Bill Text: FL S7078 | 2019 | Regular Session | Comm Sub
Bill Title: Health Care
Spectrum: Committee Bill
Status: (Introduced - Dead) 2019-04-26 - Laid on Table, companion bill(s) passed, see CS/HB 843 (Ch. 2019-138), CS/HB 7 (Ch. 2019-105) [S7078 Detail]
Download: Florida-2019-S7078-Comm_Sub.html
Florida Senate - 2019 CS for SB 7078 By the Committees on Appropriations; and Health Policy 576-04629B-19 20197078c1 1 A bill to be entitled 2 An act relating to health care; providing legislative 3 intent; creating s. 381.4019, F.S.; establishing the 4 Dental Student Loan Repayment Program to support 5 dentists who practice in public health programs 6 located in certain underserved areas; providing 7 definitions; requiring the Department of Health to 8 establish a dental student loan repayment program for 9 specified purposes; providing for the award of funds; 10 providing the maximum number of years for which funds 11 may be awarded; providing eligibility requirements; 12 requiring the department to adopt rules; specifying 13 that implementation of the program is subject to 14 legislative appropriation; creating s. 381.40195, 15 F.S.; providing a short title; providing definitions; 16 requiring the Department of Health to establish the 17 Donated Dental Services Program to provide 18 comprehensive dental care to certain eligible 19 individuals; requiring the department to contract with 20 a nonprofit organization to implement and administer 21 the program; specifying minimum contractual 22 responsibilities; requiring the department to adopt 23 rules; specifying that implementation of the program 24 is subject to legislative appropriation; amending s. 25 395.1012, F.S.; requiring a licensed hospital to 26 provide specified information and data relating to 27 patient safety and quality measures to a patient under 28 certain circumstances or to any person upon request; 29 creating s. 395.1052, F.S.; requiring a hospital to 30 notify a patient’s primary care provider within a 31 specified timeframe after the patient’s admission; 32 requiring a hospital to inform a patient, upon 33 admission, of the option to request consultation 34 between the hospital’s treating physician and the 35 patient’s primary care provider or specialist 36 provider; requiring a hospital to notify a patient’s 37 primary care provider of the patient’s discharge and 38 provide specified information and records to the 39 primary care provider within a specified timeframe 40 after discharge; amending s. 395.002, F.S.; revising 41 the definition of the term “ambulatory surgical 42 center”; amending s. 395.1055, F.S.; requiring the 43 Agency for Health Care Administration, in consultation 44 with the Board of Medicine and the Board of 45 Osteopathic Medicine, to adopt rules that establish 46 requirements related to the delivery of surgical care 47 to children in ambulatory surgical centers, in 48 accordance with specified standards; specifying that 49 ambulatory surgical centers may provide certain 50 procedures only if authorized by agency rule; 51 authorizing the reimbursement of per diem and travel 52 expenses to members of the pediatric cardiac technical 53 advisory panel, established within the Agency for 54 Health Care Administration; revising panel membership 55 to include certain alternate at-large members; 56 providing term limits for voting members; providing 57 that members of the panel under certain circumstances 58 are agents of the state for a specified purpose; 59 requiring the Secretary of Health Care Administration 60 to consult the panel for advisory recommendations on 61 certain certificate of need applications; authorizing 62 the secretary to request announced or unannounced site 63 visits to any existing pediatric cardiac surgical 64 center or facility seeking licensure as a pediatric 65 cardiac surgical center through the certificate of 66 need process; providing a process for the appointment 67 of physician experts to a site visit team; requiring 68 each member of a site visit team to submit a report to 69 the panel; requiring the panel to discuss such reports 70 and present an advisory opinion to the secretary; 71 providing requirements for an on-site inspection; 72 requiring the Surgeon General of the Department of 73 Health to provide specified reports to the secretary; 74 395.301, F.S.; requiring a licensed facility, upon 75 placing a patient on observation status, to 76 immediately notify the patient of such status using a 77 specified form; requiring that such notification be 78 documented in the patient’s medical records and 79 discharge papers; creating s. 542.336, F.S.; 80 specifying that certain restrictive covenants entered 81 into with certain physicians are not supported by 82 legitimate business interests; providing legislative 83 findings; providing that such restrictive covenants 84 are void and remain void and unenforceable for a 85 specified period; amending s. 624.27, F.S.; expanding 86 the scope of direct primary care agreements, which are 87 renamed “direct health care agreements”; conforming 88 provisions to changes made by the act; creating s. 89 627.42393, F.S.; prohibiting certain health insurers 90 from employing step-therapy protocols under certain 91 circumstances; defining the term “health coverage 92 plan”; clarifying that a health insurer is not 93 required to take specific actions regarding 94 prescription drugs; amending s. 641.31, F.S.; 95 prohibiting certain health maintenance organizations 96 from employing step-therapy protocols under certain 97 circumstances; defining the term “health coverage 98 plan”; clarifying that a health maintenance 99 organization is not required to take specific actions 100 regarding prescription drugs; requiring the Office of 101 Program Policy Analysis and Government Accountability 102 to submit by a specified date a report and 103 recommendations to the Governor and the Legislature 104 which addresses this state’s prospective entrance into 105 the Interstate Medical Licensure Compact as a member 106 state; providing parameters for the report; providing 107 effective dates. 