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; providing an effective date.
218
219Be It Enacted by the Legislature of the State of Florida:
220
221     Section 1.  Paragraph (e) of subsection (10) of section
222112.0455, Florida Statutes, is repealed, and paragraph (e) of
223subsection (14) of that section is amended to read:
224     112.0455  Drug-Free Workplace Act.-
225     (14)  DISCIPLINE REMEDIES.-
226     (e)  Upon resolving an appeal filed pursuant to paragraph
227(c), and finding a violation of this section, the commission may
228order the following relief:
229     1.  Rescind the disciplinary action, expunge related
230records from the personnel file of the employee or job applicant
231and reinstate the employee.
232     2.  Order compliance with paragraph (10)(f)(g).
233     3.  Award back pay and benefits.
234     4.  Award the prevailing employee or job applicant the
235necessary costs of the appeal, reasonable attorney's fees, and
236expert witness fees.
237     Section 2.  Subsection (3) is added to section 381.00315,
238Florida Statutes, to read:
239     381.00315  Public health advisories; public health
240emergencies.-The State Health Officer is responsible for
241declaring public health emergencies and issuing public health
242advisories.
243     (3)  To facilitate effective emergency management, when the
244United States Department of Health and Human Services contracts
245for the manufacture and delivery of licensable products in
246response to a public health emergency and the terms of those
247contracts are made available to the states, the department shall
248accept funds provided by cities, counties, and other entities
249designated in the state emergency management plan required under
250s. 252.35(2)(a) for the purpose of participation in those
251contracts. The department shall deposit those funds in the
252Grants and Donations Trust Fund and expend those funds on behalf
253of the donor city, county, or other entity for the purchase of
254the licensable products made available under the contract.
255     Section 3.  Paragraphs (a) and (b) of subsection (3) of
256section 381.932, Florida Statutes, are amended to read:
257     381.932  Breast cancer early detection and treatment
258referral program.-
259     (3)  The program shall include, but not be limited to, the:
260     (a)  Establishment of a public education and outreach
261initiative to publicize breast cancer early detection services,
262the benefits of early detection of breast cancer, and the
263recommended frequency for receiving screening services,
264including clinical breast examinations and mammography
265guidelines currently employed established by the United States
266Centers for Disease Control and Prevention Preventive Services
267Task Force.
268     (b)  Development of professional education programs that
269include information regarding the benefits of the early
270detection of breast cancer and the recommended frequency for
271receiving a mammogram, as recommended in the most current breast
272cancer screening guidelines currently employed established by
273the United States Centers for Disease Control and Prevention
274Preventive Services Task Force.
275     Section 4.  Subsection (2) of section 381.06015, Florida
276Statutes, is amended, and subsection (8) is added to that
277section, to read:
278     381.06015  Public Cord Blood Tissue Bank.-
279     (2)(a)  The Agency for Health Care Administration and the
280Department of Health shall encourage health care providers,
281including, but not limited to, hospitals, birthing facilities,
282county health departments, physicians, midwives, and nurses, to
283disseminate information about the Public Cord Blood Tissue Bank.
284     (b)  The State Surgeon General shall make publicly
285available, by posting on the Internet website of the Department
286of Health, resources and an Internet website link to materials
287relating to umbilical cord blood that have been developed by the
288Parent's Guide to Cord Blood Foundation.
289     (8)  Beginning October 1, 2010, the Department of Health
290shall encourage health care professionals who provide health
291care services that are directly related to a woman's pregnancy
292to make available to the patient before her third trimester of
293pregnancy, or, if later, at the first visit of such pregnant
294woman to the provider, information developed under paragraph
295(2)(b) relating to the woman's options with respect to umbilical
296cord blood banking.
297     Section 5.  Section 383.325, Florida Statutes, is repealed.
298     Section 6.  Paragraph (b) of subsection (1) of section
299395.1055, Florida Statutes, is amended to read:
300     395.1055  Rules and enforcement.-
301     (1)  The agency shall adopt rules pursuant to ss.
302120.536(1) and 120.54 to implement the provisions of this part,
303which shall include reasonable and fair minimum standards for
304ensuring that:
305     (b)  Infection control, housekeeping, sanitary conditions,
306and medical record procedures that will adequately protect
307patient care and safety are established and implemented.  
