Bill Text: FL H1503 | 2010 | Regular Session | Engrossed


Bill Title: Health Care [SPSC]

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2010-04-30 - Died in Committee on Health Regulation, companion bill(s) passed, see HB 5311 (Ch. 2010-161), CS/CS/SB 1412 (Ch. 2010-102) [H1503 Detail]

Download: Florida-2010-H1503-Engrossed.html
CS/CS/HB 1503
1
A bill to be entitled
2An act relating to health care; amending s. 112.0455,
3F.S., and repealing paragraph (10)(e), relating to a
4prohibition against applying the Drug-Free Workplace Act
5retroactively; conforming a cross-reference; amending s.
6381.00315, F.S.; directing the Department of Health to
7accept funds from counties, municipalities, and certain
8other entities for the purchase of certain products made
9available under a contract with the United States
10Department of Health and Human Services for the
11manufacture and delivery of such products in response to a
12public health emergency; amending s. 381.932, F.S.;
13revising certain criteria of the breast cancer early
14detection and treatment referral program by requiring that
15the public education and outreach initiative and
16professional education programs use guidelines currently
17employed by the United States Centers for Disease Control
18and Prevention rather than the United States Preventive
19Services Task Force; amending s. 381.06015, F.S.;
20requiring the State Surgeon General to make certain
21resources and materials relating to umbilical cord blood
22available on the Internet website of the Department of
23Health; requiring the Department of Health to encourage
24certain health care professionals to make specified
25information available to patients; repealing s. 383.325,
26F.S., relating to the requirement of a licensed facility
27under s. 383.305, F.S., to maintain inspection reports;
28amending s. 395.1055, F.S., requiring Agency for Health
29Care Administration rules related to infection control to
30include a requirement that hospitals establish a
31comprehensive plan to reduce health care associated
32infections; establishing components for the plan;
33repealing s. 395.1046, F.S., relating to the investigation
34of complaints regarding hospitals; repealing s. 395.3037,
35F.S.; deleting definitions relating to obsolete provisions
36governing primary and comprehensive stroke centers;
37amending s. 400.0239, F.S.; deleting an obsolete
38provision; repealing s. 400.147(10), F.S., relating to a
39requirement that a nursing home facility report any notice
40of a filing of a claim for a violation of a resident's
41rights or a claim of negligence; repealing s. 400.148,
42F.S., relating to the Medicaid "Up-or-Out" Quality of Care
43Contract Management Program; repealing s. 400.195, F.S.,
44relating to reporting requirements for the Agency for
45Health Care Administration; amending s. 400.476, F.S.;
46providing requirements for an alternate administrator of a
47home health agency; revising the duties of the
48administrator; revising the requirements for a director of
49nursing for a specified number of home health agencies;
50prohibiting a home health agency from using an individual
51as a home health aide unless the person has completed
52training and an evaluation program; requiring a home
53health aide to meet certain standards in order to be
54competent in performing certain tasks; requiring a home
55health agency and staff to comply with accepted
56professional standards; providing certain requirements for
57a written contract between certain personnel and the
58agency; requiring a home health agency to provide certain
59services through its employees; authorizing a home health
60agency to provide additional services with another
61organization; providing responsibilities of a home health
62agency when it provides home health aide services through
63another organization; requiring the home health agency to
64coordinate personnel who provide home health services;
65requiring personnel to communicate with the home health
66agency; amending s. 400.487, F.S.; requiring a home health
67agency to provide a patient or the patient's legal
68representative a copy of the agreement between the agency
69and the patient which specifies the home health services
70to be provided; providing the rights that are protected by
71the home health agency; requiring the home health agency
72to furnish nursing services by or under the supervision of
73a registered nurse; requiring the home health agency to
74provide therapy services through a qualified therapist or
75therapy assistant; providing the duties and qualifications
76of a therapist and therapy assistant; requiring
77supervision by a physical therapist or occupational
78therapist of a physical therapist assistant or
79occupational therapy assistant; providing duties of a
80physical therapist assistant or occupational therapy
81assistant; providing for speech therapy services to be
82provided by a qualified speech-language pathologist or
83audiologist; providing for a plan of care; providing that
84only the staff of a home health agency may administer
85drugs and treatments as ordered by certain health
86professionals; providing requirements for verbal orders;
87providing duties of a registered nurse, licensed practical
88nurse, home health aide, and certified nursing assistant
89who work for a home health agency; providing for
90supervisory visits of services provided by a home health
91agency; amending s. 400.9905, F.S.; revising the
92definition of the term "clinic" applicable to the Health
93Care Clinic Act; providing exemptions from licensure
94requirements for certain legal entities that provide
95health care services; repealing s. 408.802(11), F.S.,
96relating to the applicability of the Health Care Licensing
97Procedures Act to private review agents; repealing s.
98409.912(15)(e), (f), and (g), F.S., relating to a
99requirement for the Agency for Health Care Administration
100to submit a report to the Legislature regarding the
101operations of the CARE program; repealing s. 409.9122(13),
102F.S., relating to Medicaid managed prepaid plan minimum
103enrollment levels for plans operating in Miami-Dade
104County; amending s. 409.91255, F.S.; transferring
105administrative responsibility for the application
106procedure for federally qualified health centers from the
107Department of Health to the Agency for Health Care
108Administration; requiring the Florida Association of
109Community Health Centers, Inc., to provide support and
110assume administrative costs for the program; amending s.
111429.075, F.S.; requiring certain assisted living
112facilities to maintain certain security services;
113repealing s. 429.12(2), F.S., relating to the sale or
114transfer of ownership of an assisted living facility;
115repealing s. 429.23(5), F.S., relating to each assisted
116living facility's requirement to submit a report to the
117agency regarding liability claims filed against it;
118repealing s. 429.911(2)(a), F.S., relating to an
119intentional or negligent act materially affecting the
120health or safety of center participants as grounds for
121which the agency may take action against the owner of an
122adult day care center or its operator or employee;
123requiring persons who apply for licensure renewal as a
124dentist or dental hygienist to furnish certain information
125to the Department of Health in a dental workforce survey;
126requiring the Board of Dentistry to issue a
127nondisciplinary citation and a notice for failure to
128complete the survey within a specified time; providing
129notification requirements for the citation; requiring the
130department to serve as the coordinating body for the
131purpose of collecting, disseminating, and updating dental
132workforce data; requiring the department to maintain a
133database regarding the state's dental workforce; requiring
134the department to develop strategies to maximize federal
135and state programs and to work with an advisory body to
136address matters relating to the state's dental workforce;
137providing membership of the advisory body; providing for
138members of the advisory body to serve without
139compensation; requiring the department to act as a
140clearinghouse for collecting and disseminating information
141regarding the dental workforce; requiring the department
142and the board to adopt rules; providing legislative intent
143regarding implementation of the act within existing
144resources; amending s. 499.01, F.S.; exempting certain
145persons from requirements for medical device manufacturer
146permits; authorizing certain business entities to pay for
147prescription drugs obtained by practitioners licensed
148under ch. 466, F.S.; amending s. 499.003, F.S.; defining
149the term "medical convenience kit" for purposes of the
150Florida Drug and Cosmetic Act; conforming cross-
151references; amending ss. 409.9201, 465.0265, 499.0121,
152499.01211, 499.03, 499.05, and 794.075, F.S.; conforming
153cross-references; amending s. 624.91, F.S.; revising the
154membership of the board of directors of the Florida
155Healthy Kids Corporation to include a member nominated by
156the Florida Dental Association and appointed by the
157Governor; amending s. 381.0403, F.S.; deleting provisions
158relating to the program for graduate medical education
159innovations and the graduate medical education committee
160and report; conforming cross-references; amending s.
161381.4018, F.S.; providing definitions; requiring the
162Department of Health to coordinate and enhance activities
163regarding the reentry of retired military and other
164physicians into the physician workforce; revising the list
165of governmental stakeholders that the department is
166required to work with regarding the state strategic plan
167and in assessing the state's physician workforce; creating
168the Physician Workforce Advisory Council; providing
169membership of the council; providing for appointments to
170the council; providing terms of membership; providing for
171removal of a council member; providing for a chair and
172vice chair of the council; providing that council members
173are not entitled to receive compensation or reimbursement
174for per diem or travel expenses; providing the duties of
175the council; establishing the physician workforce graduate
176medical education innovation pilot projects under the
177department; providing the purposes of the pilot projects;
178providing for the appropriation of state funds for the
179pilot projects; requiring the pilot projects to meet
180certain policy needs of the physician workforce in this
181state; providing criteria for prioritizing proposals for
182pilot projects; requiring the department to adopt by rule
183appropriate performance measures; requiring participating
184pilot projects to submit an annual report to the
185department; requiring state funds to be used to supplement
186funds from other sources; requiring the department to
187adopt rules; amending s. 400.9905, F.S.; revising the
188definition of the term "clinic"; amending ss. 458.3192 and
189459.0082, F.S.; requiring the department to determine by
190geographic area and specialty the number of physicians and
191osteopathic physicians who plan to relocate outside the
192state, practice medicine in this state, and reduce or
193modify the scope of their practice; authorizing the
194department to report additional information in its
195findings to the Governor and the Legislature; amending s.
196458.315, F.S.; revising the standards for the Board of
197Medicine to issue a temporary certificate to a certain
198physicians to practice medicine in areas of critical need;
199authorizing the State Surgeon General to designate areas
200of critical need; creating s. 459.0076, F.S.; authorizing
201the Board of Osteopathic Medicine to issue temporary
202certificates to osteopathic physicians who meet certain
203requirements to practice osteopathic medicine in areas of
204critical need; providing restrictions for issuance of a
205temporary certificate; authorizing the State Surgeon
206General to designate areas of critical need; authorizing
207the Board of Osteopathic Medicine to waive the application
208fee and licensure fees for obtaining temporary
209certificates for certain purposes; amending s. 499.01212,
210F.S.; exempting prescription drugs contained in sealed
211medical convenience kits from the pedigree paper
212requirements under specified circumstances; reenacting s.
213465.0251, F.S., to require the Board of Pharmacy and the
214Board of Medicine to remove certain drugs from the
215negative formulary for generic and brand-name drugs based
216on current references published by the United States Food
217and Drug Administration; amending s. 626.9541, F.S.;
218authorizing an insurer offering a group or individual
219health benefit plan to offer a wellness program;
220authorizing rewards or incentives; providing that such
221rewards or incentives are not insurance benefits;
222providing for verification of a member's inability to
223participate for medical reasons; providing an effective
224date.
225
226Be It Enacted by the Legislature of the State of Florida:
227
228 Section 1. Paragraph (e) of subsection (10) of section
229112.0455, Florida Statutes, is repealed, and paragraph (e) of
230subsection (14) of that section is amended to read:
231 112.0455 Drug-Free Workplace Act.-
232 (14) DISCIPLINE REMEDIES.-
233 (e) Upon resolving an appeal filed pursuant to paragraph
234(c), and finding a violation of this section, the commission may
235order the following relief:
236 1. Rescind the disciplinary action, expunge related
237records from the personnel file of the employee or job applicant
238and reinstate the employee.
239 2. Order compliance with paragraph (10)(f)(g).
240 3. Award back pay and benefits.
241 4. Award the prevailing employee or job applicant the
242necessary costs of the appeal, reasonable attorney's fees, and
243expert witness fees.
244 Section 2. Subsection (3) is added to section 381.00315,
245Florida Statutes, to read:
246 381.00315 Public health advisories; public health
247emergencies.-The State Health Officer is responsible for
248declaring public health emergencies and issuing public health
249advisories.
250 (3) To facilitate effective emergency management, when the
251United States Department of Health and Human Services contracts
252for the manufacture and delivery of licensable products in
253response to a public health emergency and the terms of those
254contracts are made available to the states, the department shall
255accept funds provided by cities, counties, and other entities
256designated in the state emergency management plan required under
257s. 252.35(2)(a) for the purpose of participation in those
258contracts. The department shall deposit those funds in the
259Grants and Donations Trust Fund and expend those funds on behalf
260of the donor city, county, or other entity for the purchase of
261the licensable products made available under the contract.
262 Section 3. Paragraphs (a) and (b) of subsection (3) of
263section 381.932, Florida Statutes, are amended to read:
264 381.932 Breast cancer early detection and treatment
265referral program.-
266 (3) The program shall include, but not be limited to, the:
267 (a) Establishment of a public education and outreach
268initiative to publicize breast cancer early detection services,
269the benefits of early detection of breast cancer, and the
270recommended frequency for receiving screening services,
271including clinical breast examinations and mammography
272guidelines currently employed established by the United States
273Centers for Disease Control and Prevention Preventive Services
274Task Force.