108 109 Be It Enacted by the Legislature of the State of Florida: 110 111 Section 1. It is the intent of the Legislature to promote 112 programs and initiatives that help make available preventive and 113 educational dental services for the residents of the state, as 114 well as provide quality dental treatment services. The 115 geographic characteristics among the residents of the state are 116 distinctive and vary from region to region, with such residents 117 having unique needs regarding access to dental care. The 118 Legislature recognizes that maintaining good oral health is 119 integral to the overall health status of individuals and that 120 the good health of the residents of this state is an important 121 contributing factor in economic development. Better health, 122 including better oral health, increases workplace productivity, 123 reduces the burden of health care costs, and improves the 124 cognitive development of children, resulting in a reduction of 125 missed school days. 126 Section 2. Section 381.4019, Florida Statutes, is created 127 to read: 128 381.4019 Dental Student Loan Repayment Program.—The Dental 129 Student Loan Repayment Program is established to promote access 130 to dental care by supporting qualified dentists who treat 131 medically underserved populations in dental health professional 132 shortage areas or medically underserved areas. 133 (1) As used in this section, the term: 134 (a) “Dental health professional shortage area” means a 135 geographic area designated as such by the Health Resources and 136 Services Administration of the United States Department of 137 Health and Human Services. 138 (b) “Department” means the Department of Health. 139 (c) “Loan program” means the Dental Student Loan Repayment 140 Program. 141 (d) “Medically underserved area” means a geographic area, 142 an area having a special population, or a facility which is 143 designated by department rule as a health professional shortage 144 area as defined by federal regulation and which has a shortage 145 of dental health professionals who serve Medicaid recipients and 146 other low-income patients. 147 (e) “Public health program” means a county health 148 department, the Children’s Medical Services program, a federally 149 funded community health center, a federally funded migrant 150 health center, or other publicly funded or nonprofit health care 151 program designated by the department. 152 (2) The department shall establish a dental student loan 153 repayment program to benefit Florida-licensed dentists who 154 demonstrate, as required by department rule, active employment 155 in a public health program that serves Medicaid recipients and 156 other low-income patients and is located in a dental health 157 professional shortage area or a medically underserved area. 158 (3) The department shall award funds from the loan program 159 to repay the student loans of a dentist who meets the 160 requirements of subsection (2). 161 (a) An award may not exceed $50,000 per year per eligible 162 dentist. 163 (b) Only loans to pay the costs of tuition, books, dental 164 equipment and supplies, uniforms, and living expenses may be 165 covered. 166 (c) All repayments are contingent upon continued proof of 167 eligibility and must be made directly to the holder of the loan. 168 The state bears no responsibility for the collection of any 169 interest charges or other remaining balances. 170 (d) A dentist may receive funds under the loan program for 171 at least 1 year, up to a maximum of 5 years. 172 (e) The department shall limit the number of new dentists 173 participating in the loan program to not more than 10 per fiscal 174 year. 175 (4) A dentist is no longer eligible to receive funds under 176 the loan program if the dentist: 177 (a) Is no longer employed by a public health program that 178 meets the requirements of subsection (2). 179 (b) Ceases to participate in the Florida Medicaid program. 180 (c) Has disciplinary action taken against his or her 181 license by the Board of Dentistry for a violation of s. 466.028. 182 (5) The department shall adopt rules to administer the loan 183 program. 184 (6) Implementation of the loan program is subject to 185 legislative appropriation. 186 Section 3. Section 381.40195, Florida Statutes, is created 187 to read: 188 381.40195 Donated Dental Services Program.— 189 (1) This act may be cited as the “Donated Dental Services 190 Act.” 191 (2) As used in this section, the term: 192 (a) “Department” means the Department of Health. 193 (b) “Program” means the Donated Dental Services Program as 194 established pursuant to subsection (3). 