308Infection control rules shall include a requirement to establish
309and implement a comprehensive plan to reduce health care
310associated infections. The plan must include all of the
311following components:
312     1.  A baseline measurement of health care associated
313infections in the hospital that uses the National Healthcare
314Safety Network and Centers for Disease Control and Prevention
315surveillance definitions and reports the number of infections in
316each category relative to the volume of possible cases in the
317hospital.
318     2.  A goal for reducing the incidence of infections by a
319specific amount within a defined period of time. The hospital's
320goal for reduction of infections must be commensurate with the
321national goal for reducing each type of health care associated
322infection.
323     3.  An action plan for reducing each type of health care
324associated infection, including the use of real-time infection
325surveillance technology or automated infection control or
326prevention technology.
327     4.  Methods for making information available to patients
328and the public regarding baseline measurements and periodic
329reports on the hospital's progress in improving measures
330designed to reduce health care associated infections.
331     Section 7.  Section 395.1046, Florida Statutes, is
332repealed.
333     Section 8.  Section 395.3037, Florida Statutes, is
334repealed.
335     Section 9.  Paragraph (g) of subsection (2) of section
336400.0239, Florida Statutes, is amended to read:
337     400.0239  Quality of Long-Term Care Facility Improvement
338Trust Fund.-
339     (2)  Expenditures from the trust fund shall be allowable
340for direct support of the following:
341     (g)  Other initiatives authorized by the Centers for
342Medicare and Medicaid Services for the use of federal civil
343monetary penalties, including projects recommended through the
344Medicaid "Up-or-Out" Quality of Care Contract Management Program
345pursuant to s. 400.148.
346     Section 10.  Subsection (10) of section 400.147, Florida
347Statutes, is repealed.
348     Section 11.  Section 400.148, Florida Statutes, is
349repealed.
350     Section 12.  Section 400.195, Florida Statutes, is
351repealed.
352     Section 13.  Section 400.476, Florida Statutes, is amended
353to read:
354     400.476  Staffing requirements; notifications; limitations
355on staffing services.-
356     (1)  ADMINISTRATOR.-
357     (a)  An administrator may manage only one home health
358agency, except that an administrator may manage up to five home
359health agencies if all five home health agencies have identical
360controlling interests as defined in s. 408.803 and are located
361within one agency geographic service area or within an
362immediately contiguous county. If the home health agency is
363licensed under this chapter and is part of a retirement
364community that provides multiple levels of care, an employee of
365the retirement community may administer the home health agency
366and up to a maximum of four entities licensed under this chapter
367or chapter 429 which all have identical controlling interests as
368defined in s. 408.803. An administrator shall designate, in
369writing, for each licensed entity, a qualified alternate
370administrator to serve during the administrator's absence. An
371alternate administrator must meet the requirements in this
372paragraph and s. 400.462(1).
373     (b)  An administrator of a home health agency who is a
374licensed physician, physician assistant, or registered nurse
375licensed to practice in this state may also be the director of
376nursing for a home health agency. An administrator may serve as
377a director of nursing for up to the number of entities
378authorized in subsection (2) only if there are 10 or fewer full-
379time equivalent employees and contracted personnel in each home
380health agency.
381     (c)  The administrator shall organize and direct the
382agency's ongoing functions, maintain an ongoing liaison with the
383board members and the staff, employ qualified personnel and
384ensure adequate staff education and evaluations, ensure the
385accuracy of public informational materials and activities,
386implement an effective budgeting and accounting system, and
387ensure that the home health agency operates in compliance with
388this part and part II of chapter 408 and rules adopted for these
389laws.
390     (d)  The administrator shall clearly set forth in writing
391the organizational chart, services furnished, administrative
392control authority, and lines of authority for the delegation of
393responsibilities for patient care. These responsibilities must
394be readily identifiable. Administrative and supervisory
395functions may not be delegated to another agency or
396organization, and the primary home health agency shall monitor
397and control all services that are not furnished directly,
398including services provided through contracts.
