Florida Senate - 2012 CS for CS for SB 1316
By the Committees on Budget Subcommittee on Health and Human
Services Appropriations; and Health Regulation; and Senator
Gaetz
603-04243-12 20121316c2
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; amending s. 893.02, F.S.; revising
173 the definition of the term “practitioner” to include
174 certified optometrists for purposes of the Florida
175 Comprehensive Drug Abuse Prevention and Control Act;
176 amending s. 893.05, F.S.; prohibiting certified
177 optometrists from administering and prescribing
178 certain controlled substances; requiring the Agency
179 for Health Care Administration to prepare a report for
180 public comment and submission to the Legislature
181 following the expansion of services to new populations
182 or of new services; providing for severability;
183 providing effective dates.
184
185 Be It Enacted by the Legislature of the State of Florida:
186
187 Section 1. Subsection (1) of section 395.002, Florida
188 Statutes, is amended to read:
189 395.002 Definitions.—As used in this chapter:
190 (1) “Accrediting organizations” means national
191 accreditation organizations that are approved by the Centers for
192 Medicare and Medicaid Services and whose standards incorporate
193 comparable licensure regulations required by the state the Joint
194 Commission on Accreditation of Healthcare Organizations, the
195 American Osteopathic Association, the Commission on
196 Accreditation of Rehabilitation Facilities, and the
197 Accreditation Association for Ambulatory Health Care, Inc.
198 Section 2. Subsection (6) of section 400.474, Florida
199 Statutes, is amended, present subsection (7) of that section is
200 renumbered as subsection (8), and a new subsection (7) is added
201 to that section, to read:
202 400.474 Administrative penalties.—
203 (6) The agency may deny, revoke, or suspend the license of
204 a home health agency and shall impose a fine of $5,000 against a
205 home health agency that:
206 (a) Gives remuneration for staffing services to:
207 1. Another home health agency with which it has formal or
208 informal patient-referral transactions or arrangements; or
209 2. A health services pool with which it has formal or
210 informal patient-referral transactions or arrangements,
211
212 unless the home health agency has activated its comprehensive
213 emergency management plan in accordance with s. 400.492. This
214 paragraph does not apply to a Medicare-certified home health
215 agency that provides fair market value remuneration for staffing
216 services to a non-Medicare-certified home health agency that is
217 part of a continuing care facility licensed under chapter 651
218 for providing services to its own residents if each resident
219 receiving home health services pursuant to this arrangement
220 attests in writing that he or she made a decision without
221 influence from staff of the facility to select, from a list of
222 Medicare-certified home health agencies provided by the
223 facility, that Medicare-certified home health agency to provide
224 the services.
225 (b) Provides services to residents in an assisted living
226 facility for which the home health agency does not receive fair
227 market value remuneration.
228 (c) Provides staffing to an assisted living facility for
229 which the home health agency does not receive fair market value
230 remuneration.
231 (d) Fails to provide the agency, upon request, with copies
232 of all contracts with assisted living facilities which were
233 executed within 5 years before the request.
234 (e) Gives remuneration to a case manager, discharge
235 planner, facility-based staff member, or third-party vendor who
236 is involved in the discharge planning process of a facility
237 licensed under chapter 395, chapter 429, or this chapter from
238 whom the home health agency receives referrals.
239 (f) Fails to submit to the agency, within 15 days after the
240 end of each calendar quarter, a written report that includes the
241 following data based on data as it existed on the last day of
242 the quarter:
243 1. The number of insulin-dependent diabetic patients
244 receiving insulin-injection services from the home health
245 agency;
246 2. The number of patients receiving both home health
247 services from the home health agency and hospice services;
248 3. The number of patients receiving home health services
249 from that home health agency; and
250 4. The names and license numbers of nurses whose primary
251 job responsibility is to provide home health services to
252 patients and who received remuneration from the home health
253 agency in excess of $25,000 during the calendar quarter.
254 (f)(g) Gives cash, or its equivalent, to a Medicare or
255 Medicaid beneficiary.
256 (g)(h) Has more than one medical director contract in
257 effect at one time or more than one medical director contract
258 and one contract with a physician-specialist whose services are
259 mandated for the home health agency in order to qualify to
260 participate in a federal or state health care program at one
261 time.
262 (h)(i) Gives remuneration to a physician without a medical
263 director contract being in effect. The contract must:
264 1. Be in writing and signed by both parties;
265 2. Provide for remuneration that is at fair market value
266 for an hourly rate, which must be supported by invoices
267 submitted by the medical director describing the work performed,
268 the dates on which that work was performed, and the duration of
269 that work; and
270 3. Be for a term of at least 1 year.
271
272 The hourly rate specified in the contract may not be increased
273 during the term of the contract. The home health agency may not
274 execute a subsequent contract with that physician which has an
275 increased hourly rate and covers any portion of the term that
276 was in the original contract.
277 (i)(j) Gives remuneration to:
278 1. A physician, and the home health agency is in violation
279 of paragraph (g) (h) or paragraph (h) (i);
280 2. A member of the physician’s office staff; or
281 3. An immediate family member of the physician,
282
283 if the home health agency has received a patient referral in the
284 preceding 12 months from that physician or physician’s office
285 staff.
286 (j)(k) Fails to provide to the agency, upon request, copies
287 of all contracts with a medical director which were executed
288 within 5 years before the request.
289 (k)(l) Demonstrates a pattern of billing the Medicaid
290 program for services to Medicaid recipients which are medically
291 unnecessary as determined by a final order. A pattern may be
292 demonstrated by a showing of at least two such medically
293 unnecessary services within one Medicaid program integrity audit
294 period.
295
296 Paragraphs (e) and (i) do not apply to or preclude Nothing in
297 paragraph (e) or paragraph (j) shall be interpreted as applying
298 to or precluding any discount, compensation, waiver of payment,
299 or payment practice permitted by 42 U.S.C. s. 1320a-7(b) or
300 regulations adopted thereunder, including 42 C.F.R. s. 1001.952
301 or s. 1395nn or regulations adopted thereunder.
302 (7) The agency shall impose a fine of $50 per day against a
303 home health agency that fails to submit to the agency, within 15
304 days after the end of each calendar quarter, a written report
305 that includes the following data based on data as it existed on
306 the last day of the quarter:
307 (a) The number of patients receiving both home health
308 services from the home health agency and hospice services;
309 (b) The number of patients receiving home health services
310 from the home health agency;
311 (c) The number of insulin-dependent diabetic patients
312 receiving insulin-injection services from the home health
313 agency; and
314 (d) The names and license numbers of nurses whose primary
315 job responsibility is to provide home health services to
316 patients and who received remuneration from the home health
317 agency in excess of $25,000 during the calendar quarter.
318 Section 3. Paragraph (l) of subsection (4) of section
319 400.9905, Florida Statutes, is amended, and paragraph (m) is
320 added to that subsection, to read:
321 400.9905 Definitions.—
322 (4) “Clinic” means an entity at which health care services
323 are provided to individuals and which tenders charges for
324 reimbursement for such services, including a mobile clinic and a
325 portable equipment provider. For purposes of this part, the term
326 does not include and the licensure requirements of this part do
327 not apply to:
328 (l) Orthotic, or prosthetic, pediatric cardiology, or
329 perinatology clinical facilities or anesthesia clinical
330 facilities that are not otherwise exempt under paragraph (a) or
331 paragraph (k) and that are a publicly traded corporation or that
332 are wholly owned, directly or indirectly, by a publicly traded
333 corporation. As used in this paragraph, a publicly traded
334 corporation is a corporation that issues securities traded on an
335 exchange registered with the United States Securities and
336 Exchange Commission as a national securities exchange.
337 (m) Entities that are owned or controlled, directly or
338 indirectly, by a publicly traded entity that has $100 million or
339 more, in the aggregate, in total annual revenues derived from
340 providing health care services by licensed health care
341 practitioners who are employed or contracted by an entity
342 described in this paragraph.
343 Section 4. Paragraph (i) of subsection (4) of section
344 409.221, Florida Statutes, is amended to read:
345 409.221 Consumer-directed care program.—
346 (4) CONSUMER-DIRECTED CARE.—
347 (i) Background screening requirements.—All persons who
348 render care under this section must undergo level 2 background
349 screening pursuant to chapter 435 and s. 408.809. The agency
350 shall, as allowable, reimburse consumer-employed caregivers for
351 the cost of conducting such background screening as required by
352 this section. For purposes of this section, a person who has
353 undergone screening, who is qualified for employment under this
354 section and applicable rule, and who has not been unemployed for
355 more than 90 days following such screening is not required to be
356 rescreened. Such person must attest under penalty of perjury to
357 not having been convicted of a disqualifying offense since
358 completing such screening.
359 Section 5. Paragraph (c) of subsection (3) of section
360 409.907, Florida Statutes, is amended, paragraph (k) is added to
361 that subsection, and subsections (6), (7), and (8) of that
362 section are amended, to read:
363 409.907 Medicaid provider agreements.—The agency may make
364 payments for medical assistance and related services rendered to
365 Medicaid recipients only to an individual or entity who has a
366 provider agreement in effect with the agency, who is performing
367 services or supplying goods in accordance with federal, state,
368 and local law, and who agrees that no person shall, on the
369 grounds of handicap, race, color, or national origin, or for any
370 other reason, be subjected to discrimination under any program
371 or activity for which the provider receives payment from the
372 agency.
373 (3) The provider agreement developed by the agency, in
374 addition to the requirements specified in subsections (1) and
375 (2), shall require the provider to:
376 (c) Retain all medical and Medicaid-related records for 6 a
377 period of 5 years to satisfy all necessary inquiries by the
378 agency.
379 (k) Report a change in any principal of the provider,
380 including any officer, director, agent, managing employee, or
381 affiliated person, or any partner or shareholder who has an
382 ownership interest equal to 5 percent or more in the provider,
383 to the agency in writing no later than 30 days after the change
384 occurs. For a hospital licensed under chapter 395 or a nursing
385 home licensed under part II of chapter 400, a principal of the
386 provider is one who meets the definition of a controlling
387 interest under s. 408.803.
388 (6) A Medicaid provider agreement may be revoked, at the
389 option of the agency, due to as the result of a change of
390 ownership of any facility, association, partnership, or other
391 entity named as the provider in the provider agreement.