195 (3) The department shall establish the Donated Dental 196 Services Program for the purpose of providing comprehensive 197 dental care through a network of volunteer dentists and other 198 dental providers to needy, disabled, elderly, and medically 199 compromised individuals who cannot afford necessary treatment 200 but are ineligible for public assistance. An eligible individual 201 may receive treatment in a volunteer dentist’s or participating 202 dental provider’s private office or at any other suitable 203 location. An eligible individual is not required to pay any fee 204 or cost associated with the treatment he or she receives. 205 (4) The department shall establish the program. The 206 department shall contract with a nonprofit organization that has 207 experience in providing similar services or administering 208 similar programs. The contract must specify the responsibilities 209 of the nonprofit organization, which may include, but are not 210 limited to: 211 (a) Maintaining a network of volunteer dentists and other 212 dental providers, including, but not limited to, dental 213 specialists and dental laboratories, to provide comprehensive 214 dental services to eligible individuals. 215 (b) Maintaining a system to refer eligible individuals to 216 the appropriate volunteer dentist or participating dental 217 provider. 218 (c) Developing a public awareness and marketing campaign to 219 promote the program and educate eligible individuals about its 220 availability and services. 221 (d) Providing the necessary administrative and technical 222 support to administer the program. 223 (e) Submitting an annual report to the department which 224 must include, at a minimum: 225 1. Financial data relating to administering the program. 226 2. Demographic data and other information relating to the 227 eligible individuals who are referred to and receive treatment 228 through the program. 229 3. Demographic data and other information relating to the 230 volunteer dentists and participating dental providers who 231 provide dental services through the program. 232 4. Any other data or information that the department may 233 require. 234 (f) Performing any other program-related duties and 235 responsibilities as required by the department. 236 (5) The department shall adopt rules to administer the 237 program. 238 (6) Implementation of the program is subject to legislative 239 appropriation. 240 Section 4. Subsection (3) is added to section 395.1012, 241 Florida Statutes, to read: 242 395.1012 Patient safety.— 243 (3)(a) Each hospital shall provide to any patient upon 244 admission, upon scheduling of nonemergency care, or before 245 treatment, written information on a form created by the agency 246 which contains the following information available for the 247 hospital for the most recent year and the statewide average for 248 all hospitals related to the following quality measures: 249 1. The rate of hospital-acquired infections; 250 2. The overall rating of the Hospital Consumer Assessment 251 of Healthcare Providers and Systems survey; and 252 3. The 15-day readmission rate. 253 (b) A hospital shall also provide to any person, upon 254 request, the written information specified in paragraph (a). 255 (c) The information required by this subsection must be 256 presented in a manner that is easily understandable and 257 accessible to the patient and must also include an explanation 258 of the quality measures and the relationship between patient 259 safety and the hospital’s data for the quality measures. 260 Section 5. Section 395.1052, Florida Statutes, is created 261 to read: 262 395.1052 Patient access to primary care and specialty 263 providers; notification.—A hospital shall: 264 (1) Notify each patient’s primary care provider, if any, 265 within 24 hours after the patient’s admission to the hospital. 266 (2) Inform the patient immediately upon admission that he 267 or she may request to have the hospital’s treating physician 268 consult with the patient’s primary care provider or specialist 269 provider, if any, when developing the patient’s plan of care. 270 Upon the patient’s request, the hospital’s treating physician 271 shall make reasonable efforts to consult with the patient’s 272 primary care provider or specialist provider when developing the 273 patient’s plan of care. 274 (3) Notify the patient’s primary care provider, if any, of 275 the patient’s discharge from the hospital within 24 hours after 276 the discharge. 277 (4) Provide the discharge summary and any related 278 information or records to the patient’s primary care provider, 279 if any, within 14 days after the patient’s discharge from the 280 hospital. 281 Section 6. Subsection (3) of section 395.002, Florida 282 Statutes, is amended to read: 283 395.002 Definitions.—As used in this chapter: 284 (3) “Ambulatory surgical center” means a facility the 285 primary purpose of which is to provide elective surgical care, 286 in which the patient is admitted to and discharged from such 287 facility within 24 hoursthe same working day and is not288permitted to stay overnight, and which is not part of a 289 hospital. However, a facility existing for the primary purpose 290 of performing terminations of pregnancy, an office maintained by 291 a physician for the practice of medicine, or an office 292 maintained for the practice of dentistry may not be construed to 293 be an ambulatory surgical center, provided that any facility or 294 office which is certified or seeks certification as a Medicare 295 ambulatory surgical center shall be licensed as an ambulatory 296 surgical center pursuant to s. 395.003. 