform accounting system. 1151 (f) The care, treatment, and maintenance of residents and 1152 measurement of the quality and adequacy thereof. 1153 (g) The preparation and annual update of a comprehensive 1154 emergency management plan. The agency shall adopt rules 1155 establishing minimum criteria for the plan after consultation 1156 with the Division of Emergency Management. At a minimum, the 1157 rules must provide for plan components that address emergency 1158 evacuation transportation; adequate sheltering arrangements; 1159 postdisaster activities, including emergency power, food, and 1160 water; postdisaster transportation; supplies; staffing; 1161 emergency equipment; individual identification of residents and 1162 transfer of records; and responding to family inquiries. The 1163 comprehensive emergency management plan is subject to review and 1164 approval by the local emergency management agency. During its 1165 review, the local emergency management agency shall ensure that 1166 the following agencies, at a minimum, are given the opportunity 1167 to review the plan: the Department of Elderly Affairs, the 1168 Agency for Persons with Disabilities, the Agency for Health Care 1169 Administration, and the Division of Emergency Management. Also, 1170 appropriate volunteer organizations must be given the 1171 opportunity to review the plan. The local emergency management 1172 agency shall complete its review within 60 days and either 1173 approve the plan or advise the facility of necessary revisions. 1174 (h) The use of restraint and seclusion. Such rules must be 1175 consistent with recognized best practices; prohibit inherently 1176 dangerous restraint or seclusion procedures; establish 1177 limitations on the use and duration of restraint and seclusion; 1178 establish measures to ensure the safety of clients and staff 1179 during an incident of restraint or seclusion; establish 1180 procedures for staff to follow before, during, and after 1181 incidents of restraint or seclusion, including individualized 1182 plans for the use of restraints or seclusion in emergency 1183 situations; establish professional qualifications of and 1184 training for staff who may order or be engaged in the use of 1185 restraint or seclusion; establish requirements for facility data 1186 collection and reporting relating to the use of restraint and 1187 seclusion; and establish procedures relating to the 1188 documentation of the use of restraint or seclusion in the 1189 client’s facility or program record. 1190 (3) The agency shall adopt rules to provide that, when the 1191 criteria established under this part and part II of chapter 408 1192 are not met, such violationsdeficienciesshall be classified 1193 according to the nature of the violationdeficiency. The agency 1194 shall indicate the classification on the face of the notice of 1195 violationdeficienciesas follows: 1196 (a) A class I violation is defined in s. 408.813 1197deficiencies are those which the agency determines present an1198imminent danger to the residents or guests of the facility or a1199substantial probability that death or serious physical harm1200would result therefrom.The condition or practice constituting a1201class I violation must be abated or eliminated immediately,1202unless a fixed period of time, as determined by the agency, is1203required for correction.A class I violationdeficiencyis 1204 subject to a civil penalty in an amount not less than $5,000 and 1205 not exceeding $10,000 for each violationdeficiency. A fine may 1206 be levied notwithstanding the correction of the violation 1207deficiency. 1208 (b) A class II violation is defined in s. 408.813 1209deficiencies are those which the agency determines have a direct1210or immediate relationship to the health, safety, or security of1211the facility residents, other than class I deficiencies. A class 1212 II violationdeficiencyis subject to a civil penalty in an 1213 amount not less than $1,000 and not exceeding $5,000 for each 1214 violationdeficiency. A citation for a class II violation 1215deficiencyshall specify the time within which the violation 1216deficiencymust be corrected. If a class II violationdeficiency1217 is corrected within the time specified, no civil penalty shall 1218 be imposed, unless it is a repeated offense. 1219 (c) A class III violation is defined in s. 408.813 1220deficiencies are those which the agency determines to have an1221indirect or potential relationship to the health, safety, or1222security of the facility residents, other than class I or class1223II deficiencies. A class III violationdeficiencyis subject to 1224 a civil penalty of not less than $500 and not exceeding $1,000 1225 for each violationdeficiency. A citation for a class III 1226 violationdeficiencyshall specify the time within which the 1227 violationdeficiencymust be corrected. If a class III violation 1228deficiencyis corrected within the time specified, no civil 1229 penalty shall be imposed, unless it is a repeated offense. 1230 (d) A class IV violation is defined in s. 408.813. Upon 1231 finding an uncorrected or repeated class IV violation, the 1232 agency shall impose an administrative fine not to exceed $500 1233 for each occurrence and each day that the uncorrected or 1234 repeated violation exists. 1235 (4) The agency shall approve or disapprove the plans and 1236 specifications within 60 days after receipt of the final plans 1237 and specifications. The agency may be granted one 15-day 1238 extension for the review period, if the secretary of the agency 1239 so approves. If the agency fails to act within the specified 1240 time, it is deemed to have approved the plans and 1241 specifications. When the agency disapproves plans and 1242 specifications, it must set forth in writing the reasons for 1243 disapproval. Conferences and consultations may be provided as 1244 necessary. 1245 (5) The agency may charge an initial fee of $2,000 for 1246 review of plans and construction on all projects, no part of 1247 which is refundable. The agency may also collect a fee, not to 1248 exceed 1 percent of the estimated construction cost or the 1249 actual cost of review, whichever is less, for the portion of the 1250 review which encompasses initial review through the initial 1251 revised construction document review. The agency may collect its 1252 actual costs on all subsequent portions of the review and 1253 construction inspections. Initial fee payment must accompany the 1254 initial submission of plans and specifications. Any subsequent 1255 payment that is due is payable upon receipt of the invoice from 1256 the agency. Notwithstanding any other provision of law, all 1257 money received by the agency under this section shall be deemed 1258 to be trust funds, to be held and applied solely for the 1259 operations required under this section. 1260 Section 29. Subsections (4) and (7) of section 400.9905, 1261 Florida Statutes, are amended to read: 1262 400.9905 Definitions.— 1263 (4) “Clinic” means an entity at which health care services 1264 are provided to individuals and which tenders charges for 1265 reimbursement for such services, including a mobile clinic and a 1266 portable health service or equipment provider. For purposes of 1267 this part, the term does not include and the licensure 1268 requirements of this part do not apply to: 1269 (a) Entities licensed or registered by the state under 1270 chapter 395; or entities licensed or registered by the state and 1271 providing only health care services within the scope of services 1272 authorized under their respective licenses granted under ss. 1273 383.30-383.335, chapter 390, chapter 394, chapter 397, this 1274 chapter except part X, chapter 429, chapter 463, chapter 465, 1275 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 1276 chapter 651; end-stage renal disease providers authorized under 1277 42 C.F.R. part 405, subpart U; or providers certified under 42 1278 C.F.R. part 485, subpart B or subpart H; or any entity that 1279 provides neonatal or pediatric hospital-based health care 1280 services or other health care services by licensed practitioners 1281 solely within a hospital licensed under chapter 395. 1282 (b) Entities that own, directly or indirectly, entities 1283 licensed or registered by the state pursuant to chapter 395; or 1284 entities that own, directly or indirectly, entities licensed or 1285 registered by the state and providing only health care services 1286 within the scope of services authorized pursuant to their 1287 respective licenses granted under ss. 383.30-383.335, chapter 1288 390, chapter 394, chapter 397, this chapter except part X, 1289 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 1290 part I of chapter 483, chapter 484, chapter 651; end-stage renal 1291 disease providers authorized under 42 C.F.R. part 405, subpart 1292 U; or providers certified under 42 C.F.R. part 485, subpart B or 1293 subpart H; or any entity that provides neonatal or pediatric 1294 hospital-based health care services by licensed practitioners 1295 solely within a hospital licensed under chapter 395. 1296 (c) Entities that are owned, directly or indirectly, by an 1297 entity licensed or registered by the state pursuant to chapter 1298 395; or entities that are owned, directly or indirectly, by an 1299 entity licensed or registered by the state and providing only 1300 health care services within the scope of services authorized 1301 pursuant to their respective licenses granted under ss. 383.30 1302 383.335, chapter 390, chapter 394, chapter 397, this chapter 1303 except part X, chapter 429, chapter 463, chapter 465, chapter 1304 466, chapter 478, part I of chapter 483, chapter 484, or chapter 1305 651; end-stage renal disease providers authorized under 42 1306 C.F.R. part 405, subpart U; or providers certified under 42 1307 C.F.R. part 485, subpart B or subpart H; or any entity that 1308 provides neonatal or pediatric hospital-based health care 1309 services by licensed practitioners solely within a hospital 1310 under chapter 395. 1311 (d) Entities that are under common ownership, directly or 1312 indirectly, with an entity licensed or registered by the state 1313 pursuant to chapter 395; or entities that are under common 1314 ownership, directly or indirectly, with an entity licensed or 1315 registered by the state and providing only health care services 1316 within the scope of services authorized pursuant to their 1317 respective licenses granted under ss. 383.30-383.335, chapter 1318 390, chapter 394, chapter 397, this chapter except part X, 1319 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 1320 part I of chapter 483, chapter 484, or chapter 651; end-stage 1321 renal disease providers authorized under 42 C.F.R. part 405, 1322 subpart U; or providers certified under 42 C.F.R. part 485, 1323 subpart B or subpart H; or any entity that provides neonatal or 1324 pediatric hospital-based health care services by licensed 1325 practitioners solely within a hospital licensed under chapter 1326 395. 1327 (e) An entity that is exempt from federal taxation under 26 1328 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 1329 under 26 U.S.C. s. 409 that has a board of trustees not less 1330 than two-thirds of which are Florida-licensed health care 1331 practitioners and provides only physical therapy services under 1332 physician orders, any community college or university clinic, 1333 and any entity owned or operated by the federal or state 1334 government, including agencies, subdivisions, or municipalities 1335 thereof. 1336 (f) A sole proprietorship, group practice, partnership, or 1337 corporation that provides health care services by physicians 1338 covered by s. 627.419, that is directly supervised by one or 1339 more of such physicians, and that is wholly owned by one or more 1340 of those physicians or by a physician and the spouse, parent, 1341 child, or sibling of that physician. 