Florida Senate - 2010 SB 2480
By Senator Garcia
40-01188-10 20102480__
1 A bill to be entitled
2 An act relating to health care; amending s. 400.990,
3 F.S.; providing additional legislative findings;
4 amending s. 400.9905, F.S.; redefining the term
5 “clinic” for purposes of the Health Care Clinic Act to
6 include certain additional providers; defining the
7 term “specialty clinic”; including certain facilities
8 owned by publicly traded corporations excluded by the
9 definition of the term “clinic”; defining the terms
10 “infusion therapy” and “fraud”; amending s. 400.991,
11 F.S.; requiring specialty clinics to be subject to
12 licensure requirements; requiring additional persons
13 to be subject to background screening; revising
14 certain requirements for applying for licensure as a
15 health care clinic; creating additional requirements
16 for applying for licensure as a specialty clinic;
17 creating s. 400.9914, F.S.; providing additional
18 grounds under which the Agency for Health Care
19 Administration is required to deny or revoke a license
20 due to a finding of guilt for committing a felony;
21 providing grounds for the denial of specialty clinic
22 licensure; amending s. 400.9915, F.S.; providing
23 additional grounds for an emergency suspension of a
24 license; creating s. 400.9921, F.S.; providing
25 additional requirements for license renewal, and
26 transfer of ownership; amending s. 400.9925, F.S.;
27 authorizing the agency to adopt rules regarding
28 specialty clinics; amending s. 400.993, F.S.;
29 including specialty clinics within provisions
30 regarding unlicensed clinics; amending s. 400.9935,
31 F.S.; including specialty clinics within provisions
32 regarding clinic responsibilities; revising the
33 responsibilities of the medical director and the
34 clinical director; requiring all persons providing
35 health care services to individuals in a specialty
36 clinic to comply with the licensure laws and rules
37 under which that person is licensed; providing for a
38 certificate of exemption from licensure as a clinic to
39 expire within a specified period; providing for
40 renewal of the certificate of exemption; providing the
41 application procedures for a certificate of exemption;
42 providing grounds for the denial, withdrawal, or
43 emergency suspension of a certificate of exemption by
44 the Agency for Health Care Administration; providing
45 that it is a third-degree felony for an applicant to
46 submit fraudulent or material and misleading
47 information to the agency; requiring specialty clinics
48 to display signs containing certain information
49 relating to insurance fraud; authorizing compliance
50 inspections by the Division of Insurance Fraud;
51 requiring clinics to allow inspection access;
52 requiring a specialty clinic to file an audited
53 report; providing requirements for the audited report;
54 requiring a specialty clinic to maintain compliance
55 with part X of ch. 400, F.S.; amending s. 400.995,
56 F.S.; authorizing the agency to impose administrative
57 penalties against a specialty clinic; authorizing the
58 agency to request a plan of corrective action from the
59 clinic or specialty clinic; creating s. 400.996, F.S.;
60 creating a process whereby the agency receives,
61 documents, and processes complaints about specialty
62 clinics; requiring the agency to request that
63 complaints regarding billing fraud by a specialty
64 clinic be made by sworn affidavit; requiring the
65 agency to refer to the Office of Fiscal Integrity
66 within the Department of Financial Services any sworn
67 affidavit asserting billing fraud by a specialty
68 clinic; requiring the department to report findings
69 regarding billing fraud by a specialty clinic to the
70 agency; requiring the department to refer an
71 investigation to prosecutorial authorities and provide
72 investigative assistance under certain circumstances;
73 providing that it is a first-degree misdemeanor to
74 submit an affidavit asserting billing fraud by a
75 specialty clinic which is without any factual basis;
76 allowing the department to conduct unannounced
77 reviews, investigations, analyses, and audits to
78 investigate complaints of billing fraud by a specialty
79 clinic; authorizing the department to enter upon the
80 premises of a specialty clinic and immediately secure
81 copies of certain documents; requiring a specialty
82 clinic to allow full and immediate access to the
83 premises and records of the clinic to a department
84 officer or employee under s. 400.996, F.S.; providing
85 that failure to provide such access is a ground for
86 emergency suspension of the license of the specialty
87 clinic; permitting the agency to assess a fee against
88 a specialty clinic equal to the cost of conducting a
89 review, investigation, analysis, or audit performed by
90 the agency or the department; providing that all
91 investigators designated by the Chief Financial
92 Officer to perform duties under part X of ch. 400,
93 F.S., and certified under s. 943.1395, F.S., are law
94 enforcement officers of the state; amending s.
95 408.802, F.S.; providing that specialty clinics are
96 subject to part X of ch. 400, F.S.; amending s.
97 408.820, F.S.; providing that specialty clinics are
98 exempt from s. 408.810(6), (7), and (10), F.S.;
99 amending s. 456.072, F.S.; providing that
100 intentionally placing false information in an
101 application for a certificate of exemption from clinic
102 licensure constitutes grounds for disciplinary action;
103 designating the Florida Center for Nursing as the
104 “Florida Barbara B. Lumpkin Center for Nursing”;
105 directing the Department of Health to erect suitable
106 markers; authorizing additional positions and
107 providing an appropriation; providing an effective
108 date.
109
110 Be It Enacted by the Legislature of the State of Florida:
111
112 Section 1. Section 400.990, Florida Statutes, is amended to
113 read:
114 400.990 Short title; legislative findings.—
115 (1) This part, consisting of ss. 400.990-400.996 ss.
116 400.990-400.995, may be cited as the “Health Care Clinic Act.”
117 (2) The Legislature finds that the regulation of health
118 care clinics must be strengthened to prevent significant cost
119 and harm to consumers. The purpose of this part is to provide
120 for the licensure, establishment, and enforcement of basic
121 standards for health care clinics and to provide administrative
122 oversight by the Agency for Health Care Administration.
123 (3) The Legislature further finds the additional regulation
124 of specialty health care clinics is necessary to prevent
125 significant fraudulent practices in the provision of infusion
126 therapy services in this state.
127 (4) The purpose of this part is to provide for the
128 licensure, establishment, and enforcement of basic standards for
129 health care clinics and to provide administrative oversight by
130 the Agency for Health Care Administration.