297 Section 7. Section 395.1055, Florida Statutes, is amended 298 to read: 299 395.1055 Rules and enforcement.— 300 (1) The agency shall adopt rules pursuant to ss. 120.536(1) 301 and 120.54 to implement the provisions of this part, which shall 302 include reasonable and fair minimum standards for ensuring that: 303 (a) Sufficient numbers and qualified types of personnel and 304 occupational disciplines are on duty and available at all times 305 to provide necessary and adequate patient care and safety. 306 (b) Infection control, housekeeping, sanitary conditions, 307 and medical record procedures that will adequately protect 308 patient care and safety are established and implemented. 309 (c) A comprehensive emergency management plan is prepared 310 and updated annually. Such standards must be included in the 311 rules adopted by the agency after consulting with the Division 312 of Emergency Management. At a minimum, the rules must provide 313 for plan components that address emergency evacuation 314 transportation; adequate sheltering arrangements; postdisaster 315 activities, including emergency power, food, and water; 316 postdisaster transportation; supplies; staffing; emergency 317 equipment; individual identification of residents and transfer 318 of records, and responding to family inquiries. The 319 comprehensive emergency management plan is subject to review and 320 approval by the local emergency management agency. During its 321 review, the local emergency management agency shall ensure that 322 the following agencies, at a minimum, are given the opportunity 323 to review the plan: the Department of Elderly Affairs, the 324 Department of Health, the Agency for Health Care Administration, 325 and the Division of Emergency Management. Also, appropriate 326 volunteer organizations must be given the opportunity to review 327 the plan. The local emergency management agency shall complete 328 its review within 60 days and either approve the plan or advise 329 the facility of necessary revisions. 330 (d) Licensed facilities are established, organized, and 331 operated consistent with established standards and rules. 332 (e) Licensed facility beds conform to minimum space, 333 equipment, and furnishings standards as specified by the 334 department. 335 (f) All hospitals submit such data as necessary to conduct 336 certificate-of-need reviews required under part I of chapter 337 408. Such data shall include, but shall not be limited to, 338 patient origin data, hospital utilization data, type of service 339 reporting, and facility staffing data. The agency may not 340 collect data that identifies or could disclose the identity of 341 individual patients. The agency shall utilize existing uniform 342 statewide data sources when available and shall minimize 343 reporting costs to hospitals. 344 (g) Each hospital has a quality improvement program 345 designed according to standards established by their current 346 accrediting organization. This program will enhance quality of 347 care and emphasize quality patient outcomes, corrective action 348 for problems, governing board review, and reporting to the 349 agency of standardized data elements necessary to analyze 350 quality of care outcomes. The agency shall use existing data, 351 when available, and shall not duplicate the efforts of other 352 state agencies in order to obtain such data. 353 (h) Licensed facilities make available on their Internet 354 websites, no later than October 1, 2004, and in a hard copy 355 format upon request, a description of and a link to the patient 356 charge and performance outcome data collected from licensed 357 facilities pursuant to s. 408.061. 358 (i) All hospitals providing organ transplantation, neonatal 359 intensive care services, inpatient psychiatric services, 360 inpatient substance abuse services, or comprehensive medical 361 rehabilitation meet the minimum licensure requirements adopted 362 by the agency. Such licensure requirements must include quality 363 of care, nurse staffing, physician staffing, physical plant, 364 equipment, emergency transportation, and data reporting 365 standards. 366 (2) Separate standards may be provided for general and 367 specialty hospitals, ambulatory surgical centers, and statutory 368 rural hospitals as defined in s. 395.602. 369 (3)(a) The agency, in consultation with the Board of 370 Medicine and the Board of Osteopathic Medicine, shall adopt 371 rules that establish requirements to ensure the safe and 372 effective delivery of surgical care to children kept past 373 midnight in ambulatory surgical centers. The rules must be 374 consistent with the American College of Surgeons’ 2015 standards 375 document entitled “Optimal Resources for Children’s Surgical 376 Care” and must establish minimum standards for pediatric patient 377 care in ambulatory surgical centers. 