1342 (g) A sole proprietorship, group practice, partnership, or 1343 corporation that provides health care services by licensed 1344 health care practitioners under chapter 457, chapter 458, 1345 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 1346 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 1347 chapter 490, chapter 491, or part I, part III, part X, part 1348 XIII, or part XIV of chapter 468, or s. 464.012, which are 1349 wholly owned by one or more licensed health care practitioners, 1350 or the licensed health care practitioners set forth in this 1351 paragraph and the spouse, parent, child, or sibling of a 1352 licensed health care practitioner, so long as one of the owners 1353 who is a licensed health care practitioner is supervising the 1354 business activities and is legally responsible for the entity’s 1355 compliance with all federal and state laws. However, a health 1356 care practitioner may not supervise services beyond the scope of 1357 the practitioner’s license, except that, for the purposes of 1358 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 1359 provides only services authorized pursuant to s. 456.053(3)(b) 1360 may be supervised by a licensee specified in s. 456.053(3)(b). 1361 (h) Clinical facilities affiliated with an accredited 1362 medical school at which training is provided for medical 1363 students, residents, or fellows. 1364 (i) Entities that provide only oncology or radiation 1365 therapy services by physicians licensed under chapter 458 or 1366 chapter 459 or entities that provide oncology or radiation 1367 therapy services by physicians licensed under chapter 458 or 1368 chapter 459 which are owned by a corporation whose shares are 1369 publicly traded on a recognized stock exchange. 1370 (j) Clinical facilities affiliated with a college of 1371 chiropractic accredited by the Council on Chiropractic Education 1372 at which training is provided for chiropractic students. 1373 (k) Entities that provide licensed practitioners to staff 1374 emergency departments or to deliver anesthesia services in 1375 facilities licensed under chapter 395 and that derive at least 1376 90 percent of their gross annual revenues from the provision of 1377 such services. Entities claiming an exemption from licensure 1378 under this paragraph must provide documentation demonstrating 1379 compliance. 1380 (l) Orthotic,orprosthetic, pediatric cardiology, or 1381 perinatology clinical facilities or anesthesia clinical 1382 facilities that are not otherwise exempt under paragraph (a) or 1383 paragraph (k) and that are a publicly traded corporation orthat1384 are wholly owned, directly or indirectly, by a publicly traded 1385 corporation. As used in this paragraph, a publicly traded 1386 corporation is a corporation that issues securities traded on an 1387 exchange registered with the United States Securities and 1388 Exchange Commission as a national securities exchange. 1389 (m) Entities that are owned or controlled, directly or 1390 indirectly, by a publicly traded entity with $100 million or 1391 more, in the aggregate, in total annual revenues derived from 1392 providing health care services by licensed health care 1393 practitioners that are employed or contracted by an entity 1394 described in this paragraph. 1395 (n) Entities that are owned by a corporation that has $250 1396 million or more in total annual sales of health care services 1397 provided by licensed health care practitioners if one or more of 1398 the owners of the entity is a health care practitioner who is 1399 licensed in this state, is responsible for supervising the 1400 business activities of the entity, and is legally responsible 1401 for the entity’s compliance with state law for purposes of this 1402 section. 1403 (o) Entities that employ 50 or more health care 1404 practitioners who are licensed under chapter 458 or chapter 459 1405 if the billing for medical services is under a single corporate 1406 tax identification number. The application for exemption under 1407 this paragraph must contain information that includes the name, 1408 residence address, business address, and telephone number of the 1409 entity that owns the practice; a complete list of the names and 1410 contact information of all the officers and directors of the 1411 entity; the name, residence address, business address, and 1412 medical license number of each health care practitioner who is 1413 licensed to practice in this state and employed by the entity; 1414 the corporate tax identification number of the entity seeking an 1415 exemption; a listing of health care services to be provided by 1416 the entity at the health care clinics owned or operated by the 1417 entity; and a certified statement prepared by an independent 1418 certified public accountant which states that the entity and the 1419 health care clinics owned or operated by the entity have not 1420 received payment for health care services under insurance 1421 coverage for personal injury protection for the preceding year. 1422 If the agency determines that an entity that is exempt under 1423 this paragraph has received payments for medical services for 1424 insurance coverage for personal injury protection, the agency 1425 may deny or revoke the exemption from licensure under this 1426 paragraph. 1427 (7) “Portable health service or equipment provider” means 1428 an entity that contracts with or employs persons to provide 1429 portable health services at or equipment to multiple locations 1430performing treatment or diagnostic testing of individuals, that 1431 bills third-party payors for those services, and that otherwise 1432 meets the definition of a clinic in subsection (4). 1433 Section 30. Paragraph (b) of subsection (1) and subsection 1434 (4) of section 400.991, Florida Statutes, are amended to read: 1435 400.991 License requirements; background screenings; 1436 prohibitions.— 1437 (1) 1438 (b) Each mobile clinic must obtain a separate health care 1439 clinic license and must provide to the agency, at least 1440 quarterly, its projected street location to enable the agency to 1441 locate and inspect such clinic. A portable health service or 1442 equipment provider must obtain a health care clinic license for 1443 a single administrative office and is not required to submit 1444 quarterly projected street locations. 1445 (4) In addition to the requirements of part II of chapter 1446 408, the applicant must file with the application satisfactory 1447 proof that the clinic is in compliance with this part and 1448 applicable rules, including: 1449 (a) A listing of services to be provided either directly by 1450 the applicant or through contractual arrangements with existing 1451 providers; 1452 (b) The number and discipline of each professional staff 1453 member to be employed; and 1454 (c) Proof of financial ability to operate as required under 1455 ss.s.408.810(8) and 408.8065.As an alternative to submitting1456proof of financial ability to operate as required under s.1457408.810(8), the applicant may file a surety bond of at least1458$500,000 which guarantees that the clinic will act in full1459conformity with all legal requirements for operating a clinic,1460payable to the agency. The agency may adopt rules to specify1461related requirements for such surety bond.1462 Section 31. Paragraph (a) of subsection (2) of section 1463 408.033, Florida Statutes, is amended to read: 1464 408.033 Local and state health planning.— 1465 (2) FUNDING.— 1466 (a) The Legislature intends that the cost of local health 1467 councils be borne by assessments on selected health care 1468 facilities subject to facility licensure by the Agency for 1469 Health Care Administration, including abortion clinics, assisted 1470 living facilities, ambulatory surgical centers, birthing 1471 centers, clinical laboratories except community nonprofit blood 1472 banks and clinical laboratories operated by practitioners for 1473 exclusive use regulated under s. 483.035, home health agencies, 1474 hospices, hospitals, intermediate care facilities for the 1475 developmentally disabled, nursing homes, health care clinics, 1476 and multiphasic testing centers and by assessments on 1477 organizations subject to certification by the agency pursuant to 1478 chapter 641, part III, including health maintenance 1479 organizations and prepaid health clinics. Fees assessed may be 1480 collected prospectively at the time of licensure renewal and 1481 prorated for the licensure period. 1482 Section 32. Subsection (2) of section 408.034, Florida 1483 Statutes, is amended to read: 1484 408.034 Duties and responsibilities of agency; rules.— 1485 (2) In the exercise of its authority to issue licenses to 1486 health care facilities and health service providers, as provided 1487 under chapters 393 and 395 and parts II,andIV, and VIII of 1488 chapter 400, the agency may not issue a license to any health 1489 care facility or health service provider that fails to receive a 1490 certificate of need or an exemption for the licensed facility or 1491 service. 1492 Section 33. Paragraph (d) of subsection (1) of section 1493 408.036, Florida Statutes, is amended to read: 1494 408.036 Projects subject to review; exemptions.— 1495 (1) APPLICABILITY.—Unless exempt under subsection (3), all 1496 health-care-related projects, as described in paragraphs (a) 1497 (g), are subject to review and must file an application for a 1498 certificate of need with the agency. The agency is exclusively 1499 responsible for determining whether a health-care-related 1500 project is subject to review under ss. 408.031-408.045. 1501 (d) The establishment of a hospice or hospice inpatient 1502 facility, except as provided in s.408.043. 1503 Section 34. Paragraph (c) of subsection (1) of section 1504 408.037, Florida Statutes, is amended to read: 1505 408.037 Application content.— 1506 (1) Except as provided in subsection (2) for a general 1507 hospital, an application for a certificate of need must contain: 1508 (c) An audited financial statement of the applicant or the 1509 applicant’s parent corporation if audited financial statements 1510 of the applicant do not exist. In an application submitted by an 1511 existing health care facility, health maintenance organization, 1512 or hospice, financial condition documentation must include, but 1513 need not be limited to, a balance sheet and a profit-and-loss 1514 statement of the 2 previous fiscal years’ operation. 1515 Section 35. Subsection (2) of section 408.043, Florida 1516 Statutes, is amended to read: 1517 408.043 Special provisions.— 1518 (2) HOSPICES.—When an application is made for a certificate 1519 of need to establish or to expand a hospice, the need for such 1520 hospice shall be determined on the basis of the need for and 1521 availability of hospice services in the community. The formula 1522 on which the certificate of need is based shall discourage 1523 regional monopolies and promote competition. The inpatient 1524 hospice care component of a hospice which is a freestanding 1525 facility, or a part of a facility,which is primarily engaged in1526providing inpatient care and related servicesand is not 1527 licensed as a health care facility shall also be required to 1528 obtain a certificate of need. Provision of hospice care by any 1529 current provider of health care is a significant change in 1530 service and therefore requires a certificate of need for such 1531 services. 1532 Section 36. Paragraph (a) of subsection (1) of section 1533 408.061, Florida Statutes, is amended to read: 1534 408.061 Data collection; uniform systems of financial 1535 reporting; information relating to physician charges; 1536 confidential information; immunity.