392 (a) In the event of a change of ownership, the transferor
393 remains liable for all outstanding overpayments, administrative
394 fines, and any other moneys owed to the agency before the
395 effective date of the change of ownership. In addition to the
396 continuing liability of the transferor, The transferee is also
397 liable to the agency for all outstanding overpayments identified
398 by the agency on or before the effective date of the change of
399 ownership. For purposes of this subsection, the term
400 “outstanding overpayment” includes any amount identified in a
401 preliminary audit report issued to the transferor by the agency
402 on or before the effective date of the change of ownership. In
403 the event of a change of ownership for a skilled nursing
404 facility or intermediate care facility, the Medicaid provider
405 agreement shall be assigned to the transferee if the transferee
406 meets all other Medicaid provider qualifications. In the event
407 of a change of ownership involving a skilled nursing facility
408 licensed under part II of chapter 400, liability for all
409 outstanding overpayments, administrative fines, and any moneys
410 owed to the agency before the effective date of the change of
411 ownership shall be determined in accordance with s. 400.179.
412 (b) At least 60 days before the anticipated date of the
413 change of ownership, the transferor must shall notify the agency
414 of the intended change of ownership and the transferee must
415 shall submit to the agency a Medicaid provider enrollment
416 application. If a change of ownership occurs without compliance
417 with the notice requirements of this subsection, the transferor
418 and transferee are shall be jointly and severally liable for all
419 overpayments, administrative fines, and other moneys due to the
420 agency, regardless of whether the agency identified the
421 overpayments, administrative fines, or other moneys before or
422 after the effective date of the change of ownership. The agency
423 may not approve a transferee’s Medicaid provider enrollment
424 application if the transferee or transferor has not paid or
425 agreed in writing to a payment plan for all outstanding
426 overpayments, administrative fines, and other moneys due to the
427 agency. This subsection does not preclude the agency from
428 seeking any other legal or equitable remedies available to the
429 agency for the recovery of moneys owed to the Medicaid program.
430 In the event of a change of ownership involving a skilled
431 nursing facility licensed under part II of chapter 400,
432 liability for all outstanding overpayments, administrative
433 fines, and any moneys owed to the agency before the effective
434 date of the change of ownership shall be determined in
435 accordance with s. 400.179 if the Medicaid provider enrollment
436 application for change of ownership is submitted before the
437 change of ownership.
438 (c) As used in this subsection, the term:
439 1. “Administrative fines” includes any amount identified in
440 a notice of a monetary penalty or fine which has been issued by
441 the agency or other regulatory or licensing agency that governs
442 the provider.
443 2. “Outstanding overpayment” includes any amount identified
444 in a preliminary audit report issued to the transferor by the
445 agency on or before the effective date of a change of ownership.
446 (7) The agency may require, As a condition of participating
447 in the Medicaid program and before entering into the provider
448 agreement, the agency may require that the provider to submit
449 information, in an initial and any required renewal
450 applications, concerning the professional, business, and
451 personal background of the provider and permit an onsite
452 inspection of the provider’s service location by agency staff or
453 other personnel designated by the agency to perform this
454 function. Before entering into a provider agreement, the agency
455 may shall perform an a random onsite inspection, within 60 days
456 after receipt of a fully complete new provider’s application, of
457 the provider’s service location prior to making its first
458 payment to the provider for Medicaid services to determine the
459 applicant’s ability to provide the services in compliance with
460 the Medicaid program and professional regulations that the
461 applicant is proposing to provide for Medicaid reimbursement.
462 The agency is not required to perform an onsite inspection of a
463 provider or program that is licensed by the agency, that
464 provides services under waiver programs for home and community
465 based services, or that is licensed as a medical foster home by
466 the Department of Children and Family Services. As a continuing
467 condition of participation in the Medicaid program, a provider
468 must shall immediately notify the agency of any current or
469 pending bankruptcy filing. Before entering into the provider
470 agreement, or as a condition of continuing participation in the
471 Medicaid program, the agency may also require that Medicaid
472 providers reimbursed on a fee-for-services basis or fee schedule
473 basis that which is not cost-based, post a surety bond not to
474 exceed $50,000 or the total amount billed by the provider to the
475 program during the current or most recent calendar year,
476 whichever is greater. For new providers, the amount of the
477 surety bond shall be determined by the agency based on the
478 provider’s estimate of its first year’s billing. If the
479 provider’s billing during the first year exceeds the bond
480 amount, the agency may require the provider to acquire an
481 additional bond equal to the actual billing level of the
482 provider. A provider’s bond need shall not exceed $50,000 if a
483 physician or group of physicians licensed under chapter 458,
484 chapter 459, or chapter 460 has a 50 percent or greater
485 ownership interest in the provider or if the provider is an
486 assisted living facility licensed under chapter 429. The bonds
487 permitted by this section are in addition to the bonds
488 referenced in s. 400.179(2)(d). If the provider is a
489 corporation, partnership, association, or other entity, the
490 agency may require the provider to submit information concerning
491 the background of that entity and of any principal of the
492 entity, including any partner or shareholder having an ownership
493 interest in the entity equal to 5 percent or greater, and any
494 treating provider who participates in or intends to participate
495 in Medicaid through the entity. The information must include:
496 (a) Proof of holding a valid license or operating
497 certificate, as applicable, if required by the state or local
498 jurisdiction in which the provider is located or if required by
499 the Federal Government.
500 (b) Information concerning any prior violation, fine,
501 suspension, termination, or other administrative action taken
502 under the Medicaid laws, rules, or regulations of this state or
503 of any other state or the Federal Government; any prior
504 violation of the laws, rules, or regulations relating to the
505 Medicare program; any prior violation of the rules or
506 regulations of any other public or private insurer; and any
507 prior violation of the laws, rules, or regulations of any
508 regulatory body of this or any other state.
509 (c) Full and accurate disclosure of any financial or
510 ownership interest that the provider, or any principal, partner,
511 or major shareholder thereof, may hold in any other Medicaid
512 provider or health care related entity or any other entity that
513 is licensed by the state to provide health or residential care
514 and treatment to persons.
515 (d) If a group provider, identification of all members of
516 the group and attestation that all members of the group are
517 enrolled in or have applied to enroll in the Medicaid program.
518 (8)(a) Each provider, or each principal of the provider if
519 the provider is a corporation, partnership, association, or
520 other entity, seeking to participate in the Medicaid program
521 must submit a complete set of his or her fingerprints to the
522 agency for the purpose of conducting a criminal history record
523 check. Principals of the provider include any officer, director,
524 billing agent, managing employee, or affiliated person, or any
525 partner or shareholder who has an ownership interest equal to 5
526 percent or more in the provider. However, for a hospital
527 licensed under chapter 395 or a nursing home licensed under
528 chapter 400, principals of the provider are those who meet the
529 definition of a controlling interest under s. 408.803. A
530 director of a not-for-profit corporation or organization is not
531 a principal for purposes of a background investigation as
532 required by this section if the director: serves solely in a
533 voluntary capacity for the corporation or organization, does not
534 regularly take part in the day-to-day operational decisions of
535 the corporation or organization, receives no remuneration from
536 the not-for-profit corporation or organization for his or her
537 service on the board of directors, has no financial interest in
538 the not-for-profit corporation or organization, and has no
539 family members with a financial interest in the not-for-profit
540 corporation or organization; and if the director submits an
541 affidavit, under penalty of perjury, to this effect to the
542 agency and the not-for-profit corporation or organization
543 submits an affidavit, under penalty of perjury, to this effect
544 to the agency as part of the corporation’s or organization’s
545 Medicaid provider agreement application.
546 (a) Notwithstanding the above, the agency may require a
547 background check for any person reasonably suspected by the
548 agency to have been convicted of a crime. This subsection does
549 not apply to:
550 1. A hospital licensed under chapter 395;
551 2. A nursing home licensed under chapter 400;
552 3. A hospice licensed under chapter 400;
553 4. An assisted living facility licensed under chapter 429;
554 1.5. A unit of local government, except that requirements
555 of this subsection apply to nongovernmental providers and
556 entities contracting with the local government to provide
557 Medicaid services. The actual cost of the state and national
558 criminal history record checks must be borne by the
559 nongovernmental provider or entity; or
560 2.6. Any business that derives more than 50 percent of its
561 revenue from the sale of goods to the final consumer, and the
562 business or its controlling parent is required to file a form
563 10-K or other similar statement with the Securities and Exchange
564 Commission or has a net worth of $50 million or more.
565 (b) Background screening shall be conducted in accordance
566 with chapter 435 and s. 408.809. The cost of the state and
567 national criminal record check shall be borne by the provider.
568 (c) Proof of compliance with the requirements of level 2
569 screening under chapter 435 conducted within 12 months before
570 the date the Medicaid provider application is submitted to the
571 agency fulfills the requirements of this subsection.
572 Section 6. Present paragraphs (e) and (f) of subsection (1)
573 of section 409.913, Florida Statutes, are redesignated as
574 paragraphs (f) and (g), respectively, a new paragraph (e) is
575 added to that subsection, and subsections (2), (9), (13), (15),
576 (16), (21), (22), (25), (28), (29), (30), and (31) of that
577 section are amended, to read:
578 409.913 Oversight of the integrity of the Medicaid
579 program.—The agency shall operate a program to oversee the
580 activities of Florida Medicaid recipients, and providers and
581 their representatives, to ensure that fraudulent and abusive
582 behavior and neglect of recipients occur to the minimum extent
583 possible, and to recover overpayments and impose sanctions as
584 appropriate. Beginning January 1, 2003, and each year
585 thereafter, the agency and the Medicaid Fraud Control Unit of
586 the Department of Legal Affairs shall submit a joint report to
587 the Legislature documenting the effectiveness of the state’s
588 efforts to control Medicaid fraud and abuse and to recover
589 Medicaid overpayments during the previous fiscal year. The
590 report must describe the number of cases opened and investigated
591 each year; the sources of the cases opened; the disposition of
592 the cases closed each year; the amount of overpayments alleged
593 in preliminary and final audit letters; the number and amount of
594 fines or penalties imposed; any reductions in overpayment
595 amounts negotiated in settlement agreements or by other means;
596 the amount of final agency determinations of overpayments; the
597 amount deducted from federal claiming as a result of
598 overpayments; the amount of overpayments recovered each year;
599 the amount of cost of investigation recovered each year; the
600 average length of time to collect from the time the case was
601 opened until the overpayment is paid in full; the amount
602 determined as uncollectible and the portion of the uncollectible
603 amount subsequently reclaimed from the Federal Government; the
604 number of providers, by type, that are terminated from
605 participation in the Medicaid program as a result of fraud and
606 abuse; and all costs associated with discovering and prosecuting
607 cases of Medicaid overpayments and making recoveries in such
608 cases. The report must also document actions taken to prevent
609 overpayments and the number of providers prevented from
610 enrolling in or reenrolling in the Medicaid program as a result
611 of documented Medicaid fraud and abuse and must include policy
612 recommendations necessary to prevent or recover overpayments and
613 changes necessary to prevent and detect Medicaid fraud. All
614 policy recommendations in the report must include a detailed
615 fiscal analysis, including, but not limited to, implementation
616 costs, estimated savings to the Medicaid program, and the return
617 on investment. The agency must submit the policy recommendations
618 and fiscal analyses in the report to the appropriate estimating
619 conference, pursuant to s. 216.137, by February 15 of each year.