131 Section 2. Subsection (4) of section 400.9905, Florida
132 Statutes, is amended, and subsections (8), (9), and (10) are
133 added to that section, to read:
134 400.9905 Definitions.—
135 (4) “Clinic” means an entity at which health care services
136 are provided to individuals and which tenders charges for
137 reimbursement for such services, including a mobile clinic and a
138 portable equipment provider. For purposes of this part, the term
139 does not include and the licensure requirements of this part do
140 not apply to:
141 (a) Entities licensed or registered by the state under
142 chapter 395; or entities licensed or registered by the state and
143 providing only health care services within the scope of services
144 authorized under their respective licenses granted under ss.
145 383.30-383.335, chapter 390, chapter 394, chapter 397, this
146 chapter except part X, chapter 429, chapter 463, chapter 465,
147 chapter 466, chapter 478, part I of chapter 483, chapter 484, or
148 chapter 651; end-stage renal disease providers authorized under
149 42 C.F.R. part 405, subpart U; or providers certified under 42
150 C.F.R. part 485, subpart B or subpart H; or any entity that
151 provides neonatal or pediatric hospital-based health care
152 services or other health care services by licensed practitioners
153 solely within a hospital licensed under chapter 395.
154 (b) Entities that own, directly or indirectly, entities
155 licensed or registered by the state pursuant to chapter 395; or
156 entities that own, directly or indirectly, entities licensed or
157 registered by the state and providing only health care services
158 within the scope of services authorized pursuant to their
159 respective licenses granted under ss. 383.30-383.335, chapter
160 390, chapter 394, chapter 397, this chapter except part X,
161 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
162 part I of chapter 483, chapter 484, chapter 651; end-stage renal
163 disease providers authorized under 42 C.F.R. part 405, subpart
164 U; or providers certified under 42 C.F.R. part 485, subpart B or
165 subpart H; or any entity that provides neonatal or pediatric
166 hospital-based health care services by licensed practitioners
167 solely within a hospital licensed under chapter 395.
168 (c) Entities that are owned, directly or indirectly, by an
169 entity licensed or registered by the state pursuant to chapter
170 395; or entities that are owned, directly or indirectly, by an
171 entity licensed or registered by the state and providing only
172 health care services within the scope of services authorized
173 pursuant to their respective licenses granted under ss. 383.30
174 383.335, chapter 390, chapter 394, chapter 397, this chapter
175 except part X, chapter 429, chapter 463, chapter 465, chapter
176 466, chapter 478, part I of chapter 483, chapter 484, or chapter
177 651; end-stage renal disease providers authorized under 42
178 C.F.R. part 405, subpart U; or providers certified under 42
179 C.F.R. part 485, subpart B or subpart H; or any entity that
180 provides neonatal or pediatric hospital-based health care
181 services by licensed practitioners solely within a hospital
182 under chapter 395.
183 (d) Entities that are under common ownership, directly or
184 indirectly, with an entity licensed or registered by the state
185 pursuant to chapter 395; or entities that are under common
186 ownership, directly or indirectly, with an entity licensed or
187 registered by the state and providing only health care services
188 within the scope of services authorized pursuant to their
189 respective licenses granted under ss. 383.30-383.335, chapter
190 390, chapter 394, chapter 397, this chapter except part X,
191 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
192 part I of chapter 483, chapter 484, or chapter 651; end-stage
193 renal disease providers authorized under 42 C.F.R. part 405,
194 subpart U; or providers certified under 42 C.F.R. part 485,
195 subpart B or subpart H; or any entity that provides neonatal or
196 pediatric hospital-based health care services by licensed
197 practitioners solely within a hospital licensed under chapter
198 395.
199 (e) An entity that is exempt from federal taxation under 26
200 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
201 under 26 U.S.C. s. 409 that has a board of trustees not less
202 than two-thirds of which are Florida-licensed health care
203 practitioners and provides only physical therapy services under
204 physician orders, any community college or university clinic,
205 and any entity owned or operated by the federal or state
206 government, including agencies, subdivisions, or municipalities
207 thereof.
208 (f) A sole proprietorship, group practice, partnership, or
209 corporation, or other legal entity that provides health care
210 services by physicians and physician assistants licensed under
211 chapter 458, chapter 459, chapter 460, chapter 461, or chapter
212 466 covered by s. 627.419, that is directly supervised by one or
213 more of such physicians or physician assistants, and that is
214 wholly owned by one or more of those physicians or physician
215 assistants or by a physician or physician assistant and the
216 spouse, parent, child, or sibling of that physician or physician
217 assistant.
218 (g) A sole proprietorship, group practice, partnership, or
219 corporation, or other legal entity that provides health care
220 services by licensed health care practitioners under chapter
221 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter
222 462, chapter 463, chapter 466, chapter 467, chapter 480, chapter
223 484, chapter 486, chapter 490, chapter 491, or part I, part III,
224 part X, part XIII, or part XIV of chapter 468, or s. 464.012,
225 which entities are wholly owned by one or more licensed health
226 care practitioners, or the licensed health care practitioners
227 set forth in this paragraph and the spouse, parent, child, or
228 sibling of a licensed health care practitioner, so long as one
229 of the owners who is a licensed health care practitioner is
230 supervising the health care services business activities and is
231 legally responsible for the entity’s compliance with all federal
232 and state laws. However, the a health care services provided may
233 not exceed the scope of the licensed owner’s health care
234 practitioner may not supervise services beyond the scope of the
235 practitioner’s license, except that, for the purposes of this
236 part, a clinic owned by a licensee in s. 456.053(3)(b) that
237 provides only services authorized pursuant to s. 456.053(3)(b)
238 may be supervised by a licensee specified in s. 456.053(3)(b).
239 (h) Clinical facilities affiliated with an accredited
240 medical school at which training is provided for medical
241 students, residents, or fellows.
242 (i) Entities that provide only oncology or radiation
243 therapy services by physicians licensed under chapter 458 or
244 chapter 459 or entities that provide oncology or radiation
245 therapy services by physicians licensed under chapter 458 or
246 chapter 459 which are owned by a corporation whose shares are
247 publicly traded on a recognized stock exchange.
248 (j) Clinical facilities affiliated with a college of
249 chiropractic accredited by the Council on Chiropractic Education
250 at which training is provided for chiropractic students.