— 1537 (1) The agency shall require the submission by health care 1538 facilities, health care providers, and health insurers of data 1539 necessary to carry out the agency’s duties. Specifications for 1540 data to be collected under this section shall be developed by 1541 the agency with the assistance of technical advisory panels 1542 including representatives of affected entities, consumers, 1543 purchasers, and such other interested parties as may be 1544 determined by the agency. 1545 (a) Data submitted by health care facilities, including the 1546 facilities as defined in chapter 395, shall include, but are not 1547 limited to: case-mix data, patient admission and discharge data, 1548 hospital emergency department data which shall include the 1549 number of patients treated in the emergency department of a 1550 licensed hospital reported by patient acuity level, data on 1551 hospital-acquired infections as specified by rule, data on 1552 complications as specified by rule, data on readmissions as 1553 specified by rule, with patient and provider-specific 1554 identifiers included, actual charge data by diagnostic groups, 1555 financial data, accounting data, operating expenses, expenses 1556 incurred for rendering services to patients who cannot or do not 1557 pay, interest charges, depreciation expenses based on the 1558 expected useful life of the property and equipment involved, and 1559 demographic data. The agency shall adopt nationally recognized 1560 risk adjustment methodologies or software consistent with the 1561 standards of the Agency for Healthcare Research and Quality and 1562 as selected by the agency for all data submitted as required by 1563 this section. Data may be obtained from documents such as, but 1564 not limited to: leases, contracts, debt instruments, itemized 1565 patient bills, medical record abstracts, and related diagnostic 1566 information. Reported data elements shall be reported 1567 electronically andin accordance with rule 59E-7.012, Florida1568Administrative Code. Data submitted shall becertified by the 1569 chief executive officer or an appropriate and duly authorized 1570 representative or employee of the licensed facility that the 1571 information submitted is true and accurate. 1572 Section 37. Subsection (43) of section 408.07, Florida 1573 Statutes, is amended to read: 1574 408.07 Definitions.—As used in this chapter, with the 1575 exception of ss. 408.031-408.045, the term: 1576 (43) “Rural hospital” means an acute care hospital licensed 1577 under chapter 395, having 100 or fewer licensed beds and an 1578 emergency room, and which is: 1579 (a) The sole provider within a county with a population 1580 density of no greater than 100 persons per square mile; 1581 (b) An acute care hospital, in a county with a population 1582 density of no greater than 100 persons per square mile, which is 1583 at least 30 minutes of travel time, on normally traveled roads 1584 under normal traffic conditions, from another acute care 1585 hospital within the same county; 1586 (c) A hospital supported by a tax district or subdistrict 1587 whose boundaries encompass a population of 100 persons or fewer 1588 per square mile; 1589 (d) A hospital with a service area that has a population of 1590 100 persons or fewer per square mile. As used in this paragraph, 1591 the term “service area” means the fewest number of zip codes 1592 that account for 75 percent of the hospital’s discharges for the 1593 most recent 5-year period, based on information available from 1594 the hospital inpatient discharge database in the Florida Center 1595 for Health Information and Policy Analysis at the Agency for 1596 Health Care Administration; or 1597 (e) A critical access hospital. 1598 1599 Population densities used in this subsection must be based upon 1600 the most recently completed United States census. A hospital 1601 that received funds under s. 409.9116 for a quarter beginning no 1602 later than July 1, 2002, is deemed to have been and shall 1603 continue to be a rural hospital from that date through June 30, 1604 2015, if the hospital continues to have 100 or fewer licensed 1605 beds and an emergency room, or meets the criteria of s.1606395.602(2)(e)4. An acute care hospital that has not previously 1607 been designated as a rural hospital and that meets the criteria 1608 of this subsection shall be granted such designation upon 1609 application, including supporting documentation, to the Agency 1610 for Health Care Administration. 1611 Section 38. Section 408.10, Florida Statutes, is amended to 1612 read: 1613 408.10 Consumer complaints.—The agency shall:1614(1)publish and make available to the public a toll-free 1615 telephone number for the purpose of handling consumer complaints 1616 and shall serve as a liaison between consumer entities and other 1617 private entities and governmental entities for the disposition 1618 of problems identified by consumers of health care. 1619(2) Be empowered to investigate consumer complaints1620relating to problems with health care facilities’ billing1621practices and issue reports to be made public in any cases where1622the agency determines the health care facility has engaged in1623billing practices which are unreasonable and unfair to the1624consumer.1625 Section 39. Effective May 1, 2012, subsection (15) is added 1626 to section 408.7056, Florida Statutes, to read: 1627 408.7056 Subscriber Assistance Program.— 1628 (15) This section applies only to prepaid health clinics 1629 certified under chapter 641, Florida Healthy Kids health plans, 1630 and health plans that meet the requirements of 45 C.F.R. 1631 147.140. 1632 Section 40. Subsection (11) of section 408.802, Florida 1633 Statutes, is repealed. 1634 Section 41. Subsection (3) is added to section 408.804, 1635 Florida Statutes, to read: 1636 408.804 License required; display.— 1637 (3) Any person who knowingly alters, defaces, or falsifies 1638 a license certificate issued by the agency, or causes or 1639 procures any person to commit such an offense, commits a 1640 misdemeanor of the second degree, punishable as provided in s. 1641 775.082 or s. 775.083. Any licensee or provider who displays an 1642 altered, defaced, or falsified license certificate is subject to 1643 the penalties set forth in s. 408.815 and an administrative fine 1644 of $1,000 for each day of illegal display. 1645 Section 42. Paragraph (d) of subsection (2) of section 1646 408.806, Florida Statutes, is amended, and paragraph (e) is 1647 added to that subsection, to read: 1648 408.806 License application process.— 1649 (2) 1650 (d)The agency shall notify the licensee by mail or1651electronically at least 90 days before the expiration of a1652license that a renewal license is necessary to continue1653operation.The licensee’s failure to timely filesubmita 1654 renewal application and license application fee with the agency 1655 shall result in a $50 per day late fee charged to the licensee 1656 by the agency; however, the aggregate amount of the late fee may 1657 not exceed 50 percent of the licensure fee or $500, whichever is 1658 less. The agency shall provide a courtesy notice to the licensee 1659 by United States mail, electronically, or by any other manner at 1660 its address of record or mailing address, if provided, at least 1661 90 days before the expiration of a license. This courtesy notice 1662 must inform the licensee of the expiration of the license. If 1663 the agency does not provide the courtesy notice or the licensee 1664 does not receive the courtesy notice, the licensee continues to 1665 be legally obligated to timely file the renewal application and 1666 license application fee with the agency and is not excused from 1667 the payment of a late fee. If an application is received after 1668 the required filing date and exhibits a hand-canceled postmark 1669 obtained from a United States post office dated on or before the 1670 required filing date, no fine will be levied. 1671 (e) The applicant must pay the late fee before a late 1672 application is considered complete and failure to pay the late 1673 fee is considered an omission from the application for licensure 1674 pursuant to paragraph (3)(b). 1675 Section 43. Paragraph (b) of subsection (1) of section 1676 408.8065, Florida Statutes, is amended to read: 1677 408.8065 Additional licensure requirements for home health 1678 agencies, home medical equipment providers, and health care 1679 clinics.— 1680 (1) An applicant for initial licensure, or initial 1681 licensure due to a change of ownership, as a home health agency, 1682 home medical equipment provider, or health care clinic shall: 1683 (b) Submit projectedpro formafinancial statements, 1684 including a balance sheet, income and expense statement, and a 1685 statement of cash flows for the first 2 years of operation which 1686 provide evidence that the applicant has sufficient assets, 1687 credit, and projected revenues to cover liabilities and 1688 expenses. 1689 1690 All documents required under this subsection must be prepared in 1691 accordance with generally accepted accounting principles and may 1692 be in a compilation form. The financial statements must be 1693 signed by a certified public accountant. 1694 Section 44. Section 408.809, Florida Statutes, is amended 1695 to read: 1696 408.809 Background screening; prohibited offenses.— 1697 (1) Level 2 background screening pursuant to chapter 435 1698 must be conducted through the agency on each of the following 1699 persons, who are considered employees for the purposes of 1700 conducting screening under chapter 435: 1701 (a) The licensee, if an individual. 1702 (b) The administrator or a similarly titled person who is 1703 responsible for the day-to-day operation of the provider. 1704 (c) The financial officer or similarly titled individual 1705 who is responsible for the financial operation of the licensee 1706 or provider. 1707 (d) Any person who is a controlling interest if the agency 1708 has reason to believe that such person has been convicted of any 1709 offense prohibited by s. 435.04. For each controlling interest 1710 who has been convicted of any such offense, the licensee shall 1711 submit to the agency a description and explanation of the 1712 conviction at the time of license application. 1713 (e) Any person, as required by authorizing statutes, 1714 seeking employment with a licensee or provider who is expected 1715 to, or whose responsibilities may require him or her to, provide 1716 personal care or services directly to clients or have access to 1717 client funds, personal property, or living areas; and any 1718 person, as required by authorizing statutes, contracting with a 1719 licensee or provider whose responsibilities require him or her 1720 to provide personal care or personal services directly to 1721 clients. Evidence of contractor screening may be retained by the 1722 contractor’s employer or the licensee. 