620 The agency and the Medicaid Fraud Control Unit of the Department
621 of Legal Affairs each must include detailed unit-specific
622 performance standards, benchmarks, and metrics in the report,
623 including projected cost savings to the state Medicaid program
624 during the following fiscal year.
625 (1) For the purposes of this section, the term:
626 (e) “Medicaid provider” or “provider” has the same meaning
627 as provided in s. 409.901 and, for purposes of oversight of the
628 integrity of the Medicaid program, also includes a participant
629 in a Medicaid managed care provider network.
630 (2) The agency shall conduct, or cause to be conducted by
631 contract or otherwise, reviews, investigations, analyses,
632 audits, or any combination thereof, to determine possible fraud,
633 abuse, overpayment, or recipient neglect in the Medicaid program
634 and shall report the findings of any overpayments in audit
635 reports as appropriate. At least 5 percent of all audits must
636 shall be conducted on a random basis. As part of its ongoing
637 fraud detection activities, the agency shall identify and
638 monitor, by contract or otherwise, patterns of overutilization
639 of Medicaid services based on state averages. The agency shall
640 track Medicaid provider prescription and billing patterns and
641 evaluate them against Medicaid medical necessity criteria and
642 coverage and limitation guidelines adopted by rule. Medical
643 necessity determination requires that service be consistent with
644 symptoms or confirmed diagnosis of illness or injury under
645 treatment and not in excess of the patient’s needs. The agency
646 shall conduct reviews of provider exceptions to peer group norms
647 and shall, using statistical methodologies, provider profiling,
648 and analysis of billing patterns, detect and investigate
649 abnormal or unusual increases in billing or payment of claims
650 for Medicaid services and medically unnecessary provision of
651 services. The agency may review and analyze information from
652 sources other than enrolled Medicaid providers in conducting its
653 activities under this subsection.
654 (9) A Medicaid provider shall retain medical, professional,
655 financial, and business records pertaining to services and goods
656 furnished to a Medicaid recipient and billed to Medicaid for 6 a
657 period of 5 years after the date of furnishing such services or
658 goods. The agency may investigate, review, or analyze such
659 records, which must be made available during normal business
660 hours. However, 24-hour notice must be provided if patient
661 treatment would be disrupted. The provider is responsible for
662 furnishing to the agency, and keeping the agency informed of the
663 location of, the provider’s Medicaid-related records. The
664 authority of the agency to obtain Medicaid-related records from
665 a provider is neither curtailed nor limited during a period of
666 litigation between the agency and the provider.
667 (13) The agency shall immediately terminate participation
668 of a Medicaid provider in the Medicaid program and may seek
669 civil remedies or impose other administrative sanctions against
670 a Medicaid provider, if the provider or any principal, officer,
671 director, agent, managing employee, or affiliated person of the
672 provider, or any partner or shareholder having an ownership
673 interest in the provider equal to 5 percent or greater, has been
674 convicted of a criminal offense under federal law or the law of
675 any state relating to the practice of the provider’s profession,
676 or a criminal offense listed under s. 409.907(10), s.
677 408.809(4), or s. 435.04(2) has been:
678 (a) Convicted of a criminal offense related to the delivery
679 of any health care goods or services, including the performance
680 of management or administrative functions relating to the
681 delivery of health care goods or services;
682 (b) Convicted of a criminal offense under federal law or
683 the law of any state relating to the practice of the provider’s
684 profession; or
685 (c) Found by a court of competent jurisdiction to have
686 neglected or physically abused a patient in connection with the
687 delivery of health care goods or services. If the agency
688 determines that the a provider did not participate or acquiesce
689 in the an offense specified in paragraph (a), paragraph (b), or
690 paragraph (c), termination will not be imposed. If the agency
691 effects a termination under this subsection, the agency shall
692 take final agency action issue an immediate final order pursuant
693 to s. 120.569(2)(n).
694 (15) The agency shall seek a remedy provided by law,
695 including, but not limited to, any remedy provided in
696 subsections (13) and (16) and s. 812.035, if:
697 (a) The provider’s license has not been renewed, or has
698 been revoked, suspended, or terminated, for cause, by the
699 licensing agency of any state;
700 (b) The provider has failed to make available or has
701 refused access to Medicaid-related records to an auditor,
702 investigator, or other authorized employee or agent of the
703 agency, the Attorney General, a state attorney, or the Federal
704 Government;
705 (c) The provider has not furnished or has failed to make
706 available such Medicaid-related records as the agency has found
707 necessary to determine whether Medicaid payments are or were due
708 and the amounts thereof;
709 (d) The provider has failed to maintain medical records
710 made at the time of service, or prior to service if prior
711 authorization is required, demonstrating the necessity and
712 appropriateness of the goods or services rendered;
713 (e) The provider is not in compliance with provisions of
714 Medicaid provider publications that have been adopted by
715 reference as rules in the Florida Administrative Code; with
716 provisions of state or federal laws, rules, or regulations; with
717 provisions of the provider agreement between the agency and the
718 provider; or with certifications found on claim forms or on
719 transmittal forms for electronically submitted claims that are
720 submitted by the provider or authorized representative, as such
721 provisions apply to the Medicaid program;
722 (f) The provider or person who ordered, authorized, or
723 prescribed the care, services, or supplies has furnished, or
724 ordered, or authorized the furnishing of, goods or services to a
725 recipient which are inappropriate, unnecessary, excessive, or
726 harmful to the recipient or are of inferior quality;
727 (g) The provider has demonstrated a pattern of failure to
728 provide goods or services that are medically necessary;
729 (h) The provider or an authorized representative of the
730 provider, or a person who ordered, authorized, or prescribed the
731 goods or services, has submitted or caused to be submitted false
732 or a pattern of erroneous Medicaid claims;
733 (i) The provider or an authorized representative of the
734 provider, or a person who has ordered, authorized, or prescribed
735 the goods or services, has submitted or caused to be submitted a
736 Medicaid provider enrollment application, a request for prior
737 authorization for Medicaid services, a drug exception request,
738 or a Medicaid cost report that contains materially false or
739 incorrect information;
740 (j) The provider or an authorized representative of the
741 provider has collected from or billed a recipient or a
742 recipient’s responsible party improperly for amounts that should
743 not have been so collected or billed by reason of the provider’s
744 billing the Medicaid program for the same service;
745 (k) The provider or an authorized representative of the
746 provider has included in a cost report costs that are not
747 allowable under a Florida Title XIX reimbursement plan, after
748 the provider or authorized representative had been advised in an
749 audit exit conference or audit report that the costs were not
750 allowable;
751 (l) The provider is charged by information or indictment
752 with fraudulent billing practices or any offense referenced in
753 subsection (13). The sanction applied for this reason is limited
754 to suspension of the provider’s participation in the Medicaid
755 program for the duration of the indictment unless the provider
756 is found guilty pursuant to the information or indictment;
757 (m) The provider or a person who has ordered, authorized,
758 or prescribed the goods or services is found liable for
759 negligent practice resulting in death or injury to the
760 provider’s patient;
761 (n) The provider fails to demonstrate that it had available
762 during a specific audit or review period sufficient quantities
763 of goods, or sufficient time in the case of services, to support
764 the provider’s billings to the Medicaid program;
765 (o) The provider has failed to comply with the notice and
766 reporting requirements of s. 409.907;
767 (p) The agency has received reliable information of patient
768 abuse or neglect or of any act prohibited by s. 409.920; or
769 (q) The provider has failed to comply with an agreed-upon
770 repayment schedule.
771
772 A provider is subject to sanctions for violations of this
773 subsection as the result of actions or inactions of the
774 provider, or actions or inactions of any principal, officer,
775 director, agent, managing employee, or affiliated person of the
776 provider, or any partner or shareholder having an ownership
777 interest in the provider equal to 5 percent or greater, in which
778 the provider participated or acquiesced.
779 (16) The agency shall impose any of the following sanctions
780 or disincentives on a provider or a person for any of the acts
781 described in subsection (15):
782 (a) Suspension for a specific period of time of not more
783 than 1 year. Suspension precludes shall preclude participation
784 in the Medicaid program, which includes any action that results
785 in a claim for payment to the Medicaid program as a result of
786 furnishing, supervising a person who is furnishing, or causing a
787 person to furnish goods or services.
788 (b) Termination for a specific period of time of from more
789 than 1 year to 20 years. Termination precludes shall preclude
790 participation in the Medicaid program, which includes any action
791 that results in a claim for payment to the Medicaid program as a
792 result of furnishing, supervising a person who is furnishing, or
793 causing a person to furnish goods or services.
794 (c) Imposition of a fine of up to $5,000 for each
795 violation. Each day that an ongoing violation continues, such as
796 refusing to furnish Medicaid-related records or refusing access
797 to records, is considered, for the purposes of this section, to
798 be a separate violation. Each instance of improper billing of a
799 Medicaid recipient; each instance of including an unallowable
800 cost on a hospital or nursing home Medicaid cost report after
801 the provider or authorized representative has been advised in an
802 audit exit conference or previous audit report of the cost
803 unallowability; each instance of furnishing a Medicaid recipient
804 goods or professional services that are inappropriate or of
805 inferior quality as determined by competent peer judgment; each
806 instance of knowingly submitting a materially false or erroneous
807 Medicaid provider enrollment application, request for prior
808 authorization for Medicaid services, drug exception request, or
809 cost report; each instance of inappropriate prescribing of drugs
810 for a Medicaid recipient as determined by competent peer
811 judgment; and each false or erroneous Medicaid claim leading to
812 an overpayment to a provider is considered, for the purposes of
813 this section, to be a separate violation.
814 (d) Immediate suspension, if the agency has received
815 information of patient abuse or neglect or of any act prohibited
816 by s. 409.920. Upon suspension, the agency must issue an
817 immediate final order under s. 120.569(2)(n).