275 (b) Development of professional education programs that
276include information regarding the benefits of the early
277detection of breast cancer and the recommended frequency for
278receiving a mammogram, as recommended in the most current breast
279cancer screening guidelines currently employed established by
280the United States Centers for Disease Control and Prevention
281Preventive Services Task Force.
282 Section 4. Subsection (2) of section 381.06015, Florida
283Statutes, is amended, and subsection (8) is added to that
284section, to read:
285 381.06015 Public Cord Blood Tissue Bank.-
286 (2)(a) The Agency for Health Care Administration and the
287Department of Health shall encourage health care providers,
288including, but not limited to, hospitals, birthing facilities,
289county health departments, physicians, midwives, and nurses, to
290disseminate information about the Public Cord Blood Tissue Bank.
291 (b) The State Surgeon General shall make publicly
292available, by posting on the Internet website of the Department
293of Health, resources and an Internet website link to materials
294relating to umbilical cord blood that have been developed by the
295Parent's Guide to Cord Blood Foundation.
296 (8) Beginning October 1, 2010, the Department of Health
297shall encourage health care professionals who provide health
298care services that are directly related to a woman's pregnancy
299to make available to the patient before her third trimester of
300pregnancy, or, if later, at the first visit of such pregnant
301woman to the provider, information developed under paragraph
302(2)(b) relating to the woman's options with respect to umbilical
303cord blood banking.
304 Section 5. Section 383.325, Florida Statutes, is repealed.
305 Section 6. Paragraph (b) of subsection (1) of section
306395.1055, Florida Statutes, is amended to read:
307 395.1055 Rules and enforcement.-
308 (1) The agency shall adopt rules pursuant to ss.
309120.536(1) and 120.54 to implement the provisions of this part,
310which shall include reasonable and fair minimum standards for
311ensuring that:
312 (b) Infection control, housekeeping, sanitary conditions,
313and medical record procedures that will adequately protect
314patient care and safety are established and implemented.
315Infection control rules shall include a requirement to establish
316and implement a comprehensive plan to reduce health care
317associated infections. The plan must include all of the
318following components:
319 1. A baseline measurement of health care associated
320infections in the hospital that uses the National Healthcare
321Safety Network and Centers for Disease Control and Prevention
322surveillance definitions and reports the number of infections in
323each category relative to the volume of possible cases in the
324hospital.
325 2. A goal for reducing the incidence of infections by a
326specific amount within a defined period of time. The hospital's
327goal for reduction of infections must be commensurate with the
328national goal for reducing each type of health care associated
329infection.
330 3. An action plan for reducing each type of health care
331associated infection, including the use of real-time infection
332surveillance technology or automated infection control or
333prevention technology.
334 4. Methods for making information available to patients
335and the public regarding baseline measurements and periodic
336reports on the hospital's progress in improving measures
337designed to reduce health care associated infections.
338 Section 7. Section 395.1046, Florida Statutes, is
339repealed.
340 Section 8. Section 395.3037, Florida Statutes, is
341repealed.
342 Section 9. Paragraph (g) of subsection (2) of section
343400.0239, Florida Statutes, is amended to read:
344 400.0239 Quality of Long-Term Care Facility Improvement
345Trust Fund.-
346 (2) Expenditures from the trust fund shall be allowable
347for direct support of the following:
348 (g) Other initiatives authorized by the Centers for
349Medicare and Medicaid Services for the use of federal civil
350monetary penalties, including projects recommended through the
351Medicaid "Up-or-Out" Quality of Care Contract Management Program
352pursuant to s. 400.148.
353 Section 10. Subsection (10) of section 400.147, Florida
354Statutes, is repealed.
355 Section 11. Section 400.148, Florida Statutes, is
356repealed.
357 Section 12. Section 400.195, Florida Statutes, is
358repealed.
359 Section 13. Section 400.476, Florida Statutes, is amended
360to read:
361 400.476 Staffing requirements; notifications; limitations
362on staffing services.-
363 (1) ADMINISTRATOR.-
364 (a) An administrator may manage only one home health
365agency, except that an administrator may manage up to five home
366health agencies if all five home health agencies have identical
367controlling interests as defined in s. 408.803 and are located
368within one agency geographic service area or within an
369immediately contiguous county. If the home health agency is
370licensed under this chapter and is part of a retirement
371community that provides multiple levels of care, an employee of
372the retirement community may administer the home health agency
373and up to a maximum of four entities licensed under this chapter
374or chapter 429 which all have identical controlling interests as
375defined in s. 408.803. An administrator shall designate, in
376writing, for each licensed entity, a qualified alternate
377administrator to serve during the administrator's absence. An
378alternate administrator must meet the requirements in this
379paragraph and s. 400.462(1).
380 (b) An administrator of a home health agency who is a
381licensed physician, physician assistant, or registered nurse
382licensed to practice in this state may also be the director of
383nursing for a home health agency. An administrator may serve as
384a director of nursing for up to the number of entities
385authorized in subsection (2) only if there are 10 or fewer full-
386time equivalent employees and contracted personnel in each home
387health agency.
388 (c) The administrator shall organize and direct the
389agency's ongoing functions, maintain an ongoing liaison with the
390board members and the staff, employ qualified personnel and
391ensure adequate staff education and evaluations, ensure the
392accuracy of public informational materials and activities,
393implement an effective budgeting and accounting system, and
394ensure that the home health agency operates in compliance with
395this part and part II of chapter 408 and rules adopted for these
396laws.
397 (d) The administrator shall clearly set forth in writing
398the organizational chart, services furnished, administrative
399control authority, and lines of authority for the delegation of
400responsibilities for patient care. These responsibilities must
401be readily identifiable. Administrative and supervisory
402functions may not be delegated to another agency or
403organization, and the primary home health agency shall monitor
404and control all services that are not furnished directly,
405including services provided through contracts.
406 (2) DIRECTOR OF NURSING.-
407 (a) A director of nursing may be the director of nursing
408for:
409 1. Up to two licensed home health agencies if the agencies
410have identical controlling interests as defined in s. 408.803
411and are located within one agency geographic service area or
412within an immediately contiguous county; or
413 2. Up to five licensed home health agencies if:
414 a. All of the home health agencies have identical
415controlling interests as defined in s. 408.803;
416 b. All of the home health agencies are located within one
417agency geographic service area or within an immediately
418contiguous county; and
419 c. Each home health agency has a registered nurse who
420meets the qualifications of a director of nursing and who has a
421written delegation from the director of nursing to serve as the
422director of nursing for that home health agency when the
423director of nursing is not present; and.
424 d. This person, or a similarly qualified alternate, is
425available at all times by telecommunications during operating
426hours and participates.
427
428If a home health agency licensed under this chapter is part of a
429retirement community that provides multiple levels of care, an
430employee of the retirement community may serve as the director
431of nursing of the home health agency and up to a maximum of four
432entities, other than home health agencies, licensed under this
433chapter or chapter 429 which all have identical controlling
434interests as defined in s. 408.803.
435 (b) A home health agency that provides skilled nursing
436care may not operate for more than 30 calendar days without a
437director of nursing. A home health agency that provides skilled
438nursing care and the director of nursing of a home health agency
439must notify the agency within 10 business days after termination
440of the services of the director of nursing for the home health
441agency. A home health agency that provides skilled nursing care
442must notify the agency of the identity and qualifications of the
443new director of nursing within 10 days after the new director is
444hired. If a home health agency that provides skilled nursing
445care operates for more than 30 calendar days without a director
446of nursing, the home health agency commits a class II
447deficiency. In addition to the fine for a class II deficiency,
448the agency may issue a moratorium in accordance with s. 408.814
449or revoke the license. The agency shall fine a home health
450agency that fails to notify the agency as required in this
451paragraph $1,000 for the first violation and $2,000 for a repeat
452violation. The agency may not take administrative action against
453a home health agency if the director of nursing fails to notify
454the department upon termination of services as the director of
455nursing for the home health agency.
456 (c) A home health agency that is not Medicare or Medicaid
457certified and does not provide skilled care or provides only
458physical, occupational, or speech therapy is not required to
459have a director of nursing and is exempt from paragraph (b).
460 (3) TRAINING.-A home health agency shall ensure that each
461certified nursing assistant employed by or under contract with
462the home health agency and each home health aide employed by or
463under contract with the home health agency is adequately trained
464to perform the tasks of a home health aide in the home setting.
465 (a) The home health agency may not use as a home health
466aide on a full-time, temporary, per diem, or other basis any
467individual to provide services unless the individual has
468completed a training and competency evaluation program, or a
469competency evaluation program, as permitted in s. 400.497, which
470meets the minimum standards established by the agency in state
471rules.
472 (b) A home health aide is not competent in any task for
473which he or she is evaluated as "unsatisfactory." The aide must
474perform any such task only under direct supervision by a
475licensed nurse until he or she receives training in the task and
476satisfactorily passes a subsequent evaluation in performing the
477task. A home health aide has not successfully passed a
478competency evaluation if the aide does not have a passing score
479on the test as specified by agency rule.
480 (4) STAFFING.-Staffing services may be provided anywhere
481within the state.
482 (5) PERSONNEL.-
483 (a) The home health agency and its staff must comply with
484accepted professional standards and principles that apply to
485professionals, including, but not limited to, the state practice
486acts and the home health agency's policies and procedures.
487 (b) Except for direct employees of the home health agency,
488if personnel under hourly or per-visit contracts are used by the
489home health agency, there must be a written contract between
490those personnel and the agency which specifies the following
491requirements:
492 1. Acceptance for care only of patients by the primary
493home health agency.
494 2. The services to be furnished.
495 3. The necessity to conform to all applicable agency
496policies, including personnel qualifications.
497 4. The responsibility for participating in developing
498plans of care.
499 5. The manner in which services are controlled,
500coordinated, and evaluated by the primary home health agency.
501 6. The procedures for submitting clinical and progress
502notes, scheduling visits, and providing periodic patient
503evaluations.
504 7. The procedures for payment for services furnished under
505the contract.
506 (c) A home health agency shall directly provide at least
507one of the types of authorized services through home health
508agency employees, but may provide additional services under
509arrangements with another agency or organization. Services
510furnished under such arrangements must have a written contract
511conforming to the requirements specified in paragraph (b).
512 (d) If home health aide services are provided by an
513individual who is not employed directly by the home health
514agency, the services of the home health aide must be provided
515under arrangements as stated in paragraphs (b) and (c). If the
516home health agency chooses to provide home health aide services
517under arrangements with another organization, the
518responsibilities of the home health agency include, but are not
519limited to:
520 1. Ensuring the overall quality of the care provided by
521the aide.
522 2. Supervising the aide's services as described in s.
523400.487.
524 3. Ensuring that each home health aide providing services
525under arrangements with another organization has met the
526training requirements or competency evaluation requirements of
527s. 400.497.
528 (e) The home health agency shall coordinate the efforts of
529all personnel furnishing services, and the personnel shall
530maintain communication with the home health agency to ensure
531that personnel efforts support the objectives outlined in the
532plan of care. The clinical record or minutes of case conferences
533shall ensure that effective interchange, reporting, and
534coordination of patient care occurs.
535 Section 14. Section 400.487, Florida Statutes, is amended
536to read:
537 400.487 Home health service agreements; physician's,
538physician assistant's, and advanced registered nurse
539practitioner's treatment orders; patient assessment;
540establishment and review of plan of care; provision of services;
541orders not to resuscitate.-
542 (1) Services provided by a home health agency must be
543covered by an agreement between the home health agency and the
544patient or the patient's legal representative specifying the
545home health services to be provided, the rates or charges for
546services paid with private funds, and the sources of payment,
547which may include Medicare, Medicaid, private insurance,
548personal funds, or a combination thereof. The home health agency
549shall provide a copy of the agreement to the patient or the
550patient's legal representative. A home health agency providing
551skilled care must make an assessment of the patient's needs
552within 48 hours after the start of services.
553 (2) When required by the provisions of chapter 464; part
554I, part III, or part V of chapter 468; or chapter 486, the
555attending physician, physician assistant, or advanced registered
556nurse practitioner, acting within his or her respective scope of
557practice, shall establish treatment orders for a patient who is
558to receive skilled care. The treatment orders must be signed by
559the physician, physician assistant, or advanced registered nurse
560practitioner before a claim for payment for the skilled services
561is submitted by the home health agency. If the claim is
562submitted to a managed care organization, the treatment orders
563must be signed within the time allowed under the provider
564agreement. The treatment orders shall be reviewed, as frequently
565as the patient's illness requires, by the physician, physician
566assistant, or advanced registered nurse practitioner in
567consultation with the home health agency.
568 (3) A home health agency shall arrange for supervisory
569visits by a registered nurse to the home of a patient receiving
570home health aide services as specified in subsection (9) in
571accordance with the patient's direction, approval, and agreement
572to pay the charge for the visits.