1723 (2) Every 5 years following his or her licensure, 1724 employment, or entry into a contract in a capacity that under 1725 subsection (1) would require level 2 background screening under 1726 chapter 435, each such person must submit to level 2 background 1727 rescreening as a condition of retaining such license or 1728 continuing in such employment or contractual status. For any 1729 such rescreening, the agency shall request the Department of Law 1730 Enforcement to forward the person’s fingerprints to the Federal 1731 Bureau of Investigation for a national criminal history record 1732 check. If the fingerprints of such a person are not retained by 1733 the Department of Law Enforcement under s. 943.05(2)(g), the 1734 person must file a complete set of fingerprints with the agency 1735 and the agency shall forward the fingerprints to the Department 1736 of Law Enforcement for state processing, and the Department of 1737 Law Enforcement shall forward the fingerprints to the Federal 1738 Bureau of Investigation for a national criminal history record 1739 check. The fingerprints may be retained by the Department of Law 1740 Enforcement under s. 943.05(2)(g). The cost of the state and 1741 national criminal history records checks required by level 2 1742 screening may be borne by the licensee or the person 1743 fingerprinted. Proof of compliance with level 2 screening 1744 standards submitted within the previous 5 years to meet any 1745 provider or professional licensure requirements of the Agency, 1746 the Department of Health, the Agency for Persons with 1747 Disabilities, the Department of Children and Family Services, 1748 the Department of Elderly Affairs, or the Department of 1749 Financial Services for an applicant for a certificate of 1750 authority or provisional certificate of authority to operate a 1751 continuing care retirement community under chapter 651 satisfies 1752 the requirements of this section if the screening standards and 1753 disqualifying offenses are equivalent to those specified in s. 1754 453.04 and this section, and the person subject to screening has 1755 not been unemployed for more than 90 days and such proof is 1756 accompanied, under penalty of perjury, by an affidavit of 1757 compliance with the provisions of chapter 435 and this section 1758 using forms provided by the agency. 1759 (3) All fingerprints must be provided in electronic format. 1760 Screening results shall be reviewed by the agency with respect 1761 to the offenses specified in s. 435.04 and this section, and the 1762 qualifying or disqualifying status of the person named in the 1763 request shall be maintained in a database. The qualifying or 1764 disqualifying status of the person named in the request shall be 1765 posted on a secure website for retrieval by the licensee or 1766 designated agent on the licensee’s behalf. 1767 (4) In addition to the offenses listed in s. 435.04, all 1768 persons required to undergo background screening pursuant to 1769 this part or authorizing statutes must not have an arrest 1770 awaiting final disposition for, must not have been found guilty 1771 of, regardless of adjudication, or entered a plea of nolo 1772 contendere or guilty to, and must not have been adjudicated 1773 delinquent and the record not have been sealed or expunged for 1774 any of the following offenses or any similar offense of another 1775 jurisdiction: 1776 (a) Any authorizing statutes, if the offense was a felony. 1777 (b) This chapter, if the offense was a felony. 1778 (c) Section 409.920, relating to Medicaid provider fraud. 1779 (d) Section 409.9201, relating to Medicaid fraud. 1780 (e) Section 741.28, relating to domestic violence. 1781 (f) Section 817.034, relating to fraudulent acts through 1782 mail, wire, radio, electromagnetic, photoelectronic, or 1783 photooptical systems. 1784 (g) Section 817.234, relating to false and fraudulent 1785 insurance claims. 1786 (h) Section 817.505, relating to patient brokering. 1787 (i) Section 817.568, relating to criminal use of personal 1788 identification information. 1789 (j) Section 817.60, relating to obtaining a credit card 1790 through fraudulent means. 1791 (k) Section 817.61, relating to fraudulent use of credit 1792 cards, if the offense was a felony. 1793 (l) Section 831.01, relating to forgery. 1794 (m) Section 831.02, relating to uttering forged 1795 instruments. 1796 (n) Section 831.07, relating to forging bank bills, checks, 1797 drafts, or promissory notes. 1798 (o) Section 831.09, relating to uttering forged bank bills, 1799 checks, drafts, or promissory notes. 1800 (p) Section 831.30, relating to fraud in obtaining 1801 medicinal drugs. 1802 (q) Section 831.31, relating to the sale, manufacture, 1803 delivery, or possession with the intent to sell, manufacture, or 1804 deliver any counterfeit controlled substance, if the offense was 1805 a felony. 1806 (5) A person who serves as a controlling interest of, is 1807 employed by, or contracts with a licensee on July 31, 2010, who 1808 has been screened and qualified according to standards specified 1809 in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015, 1810 in accordance with the schedule provided in paragraphs (a)-(c). 1811The agency may adopt rules to establish a schedule to stagger1812the implementation of the required rescreening over the 5-year1813period, beginning July 31, 2010, through July 31, 2015.If, upon 1814 rescreening, such person has a disqualifying offense that was 1815 not a disqualifying offense at the time of the last screening, 1816 but is a current disqualifying offense and was committed before 1817 the last screening, he or she may apply for an exemption from 1818 the appropriate licensing agency and, if agreed to by the 1819 employer, may continue to perform his or her duties until the 1820 licensing agency renders a decision on the application for 1821 exemption if the person is eligible to apply for an exemption 1822 and the exemption request is received by the agency within 30 1823 days after receipt of the rescreening results by the person. The 1824 rescreening schedule shall be as follows: 1825 (a) Individuals whose last screening was conducted before 1826 December 31, 2003, must be rescreened by July 31, 2013. 1827 (b) Individuals whose last screening was conducted between 1828 January 1, 2004, through December 31, 2007, must be rescreened 1829 by July 31, 2014. 1830 (c) Individuals whose last screening was conducted between 1831 January 1, 2008, through July 31, 2010, must be rescreened by 1832 July 31, 2015. 1833 (6)(5)The costs associated with obtaining the required 1834 screening must be borne by the licensee or the person subject to 1835 screening. Licensees may reimburse persons for these costs. The 1836 Department of Law Enforcement shall charge the agency for 1837 screening pursuant to s. 943.053(3). The agency shall establish 1838 a schedule of fees to cover the costs of screening. 1839 (7)(6)(a) As provided in chapter 435, the agency may grant 1840 an exemption from disqualification to a person who is subject to 1841 this section and who: 1842 1. Does not have an active professional license or 1843 certification from the Department of Health; or 1844 2. Has an active professional license or certification from 1845 the Department of Health but is not providing a service within 1846 the scope of that license or certification. 1847 (b) As provided in chapter 435, the appropriate regulatory 1848 board within the Department of Health, or the department itself 1849 if there is no board, may grant an exemption from 1850 disqualification to a person who is subject to this section and 1851 who has received a professional license or certification from 1852 the Department of Health or a regulatory board within that 1853 department and that person is providing a service within the 1854 scope of his or her licensed or certified practice. 1855 (8)(7)The agency and the Department of Health may adopt 1856 rules pursuant to ss. 120.536(1) and 120.54 to implement this 1857 section, chapter 435, and authorizing statutes requiring 1858 background screening and to implement and adopt criteria 1859 relating to retaining fingerprints pursuant to s. 943.05(2). 1860 (9)(8)There is no unemployment compensation or other 1861 monetary liability on the part of, and no cause of action for 1862 damages arising against, an employer that, upon notice of a 1863 disqualifying offense listed under chapter 435 or this section, 1864 terminates the person against whom the report was issued, 1865 whether or not that person has filed for an exemption with the 1866 Department of Health or the agency. 1867 Section 45. Subsection (9) of section 408.810, Florida 1868 Statutes, is amended to read: 1869 408.810 Minimum licensure requirements.—In addition to the 1870 licensure requirements specified in this part, authorizing 1871 statutes, and applicable rules, each applicant and licensee must 1872 comply with the requirements of this section in order to obtain 1873 and maintain a license. 1874 (9) A controlling interest may not withhold from the agency 1875 any evidence of financial instability, including, but not 1876 limited to, checks returned due to insufficient funds, 1877 delinquent accounts, nonpayment of withholding taxes, unpaid 1878 utility expenses, nonpayment for essential services, or adverse 1879 court action concerning the financial viability of the provider 1880 or any other provider licensed under this part that is under the 1881 control of the controlling interest. A controlling interest 1882 shall notify the agency within 10 days after a court action to 1883 initiate bankruptcy, foreclosure, or eviction proceedings 1884 concerning the provider in which the controlling interest is a 1885 petitioner or defendant. Any person who violates this subsection 1886 commits a misdemeanor of the second degree, punishable as 1887 provided in s. 775.082 or s. 775.083. Each day of continuing 1888 violation is a separate offense. 1889 Section 46. Subsection (3) is added to section 408.813, 1890 Florida Statutes, to read: 1891 408.813 Administrative fines; violations.—As a penalty for 1892 any violation of this part, authorizing statutes, or applicable 1893 rules, the agency may impose an administrative fine. 1894 (3) The agency may impose an administrative fine for a 1895 violation that is not designated as a class I, class II, class 1896 III, or class IV violation. Unless otherwise specified by law, 1897 the amount of the fine may not exceed $500 for each violation. 1898 Unclassified violations include: 1899 (a) Violating any term or condition of a license. 1900 (b) Violating any provision of this part, authorizing 1901 statutes, or applicable rules. 1902 (c) Exceeding licensed capacity. 1903 (d) Providing services beyond the scope of the license. 1904 (e) Violating a moratorium imposed pursuant to s. 408.814. 1905 Section 47. Paragraph (a) of subsection (37) of section 1906 409.912, Florida Statutes, is amended to read: 1907 409.912 Cost-effective purchasing of health care.—The 1908 agency shall purchase goods and services for Medicaid recipients 1909 in the most cost-effective manner consistent with the delivery 1910 of quality medical care. To ensure that medical services are 1911 effectively utilized, the agency may, in any case, require a 1912 confirmation or second physician’s opinion of the correct 1913 diagnosis for purposes of authorizing future services under the 1914 Medicaid program. This section does not restrict access to 1915 emergency services or poststabilization care services as defined 1916 in 42 C.F.R. part 438.114. Such confirmation or second opinion 1917 shall be rendered in a manner approved by the agency. The agency 1918 shall maximize the use of prepaid per capita and prepaid 1919 aggregate fixed-sum basis services when appropriate and other 1920 alternative service delivery and reimbursement methodologies, 1921 including competitive bidding pursuant to s. 287.057, designed 1922 to facilitate the cost-effective purchase of a case-managed 1923 continuum of care. The agency shall also require providers to 1924 minimize the exposure of recipients to the need for acute 1925 inpatient, custodial, and other institutional care and the 1926 inappropriate or unnecessary use of high-cost services. The 1927 agency shall contract with a vendor to monitor and evaluate the 1928 clinical practice patterns of providers in order to identify 1929 trends that are outside the normal practice patterns of a 1930 provider’s professional peers or the national guidelines of a 1931 provider’s professional association. The vendor must be able to 1932 provide information and counseling to a provider whose practice 1933 patterns are outside the norms, in consultation with the agency, 1934 to improve patient care and reduce inappropriate utilization. 