251 (k) Entities that provide licensed practitioners to staff
252 emergency departments or to deliver anesthesia services in
253 facilities licensed under chapter 395 and that derive at least
254 90 percent of their gross annual revenues from the provision of
255 such services. Entities claiming an exemption from licensure
256 under this paragraph must provide documentation demonstrating
257 compliance.
258 (l) Orthotic or prosthetic Clinical facilities that are a
259 publicly traded corporation or that are wholly owned, directly
260 or indirectly, by a publicly traded corporation. As used in this
261 paragraph, a publicly traded corporation is a corporation that
262 issues securities traded on an exchange registered with the
263 United States Securities and Exchange Commission as a national
264 securities exchange.
265 (8) “Specialty clinic” means a clinic, as defined in
266 subsection (4) and including those entities exempt under that
267 subsection, which are not licensed as a home health agency that
268 provides infusion therapy services to treat conditions caused by
269 or related to HIV or AIDS to outpatients who remain less than 24
270 hours at the facility or to patients who receive such services
271 where they reside. The term does not include:
272 (a) Entities licensed under part II or part III;
273 (b) Entities licensed under part IV which provide infusion
274 therapy to patients only in the home or residence of the
275 patient; or
276 (c) Entities licensed under chapter 395.
277 (9) “Infusion therapy” includes, but is not limited to, the
278 therapeutic infusion of substances into, or injection of
279 substances through, the venous peripheral system and consists of
280 activities that include observing, initiating, monitoring,
281 discontinuing, maintaining, regulating, adjusting, documenting,
282 planning, intervening, and evaluating. This definition embraces
283 the administration of nutrition, antibiotic therapy, and fluid
284 and electrolyte repletion.
285 (10) “Fraud” means deception or misrepresentation made by a
286 person or business entity with the intent that the deception
287 will likely result in an unauthorized benefit to herself or
288 himself or to another person. The term includes any act that
289 constitutes fraud under applicable federal or state law.
290 Section 3. Section 400.991, Florida Statutes, is amended to
291 read:
292 400.991 License requirements; background screenings;
293 prohibitions.—
294 (1)(a) The requirements of part II of chapter 408 apply to
295 the provision of services that require licensure pursuant to
296 this part and part II of chapter 408 and to entities licensed by
297 or applying for such licensure from the agency pursuant to this
298 part. A license issued by the agency is required in order to
299 operate a clinic and a specialty clinic in this state. Each
300 clinic and specialty clinic location shall be licensed
301 separately regardless of whether the clinic or specialty clinic
302 is operated under the same business name or management as
303 another clinic or specialty clinic.
304 (b) Each mobile clinic and specialty clinic must obtain a
305 separate health care clinic license and must provide to the
306 agency, at least quarterly, its projected street location to
307 enable the agency to locate and inspect such clinic and
308 specialty clinic. A portable equipment provider must obtain a
309 health care clinic license for a single administrative office
310 and is not required to submit quarterly projected street
311 locations.
312 (c) A specialty clinic operating without a specialty clinic
313 license on or before January 1, 2011, shall be given until July
314 2, 2011, to obtain a specialty clinic license.
315 (2) The initial clinic license application and specialty
316 clinic license application shall be filed with the agency by all
317 clinics, as defined in s. 400.9905, on or before July 1, 2004. A
318 clinic license and specialty clinic license must be renewed
319 biennially.
320 (3)(a) The application shall contain information that
321 includes, but need not be limited to, information pertaining to
322 the name, residence and business address, phone number, social
323 security number, and license number of the medical or clinic
324 director of the licensed medical providers employed or under
325 contract with the clinic.
326 (b) Any person or entity that has a pecuniary interest in a
327 clinic who may or may not own stock or an equivalent interest in
328 the clinic, but nonetheless has control over or the authority to
329 approve, directly or indirectly, clinic billing, policy,
330 business activities, or personnel decisions, including, but not
331 limited to, contracted or employed third-party billing persons
332 or entities, managers, and management companies, and persons and
333 entities, directly or indirectly, which lend, give, or gift
334 money of any denomination or anything of value exceeding an
335 aggregate of $5,000, for clinic use, with or without an
336 expectation of a return of the money or thing of value, and
337 regardless of profit motive, are subject to background screening
338 requirements under this part.
339 (c) The agency may adopt rules to administer this
340 subsection.
341 (4) An application for a specialty clinic must contain, in
342 addition to the information required in subsection (3) and s.
343 408.806:
344 (a) The correct business name of each business entity and
345 full name of each individual holding any ownership interest of 5
346 percent or more, or any pecuniary interest of $5,000 or more, in
347 any legal entity that owns or operates any specialty clinic
348 seeking licensure, whether such ownership or pecuniary interest
349 arose out of a contract, loan, gift, investment, inheritance, or
350 any other source. Individual possession of an ownership or
351 pecuniary interest in any subject specialty clinic includes, but
352 is not limited to, a direct or indirect interest in:
353 1. The business operation, equipment, or legend
354 pharmaceuticals used in the clinic;
355 2. The premises in which the clinic provides its services;
356 or
357 3. Any legal entity that owns any such interest, directly
358 or indirectly, in the business operation of the clinic; the
359 equipment used in providing infusion therapy services at the
360 clinic; the legend pharmaceuticals used at the clinic; or the
361 premises in which the clinic provides its services.
362 (b) In the case of an incorporated business entity that
363 holds any ownership interest of 5 percent or more, or any
364 pecuniary interest of $5,000 or more, in the specialty clinic,
365 copies of the articles of incorporation and bylaws, and the
366 names and addresses of all officers and directors of the
367 corporation.
368 (c) On a form furnished by the agency, a sworn, notarized
369 statement by each business entity and individual that holds any
370 ownership interest of 5 percent or more, or any pecuniary
371 interest of $5,000 or more, in the subject specialty clinic
372 which discloses the nature and degree of each such ownership or
373 pecuniary interest and discloses the source of funds which gave
374 rise to each such ownership or pecuniary interest.
375 (d) On a form furnished by the agency, a sworn, notarized
376 statement by each individual and business entity that holds any
377 ownership interest of 5 percent or more, or any pecuniary
378 interest of $5,000 or more, in the subject specialty clinic
379 which discloses whether he or she has been an owner or part
380 owner, individually or through any business entity, of any
381 business entity whose health care license has been revoked or
382 suspended in any jurisdiction.