818 (e) A fine, not to exceed $10,000, for a violation of
819 paragraph (15)(i).
820 (f) Imposition of liens against provider assets, including,
821 but not limited to, financial assets and real property, not to
822 exceed the amount of fines or recoveries sought, upon entry of
823 an order determining that such moneys are due or recoverable.
824 (g) Prepayment reviews of claims for a specified period of
825 time.
826 (h) Comprehensive followup reviews of providers every 6
827 months to ensure that they are billing Medicaid correctly.
828 (i) Corrective-action plans that would remain in effect for
829 providers for up to 3 years and that are would be monitored by
830 the agency every 6 months while in effect.
831 (j) Other remedies as permitted by law to effect the
832 recovery of a fine or overpayment.
833
834 If a provider voluntarily relinquishes its Medicaid provider
835 number or an associated license, or allows the associated
836 licensure to expire after receiving written notice that the
837 agency is conducting, or has conducted, an audit, survey,
838 inspection, or investigation and that the sanction of suspension
839 or termination will be imposed for noncompliance discovered as a
840 result of the audit, survey, inspection, or investigation, the
841 agency shall impose the sanction of termination for cause
842 against the provider. The Secretary of Health Care
843 Administration may make a determination that imposition of a
844 sanction or disincentive is not in the best interest of the
845 Medicaid program, in which case a sanction or disincentive may
846 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. A provider may not present records to
867 contest an overpayment or sanction unless such records are
868 contemporaneous and, if requested during the audit process, were
869 furnished to the agency or its agent upon request or were
870 furnished within 30 days after the provider received the final
871 audit report. This limitation does not apply to Medicaid cost
872 report audits. Notwithstanding the applicable rules of
873 discovery, all documentation to that will be offered as evidence
874 at an administrative hearing on a Medicaid overpayment or an
875 administrative sanction must be exchanged by all parties at
876 least 14 days before the administrative hearing or must be
877 excluded from consideration.
878 (25)(a) The agency shall withhold Medicaid payments, in
879 whole or in part, to a provider upon receipt of reliable
880 evidence that the circumstances giving rise to the need for a
881 withholding of payments involve fraud, willful
882 misrepresentation, or abuse under the Medicaid program, or a
883 crime committed while rendering goods or services to Medicaid
884 recipients. If it is determined that fraud, willful
885 misrepresentation, abuse, or a crime did not occur, the payments
886 withheld must be paid to the provider within 14 days after such
887 determination with interest at the rate of 10 percent a year.
888 Any money withheld in accordance with this paragraph shall be
889 placed in a suspended account, readily accessible to the agency,
890 so that any payment ultimately due the provider shall be made
891 within 14 days.
892 (b) The agency shall deny payment, or require repayment, if
893 the goods or services were furnished, supervised, or caused to
894 be furnished by a person who has been suspended or terminated
895 from the Medicaid program or Medicare program by the Federal
896 Government or any state.
897 (c) Overpayments owed to the agency bear interest at the
898 rate of 10 percent per year from the date of determination of
899 the overpayment by the agency, and payment arrangements
900 regarding overpayments and fines must be made within 30 days
901 after the date of the final order and are not subject to further
902 appeal at the conclusion of legal proceedings. A provider who
903 does not enter into or adhere to an agreed-upon repayment
904 schedule may be terminated by the agency for nonpayment or
905 partial payment.
906 (d) The agency, upon entry of a final agency order, a
907 judgment or order of a court of competent jurisdiction, or a
908 stipulation or settlement, may collect the moneys owed by all
909 means allowable by law, including, but not limited to, notifying
910 any fiscal intermediary of Medicare benefits that the state has
911 a superior right of payment. Upon receipt of such written
912 notification, the Medicare fiscal intermediary shall remit to
913 the state the sum claimed.
914 (e) The agency may institute amnesty programs to allow
915 Medicaid providers the opportunity to voluntarily repay
916 overpayments. The agency may adopt rules to administer such
917 programs.
918 (28) Venue for all Medicaid program integrity overpayment
919 cases lies shall lie in Leon County, at the discretion of the
920 agency.
921 (29) Notwithstanding other provisions of law, the agency
922 and the Medicaid Fraud Control Unit of the Department of Legal
923 Affairs may review a person’s or provider’s Medicaid-related and
924 non-Medicaid-related records in order to determine the total
925 output of a provider’s practice to reconcile quantities of goods
926 or services billed to Medicaid with quantities of goods or
927 services used in the provider’s total practice.
928 (30) The agency shall terminate a provider’s participation
929 in the Medicaid program if the provider fails to reimburse an
930 overpayment or pay a fine that has been determined by final
931 order, not subject to further appeal, within 30 35 days after
932 the date of the final order, unless the provider and the agency
933 have entered into a repayment agreement.
934 (31) If a provider requests an administrative hearing
935 pursuant to chapter 120, such hearing must be conducted within
936 90 days following assignment of an administrative law judge,
937 absent exceptionally good cause shown as determined by the
938 administrative law judge or hearing officer. Upon issuance of a
939 final order, the outstanding balance of the amount determined to
940 constitute the overpayment and fines is shall become due. If a
941 provider fails to make payments in full, fails to enter into a
942 satisfactory repayment plan, or fails to comply with the terms
943 of a repayment plan or settlement agreement, the agency shall
944 withhold medical assistance reimbursement payments for Medicaid
945 services until the amount due is paid in full.
946 Section 7. Subsection (8) of section 409.920, Florida
947 Statutes, is amended to read:
948 409.920 Medicaid provider fraud.—
949 (8) A person who provides the state, any state agency, any
950 of the state’s political subdivisions, or any agency of the
951 state’s political subdivisions with information about fraud or
952 suspected fraudulent acts fraud by a Medicaid provider,
953 including a managed care organization, is immune from civil
954 liability for libel, slander, or any other relevant tort for
955 providing any the information about fraud or suspected
956 fraudulent acts, unless the person acted with knowledge that the
957 information was false or with reckless disregard for the truth
958 or falsity of the information. For purposes of this subsection,
959 the term “fraudulent acts” includes actual or suspected fraud,
960 abuse, or overpayment, including any fraud-related matters that
961 a provider or health plan is required to report to the agency or
962 a law enforcement agency. The immunity from civil liability
963 extends to reports of fraudulent acts conveyed to the agency in
964 any manner, including any forum and with any audience as
965 directed by the agency, and includes all discussions subsequent
966 to the report and subsequent inquiries from the agency, unless
967 the person acted with knowledge that the information was false
968 or with reckless disregard for the truth or falsity of the
969 information.
970 Section 8. Paragraph (c) of subsection (2) of section
971 409.967, Florida Statutes, is amended to read:
972 409.967 Managed care plan accountability.—
973 (2) The agency shall establish such contract requirements
974 as are necessary for the operation of the statewide managed care
975 program. In addition to any other provisions the agency may deem
976 necessary, the contract must require:
977 (c) Access.—
978 1. Providers.—The agency shall establish specific standards
979 for the number, type, and regional distribution of providers in
980 managed care plan networks to ensure access to care for both
981 adults and children. Each plan must maintain a regionwide
982 network of providers in sufficient numbers to meet the access
983 standards for specific medical services for all recipients
984 enrolled in the plan. The exclusive use of mail-order pharmacies
985 is may not be sufficient to meet network access standards.
986 Consistent with the standards established by the agency,
987 provider networks may include providers located outside the
988 region. A plan may contract with a new hospital facility before
989 the date the hospital becomes operational if the hospital has
990 commenced construction, will be licensed and operational by
991 January 1, 2013, and a final order has issued in any civil or
992 administrative challenge. Each plan shall establish and maintain
993 an accurate and complete electronic database of contracted
994 providers, including information about licensure or
995 registration, locations and hours of operation, specialty
996 credentials and other certifications, specific performance
997 indicators, and such other information as the agency deems
998 necessary. The database must be available online to both the
999 agency and the public and have the capability to compare the
1000 availability of providers to network adequacy standards and to
1001 accept and display feedback from each provider’s patients. Each
1002 plan shall submit quarterly reports to the agency identifying
1003 the number of enrollees assigned to each primary care provider.
1004 2. Prescribed drugs.—
1005 a. If establishing a prescribed drug formulary or preferred
1006 drug list, a managed care plan must:
1007 (I) Provide a broad range of therapeutic options for the
1008 treatment of disease states consistent with the general needs of
1009 an outpatient population. Whenever feasible, the formulary or
1010 preferred drug list should include at least two products in a
1011 therapeutic class;
1012 (II) Include coverage via prior authorization for each drug
1013 newly approved by the federal Food and Drug Administration until
1014 the plan’s Pharmaceutical and Therapeutics Committee reviews
1015 such drug for inclusion on the formulary. The timing of the
1016 formulary review must comply with s. 409.91195; and
1017 (III) Provide a response within 24 hours after receipt of
1018 all necessary information from the medical provider for a
1019 request for prior authorization and provide a procedure for
1020 escalating a delayed prior authorization request to the pharmacy
1021 management team for resolution or to override other medical
1022 management tools.
1023 b. Each managed care plan shall must publish any prescribed
1024 drug formulary or preferred drug list on the plan’s website in a
1025 manner that is accessible to and searchable by enrollees and
1026 providers. The plan must update the list within 24 hours after
1027 making a change. Each plan must ensure that the prior
1028 authorization process for prescribed drugs is readily accessible
1029 to health care providers, including posting appropriate contact
1030 information on its website and providing timely responses to
1031 providers.
1032 c. The managed care plan must continue to permit an
1033 enrollee who was receiving a prescription drug that was on the
1034 plan’s formulary and subsequently removed or changed to continue
1035 to receive that drug if the provider submits a written request
1036 that demonstrates that the drug is medically necessary, and the
1037 enrollee meets clinical criteria to receive the drug.
1038 d. A managed care plan that imposes a step-therapy or a
1039 fail-first protocol must do so in accordance with the following:
1040 (I) If prescribed drugs for the treatment of a medical
1041 condition are restricted for use by the plan through a step
1042 therapy or fail-first protocol, the plan must provide the
1043 prescriber with access to a clear and convenient process to
1044 expeditiously request a prior authorization that includes a
1045 procedure for escalation to the pharmacy management team if not
1046 resolved in a timely manner.
