Florida Senate - 2012 CS for SB 1316
By the Committee on Health Regulation; and Senator Gaetz
588-03223-12 20121316c1
1 A bill to be entitled
2 An act relating to health care; amending s. 395.002,
3 F.S.; redefining the term “accrediting organizations”
4 as it applies to the regulation of hospitals and other
5 licensed facilities; amending s. 400.474, F.S.;
6 revising the fine that may be imposed against a home
7 health agency for failing to timely submit certain
8 information to the Agency for Health Care
9 Administration; amending s. 400.9905, F.S.; revising
10 the definition of the term “clinic” as it relates to
11 the Health Care Clinic Act; amending s. 409.221, F.S.;
12 revising the background screening requirements for
13 persons rendering care in the consumer-directed care
14 program administered by the Agency for Health Care
15 Administration; amending s. 409.907, F.S.; extending
16 the records-retention period for certain Medicaid
17 provider records; revising the provider agreement to
18 require Medicaid providers to report changes in any
19 principal of the provider to the agency; defining the
20 term “administrative fines” for purposes of revoking a
21 Medicaid provider agreement due to changes of
22 ownership; authorizing, rather than requiring, an
23 onsite inspection of a Medicaid provider’s service
24 location before entering into a provider agreement;
25 specifying the principals of a hospital or nursing
26 home provider for the purposes of submitting
27 fingerprints for background screening; removing
28 certain providers from being subject to agency
29 background checks; amending s. 409.913, F.S.; defining
30 the term “Medicaid provider” or “provider” for
31 purposes of oversight of the integrity of the Medicaid
32 program; authorizing the agency to review and analyze
33 information from sources other than Medicaid-enrolled
34 providers for purposes of determining fraud, abuse,
35 overpayment, or neglect; extending the records
36 retention period for certain Medicaid provider
37 records; revising the grounds for terminating a
38 provider from the Medicaid program; requiring the
39 agency to base its overpayment audit reports on
40 certain information; deleting a requirement that the
41 agency pay interest on certain withheld Medicaid
42 payments; requiring payment arrangements for
43 overpayments and fines to be made within a certain
44 time; specifying that the venue for all Medicaid
45 program integrity cases lies in Leon County;
46 authorizing the agency and the Medicaid Fraud Control
47 Unit to review certain records; amending s. 409.920,
48 F.S.; clarifying the applicability of immunity from
49 civil liability extended to persons who provide
50 information about fraud or suspected fraudulent acts
51 by a Medicaid provider; amending s. 409.967, F.S.;
52 specifying required components of a Medicaid managed
53 care plan relating to the provisions of medications;
54 amending s. 429.23, F.S.; requiring the agency to
55 submit a report to the Legislature on adverse incident
56 reports from assisted living facilities; amending s.
57 429.26, F.S.; authorizing the agency to require a
58 resident of an assisted living facility to undergo a
59 physical examination if the agency questions the
60 appropriateness of the resident’s placement in that
61 facility; authorizing release of the results of the
62 examination to a medical review team to be used along
63 with additional information to determine whether the
64 resident’s placement in the assisted living facility
65 is appropriate; providing for resident notification
66 and relocation if the resident’s continued placement
67 in the facility is not appropriate; authorizing the
68 agency to require the evaluation of a mental health
69 resident by a mental health professional; authorizing
70 an assisted living facility to discharge a resident
71 who requires more services or care than the facility
72 is able to provide; amending s. 456.0635, F.S.;
73 revising the grounds under which the Department of
74 Health or corresponding board is required to refuse to
75 admit a candidate to an examination and refuse to
76 issue or renew a license, certificate, or registration
77 of a health care practitioner; providing an exception;
78 amending s. 456.036, F.S.; providing that all persons
79 who were denied renewal of licensure, certification,
80 or registration under s. 456.0635(3), F.S., may regain
81 licensure, certification, or registration only by
82 completing the application process for initial
83 licensure; providing an exception; amending s.
84 456.074, F.S.; revising the federal offenses for which
85 the Department of Health must issue an emergency order
86 suspending the license of certain health care
87 professionals; amending ss. 458.309 and 459.005, F.S.;
88 requiring a physician or osteopathic physician who
89 performs certain medical procedures relating to
90 liposuction in an office setting to register the
91 office with the Department of Health unless that
92 office is licensed as a facility under ch. 395, F.S.,
93 relating to hospital licensing and regulation;
94 amending s. 463.002, F.S.; conforming provisions to
95 changes made by the act; amending s. 463.005, F.S.;
96 authorizing the Board of Optometry to adopt rules for
97 the administration and prescription of ocular
98 pharmaceutical agents; amending s. 463.0055, F.S.;
99 authorizing certified optometrists to administer and
100 prescribe pharmaceutical agents under certain
101 circumstances; requiring that a certified optometrist
102 complete a course and subsequent examination on
103 general and ocular pharmacology; providing
104 requirements for the course; requiring that the
105 Florida Medical Association and the Florida Optometric
106 Association jointly develop and administer the course
107 and examination; revising qualifications of certain
108 members of the formulary committee; providing for a
109 formulary of topical ocular pharmaceutical agents
110 which the committee may modify; specifying the agents
111 that make up the statutory formulary of oral
112 pharmaceutical agents; authorizing the deletion of an
113 oral pharmaceutical agent listed in the statutory
114 formulary under certain circumstances; prohibiting the
115 board, the Department of Health, or the State Surgeon
116 General from deleting an oral pharmaceutical agent
117 listed in the statutory formulary; amending ss.
118 463.0057 and 463.006, F.S.; conforming provisions to
119 changes made by the act; amending s. 463.0135, F.S.;
120 requiring that a certified optometrist administer and
121 prescribe oral ocular pharmaceutical agents in a
122 certain manner; requiring that a licensed practitioner
123 who diagnoses a patient who has a neovascular form of
124 glaucoma or progressive glaucoma immediately refer the
125 patient to a physician who is skilled in the diseases
126 of the eye; requiring that comanagement of
127 postoperative care be conducted pursuant to an
128 established protocol; requiring that the patient be
129 informed that a physician will be available for
130 emergency care throughout the postoperative period;
131 requiring that the patient consent in writing to the
132 comanagement relationship; amending s. 463.014, F.S.;
133 revising certain prohibited acts regarding an
134 optometrist conducting surgery and dispensing,
135 administering, ordering, supplying, or selling certain
136 drugs; creating s. 463.0141, F.S.; requiring that
137 adverse incidents in the practice of optometry be
138 reported to the Department of Health; providing
139 requirements for notifying the department of an
140 adverse incident; providing a definition; requiring
141 that the department review each incident and determine
142 whether it involved conduct that is subject to
143 disciplinary action; requiring that the Board of
144 Optometry take disciplinary action if necessary;
145 amending s. 483.035, F.S., relating to licensure and
146 regulation of clinical laboratories operated by
147 practitioners for exclusive use; providing
148 applicability to clinical laboratories operated by
149 practitioners licensed to practice optometry; amending
150 s. 483.041, F.S.; revising the definition of the term
151 “licensed practitioner” to include a practitioner
152 licensed under ch. 463, F.S.; amending s. 483.181,
153 F.S.; requiring clinical laboratories to accept human
154 specimens submitted by practitioners licensed to
155 practice under ch. 463, F.S.; amending s. 499.003,
156 F.S.; removing a requirement that a contract provider
157 or subcontractor maintain prescription drugs of the
158 agency or entity in its possession separate and apart
159 from other prescription drugs; amending s. 766.102,
160 F.S.; providing that the claimant has the burden of
161 proving by clear and convincing evidence that the
162 actions of a health care provider represented a breach
163 of the prevailing professional standard of care in an
164 action for damages based on death or personal injury
165 which alleges that the death or injury resulted from
166 the failure of a health care provider to order,
167 perform, or administer supplemental diagnostic tests;
168 amending s. 766.106, F.S.; authorizing a prospective
169 defendant to obtain informal discovery by conducting
170 ex parte interviews of treating health care providers;
171 requiring advance notice to the claimant of an ex
172 parte interview; creating s. 766.1091, F.S.;
173 authorizing a health care provider or health care
174 clinic and a patient to agree to submit a claim of
175 medical negligence to arbitration; requiring that the
176 arbitration agreement be governed by ch. 682, F.S.;
177 authorizing the arbitration agreement to contain a
178 provision that limits an award of damages; amending s.
179 893.02, F.S.; revising the definition of the term
180 “practitioner” to include certified optometrists for
181 purposes of the Florida Comprehensive Drug Abuse
182 Prevention and Control Act; amending s. 893.05, F.S.;
183 prohibiting certified optometrists from administering
184 and prescribing certain controlled substances;
185 requiring the Agency for Health Care Administration to
186 prepare a report for public comment and submission to
187 the Legislature following the expansion of services to
188 new populations or of new services; providing
189 effective dates.
190
191 Be It Enacted by the Legislature of the State of Florida:
192
193 Section 1. Subsection (1) of section 395.002, Florida
194 Statutes, is amended to read:
195 395.002 Definitions.—As used in this chapter:
196 (1) “Accrediting organizations” means national
197 accreditation organizations that are approved by the Centers for
198 Medicare and Medicaid Services and whose standards incorporate
199 comparable licensure regulations required by the state the Joint
200 Commission on Accreditation of Healthcare Organizations, the
201 American Osteopathic Association, the Commission on
202 Accreditation of Rehabilitation Facilities, and the
203 Accreditation Association for Ambulatory Health Care, Inc.
204 Section 2. Subsection (6) of section 400.474, Florida
205 Statutes, is amended, present subsection (7) of that section is
206 renumbered as subsection (8), and a new subsection (7) is added
207 to that section, to read:
208 400.474 Administrative penalties.—
209 (6) The agency may deny, revoke, or suspend the license of
210 a home health agency and shall impose a fine of $5,000 against a
211 home health agency that:
212 (a) Gives remuneration for staffing services to:
213 1. Another home health agency with which it has formal or
214 informal patient-referral transactions or arrangements; or
215 2. A health services pool with which it has formal or
216 informal patient-referral transactions or arrangements,
217
218 unless the home health agency has activated its comprehensive
219 emergency management plan in accordance with s. 400.492. This
220 paragraph does not apply to a Medicare-certified home health
221 agency that provides fair market value remuneration for staffing
222 services to a non-Medicare-certified home health agency that is
223 part of a continuing care facility licensed under chapter 651
224 for providing services to its own residents if each resident
225 receiving home health services pursuant to this arrangement
226 attests in writing that he or she made a decision without
227 influence from staff of the facility to select, from a list of
228 Medicare-certified home health agencies provided by the
229 facility, that Medicare-certified home health agency to provide
230 the services.
231 (b) Provides services to residents in an assisted living
232 facility for which the home health agency does not receive fair
233 market value remuneration.
234 (c) Provides staffing to an assisted living facility for
235 which the home health agency does not receive fair market value
236 remuneration.
237 (d) Fails to provide the agency, upon request, with copies
238 of all contracts with assisted living facilities which were
239 executed within 5 years before the request.
240 (e) Gives remuneration to a case manager, discharge
241 planner, facility-based staff member, or third-party vendor who
242 is involved in the discharge planning process of a facility
243 licensed under chapter 395, chapter 429, or this chapter from
244 whom the home health agency receives referrals.
245 (f) Fails to submit to the agency, within 15 days after the
246 end of each calendar quarter, a written report that includes the
247 following data based on data as it existed on the last day of
248 the quarter:
249 1. The number of insulin-dependent diabetic patients
250 receiving insulin-injection services from the home health
251 agency;
252 2. The number of patients receiving both home health
253 services from the home health agency and hospice services;
254 3. The number of patients receiving home health services
255 from that home health agency; and
256 4. The names and license numbers of nurses whose primary
257 job responsibility is to provide home health services to
258 patients and who received remuneration from the home health
259 agency in excess of $25,000 during the calendar quarter.