1935 The agency may mandate prior authorization, drug therapy 1936 management, or disease management participation for certain 1937 populations of Medicaid beneficiaries, certain drug classes, or 1938 particular drugs to prevent fraud, abuse, overuse, and possible 1939 dangerous drug interactions. The Pharmaceutical and Therapeutics 1940 Committee shall make recommendations to the agency on drugs for 1941 which prior authorization is required. The agency shall inform 1942 the Pharmaceutical and Therapeutics Committee of its decisions 1943 regarding drugs subject to prior authorization. The agency is 1944 authorized to limit the entities it contracts with or enrolls as 1945 Medicaid providers by developing a provider network through 1946 provider credentialing. The agency may competitively bid single 1947 source-provider contracts if procurement of goods or services 1948 results in demonstrated cost savings to the state without 1949 limiting access to care. The agency may limit its network based 1950 on the assessment of beneficiary access to care, provider 1951 availability, provider quality standards, time and distance 1952 standards for access to care, the cultural competence of the 1953 provider network, demographic characteristics of Medicaid 1954 beneficiaries, practice and provider-to-beneficiary standards, 1955 appointment wait times, beneficiary use of services, provider 1956 turnover, provider profiling, provider licensure history, 1957 previous program integrity investigations and findings, peer 1958 review, provider Medicaid policy and billing compliance records, 1959 clinical and medical record audits, and other factors. Providers 1960 are not entitled to enrollment in the Medicaid provider network. 1961 The agency shall determine instances in which allowing Medicaid 1962 beneficiaries to purchase durable medical equipment and other 1963 goods is less expensive to the Medicaid program than long-term 1964 rental of the equipment or goods. The agency may establish rules 1965 to facilitate purchases in lieu of long-term rentals in order to 1966 protect against fraud and abuse in the Medicaid program as 1967 defined in s. 409.913. The agency may seek federal waivers 1968 necessary to administer these policies. 1969 (37)(a) The agency shall implement a Medicaid prescribed 1970 drug spending-control program that includes the following 1971 components: 1972 1. A Medicaid preferred drug list, which shall be a listing 1973 of cost-effective therapeutic options recommended by the 1974 Medicaid Pharmacy and Therapeutics Committee established 1975 pursuant to s. 409.91195 and adopted by the agency for each 1976 therapeutic class on the preferred drug list. At the discretion 1977 of the committee, and when feasible, the preferred drug list 1978 should include at least two products in a therapeutic class. The 1979 agency may post the preferred drug list and updates to the list 1980 on an Internet website without following the rulemaking 1981 procedures of chapter 120. Antiretroviral agents are excluded 1982 from the preferred drug list. The agency shall also limit the 1983 amount of a prescribed drug dispensed to no more than a 34-day 1984 supply unless the drug products’ smallest marketed package is 1985 greater than a 34-day supply, or the drug is determined by the 1986 agency to be a maintenance drug in which case a 100-day maximum 1987 supply may be authorized. The agency may seek any federal 1988 waivers necessary to implement these cost-control programs and 1989 to continue participation in the federal Medicaid rebate 1990 program, or alternatively to negotiate state-only manufacturer 1991 rebates. The agency may adopt rules to administer this 1992 subparagraph. The agency shall continue to provide unlimited 1993 contraceptive drugs and items. The agency must establish 1994 procedures to ensure that: 1995 a. There is a response to a request for prior consultation 1996 by telephone or other telecommunication device within 24 hours 1997 after receipt of a request for prior consultation; and 1998 b. A 72-hour supply of the drug prescribed is provided in 1999 an emergency or when the agency does not provide a response 2000 within 24 hours as required by sub-subparagraph a. 2001 2. Reimbursement to pharmacies for Medicaid prescribed 2002 drugs shall be set at the lowest of: the average wholesale price 2003 (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC) 2004 plus 1.5 percent, the federal upper limit (FUL), the state 2005 maximum allowable cost (SMAC), or the usual and customary (UAC) 2006 charge billed by the provider. 2007 3. The agency shall develop and implement a process for 2008 managing the drug therapies of Medicaid recipients who are using 2009 significant numbers of prescribed drugs each month. The 2010 management process may include, but is not limited to, 2011 comprehensive, physician-directed medical-record reviews, claims 2012 analyses, and case evaluations to determine the medical 2013 necessity and appropriateness of a patient’s treatment plan and 2014 drug therapies. The agency may contract with a private 2015 organization to provide drug-program-management services. The 2016 Medicaid drug benefit management program shall include 2017 initiatives to manage drug therapies for HIV/AIDS patients, 2018 patients using 20 or more unique prescriptions in a 180-day 2019 period, and the top 1,000 patients in annual spending. The 2020 agency shall enroll any Medicaid recipient in the drug benefit 2021 management program if he or she meets the specifications of this 2022 provision and is not enrolled in a Medicaid health maintenance 2023 organization. 2024 4. The agency may limit the size of its pharmacy network 2025 based on need, competitive bidding, price negotiations, 2026 credentialing, or similar criteria. The agency shall give 2027 special consideration to rural areas in determining the size and 2028 location of pharmacies included in the Medicaid pharmacy 2029 network. A pharmacy credentialing process may include criteria 2030 such as a pharmacy’s full-service status, location, size, 2031 patient educational programs, patient consultation, disease 2032 management services, and other characteristics. The agency may 2033 impose a moratorium on Medicaid pharmacy enrollment if it is 2034 determined that it has a sufficient number of Medicaid 2035 participating providers. The agency must allow dispensing 2036 practitioners to participate as a part of the Medicaid pharmacy 2037 network regardless of the practitioner’s proximity to any other 2038 entity that is dispensing prescription drugs under the Medicaid 2039 program. A dispensing practitioner must meet all credentialing 2040 requirements applicable to his or her practice, as determined by 2041 the agency. 2042 5. The agency shall develop and implement a program that 2043 requires Medicaid practitioners who prescribe drugs to use a 2044 counterfeit-proof prescription pad for Medicaid prescriptions. 2045 The agency shall require the use of standardized counterfeit 2046 proof prescription pads by Medicaid-participating prescribers or 2047 prescribers who write prescriptions for Medicaid recipients. The 2048 agency may implement the program in targeted geographic areas or 2049 statewide. 2050 6. The agency may enter into arrangements that require 2051 manufacturers of generic drugs prescribed to Medicaid recipients 2052 to provide rebates of at least 15.1 percent of the average 2053 manufacturer price for the manufacturer’s generic products. 2054 These arrangements shall require that if a generic-drug 2055 manufacturer pays federal rebates for Medicaid-reimbursed drugs 2056 at a level below 15.1 percent, the manufacturer must provide a 2057 supplemental rebate to the state in an amount necessary to 2058 achieve a 15.1-percent rebate level. 2059 7. The agency may establish a preferred drug list as 2060 described in this subsection, and, pursuant to the establishment 2061 of such preferred drug list, negotiate supplemental rebates from 2062 manufacturers that are in addition to those required by Title 2063 XIX of the Social Security Act and at no less than 14 percent of 2064 the average manufacturer price as defined in 42 U.S.C. s. 1936 2065 on the last day of a quarter unless the federal or supplemental 2066 rebate, or both, equals or exceeds 29 percent. There is no upper 2067 limit on the supplemental rebates the agency may negotiate. The 2068 agency may determine that specific products, brand-name or 2069 generic, are competitive at lower rebate percentages. Agreement 2070 to pay the minimum supplemental rebate percentage guarantees a 2071 manufacturer that the Medicaid Pharmaceutical and Therapeutics 2072 Committee will consider a product for inclusion on the preferred 2073 drug list. However, a pharmaceutical manufacturer is not 2074 guaranteed placement on the preferred drug list by simply paying 2075 the minimum supplemental rebate. Agency decisions will be made 2076 on the clinical efficacy of a drug and recommendations of the 2077 Medicaid Pharmaceutical and Therapeutics Committee, as well as 2078 the price of competing products minus federal and state rebates. 2079 The agency may contract with an outside agency or contractor to 2080 conduct negotiations for supplemental rebates. For the purposes 2081 of this section, the term “supplemental rebates” means cash 2082 rebates. Value-added programs as a substitution for supplemental 2083 rebates are prohibited. The agency may seek any federal waivers 2084 to implement this initiative. 2085 8. The agency shall expand home delivery of pharmacy 2086 products. The agency may amend the state plan and issue a 2087 procurement, as necessary, in order to implement this program. 2088 The procurements must include agreements with a pharmacy or 2089 pharmacies located in the state to provide mail order delivery 2090 services at no cost to the recipients who elect to receive home 2091 delivery of pharmacy products. The procurement must focus on 2092 serving recipients with chronic diseases for which pharmacy 2093 expenditures represent a significant portion of Medicaid 2094 pharmacy expenditures or which impact a significant portion of 2095 the Medicaid population. The agency may seek and implement any 2096 federal waivers necessary to implement this subparagraph. 2097 9. The agency shall limit to one dose per month any drug 2098 prescribed to treat erectile dysfunction. 2099 10.a. The agency may implement a Medicaid behavioral drug 2100 management system. The agency may contract with a vendor that 2101 has experience in operating behavioral drug management systems 2102 to implement this program. The agency may seek federal waivers 2103 to implement this program. 2104 b. The agency, in conjunction with the Department of 2105 Children and Family Services, may implement the Medicaid 2106 behavioral drug management system that is designed to improve 2107 the quality of care and behavioral health prescribing practices 2108 based on best practice guidelines, improve patient adherence to 2109 medication plans, reduce clinical risk, and lower prescribed 2110 drug costs and the rate of inappropriate spending on Medicaid 2111 behavioral drugs. The program may include the following 2112 elements: 2113 (I) Provide for the development and adoption of best 2114 practice guidelines for behavioral health-related drugs such as 2115 antipsychotics, antidepressants, and medications for treating 2116 bipolar disorders and other behavioral conditions; translate 2117 them into practice; review behavioral health prescribers and 2118 compare their prescribing patterns to a number of indicators 2119 that are based on national standards; and determine deviations 2120 from best practice guidelines. 2121 (II) Implement processes for providing feedback to and 2122 educating prescribers using best practice educational materials 2123 and peer-to-peer consultation. 