378 (b) Ambulatory surgical centers may provide operative 379 procedures that require a length of stay past midnight on the 380 day of surgery for children younger than 18 years of age only if 381 the agency authorizes the performance of such procedures by 382 rule. 383 (4)(3)The agency shall adopt rules with respect to the 384 care and treatment of patients residing in distinct part nursing 385 units of hospitals which are certified for participation in 386 Title XVIII (Medicare) and Title XIX (Medicaid) of the Social 387 Security Act skilled nursing facility program. Such rules shall 388 take into account the types of patients treated in hospital 389 skilled nursing units, including typical patient acuity levels 390 and the average length of stay in such units, and shall be 391 limited to the appropriate portions of the Omnibus Budget 392 Reconciliation Act of 1987 (Pub. L. No. 100-203) (December 22, 393 1987), Title IV (Medicare, Medicaid, and Other Health-Related 394 Programs), Subtitle C (Nursing Home Reform), as amended. The 395 agency shall require level 2 background screening as specified 396 in s. 408.809(1)(e) pursuant to s. 408.809 and chapter 435 for 397 personnel of distinct part nursing units. 398 (5)(4)The agency shall adopt rules with respect to the 399 care and treatment of clients in intensive residential treatment 400 programs for children and adolescents and with respect to the 401 safe and healthful development, operation, and maintenance of 402 such programs. 403 (6)(5)The agency shall enforce the provisions of part I of 404 chapter 394, and rules adopted thereunder, with respect to the 405 rights, standards of care, and examination and placement 406 procedures applicable to patients voluntarily or involuntarily 407 admitted to hospitals providing psychiatric observation, 408 evaluation, diagnosis, or treatment. 409 (7)(6)No rule shall be adopted under this part by the 410 agency which would have the effect of denying a license to a 411 facility required to be licensed under this part, solely by 412 reason of the school or system of practice employed or permitted 413 to be employed by physicians therein, provided that such school 414 or system of practice is recognized by the laws of this state. 415 However, nothing in this subsection shall be construed to limit 416 the powers of the agency to provide and require minimum 417 standards for the maintenance and operation of, and for the 418 treatment of patients in, those licensed facilities which 419 receive federal aid, in order to meet minimum standards related 420 to such matters in such licensed facilities which may now or 421 hereafter be required by appropriate federal officers or 422 agencies in pursuance of federal law or promulgated in pursuance 423 of federal law. 424 (8)(7)Any licensed facility which is in operation at the 425 time of promulgation of any applicable rules under this part 426 shall be given a reasonable time, under the particular 427 circumstances, but not to exceed 1 year from the date of such 428 promulgation, within which to comply with such rules. 429 (9)(8)The agency may not adopt any rule governing the 430 design, construction, erection, alteration, modification, 431 repair, or demolition of any public or private hospital, 432 intermediate residential treatment facility, or ambulatory 433 surgical center. It is the intent of the Legislature to preempt 434 that function to the Florida Building Commission and the State 435 Fire Marshal through adoption and maintenance of the Florida 436 Building Code and the Florida Fire Prevention Code. However, the 437 agency shall provide technical assistance to the commission and 438 the State Fire Marshal in updating the construction standards of 439 the Florida Building Code and the Florida Fire Prevention Code 440 which govern hospitals, intermediate residential treatment 441 facilities, and ambulatory surgical centers. 442 (10)(9)The agency shall establish a pediatric cardiac 443 technical advisory panel, pursuant to s. 20.052, to develop 444 procedures and standards for measuring outcomes of pediatric 445 cardiac catheterization programs and pediatric cardiovascular 446 surgery programs. 447 (a) Members of the panel must have technical expertise in 448 pediatric cardiac medicine, shall serve without compensation, 449 and maynotbe reimbursed for per diem and travel expenses. 450 (b) Voting members of the panel shall include: 3 at-large 451 members, and 3 alternate at-large members with different program 452 affiliations, including 1 cardiologist who is board certified in 453 caring for adults with congenital heart disease and 2 board 454 certified pediatric cardiologists, neither of whom may be 455 employed by any of the hospitals specified in subparagraphs 1. 456 10. or their affiliates, each of whom is appointed by the 457 Secretary of Health Care Administration, and 10 members, and an 458 alternate for each member, each of whom is a pediatric 459 cardiologist or a pediatric cardiovascular surgeon, each 460 appointed by the chief executive officer of the following 461 hospitals: 462 1. Johns Hopkins All Children’s Hospital in St. Petersburg. 463 2. Arnold Palmer Hospital for Children in Orlando. 464 3. Joe DiMaggio Children’s Hospital in Hollywood. 465 4. Nicklaus Children’s Hospital in Miami. 466 5. St. Joseph’s Children’s Hospital in Tampa. 467 6. University of Florida Health Shands Hospital in 468 Gainesville. 469 7. University of Miami Holtz Children’s Hospital in Miami. 470 8. Wolfson Children’s Hospital in Jacksonville. 471 9. Florida Hospital for Children in Orlando. 472 10. Nemours Children’s Hospital in Orlando. 473 474 Appointments made under subparagraphs 1.-10. are contingent upon 475 the hospital’s maintenance of pediatric certificates of need and 476 the hospital’s compliance with this section and rules adopted 477 thereunder, as determined by the Secretary of Health Care 478 Administration. A member appointed under subparagraphs 1.