260 (f)(g) Gives cash, or its equivalent, to a Medicare or
261 Medicaid beneficiary.
262 (g)(h) Has more than one medical director contract in
263 effect at one time or more than one medical director contract
264 and one contract with a physician-specialist whose services are
265 mandated for the home health agency in order to qualify to
266 participate in a federal or state health care program at one
267 time.
268 (h)(i) Gives remuneration to a physician without a medical
269 director contract being in effect. The contract must:
270 1. Be in writing and signed by both parties;
271 2. Provide for remuneration that is at fair market value
272 for an hourly rate, which must be supported by invoices
273 submitted by the medical director describing the work performed,
274 the dates on which that work was performed, and the duration of
275 that work; and
276 3. Be for a term of at least 1 year.
277
278 The hourly rate specified in the contract may not be increased
279 during the term of the contract. The home health agency may not
280 execute a subsequent contract with that physician which has an
281 increased hourly rate and covers any portion of the term that
282 was in the original contract.
283 (i)(j) Gives remuneration to:
284 1. A physician, and the home health agency is in violation
285 of paragraph (g) (h) or paragraph (h) (i);
286 2. A member of the physician’s office staff; or
287 3. An immediate family member of the physician,
288
289 if the home health agency has received a patient referral in the
290 preceding 12 months from that physician or physician’s office
291 staff.
292 (j)(k) Fails to provide to the agency, upon request, copies
293 of all contracts with a medical director which were executed
294 within 5 years before the request.
295 (k)(l) Demonstrates a pattern of billing the Medicaid
296 program for services to Medicaid recipients which are medically
297 unnecessary as determined by a final order. A pattern may be
298 demonstrated by a showing of at least two such medically
299 unnecessary services within one Medicaid program integrity audit
300 period.
301
302 Paragraphs (e) and (i) do not apply to or preclude Nothing in
303 paragraph (e) or paragraph (j) shall be interpreted as applying
304 to or precluding any discount, compensation, waiver of payment,
305 or payment practice permitted by 42 U.S.C. s. 1320a-7(b) or
306 regulations adopted thereunder, including 42 C.F.R. s. 1001.952
307 or s. 1395nn or regulations adopted thereunder.
308 (7) The agency shall impose a fine of $50 per day against a
309 home health agency that fails to submit to the agency, within 15
310 days after the end of each calendar quarter, a written report
311 that includes the following data based on data as it existed on
312 the last day of the quarter:
313 (a) The number of patients receiving both home health
314 services from the home health agency and hospice services;
315 (b) The number of patients receiving home health services
316 from the home health agency;
317 (c) The number of insulin-dependent diabetic patients
318 receiving insulin-injection services from the home health
319 agency; and
320 (d) The names and license numbers of nurses whose primary
321 job responsibility is to provide home health services to
322 patients and who received remuneration from the home health
323 agency in excess of $25,000 during the calendar quarter.
324 Section 3. Paragraph (l) of subsection (4) of section
325 400.9905, Florida Statutes, is amended, and paragraph (m) is
326 added to that subsection, to read:
327 400.9905 Definitions.—
328 (4) “Clinic” means an entity at which health care services
329 are provided to individuals and which tenders charges for
330 reimbursement for such services, including a mobile clinic and a
331 portable equipment provider. For purposes of this part, the term
332 does not include and the licensure requirements of this part do
333 not apply to:
334 (l) Orthotic, or prosthetic, pediatric cardiology, or
335 perinatology clinical facilities or anesthesia clinical
336 facilities that are not otherwise exempt under paragraph (a) or
337 paragraph (k) and that are a publicly traded corporation or that
338 are wholly owned, directly or indirectly, by a publicly traded
339 corporation. As used in this paragraph, a publicly traded
340 corporation is a corporation that issues securities traded on an
341 exchange registered with the United States Securities and
342 Exchange Commission as a national securities exchange.
343 (m) Entities that are owned or controlled, directly or
344 indirectly, by a publicly traded entity that has $100 million or
345 more, in the aggregate, in total annual revenues derived from
346 providing health care services by licensed health care
347 practitioners who are employed or contracted by an entity
348 described in this paragraph.
349 Section 4. Paragraph (i) of subsection (4) of section
350 409.221, Florida Statutes, is amended to read:
351 409.221 Consumer-directed care program.—
352 (4) CONSUMER-DIRECTED CARE.—
353 (i) Background screening requirements.—All persons who
354 render care under this section must undergo level 2 background
355 screening pursuant to chapter 435 and s. 408.809. The agency
356 shall, as allowable, reimburse consumer-employed caregivers for
357 the cost of conducting such background screening as required by
358 this section. For purposes of this section, a person who has
359 undergone screening, who is qualified for employment under this
360 section and applicable rule, and who has not been unemployed for
361 more than 90 days following such screening is not required to be
362 rescreened. Such person must attest under penalty of perjury to
363 not having been convicted of a disqualifying offense since
364 completing such screening.
365 Section 5. Paragraph (c) of subsection (3) of section
366 409.907, Florida Statutes, is amended, paragraph (k) is added to
367 that subsection, and subsections (6), (7), and (8) of that
368 section are amended, to read:
369 409.907 Medicaid provider agreements.—The agency may make
370 payments for medical assistance and related services rendered to
371 Medicaid recipients only to an individual or entity who has a
372 provider agreement in effect with the agency, who is performing
373 services or supplying goods in accordance with federal, state,
374 and local law, and who agrees that no person shall, on the
375 grounds of handicap, race, color, or national origin, or for any
376 other reason, be subjected to discrimination under any program
377 or activity for which the provider receives payment from the
378 agency.
379 (3) The provider agreement developed by the agency, in
380 addition to the requirements specified in subsections (1) and
381 (2), shall require the provider to:
382 (c) Retain all medical and Medicaid-related records for 6 a
383 period of 5 years to satisfy all necessary inquiries by the
384 agency.
385 (k) Report a change in any principal of the provider,
386 including any officer, director, agent, managing employee, or
387 affiliated person, or any partner or shareholder who has an
388 ownership interest equal to 5 percent or more in the provider,
389 to the agency in writing no later than 30 days after the change
390 occurs.
391 (6) A Medicaid provider agreement may be revoked, at the
392 option of the agency, due to as the result of a change of
393 ownership of any facility, association, partnership, or other
394 entity named as the provider in the provider agreement.
395 (a) In the event of a change of ownership, the transferor
396 remains liable for all outstanding overpayments, administrative
397 fines, and any other moneys owed to the agency before the
398 effective date of the change of ownership. In addition to the
399 continuing liability of the transferor, The transferee is also
400 liable to the agency for all outstanding overpayments identified
401 by the agency on or before the effective date of the change of
402 ownership. For purposes of this subsection, the term
403 “outstanding overpayment” includes any amount identified in a
404 preliminary audit report issued to the transferor by the agency
405 on or before the effective date of the change of ownership. In
406 the event of a change of ownership for a skilled nursing
407 facility or intermediate care facility, the Medicaid provider
408 agreement shall be assigned to the transferee if the transferee
409 meets all other Medicaid provider qualifications. In the event
410 of a change of ownership involving a skilled nursing facility
411 licensed under part II of chapter 400, liability for all
412 outstanding overpayments, administrative fines, and any moneys
413 owed to the agency before the effective date of the change of
414 ownership shall be determined in accordance with s. 400.179.
415 (b) At least 60 days before the anticipated date of the
416 change of ownership, the transferor must shall notify the agency
417 of the intended change of ownership and the transferee must
418 shall submit to the agency a Medicaid provider enrollment
419 application. If a change of ownership occurs without compliance
420 with the notice requirements of this subsection, the transferor
421 and transferee are shall be jointly and severally liable for all
422 overpayments, administrative fines, and other moneys due to the
423 agency, regardless of whether the agency identified the
424 overpayments, administrative fines, or other moneys before or
425 after the effective date of the change of ownership. The agency
426 may not approve a transferee’s Medicaid provider enrollment
427 application if the transferee or transferor has not paid or
428 agreed in writing to a payment plan for all outstanding
429 overpayments, administrative fines, and other moneys due to the
430 agency. This subsection does not preclude the agency from
431 seeking any other legal or equitable remedies available to the
432 agency for the recovery of moneys owed to the Medicaid program.
433 In the event of a change of ownership involving a skilled
434 nursing facility licensed under part II of chapter 400,
435 liability for all outstanding overpayments, administrative
436 fines, and any moneys owed to the agency before the effective
437 date of the change of ownership shall be determined in
438 accordance with s. 400.179 if the Medicaid provider enrollment
439 application for change of ownership is submitted before the
440 change of ownership.
441 (c) As used in this subsection, the term:
442 1. “Administrative fines” includes any amount identified in
443 a notice of a monetary penalty or fine which has been issued by
444 the agency or other regulatory or licensing agency that governs
445 the provider.
446 2. “Outstanding overpayment” includes any amount identified
447 in a preliminary audit report issued to the transferor by the
448 agency on or before the effective date of a change of ownership.
449 (7) The agency may require, As a condition of participating
450 in the Medicaid program and before entering into the provider
451 agreement, the agency may require that the provider to submit
452 information, in an initial and any required renewal
453 applications, concerning the professional, business, and
454 personal background of the provider and permit an onsite
455 inspection of the provider’s service location by agency staff or
456 other personnel designated by the agency to perform this
457 function. Before entering into a provider agreement, the agency
458 may shall perform an a random onsite inspection, within 60 days
459 after receipt of a fully complete new provider’s application, of
460 the provider’s service location prior to making its first
461 payment to the provider for Medicaid services to determine the
462 applicant’s ability to provide the services in compliance with
463 the Medicaid program and professional regulations that the
464 applicant is proposing to provide for Medicaid reimbursement.
465 The agency is not required to perform an onsite inspection of a
466 provider or program that is licensed by the agency, that
467 provides services under waiver programs for home and community
468 based services, or that is licensed as a medical foster home by
469 the Department of Children and Family Services. As a continuing
470 condition of participation in the Medicaid program, a provider
471 must shall immediately notify the agency of any current or
472 pending bankruptcy filing. Before entering into the provider
473 agreement, or as a condition of continuing participation in the
474 Medicaid program, the agency may also require that Medicaid
475 providers reimbursed on a fee-for-services basis or fee schedule
476 basis that which is not cost-based, post a surety bond not to
477 exceed $50,000 or the total amount billed by the provider to the
478 program during the current or most recent calendar year,
479 whichever is greater. For new providers, the amount of the
480 surety bond shall be determined by the agency based on the
481 provider’s estimate of its first year’s billing. If the
482 provider’s billing during the first year exceeds the bond
483 amount, the agency may require the provider to acquire an
484 additional bond equal to the actual billing level of the
485 provider. A provider’s bond need shall not exceed $50,000 if a
486 physician or group of physicians licensed under chapter 458,
487 chapter 459, or chapter 460 has a 50 percent or greater
488 ownership interest in the provider or if the provider is an
489 assisted living facility licensed under chapter 429. The bonds
490 permitted by this section are in addition to the bonds
491 referenced in s. 400.179(2)(d). If the provider is a
492 corporation, partnership, association, or other entity, the
493 agency may require the provider to submit information concerning
494 the background of that entity and of any principal of the
495 entity, including any partner or shareholder having an ownership
496 interest in the entity equal to 5 percent or greater, and any
497 treating provider who participates in or intends to participate
498 in Medicaid through the entity. The information must include:
499 (a) Proof of holding a valid license or operating
500 certificate, as applicable, if required by the state or local
501 jurisdiction in which the provider is located or if required by
502 the Federal Government.