573 (4) The home health agency shall protect and promote the
574rights of each individual under its care, including each of the
575following rights:
576 (a) Notice of rights.-The home health agency shall provide
577the patient with a written notice of the patient's rights in
578advance of furnishing care to the patient or during the initial
579evaluation visit before the initiation of treatment. The home
580health agency must maintain documentation showing that it has
581complied with the requirements of this section.
582 (b) Exercise of rights and respect for property and
583person.-
584 1. The patient has the right to exercise his or her rights
585as a patient of the home health agency.
586 2. The patient has the right to have his or her property
587treated with respect.
588 3. The patient has the right to voice grievances regarding
589treatment or care that is or fails to be furnished, or regarding
590the lack of respect for property by anyone who is furnishing
591services on behalf of the home health agency, and not be
592subjected to discrimination or reprisal for doing so.
593 4. The home health agency must investigate complaints made
594by a patient or the patient's family or guardian regarding
595treatment or care that is or fails to be furnished or regarding
596the lack of respect for the patient's property by anyone
597furnishing services on behalf of the home health agency. The
598home health agency shall document the existence of the complaint
599and its resolution.
600 5. The patient and his or her immediate family or
601representative must be informed of the right to report
602complaints via the statewide toll-free telephone number to the
603agency as required in s. 408.810.
604 (c) Right to be informed and to participate in planning
605care and treatment.-
606 1. The patient has the right to be informed, in advance,
607about the care to be furnished and of any changes in the care to
608be furnished. The home health agency shall advise the patient in
609advance of which disciplines will furnish care and the frequency
610of visits proposed to be furnished. The home health agency must
611advise the patient in advance of any change in the plan of care
612before the change is made.
613 2. The patient has the right to participate in the
614planning of the care. The home health agency must advise the
615patient in advance of the right to participate in planning the
616care or treatment and in planning changes in the care or
617treatment. Each patient has the right to be informed of and to
618participate in the planning of his or her care. Each patient
619must be provided, upon request, a copy of the plan of care
620established and maintained for that patient by the home health
621agency.
622 (5) When nursing services are ordered, the home health
623agency to which a patient has been admitted for care must
624provide the initial admission visit, all service evaluation
625visits, and the discharge visit by a direct employee. Services
626provided by others under contractual arrangements to a home
627health agency must be monitored and managed by the admitting
628home health agency. The admitting home health agency is fully
629responsible for ensuring that all care provided through its
630employees or contract staff is delivered in accordance with this
631part and applicable rules.
632 (6) The skilled care services provided by a home health
633agency, directly or under contract, must be supervised and
634coordinated in accordance with the plan of care. The home health
635agency shall furnish skilled nursing services by or under the
636supervision of a registered nurse and in accordance with the
637plan of care. Any therapy services offered directly or under
638arrangement by the home health agency must be provided by a
639qualified therapist or by a qualified therapy assistant under
640the supervision of a qualified therapist and in accordance with
641the plan of care.
642 (a) Physical therapy services.-Physical therapy services
643shall be furnished only by or under the supervision of a
644licensed physical therapist or licensed physical therapist
645assistant as required under chapter 486 and related applicable
646rules. A physical therapist assistant shall perform services
647planned, delegated, and supervised by the physical therapist,
648assist in preparing clinical notes and progress reports,
649participate in educating the patient and his or her family, and
650participate in in-service programs. This paragraph does not
651limit the services provided by a physician licensed under
652chapter 458 or chapter 459.
653 (b) Occupational therapy services.-Occupational therapy
654services shall be furnished only by or under the supervision of
655a licensed occupational therapist or occupational therapy
656assistant as provided under part III of chapter 468 and related
657applicable rules. An occupational therapy assistant shall
658perform any services planned, delegated, and supervised by an
659occupational therapist, assist in preparing clinical notes and
660progress reports, participate in educating the patient and his
661or her family, and participate in in-service programs. This
662paragraph does not limit the services provided by a physician
663licensed under chapter 458 or chapter 459.
664 (c) Speech therapy services.-Speech therapy services shall
665be furnished only by or under supervision of a qualified speech-
666language pathologist or audiologist as required in part I of
667chapter 468 and applicable rules.
668 (d) Care follows a written plan of care.-The plan of care
669shall be reviewed by the physician or health professional who
670provided the treatment orders pursuant to subsection (2) and
671home health agency personnel as often as the severity of the
672patient's condition requires, but at least once every 60 days or
673more when there is a patient-elected transfer, a significant
674change in condition, or a discharge and return to the same home
675health agency during the 60-day episode. Professional staff of a
676home health agency shall promptly alert the physician or other
677health professional who provided the treatment orders of any
678change that suggests a need to alter the plan of care.
679 (e) Administration of drugs and treatment.-Only
680professional staff of a home health agency may administer drugs
681and treatments as ordered by the physician or health
682professional pursuant to subsection (2), with the exception of
683influenza and pneumococcal polysaccharide vaccines, which may be
684administered according to the policy of the home health agency
685developed in consultation with a physician and after an
686assessment for contraindications. Verbal orders shall be in
687writing and signed and dated with the date of receipt by the
688registered nurse or qualified therapist who is responsible for
689furnishing or supervising the ordered service. A verbal order
690may be accepted only by personnel who are authorized to do so by
691applicable state laws, rules, and internal policies of the home
692health agency.
693 (7) A registered nurse shall conduct the initial
694evaluation visit, regularly reevaluate the patient's nursing
695needs, initiate the plan of care and necessary revisions,
696furnish those services requiring substantial and specialized
697nursing skill, initiate appropriate preventive and
698rehabilitative nursing procedures, prepare clinical and progress
699notes, coordinate services, inform the physician and other
700personnel of changes in the patient's condition and needs,
701counsel the patient and his or her family in meeting nursing and
702related needs, participate in in-service programs, and supervise
703and teach other nursing personnel, unless the home health agency
704providing the home health aide services is not Medicare-
705certified or Medicaid-certified and does not provide skilled
706care or the patient is not receiving skilled care.
707 (8) A licensed practical nurse shall furnish services in
708accordance with agency policies, prepare clinical and progress
709notes, assist the physician and registered nurse in performing
710specialized procedures, prepare equipment and materials for
711treatments observing aseptic technique as required, and assist
712the patient in learning appropriate self-care techniques.
713 (9) A home health aide and certified nursing assistant
714shall provide services that are in the service provision plan
715provided in s. 400.491 and other services that the home health
716aide or certified nursing assistant is permitted to perform
717under state law. The duties of a home health aide or certified
718nursing assistant include the provision of hands-on personal
719care, performance of simple procedures as an extension of
720therapy or nursing services, assistance in ambulation or
721exercises, and assistance in administering medications that are
722ordinarily self-administered and are specified in agency rules.
723Any services by a home health aide which are offered by a home
724health agency must be provided by a qualified home health aide
725or certified nursing assistant.
726 (a) Assignment and duties.-A home health aide or certified
727nursing assistant shall be assigned to a specific patient by a
728registered nurse, unless the home health agency providing the
729home health aide services is not Medicare-certified or Medicaid-
730certified and does not provide skilled care or the patient is
731not receiving skilled care. Written patient care instructions
732for the home health aide and certified nursing assistant must be
733prepared by the registered nurse or other appropriate
734professional who is responsible for the supervision of the home
735health aide and certified nursing assistant as stated in this
736section.
737 (b) Supervision.-If a patient receives skilled nursing
738care, the registered nurse shall perform the supervisory visit.
739If the patient is not receiving skilled nursing care but is
740receiving physical therapy, occupational therapy, or speech-
741language pathology services, the appropriate therapist may
742provide the supervision. A registered nurse or other
743professional must make an onsite visit to the patient's home at
744least once every 2 weeks. The visit is not required while the
745aide is providing care.
746 (c) Supervisory visits.-If home health aide services are
747provided to a patient who is not receiving skilled nursing care,
748physical or occupational therapy, or speech-language pathology
749services, a registered nurse must make a supervisory visit to
750the patient's home at least once every 60 days, unless the home
751health agency providing the home health aide services is not
752Medicare-certified or Medicaid-certified and does not provide
753skilled care, either directly or through contracts. The
754registered nurse shall ensure that the aide is properly caring
755for the patient and each supervisory visit must occur while the
756home health aide is providing patient care. In addition to the
757requirements in this subsection, a home health agency shall
758arrange for additional supervisory visits by a registered nurse
759to the home of a patient receiving home health aide services in
760accordance with the patient's direction, approval, and agreement
761to pay the charge for the visits.
762 (10)(7) Home health agency personnel may withhold or
763withdraw cardiopulmonary resuscitation if presented with an
764order not to resuscitate executed pursuant to s. 401.45. The
765agency shall adopt rules providing for the implementation of
766such orders. Home health personnel and agencies shall not be
767subject to criminal prosecution or civil liability, nor be
768considered to have engaged in negligent or unprofessional
769conduct, for withholding or withdrawing cardiopulmonary
770resuscitation pursuant to such an order and rules adopted by the
771agency.
772 Section 15. Paragraphs (f) and (g) of subsection (4) of
773section 400.9905, Florida Statutes, are amended to read:
774 400.9905 Definitions.-
775 (4) "Clinic" means an entity at which health care services
776are provided to individuals and which tenders charges for
777reimbursement for such services, including a mobile clinic and a
778portable equipment provider. For purposes of this part, the term
779does not include and the licensure requirements of this part do
780not apply to:
781 (f) A sole proprietorship, group practice, partnership, or
782corporation, or other legal entity that provides health care
783services by practitioners licensed under chapter 458, chapter
784459, chapter 461, chapter 466, or chapter 460 and subject to the
785limitations of s. 460.4167 physicians covered by s. 627.419,
786that is directly supervised by one or more of such physicians or
787physician assistants, and that is wholly owned by one or more of
788those physicians or physician assistants or by a physician or
789physician assistant or and the spouse, parent, child, or sibling
790of that physician or physician assistant. A certificate of
791exemption is valid only for the entity, persons, and location
792for which it was originally issued.
793 1. An individual who is not a medical professional or
794family member listed in this paragraph may own up to 30 percent
795of a health care clinic entity that is exempt under this
796paragraph if the individual obtains prior approval from the
797agency for ownership of a percentage of a health care clinic.
798Such an individual is considered an "applicant" under s.
799400.991(5) and must meet all the requirements of that section
800and the level 2 background screening requirements of s. 408.809
801before being approved by the agency for ownership of a minority
802interest in a health care clinic.
803 2. If an individual who is not a medical professional or
804family member listed in this paragraph assumes ownership of an
805investment interest in a health care clinic without the prior
806approval of the agency, the health care clinic shall lose its
807exemption from licensure under this paragraph.
808 3. Ownership of a health care clinic by an individual
809other than the physician or physician assistant, or by the
810spouse, parent, child, or sibling of the physician or physician
811assistant to whom the exemption was granted, may not exceed 30
812percent.
813 (g) A sole proprietorship, group practice, partnership, or
814corporation that provides health care services by licensed
815health care practitioners under chapter 457, chapter 458,
816chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
817chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
818chapter 490, chapter 491, or part I, part III, part X, part
819XIII, or part XIV of chapter 468, or s. 464.012, which are
820wholly owned by one or more licensed health care practitioners,
821or the licensed health care practitioners set forth in this
822paragraph and the spouse, parent, child, or sibling of a
823licensed health care practitioner, so long as one of the owners
824who is a licensed health care practitioner is supervising the
825business activities and is legally responsible for the entity's
826compliance with all federal and state laws. However, a health
827care practitioner who is a supervising owner may not supervise
828services beyond the scope of the practitioner's license, except
829that, for the purposes of this part, a clinic owned by a
830licensee in s. 456.053(3)(b) that provides only services
831authorized pursuant to s. 456.053(3)(b) may be supervised by a
832licensee specified in s. 456.053(3)(b). A certificate of
833exemption is valid only for the entity, persons, and location
834for which it was originally issued.
835 Section 16. Subsection (11) of section 408.802, Florida
836Statutes, is repealed.
837 Section 17. Paragraphs (e), (f), and (g) of subsection
838(15) of section 409.912, Florida Statutes, are repealed.
839 Section 18. Subsection (13) of section 409.9122, Florida
840Statutes, is repealed.
841 Section 19. Section 409.91255, Florida Statutes, is
842amended to read:
843 409.91255 Federally qualified health center access
844program.-
845 (1) SHORT TITLE.-This section may be cited as the
846"Community Health Center Access Program Act."
847 (2) LEGISLATIVE FINDINGS AND INTENT.-
848 (a) The Legislature finds that, despite significant
849investments in health care programs, nearly 6 more than 2
850million low-income Floridians, primarily the working poor and
851minority populations, continue to lack access to basic health
852care services. Further, the Legislature recognizes that
853federally qualified health centers have a proven record of
854providing cost-effective, comprehensive primary and preventive
855health care and are uniquely qualified to address the lack of
856adequate health care services for the uninsured.