-10. 479 whose hospital fails to maintain such certificates or comply 480 with standards may serve only as a nonvoting member until the 481 hospital restores such certificates or complies with such 482 standards. A voting member may serve a maximum of two 2-year 483 terms and may be reappointed to the panel after being retired 484 from the panel for a full 2-year term. 485 (c) The Secretary of Health Care Administration may appoint 486 nonvoting members to the panel. Nonvoting members may include: 487 1. The Secretary of Health Care Administration. 488 2. The Surgeon General. 489 3. The Deputy Secretary of Children’s Medical Services. 490 4. Any current or past Division Director of Children’s 491 Medical Services. 492 5. A parent of a child with congenital heart disease. 493 6. An adult with congenital heart disease. 494 7. A representative from each of the following 495 organizations: the Florida Chapter of the American Academy of 496 Pediatrics, the Florida Chapter of the American College of 497 Cardiology, the Greater Southeast Affiliate of the American 498 Heart Association, the Adult Congenital Heart Association, the 499 March of Dimes, the Florida Association of Children’s Hospitals, 500 and the Florida Society of Thoracic and Cardiovascular Surgeons. 501 (d) The panel shall meet biannually, or more frequently 502 upon the call of the Secretary of Health Care Administration. 503 Such meetings may be conducted telephonically, or by other 504 electronic means. 505 (e) The duties of the panel include recommending to the 506 agency standards for quality of care, personnel, physical plant, 507 equipment, emergency transportation, and data reporting for 508 hospitals that provide pediatric cardiac services. 509 (f) Beginning on January 1, 2020, and annually thereafter, 510 the panel shall submit a report to the Governor, the President 511 of the Senate, the Speaker of the House of Representatives, the 512 Secretary of Health Care Administration, and the State Surgeon 513 General. The report must summarize the panel’s activities during 514 the preceding fiscal year and include data and performance 515 measures on surgical morbidity and mortality for all pediatric 516 cardiac programs. 517 (g) Panel members are agents of the state for purposes of 518 s. 768.28 throughout the good faith performance of the duties 519 assigned to them by the Secretary of Health Care Administration. 520 (11) The Secretary of Health Care Administration shall 521 consult the pediatric cardiac technical advisory panel for an 522 advisory recommendation on all certificate of need applications 523 to establish pediatric cardiac surgical centers. 524 (12)(10)Based on the recommendations of the pediatric 525 cardiac technical advisory panelin subsection (9), the agency 526 shall adopt rules for pediatric cardiac programs which, at a 527 minimum, include: 528 (a) Standards for pediatric cardiac catheterization 529 services and pediatric cardiovascular surgery including quality 530 of care, personnel, physical plant, equipment, emergency 531 transportation, data reporting, and appropriate operating hours 532 and timeframes for mobilization for emergency procedures. 533 (b) Outcome standards consistent with nationally 534 established levels of performance in pediatric cardiac programs. 535 (c) Specific steps to be taken by the agency and licensed 536 facilities when the facilities do not meet the outcome standards 537 within a specified time, including time required for detailed 538 case reviews and the development and implementation of 539 corrective action plans. 540 (13)(11)A pediatric cardiac program shall: 541 (a) Have a pediatric cardiology clinic affiliated with a 542 hospital licensed under this chapter. 543 (b) Have a pediatric cardiac catheterization laboratory and 544 a pediatric cardiovascular surgical program located in the 545 hospital. 546 (c) Have a risk adjustment surgical procedure protocol 547 following the guidelines established by the Society of Thoracic 548 Surgeons. 549 (d) Have quality assurance and quality improvement 550 processes in place to enhance clinical operation and patient 551 satisfaction with services. 552 (e) Participate in the clinical outcome reporting systems 553 operated by the Society of Thoracic Surgeons and the American 554 College of Cardiology. 555 (14)(a) The Secretary of Health Care Administration may 556 request announced or unannounced site visits to any existing 557 pediatric cardiac surgical center or facility seeking licensure 558 as a pediatric cardiac surgical center through the certificate 559 of need process, to ensure compliance with this section and 560 rules adopted hereunder. 561 (b) At the request of the Secretary of Health Care 562 Administration, the pediatric cardiac technical advisory panel 563 shall recommend in-state physician experts to conduct an on-site 564 visit. The Secretary may also appoint up to two out-of-state 565 physician experts. 566 (c) A site visit team shall conduct an on-site inspection 567 of the designated hospital’s pediatric medical and surgical 568 programs, and each member shall submit a written report of his 569 or her findings to the panel. The panel shall discuss the 570 written reports and present an advisory opinion to the Secretary 571 of Health Care Administration which includes recommendations and 572 any suggested actions for correction. 