383 (e) On a form furnished by the agency, an estimate of the
384 costs for establishing the specialty clinic and the source of
385 funds for payment of those costs and for sustaining the
386 operation of the clinic until its operation produces a positive
387 cash flow.
388
389 For purposes of this subsection, the terms “ownership or
390 pecuniary interest” does not include an individual whose
391 interest in a specialty clinic arises only out of his or her
392 interest in a lending company, insurance company, or banking
393 institution licensed by this state or any other state of the
394 United States; a company regularly trading on a national stock
395 exchange of the United States; or a governmental entity in the
396 United States.
397 (5)(4) In addition to the requirements of part II of
398 chapter 408, the applicant must file with the application
399 satisfactory proof that the clinic or specialty clinic is in
400 compliance with this part and applicable rules, including:
401 (a) A listing of services to be provided either directly by
402 the applicant or through contractual arrangements with existing
403 providers;
404 (b) The number and discipline of each professional staff
405 member to be employed; and
406 (c) Proof of financial ability to operate as required under
407 s. 408.810(8). As an alternative to submitting proof of
408 financial ability to operate as required under s. 408.810(8),
409 the applicant may file a surety bond of at least $500,000 which
410 guarantees that the clinic or specialty clinic will act in full
411 conformity with all legal requirements for operating a clinic,
412 payable to the agency. The agency may adopt rules to specify
413 related requirements for such surety bond.
414 (6)(5) Each applicant for licensure shall comply with the
415 following requirements:
416 (a) As used in this subsection, the term “applicant” means
417 an individual individuals owning or controlling, directly or
418 indirectly, 5 percent or more of an interest in a clinic or an
419 individual owning or controlling, directly or indirectly, any
420 interest in a specialty clinic; the medical or clinic director,
421 or a similarly titled person who is responsible for the day-to
422 day operation of the licensed clinic; the financial officer or
423 similarly titled individual who is responsible for the financial
424 operation of the clinic; and licensed health care practitioners
425 at the clinic.
426 (b) Upon receipt of a completed, signed, and dated
427 application, the agency shall require background screening of
428 the applicant, in accordance with the level 2 standards for
429 screening set forth in paragraph (d) chapter 435. Proof of
430 compliance with the level 2 background screening requirements of
431 paragraph (d) chapter 435 which has been submitted within the
432 previous 5 years in compliance with the any other health care
433 clinic licensure requirements of this part state is acceptable
434 in fulfillment of this paragraph. Applicants who own less than
435 10 percent of a health care clinic are not required to submit
436 fingerprints under this section.
437 (c) Each applicant must submit to the agency, with the
438 application, a description and explanation of any exclusions,
439 permanent suspensions, or terminations of an applicant from the
440 Medicare or Medicaid programs. Proof of compliance with the
441 requirements for disclosure of ownership and control interest
442 under the Medicaid or Medicare programs may be accepted in lieu
443 of this submission. The description and explanation may indicate
444 whether such exclusions, suspensions, or terminations were
445 voluntary or not voluntary on the part of the applicant. The
446 agency may deny or revoke licensure based on information
447 received under this paragraph.
448 (d) A license may not be granted to a clinic if the
449 applicant, or a person or entity identified in paragraph (3)(b),
450 has been found guilty of, regardless of adjudication, or has
451 entered a plea of nolo contendere or guilty to, any offense
452 prohibited under the level 2 standards for screening set forth
453 in chapter 435; any felony under chapter 400, chapter 408,
454 chapter 409, chapter 440, chapter 624, chapter 626, chapter 627,
455 chapter 812, chapter 817, chapter 831, chapter 837, chapter 838,
456 chapter 895, or chapter 896; or any substantially comparable
457 offense or crime of another state or of the United States, if a
458 felony in that jurisdiction, within the past 10 years. Each
459 person required to provide background screening shall disclose
460 to the agency any arrest for any crime for which any court
461 disposition other than dismissal has been made within the past
462 10 years. Failure to provide such information is a material
463 omission in the application process., or a violation of
464 insurance fraud under s. 817.234, within the past 5 years. If
465 the applicant has been convicted of an offense prohibited under
466 the level 2 standards or insurance fraud in any jurisdiction,
467 the applicant must show that his or her civil rights have been
468 restored prior to submitting an application.
469 (e) Each applicant that performs the technical component of
470 magnetic resonance imaging, static radiographs, computed
471 tomography, or positron emission tomography, and also provides
472 the professional components of such services through an employee
473 or independent contractor, must provide to the agency on a form
474 provided by the agency, the name and address of the clinic, the
475 serial or operating number of each magnetic resonance imaging,
476 static radiograph, computed tomography, and positron emission
477 tomography machine, the name of the manufacturer of the machine,
478 and such other information as required by the agency to identify
479 the machine. The information must be provided to the agency upon
480 renewal of the clinic’s licensure and within 30 days after a
481 clinic begins using a machine for which it has not provided the
482 information to the agency.
483 Section 4. Section 400.9914, Florida Statutes, is created
484 to read:
485 400.9914 Revocation or denial of a specialty clinic
486 license.—In addition to s. 408.831, the agency:
487 (1) Shall deny or revoke a specialty clinic license if an
488 applicant has been found guilty of, regardless of adjudication,
489 or entered a plea of nolo contendere or guilty to, any felony
490 involving dishonesty or making a false statement in any
491 jurisdiction within the preceding 10 years.
492 (2) Shall deny a specialty clinic license application when
493 any business entity or individual possessing an ownership or
494 pecuniary interest in the specialty clinic also possessed an
495 ownership or pecuniary interest, individually or through any
496 business entity, in any health care facility whose license was
497 revoked in any jurisdiction during the pendency of that
498 interest.
499 (3) May not issue a specialty clinic license to any
500 applicant to whom the agency has sent notice that there is a
501 pending question as to whether one or more of the individuals
502 having an ownership of 5 percent or more or a pecuniary interest
503 of $5,000 or more in the clinic has a disqualifying criminal
504 record. The agency notice shall request the applicant to submit
505 any additional information necessary to resolve the pending
506 criminal background question within 21 days after receipt of the
507 notice. The agency shall deny a specialty clinic license
508 application if the applicant fails to resolve a criminal
509 background screening issue pertaining to an individual who is
510 required to meet criminal background screening requirements of
511 this part and the agency raised such background screening issue
512 by notice as set forth in this part.