1047 (II) Escalation to the pharmacy management team must be
1048 expeditiously granted by the plan if the prescriber can submit
1049 appropriate and complete medical documentation to the plan that
1050 the preferred treatment required under the step-therapy or fail
1051 first protocol:
1052 (A) Has been ineffective in the treatment of the enrollee’s
1053 disease or medical condition;
1054 (B) Is reasonably expected to be ineffective based on the
1055 known relevant physical or mental characteristics and medical
1056 history of the enrollee and known characteristics of the drug
1057 regimen; or
1058 (C) Will cause or will likely cause an adverse reaction or
1059 other physical harm to the enrollee.
1060 (III) The pharmacy management team shall work directly with
1061 the medical provider to bring the prior-authorization request to
1062 a clinically appropriate, cost-effective, and timely resolution.
1063 e. For enrollees Medicaid recipients diagnosed with
1064 hemophilia who have been prescribed anti-hemophilic-factor
1065 replacement products, the agency shall provide for those
1066 products and hemophilia overlay services through the agency’s
1067 hemophilia disease management program.
1068 3. Prior authorization.—
1069 a. Each managed care plan must ensure that the prior
1070 authorization process for prescribed drugs is readily accessible
1071 to health care providers, including posting appropriate contact
1072 information on its website and providing timely responses to
1073 providers.
1074 b. If a drug, determined to be medically necessary and
1075 prescribed for an enrollee by a physician using sound clinical
1076 judgment, is subject to prior authorization and approved, the
1077 managed care plan must provide for sufficient refills to
1078 complete the duration of the prescription. If the medication is
1079 still clinically appropriate for ongoing therapy after the
1080 initial prior authorization expires, the plan must provide a
1081 process of expedited review to evaluate ongoing therapy.
1082 c. If a prescribed drug requires prior authorization, the
1083 managed care plan shall reimburse the pharmacist for dispensing
1084 a 72-hour supply of oral maintenance medications to the enrollee
1085 and process the prior authorization request. Dispensing a 72
1086 hour supply must be consistent with laws that govern pharmacy
1087 practice and controlled substances. The managed care plan shall
1088 process all prior authorization requests in as timely a manner
1089 as possible.
1090 d.3. Managed care plans, and their fiscal agents or
1091 intermediaries, must accept prior authorization requests for
1092 prescribed drugs any service electronically.
1093 Section 9. Subsection (11) is added to section 429.23,
1094 Florida Statutes, to read:
1095 429.23 Internal risk management and quality assurance
1096 program; adverse incidents and reporting requirements.—
1097 (11) The agency shall annually submit a report to the
1098 Legislature on adverse incident reports by assisted living
1099 facilities. The report must include the following information
1100 arranged by county:
1101 (a) A total number of adverse incidents;
1102 (b) A listing, by category, of the type of adverse
1103 incidents occurring within each category and the type of staff
1104 involved;
1105 (c) A listing, by category, of the types of injuries, if
1106 any, and the number of injuries occurring within each category;
1107 (d) Types of liability claims filed based on an adverse
1108 incident report or reportable injury; and
1109 (e) Disciplinary action taken against staff, categorized by
1110 the type of staff involved.
1111 Section 10. Present subsections (9), (10), and (11) of
1112 section 429.26, Florida Statutes, are renumbered as subsections
1113 (12), (13), and (14), respectively, and new subsections (9),
1114 (10), and (11) are added to that section, to read:
1115 429.26 Appropriateness of placements; examinations of
1116 residents.—
1117 (9) If, at any time after admission to a facility, agency
1118 personnel question whether a resident needs care beyond that
1119 which the facility is licensed to provide, the agency may
1120 require the resident to be physically examined by a licensed
1121 physician, licensed physician assistant, or certified nurse
1122 practitioner. To the extent possible, the examination must be
1123 performed by the resident’s preferred physician, physician
1124 assistant, or nurse practitioner and paid for by the resident
1125 with personal funds, except as provided in s. 429.18(2). This
1126 subsection does not preclude the agency from imposing sanctions
1127 for violations of subsection (1).
1128 (a) Following examination, the examining physician,
1129 physician assistant, or nurse practitioner shall complete and
1130 sign a medical form provided by the agency. The completed
1131 medical form must be submitted to the agency within 30 days
1132 after the date the facility owner or administrator was notified
1133 by the agency that a physical examination is required.
1134 (b) A medical review team designated by the agency shall
1135 determine whether the resident is appropriately residing in the
1136 facility based on the completed medical form and, if necessary,
1137 consultation with the physician, physician assistant, or nurse
1138 practitioner who performed the examination. Members of the
1139 medical review team making the determination may not include the
1140 agency personnel who initially questioned the appropriateness of
1141 the resident’s placement. The medical review team shall base its
1142 decision on a comprehensive review of the resident’s physical
1143 and functional status. A determination that the resident’s
1144 placement is not appropriate is final and binding upon the
1145 facility and the resident.
1146 (c) A resident who is determined by the medical review team
1147 to be inappropriately residing in a facility shall be given 30
1148 days’ written notice to relocate by the owner or administrator,
1149 unless the resident’s continued residence in the facility
1150 presents an imminent danger to the health, safety, or welfare of
1151 the resident or a substantial probability exists that death or
1152 serious physical harm to the resident would result if the
1153 resident is allowed to remain in the facility.
1154 (10) If a mental health resident appears to have needs in
1155 addition to those identified in the community living support
1156 plan, the agency may require an evaluation by a mental health
1157 professional, as determined by the Department of Children and
1158 Family Services.
1159 (11) A facility may not be required to retain a resident
1160 who requires more services or care than the facility is able to
1161 provide in accordance with its policies and criteria for
1162 admission and continued residency.
1163 Section 11. Effective July 1, 2012, section 456.0635,
1164 Florida Statutes, is amended to read:
1165 456.0635 Health care Medicaid fraud; disqualification for
1166 license, certificate, or registration.—
1167 (1) Health care Medicaid fraud in the practice of a health
1168 care profession is prohibited.
1169 (2) Each board under within the jurisdiction of the
1170 department, or the department if there is no board, shall refuse
1171 to admit a candidate to an any examination and refuse to issue
1172 or renew a license, certificate, or registration to an any
1173 applicant if the candidate or applicant or any principal,
1174 officer, agent, managing employee, or affiliated person of the
1175 applicant, has been:
1176 (a) Has been convicted of, or entered a plea of guilty or
1177 nolo contendere to, regardless of adjudication, a felony under
1178 chapter 409, chapter 817, or chapter 893, or a similar felony
1179 offense committed in another state or jurisdiction, unless the
1180 candidate or applicant has successfully completed a drug court
1181 program for that felony and provides proof that the plea has
1182 been withdrawn or the charges have been dismissed. Any such
1183 conviction or plea shall exclude the applicant or candidate from
1184 licensure, examination, certification, or registration 21 U.S.C.
1185 ss. 801-970, or 42 U.S.C. ss. 1395-1396, unless the sentence and
1186 any subsequent period of probation for such conviction or plea
1187 pleas ended: more than 15 years prior to the date of the
1188 application;
1189 1. For felonies of the first or second degree, more than 15
1190 years before the date of application.
1191 2. For felonies of the third degree, more than 10 years
1192 before the date of application, except for felonies of the third
1193 degree under s. 893.13(6)(a).
1194 3. For felonies of the third degree under s. 893.13(6)(a),
1195 more than 5 years before the date of application.
1196 (b) Has been convicted of, or entered a plea of guilty or
1197 nolo contendere to, regardless of adjudication, a felony under
1198 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396, unless the
1199 sentence and any subsequent period of probation for such
1200 conviction or plea ended more than 15 years before the date of
1201 the application.
1202 (c)(b) Has been terminated for cause from the Florida
1203 Medicaid program pursuant to s. 409.913, unless the candidate or
1204 applicant has been in good standing with the Florida Medicaid
1205 program for the most recent 5 years.;
1206 (d)(c) Has been terminated for cause, pursuant to the
1207 appeals procedures established by the state or Federal
1208 Government, from any other state Medicaid program or the federal
1209 Medicare program, unless the candidate or applicant has been in
1210 good standing with that a state Medicaid program or the federal
1211 Medicare program for the most recent 5 years and the termination
1212 occurred at least 20 years before prior to the date of the
1213 application.
1214 (e) Is currently listed on the United States Department of
1215 Health and Human Services Office of Inspector General’s List of
1216 Excluded Individuals and Entities.
1217
1218 This subsection does not apply to candidates or applicants for
1219 initial licensure or certification who were enrolled in an
1220 educational or training program on or before July 1, 2009, which
1221 was recognized by a board or, if there is no board, recognized
1222 by the department, and who applied for licensure after July 1,
1223 2012.
1224 (3) The department shall refuse to renew a license,
1225 certificate, or registration of any applicant if the applicant
1226 or any principal, officer, agent, managing employee, or
1227 affiliated person of the applicant:
1228 (a) Has been convicted of, or entered a plea of guilty or
1229 nolo contendere to, regardless of adjudication, a felony under
1230 chapter 409, chapter 817, or chapter 893, or a similar felony
1231 offense committed in another state or jurisdiction, unless the
1232 applicant is currently enrolled in a drug court program that
1233 allows the withdrawal of the plea for that felony upon
1234 successful completion of that program. Any such conviction or
1235 plea excludes the applicant or candidate from licensure,
1236 examination, certification, or registration unless the sentence
1237 and any subsequent period of probation for such conviction or
1238 plea ended:
1239 1. For felonies of the first or second degree, more than 15
1240 years before the date of application.
1241 2. For felonies of the third degree, more than 10 years
1242 before the date of application, except for felonies of the third
1243 degree under s. 893.13(6)(a).
1244 3. For felonies of the third degree under s. 893.13(6)(a),
1245 more than 5 years before the date of application.
1246 (b) Has been convicted of, or entered a plea of guilty or
1247 nolo contendere to, regardless of adjudication, a felony under
1248 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
1249 2009, unless the sentence and any subsequent period of probation
1250 for such conviction or plea ended more than 15 years before the
1251 date of the application.
1252 (c) Has been terminated for cause from the Florida Medicaid
1253 program pursuant to s. 409.913, unless the applicant has been in
1254 good standing with the Florida Medicaid program for the most
1255 recent 5 years.
1256 (d) Has been terminated for cause, pursuant to the appeals
1257 procedures established by the state, from any other state
1258 Medicaid program, unless the applicant has been in good standing
1259 with that state Medicaid program for the most recent 5 years and
1260 the termination occurred at least 20 years before the date of
1261 the application.
1262 (e) Is currently listed on the United States Department of
1263 Health and Human Services Office of Inspector General’s List of
1264 Excluded Individuals and Entities.
1265 (4)(3) Licensed health care practitioners shall report
1266 allegations of health care Medicaid fraud to the department,
1267 regardless of the practice setting in which the alleged health
1268 care Medicaid fraud occurred.