503 (b) Information concerning any prior violation, fine,
504 suspension, termination, or other administrative action taken
505 under the Medicaid laws, rules, or regulations of this state or
506 of any other state or the Federal Government; any prior
507 violation of the laws, rules, or regulations relating to the
508 Medicare program; any prior violation of the rules or
509 regulations of any other public or private insurer; and any
510 prior violation of the laws, rules, or regulations of any
511 regulatory body of this or any other state.
512 (c) Full and accurate disclosure of any financial or
513 ownership interest that the provider, or any principal, partner,
514 or major shareholder thereof, may hold in any other Medicaid
515 provider or health care related entity or any other entity that
516 is licensed by the state to provide health or residential care
517 and treatment to persons.
518 (d) If a group provider, identification of all members of
519 the group and attestation that all members of the group are
520 enrolled in or have applied to enroll in the Medicaid program.
521 (8)(a) Each provider, or each principal of the provider if
522 the provider is a corporation, partnership, association, or
523 other entity, seeking to participate in the Medicaid program
524 must submit a complete set of his or her fingerprints to the
525 agency for the purpose of conducting a criminal history record
526 check. Principals of the provider include any officer, director,
527 billing agent, managing employee, or affiliated person, or any
528 partner or shareholder who has an ownership interest equal to 5
529 percent or more in the provider. However, for a hospital
530 licensed under chapter 395 or a nursing home licensed under
531 chapter 400, principals of the provider are those who meet the
532 definition of a controlling interest under s. 408.803. A
533 director of a not-for-profit corporation or organization is not
534 a principal for purposes of a background investigation as
535 required by this section if the director: serves solely in a
536 voluntary capacity for the corporation or organization, does not
537 regularly take part in the day-to-day operational decisions of
538 the corporation or organization, receives no remuneration from
539 the not-for-profit corporation or organization for his or her
540 service on the board of directors, has no financial interest in
541 the not-for-profit corporation or organization, and has no
542 family members with a financial interest in the not-for-profit
543 corporation or organization; and if the director submits an
544 affidavit, under penalty of perjury, to this effect to the
545 agency and the not-for-profit corporation or organization
546 submits an affidavit, under penalty of perjury, to this effect
547 to the agency as part of the corporation’s or organization’s
548 Medicaid provider agreement application.
549 (a) Notwithstanding the above, the agency may require a
550 background check for any person reasonably suspected by the
551 agency to have been convicted of a crime. This subsection does
552 not apply to:
553 1. A hospital licensed under chapter 395;
554 2. A nursing home licensed under chapter 400;
555 3. A hospice licensed under chapter 400;
556 4. An assisted living facility licensed under chapter 429;
557 1.5. A unit of local government, except that requirements
558 of this subsection apply to nongovernmental providers and
559 entities contracting with the local government to provide
560 Medicaid services. The actual cost of the state and national
561 criminal history record checks must be borne by the
562 nongovernmental provider or entity; or
563 2.6. Any business that derives more than 50 percent of its
564 revenue from the sale of goods to the final consumer, and the
565 business or its controlling parent is required to file a form
566 10-K or other similar statement with the Securities and Exchange
567 Commission or has a net worth of $50 million or more.
568 (b) Background screening shall be conducted in accordance
569 with chapter 435 and s. 408.809. The cost of the state and
570 national criminal record check shall be borne by the provider.
571 (c) Proof of compliance with the requirements of level 2
572 screening under chapter 435 conducted within 12 months before
573 the date the Medicaid provider application is submitted to the
574 agency fulfills the requirements of this subsection.
575 Section 6. Present paragraphs (e) and (f) of subsection (1)
576 of section 409.913, Florida Statutes, are redesignated as
577 paragraphs (f) and (g), respectively, a new paragraph (e) is
578 added to that subsection, and subsections (2), (9), (13), (15),
579 (16), (21), (22), (25), (28), (29), (30), and (31) of that
580 section are amended, to read:
581 409.913 Oversight of the integrity of the Medicaid
582 program.—The agency shall operate a program to oversee the
583 activities of Florida Medicaid recipients, and providers and
584 their representatives, to ensure that fraudulent and abusive
585 behavior and neglect of recipients occur to the minimum extent
586 possible, and to recover overpayments and impose sanctions as
587 appropriate. Beginning January 1, 2003, and each year
588 thereafter, the agency and the Medicaid Fraud Control Unit of
589 the Department of Legal Affairs shall submit a joint report to
590 the Legislature documenting the effectiveness of the state’s
591 efforts to control Medicaid fraud and abuse and to recover
592 Medicaid overpayments during the previous fiscal year. The
593 report must describe the number of cases opened and investigated
594 each year; the sources of the cases opened; the disposition of
595 the cases closed each year; the amount of overpayments alleged
596 in preliminary and final audit letters; the number and amount of
597 fines or penalties imposed; any reductions in overpayment
598 amounts negotiated in settlement agreements or by other means;
599 the amount of final agency determinations of overpayments; the
600 amount deducted from federal claiming as a result of
601 overpayments; the amount of overpayments recovered each year;
602 the amount of cost of investigation recovered each year; the
603 average length of time to collect from the time the case was
604 opened until the overpayment is paid in full; the amount
605 determined as uncollectible and the portion of the uncollectible
606 amount subsequently reclaimed from the Federal Government; the
607 number of providers, by type, that are terminated from
608 participation in the Medicaid program as a result of fraud and
609 abuse; and all costs associated with discovering and prosecuting
610 cases of Medicaid overpayments and making recoveries in such
611 cases. The report must also document actions taken to prevent
612 overpayments and the number of providers prevented from
613 enrolling in or reenrolling in the Medicaid program as a result
614 of documented Medicaid fraud and abuse and must include policy
615 recommendations necessary to prevent or recover overpayments and
616 changes necessary to prevent and detect Medicaid fraud. All
617 policy recommendations in the report must include a detailed
618 fiscal analysis, including, but not limited to, implementation
619 costs, estimated savings to the Medicaid program, and the return
620 on investment. The agency must submit the policy recommendations
621 and fiscal analyses in the report to the appropriate estimating
622 conference, pursuant to s. 216.137, by February 15 of each year.
623 The agency and the Medicaid Fraud Control Unit of the Department
624 of Legal Affairs each must include detailed unit-specific
625 performance standards, benchmarks, and metrics in the report,
626 including projected cost savings to the state Medicaid program
627 during the following fiscal year.
628 (1) For the purposes of this section, the term:
629 (e) “Medicaid provider” or “provider” has the same meaning
630 as provided in s. 409.901 and, for purposes of oversight of the
631 integrity of the Medicaid program, also includes a participant
632 in a Medicaid managed care provider network.
633 (2) The agency shall conduct, or cause to be conducted by
634 contract or otherwise, reviews, investigations, analyses,
635 audits, or any combination thereof, to determine possible fraud,
636 abuse, overpayment, or recipient neglect in the Medicaid program
637 and shall report the findings of any overpayments in audit
638 reports as appropriate. At least 5 percent of all audits must
639 shall be conducted on a random basis. As part of its ongoing
640 fraud detection activities, the agency shall identify and
641 monitor, by contract or otherwise, patterns of overutilization
642 of Medicaid services based on state averages. The agency shall
643 track Medicaid provider prescription and billing patterns and
644 evaluate them against Medicaid medical necessity criteria and
645 coverage and limitation guidelines adopted by rule. Medical
646 necessity determination requires that service be consistent with
647 symptoms or confirmed diagnosis of illness or injury under
648 treatment and not in excess of the patient’s needs. The agency
649 shall conduct reviews of provider exceptions to peer group norms
650 and shall, using statistical methodologies, provider profiling,
651 and analysis of billing patterns, detect and investigate
652 abnormal or unusual increases in billing or payment of claims
653 for Medicaid services and medically unnecessary provision of
654 services. The agency may review and analyze information from
655 sources other than enrolled Medicaid providers in conducting its
656 activities under this subsection.
657 (9) A Medicaid provider shall retain medical, professional,
658 financial, and business records pertaining to services and goods
659 furnished to a Medicaid recipient and billed to Medicaid for 6 a
660 period of 5 years after the date of furnishing such services or
661 goods. The agency may investigate, review, or analyze such
662 records, which must be made available during normal business
663 hours. However, 24-hour notice must be provided if patient
664 treatment would be disrupted. The provider is responsible for
665 furnishing to the agency, and keeping the agency informed of the
666 location of, the provider’s Medicaid-related records. The
667 authority of the agency to obtain Medicaid-related records from
668 a provider is neither curtailed nor limited during a period of
669 litigation between the agency and the provider.
670 (13) The agency shall immediately terminate participation
671 of a Medicaid provider in the Medicaid program and may seek
672 civil remedies or impose other administrative sanctions against
673 a Medicaid provider, if the provider or any principal, officer,
674 director, agent, managing employee, or affiliated person of the
675 provider, or any partner or shareholder having an ownership
676 interest in the provider equal to 5 percent or greater, has been
677 convicted of a criminal offense under federal law or the law of
678 any state relating to the practice of the provider’s profession,
679 or an offense listed under s. 409.907(10), s. 408.809(4), or s.
680 435.04(2) has been:
681 (a) Convicted of a criminal offense related to the delivery
682 of any health care goods or services, including the performance
683 of management or administrative functions relating to the
684 delivery of health care goods or services;
685 (b) Convicted of a criminal offense under federal law or
686 the law of any state relating to the practice of the provider’s
687 profession; or
688 (c) Found by a court of competent jurisdiction to have
689 neglected or physically abused a patient in connection with the
690 delivery of health care goods or services. If the agency
691 determines that the a provider did not participate or acquiesce
692 in the an offense specified in paragraph (a), paragraph (b), or
693 paragraph (c), termination will not be imposed. If the agency
694 effects a termination under this subsection, the agency shall
695 issue an immediate final order pursuant to s. 120.569(2)(n).