513 Section 5. Section 400.9915, Florida Statutes, is amended
514 to read:
515 400.9915 Emergency suspension; costs.—
516 (1) Failure by a clinic or specialty clinic licensed under
517 this part to allow full and complete access to the premises and
518 to billing records or information to any representative of the
519 agency who makes a request to inspect the clinic or specialty
520 clinic to determine compliance with this part or failure by a
521 clinic or specialty clinic to employ a qualified medical
522 director or clinic director constitutes a ground for emergency
523 suspension of the license by the agency pursuant to s. 408.814.
524 (2) In addition to any administrative fines imposed
525 pursuant to this part or part II of chapter 408, the agency may
526 assess a fee equal to the cost of conducting a complaint
527 investigation.
528 Section 6. Section 400.9921, Florida Statutes, is created
529 to read:
530 400.9921 License renewal; transfer of ownership.—In
531 addition to the requirements set forth in ss. 408.806 and
532 408.807:
533 (1) An application for license renewal must contain
534 information as required by the agency.
535 (2) The clinic or specialty clinic must file with the
536 renewal application satisfactory proof that it is in compliance
537 with this part and applicable rules. If there is evidence of
538 financial instability, the clinic or specialty clinic must
539 submit satisfactory proof of its financial ability to comply
540 with the requirements of this part.
541 (3) An application for change of ownership of a clinic or
542 specialty clinic is required only when 45 percent or more of the
543 ownership, voting shares, or controlling interest of a clinic or
544 specialty clinic is transferred or assigned, including the final
545 transfer or assignment of multiple transfers or assignments over
546 a 2-year period which cumulatively total 45 percent or greater.
547 (4) The license may not be sold, leased, assigned, or
548 otherwise transferred, voluntarily or involuntarily, and is
549 valid only for the clinic or specialty clinic owners and
550 location for which originally issued.
551 Section 7. Section 400.9925, Florida Statutes, is amended
552 to read:
553 400.9925 Rulemaking authority; license fees.—
554 (1) The agency shall adopt rules necessary to administer
555 the clinic and specialty clinic administration, regulation, and
556 licensure program, including rules pursuant to this part and
557 part II of chapter 408, establishing the specific licensure
558 requirements, procedures, forms, and fees. It shall adopt rules
559 establishing a procedure for the biennial renewal of licenses.
560 The agency may issue initial licenses for less than the full 2
561 year period by charging a prorated licensure fee and specifying
562 a different renewal date than would otherwise be required for
563 biennial licensure. The rules shall specify the expiration dates
564 of licenses, the process of tracking compliance with financial
565 responsibility requirements, and any other conditions of renewal
566 required by law or rule.
567 (2) The agency shall adopt rules specifying limitations on
568 the number of licensed clinics and specialty clinics and
569 licensees for which a medical director or a clinic director may
570 assume responsibility for purposes of this part. In determining
571 the quality of supervision a medical director or a clinic
572 director can provide, the agency shall consider the number of
573 clinic or specialty clinic employees, the clinic location or the
574 specialty clinic location, and the health care services provided
575 by the clinic or specialty clinic.
576 (3) In accordance with s. 408.805, an applicant or a
577 licensee shall pay a fee for each license application submitted
578 under this part, part II of chapter 408, and applicable rules.
579 The amount of the fee shall be established by rule and may not
580 exceed $2,000.
581 Section 8. Subsection (3) of section 400.993, Florida
582 Statutes, is amended to read:
583 400.993 Unlicensed clinics; reporting.—
584 (3) In addition to the requirements of part II of chapter
585 408, any health care provider who is aware of the operation of
586 an unlicensed clinic or specialty clinic shall report that
587 facility to the agency. Failure to report a clinic or specialty
588 clinic that the provider knows or has reasonable cause to
589 suspect is unlicensed shall be reported to the provider’s
590 licensing board.
591 Section 9. Section 400.9935, Florida Statutes, is amended
592 to read:
593 400.9935 Clinic responsibilities.—
594 (1) Each clinic and specialty clinic shall appoint a
595 medical director or clinic director who shall agree in writing
596 to accept legal responsibility for the following activities on
597 behalf of the clinic or specialty clinic. The medical director
598 or the clinic director shall:
599 (a) Have signs identifying the medical director or clinic
600 director posted in a conspicuous location within the clinic
601 readily visible to all patients.
602 (b) Ensure that all practitioners providing health care
603 services or supplies to patients maintain a current active and
604 unencumbered Florida license.
605 (c) Review any patient referral contracts or agreements
606 executed by the clinic.
607 (d) Ensure that all health care practitioners at the clinic
608 have active appropriate certification or licensure for the level
609 of care being provided.
610 (e) Serve as the clinic records owner as defined in s.
611 456.057.
612 (f) Ensure compliance with the recordkeeping, office
613 surgery, and adverse incident reporting requirements of chapter
614 456, the respective practice acts, and rules adopted under this
615 part and part II of chapter 408.
616 (g) Conduct systematic reviews of clinic billings to ensure
617 that the billings are not fraudulent or unlawful. Upon discovery
618 of an unlawful charge, the medical director or clinic director
619 shall take immediate corrective action. If the clinic performs
620 only the technical component of magnetic resonance imaging,
621 static radiographs, computed tomography, or positron emission
622 tomography, and provides the professional interpretation of such
623 services, in a fixed facility that is accredited by the Joint
624 Commission on Accreditation of Healthcare Organizations or the
625 Accreditation Association for Ambulatory Health Care, and the
626 American College of Radiology; and if, in the preceding quarter,
627 the percentage of scans performed by that clinic which was
628 billed to all personal injury protection insurance carriers was
629 less than 15 percent, the chief financial officer of the clinic
630 may, in a written acknowledgment provided to the agency, assume
631 the responsibility for the conduct of the systematic reviews of
632 clinic billings to ensure that the billings are not fraudulent
633 or unlawful.