857 (b) It is the intent of the Legislature to recognize the
858significance of increased federal investments in federally
859qualified health centers and to leverage that investment through
860the creation of a program to provide for the expansion of the
861primary and preventive health care services offered by federally
862qualified health centers. Further, such a program will support
863the coordination of federal, state, and local resources to
864assist such health centers in developing an expanded community-
865based primary care delivery system.
866 (3) ASSISTANCE TO FEDERALLY QUALIFIED HEALTH CENTERS.-The
867agency shall administer Department of Health shall develop a
868program for the expansion of federally qualified health centers
869for the purpose of providing comprehensive primary and
870preventive health care and urgent care services that may reduce
871the morbidity, mortality, and cost of care among the uninsured
872population of the state. The program shall provide for
873distribution of financial assistance to federally qualified
874health centers that apply and demonstrate a need for such
875assistance in order to sustain or expand the delivery of primary
876and preventive health care services. In selecting centers to
877receive this financial assistance, the program:
878 (a) Shall give preference to communities that have few or
879no community-based primary care services or in which the current
880services are unable to meet the community's needs. To assist in
881the assessment and identification of areas of critical need, a
882federally qualified health-center-based statewide assessment and
883strategic plan shall be developed by the Florida Association of
884Community Health Centers, Inc., every 5 years, beginning January
8851, 2011.
886 (b) Shall require that primary care services be provided
887to the medically indigent using a sliding fee schedule based on
888income.
889 (c) Shall promote allow innovative and creative uses of
890federal, state, and local health care resources.
891 (d) Shall require that the funds provided be used to pay
892for operating costs of a projected expansion in patient
893caseloads or services or for capital improvement projects.
894Capital improvement projects may include renovations to existing
895facilities or construction of new facilities, provided that an
896expansion in patient caseloads or services to a new patient
897population will occur as a result of the capital expenditures.
898The agency department shall include in its standard contract
899document a requirement that any state funds provided for the
900purchase of or improvements to real property are contingent upon
901the contractor granting to the state a security interest in the
902property at least to the amount of the state funds provided for
903at least 5 years from the date of purchase or the completion of
904the improvements or as further required by law. The contract
905must include a provision that, as a condition of receipt of
906state funding for this purpose, the contractor agrees that, if
907it disposes of the property before the agency's department's
908interest is vacated, the contractor will refund the
909proportionate share of the state's initial investment, as
910adjusted by depreciation.
911 (e) Shall May require in-kind support from other sources.
912 (f) Shall promote May encourage coordination among
913federally qualified health centers, other private sector
914providers, and publicly supported programs.
915 (g) Shall promote allow the development of community
916emergency room diversion programs in conjunction with local
917resources, providing extended hours of operation to urgent care
918patients. Diversion programs shall include case management for
919emergency room followup care.
920 (4) EVALUATION OF APPLICATIONS.-A review panel shall be
921established, consisting of four persons appointed by the
922Secretary of Health Care Administration State Surgeon General
923and three persons appointed by the chief executive officer of
924the Florida Association of Community Health Centers, Inc., to
925review all applications for financial assistance under the
926program. Applicants shall specify in the application whether the
927program funds will be used for the expansion of patient
928caseloads or services or for capital improvement projects to
929expand and improve patient facilities. The panel shall use the
930following elements in reviewing application proposals and shall
931determine the relative weight for scoring and evaluating these
932elements:
933 (a) The target population to be served.
934 (b) The health benefits to be provided.
935 (c) The methods that will be used to measure cost-
936effectiveness.
937 (d) How patient satisfaction will be measured.
938 (e) The proposed internal quality assurance process.
939 (f) Projected health status outcomes.
940 (g) How data will be collected to measure cost-
941effectiveness, health status outcomes, and overall achievement
942of the goals of the proposal.
943 (h) All resources, including cash, in-kind, voluntary, or
944other resources that will be dedicated to the proposal.
945 (5) ADMINISTRATION AND TECHNICAL ASSISTANCE.-The agency
946shall Department of Health may contract with the Florida
947Association of Community Health Centers, Inc., to develop and
948coordinate administer the program and provide technical
949assistance to the federally qualified health centers selected to
950receive financial assistance. The contracted entity shall be
951responsible for program support and assume all costs related to
952administration of this program.
953 Section 20. Subsection (2) of section 429.075, Florida
954Statutes, is amended to read:
955 429.075 Limited mental health license.-An assisted living
956facility that serves three or more mental health residents must
957obtain a limited mental health license.
958 (2) Facilities licensed to provide services to mental
959health residents shall provide appropriate supervision and
960staffing to provide for the health, safety, and welfare of such
961residents. Assisted living facilities within an area zoned for
962residential use in a municipality having a population of more
963than 400,000, which house persons identified as being part of a
964priority population that includes adult and adolescent residents
965who have severe and persistent mental illness, as described in
966s. 394.674, must maintain 24-hour security services provided by
967uniformed security personnel licensed under part III of chapter
968493.
969 Section 21. Subsection (2) of section 429.12, Florida
970Statutes, is repealed.
971 Section 22. Subsection (5) of section 429.23, Florida
972Statutes, is repealed.
973 Section 23. Paragraph (a) of subsection (2) of section
974429.911, Florida Statutes, is repealed.
975 Section 24. Dental workforce survey.-
976 (1) Beginning in 2012, each person who applies for
977licensure renewal as a dentist or dental hygienist under chapter
978466, Florida Statutes, must, in conjunction with the renewal of
979such license under procedures and forms adopted by the Board of
980Dentistry and in addition to any other information that may be
981required from the applicant, furnish the following information
982to the Department of Health, working in conjunction with the
983board, in a dental workforce survey:
984 (a) Licensee information, including, but not limited to:
985 1. The name of the dental school or dental hygiene program
986that the dentist or dental hygienist graduated from and the year
987of graduation.
988 2. The year that the dentist or dental hygienist began
989practicing or working in this state.
990 3. The geographic location of the dentist's or dental
991hygienist's practice or address within the state.
992 4. For a dentist in private practice:
993 a. The number of full-time dental hygienists employed by
994the dentist during the reporting period.
995 b. The number of full-time dental assistants employed by
996the dentist during the reporting period.
997 c. The average number of patients treated per week by the
998dentist during the reporting period.
999 d. The settings where the dental care was delivered.
1000 5. Anticipated plans of the dentist to change the status
1001of his or her license or practice.
1002 6. The dentist's areas of specialty or certification.
1003 7. The year that the dentist completed a specialty program
1004recognized by the American Dental Association.
1005 8. For a hygienist:
1006 a. The average number of patients treated per week by the
1007hygienist during the reporting period.
1008 b. The settings where the dental care was delivered.
1009 9. The dentist's memberships in professional
1010organizations.
1011 10. The number of pro bono hours provided by the dentist
1012or dental hygienist during the last biennium.
1013 (b) Information concerning the availability and trends
1014relating to critically needed services, including, but not
1015limited to, the following types of care provided by the dentist
1016or dental hygienist:
1017 1. Dental care to children having special needs.
1018 2. Geriatric dental care.
1019 3. Dental services in emergency departments.
1020 4. Medicaid services.
1021 5. Other critically needed specialty areas, as determined
1022by the advisory body.
1023 (2) In addition to the completed survey, the dentist or
1024dental hygienist must submit a statement that the information
1025provided is true and accurate to the best of his or her
1026knowledge and belief.
1027 (3) Beginning in 2012, renewal of a license by a dentist
1028or dental hygienist licensed under chapter 466, Florida
1029Statutes, is not contingent upon the completion and submission
1030of the dental workforce survey; however, for any subsequent
1031license renewal, the board may not renew the license of any
1032dentist or dental hygienist until the survey required under this
1033section is completed and submitted by the licensee.
1034 (4)(a) Beginning in 2012, the Board of Dentistry shall
1035issue a nondisciplinary citation to any dentist or dental
1036hygienist licensed under chapter 466, Florida Statutes, who
1037fails to complete the survey within 90 days after the renewal of
1038his or her license to practice as a dentist or dental hygienist.
1039 (b) The citation must notify a dentist or dental hygienist
1040who fails to complete the survey required by this section that
1041his or her license will not be renewed for any subsequent
1042license renewal unless the dentist or dental hygienist completes
1043the survey.
1044 (c) In conjunction with issuing the license renewal notice
1045required by s. 456.038, Florida Statutes, the board shall notify
1046each dentist or dental hygienist licensed under chapter 466,
1047Florida Statutes, who fails to complete the survey that the
1048survey must be completed before the subsequent license renewal.
1049 Section 25. (1) The Department of Health shall serve as
1050the coordinating body for the purpose of collecting and
1051regularly updating and disseminating dental workforce data. The
1052department shall work with multiple stakeholders, including the
1053Florida Dental Association and the Florida Dental Hygiene
1054Association, to assess and share with all communities of
1055interest all data collected in a timely fashion.
1056 (2) The Department of Health shall maintain a current
1057database to serve as a statewide source of data concerning the
1058dental workforce. The department, in conjunction with the Board
1059of Dentistry, shall also:
1060 (a) Develop strategies to maximize federal and state
1061programs that provide incentives for dentists to practice in
1062shortage areas that are federally designated. Strategies shall
1063include programs such as the Florida Health Services Corps
1064established under s. 381.0302, Florida Statutes.
1065 (b) Work in conjunction with an advisory body to address
1066matters relating to the state's dental workforce. The advisory
1067body shall provide input on developing questions for the dentist
1068workforce survey. The advisory body shall include, but need not
1069be limited to, the State Surgeon General or his or her designee,
1070the dean of each dental school accredited in the United States
1071and based in this state or his or her designee, a representative
1072from the Florida Dental Association, a representative from the
1073Florida Dental Hygiene Association, a representative from the
1074Board of Dentistry, and a dentist from each of the dental
1075specialties recognized by the American Dental Association's
1076Commission on Dental Accreditation. Members of the advisory body
1077shall serve without compensation.
1078 (c) Act as a clearinghouse for collecting and
1079disseminating information concerning the dental workforce.
1080 (3) The Department of Health and the Board of Dentistry
1081shall adopt rules necessary to administer this section.
1082 Section 26. It is the intent of the Legislature that the
1083Department of Health and the Board of Dentistry implement the
1084provisions of sections 16 through 20 of this act within existing
1085resources.
1086 Section 27. Paragraphs (q) and (t) of subsection (2) of
1087section 499.01, Florida Statutes, are amended to read:
1088 499.01 Permits.-
1089 (2) The following permits are established:
1090 (q) Device manufacturer permit.-
1091 1. A device manufacturer permit is required for any person
1092that engages in the manufacture, repackaging, or assembly of
1093medical devices for human use in this state, except that a
1094permit is not required if:
1095 a. The person manufactures, repackages, or assembles only
1096those medical devices or components for such devices which are
1097exempt from registration pursuant to s. 499.015(8); or
1098 b. The person is engaged only in manufacturing,
1099repackaging, or assembling a medical device pursuant to a
1100practitioner's order for a specific patient.
1101 2.1. A manufacturer or repackager of medical devices in
1102this state must comply with all appropriate state and federal
1103good manufacturing practices and quality system rules.
1104 3.2. The department shall adopt rules related to storage,
1105handling, and recordkeeping requirements for manufacturers of
1106medical devices for human use.
1107 (t) Health care clinic establishment permit.-Effective
1108January 1, 2009, a health care clinic establishment permit is
1109required for the purchase of a prescription drug by a place of
1110business at one general physical location that provides health
1111care or veterinary services, which is owned and operated by a
1112business entity that has been issued a federal employer tax
1113identification number. For the purpose of this paragraph, the
1114term "qualifying practitioner" means a licensed health care
1115practitioner defined in s. 456.001, or a veterinarian licensed
1116under chapter 474, who is authorized under the appropriate
1117practice act to prescribe and administer a prescription drug.
1118 1. An establishment must provide, as part of the
1119application required under s. 499.012, designation of a
1120qualifying practitioner who will be responsible for complying
1121with all legal and regulatory requirements related to the
1122purchase, recordkeeping, storage, and handling of the
1123prescription drugs. In addition, the designated qualifying
1124practitioner shall be the practitioner whose name, establishment
1125address, and license number is used on all distribution
1126documents for prescription drugs purchased or returned by the
1127health care clinic establishment. Upon initial appointment of a
1128qualifying practitioner, the qualifying practitioner and the
1129health care clinic establishment shall notify the department on
1130a form furnished by the department within 10 days after such
1131employment. In addition, the qualifying practitioner and health
1132care clinic establishment shall notify the department within 10
1133days after any subsequent change.
1134 2. The health care clinic establishment must employ a
1135qualifying practitioner at each establishment.