573 (d) Each on-site inspection must include all of the 574 following: 575 1. An inspection of the program’s physical facilities, 576 clinics, and laboratories. 577 2. Interviews with support staff and hospital 578 administrators. 579 3. A review of: 580 a. Randomly selected medical records and reports, 581 including, but not limited to, advanced cardiac imaging, 582 computed tomography, magnetic resonance imaging, cardiac 583 ultrasound, cardiac catheterization, and surgical operative 584 notes. 585 b. The program’s clinical outcome data submitted to the 586 Society of Thoracic Surgeons and the American College of 587 Cardiology pursuant to s. 408.05(3)(k). 588 c. Mortality reports from cardiac-related deaths that 589 occurred in the previous year. 590 d. Program volume data from the preceding year for 591 interventional and electrophysiology catheterizations and 592 surgical procedures. 593 (15) The Surgeon General shall provide quarterly reports to 594 the Secretary of Health Care Administration consisting of data 595 from the Children’s Medical Services’ critical congenital heart 596 disease screening program for review by the advisory panel. 597 (16)(12)The agency may adopt rules to administer the 598 requirements of part II of chapter 408. 599 Section 8. Subsection (3) of section 395.301, Florida 600 Statutes, is amended to read: 601 395.301 Price transparency; itemized patient statement or 602 bill; patient admission status notification.— 603 (3) If a licensed facility places a patient on observation 604 status rather than inpatient status, the licensed facility must 605 immediately notify the patient of such status using the form 606 adopted under 42 C.F.R. s. 489.20 for Medicare patients or a 607 form adopted by agency rule for non-Medicare patients. Such 608 notification mustobservation servicesshallbe documented in 609 the patient’s medical records and discharge papers. Thepatient610or thepatient’s survivor or legal guardian mustshallbe 611 notified of observation services through discharge papers, which 612 may also include brochures, signage, or other forms of 613 communication for this purpose. 614 Section 9. Section 542.336, Florida Statutes, is created to 615 read: 616 542.336 Invalid restrictive covenants.—A restrictive 617 covenant entered into with a physician who is licensed under 618 chapter 458 or chapter 459 and who practices a medical specialty 619 in a county wherein one entity employs or contracts with, either 620 directly or through related or affiliated entities, all 621 physicians who practice such specialty in that county is not 622 supported by a legitimate business interest. The Legislature 623 finds that such covenants restrict patient access to physicians, 624 increase costs, and are void and unenforceable under current 625 law. Such restrictive covenants shall remain void and 626 unenforceable for 3 years after the date on which a second 627 entity that employs or contracts with, either directly or 628 through related or affiliated entities, one or more physicians 629 who practice such specialty begins offering such specialty 630 services in that county. 631 Section 10. Section 624.27, Florida Statutes, is amended to 632 read: 633 624.27 Direct healthprimarycare agreements; exemption 634 from code.— 635 (1) As used in this section, the term: 636 (a) “Direct healthprimarycare agreement” means a contract 637 between a healthprimarycare provider and a patient, a 638 patient’s legal representative, or a patient’s employer, which 639 meets the requirements of subsection (4) and does not indemnify 640 for services provided by a third party. 641 (b) “HealthPrimarycare provider” means a health care 642 provider licensed under chapter 458, chapter 459, chapter 460, 643orchapter 464, or chapter 466, or a healthprimarycare group 644 practice, who provides healthprimarycare services to patients. 645 (c) “HealthPrimarycare services” means the screening, 646 assessment, diagnosis, and treatment of a patient conducted 647 within the competency and training of the healthprimarycare 648 provider for the purpose of promoting health or detecting and 649 managing disease or injury. 650 (2) A direct healthprimarycare agreement does not 651 constitute insurance and is not subject to the Florida Insurance 652 Code. The act of entering into a direct healthprimarycare 653 agreement does not constitute the business of insurance and is 654 not subject to the Florida Insurance Code. 655 (3) A healthprimarycare provider or an agent of a health 656primarycare provider is not required to obtain a certificate of 657 authority or license under the Florida Insurance Code to market, 658 sell, or offer to sell a direct healthprimarycare agreement. 659 (4) For purposes of this section, a direct healthprimary660 care agreement must: 661 (a) Be in writing. 662 (b) Be signed by the healthprimarycare provider or an 663 agent of the healthprimarycare provider and the patient, the 664 patient’s legal representative, or the patient’s employer. 665 (c) Allow a party to terminate the agreement by giving the 666 other party at least 30 days’ advance written notice. The 667 agreement may provide for immediate termination due to a 668 violation of the physician-patient relationship or a breach of 669 the terms of the agreement. 