634 (h) Not refer a patient to the clinic if the clinic
635 performs magnetic resonance imaging, static radiographs,
636 computed tomography, or positron emission tomography. The term
637 “refer a patient” means the referral of one or more patients of
638 the medical or clinical director or a member of the medical or
639 clinical director’s group practice to the clinic for magnetic
640 resonance imaging, static radiographs, computed tomography, or
641 positron emission tomography. A medical director who is found to
642 violate this paragraph commits a felony of the third degree,
643 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
644 (i) Serve in that capacity for no more than a maximum of
645 five health care clinics that have a cumulative total of no more
646 than 200 employees and persons under contract with the health
647 care clinic at a given time. A medical or clinic director may
648 not supervise a health care clinic more than 200 miles away from
649 any other health care clinic supervised by the same medical or
650 clinic director. The agency may allow for waivers to the
651 limitations of this paragraph upon a showing of good cause and a
652 determination by the agency that the medical director will be
653 able to adequately perform the requirements of this subsection.
654 (2) Any contract to serve as a medical director or a clinic
655 director entered into or renewed by a physician or a licensed
656 health care practitioner in violation of this part is void as
657 contrary to public policy. This subsection shall apply to
658 contracts entered into or renewed on or after March 1, 2004.
659 (3) All charges or reimbursement claims made by or on
660 behalf of a clinic that is required to be licensed under this
661 part, but that is not so licensed, or that is otherwise
662 operating in violation of this part, are unlawful charges, and
663 therefore are noncompensable and unenforceable.
664 (4) In addition to the requirements of s. 408.812, any
665 person establishing, operating, or managing an unlicensed clinic
666 otherwise required to be licensed under this part or part II of
667 chapter 408, or any person who knowingly files a false or
668 misleading license application or license renewal application,
669 or false or misleading information related to such application
670 or department rule, commits a felony of the third degree,
671 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
672 (5) Any licensed health care provider who violates this
673 part is subject to discipline in accordance with this chapter
674 and his or her respective practice act.
675 (6) Any person or entity providing health care services
676 which is not a clinic or specialty clinic, as defined under s.
677 400.9905, may voluntarily apply for a certificate of exemption
678 from licensure under its exempt status. Other than certificates
679 of exemptions granted pursuant to the exemption under s.
680 400.9905(4)(f), certificates of exemption shall expire after 2
681 years and may be renewed. with the agency on a form that sets
682 forth its name or names and addresses, a statement of the
683 reasons why it cannot be defined as a clinic, and other
684 information deemed necessary by the agency. An exemption is not
685 transferable. The agency may charge an applicant for a
686 certificate of exemption in an amount equal to $100 or the
687 actual cost of processing the certificate, whichever is less.
688 (a) The agency shall provide a form that requires the name
689 or names and addresses, a statement of the reasons why the
690 applicant is exempt from licensure as a health care clinic or
691 specialty clinic, and other information deemed necessary by the
692 agency. The signature on an application for a certificate of
693 exemption must be notarized and signed by persons having
694 knowledge of the truth of its contents. An exemption is not
695 transferable and is valid only for the reasons, location,
696 persons, and entity set forth on the application form. A person
697 or entity that claims an exemption under this part or that holds
698 a current certificate of exemption must be exempt from the
699 licensing provisions of this part at all times, or such claim or
700 certificate is invalid from the date that such person or entity
701 is not exempt.
702 (b) The agency shall charge an applicant for a certificate
703 of exemption a fee of $100 to cover the cost of processing the
704 certificate or the actual cost of processing the certificate,
705 whichever is less.
706 (c) An application for the renewal of a certificate of
707 exemption must be submitted to the agency before the expiration
708 of the certificate of exemption. The agency may investigate any
709 applicant, person, or entity claiming an exemption for purposes
710 of determining compliance when a certificate of exemption is
711 sought. Authorized personnel of the agency shall have access to
712 the premises of any certificateholder, applicant, or specialty
713 clinic, other than a person or entity who is exempt pursuant to
714 s. 400.9905(4)(f), for the sole purpose of determining
715 compliance with an exemption under this part. The agency shall
716 have access to all billings and records. The agency may deny or
717 withdraw a certificate of exemption when a person or entity does
718 not qualify under this part.
719 (d) A certificate of exemption is considered withdrawn when
720 the agency determines that an exempt status cannot be confirmed.
721 The provisions applicable to the unlicensed operation of a
722 health care clinic or specialty clinic apply to any health care
723 provider that self-determines or claims an exemption or that is
724 issued a certificate of exemption if, in fact, such clinic does
725 not meet the exemption claimed.
726 (e) Any person or entity that submits an application for a
727 certificate of exemption which contains fraudulent or material
728 and misleading information commits a felony of the third degree,
729 punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
730 (f) A response to a request in writing for additional
731 information or clarification must be filed with the agency no
732 later than 21 days after receipt of the request or the
733 application shall be denied.
734 (g) The agency shall grant or deny an application for a
735 certificate of exemption in accordance with s. 120.60(1).
736 (h) A person or entity that qualifies as a health care
737 clinic or specialty clinic and has been denied a certificate of
738 exemption must file an initial application and pay the fee. A
739 certificate of exemption is valid only when issued and current.
740 (i) The agency shall issue an emergency order of suspension
741 of a certificate of exemption when the agency finds that the
742 applicant has provided false or misleading material information
743 or omitted any material fact from the application for a
744 certificate of exemption which is permitted or required by this
745 part, or has submitted false or misleading information to the
746 agency when self-determining an exempt status and materially
747 misleading the agency as to such status.
748 (7)(a) Each clinic engaged in magnetic resonance imaging
749 services must be accredited by the Joint Commission on
750 Accreditation of Healthcare Organizations, the American College
751 of Radiology, or the Accreditation Association for Ambulatory
752 Health Care, within 1 year after licensure. A clinic that is
753 accredited by the American College of Radiology or is within the
754 original 1-year period after licensure and replaces its core
755 magnetic resonance imaging equipment shall be given 1 year after
756 the date on which the equipment is replaced to attain
757 accreditation. However, a clinic may request a single, 6-month
758 extension if it provides evidence to the agency establishing
759 that, for good cause shown, such clinic cannot be accredited
760 within 1 year after licensure, and that such accreditation will
761 be completed within the 6-month extension. After obtaining
762 accreditation as required by this subsection, each such clinic
763 must maintain accreditation as a condition of renewal of its
764 license. A clinic that files a change of ownership application
765 must comply with the original accreditation timeframe
766 requirements of the transferor. The agency shall deny a change
767 of ownership application if the clinic is not in compliance with
768 the accreditation requirements. When a clinic adds, replaces, or
769 modifies magnetic resonance imaging equipment and the
770 accreditation agency requires new accreditation, the clinic must
771 be accredited within 1 year after the date of the addition,
772 replacement, or modification but may request a single, 6-month
773 extension if the clinic provides evidence of good cause to the
774 agency.