1269 (5)(4) The acceptance by a licensing authority of a
1270 licensee’s candidate’s relinquishment of a license which is
1271 offered in response to or anticipation of the filing of
1272 administrative charges alleging health care Medicaid fraud or
1273 similar charges constitutes the permanent revocation of the
1274 license.
1275 Section 12. Effective July 1, 2012, present subsections
1276 (14) and (15) of section 456.036, Florida Statutes, are
1277 renumbered as subsections (15) and (16), respectively, and a new
1278 subsection (14) is added to that section, to read:
1279 456.036 Licenses; active and inactive status; delinquency.—
1280 (14) A person who has been denied license renewal,
1281 certification, or registration under s. 456.0635(3) may regain
1282 licensure, certification, or registration only by meeting the
1283 qualifications and completing the application process for
1284 initial licensure as defined by the board, or the department if
1285 there is no board. However, a person who was denied renewal of
1286 licensure, certification, or registration under s. 24 of chapter
1287 2009-223, Laws of Florida, between July 1, 2009, and June 30,
1288 2012, is not required to retake and pass examinations applicable
1289 for initial licensure, certification, or registration.
1290 Section 13. Subsection (1) of section 456.074, Florida
1291 Statutes, is amended to read:
1292 456.074 Certain health care practitioners; immediate
1293 suspension of license.—
1294 (1) The department shall issue an emergency order
1295 suspending the license of any person licensed under chapter 458,
1296 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
1297 chapter 464, chapter 465, chapter 466, or chapter 484 who pleads
1298 guilty to, is convicted or found guilty of, or who enters a plea
1299 of nolo contendere to, regardless of adjudication, to:
1300 (a) A felony under chapter 409, chapter 817, or chapter 893
1301 or under 21 U.S.C. ss. 801-970 or under 42 U.S.C. ss. 1395-1396;
1302 or
1303 (b) A misdemeanor or felony under 18 U.S.C. s. 669, ss.
1304 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s.
1305 1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the
1306 Medicaid program.
1307 Section 14. Subsection (3) of section 458.309, Florida
1308 Statutes, is amended to read:
1309 458.309 Rulemaking authority.—
1310 (3) A physician All physicians who performs liposuction
1311 procedures in which more than 1,000 cubic centimeters of
1312 supernatant fat is removed, perform level 2 procedures lasting
1313 more than 5 minutes, and all level 3 surgical procedures in an
1314 office setting must register the office with the department
1315 unless that office is licensed as a facility under pursuant to
1316 chapter 395. The department shall inspect the physician’s office
1317 annually unless the office is accredited by a nationally
1318 recognized accrediting agency or an accrediting organization
1319 subsequently approved by the Board of Medicine. The actual costs
1320 for registration and inspection or accreditation shall be paid
1321 by the person seeking to register and operate the office setting
1322 in which office surgery is performed.
1323 Section 15. Subsection (2) of section 459.005, Florida
1324 Statutes, is amended to read:
1325 459.005 Rulemaking authority.—
1326 (2) A physician All physicians who performs liposuction
1327 procedures in which more than 1,000 cubic centimeters of
1328 supernatant fat is removed, perform level 2 procedures lasting
1329 more than 5 minutes, and all level 3 surgical procedures in an
1330 office setting must register the office with the department
1331 unless that office is licensed as a facility under pursuant to
1332 chapter 395. The department shall inspect the physician’s office
1333 annually unless the office is accredited by a nationally
1334 recognized accrediting agency or an accrediting organization
1335 subsequently approved by the Board of Osteopathic Medicine. The
1336 actual costs for registration and inspection or accreditation
1337 shall be paid by the person seeking to register and operate the
1338 office setting in which office surgery is performed.
1339 Section 16. Subsections (3), (4), and (5) of section
1340 463.002, Florida Statutes, are amended to read:
1341 463.002 Definitions.—As used in this chapter, the term:
1342 (3)(a) “Licensed practitioner” means a person who is a
1343 primary health care provider licensed to engage in the practice
1344 of optometry under the authority of this chapter.
1345 (b) A licensed practitioner who is not a certified
1346 optometrist shall be required to display at her or his place of
1347 practice a sign which states, “I am a Licensed Practitioner, not
1348 a Certified Optometrist, and I am not able to prescribe topical
1349 ocular pharmaceutical agents.”
1350 (c) All practitioners initially licensed after July 1,
1351 1993, must be certified optometrists.
1352 (4) “Certified optometrist” means a licensed practitioner
1353 authorized by the board to administer and prescribe topical
1354 ocular pharmaceutical agents.
1355 (5) “Optometry” means the diagnosis of conditions of the
1356 human eye and its appendages; the employment of any objective or
1357 subjective means or methods, including the administration of
1358 topical ocular pharmaceutical agents, for the purpose of
1359 determining the refractive powers of the human eyes, or any
1360 visual, muscular, neurological, or anatomic anomalies of the
1361 human eyes and their appendages; and the prescribing and
1362 employment of lenses, prisms, frames, mountings, contact lenses,
1363 orthoptic exercises, light frequencies, and any other means or
1364 methods, including topical ocular pharmaceutical agents, for the
1365 correction, remedy, or relief of any insufficiencies or abnormal
1366 conditions of the human eyes and their appendages.
1367 Section 17. Paragraph (g) of subsection (1) of section
1368 463.005, Florida Statutes, is amended to read:
1369 463.005 Authority of the board.—
1370 (1) The Board of Optometry has authority to adopt rules
1371 pursuant to ss. 120.536(1) and 120.54 to implement the
1372 provisions of this chapter conferring duties upon it. Such rules
1373 shall include, but not be limited to, rules relating to:
1374 (g) Administration and prescription of topical ocular
1375 pharmaceutical agents.
1376 Section 18. Section 463.0055, Florida Statutes, is amended
1377 to read:
1378 463.0055 Administration and prescription of topical ocular
1379 pharmaceutical agents; committee.—
1380 (1)(a) Certified optometrists may administer and prescribe
1381 topical ocular pharmaceutical agents as provided in this section
1382 for the diagnosis and treatment of ocular conditions of the
1383 human eye and its appendages without the use of surgery or other
1384 invasive techniques. However, a licensed practitioner who is not
1385 certified may use topically applied anesthetics solely for the
1386 purpose of glaucoma examinations, but is otherwise prohibited
1387 from administering or prescribing topical ocular pharmaceutical
1388 agents.
1389 (b) Before a certified optometrist may administer or
1390 prescribe oral ocular pharmaceutical agents, the certified
1391 optometrist must complete a course and subsequent examination on
1392 general and ocular pharmacology which have a particular emphasis
1393 on the ingestion of oral pharmaceutical agents and the side
1394 effects of those agents. For certified optometrists licensed
1395 before January 1, 1990, the course shall consist of 50 contact
1396 hours and 25 of those hours shall be Internet-based. For
1397 certified optometrists licensed on or after January 1, 1990, the
1398 course shall consist of 20 contact hours and 10 of those hours
1399 shall be Internet-based. The first course and examination shall
1400 be presented by January 1, 2013, and shall thereafter be
1401 administered at least annually. The Florida Medical Association
1402 and the Florida Optometric Association shall jointly develop and
1403 administer a course and examination for such purpose and jointly
1404 determine the site or sites for the course and examination.
1405 (2)(a) There is hereby created a committee composed of two
1406 certified optometrists licensed pursuant to this chapter,
1407 appointed by the Board of Optometry, two board-certified
1408 ophthalmologists licensed pursuant to chapter 458 or chapter
1409 459, appointed by the Board of Medicine, and one additional
1410 person with a doctorate degree in pharmacology who is not
1411 licensed pursuant to chapter 458, chapter 459, or this chapter,
1412 appointed by the State Surgeon General. The committee shall
1413 review requests for additions to, deletions from, or
1414 modifications of a formulary of topical ocular pharmaceutical
1415 agents for administration and prescription by certified
1416 optometrists and shall provide to the board advisory opinions
1417 and recommendations on such requests. The formulary of topical
1418 ocular pharmaceutical agents shall consist of those topical
1419 ocular pharmaceutical agents that are appropriate to treat and
1420 diagnose ocular diseases and disorders and that which the
1421 certified optometrist is qualified to use in the practice of
1422 optometry. The board shall establish, add to, delete from, or
1423 modify the formulary by rule. Notwithstanding any provision of
1424 chapter 120 to the contrary, the formulary rule shall become
1425 effective 60 days from the date it is filed with the Secretary
1426 of State.
1427 (b) The topical formulary may be added to, deleted from, or
1428 modified according to the procedure described in paragraph (a).
1429 Any person who requests an addition, deletion, or modification
1430 of an authorized topical ocular pharmaceutical agent shall have
1431 the burden of proof to show cause why such addition, deletion,
1432 or modification should be made.
1433 (c) The State Surgeon General shall have standing to
1434 challenge any rule or proposed rule of the board pursuant to s.
1435 120.56. In addition to challenges for any invalid exercise of
1436 delegated legislative authority, the administrative law judge,
1437 upon such a challenge by the State Surgeon General, may declare
1438 all or part of a rule or proposed rule invalid if it:
1439 1. Does not protect the public from any significant and
1440 discernible harm or damages;
1441 2. Unreasonably restricts competition or the availability
1442 of professional services in the state or in a significant part
1443 of the state; or
1444 3. Unnecessarily increases the cost of professional
1445 services without a corresponding or equivalent public benefit.
1446
1447 However, there shall not be created a presumption of the
1448 existence of any of the conditions cited in this subsection in
1449 the event that the rule or proposed rule is challenged.
1450 (d) Upon adoption of the topical formulary required by this
1451 section, and upon each addition, deletion, or modification to
1452 the topical formulary, the board shall mail a copy of the
1453 amended topical formulary to each certified optometrist and to
1454 each pharmacy licensed by the state.
1455 (3) In addition to the formulary of topical ocular
1456 pharmaceutical agents in subsection (2), a statutory formulary
1457 of oral pharmaceutical agents is established, which includes the
1458 following agents:
1459 (a) The following analgesics, or their generic or
1460 therapeutic equivalents, which may not be administered or
1461 prescribed for more than 72 hours:
1462 1. Tramadol hydrochloride.
1463 2. Acetaminophen 300 mg with No. 3 codeine phosphate 30 mg.