696 (15) The agency shall seek a remedy provided by law,
697 including, but not limited to, any remedy provided in
698 subsections (13) and (16) and s. 812.035, if:
699 (a) The provider’s license has not been renewed, or has
700 been revoked, suspended, or terminated, for cause, by the
701 licensing agency of any state;
702 (b) The provider has failed to make available or has
703 refused access to Medicaid-related records to an auditor,
704 investigator, or other authorized employee or agent of the
705 agency, the Attorney General, a state attorney, or the Federal
706 Government;
707 (c) The provider has not furnished or has failed to make
708 available such Medicaid-related records as the agency has found
709 necessary to determine whether Medicaid payments are or were due
710 and the amounts thereof;
711 (d) The provider has failed to maintain medical records
712 made at the time of service, or prior to service if prior
713 authorization is required, demonstrating the necessity and
714 appropriateness of the goods or services rendered;
715 (e) The provider is not in compliance with provisions of
716 Medicaid provider publications that have been adopted by
717 reference as rules in the Florida Administrative Code; with
718 provisions of state or federal laws, rules, or regulations; with
719 provisions of the provider agreement between the agency and the
720 provider; or with certifications found on claim forms or on
721 transmittal forms for electronically submitted claims that are
722 submitted by the provider or authorized representative, as such
723 provisions apply to the Medicaid program;
724 (f) The provider or person who ordered, authorized, or
725 prescribed the care, services, or supplies has furnished, or
726 ordered, or authorized the furnishing of, goods or services to a
727 recipient which are inappropriate, unnecessary, excessive, or
728 harmful to the recipient or are of inferior quality;
729 (g) The provider has demonstrated a pattern of failure to
730 provide goods or services that are medically necessary;
731 (h) The provider or an authorized representative of the
732 provider, or a person who ordered, authorized, or prescribed the
733 goods or services, has submitted or caused to be submitted false
734 or a pattern of erroneous Medicaid claims;
735 (i) The provider or an authorized representative of the
736 provider, or a person who has ordered, authorized, or prescribed
737 the goods or services, has submitted or caused to be submitted a
738 Medicaid provider enrollment application, a request for prior
739 authorization for Medicaid services, a drug exception request,
740 or a Medicaid cost report that contains materially false or
741 incorrect information;
742 (j) The provider or an authorized representative of the
743 provider has collected from or billed a recipient or a
744 recipient’s responsible party improperly for amounts that should
745 not have been so collected or billed by reason of the provider’s
746 billing the Medicaid program for the same service;
747 (k) The provider or an authorized representative of the
748 provider has included in a cost report costs that are not
749 allowable under a Florida Title XIX reimbursement plan, after
750 the provider or authorized representative had been advised in an
751 audit exit conference or audit report that the costs were not
752 allowable;
753 (l) The provider is charged by information or indictment
754 with fraudulent billing practices or any offense referenced in
755 subsection (13). The sanction applied for this reason is limited
756 to suspension of the provider’s participation in the Medicaid
757 program for the duration of the indictment unless the provider
758 is found guilty pursuant to the information or indictment;
759 (m) The provider or a person who has ordered, authorized,
760 or prescribed the goods or services is found liable for
761 negligent practice resulting in death or injury to the
762 provider’s patient;
763 (n) The provider fails to demonstrate that it had available
764 during a specific audit or review period sufficient quantities
765 of goods, or sufficient time in the case of services, to support
766 the provider’s billings to the Medicaid program;
767 (o) The provider has failed to comply with the notice and
768 reporting requirements of s. 409.907;
769 (p) The agency has received reliable information of patient
770 abuse or neglect or of any act prohibited by s. 409.920; or
771 (q) The provider has failed to comply with an agreed-upon
772 repayment schedule.
773
774 A provider is subject to sanctions for violations of this
775 subsection as the result of actions or inactions of the
776 provider, or actions or inactions of any principal, officer,
777 director, agent, managing employee, or affiliated person of the
778 provider, or any partner or shareholder having an ownership
779 interest in the provider equal to 5 percent or greater, in which
780 the provider participated or acquiesced.
781 (16) The agency shall impose any of the following sanctions
782 or disincentives on a provider or a person for any of the acts
783 described in subsection (15):
784 (a) Suspension for a specific period of time of not more
785 than 1 year. Suspension precludes shall preclude participation
786 in the Medicaid program, which includes any action that results
787 in a claim for payment to the Medicaid program as a result of
788 furnishing, supervising a person who is furnishing, or causing a
789 person to furnish goods or services.
790 (b) Termination for a specific period of time of from more
791 than 1 year to 20 years. Termination precludes shall preclude
792 participation in the Medicaid program, which includes any action
793 that results in a claim for payment to the Medicaid program as a
794 result of furnishing, supervising a person who is furnishing, or
795 causing a person to furnish goods or services.
796 (c) Imposition of a fine of up to $5,000 for each
797 violation. Each day that an ongoing violation continues, such as
798 refusing to furnish Medicaid-related records or refusing access
799 to records, is considered, for the purposes of this section, to
800 be a separate violation. Each instance of improper billing of a
801 Medicaid recipient; each instance of including an unallowable
802 cost on a hospital or nursing home Medicaid cost report after
803 the provider or authorized representative has been advised in an
804 audit exit conference or previous audit report of the cost
805 unallowability; each instance of furnishing a Medicaid recipient
806 goods or professional services that are inappropriate or of
807 inferior quality as determined by competent peer judgment; each
808 instance of knowingly submitting a materially false or erroneous
809 Medicaid provider enrollment application, request for prior
810 authorization for Medicaid services, drug exception request, or
811 cost report; each instance of inappropriate prescribing of drugs
812 for a Medicaid recipient as determined by competent peer
813 judgment; and each false or erroneous Medicaid claim leading to
814 an overpayment to a provider is considered, for the purposes of
815 this section, to be a separate violation.
816 (d) Immediate suspension, if the agency has received
817 information of patient abuse or neglect or of any act prohibited
818 by s. 409.920. Upon suspension, the agency must issue an
819 immediate final order under s. 120.569(2)(n).
820 (e) A fine, not to exceed $10,000, for a violation of
821 paragraph (15)(i).
822 (f) Imposition of liens against provider assets, including,
823 but not limited to, financial assets and real property, not to
824 exceed the amount of fines or recoveries sought, upon entry of
825 an order determining that such moneys are due or recoverable.
826 (g) Prepayment reviews of claims for a specified period of
827 time.
828 (h) Comprehensive followup reviews of providers every 6
829 months to ensure that they are billing Medicaid correctly.
830 (i) Corrective-action plans that would remain in effect for
831 providers for up to 3 years and that are would be monitored by
832 the agency every 6 months while in effect.
833 (j) Other remedies as permitted by law to effect the
834 recovery of a fine or overpayment.
835
836 If a provider voluntarily relinquishes its Medicaid provider
837 number after receiving written notice that the agency is
838 conducting, or has conducted, an audit or investigation and the
839 sanction of suspension or termination will be imposed for
840 noncompliance discovered as a result of the audit or
841 investigation, the agency shall impose the sanction of
842 termination for cause against the provider. The Secretary of
843 Health Care Administration may make a determination that
844 imposition of a sanction or disincentive is not in the best
845 interest of the Medicaid program, in which case a sanction or
846 disincentive may shall not be imposed.
847 (21) When making a determination that an overpayment has
848 occurred, the agency shall prepare and issue an audit report to
849 the provider showing the calculation of overpayments. The
850 agency’s determination shall be based solely upon information
851 available to it before issuance of the audit report and, in the
852 case of documentation obtained to substantiate claims for
853 Medicaid reimbursement, based solely upon contemporaneous
854 records.
855 (22) The audit report, supported by agency work papers,
856 showing an overpayment to a provider constitutes evidence of the
857 overpayment. A provider may not present or elicit testimony,
858 either on direct examination or cross-examination in any court
859 or administrative proceeding, regarding the purchase or
860 acquisition by any means of drugs, goods, or supplies; sales or
861 divestment by any means of drugs, goods, or supplies; or
862 inventory of drugs, goods, or supplies, unless such acquisition,
863 sales, divestment, or inventory is documented by written
864 invoices, written inventory records, or other competent written
865 documentary evidence maintained in the normal course of the
866 provider’s business. Testimony or evidence that is not based
867 upon contemporaneous records or that was not furnished to the
868 agency within 21 days after the issuance of the audit report is
869 inadmissible in an administrative hearing on a Medicaid
870 overpayment or an administrative sanction. Notwithstanding the
871 applicable rules of discovery, all documentation to that will be
872 offered as evidence at an administrative hearing on a Medicaid
873 overpayment or an administrative sanction must be exchanged by
874 all parties at least 14 days before the administrative hearing
875 or must be excluded from consideration.
876 (25)(a) The agency shall withhold Medicaid payments, in
877 whole or in part, to a provider upon receipt of reliable
878 evidence that the circumstances giving rise to the need for a
879 withholding of payments involve fraud, willful
880 misrepresentation, or abuse under the Medicaid program, or a
881 crime committed while rendering goods or services to Medicaid
882 recipients. If it is determined that fraud, willful
883 misrepresentation, abuse, or a crime did not occur, the payments
884 withheld must be paid to the provider within 14 days after such
885 determination with interest at the rate of 10 percent a year.
886 Any money withheld in accordance with this paragraph shall be
887 placed in a suspended account, readily accessible to the agency,
888 so that any payment ultimately due the provider shall be made
889 within 14 days.
890 (b) The agency shall deny payment, or require repayment, if
891 the goods or services were furnished, supervised, or caused to
892 be furnished by a person who has been suspended or terminated
893 from the Medicaid program or Medicare program by the Federal
894 Government or any state.
895 (c) Overpayments owed to the agency bear interest at the
896 rate of 10 percent per year from the date of determination of
897 the overpayment by the agency, and payment arrangements
898 regarding overpayments and fines must be made within 30 days
899 after the date of the final order and are not subject to further
900 appeal at the conclusion of legal proceedings. A provider who
901 does not enter into or adhere to an agreed-upon repayment
902 schedule may be terminated by the agency for nonpayment or
903 partial payment.
904 (d) The agency, upon entry of a final agency order, a
905 judgment or order of a court of competent jurisdiction, or a
906 stipulation or settlement, may collect the moneys owed by all
907 means allowable by law, including, but not limited to, notifying
908 any fiscal intermediary of Medicare benefits that the state has
909 a superior right of payment. Upon receipt of such written
910 notification, the Medicare fiscal intermediary shall remit to
911 the state the sum claimed.
912 (e) The agency may institute amnesty programs to allow
913 Medicaid providers the opportunity to voluntarily repay
914 overpayments. The agency may adopt rules to administer such
915 programs.
916 (28) Venue for all Medicaid program integrity overpayment
917 cases lies shall lie in Leon County, at the discretion of the
918 agency.
919 (29) Notwithstanding other provisions of law, the agency
920 and the Medicaid Fraud Control Unit of the Department of Legal
921 Affairs may review a person’s or provider’s Medicaid-related and
922 non-Medicaid-related records in order to determine the total
923 output of a provider’s practice to reconcile quantities of goods
924 or services billed to Medicaid with quantities of goods or
925 services used in the provider’s total practice.
926 (30) The agency shall terminate a provider’s participation
927 in the Medicaid program if the provider fails to reimburse an
928 overpayment or pay a fine that has been determined by final
929 order, not subject to further appeal, within 30 35 days after
930 the date of the final order, unless the provider and the agency
931 have entered into a repayment agreement.
932 (31) If a provider requests an administrative hearing
933 pursuant to chapter 120, such hearing must be conducted within
934 90 days following assignment of an administrative law judge,
935 absent exceptionally good cause shown as determined by the
936 administrative law judge or hearing officer. Upon issuance of a
937 final order, the outstanding balance of the amount determined to
938 constitute the overpayment and fines is shall become due. If a
939 provider fails to make payments in full, fails to enter into a
940 satisfactory repayment plan, or fails to comply with the terms
941 of a repayment plan or settlement agreement, the agency shall
942 withhold medical assistance reimbursement payments for Medicaid
943 services until the amount due is paid in full.
944 Section 7. Subsection (8) of section 409.920, Florida
945 Statutes, is amended to read:
946 409.920 Medicaid provider fraud.—
947 (8) A person who provides the state, any state agency, any
948 of the state’s political subdivisions, or any agency of the
949 state’s political subdivisions with information about fraud or
950 suspected fraudulent acts fraud by a Medicaid provider,
951 including a managed care organization, is immune from civil
952 liability for libel, slander, or any other relevant tort for
953 providing any the information about fraud or suspected
954 fraudulent acts, unless the person acted with knowledge that the
955 information was false or with reckless disregard for the truth
956 or falsity of the information. For purposes of this subsection,
957 the term “fraudulent acts” includes actual or suspected fraud,
958 abuse, or overpayment, including any fraud-related matters that
959 a provider or health plan is required to report to the agency or
960 a law enforcement agency. The immunity from civil liability
961 extends to reports of fraudulent acts conveyed to the agency in
962 any manner, including any forum and with any audience as
963 directed by the agency, and includes all discussions subsequent
964 to the report and subsequent inquiries from the agency, unless
965 the person acted with knowledge that the information was false
966 or with reckless disregard for the truth or falsity of the
967 information.