1136 3. In addition to the remedies and penalties provided in
1137this part, a violation of this chapter by the health care clinic
1138establishment or qualifying practitioner constitutes grounds for
1139discipline of the qualifying practitioner by the appropriate
1140regulatory board.
1141 4. The purchase of prescription drugs by the health care
1142clinic establishment is prohibited during any period of time
1143when the establishment does not comply with this paragraph.
1144 5. A health care clinic establishment permit is not a
1145pharmacy permit or otherwise subject to chapter 465. A health
1146care clinic establishment that meets the criteria of a modified
1147Class II institutional pharmacy under s. 465.019 is not eligible
1148to be permitted under this paragraph.
1149 6. This paragraph does not apply to the purchase of a
1150prescription drug by a licensed practitioner under his or her
1151license. A professional corporation or limited liability company
1152composed of dentists and operating as authorized in s. 466.0285
1153may pay for prescription drugs obtained by a practitioner
1154licensed under chapter 466, and the licensed practitioner is
1155deemed the purchaser and owner of the prescription drugs.
1156 Section 28. Subsections (32) through (54) of section
1157499.003, Florida Statutes, are renumbered as subsections (33)
1158through (55), respectively, present subsection (42) is amended,
1159and a new subsection (32) is added to that section, to read:
1160 499.003 Definitions of terms used in this part.-As used in
1161this part, the term:
1162 (32) "Medical convenience kit" means a package or unit
1163that contains combination products as described in 21 C.F.R. s.
11643.2(e)(2).
1165 (43)(42) "Prescription drug" means a prescription,
1166medicinal, or legend drug, including, but not limited to,
1167finished dosage forms or active ingredients subject to, defined
1168by, or described by s. 503(b) of the Federal Food, Drug, and
1169Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
1170(11), subsection (46) (45), or subsection (53) (52).
1171 Section 29. Paragraph (a) of subsection (1) of section
1172409.9201, Florida Statutes, is amended to read:
1173 409.9201 Medicaid fraud.-
1174 (1) As used in this section, the term:
1175 (a) "Prescription drug" means any drug, including, but not
1176limited to, finished dosage forms or active ingredients that are
1177subject to, defined by, or described by s. 503(b) of the Federal
1178Food, Drug, and Cosmetic Act or by s. 465.003(8), s.
1179499.003(45)(45) or (53) (52), or s. 499.007(13).
1180
1181The value of individual items of the legend drugs or goods or
1182services involved in distinct transactions committed during a
1183single scheme or course of conduct, whether involving a single
1184person or several persons, may be aggregated when determining
1185the punishment for the offense.
1186 Section 30. Subsection (3) of section 465.0265, Florida
1187Statutes, is amended to read:
1188 465.0265 Centralized prescription filling.-
1189 (3) The filling, delivery, and return of a prescription by
1190one pharmacy for another pursuant to this section shall not be
1191construed as the filling of a transferred prescription as set
1192forth in s. 465.026 or as a wholesale distribution as set forth
1193in s. 499.003(54)(53).
1194 Section 31. Paragraph (d) of subsection (4) of section
1195499.0121, Florida Statutes, is amended to read:
1196 499.0121 Storage and handling of prescription drugs;
1197recordkeeping.-The department shall adopt rules to implement
1198this section as necessary to protect the public health, safety,
1199and welfare. Such rules shall include, but not be limited to,
1200requirements for the storage and handling of prescription drugs
1201and for the establishment and maintenance of prescription drug
1202distribution records.
1203 (4) EXAMINATION OF MATERIALS AND RECORDS.-
1204 (d) Upon receipt, a wholesale distributor must review
1205records required under this section for the acquisition of
1206prescription drugs for accuracy and completeness, considering
1207the total facts and circumstances surrounding the transactions
1208and the wholesale distributors involved. This includes
1209authenticating each transaction listed on a pedigree paper, as
1210defined in s. 499.003(37)(36).
1211 Section 32. Paragraphs (a) and (b) of subsection (2) of
1212section 499.01211, Florida Statutes, are amended to read:
1213 499.01211 Drug Wholesale Distributor Advisory Council.-
1214 (2) The State Surgeon General, or his or her designee, and
1215the Secretary of Health Care Administration, or her or his
1216designee, shall be members of the council. The State Surgeon
1217General shall appoint nine additional members to the council who
1218shall be appointed to a term of 4 years each, as follows:
1219 (a) Three different persons each of whom is employed by a
1220different prescription drug wholesale distributor licensed under
1221this part which operates nationally and is a primary wholesale
1222distributor, as defined in s. 499.003(47)(46).
1223 (b) One person employed by a prescription drug wholesale
1224distributor licensed under this part which is a secondary
1225wholesale distributor, as defined in s. 499.003(52)(51).
1226 Section 33. Subsection (1) of section 499.03, Florida
1227Statutes, is amended to read:
1228 499.03 Possession of certain drugs without prescriptions
1229unlawful; exemptions and exceptions.-
1230 (1) A person may not possess, or possess with intent to
1231sell, dispense, or deliver, any habit-forming, toxic, harmful,
1232or new drug subject to s. 499.003(33)(32), or prescription drug
1233as defined in s. 499.003(43)(42), unless the possession of the
1234drug has been obtained by a valid prescription of a practitioner
1235licensed by law to prescribe the drug. However, this section
1236does not apply to the delivery of such drugs to persons included
1237in any of the classes named in this subsection, or to the agents
1238or employees of such persons, for use in the usual course of
1239their businesses or practices or in the performance of their
1240official duties, as the case may be; nor does this section apply
1241to the possession of such drugs by those persons or their agents
1242or employees for such use:
1243 (a) A licensed pharmacist or any person under the licensed
1244pharmacist's supervision while acting within the scope of the
1245licensed pharmacist's practice;
1246 (b) A licensed practitioner authorized by law to prescribe
1247prescription drugs or any person under the licensed
1248practitioner's supervision while acting within the scope of the
1249licensed practitioner's practice;
1250 (c) A qualified person who uses prescription drugs for
1251lawful research, teaching, or testing, and not for resale;
1252 (d) A licensed hospital or other institution that procures
1253such drugs for lawful administration or dispensing by
1254practitioners;
1255 (e) An officer or employee of a federal, state, or local
1256government; or
1257 (f) A person that holds a valid permit issued by the
1258department pursuant to this part which authorizes that person to
1259possess prescription drugs.
1260 Section 34. Paragraphs (i) and (m) of subsection (1) of
1261section 499.05, Florida Statutes, are amended to read:
1262 499.05 Rules.-
1263 (1) The department shall adopt rules to implement and
1264enforce this part with respect to:
1265 (i) Additional conditions that qualify as an emergency
1266medical reason under s. 499.003(54)(53)(b)2.
1267 (m) The recordkeeping, storage, and handling with respect
1268to each of the distributions of prescription drugs specified in
1269s. 499.003(54)(53)(a)-(d).
1270 Section 35. Subsection (1) of section 794.075, Florida
1271Statutes, is amended to read:
1272 794.075 Sexual predators; erectile dysfunction drugs.-
1273 (1) A person may not possess a prescription drug, as
1274defined in s. 499.003(43)(42), for the purpose of treating
1275erectile dysfunction if the person is designated as a sexual
1276predator under s. 775.21.
1277 Section 36. Paragraph (a) of subsection (6) of section
1278624.91, Florida Statutes, is amended to read:
1279 624.91 The Florida Healthy Kids Corporation Act.-
1280 (6) BOARD OF DIRECTORS.-
1281 (a) The Florida Healthy Kids Corporation shall operate
1282subject to the supervision and approval of a board of directors
1283chaired by the Chief Financial Officer or her or his designee,
1284and composed of 12 11 other members selected for 3-year terms of
1285office as follows:
1286 1. The Secretary of Health Care Administration, or his or
1287her designee.
1288 2. One member appointed by the Commissioner of Education
1289from the Office of School Health Programs of the Florida
1290Department of Education.
1291 3. One member appointed by the Chief Financial Officer
1292from among three members nominated by the Florida Pediatric
1293Society.
1294 4. One member, appointed by the Governor, who represents
1295the Children's Medical Services Program.
1296 5. One member appointed by the Chief Financial Officer
1297from among three members nominated by the Florida Hospital
1298Association.
1299 6. One member, appointed by the Governor, who is an expert
1300on child health policy.
1301 7. One member, appointed by the Chief Financial Officer,
1302from among three members nominated by the Florida Academy of
1303Family Physicians.
1304 8. One member, appointed by the Governor, who represents
1305the state Medicaid program.
1306 9. One member, appointed by the Chief Financial Officer,
1307from among three members nominated by the Florida Association of
1308Counties.
1309 10. The State Health Officer or her or his designee.
1310 11. The Secretary of Children and Family Services, or his
1311or her designee.
1312 12. One member, appointed by the Governor, from among
1313three members nominated by the Florida Dental Association.
1314 Section 37. Section 381.0403, Florida Statutes, is amended
1315to read:
1316 381.0403 The Community Hospital Education Act.-
1317 (1) SHORT TITLE.-This section shall be known and cited as
1318"The Community Hospital Education Act."
1319 (2) LEGISLATIVE INTENT.-
1320 (a) It is the intent of the Legislature that health care
1321services for the citizens of this state be upgraded and that a
1322program for continuing these services be maintained through a
1323plan for community medical education. The program is intended to
1324provide additional outpatient and inpatient services, a
1325continuing supply of highly trained physicians, and graduate
1326medical education.
1327 (b) The Legislature further acknowledges the critical need
1328for increased numbers of primary care physicians to provide the
1329necessary current and projected health and medical services. In
1330order to meet both present and anticipated needs, the
1331Legislature supports an expansion in the number of family
1332practice residency positions. The Legislature intends that the
1333funding for graduate education in family practice be maintained
1334and that funding for all primary care specialties be provided at
1335a minimum of $10,000 per resident per year. Should funding for
1336this act remain constant or be reduced, it is intended that all
1337programs funded by this act be maintained or reduced
1338proportionately.
1339 (3) PROGRAM FOR COMMUNITY HOSPITAL EDUCATION; STATE AND
1340LOCAL PLANNING.-
1341 (a) There is established under the Department of Health a
1342program for statewide graduate medical education. It is intended
1343that continuing graduate medical education programs for interns
1344and residents be established on a statewide basis. The program
1345shall provide financial support for primary care specialty
1346interns and residents based on policies recommended and approved
1347by the Community Hospital Education Council, herein established,
1348and the Department of Health. Only those programs with at least
1349three residents or interns in each year of the training program
1350are qualified to apply for financial support. Programs with
1351fewer than three residents or interns per training year are
1352qualified to apply for financial support, but only if the
1353appropriate accrediting entity for the particular specialty has
1354approved the program for fewer positions. Programs added after
1355fiscal year 1997-1998 shall have 5 years to attain the requisite
1356number of residents or interns. When feasible and to the extent
1357allowed through the General Appropriations Act, state funds
1358shall be used to generate federal matching funds under Medicaid,
1359or other federal programs, and the resulting combined state and
1360federal funds shall be allocated to participating hospitals for
1361the support of graduate medical education. The department may
1362spend up to $75,000 of the state appropriation for
1363administrative costs associated with the production of the
1364annual report as specified in subsection (9), and for
1365administration of the program.
1366 (b) For the purposes of this section, primary care
1367specialties include emergency medicine, family practice,
1368internal medicine, pediatrics, psychiatry,
1369obstetrics/gynecology, and combined pediatrics and internal
1370medicine, and other primary care specialties as may be included
1371by the council and Department of Health.
1372 (c) Medical institutions throughout the state may apply to
1373the Community Hospital Education Council for grants-in-aid for
1374financial support of their approved programs. Recommendations
1375for funding of approved programs shall be forwarded to the
1376Department of Health.
1377 (d) The program shall provide a plan for community
1378clinical teaching and training with the cooperation of the
1379medical profession, hospitals, and clinics. The plan shall also
1380include formal teaching opportunities for intern and resident
1381training. In addition, the plan shall establish an off-campus
1382medical faculty with university faculty review to be located
1383throughout the state in local communities.
1384 (4) PROGRAM FOR GRADUATE MEDICAL EDUCATION INNOVATIONS.-
1385 (a) There is established under the Department of Health a
1386program for fostering graduate medical education innovations.
1387Funds appropriated annually by the Legislature for this purpose
1388shall be distributed to participating hospitals or consortia of
1389participating hospitals and Florida medical schools or to a
1390Florida medical school for the direct costs of providing
1391graduate medical education in community-based clinical settings
1392on a competitive grant or formula basis to achieve state health
1393care workforce policy objectives, including, but not limited to:
1394 1. Increasing the number of residents in primary care and
1395other high demand specialties or fellowships;
1396 2. Enhancing retention of primary care physicians in
1397Florida practice;
1398 3. Promoting practice in medically underserved areas of
1399the state;
1400 4. Encouraging racial and ethnic diversity within the
1401state's physician workforce; and
1402 5. Encouraging increased production of geriatricians.