399     (2)  DIRECTOR OF NURSING.-
400     (a)  A director of nursing may be the director of nursing
401for:
402     1.  Up to two licensed home health agencies if the agencies
403have identical controlling interests as defined in s. 408.803
404and are located within one agency geographic service area or
405within an immediately contiguous county; or
406     2.  Up to five licensed home health agencies if:
407     a.  All of the home health agencies have identical
408controlling interests as defined in s. 408.803;
409     b.  All of the home health agencies are located within one
410agency geographic service area or within an immediately
411contiguous county; and
412     c.  Each home health agency has a registered nurse who
413meets the qualifications of a director of nursing and who has a
414written delegation from the director of nursing to serve as the
415director of nursing for that home health agency when the
416director of nursing is not present; and.
417     d.  This person, or a similarly qualified alternate, is
418available at all times by telecommunications during operating
419hours and participates.
420
421If a home health agency licensed under this chapter is part of a
422retirement community that provides multiple levels of care, an
423employee of the retirement community may serve as the director
424of nursing of the home health agency and up to a maximum of four
425entities, other than home health agencies, licensed under this
426chapter or chapter 429 which all have identical controlling
427interests as defined in s. 408.803.
428     (b)  A home health agency that provides skilled nursing
429care may not operate for more than 30 calendar days without a
430director of nursing. A home health agency that provides skilled
431nursing care and the director of nursing of a home health agency
432must notify the agency within 10 business days after termination
433of the services of the director of nursing for the home health
434agency. A home health agency that provides skilled nursing care
435must notify the agency of the identity and qualifications of the
436new director of nursing within 10 days after the new director is
437hired. If a home health agency that provides skilled nursing
438care operates for more than 30 calendar days without a director
439of nursing, the home health agency commits a class II
440deficiency. In addition to the fine for a class II deficiency,
441the agency may issue a moratorium in accordance with s. 408.814
442or revoke the license. The agency shall fine a home health
443agency that fails to notify the agency as required in this
444paragraph $1,000 for the first violation and $2,000 for a repeat
445violation. The agency may not take administrative action against
446a home health agency if the director of nursing fails to notify
447the department upon termination of services as the director of
448nursing for the home health agency.
449     (c)  A home health agency that is not Medicare or Medicaid
450certified and does not provide skilled care or provides only
451physical, occupational, or speech therapy is not required to
452have a director of nursing and is exempt from paragraph (b).
453     (3)  TRAINING.-A home health agency shall ensure that each
454certified nursing assistant employed by or under contract with
455the home health agency and each home health aide employed by or
456under contract with the home health agency is adequately trained
457to perform the tasks of a home health aide in the home setting.
458     (a)  The home health agency may not use as a home health
459aide on a full-time, temporary, per diem, or other basis any
460individual to provide services unless the individual has
461completed a training and competency evaluation program, or a
462competency evaluation program, as permitted in s. 400.497, which
463meets the minimum standards established by the agency in state
464rules.
465     (b)  A home health aide is not competent in any task for
466which he or she is evaluated as "unsatisfactory." The aide must
467perform any such task only under direct supervision by a
468licensed nurse until he or she receives training in the task and
469satisfactorily passes a subsequent evaluation in performing the
470task. A home health aide has not successfully passed a
471competency evaluation if the aide does not have a passing score
472on the test as specified by agency rule.
473     (4)  STAFFING.-Staffing services may be provided anywhere
474within the state.
475     (5)  PERSONNEL.-
476     (a)  The home health agency and its staff must comply with
477accepted professional standards and principles that apply to
478professionals, including, but not limited to, the state practice
479acts and the home health agency's policies and procedures.
480     (b)  Except for direct employees of the home health agency,
481if personnel under hourly or per-visit contracts are used by the
482home health agency, there must be a written contract between
483those personnel and the agency which specifies the following
484requirements:
485     1.  Acceptance for care only of patients by the primary
486home health agency.
487     2.  The services to be furnished.
488     3.  The necessity to conform to all applicable agency
489policies, including personnel qualifications.
490     4.  The responsibility for participating in developing
491plans of care.
492     5.  The manner in which services are controlled,
493coordinated, and evaluated by the primary home health agency.
494     6.  The procedures for submitting clinical and progress
495notes, scheduling visits, and providing periodic patient
496evaluations.