968 Section 8. Paragraph (c) of subsection (2) of section
969 409.967, Florida Statutes, is amended to read:
970 409.967 Managed care plan accountability.—
971 (2) The agency shall establish such contract requirements
972 as are necessary for the operation of the statewide managed care
973 program. In addition to any other provisions the agency may deem
974 necessary, the contract must require:
975 (c) Access.—
976 1. Providers.—The agency shall establish specific standards
977 for the number, type, and regional distribution of providers in
978 managed care plan networks to ensure access to care for both
979 adults and children. Each plan must maintain a regionwide
980 network of providers in sufficient numbers to meet the access
981 standards for specific medical services for all recipients
982 enrolled in the plan. The exclusive use of mail-order pharmacies
983 is may not be sufficient to meet network access standards.
984 Consistent with the standards established by the agency,
985 provider networks may include providers located outside the
986 region. A plan may contract with a new hospital facility before
987 the date the hospital becomes operational if the hospital has
988 commenced construction, will be licensed and operational by
989 January 1, 2013, and a final order has issued in any civil or
990 administrative challenge. Each plan shall establish and maintain
991 an accurate and complete electronic database of contracted
992 providers, including information about licensure or
993 registration, locations and hours of operation, specialty
994 credentials and other certifications, specific performance
995 indicators, and such other information as the agency deems
996 necessary. The database must be available online to both the
997 agency and the public and have the capability to compare the
998 availability of providers to network adequacy standards and to
999 accept and display feedback from each provider’s patients. Each
1000 plan shall submit quarterly reports to the agency identifying
1001 the number of enrollees assigned to each primary care provider.
1002 2. Prescribed drugs.—
1003 a. If establishing a prescribed drug formulary or preferred
1004 drug list, a managed care plan must:
1005 (I) Provide a broad range of therapeutic options for the
1006 treatment of disease states consistent with the general needs of
1007 an outpatient population. Whenever feasible, the formulary or
1008 preferred drug list should include at least two products in a
1009 therapeutic class;
1010 (II) Include coverage via prior authorization for each drug
1011 newly approved by the federal Food and Drug Administration until
1012 the plan’s Pharmaceutical and Therapeutics Committee reviews
1013 such drug for inclusion on the formulary. The timing of the
1014 formulary review must comply with s. 409.91195; and
1015 (III) Provide a response within 24 hours after receipt of
1016 all necessary information from the medical provider for a
1017 request for prior authorization and provide a procedure for
1018 escalating a delayed prior authorization request to the pharmacy
1019 management team for resolution or to override other medical
1020 management tools.
1021 b. Each managed care plan shall must publish any prescribed
1022 drug formulary or preferred drug list on the plan’s website in a
1023 manner that is accessible to and searchable by enrollees and
1024 providers. The plan must update the list within 24 hours after
1025 making a change. Each plan must ensure that the prior
1026 authorization process for prescribed drugs is readily accessible
1027 to health care providers, including posting appropriate contact
1028 information on its website and providing timely responses to
1029 providers.
1030 c. The managed care plan must continue to permit an
1031 enrollee who was receiving a prescription drug that was on the
1032 plan’s formulary and subsequently removed or changed to continue
1033 to receive that drug if the provider submits a written request
1034 that demonstrates that the drug is medically necessary, and the
1035 enrollee meets clinical criteria to receive the drug.
1036 d. A managed care plan that imposes a step-therapy or a
1037 fail-first protocol must do so in accordance with the following:
1038 (I) If prescribed drugs for the treatment of a medical
1039 condition are restricted for use by the plan through a step
1040 therapy or fail-first protocol, the plan must provide the
1041 prescriber with access to a clear and convenient process to
1042 expeditiously request a prior authorization that includes a
1043 procedure for escalation to the pharmacy management team if not
1044 resolved in a timely manner.
1045 (II) Escalation to the pharmacy management team must be
1046 expeditiously granted by the plan if the prescriber can submit
1047 appropriate and complete medical documentation to the plan that
1048 the preferred treatment required under the step-therapy or fail
1049 first protocol:
1050 (A) Has been ineffective in the treatment of the enrollee’s
1051 disease or medical condition;
1052 (B) Is reasonably expected to be ineffective based on the
1053 known relevant physical or mental characteristics and medical
1054 history of the enrollee and known characteristics of the drug
1055 regimen; or
1056 (C) Will cause or will likely cause an adverse reaction or
1057 other physical harm to the enrollee.
1058 (III) The pharmacy management team shall work directly with
1059 the medical provider to bring the prior-authorization request to
1060 a clinically appropriate, cost-effective, and timely resolution.
1061 e. For enrollees Medicaid recipients diagnosed with
1062 hemophilia who have been prescribed anti-hemophilic-factor
1063 replacement products, the agency shall provide for those
1064 products and hemophilia overlay services through the agency’s
1065 hemophilia disease management program.
1066 3. Prior authorization.—
1067 a. Each managed care plan must ensure that the prior
1068 authorization process for prescribed drugs is readily accessible
1069 to health care providers, including posting appropriate contact
1070 information on its website and providing timely responses to
1071 providers.
1072 b. If a drug, determined to be medically necessary and
1073 prescribed for an enrollee by a physician using sound clinical
1074 judgment, is subject to prior authorization and approved, the
1075 managed care plan must provide for sufficient refills to
1076 complete the duration of the prescription. If the medication is
1077 still clinically appropriate for ongoing therapy after the
1078 initial prior authorization expires, the plan must provide a
1079 process of expedited review to evaluate ongoing therapy.
1080 c. If a prescribed drug requires prior authorization, the
1081 managed care plan shall reimburse the pharmacist for dispensing
1082 a 72-hour supply of oral maintenance medications to the enrollee
1083 and process the prior authorization request. Dispensing a 72
1084 hour supply must be consistent with laws that govern pharmacy
1085 practice and controlled substances. The managed care plan shall
1086 process all prior authorization requests in as timely a manner
1087 as possible.
1088 d.3. Managed care plans, and their fiscal agents or
1089 intermediaries, must accept prior authorization requests for
1090 prescribed drugs any service electronically.
1091 Section 9. Subsection (11) is added to section 429.23,
1092 Florida Statutes, to read:
1093 429.23 Internal risk management and quality assurance
1094 program; adverse incidents and reporting requirements.—
1095 (11) The agency shall annually submit a report to the
1096 Legislature on adverse incident reports by assisted living
1097 facilities. The report must include the following information
1098 arranged by county:
1099 (a) A total number of adverse incidents;
1100 (b) A listing, by category, of the type of adverse
1101 incidents occurring within each category and the type of staff
1102 involved;
1103 (c) A listing, by category, of the types of injuries, if
1104 any, and the number of injuries occurring within each category;
1105 (d) Types of liability claims filed based on an adverse
1106 incident report or reportable injury; and
1107 (e) Disciplinary action taken against staff, categorized by
1108 the type of staff involved.
1109 Section 10. Present subsections (9), (10), and (11) of
1110 section 429.26, Florida Statutes, are renumbered as subsections
1111 (12), (13), and (14), respectively, and new subsections (9),
1112 (10), and (11) are added to that section, to read:
1113 429.26 Appropriateness of placements; examinations of
1114 residents.—
1115 (9) If, at any time after admission to a facility, agency
1116 personnel question whether a resident needs care beyond that
1117 which the facility is licensed to provide, the agency may
1118 require the resident to be physically examined by a licensed
1119 physician, licensed physician assistant, or certified nurse
1120 practitioner. To the extent possible, the examination must be
1121 performed by the resident’s preferred physician, physician
1122 assistant, or nurse practitioner and paid for by the resident
1123 with personal funds, except as provided in s. 429.18(2). This
1124 subsection does not preclude the agency from imposing sanctions
1125 for violations of subsection (1).
1126 (a) Following examination, the examining physician,
1127 physician assistant, or nurse practitioner shall complete and
1128 sign a medical form provided by the agency. The completed
1129 medical form must be submitted to the agency within 30 days
1130 after the date the facility owner or administrator was notified
1131 by the agency that a physical examination is required.
1132 (b) A medical review team designated by the agency shall
1133 determine whether the resident is appropriately residing in the
1134 facility based on the completed medical form and, if necessary,
1135 consultation with the physician, physician assistant, or nurse
1136 practitioner who performed the examination. Members of the
1137 medical review team making the determination may not include the
1138 agency personnel who initially questioned the appropriateness of
1139 the resident’s placement. The medical review team shall base its
1140 decision on a comprehensive review of the resident’s physical
1141 and functional status. A determination that the resident’s
1142 placement is not appropriate is final and binding upon the
1143 facility and the resident.
1144 (c) A resident who is determined by the medical review team
1145 to be inappropriately residing in a facility shall be given 30
1146 days’ written notice to relocate by the owner or administrator,
1147 unless the resident’s continued residence in the facility
1148 presents an imminent danger to the health, safety, or welfare of
1149 the resident or a substantial probability exists that death or
1150 serious physical harm to the resident would result if the
1151 resident is allowed to remain in the facility.
1152 (10) If a mental health resident appears to have needs in
1153 addition to those identified in the community living support
1154 plan, the agency may require an evaluation by a mental health
1155 professional, as determined by the Department of Children and
1156 Family Services.
1157 (11) A facility may not be required to retain a resident
1158 who requires more services or care than the facility is able to
1159 provide in accordance with its policies and criteria for
1160 admission and continued residency.
1161 Section 11. Effective July 1, 2012, section 456.0635,
1162 Florida Statutes, is amended to read:
1163 456.0635 Health care Medicaid fraud; disqualification for
1164 license, certificate, or registration.—
1165 (1) Health care Medicaid fraud in the practice of a health
1166 care profession is prohibited.
1167 (2) Each board under within the jurisdiction of the
1168 department, or the department if there is no board, shall refuse
1169 to admit a candidate to an any examination and refuse to issue
1170 or renew a license, certificate, or registration to an any
1171 applicant if the candidate or applicant or any principal,
1172 officer, agent, managing employee, or affiliated person of the
1173 applicant, has been:
1174 (a) Has been convicted of, or entered a plea of guilty or
1175 nolo contendere to, regardless of adjudication, a felony under
1176 chapter 409, chapter 817, or chapter 893, or a similar felony
1177 offense committed in another state or jurisdiction, unless the
1178 candidate or applicant has successfully completed a drug court
1179 program for that felony and provides proof that the plea has
1180 been withdrawn or the charges have been dismissed. Any such
1181 conviction or plea shall exclude the applicant or candidate from
1182 licensure, examination, certification, or registration 21 U.S.C.
1183 ss. 801-970, or 42 U.S.C. ss. 1395-1396, unless the sentence and
1184 any subsequent period of probation for such conviction or plea
1185 pleas ended: more than 15 years prior to the date of the
1186 application;
1187 1. For felonies of the first or second degree, more than 15
1188 years before the date of application.
1189 2. For felonies of the third degree, more than 10 years
1190 before the date of application, except for felonies of the third
1191 degree under s. 893.13(6)(a).
1192 3. For felonies of the third degree under s. 893.13(6)(a),
1193 more than 5 years before the date of application.
1194 (b) Has been convicted of, or entered a plea of guilty or
1195 nolo contendere to, regardless of adjudication, a felony under
1196 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396, unless the
1197 sentence and any subsequent period of probation for such
1198 conviction or plea ended more than 15 years before the date of
1199 the application.