1403 (b) Participating hospitals or consortia of participating
1404hospitals and Florida medical schools or a Florida medical
1405school providing graduate medical education in community-based
1406clinical settings may apply to the Community Hospital Education
1407Council for funding under this innovations program, except when
1408such innovations directly compete with services or programs
1409provided by participating hospitals or consortia of
1410participating hospitals, or by both hospitals and consortia.
1411Innovations program funding shall provide funding based on
1412policies recommended and approved by the Community Hospital
1413Education Council and the Department of Health.
1414 (c) Participating hospitals or consortia of participating
1415hospitals and Florida medical schools or Florida medical schools
1416awarded an innovations grant shall provide the Community
1417Hospital Education Council and Department of Health with an
1418annual report on their project.
1419 (4)(5) FAMILY PRACTICE RESIDENCIES.-In addition to the
1420programs established in subsection (3), the Community Hospital
1421Education Council and the Department of Health shall establish
1422an ongoing statewide program of family practice residencies. The
1423administration of this program shall be in the manner described
1424in this section.
1425 (5)(6) COUNCIL AND DIRECTOR.-
1426 (a) There is established the Community Hospital Education
1427Council, hereinafter referred to as the council, which shall
1428consist of 11 members, as follows:
1429 1. Seven members must be program directors of accredited
1430graduate medical education programs or practicing physicians who
1431have faculty appointments in accredited graduate medical
1432education programs. Six of these members must be board certified
1433or board eligible in family practice, internal medicine,
1434pediatrics, emergency medicine, obstetrics-gynecology, and
1435psychiatry, respectively, and licensed pursuant to chapter 458.
1436No more than one of these members may be appointed from any one
1437specialty. One member must be licensed pursuant to chapter 459.
1438 2. One member must be a representative of the
1439administration of a hospital with an approved community hospital
1440medical education program;
1441 3. One member must be the dean of a medical school in this
1442state; and
1443 4. Two members must be consumer representatives.
1444
1445All of the members shall be appointed by the Governor for terms
1446of 4 years each.
1447 (b) Council membership shall cease when a member's
1448representative status no longer exists. Members of similar
1449representative status shall be appointed to replace retiring or
1450resigning members of the council.
1451 (c) The State Surgeon General shall designate an
1452administrator to serve as staff director. The council shall
1453elect a chair from among its membership. Such other personnel as
1454may be necessary to carry out the program shall be employed as
1455authorized by the Department of Health.
1456 (6)(7) DEPARTMENT OF HEALTH; STANDARDS.-
1457 (a) The Department of Health, with recommendations from
1458the council, shall establish standards and policies for the use
1459and expenditure of graduate medical education funds appropriated
1460pursuant to subsection (7) (8) for a program of community
1461hospital education. The Department of Health shall establish
1462requirements for hospitals to be qualified for participation in
1463the program which shall include, but not be limited to:
1464 1. Submission of an educational plan and a training
1465schedule.
1466 2. A determination by the council to ascertain that each
1467portion of the program of the hospital provides a high degree of
1468academic excellence and is accredited by the Accreditation
1469Council for Graduate Medical Education of the American Medical
1470Association or is accredited by the American Osteopathic
1471Association.
1472 3. Supervision of the educational program of the hospital
1473by a physician who is not the hospital administrator.
1474 (b) The Department of Health shall periodically review the
1475educational program provided by a participating hospital to
1476assure that the program includes a reasonable amount of both
1477formal and practical training and that the formal sessions are
1478presented as scheduled in the plan submitted by each hospital.
1479 (c) In years that funds are transferred to the Agency for
1480Health Care Administration, the Department of Health shall
1481certify to the Agency for Health Care Administration on a
1482quarterly basis the number of primary care specialty residents
1483and interns at each of the participating hospitals for which the
1484Community Hospital Education Council and the department
1485recommends funding.
1486 (7)(8) MATCHING FUNDS.-State funds shall be used to match
1487funds from any local governmental or hospital source. The state
1488shall provide up to 50 percent of the funds, and the community
1489hospital medical education program shall provide the remainder.
1490However, except for fixed capital outlay, the provisions of this
1491subsection shall not apply to any program authorized under the
1492provisions of subsection (5) for the first 3 years after such
1493program is in operation.
1494 (9) ANNUAL REPORT ON GRADUATE MEDICAL EDUCATION;
1495COMMITTEE.-The Executive Office of the Governor, the Department
1496of Health, and the Agency for Health Care Administration shall
1497collaborate to establish a committee that shall produce an
1498annual report on graduate medical education. The committee shall
1499be comprised of 11 members: five members shall be deans of the
1500medical schools or their designees; the Governor shall appoint
1501two members, one of whom must be a representative of the Florida
1502Medical Association who has supervised or currently supervises
1503residents or interns and one of whom must be a representative of
1504the Florida Hospital Association; the Secretary of Health Care
1505Administration shall appoint two members, one of whom must be a
1506representative of a statutory teaching hospital and one of whom
1507must be a physician who has supervised or is currently
1508supervising residents or interns; and the State Surgeon General
1509shall appoint two members, one of whom must be a representative
1510of a statutory family practice teaching hospital and one of whom
1511must be a physician who has supervised or is currently
1512supervising residents or interns. With the exception of the
1513deans, members shall serve 4-year terms. In order to stagger the
1514terms, the Governor's appointees shall serve initial terms of 4
1515years, the State Surgeon General's appointees shall serve
1516initial terms of 3 years, and the Secretary of Health Care
1517Administration's appointees shall serve initial terms of 2
1518years. A member's term shall be deemed terminated when the
1519member's representative status no longer exists. Once the
1520committee is appointed, it shall elect a chair to serve for a 1-
1521year term. The report shall be provided to the Governor, the
1522President of the Senate, and the Speaker of the House of
1523Representatives by January 15 annually. Committee members shall
1524serve without compensation. The report shall address the
1525following:
1526 (a) The role of residents and medical faculty in the
1527provision of health care.
1528 (b) The relationship of graduate medical education to the
1529state's physician workforce.
1530 (c) The costs of training medical residents for hospitals,
1531medical schools, teaching hospitals, including all hospital-
1532medical affiliations, practice plans at all of the medical
1533schools, and municipalities.
1534 (d) The availability and adequacy of all sources of
1535revenue to support graduate medical education and recommend
1536alternative sources of funding for graduate medical education.
1537 (e) The use of state and federal appropriated funds for
1538graduate medical education by hospitals receiving such funds.
1539 (9)(10) RULEMAKING.-The department has authority to adopt
1540rules pursuant to ss. 120.536(1) and 120.54 to implement the
1541provisions of this section.
1542 Section 38. Section 381.4018, Florida Statutes, is amended
1543to read:
1544 381.4018 Physician workforce assessment and development.-
1545 (1) DEFINITIONS.-As used in this section, the term:
1546 (a) "Consortium" or "consortia" means a combination of
1547statutory teaching hospitals, specialty children's hospitals,
1548statutory rural hospitals, other hospitals, accredited medical
1549schools, clinics operated by the department, clinics operated by
1550the Department of Veterans' Affairs, area health education
1551centers, community health centers, federally qualified health
1552centers, prison clinics, local community clinics, or other
1553programs. At least one member of the consortium shall be a
1554sponsoring institution accredited or currently seeking
1555accreditation by the Accreditation Council for Graduate Medical
1556Education or the American Osteopathic Association.
1557 (b) "Council" means the Physician Workforce Advisory
1558Council.
1559 (c) "Department" means the Department of Health.
1560 (d) "Graduate medical education program" means a program
1561accredited by the Accreditation Council for Graduate Medical
1562Education or the American Osteopathic Association.
1563 (e) "Primary care specialty" means emergency medicine,
1564family practice, internal medicine, pediatrics, psychiatry,
1565geriatrics, general surgery, obstetrics and gynecology, and
1566combined pediatrics and internal medicine and other specialties
1567as determined by the Physician Workforce Advisory Council or the
1568Department of Health.
1569 (2)(1) LEGISLATIVE INTENT.-The Legislature recognizes that
1570physician workforce planning is an essential component of
1571ensuring that there is an adequate and appropriate supply of
1572well-trained physicians to meet this state's future health care
1573service needs as the general population and elderly population
1574of the state increase. The Legislature finds that items to
1575consider relative to assessing the physician workforce may
1576include physician practice status; specialty mix; geographic
1577distribution; demographic information, including, but not
1578limited to, age, gender, race, and cultural considerations; and
1579needs of current or projected medically underserved areas in the
1580state. Long-term strategic planning is essential as the period
1581from the time a medical student enters medical school to
1582completion of graduate medical education may range from 7 to 10
1583years or longer. The Legislature recognizes that strategies to
1584provide for a well-trained supply of physicians must include
1585ensuring the availability and capacity of quality graduate
1586medical schools and graduate medical education programs in this
1587state, as well as using new or existing state and federal
1588programs providing incentives for physicians to practice in
1589needed specialties and in underserved areas in a manner that
1590addresses projected needs for physician manpower.
1591 (3)(2) PURPOSE.-The department of Health shall serve as a
1592coordinating and strategic planning body to actively assess the
1593state's current and future physician workforce needs and work
1594with multiple stakeholders to develop strategies and
1595alternatives to address current and projected physician
1596workforce needs.
1597 (4)(3) GENERAL FUNCTIONS.-The department shall maximize
1598the use of existing programs under the jurisdiction of the
1599department and other state agencies and coordinate governmental
1600and nongovernmental stakeholders and resources in order to
1601develop a state strategic plan and assess the implementation of
1602such strategic plan. In developing the state strategic plan, the
1603department shall:
1604 (a) Monitor, evaluate, and report on the supply and
1605distribution of physicians licensed under chapter 458 or chapter
1606459. The department shall maintain a database to serve as a
1607statewide source of data concerning the physician workforce.
1608 (b) Develop a model and quantify, on an ongoing basis, the
1609adequacy of the state's current and future physician workforce
1610as reliable data becomes available. Such model must take into
1611account demographics, physician practice status, place of
1612education and training, generational changes, population growth,
1613economic indicators, and issues concerning the "pipeline" into
1614medical education.
1615 (c) Develop and recommend strategies to determine whether
1616the number of qualified medical school applicants who might
1617become competent, practicing physicians in this state will be
1618sufficient to meet the capacity of the state's medical schools.
1619If appropriate, the department shall, working with
1620representatives of appropriate governmental and nongovernmental
1621entities, develop strategies and recommendations and identify
1622best practice programs that introduce health care as a
1623profession and strengthen skills needed for medical school
1624admission for elementary, middle, and high school students, and
1625improve premedical education at the precollege and college level
1626in order to increase this state's potential pool of medical
1627students.
1628 (d) Develop strategies to ensure that the number of
1629graduates from the state's public and private allopathic and
1630osteopathic medical schools is are adequate to meet physician
1631workforce needs, based on the analysis of the physician
1632workforce data, so as to provide a high-quality medical
1633education to students in a manner that recognizes the uniqueness
1634of each new and existing medical school in this state.
1635 (e) Pursue strategies and policies to create, expand, and
1636maintain graduate medical education positions in the state based
1637on the analysis of the physician workforce data. Such strategies
1638and policies must take into account the effect of federal
1639funding limitations on the expansion and creation of positions
1640in graduate medical education. The department shall develop
1641options to address such federal funding limitations. The
1642department shall consider options to provide direct state
1643funding for graduate medical education positions in a manner
1644that addresses requirements and needs relative to accreditation
1645of graduate medical education programs. The department shall
1646consider funding residency positions as a means of addressing
1647needed physician specialty areas, rural areas having a shortage
1648of physicians, and areas of ongoing critical need, and as a
1649means of addressing the state's physician workforce needs based
1650on an ongoing analysis of physician workforce data.
1651 (f) Develop strategies to maximize federal and state
1652programs that provide for the use of incentives to attract
1653physicians to this state or retain physicians within the state.
1654Such strategies should explore and maximize federal-state
1655partnerships that provide incentives for physicians to practice
1656in federally designated shortage areas. Strategies shall also
1657consider the use of state programs, such as the Florida Health
1658Service Corps established pursuant to s. 381.0302 and the
1659Medical Education Reimbursement and Loan Repayment Program
1660pursuant to s. 1009.65, which provide for education loan
1661repayment or loan forgiveness and provide monetary incentives
1662for physicians to relocate to underserved areas of the state.
1663 (g) Coordinate and enhance activities relative to
1664physician workforce needs, undergraduate medical education, and
1665graduate medical education, and reentry of retired military and
1666other physicians into the physician workforce provided by the
1667Division of Medical Quality Assurance, the Community Hospital
1668Education Program and the Graduate Medical Education Committee
1669established pursuant to s. 381.0403, area health education
1670center networks established pursuant to s. 381.0402, and other
1671offices and programs within the department of Health as
1672designated by the State Surgeon General.