1464
1465 If any of the oral analgesic agents set forth in this paragraph
1466 are administered or prescribed, the certified optometrists must
1467 immediately notify the patient’s primary care physician or a
1468 physician licensed under chapter 458 or chapter 459 who is
1469 skilled in diseases of the eye.
1470 (b) The following antibiotics, or their generic or
1471 therapeutic equivalents:
1472 1. Amoxicillin.
1473 2. Azithromycin.
1474 3. Ciproflaxacin.
1475 4. Dicloxacillin.
1476 5. Doxycycline.
1477 6. Keflex.
1478 7. Minocycline.
1479 (c) The following antivirals, or their generic or
1480 therapeutic equivalents:
1481 1. Acyclovir.
1482 2. Famciclovir.
1483 3. Valacyclovir.
1484 (d) The following oral anti-glaucoma agents, or their
1485 generic or therapeutic equivalents, which may not be
1486 administered or prescribed for more than 72 hours:
1487 1. Acetazolamide.
1488 2. Methazolamide.
1489
1490 If any of the oral anti-glaucoma agents set forth in this
1491 paragraph are administered or prescribed, the certified
1492 optometrist must immediately notify the patient’s primary care
1493 physician or a physician licensed under chapter 458 or chapter
1494 459 who is skilled in diseases of the eye.
1495
1496 Any oral pharmaceutical agent listed in the statutory formulary
1497 set forth in this subsection which is subsequently determined by
1498 the United States Food and Drug Administration to be unsafe for
1499 administration or prescription shall be considered to have been
1500 deleted from the formulary of oral pharmaceutical agents. The
1501 oral pharmaceutical agents on the statutory formulary set forth
1502 in this subsection may not otherwise be deleted by the board,
1503 the department, or the State Surgeon General.
1504 (4)(3) A certified optometrist shall be issued a prescriber
1505 number by the board. Any prescription written by a certified
1506 optometrist for a topical ocular pharmaceutical agent pursuant
1507 to this section shall have the prescriber number printed
1508 thereon.
1509 Section 19. Subsection (3) of section 463.0057, Florida
1510 Statutes, is amended to read:
1511 463.0057 Optometric faculty certificate.—
1512 (3) The holder of a faculty certificate may engage in the
1513 practice of optometry as permitted by this section, but may not
1514 administer or prescribe topical ocular pharmaceutical agents
1515 unless the certificateholder has satisfied the requirements of
1516 ss. 463.0055(1)(b) and s. 463.006(1)(b)4. and 5.
1517 Section 20. Subsections (2) and (3) of section 463.006,
1518 Florida Statutes, are amended to read:
1519 463.006 Licensure and certification by examination.—
1520 (2) The examination shall consist of the appropriate
1521 subjects, including applicable state laws and rules and general
1522 and ocular pharmacology with emphasis on the use topical
1523 application and side effects of ocular pharmaceutical agents.
1524 The board may by rule substitute a national examination as part
1525 or all of the examination and may by rule offer a practical
1526 examination in addition to the written examination.
1527 (3) Each applicant who successfully passes the examination
1528 and otherwise meets the requirements of this chapter is entitled
1529 to be licensed as a practitioner and to be certified to
1530 administer and prescribe topical ocular pharmaceutical agents in
1531 the diagnosis and treatment of ocular conditions.
1532 Section 21. Subsections (1) and (2) of section 463.0135,
1533 Florida Statutes, are amended, and subsection (10) is added to
1534 that section, to read:
1535 463.0135 Standards of practice.—
1536 (1) A licensed practitioner shall provide that degree of
1537 care which conforms to that level of care provided by medical
1538 practitioners in the same or similar communities. A certified
1539 optometrist shall administer and prescribe oral ocular
1540 pharmaceutical agents in a manner consistent with applicable
1541 preferred practice patterns of the American Academy of
1542 Ophthalmology. A licensed practitioner shall advise or assist
1543 her or his patient in obtaining further care when the service of
1544 another health care practitioner is required.
1545 (2) A licensed practitioner diagnosing angle closure,
1546 neovascular, infantile, or congenital forms of glaucoma shall
1547 promptly and without unreasonable delay refer the patient to a
1548 physician skilled in diseases of the eye and licensed under
1549 chapter 458 or chapter 459. In addition, a licensed practitioner
1550 shall timely refer any patient who experiences progressive
1551 glaucoma due to failed pharmaceutical intervention to a
1552 physician who is skilled in diseases of the eye and licensed
1553 under chapter 458 or chapter 459.
1554 (10) Comanagement of postoperative care shall be conducted
1555 pursuant to an established protocol that governs the
1556 relationship between the operating surgeon and the optometrist.
1557 The patient shall be informed that either physician will be
1558 available for emergency care throughout the postoperative
1559 period, and the patient shall consent in writing to the
1560 comanagement relationship.
1561 Section 22. Subsections (3) and (4) of section 463.014,
1562 Florida Statutes, are amended to read:
1563 463.014 Certain acts prohibited.—
1564 (3) Prescribing, ordering, dispensing, administering,
1565 supplying, selling, or giving any systemic drugs for the purpose
1566 of treating a systemic disease by a licensed practitioner is
1567 prohibited. However, a certified optometrist is permitted to use
1568 commonly accepted means or methods to immediately address
1569 incidents of anaphylaxis.
1570 (4) Surgery of any kind, including the use of lasers, is
1571 expressly prohibited. For purposes of this subsection, the term
1572 “surgery” means a procedure using an instrument, including
1573 lasers, scalpels, or needles, in which human tissue is cut,
1574 burned, or vaporized by incision, injection, ultrasound, laser,
1575 or radiation. The term includes procedures using instruments
1576 that require closing by suturing, clamping, or another such
1577 device. Certified optometrists may remove superficial foreign
1578 bodies. For the purposes of this subsection, the term
1579 “superficial foreign bodies” means any foreign matter that is
1580 embedded in the conjunctiva or cornea but which has not
1581 penetrated the globe.
1582 Section 23. Section 463.0141, Florida Statutes, is created
1583 to read:
1584 463.0141 Reports of adverse incidents in the practice of
1585 optometry.—
1586 (1) Any adverse incident that occurs on or after January 1,
1587 2013, in the practice of optometry must be reported to the
1588 department in the accordance with this section.
1589 (2) The required notification to the department must be
1590 submitted in writing by certified mail and postmarked within 15
1591 days after the occurrence of the adverse incident.
1592 (3) For purposes of notification to the department, the
1593 term “adverse incident,” as used in this section, means an event
1594 that is associated in whole or in part with the prescribing of
1595 an oral ocular pharmaceutical agent and that results in one of
1596 the following:
1597 (a) Any condition that requires the transfer of a patient
1598 to a hospital licensed under chapter 395;
1599 (b) Any condition that requires the patient to obtain care
1600 from a physician licensed under chapter 458 or chapter 459,
1601 other than a referral or a consultation required under this
1602 chapter;
1603 (c) Permanent physical injury to the patient;
1604 (d) Partial or complete permanent loss of sight by the
1605 patient; or
1606 (e) Death of the patient.
1607 (4) The department shall review each incident and determine
1608 whether it potentially involved conduct by the licensed
1609 practitioner which may be subject to disciplinary action, in
1610 which case s. 456.073 applies. Disciplinary action, if any,
1611 shall be taken by the board.
1612 Section 24. Subsection (1) of section 483.035, Florida
1613 Statutes, is amended to read:
1614 483.035 Clinical laboratories operated by practitioners for
1615 exclusive use; licensure and regulation.—
1616 (1) A clinical laboratory operated by one or more
1617 practitioners licensed under chapter 458, chapter 459, chapter
1618 460, chapter 461, chapter 462, chapter 463, or chapter 466,
1619 exclusively in connection with the diagnosis and treatment of
1620 their own patients, must be licensed under this part and must
1621 comply with the provisions of this part, except that the agency
1622 shall adopt rules for staffing, for personnel, including
1623 education and training of personnel, for proficiency testing,
1624 and for construction standards relating to the licensure and
1625 operation of the laboratory based upon and not exceeding the
1626 same standards contained in the federal Clinical Laboratory
1627 Improvement Amendments of 1988 and the federal regulations
1628 adopted thereunder.
1629 Section 25. Subsection (7) of section 483.041, Florida
1630 Statutes, is amended to read:
1631 483.041 Definitions.—As used in this part, the term:
1632 (7) “Licensed practitioner” means a physician licensed
1633 under chapter 458, chapter 459, chapter 460, or chapter 461, or
1634 chapter 463; a dentist licensed under chapter 466; a person
1635 licensed under chapter 462; or an advanced registered nurse
1636 practitioner licensed under part I of chapter 464; or a duly
1637 licensed practitioner from another state licensed under similar
1638 statutes who orders examinations on materials or specimens for
1639 nonresidents of the State of Florida, but who reside in the same
1640 state as the requesting licensed practitioner.
1641 Section 26. Subsection (5) of section 483.181, Florida
1642 Statutes, is amended to read:
1643 483.181 Acceptance, collection, identification, and
1644 examination of specimens.—
1645 (5) A clinical laboratory licensed under this part must
1646 accept a human specimen submitted for examination by a
1647 practitioner licensed under chapter 458, chapter 459, chapter
1648 460, chapter 461, chapter 462, chapter 463, s. 464.012, or
1649 chapter 466, if the specimen and test are the type performed by
1650 the clinical laboratory. A clinical laboratory may only refuse a
1651 specimen based upon a history of nonpayment for services by the
1652 practitioner. A clinical laboratory shall not charge different
1653 prices for tests based upon the chapter under which a
1654 practitioner submitting a specimen for testing is licensed.
1655 Section 27. Paragraph (a) of subsection (54) of section
1656 499.003, Florida Statutes, is amended to read:
1657 499.003 Definitions of terms used in this part.—As used in
1658 this part, the term:
1659 (54) “Wholesale distribution” means distribution of
1660 prescription drugs to persons other than a consumer or patient,
1661 but does not include:
1662 (a) Any of the following activities, which is not a
1663 violation of s. 499.005(21) if such activity is conducted in
1664 accordance with s. 499.01(2)(g):
1665 1. The purchase or other acquisition by a hospital or other
1666 health care entity that is a member of a group purchasing
1667 organization of a prescription drug for its own use from the
1668 group purchasing organization or from other hospitals or health
1669 care entities that are members of that organization.
1670 2. The sale, purchase, or trade of a prescription drug or
1671 an offer to sell, purchase, or trade a prescription drug by a
1672 charitable organization described in s. 501(c)(3) of the
1673 Internal Revenue Code of 1986, as amended and revised, to a
1674 nonprofit affiliate of the organization to the extent otherwise
1675 permitted by law.