1200 (c)(b) Has been terminated for cause from the Florida
1201 Medicaid program pursuant to s. 409.913, unless the candidate or
1202 applicant has been in good standing with the Florida Medicaid
1203 program for the most recent 5 years.;
1204 (d)(c) Has been terminated for cause, pursuant to the
1205 appeals procedures established by the state or Federal
1206 Government, from any other state Medicaid program or the federal
1207 Medicare program, unless the candidate or applicant has been in
1208 good standing with that a state Medicaid program or the federal
1209 Medicare program for the most recent 5 years and the termination
1210 occurred at least 20 years before prior to the date of the
1211 application.
1212 (e) Is currently listed on the United States Department of
1213 Health and Human Services Office of Inspector General’s List of
1214 Excluded Individuals and Entities.
1215
1216 This subsection does not apply to candidates or applicants for
1217 initial licensure or certification who were enrolled in an
1218 educational or training program on or before July 1, 2009, which
1219 was recognized by a board or, if there is no board, recognized
1220 by the department, and who applied for licensure after July 1,
1221 2012.
1222 (3) The department shall refuse to renew a license,
1223 certificate, or registration of any applicant if the applicant
1224 or any principal, officer, agent, managing employee, or
1225 affiliated person of the applicant:
1226 (a) Has been convicted of, or entered a plea of guilty or
1227 nolo contendere to, regardless of adjudication, a felony under
1228 chapter 409, chapter 817, or chapter 893, or a similar felony
1229 offense committed in another state or jurisdiction, unless the
1230 applicant is currently enrolled in a drug court program that
1231 allows the withdrawal of the plea for that felony upon
1232 successful completion of that program. Any such conviction or
1233 plea excludes the applicant or candidate from licensure,
1234 examination, certification, or registration unless the sentence
1235 and any subsequent period of probation for such conviction or
1236 plea ended:
1237 1. For felonies of the first or second degree, more than 15
1238 years before the date of application.
1239 2. For felonies of the third degree, more than 10 years
1240 before the date of application, except for felonies of the third
1241 degree under s. 893.13(6)(a).
1242 3. For felonies of the third degree under s. 893.13(6)(a),
1243 more than 5 years before the date of application.
1244 (b) Has been convicted of, or entered a plea of guilty or
1245 nolo contendere to, regardless of adjudication, a felony under
1246 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
1247 2009, unless the sentence and any subsequent period of probation
1248 for such conviction or plea ended more than 15 years before the
1249 date of the application.
1250 (c) Has been terminated for cause from the Florida Medicaid
1251 program pursuant to s. 409.913, unless the applicant has been in
1252 good standing with the Florida Medicaid program for the most
1253 recent 5 years.
1254 (d) Has been terminated for cause, pursuant to the appeals
1255 procedures established by the state, from any other state
1256 Medicaid program, unless the applicant has been in good standing
1257 with that state Medicaid program for the most recent 5 years and
1258 the termination occurred at least 20 years before the date of
1259 the application.
1260 (e) Is currently listed on the United States Department of
1261 Health and Human Services Office of Inspector General’s List of
1262 Excluded Individuals and Entities.
1263 (4)(3) Licensed health care practitioners shall report
1264 allegations of health care Medicaid fraud to the department,
1265 regardless of the practice setting in which the alleged health
1266 care Medicaid fraud occurred.
1267 (5)(4) The acceptance by a licensing authority of a
1268 licensee’s candidate’s relinquishment of a license which is
1269 offered in response to or anticipation of the filing of
1270 administrative charges alleging health care Medicaid fraud or
1271 similar charges constitutes the permanent revocation of the
1272 license.
1273 Section 12. Effective July 1, 2012, present subsections
1274 (14) and (15) of section 456.036, Florida Statutes, are
1275 renumbered as subsections (15) and (16), respectively, and a new
1276 subsection (14) is added to that section, to read:
1277 456.036 Licenses; active and inactive status; delinquency.—
1278 (14) A person who has been denied license renewal,
1279 certification, or registration under s. 456.0635(3) may regain
1280 licensure, certification, or registration only by meeting the
1281 qualifications and completing the application process for
1282 initial licensure as defined by the board, or the department if
1283 there is no board. However, a person who was denied renewal of
1284 licensure, certification, or registration under s. 24 of chapter
1285 2009-223, Laws of Florida, between July 1, 2009, and June 30,
1286 2012, is not required to retake and pass examinations applicable
1287 for initial licensure, certification, or registration.
1288 Section 13. Subsection (1) of section 456.074, Florida
1289 Statutes, is amended to read:
1290 456.074 Certain health care practitioners; immediate
1291 suspension of license.—
1292 (1) The department shall issue an emergency order
1293 suspending the license of any person licensed under chapter 458,
1294 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
1295 chapter 464, chapter 465, chapter 466, or chapter 484 who pleads
1296 guilty to, is convicted or found guilty of, or who enters a plea
1297 of nolo contendere to, regardless of adjudication, to:
1298 (a) A felony under chapter 409, chapter 817, or chapter 893
1299 or under 21 U.S.C. ss. 801-970 or under 42 U.S.C. ss. 1395-1396;
1300 or
1301 (b) A misdemeanor or felony under 18 U.S.C. s. 669, ss.
1302 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s.
1303 1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the
1304 Medicaid program.
1305 Section 14. Subsection (3) of section 458.309, Florida
1306 Statutes, is amended to read:
1307 458.309 Rulemaking authority.—
1308 (3) A physician All physicians who performs liposuction
1309 procedures in which more than 1,000 cubic centimeters of
1310 supernatant fat is removed, perform level 2 procedures lasting
1311 more than 5 minutes, and all level 3 surgical procedures in an
1312 office setting must register the office with the department
1313 unless that office is licensed as a facility under pursuant to
1314 chapter 395. The department shall inspect the physician’s office
1315 annually unless the office is accredited by a nationally
1316 recognized accrediting agency or an accrediting organization
1317 subsequently approved by the Board of Medicine. The actual costs
1318 for registration and inspection or accreditation shall be paid
1319 by the person seeking to register and operate the office setting
1320 in which office surgery is performed.
1321 Section 15. Subsection (2) of section 459.005, Florida
1322 Statutes, is amended to read:
1323 459.005 Rulemaking authority.—
1324 (2) A physician All physicians who performs liposuction
1325 procedures in which more than 1,000 cubic centimeters of
1326 supernatant fat is removed, perform level 2 procedures lasting
1327 more than 5 minutes, and all level 3 surgical procedures in an
1328 office setting must register the office with the department
1329 unless that office is licensed as a facility under pursuant to
1330 chapter 395. The department shall inspect the physician’s office
1331 annually unless the office is accredited by a nationally
1332 recognized accrediting agency or an accrediting organization
1333 subsequently approved by the Board of Osteopathic Medicine. The
1334 actual costs for registration and inspection or accreditation
1335 shall be paid by the person seeking to register and operate the
1336 office setting in which office surgery is performed.
1337 Section 16. Subsections (3), (4), and (5) of section
1338 463.002, Florida Statutes, are amended to read:
1339 463.002 Definitions.—As used in this chapter, the term:
1340 (3)(a) “Licensed practitioner” means a person who is a
1341 primary health care provider licensed to engage in the practice
1342 of optometry under the authority of this chapter.
1343 (b) A licensed practitioner who is not a certified
1344 optometrist shall be required to display at her or his place of
1345 practice a sign which states, “I am a Licensed Practitioner, not
1346 a Certified Optometrist, and I am not able to prescribe topical
1347 ocular pharmaceutical agents.”
1348 (c) All practitioners initially licensed after July 1,
1349 1993, must be certified optometrists.
1350 (4) “Certified optometrist” means a licensed practitioner
1351 authorized by the board to administer and prescribe topical
1352 ocular pharmaceutical agents.
1353 (5) “Optometry” means the diagnosis of conditions of the
1354 human eye and its appendages; the employment of any objective or
1355 subjective means or methods, including the administration of
1356 topical ocular pharmaceutical agents, for the purpose of
1357 determining the refractive powers of the human eyes, or any
1358 visual, muscular, neurological, or anatomic anomalies of the
1359 human eyes and their appendages; and the prescribing and
1360 employment of lenses, prisms, frames, mountings, contact lenses,
1361 orthoptic exercises, light frequencies, and any other means or
1362 methods, including topical ocular pharmaceutical agents, for the
1363 correction, remedy, or relief of any insufficiencies or abnormal
1364 conditions of the human eyes and their appendages.
1365 Section 17. Paragraph (g) of subsection (1) of section
1366 463.005, Florida Statutes, is amended to read:
1367 463.005 Authority of the board.—
1368 (1) The Board of Optometry has authority to adopt rules
1369 pursuant to ss. 120.536(1) and 120.54 to implement the
1370 provisions of this chapter conferring duties upon it. Such rules
1371 shall include, but not be limited to, rules relating to:
1372 (g) Administration and prescription of topical ocular
1373 pharmaceutical agents.
1374 Section 18. Section 463.0055, Florida Statutes, is amended
1375 to read:
1376 463.0055 Administration and prescription of topical ocular
1377 pharmaceutical agents; committee.—
1378 (1)(a) Certified optometrists may administer and prescribe
1379 topical ocular pharmaceutical agents as provided in this section
1380 for the diagnosis and treatment of ocular conditions of the
1381 human eye and its appendages without the use of surgery or other
1382 invasive techniques. However, a licensed practitioner who is not
1383 certified may use topically applied anesthetics solely for the
1384 purpose of glaucoma examinations, but is otherwise prohibited
1385 from administering or prescribing topical ocular pharmaceutical
1386 agents.
1387 (b) Before a certified optometrist may administer or
1388 prescribe oral ocular pharmaceutical agents, the certified
1389 optometrist must complete a course and subsequent examination on
1390 general and ocular pharmacology which have a particular emphasis
1391 on the ingestion of oral pharmaceutical agents and the side
1392 effects of those agents. For certified optometrists licensed
1393 before January 1, 1990, the course shall consist of 50 contact
1394 hours and 25 of those hours shall be Internet-based. For
1395 certified optometrists licensed on or after January 1, 1990, the
1396 course shall consist of 20 contact hours and 10 of those hours
1397 shall be Internet-based. The first course and examination shall
1398 be presented by January 1, 2013, and shall thereafter be
1399 administered at least annually. The Florida Medical Association
1400 and the Florida Optometric Association shall jointly develop and
1401 administer a course and examination for such purpose and jointly
1402 determine the site or sites for the course and examination.
1403 (2)(a) There is hereby created a committee composed of two
1404 certified optometrists licensed pursuant to this chapter,
1405 appointed by the Board of Optometry, two board-certified
1406 ophthalmologists licensed pursuant to chapter 458 or chapter
1407 459, appointed by the Board of Medicine, and one additional
1408 person with a doctorate degree in pharmacology who is not
1409 licensed pursuant to chapter 458, chapter 459, or this chapter,
1410 appointed by the State Surgeon General. The committee shall
1411 review requests for additions to, deletions from, or
1412 modifications of a formulary of topical ocular pharmaceutical
1413 agents for administration and prescription by certified
1414 optometrists and shall provide to the board advisory opinions
1415 and recommendations on such requests. The formulary of topical
1416 ocular pharmaceutical agents shall consist of those topical
1417 ocular pharmaceutical agents that are appropriate to treat and
1418 diagnose ocular diseases and disorders and that which the
1419 certified optometrist is qualified to use in the practice of
1420 optometry. The board shall establish, add to, delete from, or
1421 modify the formulary by rule. Notwithstanding any provision of
1422 chapter 120 to the contrary, the formulary rule shall become
1423 effective 60 days from the date it is filed with the Secretary
1424 of State.