1673 (h) Work in conjunction with and act as a coordinating
1674body for governmental and nongovernmental stakeholders to
1675address matters relating to the state's physician workforce
1676assessment and development for the purpose of ensuring an
1677adequate supply of well-trained physicians to meet the state's
1678future needs. Such governmental stakeholders shall include, but
1679need not be limited to, the State Surgeon General or his or her
1680designee, the Commissioner of Education or his or her designee,
1681the Secretary of Health Care Administration or his or her
1682designee, and the Chancellor of the State University System or
1683his or her designee from the Board of Governors of the State
1684University System, and, at the discretion of the department,
1685other representatives of state and local agencies that are
1686involved in assessing, educating, or training the state's
1687current or future physicians. Other stakeholders shall include,
1688but need not be limited to, organizations representing the
1689state's public and private allopathic and osteopathic medical
1690schools; organizations representing hospitals and other
1691institutions providing health care, particularly those that
1692currently provide or have an interest in providing accredited
1693medical education and graduate medical education to medical
1694students and medical residents; organizations representing
1695allopathic and osteopathic practicing physicians; and, at the
1696discretion of the department, representatives of other
1697organizations or entities involved in assessing, educating, or
1698training the state's current or future physicians.
1699 (i) Serve as a liaison with other states and federal
1700agencies and programs in order to enhance resources available to
1701the state's physician workforce and medical education continuum.
1702 (j) Act as a clearinghouse for collecting and
1703disseminating information concerning the physician workforce and
1704medical education continuum in this state.
1705 (5) PHYSICIAN WORKFORCE ADVISORY COUNCIL.-There is created
1706in the department the Physician Workforce Advisory Council, an
1707advisory council as defined in s. 20.03. The council shall
1708comply with the requirements of s. 20.052, except as otherwise
1709provided in this section.
1710 (a) The council shall consist of 19 members. Members
1711appointed by the State Surgeon General shall include:
1712 1. A designee from the department who is a physician
1713licensed under chapter 458 or chapter 459 and recommended by the
1714State Surgeon General.
1715 2. An individual who is affiliated with the Science
1716Students Together Reaching Instructional Diversity and
1717Excellence program and recommended by the area health education
1718center network.
1719 3. Two individuals who are recommended by the Council of
1720Florida Medical School Deans, one who represents a college of
1721allopathic medicine and one who represents a college of
1722osteopathic medicine.
1723 4. One individual who is recommended by the Florida
1724Hospital Association and represents a hospital that is licensed
1725under chapter 395, has an accredited graduate medical education
1726program, and is not a statutory teaching hospital.
1727 5. One individual who represents a statutory teaching
1728hospital as defined in s. 408.07 and is recommended by the
1729Safety Net Hospital Alliance.
1730 6. One individual who represents a family practice
1731teaching hospital as defined in s. 395.805 and is recommended by
1732the Council of Family Medicine and Community Teaching Hospitals.
1733 7. Two individuals who are recommended by the Florida
1734Medical Association, one who represents a primary care specialty
1735and one who represents a nonprimary care specialty.
1736 8. Two individuals who are recommended by the Florida
1737Osteopathic Medical Association, one who represents a primary
1738care specialty and one who represents a nonprimary care
1739specialty.
1740 9. Two individuals who are program directors of accredited
1741graduate medical education programs, one who represents a
1742program that is accredited by the Accreditation Council for
1743Graduate Medical Education and one who represents a program that
1744is accredited by the American Osteopathic Association.
1745 10. An individual who is recommended by the Florida
1746Association of Community Health Centers and represents a
1747federally qualified health center located in a rural area as
1748defined in s. 381.0406(2)(a).
1749 11. An individual who is recommended by the Florida
1750Academy of Family Physicians.
1751 12. An individual who is recommended by the Florida
1752Alliance for Health Professions Diversity.
1753 13. The Chancellor of the State University System or his
1754or her designee.
1755 14. A layperson member as determined by the State Surgeon
1756General.
1757
1758Each entity authorized to make recommendations under this
1759subsection shall make at least two recommendations to the State
1760Surgeon General for each appointment to the council. The State
1761Surgeon General shall name one appointee for each position from
1762the recommendations made by each authorized entity.
1763 (b) Each council member shall be appointed to a 4-year
1764term. An individual may not serve more than two terms. Any
1765council member may be removed from office for malfeasance,
1766misfeasance, neglect of duty, incompetence, permanent inability
1767to perform official duties, or pleading guilty or nolo
1768contendere to, or being found guilty of, a felony. Any council
1769member who meets the criteria for removal, or who is otherwise
1770unwilling or unable to properly fulfill the duties of the
1771office, shall be succeeded by an individual chosen by the State
1772Surgeon General to serve out the remainder of the council
1773member's term. If the remainder of the replaced council member's
1774term is less than 18 months, notwithstanding the provisions of
1775this paragraph, the succeeding council member may be reappointed
1776twice by the State Surgeon General.
1777 (c) The chair of the council is the State Surgeon General,
1778who shall designate a vice chair from the membership of the
1779council to serve in the absence of the State Surgeon General. A
1780vacancy shall be filled for the remainder of the unexpired term
1781in the same manner as the original appointment.
1782 (d) Council members are not entitled to receive
1783compensation or reimbursement for per diem or travel expenses.
1784 (e) The council shall meet at least twice a year in person
1785or by teleconference.
1786 (f) The council shall:
1787 1. Advise the State Surgeon General and the department on
1788matters concerning current and future physician workforce needs
1789in this state;
1790 2. Review survey materials and the compilation of survey
1791information;
1792 3. Annually review the number, location, cost, and
1793reimbursement of graduate medical education programs and
1794positions;
1795 4. Provide recommendations to the department regarding the
1796survey completed by physicians licensed under chapter 458 or
1797chapter 459;
1798 5. Assist the department in preparing the annual report to
1799the Legislature pursuant to ss. 458.3192 and 459.0082;
1800 6. Assist the department in preparing an initial strategic
1801plan, conduct ongoing strategic planning in accordance with this
1802section, and provide ongoing advice on implementing the
1803recommendations;
1804 7. Monitor and provide recommendations regarding the need
1805for an increased number of primary care or other physician
1806specialties to provide the necessary current and projected
1807health and medical services for the state; and
1808 8. Monitor and make recommendations regarding the status
1809of the needs relating to graduate medical education in this
1810state.
1811 (6) PHYSICIAN WORKFORCE GRADUATE MEDICAL EDUCATION
1812INNOVATION PILOT PROJECTS.-
1813 (a) The Legislature finds that:
1814 1. In order to ensure a physician workforce that is
1815adequate to meet the needs of this state's residents and its
1816health care system, policymakers must consider the education and
1817training of future generations of well-trained health care
1818providers.
1819 2. Physicians are likely to practice in the state where
1820they complete their graduate medical education.
1821 3. It can directly affect the makeup of the physician
1822workforce by selectively funding graduate medical education
1823programs to provide needed specialists in geographic areas of
1824the state that have a deficient number of such specialists.
1825 4. Developing additional positions in graduate medical
1826education programs is essential to the future of this state's
1827health care system.
1828 5. It was necessary in 2007 to pass legislation that
1829provided for an assessment of the status of this state's current
1830and future physician workforce. The department is collecting and
1831analyzing information on an ongoing basis to assess this state's
1832physician workforce needs, and such assessment may facilitate
1833the determination of graduate medical education needs and
1834strategies for the state.
1835 (b) There is established under the department a program to
1836foster innovative graduate medical education pilot projects that
1837are designed to promote the expansion of graduate medical
1838education programs or positions to prepare physicians to
1839practice in needed specialties and underserved areas or settings
1840and to provide demographic and cultural representation in a
1841manner that addresses current and projected needs for this
1842state's physician workforce. Funds appropriated annually by the
1843Legislature for this purpose shall be distributed to
1844participating hospitals, medical schools, other sponsors of
1845graduate medical education programs, consortia engaged in
1846developing new graduate medical education programs or positions
1847in those programs, or pilot projects providing innovative
1848graduate medical education in community-based clinical settings.
1849Pilot projects shall be selected on a competitive grant basis,
1850subject to available funds.
1851 (c) Pilot projects shall be designed to meet one or more
1852of this state's physician workforce needs, as determined
1853pursuant to this section, including, but not limited to:
1854 1. Increasing the number of residencies or fellowships in
1855primary care or other needed specialties.
1856 2. Enhancing the retention of primary care physicians or
1857other needed specialties in this state.
1858 3. Promoting practice in rural or medically underserved
1859areas of the state.
1860 4. Encouraging racial and ethnic diversity within the
1861state's physician workforce.
1862 5. Encouraging practice in community health care or other
1863ambulatory care settings.
1864 6. Encouraging practice in clinics operated by the
1865department, including, but not limited to, county health
1866departments, clinics operated by the Department of Veterans'
1867Affairs, prison clinics, or similar settings of need.
1868 7. Encouraging the increased production of geriatricians.
1869 (d) Priority shall be given to a proposal for a pilot
1870project that:
1871 1. Demonstrates a collaboration of federal, state, and
1872local entities that are public or private.
1873 2. Obtains funding from multiple sources.
1874 3. Focuses on enhancing graduate medical education in
1875rural or underserved areas.
1876 4. Focuses on enhancing graduate medical education in
1877ambulatory or community-based settings other than a hospital
1878environment.
1879 5. Includes the use of technology, such as electronic
1880medical records, distance consultation, and telemedicine, to
1881ensure that residents are better prepared to care for patients
1882in this state, regardless of the community in which the
1883residents practice.
1884 6. Is designed to meet multiple policy needs as enumerated
1885in subsection (4).
1886 7. Uses a consortium to provide for graduate medical
1887education experiences.
1888 (e) The department shall adopt by rule appropriate
1889performance measures to use in order to consistently evaluate
1890the effectiveness, safety, and quality of the programs, as well
1891as the impact of each program on meeting this state's physician
1892workforce needs.
1893 (f) Participating pilot projects shall submit to the
1894department an annual report on the project in a manner required
1895by the department.
1896 (g) Funding provided to a pilot project may be used only
1897for the direct costs of providing graduate medical education.
1898Accounting of such costs and expenditures shall be documented in
1899the annual report.
1900 (h) State funds shall be used to supplement funds from any
1901local government, community, or private source. The state may
1902provide up to 50 percent of the funds, and local governmental
1903grants or community or private sources shall provide the
1904remainder of the funds.
1905 (7) RULEMAKING.-The department shall adopt rules as
1906necessary to administer this section.
1907 Section 39. Paragraph (l) of subsection (4) of section
1908400.9905, Florida Statutes, is amended to read:
1909 400.9905 Definitions.-
1910 (4) "Clinic" means an entity at which health care services
1911are provided to individuals and which tenders charges for
1912reimbursement for such services, including a mobile clinic and a
1913portable equipment provider. For purposes of this part, the term
1914does not include and the licensure requirements of this part do
1915not apply to:
1916 (l) Orthotic, or prosthetic, pediatric cardiology, or
1917perinatology clinical facilities that are a publicly traded
1918corporation or that are wholly owned, directly or indirectly, by
1919a publicly traded corporation. As used in this paragraph, a
1920publicly traded corporation is a corporation that issues
1921securities traded on an exchange registered with the United
1922States Securities and Exchange Commission as a national
1923securities exchange.
1924 Section 40. Section 458.3192, Florida Statutes, is amended
1925to read:
1926 458.3192 Analysis of survey results; report.-
1927 (1) Each year, the Department of Health shall analyze the
1928results of the physician survey required by s. 458.3191 and
1929determine by geographic area and specialty the number of
1930physicians who:
1931 (a) Perform deliveries of children in this state Florida.
1932 (b) Read mammograms and perform breast-imaging-guided
1933procedures in this state Florida.
1934 (c) Perform emergency care on an on-call basis for a
1935hospital emergency department.
1936 (d) Plan to reduce or increase emergency on-call hours in
1937a hospital emergency department.
1938 (e) Plan to relocate their allopathic or osteopathic
1939practice outside the state.
1940 (f) Practice medicine in this state.
1941 (g) Plan to reduce or modify the scope of their practice.
1942 (2) The Department of Health must report its findings to
1943the Governor, the President of the Senate, and the Speaker of
1944the House of Representatives by November 1 each year. The
1945department shall also include in its report findings,
1946recommendations, and strategic planning activities as provided
1947in s. 381.4018. The department may also include other
1948information requested by the Physician Workforce Advisory
1949Council.
1950 Section 41. Section 459.0082, Florida Statutes, is amended
1951to read:
1952 459.0082 Analysis of survey results; report.-
1953 (1) Each year, the Department of Health shall analyze the
1954results of the physician survey required by s. 459.0081 and
1955determine by geographic area and specialty the number of
1956physicians who:
1957 (a) Perform deliveries of children in this state Florida.