775 (b) The agency may deny the application or revoke the
776 license of any entity formed for the purpose of avoiding
777 compliance with the accreditation provisions of this subsection
778 and whose principals were previously principals of an entity
779 that was unable to meet the accreditation requirements within
780 the specified timeframes. The agency may adopt rules as to the
781 accreditation of magnetic resonance imaging clinics.
782 (8) The agency shall give full faith and credit pertaining
783 to any past variance and waiver granted to a magnetic resonance
784 imaging clinic from rule 64-2002, Florida Administrative Code,
785 by the Department of Health, until September 2004. After that
786 date, such clinic must request a variance and waiver from the
787 agency under s. 120.542.
788 (9) In addition to the requirements of part II of chapter
789 408, the clinic or specialty clinic shall display a sign in a
790 conspicuous location within the clinic or specialty clinic
791 readily visible to all patients indicating that, pursuant to s.
792 626.9892, the Department of Financial Services may pay rewards
793 of up to $25,000 to persons providing information leading to the
794 arrest and conviction of persons committing crimes investigated
795 by the Division of Insurance Fraud arising from violations of s.
796 440.105, s. 624.15, s. 626.9541, s. 626.989, or s. 817.234. An
797 authorized employee of the Division of Insurance Fraud may make
798 unannounced inspections of a clinic or specialty clinic licensed
799 under this part as necessary to determine whether the clinic or
800 specialty clinic is in compliance with this subsection. A
801 licensed clinic or specialty clinic shall allow full and
802 complete access to the premises to such authorized employee of
803 the division who makes an inspection to determine compliance
804 with this subsection.
805 (10) In addition to the requirements set forth in s.
806 408.8065, every licensed specialty clinic shall annually file
807 with the agency, including concurrently with the filing of any
808 change of ownership application, upon forms to be furnished by
809 the agency, an audited report showing the following information:
810 (a) A report of the number of patients served by the
811 specialty clinic during the previous 12-month period. The report
812 may exclude any partial month for the month when the report was
813 prepared;
814 (b) Total specialty clinic operating expenses;
815 (c) Gross patient charges by payor category, including
816 Medicare, Medicaid, county indigent programs, any other
817 governmental programs, private insurance, self-paying patients,
818 nonpaying patients, and other payees;
819 (d) The cost of operation of the specialty clinic during
820 the previous 12-month period, excluding any partial month during
821 which time the report was prepared;
822 (e) Unless the specialty clinic can demonstrate that the
823 clinic already has furnished the required information regarding
824 a particular subject individual, the full name of any individual
825 who became an owner or became possessed of any pecuniary
826 interest in the subject clinic since the last report to the
827 agency, along with the disclosure of the information required by
828 s. 400.991 as to such individual; and
829 (f) A current statement of the source of funds for payment
830 of the costs of establishing the specialty clinic and for
831 sustaining the operation of the specialty clinic until its
832 operation produces a positive cash flow.
833 (11) Each licensee of a specialty clinic has a continuing
834 obligation to comply with this part and to report to the agency
835 any change of circumstance related to the clinic’s continuing
836 compliance with this part. Such change of circumstance includes,
837 but is not limited to, any change in the ownership of the
838 specialty clinic, the addition of any individual or business
839 entity possessing a pecuniary interest in the specialty clinic,
840 the employment of any individual as a member of the specialty
841 clinic’s staff who would be required to undergo a criminal
842 background screening if such individual had been an employee at
843 the time of the initial licensure, and any change in the medical
844 or clinic director. The specialty clinic shall furnish the
845 information about any change of circumstances which is required
846 under this part and s. 400.991 within 30 days after the
847 occurrence of such change of circumstance.
848 Section 10. Section 400.995, Florida Statutes, is amended
849 to read:
850 400.995 Agency administrative penalties.—
851 (1) In addition to the requirements of part II of chapter
852 408, the agency may deny the application for a license renewal,
853 revoke and suspend the license, and impose administrative fines
854 of up to $5,000 per violation for violations of the requirements
855 of this part or rules of the agency. In determining if a penalty
856 is to be imposed and in fixing the amount of the fine, the
857 agency shall consider the following factors:
858 (a) The gravity of the violation, including the probability
859 that death or serious physical or emotional harm to a patient
860 will result or has resulted, the severity of the action or
861 potential harm, and the extent to which the provisions of the
862 applicable laws or rules were violated.
863 (b) Actions taken by the owner, medical director, or clinic
864 director to correct violations.
865 (c) Any previous violations.
866 (d) The financial benefit to the clinic or specialty clinic
867 of committing or continuing the violation.
868 (2) Each day of continuing violation after the date fixed
869 for termination of the violation, as ordered by the agency,
870 constitutes an additional, separate, and distinct violation.
871 (3) Any action taken to correct a violation shall be
872 documented in writing by the owner, medical director, or clinic
873 director of the clinic or specialty clinic and verified through
874 followup visits by agency personnel. The agency may impose a
875 fine and, in the case of an owner-operated clinic or specialty
876 clinic, revoke or deny a clinic’s license when a clinic medical
877 director or clinic director knowingly misrepresents actions
878 taken to correct a violation.
879 (4) Any licensed clinic whose owner, medical director, or
880 clinic director concurrently operates an unlicensed clinic shall
881 be subject to an administrative fine of $5,000 per day.
882 (5) Any clinic or specialty clinic whose owner fails to
883 apply for a change-of-ownership license and operates the clinic
884 or specialty clinic under the new ownership is subject to a fine
885 of $5,000.