2124 (III) Assess Medicaid beneficiaries who are outliers in 2125 their use of behavioral health drugs with regard to the numbers 2126 and types of drugs taken, drug dosages, combination drug 2127 therapies, and other indicators of improper use of behavioral 2128 health drugs. 2129 (IV) Alert prescribers to patients who fail to refill 2130 prescriptions in a timely fashion, are prescribed multiple same 2131 class behavioral health drugs, and may have other potential 2132 medication problems. 2133 (V) Track spending trends for behavioral health drugs and 2134 deviation from best practice guidelines. 2135 (VI) Use educational and technological approaches to 2136 promote best practices, educate consumers, and train prescribers 2137 in the use of practice guidelines. 2138 (VII) Disseminate electronic and published materials. 2139 (VIII) Hold statewide and regional conferences. 2140 (IX) Implement a disease management program with a model 2141 quality-based medication component for severely mentally ill 2142 individuals and emotionally disturbed children who are high 2143 users of care. 2144 11. The agency shall implement a Medicaid prescription drug 2145 management system. 2146 a. The agency may contract with a vendor that has 2147 experience in operating prescription drug management systems in 2148 order to implement this system. Any management system that is 2149 implemented in accordance with this subparagraph must rely on 2150 cooperation between physicians and pharmacists to determine 2151 appropriate practice patterns and clinical guidelines to improve 2152 the prescribing, dispensing, and use of drugs in the Medicaid 2153 program. The agency may seek federal waivers to implement this 2154 program. 2155 b. The drug management system must be designed to improve 2156 the quality of care and prescribing practices based on best 2157 practice guidelines, improve patient adherence to medication 2158 plans, reduce clinical risk, and lower prescribed drug costs and 2159 the rate of inappropriate spending on Medicaid prescription 2160 drugs. The program must: 2161 (I) Provide for the adoption of best practice guidelines 2162 for the prescribing and use of drugs in the Medicaid program, 2163 including translating best practice guidelines into practice; 2164 reviewing prescriber patterns and comparing them to indicators 2165 that are based on national standards and practice patterns of 2166 clinical peers in their community, statewide, and nationally; 2167 and determine deviations from best practice guidelines. 2168 (II) Implement processes for providing feedback to and 2169 educating prescribers using best practice educational materials 2170 and peer-to-peer consultation. 2171 (III) Assess Medicaid recipients who are outliers in their 2172 use of a single or multiple prescription drugs with regard to 2173 the numbers and types of drugs taken, drug dosages, combination 2174 drug therapies, and other indicators of improper use of 2175 prescription drugs. 2176 (IV) Alert prescribers to recipients who fail to refill 2177 prescriptions in a timely fashion, are prescribed multiple drugs 2178 that may be redundant or contraindicated, or may have other 2179 potential medication problems. 2180 12. The agency may contract for drug rebate administration, 2181 including, but not limited to, calculating rebate amounts, 2182 invoicing manufacturers, negotiating disputes with 2183 manufacturers, and maintaining a database of rebate collections. 2184 13. The agency may specify the preferred daily dosing form 2185 or strength for the purpose of promoting best practices with 2186 regard to the prescribing of certain drugs as specified in the 2187 General Appropriations Act and ensuring cost-effective 2188 prescribing practices. 2189 14. The agency may require prior authorization for 2190 Medicaid-covered prescribed drugs. The agency may prior 2191 authorize the use of a product: 2192 a. For an indication not approved in labeling; 2193 b. To comply with certain clinical guidelines; or 2194 c. If the product has the potential for overuse, misuse, or 2195 abuse. 2196 2197 The agency may require the prescribing professional to provide 2198 information about the rationale and supporting medical evidence 2199 for the use of a drug. The agency may post prior authorization 2200 and step-edit criteria,andprotocol, and updates to the list of 2201 drugs that are subject to prior authorization on the agency’san2202 Internet website within 21 days after the prior authorization 2203 criteria, protocol, or updates are approved by the agency 2204without amending its rule or engaging in additional rulemaking. 2205 15. The agency, in conjunction with the Pharmaceutical and 2206 Therapeutics Committee, may require age-related prior 2207 authorizations for certain prescribed drugs. The agency may 2208 preauthorize the use of a drug for a recipient who may not meet 2209 the age requirement or may exceed the length of therapy for use 2210 of this product as recommended by the manufacturer and approved 2211 by the Food and Drug Administration. Prior authorization may 2212 require the prescribing professional to provide information 2213 about the rationale and supporting medical evidence for the use 2214 of a drug. 2215 16. The agency shall implement a step-therapy prior 2216 authorization approval process for medications excluded from the 2217 preferred drug list. Medications listed on the preferred drug 2218 list must be used within the previous 12 months before the 2219 alternative medications that are not listed. The step-therapy 2220 prior authorization may require the prescriber to use the 2221 medications of a similar drug class or for a similar medical 2222 indication unless contraindicated in the Food and Drug 2223 Administration labeling. The trial period between the specified 2224 steps may vary according to the medical indication. The step 2225 therapy approval process shall be developed in accordance with 2226 the committee as stated in s. 409.91195(7) and (8). A drug 2227 product may be approved without meeting the step-therapy prior 2228 authorization criteria if the prescribing physician provides the 2229 agency with additional written medical or clinical documentation 2230 that the product is medically necessary because: 2231 a. There is not a drug on the preferred drug list to treat 2232 the disease or medical condition which is an acceptable clinical 2233 alternative; 2234 b. The alternatives have been ineffective in the treatment 2235 of the beneficiary’s disease; or 2236 c. Based on historic evidence and known characteristics of 2237 the patient and the drug, the drug is likely to be ineffective, 2238 or the number of doses have been ineffective. 2239 2240 The agency shall work with the physician to determine the best 2241 alternative for the patient. The agency may adopt rules waiving 2242 the requirements for written clinical documentation for specific 2243 drugs in limited clinical situations. 2244 17. The agency shall implement a return and reuse program 2245 for drugs dispensed by pharmacies to institutional recipients, 2246 which includes payment of a $5 restocking fee for the 2247 implementation and operation of the program. The return and 2248 reuse program shall be implemented electronically and in a 2249 manner that promotes efficiency. The program must permit a 2250 pharmacy to exclude drugs from the program if it is not 2251 practical or cost-effective for the drug to be included and must 2252 provide for the return to inventory of drugs that cannot be 2253 credited or returned in a cost-effective manner. The agency 2254 shall determine if the program has reduced the amount of 2255 Medicaid prescription drugs which are destroyed on an annual 2256 basis and if there are additional ways to ensure more 2257 prescription drugs are not destroyed which could safely be 2258 reused. 2259 Section 48. Subsections (1), (7), and (8) of section 2260 409.91195, Florida Statutes, are amended to read: 2261 409.91195 Medicaid Pharmaceutical and Therapeutics 2262 Committee.—There is created a Medicaid Pharmaceutical and 2263 Therapeutics Committee within the agency for the purpose of 2264 developing a Medicaid preferred drug list. 2265 (1)(a) The committee shall be composed of 11 members 2266 appointed by the Governor as follows: one member licensed under 2267 chapter 458 or chapter 459 who is nominated by the Florida 2268 Medical Association; one member licensed under chapter 459 who 2269 is nominated by the Florida Osteopathic Medical Association; one 2270 member licensed under chapter 458 or chapter 459 who is 2271 nominated by the American Academy of Family Physicians, Florida 2272 Chapter; one member licensed under chapter 458 or chapter 459 2273 who is nominated by the American Academy of Pediatrics, Florida 2274 Chapter; one member licensed under chapter 458 or chapter 459 2275 nominated by the Florida Psychiatric Society; one member 2276 licensed under chapter 465 who is nominated by the Florida 2277 Pharmacy Association; one member licensed under chapter 465 who 2278 is nominated by the Florida Society of Health System 2279 Pharmacists, Inc.; one member licensed under chapter 465 who is 2280 nominated by the Florida Retail Federation; one member licensed 2281 under chapter 465 who works in a retail setting for an 2282 independent, nonchain pharmacy; one member licensed under 2283 chapter 458 or chapter 459 who is nominated by the Florida 2284 Academy of Physician Assistants; and one consumer representative 2285 who represents a patient advocacy group. 2286 (b) Each member of the committee, except the consumer 2287 representative, must practice in this state and participate in 2288 the Florida Medicaid Fee for Service Pharmacy Program. 2289 (c) The Governor shall appoint the members for 2-year 2290 terms. Members may be appointed to more than one term. The 2291 agency shall serve as staff for the committee and assist the 2292 members with administrative duties.Four members shall be2293physicians, licensed under chapter 458; one member licensed2294under chapter 459; five members shall be pharmacists licensed2295under chapter 465; and one member shall be a consumer2296representative. The members shall be appointed to serve for2297terms of 2 years from the date of their appointment. Members may2298be appointed to more than one term. The agency shall serve as2299staff for the committee and assist them with all ministerial2300duties. The Governor shall ensure that at least some of the2301members of the committee represent Medicaid participating2302physicians and pharmacies serving all segments and diversity of2303the Medicaid population, and have experience in either2304developing or practicing under a preferred drug list. At least2305one of the members shall represent the interests of2306pharmaceutical manufacturers.2307 (7) The committee shall ensure that interested parties, 2308 including pharmaceutical manufacturers agreeing to provide a 2309 supplemental rebate as outlined in this chapter, have an 2310 opportunity to present public testimony to the committee with 2311 information or evidence supporting inclusion of a product on the 2312 preferred drug list. Such public testimony shall occur prior to 2313 any recommendations made by the committee for inclusion or 2314 exclusion from the preferred drug list, allow for members of the 2315 committee to ask questions of the presenters of the public 2316 testimony, and allow for 3 minutes of testimony for each drug 2317 reviewed. The agency may not limit the number of interested 2318 parties that provide public testimony. Upon timely notice, the 2319 agency shall ensure that any drug that has been approved or had 2320 any of its particular uses approved by the United States Food 2321 and Drug Administration under a priority review classification 2322 will be reviewed by the committee at the next regularly 2323 scheduled meeting following 3 months of distribution of the drug 2324 to the general public. 