670 (d) Describe the scope of healthprimarycare services that 671 are covered by the monthly fee. 672 (e) Specify the monthly fee and any fees for healthprimary673 care services not covered by the monthly fee. 674 (f) Specify the duration of the agreement and any automatic 675 renewal provisions. 676 (g) Offer a refund to the patient, the patient’s legal 677 representative, or the patient’s employer of monthly fees paid 678 in advance if the healthprimarycare provider ceases to offer 679 healthprimarycare services for any reason. 680 (h) Contain, in contrasting color and in at least 12-point 681 type, the following statement on the signature page: “This 682 agreement is not health insurance and the healthprimarycare 683 provider will not file any claims against the patient’s health 684 insurance policy or plan for reimbursement of any healthprimary685 care services covered by the agreement. This agreement does not 686 qualify as minimum essential coverage to satisfy the individual 687 shared responsibility provision of the Patient Protection and 688 Affordable Care Act, 26 U.S.C. s. 5000A. This agreement is not 689 workers’ compensation insurance and does not replace an 690 employer’s obligations under chapter 440.” 691 Section 11. Effective January 1, 2020, section 627.42393, 692 Florida Statutes, is created to read: 693 627.42393 Step-therapy protocol.— 694 (1) A health insurer issuing a major medical individual or 695 group policy may not require a step-therapy protocol under the 696 policy for a covered prescription drug requested by an insured 697 if: 698 (a) The insured has previously been approved to receive the 699 prescription drug through the completion of a step-therapy 700 protocol required by a separate health coverage plan; and 701 (b) The insured provides documentation originating from the 702 health coverage plan that approved the prescription drug as 703 described in paragraph (a) indicating that the health coverage 704 plan paid for the drug on the insured’s behalf during the 90 705 days immediately before the request. 706 (2) As used in this section, the term “health coverage 707 plan” means any of the following which is currently or was 708 previously providing major medical or similar comprehensive 709 coverage or benefits to the insured: 710 (a) A health insurer or health maintenance organization. 711 (b) A plan established or maintained by an individual 712 employer as provided by the Employee Retirement Income Security 713 Act of 1974, Pub. L. No. 93-406. 714 (c) A multiple-employer welfare arrangement as defined in 715 s. 624.437. 716 (d) A governmental entity providing a plan of self 717 insurance. 718 (3) This section does not require a health insurer to add a 719 drug to its prescription drug formulary or to cover a 720 prescription drug that the insurer does not otherwise cover. 721 Section 12. Effective January 1, 2020, subsection (45) is 722 added to section 641.31, Florida Statutes, to read: 723 641.31 Health maintenance contracts.— 724 (45)(a) A health maintenance organization issuing major 725 medical coverage through an individual or group contract may not 726 require a step-therapy protocol under the contract for a covered 727 prescription drug requested by a subscriber if: 728 1. The subscriber has previously been approved to receive 729 the prescription drug through the completion of a step-therapy 730 protocol required by a separate health coverage plan; and 731 2. The subscriber provides documentation originating from 732 the health coverage plan that approved the prescription drug as 733 described in subparagraph 1. indicating that the health coverage 734 plan paid for the drug on the subscriber’s behalf during the 90 735 days immediately before the request. 736 (b) As used in this subsection, the term “health coverage 737 plan” means any of the following which previously provided or is 738 currently providing major medical or similar comprehensive 739 coverage or benefits to the subscriber: 740 1. A health insurer or health maintenance organization; 741 2. A plan established or maintained by an individual 742 employer as provided by the Employee Retirement Income Security 743 Act of 1974, Pub. L. No. 93-406; 744 3. A multiple-employer welfare arrangement as defined in s. 745 624.437; or 746 4. A governmental entity providing a plan of self 747 insurance. 748 (c) This subsection does not require a health maintenance 749 organization to add a drug to its prescription drug formulary or 750 to cover a prescription drug that the health maintenance 751 organization does not otherwise cover. 752 Section 13. The Office of Program Policy Analysis and 753 Government Accountability shall research and analyze the 754 Interstate Medical Licensure Compact and the relevant 755 requirements and provisions of general law and the State 756 Constitution and shall develop a report and recommendations 757 addressing this state’s prospective entrance into the compact as 758 a member state while remaining consistent with those 759 requirements and provisions. In conducting such research and 760 analysis, the office may consult with the executive director, 761 other executive staff, or the executive committee of the 762 Interstate Medical Licensure Compact Commission. The office 763 shall submit the report and recommendations to the Governor, the 764 President of the Senate, and the Speaker of the House of 765 Representatives by not later than October 1, 2019. 766 Section 14. Except as otherwise expressly provided in this 767 act, this act shall take effect July 1, 2019.