886 (6) As an alternative to or in conjunction with an
887 administrative action against a clinic or specialty clinic for
888 violations of this part and adopted rules During an inspection,
889 the agency shall make a reasonable attempt to discuss during the
890 inspection each violation with the owner, medical director, or
891 clinic director of the clinic or specialty clinic, prior to
892 written notification. The agency, instead of fixing a period
893 within which the clinic or specialty clinic shall enter into
894 compliance with standards, may request a plan of corrective
895 action from the clinic or specialty clinic which demonstrates a
896 good faith effort to remedy each violation by a specific date,
897 subject to the approval of the agency.
898 Section 11. Section 400.996, Florida Statutes, is created
899 to read:
900 400.996 Specialty clinics; complaints; audits; referrals.—
901 (1) The agency shall receive, document, and process
902 complaints about specialty clinics. Upon receipt of any
903 complaint that asserts the existence of facts evidencing
904 possible billing fraud by a specialty clinic or by any employee
905 of a specialty clinic, the agency shall request the complainant
906 to make such assertions by sworn affidavit.
907 (2) Upon receipt of any sworn affidavit that asserts the
908 existence of facts evidencing possible billing fraud by a
909 specialty clinic or any of its employees, the agency shall refer
910 the complaint to the Office of Fiscal Integrity within the
911 Department of Financial Services.
912 (3) The Department of Financial Services shall report
913 findings to the agency for any appropriate licensure action.
914 Such report shall include a statement of facts as determined by
915 the Department of Financial Services to exist, specifically with
916 regard to the possible violations of licensure requirements. If,
917 during an investigation, the Department of Financial Services
918 has reason to believe that any criminal law of this state has or
919 may have been violated, the department shall refer such
920 investigation to appropriate prosecutorial agencies and shall
921 provide investigative assistance to those agencies as required.
922 (4) The investigating authority and the agency shall
923 cooperate with each other and prepare a record and share
924 information from which the agency may determine if any action
925 for sanctions under this part are warranted.
926 (5) A person commits a misdemeanor of the first degree,
927 punishable as provided in s. 775.082 or s. 775.083 if:
928 (a) He or she submits a sworn complaint that initiates a
929 complaint investigation pursuant to this section; and
930 (b) The sworn complaint is determined to be totally without
931 any factual basis to support the assertions made in the
932 complaint that facts existed evidencing possible fraudulent
933 practices by a specialty clinic or any of its employees.
934 (6) The Office of Fiscal Integrity within the Department of
935 Financial Services shall conduct unannounced reviews,
936 investigations, analyses, and audits to investigate complaints
937 and, as necessary, to determine whether a specialty clinic’s
938 billings are fraudulent or unlawful. The Department of Financial
939 Services may enter upon the premises of the clinic during
940 regular business hours and demand and immediately secure copies
941 of billing and other records of the clinic which will enable the
942 Department of Financial Services to investigate complaints or
943 determine whether a specialty clinic’s billings are fraudulent
944 or unlawful.
945 (7) A licensed specialty clinic shall allow full, complete,
946 and immediate access to the premises and to billing records or
947 information to any such officer or employee who conducts a
948 review, investigation, analysis, or audit to determine
949 compliance with this part and with applicable rules. Failure to
950 allow full, complete, and immediate access to the premises and
951 to billing records or information to any representative of the
952 agency or Department of Financial Services who attempts to
953 conduct a review, investigation, analysis, or audit to determine
954 compliance with this part constitutes a ground for emergency
955 suspension of the license by the agency pursuant to s.
956 120.60(6).
957 (8) In addition to any administrative fines imposed, the
958 agency may assess a fee equal to the cost of conducting any
959 review, investigation, analysis, or audit performed by the
960 agency or the Department of Financial Services.
961 (9) All investigators designated by the Chief Financial
962 Officer to perform duties under this part and who are certified
963 under s. 943.1395 are law enforcement officers of the state.
964 Such investigators may conduct criminal investigations, bear
965 arms, make arrests, and apply for, serve, and execute search
966 warrants, arrest warrants, capias, and other processes
967 throughout the state pertaining to fraud investigations under
968 this section.
969 Section 12. Subsection (27) of section 408.802, Florida
970 Statutes, is amended to read:
971 408.802 Applicability.—The provisions of this part apply to
972 the provision of services that require licensure as defined in
973 this part and to the following entities licensed, registered, or
974 certified by the agency, as described in chapters 112, 383, 390,
975 394, 395, 400, 429, 440, 483, and 765:
976 (27) Health care clinics and specialty clinics, as provided
977 under part X of chapter 400.
978 Section 13. Subsection (25) of section 408.820, Florida
979 Statutes, is amended to read:
980 408.820 Exemptions.—Except as prescribed in authorizing
981 statutes, the following exemptions shall apply to specified
982 requirements of this part:
983 (25) Health care clinics and specialty clinics, as provided
984 under part X of chapter 400, are exempt from s. 408.810(6), (7),
985 and (10).
986 Section 14. Paragraph (mm) is added to subsection (1) of
987 section 456.072, Florida Statutes, to read:
988 456.072 Grounds for discipline; penalties; enforcement.—
989 (1) The following acts shall constitute grounds for which
990 the disciplinary actions specified in subsection (2) may be
991 taken:
992 (mm) Intentionally providing false information on an
993 application for a certificate of exemption from clinic licensure
994 under part XIII of chapter 400.
995 Section 15. Florida Barbara B. Lumpkin Center for Nursing
996 designated; Department of Health to erect suitable markers.—
997 (1) The Florida Center for Nursing, created by s. 464.0195,
998 Florida Statutes, and located in Orlando is designated as the
999 “Florida Barbara B. Lumpkin Center for Nursing.”
1000 (2) The Department of Health is directed to erect suitable
1001 markers designating the Florida Barbara B. Lumpkin Center for
1002 Nursing as described in subsection (1).
1003 Section 16. The sums of $212,528 in recurring funds from
1004 the Health Care Trust Fund, and $25,347 in nonrecurring funds
1005 from the Health Care Trust Fund are appropriated to the Agency
1006 for Health Care Administration and four full-time equivalent
1007 positions and associated salary rate of 134,455 are authorized,
1008 for the 2010-2011 fiscal year for the purpose of administering
1009 the provisions of this act.
1010 Section 17. This act shall take effect July 1, 2010.