1958 (b) Read mammograms and perform breast-imaging-guided
1959procedures in this state Florida.
1960 (c) Perform emergency care on an on-call basis for a
1961hospital emergency department.
1962 (d) Plan to reduce or increase emergency on-call hours in
1963a hospital emergency department.
1964 (e) Plan to relocate their allopathic or osteopathic
1965practice outside the state.
1966 (f) Practice medicine in this state.
1967 (g) Plan to reduce or modify the scope of their practice.
1968 (2) The Department of Health must report its findings to
1969the Governor, the President of the Senate, and the Speaker of
1970the House of Representatives by November 1 each year. The
1971department shall also include in its report findings,
1972recommendations, and strategic planning activities as provided
1973in s. 381.4018. The department may also include other
1974information requested by the Physician Workforce Advisory
1975Council.
1976 Section 42. Section 458.315, Florida Statutes, is amended
1977to read:
1978 458.315 Temporary certificate for practice in areas of
1979critical need.-
1980 (1) Any physician who:
1981 (a) Is licensed to practice in any jurisdiction in the
1982United States and other state, whose license is currently valid;
1983or,
1984 (b) Has served as a physician in the United States Armed
1985Forces for at least 10 years and received an honorable discharge
1986from the military;
1987
1988and who pays an application fee of $300 may be issued a
1989temporary certificate for to practice in areas of communities of
1990Florida where there is a critical need for physicians.
1991 (2) A certificate may be issued to a physician who:
1992 (a) Practices in an area of critical need;
1993 (b) Will be employed by or practice in a county health
1994department, correctional facility, Department of Veterans'
1995Affairs clinic, community health center funded by s. 329, s.
1996330, or s. 340 of the United States Public Health Services Act,
1997or other agency or institution that is approved by the State
1998Surgeon General and provides health care to meet the needs of
1999underserved populations in this state; or
2000 (c) Will practice for a limited time to address critical
2001physician-specialty, demographic, or geographic needs for this
2002state's physician workforce as determined by the State Surgeon
2003General entity that provides health care to indigents and that
2004is approved by the State Health Officer.
2005 (3) The Board of Medicine may issue this temporary
2006certificate with the following restrictions:
2007 (a)(1) The State Surgeon General board shall determine the
2008areas of critical need, and the physician so certified may
2009practice in any of those areas for a time to be determined by
2010the board. Such areas shall include, but are not be limited to,
2011health professional shortage areas designated by the United
2012States Department of Health and Human Services.
2013 1.(a) A recipient of a temporary certificate for practice
2014in areas of critical need may use the certificate license to
2015work for any approved entity employer in any area of critical
2016need or as authorized by the State Surgeon General approved by
2017the board.
2018 2.(b) The recipient of a temporary certificate for
2019practice in areas of critical need shall, within 30 days after
2020accepting employment, notify the board of all approved
2021institutions in which the licensee practices and of all approved
2022institutions where practice privileges have been denied.
2023 (b)(2) The board may administer an abbreviated oral
2024examination to determine the physician's competency, but a no
2025written regular examination is not required necessary. Within 60
2026days after receipt of an application for a temporary
2027certificate, the board shall review the application and issue
2028the temporary certificate, or notify the applicant of denial, or
2029notify the applicant that the board recommends additional
2030assessment, training, education, or other requirements as a
2031condition of certification. If the applicant has not actively
2032practiced during the prior 3 years and the board determines that
2033the applicant may lack clinical competency, possess diminished
2034or inadequate skills, lack necessary medical knowledge, or
2035exhibit patterns of deficits in clinical decisionmaking, the
2036board may:
2037 1. Deny the application;
2038 2. Issue a temporary certificate with reasonable
2039restrictions that may include, but are not limited to, a
2040requirement for the applicant to practice under the supervision
2041of a physician approved by the board; or
2042 3. Issue a temporary certificate upon receipt of
2043documentation confirming that the applicant has met any
2044reasonable conditions of the board which may include, but are
2045not limited to, completing continuing education or undergoing an
2046assessment of skills and training.
2047 (c)(3) Any certificate issued under this section is shall
2048be valid only so long as the State Surgeon General determines
2049that the reason area for which it was is issued remains a an
2050area of critical need to the state. The Board of Medicine shall
2051review each temporary certificateholder the service within said
2052area not less than annually to ascertain that the minimum
2053requirements of the Medical Practice Act and its adopted the
2054rules and regulations promulgated thereunder are being complied
2055with. If it is determined that such minimum requirements are not
2056being met, the board shall forthwith revoke such certificate or
2057shall impose restrictions or conditions, or both, as a condition
2058of continued practice under the certificate.
2059 (d)(4) The board may shall not issue a temporary
2060certificate for practice in an area of critical need to any
2061physician who is under investigation in any jurisdiction in the
2062United States another state for an act that which would
2063constitute a violation of this chapter until such time as the
2064investigation is complete, at which time the provisions of s.
2065458.331 shall apply.
2066 (4)(5) The application fee and all licensure fees,
2067including neurological injury compensation assessments, shall be
2068waived for those persons obtaining a temporary certificate to
2069practice in areas of critical need for the purpose of providing
2070volunteer, uncompensated care for low-income residents
2071Floridians. The applicant must submit an affidavit from the
2072employing agency or institution stating that the physician will
2073not receive any compensation for any service involving the
2074practice of medicine.
2075 Section 43. Section 459.0076, Florida Statutes, is created
2076to read:
2077 459.0076 Temporary certificate for practice in areas of
2078critical need.-
2079 (1) Any physician who:
2080 (a) Is licensed to practice in any jurisdiction in the
2081United States and whose license is currently valid; or
2082 (b) Has served as a physician in the United States Armed
2083Forces for at least 10 years and received an honorable discharge
2084from the military;
2085
2086and who pays an application fee of $300 may be issued a
2087temporary certificate for practice in areas of critical need.
2088 (2) A certificate may be issued to a physician who:
2089 (a) Will practice in an area of critical need;
2090 (b) Will be employed by or practice in a county health
2091department, correctional facility, Department of Veterans'
2092Affairs clinic, community health center funded by s. 329, s.
2093330, or s. 340 of the United States Public Health Services Act,
2094or other agency or institution that is approved by the State
2095Surgeon General and provides health care to meet the needs of
2096underserved populations in this state; or
2097 (c) Will practice for a limited time to address critical
2098physician-specialty, demographic, or geographic needs for this
2099state's physician workforce as determined by the State Surgeon
2100General.
2101 (3) The Board of Osteopathic Medicine may issue this
2102temporary certificate with the following restrictions:
2103 (a) The State Surgeon General shall determine the areas of
2104critical need. Such areas include, but are not limited to,
2105health professional shortage areas designated by the United
2106States Department of Health and Human Services.
2107 1. A recipient of a temporary certificate for practice in
2108areas of critical need may use the certificate to work for any
2109approved entity in any area of critical need or as authorized by
2110the State Surgeon General.
2111 2. The recipient of a temporary certificate for practice
2112in areas of critical need shall, within 30 days after accepting
2113employment, notify the board of all approved institutions in
2114which the licensee practices and of all approved institutions
2115where practice privileges have been denied.
2116 (b) The board may administer an abbreviated oral
2117examination to determine the physician's competency, but a
2118written regular examination is not required. Within 60 days
2119after receipt of an application for a temporary certificate, the
2120board shall review the application and issue the temporary
2121certificate, notify the applicant of denial, or notify the
2122applicant that the board recommends additional assessment,
2123training, education, or other requirements as a condition of
2124certification. If the applicant has not actively practiced
2125during the prior 3 years and the board determines that the
2126applicant may lack clinical competency, possess diminished or
2127inadequate skills, lack necessary medical knowledge, or exhibit
2128patterns of deficits in clinical decisionmaking, the board may:
2129 1. Deny the application;
2130 2. Issue a temporary certificate having reasonable
2131restrictions that may include, but are not limited to, a
2132requirement for the applicant to practice under the supervision
2133of a physician approved by the board; or
2134 3. Issue a temporary certificate upon receipt of
2135documentation confirming that the applicant has met any
2136reasonable conditions of the board, which may include, but are
2137not limited to, completing continuing education or undergoing an
2138assessment of skills and training.
2139 (c) Any certificate issued under this section is valid
2140only so long as the State Surgeon General determines that the
2141reason for which it was issued remains a critical need to the
2142state. The Board of Osteopathic Medicine shall review each
2143temporary certificateholder not less than annually to ascertain
2144that the minimum requirements of the Osteopathic Medical
2145Practice Act and its adopted rules are being complied with. If
2146it is determined that such minimum requirements are not being
2147met, the board shall revoke such certificate or shall impose
2148restrictions or conditions, or both, as a condition of continued
2149practice under the certificate.
2150 (d) The board may not issue a temporary certificate for
2151practice in an area of critical need to any physician who is
2152under investigation in any jurisdiction in the United States for
2153an act that would constitute a violation of this chapter until
2154such time as the investigation is complete, at which time the
2155provisions of s. 459.015 apply.
2156 (4) The application fee and all licensure fees, including
2157neurological injury compensation assessments, shall be waived
2158for those persons obtaining a temporary certificate to practice
2159in areas of critical need for the purpose of providing
2160volunteer, uncompensated care for low-income residents. The
2161applicant must submit an affidavit from the employing agency or
2162institution stating that the physician will not receive any
2163compensation for any service involving the practice of medicine.
2164 Section 44. Paragraph (i) is added to subsection (3) of
2165section 499.01212, Florida Statutes, to read:
2166 499.01212 Pedigree paper.-
2167 (3) EXCEPTIONS.-A pedigree paper is not required for:
2168 (i) The wholesale distribution of prescription drugs
2169within a medical convenience kit if:
2170 1. The medical convenience kit is assembled in an
2171establishment that is registered with the United States Food and
2172Drug Administration as a medical device manufacturer;
2173 2. The medical convenience kit manufacturer is an
2174authorized distributor of record, as defined by 21 C.F.R. s.
2175203.3, for the manufacturer of the specific drugs contained
2176within the kit; and
2177 3. The drugs contained in the medical convenience kit are:
2178 a. Intravenous solutions intended for the replenishment of
2179fluids and electrolytes;
2180 b. Products intended to maintain the equilibrium of water
2181and minerals in the body;
2182 c. Products intended for irrigation or reconstitution;
2183 d. Anesthetics; or
2184 e. Anticoagulants.
2185
2186This paragraph does not apply to a medical convenience kit
2187containing any controlled substance that appears in any schedule
2188contained in or subject to chapter 893 or the Federal
2189Comprehensive Drug Abuse Prevention and Control Act of 1970.
2190 Section 45. Subsection (1) of section 465.0251, Florida
2191Statutes, is reenacted to read:
2192 465.0251 Generic drugs; removal from formulary under
2193specified circumstances.-
2194 (1) The Board of Pharmacy and the Board of Medicine shall
2195remove any generic named drug product from the formulary
2196established by s. 465.025(6), if every commercially marketed
2197equivalent of that drug product is "A" rated as therapeutically
2198equivalent to a reference listed drug or is a reference listed
2199drug as referred to in "Approved Drug Products with Therapeutic
2200Equivalence Evaluations" (Orange Book) published by the United
2201States Food and Drug Administration.
2202 Section 46. Subsection (3) is added to section 626.9541,
2203Florida Statutes, to read:
2204 626.9541 Unfair methods of competition and unfair or
2205deceptive acts or practices defined; alternative rates of
2206payment; wellness programs.-
2207 (3) WELLNESS PROGRAMS.-An insurer issuing a group or
2208individual health benefit plan may offer a voluntary wellness or
2209health-improvement program that allows for rewards or
2210incentives, including, but not limited to, merchandise, gift
2211cards, debit cards, premium discounts or rebates, contributions
2212towards a member's health savings account, modifications to
2213copayment, deductible, or coinsurance amounts, or any
2214combination of these incentives, to encourage or reward
2215participation in the program. The health plan member may be
2216required to provide verification, such as a statement from his
2217or her physician, that a medical condition makes it unreasonably
2218difficult or medically inadvisable for the individual to
2219participate in the wellness program. Any reward or incentive
2220established under this subsection is not an insurance benefit
2221and does not violate this section. This subsection does not
2222prohibit an insurer from offering incentives or rewards to
2223members for adherence to wellness or health improvement programs
2224if otherwise allowed by state or federal law. Notwithstanding
2225any provision of this subsection, no insurer, nor its agent, may
2226use any incentive authorized by this subsection for the purpose
2227of redirecting patients from one health care insurance plan to
2228another.
2229 Section 47. This act shall take effect July 1, 2010.
CODING: Words stricken are deletions; words underlined are additions.
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