1425 (b) The topical formulary may be added to, deleted from, or
1426 modified according to the procedure described in paragraph (a).
1427 Any person who requests an addition, deletion, or modification
1428 of an authorized topical ocular pharmaceutical agent shall have
1429 the burden of proof to show cause why such addition, deletion,
1430 or modification should be made.
1431 (c) The State Surgeon General shall have standing to
1432 challenge any rule or proposed rule of the board pursuant to s.
1433 120.56. In addition to challenges for any invalid exercise of
1434 delegated legislative authority, the administrative law judge,
1435 upon such a challenge by the State Surgeon General, may declare
1436 all or part of a rule or proposed rule invalid if it:
1437 1. Does not protect the public from any significant and
1438 discernible harm or damages;
1439 2. Unreasonably restricts competition or the availability
1440 of professional services in the state or in a significant part
1441 of the state; or
1442 3. Unnecessarily increases the cost of professional
1443 services without a corresponding or equivalent public benefit.
1444
1445 However, there shall not be created a presumption of the
1446 existence of any of the conditions cited in this subsection in
1447 the event that the rule or proposed rule is challenged.
1448 (d) Upon adoption of the topical formulary required by this
1449 section, and upon each addition, deletion, or modification to
1450 the topical formulary, the board shall mail a copy of the
1451 amended topical formulary to each certified optometrist and to
1452 each pharmacy licensed by the state.
1453 (3) In addition to the formulary of topical ocular
1454 pharmaceutical agents in subsection (2), there is created a
1455 statutory formulary of oral pharmaceutical agents, which include
1456 the following agents:
1457 (a) The following analgesics, or their generic or
1458 therapeutic equivalents, which may not be administered or
1459 prescribed for more than 72 hours without consultation with a
1460 physician licensed under chapter 458 or chapter 459 who is
1461 skilled in diseases of the eye:
1462 1. Tramadol hydrochloride.
1463 2. Acetaminophen 300 mg with No. 3 codeine phosphate 30 mg.
1464 (b) The following antibiotics, or their generic or
1465 therapeutic equivalents:
1466 1. Amoxicillin.
1467 2. Azithromycin.
1468 3. Ciprofloxacin.
1469 4. Dicloxacillin.
1470 5. Doxycycline.
1471 6. Keflex.
1472 7. Minocycline.
1473 (c) The following antivirals, or their generic or
1474 therapeutic equivalents:
1475 1. Acyclovir.
1476 2. Famciclovir.
1477 3. Valacyclovir.
1478 (d) The following oral anti-glaucoma agents, or their
1479 generic or therapeutic equivalents, which may not be
1480 administered or prescribed for more than 72 hours without
1481 consultation with a physician licensed under chapter 458 or
1482 chapter 459 who is skilled in diseases of the eye:
1483 1. Acetazolamide.
1484 2. Methazolamide.
1485
1486 Any oral pharmaceutical agent listed in the statutory formulary
1487 set forth in this subsection which is subsequently determined by
1488 the United States Food and Drug Administration to be unsafe for
1489 administration or prescription shall be considered to have been
1490 deleted from the formulary of oral pharmaceutical agents. The
1491 oral pharmaceutical agents on the statutory formulary set forth
1492 in this subsection may not otherwise be deleted by the board,
1493 the department, or the State Surgeon General.
1494 (4)(3) A certified optometrist shall be issued a prescriber
1495 number by the board. Any prescription written by a certified
1496 optometrist for a topical ocular pharmaceutical agent pursuant
1497 to this section shall have the prescriber number printed
1498 thereon.
1499 Section 19. Subsection (3) of section 463.0057, Florida
1500 Statutes, is amended to read:
1501 463.0057 Optometric faculty certificate.—
1502 (3) The holder of a faculty certificate may engage in the
1503 practice of optometry as permitted by this section, but may not
1504 administer or prescribe topical ocular pharmaceutical agents
1505 unless the certificateholder has satisfied the requirements of
1506 ss. 463.0055(1)(b) and s. 463.006(1)(b)4. and 5.
1507 Section 20. Subsections (2) and (3) of section 463.006,
1508 Florida Statutes, are amended to read:
1509 463.006 Licensure and certification by examination.—
1510 (2) The examination shall consist of the appropriate
1511 subjects, including applicable state laws and rules and general
1512 and ocular pharmacology with emphasis on the use topical
1513 application and side effects of ocular pharmaceutical agents.
1514 The board may by rule substitute a national examination as part
1515 or all of the examination and may by rule offer a practical
1516 examination in addition to the written examination.
1517 (3) Each applicant who successfully passes the examination
1518 and otherwise meets the requirements of this chapter is entitled
1519 to be licensed as a practitioner and to be certified to
1520 administer and prescribe topical ocular pharmaceutical agents in
1521 the diagnosis and treatment of ocular conditions.
1522 Section 21. Subsections (1) and (2) of section 463.0135,
1523 Florida Statutes, are amended, and subsection (10) is added to
1524 that section, to read:
1525 463.0135 Standards of practice.—
1526 (1) A licensed practitioner shall provide that degree of
1527 care which conforms to that level of care provided by medical
1528 practitioners in the same or similar communities. A certified
1529 optometrist shall administer and prescribe oral ocular
1530 pharmaceutical agents in a manner consistent with applicable
1531 preferred practice patterns of the American Academy of
1532 Ophthalmology. A licensed practitioner shall advise or assist
1533 her or his patient in obtaining further care when the service of
1534 another health care practitioner is required.
1535 (2) A licensed practitioner diagnosing angle closure,
1536 neovascular, infantile, or congenital forms of glaucoma shall
1537 promptly and without unreasonable delay refer the patient to a
1538 physician skilled in diseases of the eye and licensed under
1539 chapter 458 or chapter 459. In addition, a licensed practitioner
1540 shall timely refer any patient who experiences progressive
1541 glaucoma due to failed pharmaceutical intervention to a
1542 physician who is skilled in diseases of the eye and licensed
1543 under chapter 458 or chapter 459.
1544 (10) Comanagement of postoperative care shall be conducted
1545 pursuant to an established protocol that governs the
1546 relationship between the operating surgeon and the optometrist.
1547 The patient shall be informed that either physician will be
1548 available for emergency care throughout the postoperative
1549 period, and the patient shall consent in writing to the
1550 comanagement relationship.
1551 Section 22. Subsections (3) and (4) of section 463.014,
1552 Florida Statutes, are amended to read:
1553 463.014 Certain acts prohibited.—
1554 (3) Prescribing, ordering, dispensing, administering,
1555 supplying, selling, or giving any systemic drugs for the purpose
1556 of treating a systemic disease by a licensed practitioner is
1557 prohibited. However, a certified optometrist is permitted to use
1558 commonly accepted means or methods to immediately address
1559 incidents of anaphylaxis.
1560 (4) Surgery of any kind, including the use of lasers, is
1561 expressly prohibited. For purposes of this subsection, the term
1562 “surgery” means a procedure using an instrument, including
1563 lasers, scalpels, or needles, in which human tissue is cut,
1564 burned, or vaporized by incision, injection, ultrasound, laser,
1565 or radiation. The term includes procedures using instruments
1566 that require closing by suturing, clamping, or another such
1567 device. Certified optometrists may remove superficial foreign
1568 bodies. For the purposes of this subsection, the term
1569 “superficial foreign bodies” means any foreign matter that is
1570 embedded in the conjunctiva or cornea but which has not
1571 penetrated the globe.
1572 Section 23. Section 463.0141, Florida Statutes, is created
1573 to read:
1574 463.0141 Reports of adverse incidents in the practice of
1575 optometry.—
1576 (1) Any adverse incident that occurs on or after January 1,
1577 2013, in the practice of optometry must be reported to the
1578 department in the accordance with this section.
1579 (2) The required notification to the department must be
1580 submitted in writing by certified mail and postmarked within 15
1581 days after the occurrence of the adverse incident.
1582 (3) For purposes of notification to the department, the
1583 term “adverse incident,” as used in this section, means an event
1584 that is associated in whole or in part with the prescribing of
1585 an oral ocular pharmaceutical agent and that results in one of
1586 the following:
1587 (a) Any condition that requires the transfer of a patient
1588 to a hospital licensed under chapter 395;
1589 (b) Any condition that requires the patient to obtain care
1590 from a physician licensed under chapter 458 or chapter 459,
1591 other than a referral or a consultation required under this
1592 chapter;
1593 (c) Permanent physical injury to the patient;
1594 (d) Partial or complete permanent loss of sight by the
1595 patient; or
1596 (e) Death of the patient.
1597 (4) The department shall review each incident and determine
1598 whether it potentially involved conduct by the licensed
1599 practitioner which may be subject to disciplinary action, in
1600 which case s. 456.073 applies. Disciplinary action, if any,
1601 shall be taken by the board.
1602 Section 24. Subsection (1) of section 483.035, Florida
1603 Statutes, is amended to read:
1604 483.035 Clinical laboratories operated by practitioners for
1605 exclusive use; licensure and regulation.—
1606 (1) A clinical laboratory operated by one or more
1607 practitioners licensed under chapter 458, chapter 459, chapter
1608 460, chapter 461, chapter 462, chapter 463, or chapter 466,
1609 exclusively in connection with the diagnosis and treatment of
1610 their own patients, must be licensed under this part and must
1611 comply with the provisions of this part, except that the agency
1612 shall adopt rules for staffing, for personnel, including
1613 education and training of personnel, for proficiency testing,
1614 and for construction standards relating to the licensure and
1615 operation of the laboratory based upon and not exceeding the
1616 same standards contained in the federal Clinical Laboratory
1617 Improvement Amendments of 1988 and the federal regulations
1618 adopted thereunder.
1619 Section 25. Subsection (7) of section 483.041, Florida
1620 Statutes, is amended to read:
1621 483.041 Definitions.—As used in this part, the term:
1622 (7) “Licensed practitioner” means a physician licensed
1623 under chapter 458, chapter 459, chapter 460, or chapter 461, or
1624 chapter 463; a dentist licensed under chapter 466; a person
1625 licensed under chapter 462; or an advanced registered nurse
1626 practitioner licensed under part I of chapter 464; or a duly
1627 licensed practitioner from another state licensed under similar
1628 statutes who orders examinations on materials or specimens for
1629 nonresidents of the State of Florida, but who reside in the same
1630 state as the requesting licensed practitioner.
1631 Section 26. Subsection (5) of section 483.181, Florida
1632 Statutes, is amended to read:
1633 483.181 Acceptance, collection, identification, and
1634 examination of specimens.—
1635 (5) A clinical laboratory licensed under this part must
1636 accept a human specimen submitted for examination by a
1637 practitioner licensed under chapter 458, chapter 459, chapter
1638 460, chapter 461, chapter 462, chapter 463, s. 464.012, or
1639 chapter 466, if the specimen and test are the type performed by
1640 the clinical laboratory. A clinical laboratory may only refuse a
1641 specimen based upon a history of nonpayment for services by the
1642 practitioner. A clinical laboratory shall not charge different
1643 prices for tests based upon the chapter under which a
1644 practitioner submitting a specimen for testing is licensed.
1645 Section 27. Paragraph (a) of subsection (54) of section
1646 499.003, Florida Statutes, is amended to read:
1647 499.003 Definitions of terms used in this part.—As used in
1648 this part, the term:
1649 (54) “Wholesale distribution” means distribution of
1650 prescription drugs to persons other than a consumer or patient,
1651 but does not include:
1652 (a) Any of the following activities, which is not a
1653 violation of s. 499.005(21) if such activity is conducted in
1654 accordance with s. 499.01(2)(g):
1655 1. The purchase or other acquisition by a hospital or other
1656 health care entity that is a member of a group purchasing
1657 organization of a prescription drug for its own use from the
1658 group purchasing organization or from other hospitals or health
1659 care entities that are members of that organization.