2325 (8) The committee shall develop its preferred drug list 2326 recommendations by considering the clinical efficacy, safety, 2327 and cost-effectiveness of a product. If the agency does not 2328 follow a recommendation of the committee, the committee members 2329 must be informed in writing of the agency’s action at the next 2330 meeting of the committee following the reversal of its 2331 recommendation. 2332 Section 49. Effective upon this act becoming a law, 2333 paragraph (e) is added to subsection (1) of section 409.975, 2334 Florida Statutes, to read: 2335 409.975 Managed care plan accountability.—In addition to 2336 the requirements of s. 409.967, plans and providers 2337 participating in the managed medical assistance program shall 2338 comply with the requirements of this section. 2339 (1) PROVIDER NETWORKS.—Managed care plans must develop and 2340 maintain provider networks that meet the medical needs of their 2341 enrollees in accordance with standards established pursuant to 2342 s. 409.967(2)(b). Except as provided in this section, managed 2343 care plans may limit the providers in their networks based on 2344 credentials, quality indicators, and price. 2345 (e) Before the selection of managed care plans as specified 2346 in s. 409.966, each essential provider and each hospital that 2347 are necessary in order for a managed care plan to demonstrate an 2348 adequate network, as determined by the agency, are a part of 2349 that managed care plan’s network for purposes of the provider’s 2350 or hospital’s application for enrollment or expansion in the 2351 Medicaid program. A managed care plan’s payment under this 2352 section to an essential provider must be made in accordance with 2353 this section. 2354 Section 50. Subsection (6) of section 429.11, Florida 2355 Statutes, is repealed. 2356 Section 51. Subsection (1) of section 429.294, Florida 2357 Statutes is amended to read: 2358 429.294 Availability of facility records for investigation 2359 of resident’s rights violations and defenses; penalty.— 2360 (1) Failure to provide complete copies of a resident’s 2361 records, including, but not limited to, all medical records and 2362 the resident’s chart, within the control or possession of the 2363 facility within 10 days, in accordance with the provisions of s. 2364 400.141(3)400.145, shall constitute evidence of failure of that 2365 party to comply with good faith discovery requirements and shall 2366 waive the good faith certificate and presuit notice requirements 2367 under this part by the requesting party. 2368 Section 52. Subsections (1) and (5) of section 429.71, 2369 Florida Statutes, are amended to read: 2370 429.71 Classification of violationsdeficiencies; 2371 administrative fines.— 2372 (1) In addition to the requirements of part II of chapter 2373 408 and in addition to any other liability or penalty provided 2374 by law, the agency may impose an administrative fine on a 2375 provider according to the following classification: 2376 (a) Class I violations are defined in s. 408.813those2377conditions or practices related to the operation and maintenance2378of an adult family-care home or to the care of residents which2379the agency determines present an imminent danger to the2380residents or guests of the facility or a substantial probability2381that death or serious physical or emotional harm would result2382therefrom. The condition or practice that constitutes a class I2383violation must be abated or eliminated within 24 hours, unless a2384fixed period, as determined by the agency, is required for2385correction. A class I violationdeficiencyis subject to an 2386 administrative fine in an amount not less than $500 and not 2387 exceeding $1,000 for each violation.A fine may be levied2388notwithstanding the correction of the deficiency.2389 (b) Class II violations are defined in s. 408.813those2390conditions or practices related to the operation and maintenance2391of an adult family-care home or to the care of residents which2392the agency determines directly threaten the physical or2393emotional health, safety, or security of the residents, other2394than class I violations. A class II violation is subject to an 2395 administrative fine in an amount not less than $250 and not 2396 exceeding $500 for each violation.A citation for a class II2397violation must specify the time within which the violation is2398required to be corrected. If a class II violation is corrected2399within the time specified, no civil penalty shall be imposed,2400unless it is a repeated offense.2401 (c) Class III violations are defined in s. 408.813those2402conditions or practices related to the operation and maintenance2403of an adult family-care home or to the care of residents which2404the agency determines indirectly or potentially threaten the2405physical or emotional health, safety, or security of residents,2406other than class I or class II violations. A class III violation 2407 is subject to an administrative fine in an amount not less than 2408 $100 and not exceeding $250 for each violation.A citation for a2409class III violation shall specify the time within which the2410violation is required to be corrected.If a class III violation 2411 is corrected within the time specified, no civil penalty shall 2412 be imposed, unless it is a repeated violationoffense. 2413 (d) Class IV violations are defined in s. 408.813those2414conditions or occurrences related to the operation and2415maintenance of an adult family-care home, or related to the2416required reports, forms, or documents, which do not have the2417potential of negatively affecting the residents.A provider that2418does not correctA class IV violationwithin the time limit2419specified by the agencyis subject to an administrative fine in 2420 an amount not less than $50 and not exceeding $100 for each 2421 violation. Any class IV violation that is corrected during the 2422 time the agency survey is conducted will be identified as an 2423 agency finding and not as a violation, unless it is a repeat 2424 violation. 2425(5) As an alternative to or in conjunction with an2426administrative action against a provider, the agency may request2427a plan of corrective action that demonstrates a good faith2428effort to remedy each violation by a specific date, subject to2429the approval of the agency.2430 Section 53. Section 429.915, Florida Statutes, is amended 2431 to read: 2432 429.915 Conditional license.—In addition to the license 2433 categories available in part II of chapter 408, the agency may 2434 issue a conditional license to an applicant for license renewal 2435 or change of ownership if the applicant fails to meet all 2436 standards and requirements for licensure. A conditional license 2437 issued under this subsection must be limited to a specific 2438 period not exceeding 6 months, as determined by the agency, and2439must be accompanied by an approved plan of correction. 2440 Section 54. Subsection (3) of section 430.80, Florida 2441 Statutes, is amended to read: 2442 430.80 Implementation of a teaching nursing home pilot 2443 project.— 2444 (3) To be designated as a teaching nursing home, a nursing 2445 home licensee must, at a minimum: 2446 (a) Provide a comprehensive program of integrated senior 2447 services that include institutional services and community-based 2448 services; 2449 (b) Participate in a nationally recognized accreditation 2450 program and hold a valid accreditation, such as the 2451 accreditation awarded by the Joint Commission on Accreditation 2452 of Healthcare Organizations, or, at the time of initial 2453 designation, possess a Gold Seal Award as conferred by the state 2454 on its licensed nursing home; 2455 (c) Have been in business in this state for a minimum of 10 2456 consecutive years; 2457 (d) Demonstrate an active program in multidisciplinary 2458 education and research that relates to gerontology; 2459 (e) Have a formalized contractual relationship with at 2460 least one accredited health profession education program located 2461 in this state; 2462 (f) Have senior staff members who hold formal faculty 2463 appointments at universities, which must include at least one 2464 accredited health profession education program; and 2465 (g) Maintain insurance coverage pursuant to s. 2466 400.141(1)(q)s.400.141(1)(s)or proof of financial 2467 responsibility in a minimum amount of $750,000. Such proof of 2468 financial responsibility may include: 2469 1. Maintaining an escrow account consisting of cash or 2470 assets eligible for deposit in accordance with s. 625.52; or 2471 2. Obtaining and maintaining pursuant to chapter 675 an 2472 unexpired, irrevocable, nontransferable and nonassignable letter 2473 of credit issued by any bank or savings association organized 2474 and existing under the laws of this state or any bank or savings 2475 association organized under the laws of the United States that 2476 has its principal place of business in this state or has a 2477 branch office which is authorized to receive deposits in this 2478 state. The letter of credit shall be used to satisfy the 2479 obligation of the facility to the claimant upon presentment of a 2480 final judgment indicating liability and awarding damages to be 2481 paid by the facility or upon presentment of a settlement 2482 agreement signed by all parties to the agreement when such final 2483 judgment or settlement is a result of a liability claim against 2484 the facility. 2485 Section 55. Paragraph (h) of subsection (2) of section 2486 430.81, Florida Statutes, is amended to read: 2487 430.81 Implementation of a teaching agency for home and 2488 community-based care.— 2489 (2) The Department of Elderly Affairs may designate a home 2490 health agency as a teaching agency for home and community-based 2491 care if the home health agency: 2492 (h) Maintains insurance coverage pursuant to s. 2493 400.141(1)(q)s.400.141(1)(s)or proof of financial 2494 responsibility in a minimum amount of $750,000. Such proof of 2495 financial responsibility may include: 2496 1. Maintaining an escrow account consisting of cash or 2497 assets eligible for deposit in accordance with s. 625.52; or 2498 2. Obtaining and maintaining, pursuant to chapter 675, an 2499 unexpired, irrevocable, nontransferable, and nonassignable 2500 letter of credit issued by any bank or savings association 2501 authorized to do business in this state. This letter of credit 2502 shall be used to satisfy the obligation of the agency to the 2503 claimant upon presentation of a final judgment indicating 2504 liability and awarding damages to be paid by the facility or 2505 upon presentment of a settlement agreement signed by all parties 2506 to the agreement when such final judgment or settlement is a 2507 result of a liability claim against the agency. 2508 Section 56. Paragraph (d) of subsection (9) of section 2509 440.102, Florida Statutes, is repealed. 2510 Section 57. Subsection (1) of section 483.035, Florida 2511 Statutes, is amended to read: 2512 483.035 Clinical laboratories operated by practitioners for 2513 exclusive use; licensure and regulation.— 2514 (1) A clinical laboratory operated by one or more 2515 practitioners licensed under chapter 458, chapter 459, chapter 2516 460, chapter 461, chapter 462, or chapter 466, or as an advanced 2517 registered nurse practitioner licensed under part I in chapter 2518 464, exclusively in connection with the diagnosis and treatment 2519 of their own patients, must be licensed under this part and must 2520 comply with the provisions of this part, except that the agency 2521 shall adopt rules for staffing, for personnel, including 2522 education and training of personnel, for proficiency testing, 2523 and for construction standards relating to the licensure and 2524 operation of the laboratory based upon and not exceeding the 2525 same standards contained in the federal Clinical Laboratory 2526 Improvement Amendments of 1988 and the federal regulations 2527 adopted thereunder. 