1676 3. The sale, purchase, or trade of a prescription drug or
1677 an offer to sell, purchase, or trade a prescription drug among
1678 hospitals or other health care entities that are under common
1679 control. For purposes of this subparagraph, “common control”
1680 means the power to direct or cause the direction of the
1681 management and policies of a person or an organization, whether
1682 by ownership of stock, by voting rights, by contract, or
1683 otherwise.
1684 4. The sale, purchase, trade, or other transfer of a
1685 prescription drug from or for any federal, state, or local
1686 government agency or any entity eligible to purchase
1687 prescription drugs at public health services prices pursuant to
1688 Pub. L. No. 102-585, s. 602 to a contract provider or its
1689 subcontractor for eligible patients of the agency or entity
1690 under the following conditions:
1691 a. The agency or entity must obtain written authorization
1692 for the sale, purchase, trade, or other transfer of a
1693 prescription drug under this subparagraph from the State Surgeon
1694 General or his or her designee.
1695 b. The contract provider or subcontractor must be
1696 authorized by law to administer or dispense prescription drugs.
1697 c. In the case of a subcontractor, the agency or entity
1698 must be a party to and execute the subcontract.
1699 d. A contract provider or subcontractor must maintain
1700 separate and apart from other prescription drug inventory any
1701 prescription drugs of the agency or entity in its possession.
1702 d.e. The contract provider and subcontractor must maintain
1703 and produce immediately for inspection all records of movement
1704 or transfer of all the prescription drugs belonging to the
1705 agency or entity, including, but not limited to, the records of
1706 receipt and disposition of prescription drugs. Each contractor
1707 and subcontractor dispensing or administering these drugs must
1708 maintain and produce records documenting the dispensing or
1709 administration. Records that are required to be maintained
1710 include, but are not limited to, a perpetual inventory itemizing
1711 drugs received and drugs dispensed by prescription number or
1712 administered by patient identifier, which must be submitted to
1713 the agency or entity quarterly.
1714 e.f. The contract provider or subcontractor may administer
1715 or dispense the prescription drugs only to the eligible patients
1716 of the agency or entity or must return the prescription drugs
1717 for or to the agency or entity. The contract provider or
1718 subcontractor must require proof from each person seeking to
1719 fill a prescription or obtain treatment that the person is an
1720 eligible patient of the agency or entity and must, at a minimum,
1721 maintain a copy of this proof as part of the records of the
1722 contractor or subcontractor required under sub-subparagraph e.
1723 f.g. In addition to the departmental inspection authority
1724 set forth in s. 499.051, the establishment of the contract
1725 provider and subcontractor and all records pertaining to
1726 prescription drugs subject to this subparagraph shall be subject
1727 to inspection by the agency or entity. All records relating to
1728 prescription drugs of a manufacturer under this subparagraph
1729 shall be subject to audit by the manufacturer of those drugs,
1730 without identifying individual patient information.
1731 Section 28. Subsection (4) of section 766.102, Florida
1732 Statutes, is amended to read:
1733 766.102 Medical negligence; standards of recovery; expert
1734 witness.—
1735 (4)(a) The Legislature is cognizant of the changing trends
1736 and techniques for the delivery of health care in this state and
1737 the discretion that is inherent in the diagnosis, care, and
1738 treatment of patients by different health care providers. The
1739 failure of a health care provider to order, perform, or
1740 administer supplemental diagnostic tests is shall not be
1741 actionable if the health care provider acted in good faith and
1742 with due regard for the prevailing professional standard of
1743 care.
1744 (b) The claimant has the burden of proving by clear and
1745 convincing evidence that the alleged actions of the health care
1746 provider represent a breach of the prevailing professional
1747 standard of care in an action for damages based on death or
1748 personal injury which alleges that the death or injury resulted
1749 from the failure of a health care provider to order, perform, or
1750 administer supplemental diagnostic tests.
1751 Section 29. Paragraph (b) of subsection (6) of section
1752 766.106, Florida Statutes, is amended to read:
1753 766.106 Notice before filing action for medical negligence;
1754 presuit screening period; offers for admission of liability and
1755 for arbitration; informal discovery; review.—
1756 (6) INFORMAL DISCOVERY.—
1757 (b) Informal discovery may be used by a party to obtain
1758 unsworn statements, the production of documents or things, and
1759 physical and mental examinations, and ex parte interviews, as
1760 follows:
1761 1. Unsworn statements.—Any party may require other parties
1762 to appear for the taking of an unsworn statement. Such
1763 statements may be used only for the purpose of presuit screening
1764 and are not discoverable or admissible in any civil action for
1765 any purpose by any party. A party desiring to take the unsworn
1766 statement of any party must give reasonable notice in writing to
1767 all parties. The notice must state the time and place for taking
1768 the statement and the name and address of the party to be
1769 examined. Unless otherwise impractical, the examination of any
1770 party must be done at the same time by all other parties. Any
1771 party may be represented by counsel at the taking of an unsworn
1772 statement. An unsworn statement may be recorded electronically,
1773 stenographically, or on videotape. The taking of unsworn
1774 statements is subject to the provisions of the Florida Rules of
1775 Civil Procedure and may be terminated for abuses.
1776 2. Documents or things.—Any party may request discovery of
1777 documents or things. The documents or things must be produced,
1778 at the expense of the requesting party, within 20 days after the
1779 date of receipt of the request. A party is required to produce
1780 discoverable documents or things within that party’s possession
1781 or control. Medical records shall be produced as provided in s.
1782 766.204.
1783 3. Physical and mental examinations.—A prospective
1784 defendant may require an injured claimant to appear for
1785 examination by an appropriate health care provider. The
1786 prospective defendant shall give reasonable notice in writing to
1787 all parties as to the time and place for examination. Unless
1788 otherwise impractical, a claimant is required to submit to only
1789 one examination on behalf of all potential defendants. The
1790 practicality of a single examination must be determined by the
1791 nature of the claimant’s condition, as it relates to the
1792 liability of each prospective defendant. Such examination report
1793 is available to the parties and their attorneys upon payment of
1794 the reasonable cost of reproduction and may be used only for the
1795 purpose of presuit screening. Otherwise, such examination report
1796 is confidential and exempt from the provisions of s. 119.07(1)
1797 and s. 24(a), Art. I of the State Constitution.
1798 4. Written questions.—Any party may request answers to
1799 written questions, the number of which may not exceed 30,
1800 including subparts. A response must be made within 20 days after
1801 receipt of the questions.
1802 5. Unsworn statements of treating health care providers.—A
1803 prospective defendant or his or her legal representative may
1804 also take unsworn statements of the claimant’s treating health
1805 care providers. The statements must be limited to those areas
1806 that are potentially relevant to the claim of personal injury or
1807 wrongful death. Subject to the procedural requirements of
1808 subparagraph 1., a prospective defendant may take unsworn
1809 statements from a claimant’s treating physicians. Reasonable
1810 notice and opportunity to be heard must be given to the claimant
1811 or the claimant’s legal representative before taking unsworn
1812 statements. The claimant or claimant’s legal representative has
1813 the right to attend the taking of such unsworn statements.
1814 6. Ex parte interviews of treating health care providers.—A
1815 prospective defendant or his or her legal representative may
1816 interview the claimant’s treating health care providers without
1817 the presence of the claimant or the claimant’s legal
1818 representative. If a prospective defendant or his or her legal
1819 representative intends to interview a claimant’s health care
1820 providers, the prospective defendant must provide the claimant
1821 with notice of such interview at least 10 days before the date
1822 of the interview.
1823 Section 30. Subsection (21) of section 893.02, Florida
1824 Statutes, is amended to read:
1825 893.02 Definitions.—The following words and phrases as used
1826 in this chapter shall have the following meanings, unless the
1827 context otherwise requires:
1828 (21) “Practitioner” means a physician licensed pursuant to
1829 chapter 458, a dentist licensed pursuant to chapter 466, a
1830 veterinarian licensed pursuant to chapter 474, an osteopathic
1831 physician licensed pursuant to chapter 459, a naturopath
1832 licensed pursuant to chapter 462, a certified optometrist
1833 licensed under chapter 463, or a podiatric physician licensed
1834 pursuant to chapter 461, provided such practitioner holds a
1835 valid federal controlled substance registry number.
1836 Section 31. Subsection (1) of section 893.05, Florida
1837 Statutes, is amended to read:
1838 893.05 Practitioners and persons administering controlled
1839 substances in their absence.—
1840 (1) A practitioner, in good faith and in the course of his
1841 or her professional practice only, may prescribe, administer,
1842 dispense, mix, or otherwise prepare a controlled substance, or
1843 the practitioner may cause the same to be administered by a
1844 licensed nurse or an intern practitioner under his or her
1845 direction and supervision only. A veterinarian may so prescribe,
1846 administer, dispense, mix, or prepare a controlled substance for
1847 use on animals only, and may cause it to be administered by an
1848 assistant or orderly under the veterinarian’s direction and
1849 supervision only. A certified optometrist licensed under chapter
1850 463 may not administer or prescribe pharmaceutical agents in
1851 Schedule I or Schedule II of the Florida Comprehensive Drug
1852 Abuse Prevention and Control Act.
1853 Section 32. The Agency for Health Care Administration shall
1854 prepare a report within 18 months after the implementation of an
1855 expansion of managed care to new populations or the provision of
1856 new items and services. The agency shall post a draft of the
1857 report on its website and provide an opportunity for public
1858 comment. The final report shall be submitted to the Legislature,
1859 along with a description of the process for public input. The
1860 report must include an assessment of:
1861 (1) The impact of managed care on patient access to care,
1862 including an evaluation of any new barriers to the use of
1863 services and prescription drugs, created by the use of medical
1864 management or cost-containment tools.
1865 (2) The impact of the increased managed care expansion on
1866 the utilization of services, quality of care, and patient
1867 outcomes.
1868 (3) The use of prior authorization and other utilization
1869 management tools, including an assessment of whether these tools
1870 pose an undue administrative burden for health care providers or
1871 create barriers to needed care.
1872 Section 33. If any provision of this act or its application
1873 to any person or circumstance is held invalid, the invalidity
1874 does not affect other provisions or applications of the act
1875 which can be given effect without the invalid provision or
1876 application, and to this end the provisions of this act are
1877 severable.
1878 Section 34. Except as otherwise expressly provided in this
1879 act, this act shall take effect upon becoming a law.