1660 2. The sale, purchase, or trade of a prescription drug or
1661 an offer to sell, purchase, or trade a prescription drug by a
1662 charitable organization described in s. 501(c)(3) of the
1663 Internal Revenue Code of 1986, as amended and revised, to a
1664 nonprofit affiliate of the organization to the extent otherwise
1665 permitted by law.
1666 3. The sale, purchase, or trade of a prescription drug or
1667 an offer to sell, purchase, or trade a prescription drug among
1668 hospitals or other health care entities that are under common
1669 control. For purposes of this subparagraph, “common control”
1670 means the power to direct or cause the direction of the
1671 management and policies of a person or an organization, whether
1672 by ownership of stock, by voting rights, by contract, or
1673 otherwise.
1674 4. The sale, purchase, trade, or other transfer of a
1675 prescription drug from or for any federal, state, or local
1676 government agency or any entity eligible to purchase
1677 prescription drugs at public health services prices pursuant to
1678 Pub. L. No. 102-585, s. 602 to a contract provider or its
1679 subcontractor for eligible patients of the agency or entity
1680 under the following conditions:
1681 a. The agency or entity must obtain written authorization
1682 for the sale, purchase, trade, or other transfer of a
1683 prescription drug under this subparagraph from the State Surgeon
1684 General or his or her designee.
1685 b. The contract provider or subcontractor must be
1686 authorized by law to administer or dispense prescription drugs.
1687 c. In the case of a subcontractor, the agency or entity
1688 must be a party to and execute the subcontract.
1689 d. A contract provider or subcontractor must maintain
1690 separate and apart from other prescription drug inventory any
1691 prescription drugs of the agency or entity in its possession.
1692 d.e. The contract provider and subcontractor must maintain
1693 and produce immediately for inspection all records of movement
1694 or transfer of all the prescription drugs belonging to the
1695 agency or entity, including, but not limited to, the records of
1696 receipt and disposition of prescription drugs. Each contractor
1697 and subcontractor dispensing or administering these drugs must
1698 maintain and produce records documenting the dispensing or
1699 administration. Records that are required to be maintained
1700 include, but are not limited to, a perpetual inventory itemizing
1701 drugs received and drugs dispensed by prescription number or
1702 administered by patient identifier, which must be submitted to
1703 the agency or entity quarterly.
1704 e.f. The contract provider or subcontractor may administer
1705 or dispense the prescription drugs only to the eligible patients
1706 of the agency or entity or must return the prescription drugs
1707 for or to the agency or entity. The contract provider or
1708 subcontractor must require proof from each person seeking to
1709 fill a prescription or obtain treatment that the person is an
1710 eligible patient of the agency or entity and must, at a minimum,
1711 maintain a copy of this proof as part of the records of the
1712 contractor or subcontractor required under sub-subparagraph e.
1713 f.g. In addition to the departmental inspection authority
1714 set forth in s. 499.051, the establishment of the contract
1715 provider and subcontractor and all records pertaining to
1716 prescription drugs subject to this subparagraph shall be subject
1717 to inspection by the agency or entity. All records relating to
1718 prescription drugs of a manufacturer under this subparagraph
1719 shall be subject to audit by the manufacturer of those drugs,
1720 without identifying individual patient information.
1721 Section 28. Subsection (4) of section 766.102, Florida
1722 Statutes, is amended to read:
1723 766.102 Medical negligence; standards of recovery; expert
1724 witness.—
1725 (4)(a) The Legislature is cognizant of the changing trends
1726 and techniques for the delivery of health care in this state and
1727 the discretion that is inherent in the diagnosis, care, and
1728 treatment of patients by different health care providers. The
1729 failure of a health care provider to order, perform, or
1730 administer supplemental diagnostic tests is shall not be
1731 actionable if the health care provider acted in good faith and
1732 with due regard for the prevailing professional standard of
1733 care.
1734 (b) The claimant has the burden of proving by clear and
1735 convincing evidence that the alleged actions of the health care
1736 provider represent a breach of the prevailing professional
1737 standard of care in an action for damages based on death or
1738 personal injury which alleges that the death or injury resulted
1739 from the failure of a health care provider to order, perform, or
1740 administer supplemental diagnostic tests.
1741 Section 29. Paragraph (b) of subsection (6) of section
1742 766.106, Florida Statutes, is amended to read:
1743 766.106 Notice before filing action for medical negligence;
1744 presuit screening period; offers for admission of liability and
1745 for arbitration; informal discovery; review.—
1746 (6) INFORMAL DISCOVERY.—
1747 (b) Informal discovery may be used by a party to obtain
1748 unsworn statements, the production of documents or things, and
1749 physical and mental examinations, and ex parte interviews, as
1750 follows:
1751 1. Unsworn statements.—Any party may require other parties
1752 to appear for the taking of an unsworn statement. Such
1753 statements may be used only for the purpose of presuit screening
1754 and are not discoverable or admissible in any civil action for
1755 any purpose by any party. A party desiring to take the unsworn
1756 statement of any party must give reasonable notice in writing to
1757 all parties. The notice must state the time and place for taking
1758 the statement and the name and address of the party to be
1759 examined. Unless otherwise impractical, the examination of any
1760 party must be done at the same time by all other parties. Any
1761 party may be represented by counsel at the taking of an unsworn
1762 statement. An unsworn statement may be recorded electronically,
1763 stenographically, or on videotape. The taking of unsworn
1764 statements is subject to the provisions of the Florida Rules of
1765 Civil Procedure and may be terminated for abuses.
1766 2. Documents or things.—Any party may request discovery of
1767 documents or things. The documents or things must be produced,
1768 at the expense of the requesting party, within 20 days after the
1769 date of receipt of the request. A party is required to produce
1770 discoverable documents or things within that party’s possession
1771 or control. Medical records shall be produced as provided in s.
1772 766.204.
1773 3. Physical and mental examinations.—A prospective
1774 defendant may require an injured claimant to appear for
1775 examination by an appropriate health care provider. The
1776 prospective defendant shall give reasonable notice in writing to
1777 all parties as to the time and place for examination. Unless
1778 otherwise impractical, a claimant is required to submit to only
1779 one examination on behalf of all potential defendants. The
1780 practicality of a single examination must be determined by the
1781 nature of the claimant’s condition, as it relates to the
1782 liability of each prospective defendant. Such examination report
1783 is available to the parties and their attorneys upon payment of
1784 the reasonable cost of reproduction and may be used only for the
1785 purpose of presuit screening. Otherwise, such examination report
1786 is confidential and exempt from the provisions of s. 119.07(1)
1787 and s. 24(a), Art. I of the State Constitution.
1788 4. Written questions.—Any party may request answers to
1789 written questions, the number of which may not exceed 30,
1790 including subparts. A response must be made within 20 days after
1791 receipt of the questions.
1792 5. Unsworn statements of treating health care providers.—A
1793 prospective defendant or his or her legal representative may
1794 also take unsworn statements of the claimant’s treating health
1795 care providers. The statements must be limited to those areas
1796 that are potentially relevant to the claim of personal injury or
1797 wrongful death. Subject to the procedural requirements of
1798 subparagraph 1., a prospective defendant may take unsworn
1799 statements from a claimant’s treating physicians. Reasonable
1800 notice and opportunity to be heard must be given to the claimant
1801 or the claimant’s legal representative before taking unsworn
1802 statements. The claimant or claimant’s legal representative has
1803 the right to attend the taking of such unsworn statements.
1804 6. Ex parte interviews of treating health care providers.—A
1805 prospective defendant or his or her legal representative may
1806 interview the claimant’s treating health care providers without
1807 the presence of the claimant or the claimant’s legal
1808 representative. If a prospective defendant or his or her legal
1809 representative intends to interview a claimant’s health care
1810 providers, the prospective defendant must provide the claimant
1811 with notice of such interview at least 10 days before the date
1812 of the interview.
1813 Section 30. Section 766.1091, Florida Statutes, is created
1814 to read:
1815 766.1091 Voluntary binding arbitration; damages.—
1816 (1) A health care provider licensed under chapter 458,
1817 chapter 459, chapter 463, or chapter 466; any entity owned in
1818 whole or in part by a health care provider licensed under
1819 chapter 458, chapter 459, chapter 463, or chapter 466; or any
1820 health care clinic licensed under part X of chapter 400, and a
1821 patient or prospective patient, may agree in writing to submit
1822 to arbitration any claim for medical negligence which may
1823 currently exist or may accrue in the future and would otherwise
1824 be brought pursuant to this chapter. Any arbitration agreement
1825 entered into pursuant to this section shall be governed by
1826 chapter 682.
1827 (2) Any arbitration agreement entered into pursuant to
1828 subsection (1) may contain a provision that limits the available
1829 damages in an arbitration award.
1830 Section 31. Subsection (21) of section 893.02, Florida
1831 Statutes, is amended to read:
1832 893.02 Definitions.—The following words and phrases as used
1833 in this chapter shall have the following meanings, unless the
1834 context otherwise requires:
1835 (21) “Practitioner” means a physician licensed pursuant to
1836 chapter 458, a dentist licensed pursuant to chapter 466, a
1837 veterinarian licensed pursuant to chapter 474, an osteopathic
1838 physician licensed pursuant to chapter 459, a naturopath
1839 licensed pursuant to chapter 462, a certified optometrist
1840 licensed under chapter 463, or a podiatric physician licensed
1841 pursuant to chapter 461, provided such practitioner holds a
1842 valid federal controlled substance registry number.
1843 Section 32. Subsection (1) of section 893.05, Florida
1844 Statutes, is amended to read:
1845 893.05 Practitioners and persons administering controlled
1846 substances in their absence.—
1847 (1) A practitioner, in good faith and in the course of his
1848 or her professional practice only, may prescribe, administer,
1849 dispense, mix, or otherwise prepare a controlled substance, or
1850 the practitioner may cause the same to be administered by a
1851 licensed nurse or an intern practitioner under his or her
1852 direction and supervision only. A veterinarian may so prescribe,
1853 administer, dispense, mix, or prepare a controlled substance for
1854 use on animals only, and may cause it to be administered by an
1855 assistant or orderly under the veterinarian’s direction and
1856 supervision only. A certified optometrist licensed under chapter
1857 463 may not administer or prescribe pharmaceutical agents in
1858 Schedule I or Schedule II of the Florida Comprehensive Drug
1859 Abuse Prevention and Control Act.
1860 Section 33. The Agency for Health Care Administration shall
1861 prepare a report within 18 months after the implementation of an
1862 expansion of managed care to new populations or the provision of
1863 new items and services. The agency shall post a draft of the
1864 report on its website and provide an opportunity for public
1865 comment. The final report shall be submitted to the Legislature,
1866 along with a description of the process for public input. The
1867 report must include an assessment of:
1868 (1) The impact of managed care on patient access to care,
1869 including an evaluation of any new barriers to the use of
1870 services and prescription drugs, created by the use of medical
1871 management or cost-containment tools.
1872 (2) The impact of the increased managed care expansion on
1873 the utilization of services, quality of care, and patient
1874 outcomes.
1875 (3) The use of prior authorization and other utilization
1876 management tools, including an assessment of whether these tools
1877 pose an undue administrative burden for health care providers or
1878 create barriers to needed care.
1879 Section 34. Except as otherwise expressly provided in this
1880 act, this act shall take effect upon becoming a law.