2528 Section 58. Subsections (1) and (9) of section 483.051, 2529 Florida Statutes, are amended to read: 2530 483.051 Powers and duties of the agency.—The agency shall 2531 adopt rules to implement this part, which rules must include, 2532 but are not limited to, the following: 2533 (1) LICENSING; QUALIFICATIONS.—The agency shall provide for 2534 biennial licensure of all nonwaived clinical laboratories 2535 meeting the requirements of this part and shall prescribe the 2536 qualifications necessary for such licensure, including, but not 2537 limited to, application for or proof of a federal Clinical 2538 Laboratory Improvement Amendment (CLIA) certificate. For 2539 purposes of this section, the term “nonwaived clinical 2540 laboratories” means laboratories that perform any test that the 2541 Centers for Medicare and Medicaid Services has determined does 2542 not qualify for a certificate of waiver under the Clinical 2543 Laboratory Improvement Amendments of 1988 and the federal rules 2544 adopted thereunder. 2545 (9) ALTERNATE-SITE TESTING.—The agency, in consultation 2546 with the Board of Clinical Laboratory Personnel, shall adopt, by 2547 rule, the criteria for alternate-site testing to be performed 2548 under the supervision of a clinical laboratory director. The 2549 elements to be addressed in the rule include, but are not 2550 limited to: a hospital internal needs assessment; a protocol of 2551 implementation including tests to be performed and who will 2552 perform the tests; criteria to be used in selecting the method 2553 of testing to be used for alternate-site testing; minimum 2554 training and education requirements for those who will perform 2555 alternate-site testing, such as documented training, licensure, 2556 certification, or other medical professional background not 2557 limited to laboratory professionals; documented inservice 2558 training as well as initial and ongoing competency validation; 2559 an appropriate internal and external quality control protocol; 2560 an internal mechanism for identifying and tracking alternate 2561 site testing by the central laboratory; and recordkeeping 2562 requirements.Alternate-site testing locations must register2563when the clinical laboratory applies to renew its license.For 2564 purposes of this subsection, the term “alternate-site testing” 2565 means any laboratory testing done under the administrative 2566 control of a hospital, but performed out of the physical or 2567 administrative confines of the central laboratory. 2568 Section 59. Section 483.245, Florida Statutes, is amended 2569 to read: 2570 483.245 Rebates prohibited; penalties; private action.— 2571 (1) It is unlawful for any person to pay or receive any 2572 commission, bonus, kickback, or rebate or engage in any split 2573 fee arrangement in any form whatsoever with any dialysis 2574 facility, physician, surgeon, organization, agency, or person, 2575 either directly or indirectly, for patients referred to a 2576 clinical laboratory licensed under this part. A clinical 2577 laboratory licensed under this part is prohibited from placing, 2578 directly or indirectly, through an independent staffing company 2579 or lease arrangement, or otherwise, a specimen collector or 2580 other personnel in any physician’s office, unless the clinical 2581 lab and the physician’s office are owned and operated by the 2582 same entity. 2583 (2) The agency shall adopt rules that assess administrative 2584 penalties for acts prohibited by subsection (1). In the case of 2585 an entity licensed by the agency, such penalties may include any 2586 disciplinary action available to the agency under the 2587 appropriate licensing laws. In the case of an entity not 2588 licensed by the agency, such penalties may include: 2589 (a) A fine not to exceed $1,000; 2590 (b) If applicable, a recommendation by the agency to the 2591 appropriate licensing board that disciplinary action be taken. 2592 (3) Any person aggrieved by a violation of this section may 2593 bring a civil action for appropriate relief, including an action 2594 for a declaratory judgment, injunctive relief, and actual 2595 damages. 2596 Section 60. Section 483.294, Florida Statutes, is amended 2597 to read: 2598 483.294 Inspection of centers.—In accordance with s. 2599 408.811, the agency shall biennially, at least once annually,2600 inspect the premises and operations of all centers subject to 2601 licensure under this part. 2602 Section 61. Paragraph (a) of subsection (54) of section 2603 499.003, Florida Statutes, is amended to read: 2604 499.003 Definitions of terms used in this part.—As used in 2605 this part, the term: 2606 (54) “Wholesale distribution” means distribution of 2607 prescription drugs to persons other than a consumer or patient, 2608 but does not include: 2609 (a) Any of the following activities, which is not a 2610 violation of s. 499.005(21) if such activity is conducted in 2611 accordance with s. 499.01(2)(g): 2612 1. The purchase or other acquisition by a hospital or other 2613 health care entity that is a member of a group purchasing 2614 organization of a prescription drug for its own use from the 2615 group purchasing organization or from other hospitals or health 2616 care entities that are members of that organization. 2617 2. The sale, purchase, or trade of a prescription drug or 2618 an offer to sell, purchase, or trade a prescription drug by a 2619 charitable organization described in s. 501(c)(3) of the 2620 Internal Revenue Code of 1986, as amended and revised, to a 2621 nonprofit affiliate of the organization to the extent otherwise 2622 permitted by law. 2623 3. The sale, purchase, or trade of a prescription drug or 2624 an offer to sell, purchase, or trade a prescription drug among 2625 hospitals or other health care entities that are under common 2626 control. For purposes of this subparagraph, “common control” 2627 means the power to direct or cause the direction of the 2628 management and policies of a person or an organization, whether 2629 by ownership of stock, by voting rights, by contract, or 2630 otherwise. 2631 4. The sale, purchase, trade, or other transfer of a 2632 prescription drug from or for any federal, state, or local 2633 government agency or any entity eligible to purchase 2634 prescription drugs at public health services prices pursuant to 2635 Pub. L. No. 102-585, s. 602 to a contract provider or its 2636 subcontractor for eligible patients of the agency or entity 2637 under the following conditions: 2638 a. The agency or entity must obtain written authorization 2639 for the sale, purchase, trade, or other transfer of a 2640 prescription drug under this subparagraph from the State Surgeon 2641 General or his or her designee. 2642 b. The contract provider or subcontractor must be 2643 authorized by law to administer or dispense prescription drugs. 2644 c. In the case of a subcontractor, the agency or entity 2645 must be a party to and execute the subcontract. 2646d. A contract provider or subcontractor must maintain2647separate and apart from other prescription drug inventory any2648prescription drugs of the agency or entity in its possession.2649 d.e.The contract provider and subcontractor must maintain 2650 and produce immediately for inspection all records of movement 2651 or transfer of all the prescription drugs belonging to the 2652 agency or entity, including, but not limited to, the records of 2653 receipt and disposition of prescription drugs. Each contractor 2654 and subcontractor dispensing or administering these drugs must 2655 maintain and produce records documenting the dispensing or 2656 administration. Records that are required to be maintained 2657 include, but are not limited to, a perpetual inventory itemizing 2658 drugs received and drugs dispensed by prescription number or 2659 administered by patient identifier, which must be submitted to 2660 the agency or entity quarterly. 2661 e.f.The contract provider or subcontractor may administer 2662 or dispense the prescription drugs only to the eligible patients 2663 of the agency or entity or must return the prescription drugs 2664 for or to the agency or entity. The contract provider or 2665 subcontractor must require proof from each person seeking to 2666 fill a prescription or obtain treatment that the person is an 2667 eligible patient of the agency or entity and must, at a minimum, 2668 maintain a copy of this proof as part of the records of the 2669 contractor or subcontractor required under sub-subparagraph e. 2670 f.g.In addition to the departmental inspection authority 2671 set forth in s. 499.051, the establishment of the contract 2672 provider and subcontractor and all records pertaining to 2673 prescription drugs subject to this subparagraph shall be subject 2674 to inspection by the agency or entity. All records relating to 2675 prescription drugs of a manufacturer under this subparagraph 2676 shall be subject to audit by the manufacturer of those drugs, 2677 without identifying individual patient information. 2678 Section 62. Effective May 1, 2012, paragraph (h) is added 2679 to subsection (1) of section 627.602, Florida Statutes, to read: 2680 627.602 Scope, format of policy.— 2681 (1) Each health insurance policy delivered or issued for 2682 delivery to any person in this state must comply with all 2683 applicable provisions of this code and all of the following 2684 requirements: 2685 (h) Section 641.312 and the provisions of the Employee 2686 Retirement Income Security Act of 1974, as implemented by 29 2687 C.F.R. s. 2560.503-1, relating to internal grievances. This 2688 paragraph does not apply to a health insurance policy that is 2689 subject to the Subscriber Assistance Program in s. 408.7056. 2690 Section 63. Effective May 1, 2012, section 627.6513, 2691 Florida Statutes, is created to read: 2692 627.6513 Section 641.312 and the provisions of the Employee 2693 Retirement Income Security Act of 1974, as implemented by 29 2694 C.F.R. s. 2560.503-1, relating to internal grievances, apply to 2695 all group health insurance policies issued under this part. This 2696 section does not apply to a group health insurance policy that 2697 is subject to the Subscriber Assistance Program in s. 408.7056. 2698 Section 64. Effective May 1, 2012, section 641.312, Florida 2699 Statutes, is created to read: 2700 641.312 The Office of Insurance Regulation within the 2701 Department of Financial Services shall adopt rules to administer 2702 the provisions of the National Association of Insurance 2703 Commissioners’ Uniform Health Carrier External Review Model Act, 2704 dated April 2010. This section does not apply to a health 2705 maintenance contract that is subject to the Subscriber 2706 Assistance Program in s. 408.7056. 2707 Section 65. Subsection (13) of section 651.118, Florida 2708 Statutes, is amended to read: 2709 651.118 Agency for Health Care Administration; certificates 2710 of need; sheltered beds; community beds.— 2711 (13) Residents, as defined in this chapter, are not 2712 considered new admissions for the purpose of s. 400 141(1)(n)1.d 2713s.400.141(1)(o)1.d. 2714 Section 66. In the interim between this act becoming law 2715 and the 2013 Regular Session of the Legislature, the Division of 2716 Statutory Revision shall provide the relevant substantive 2717 committees of the Senate and the House of Representatives with 2718 assistance, upon request, to enable such committees to prepare 2719 draft legislation to correct the names of accrediting 2720 organizations in the related Florida Statutes. 2721 Section 67. Except as otherwise expressly provided in this 2722 act, and except for this section, which shall take effect upon 2723 this act becoming a law, this act shall take effect July 1, 2724 2012.