497     7.  The procedures for payment for services furnished under
498the contract.
499     (c)  A home health agency shall directly provide at least
500one of the types of authorized services through home health
501agency employees, but may provide additional services under
502arrangements with another agency or organization. Services
503furnished under such arrangements must have a written contract
504conforming to the requirements specified in paragraph (b).
505     (d)  If home health aide services are provided by an
506individual who is not employed directly by the home health
507agency, the services of the home health aide must be provided
508under arrangements as stated in paragraphs (b) and (c). If the
509home health agency chooses to provide home health aide services
510under arrangements with another organization, the
511responsibilities of the home health agency include, but are not
512limited to:
513     1.  Ensuring the overall quality of the care provided by
514the aide.
515     2.  Supervising the aide's services as described in s.
516400.487.
517     3.  Ensuring that each home health aide providing services
518under arrangements with another organization has met the
519training requirements or competency evaluation requirements of
520s. 400.497.
521     (e)  The home health agency shall coordinate the efforts of
522all personnel furnishing services, and the personnel shall
523maintain communication with the home health agency to ensure
524that personnel efforts support the objectives outlined in the
525plan of care. The clinical record or minutes of case conferences
526shall ensure that effective interchange, reporting, and
527coordination of patient care occurs.
528     Section 14.  Section 400.487, Florida Statutes, is amended
529to read:
530     400.487  Home health service agreements; physician's,
531physician assistant's, and advanced registered nurse
532practitioner's treatment orders; patient assessment;
533establishment and review of plan of care; provision of services;
534orders not to resuscitate.-
535     (1)  Services provided by a home health agency must be
536covered by an agreement between the home health agency and the
537patient or the patient's legal representative specifying the
538home health services to be provided, the rates or charges for
539services paid with private funds, and the sources of payment,
540which may include Medicare, Medicaid, private insurance,
541personal funds, or a combination thereof. The home health agency
542shall provide a copy of the agreement to the patient or the
543patient's legal representative. A home health agency providing
544skilled care must make an assessment of the patient's needs
545within 48 hours after the start of services.
546     (2)  When required by the provisions of chapter 464; part
547I, part III, or part V of chapter 468; or chapter 486, the
548attending physician, physician assistant, or advanced registered
549nurse practitioner, acting within his or her respective scope of
550practice, shall establish treatment orders for a patient who is
551to receive skilled care. The treatment orders must be signed by
552the physician, physician assistant, or advanced registered nurse
553practitioner before a claim for payment for the skilled services
554is submitted by the home health agency. If the claim is
555submitted to a managed care organization, the treatment orders
556must be signed within the time allowed under the provider
557agreement. The treatment orders shall be reviewed, as frequently
558as the patient's illness requires, by the physician, physician
559assistant, or advanced registered nurse practitioner in
560consultation with the home health agency.
561     (3)  A home health agency shall arrange for supervisory
562visits by a registered nurse to the home of a patient receiving
563home health aide services as specified in subsection (9) in
564accordance with the patient's direction, approval, and agreement
565to pay the charge for the visits.
566     (4)  The home health agency shall protect and promote the
567rights of each individual under its care, including each of the
568following rights:
569     (a)  Notice of rights.-The home health agency shall provide
570the patient with a written notice of the patient's rights in
571advance of furnishing care to the patient or during the initial
572evaluation visit before the initiation of treatment. The home
573health agency must maintain documentation showing that it has
574complied with the requirements of this section.
575     (b)  Exercise of rights and respect for property and
576person.-
577     1.  The patient has the right to exercise his or her rights
578as a patient of the home health agency.
579     2.  The patient has the right to have his or her property
580treated with respect.
581     3.  The patient has the right to voice grievances regarding
582treatment or care that is or fails to be furnished, or regarding
583the lack of respect for property by anyone who is furnishing
584services on behalf of the home health agency, and not be
585subjected to discrimination or reprisal for doing so.
586     4.  The home health agency must investigate complaints made
587by a patient or the patient's family or guardian regarding
588treatment or care that is or fails to be furnished or regarding
589the lack of respect for the patient's property by anyone
590furnishing services on behalf of the home health agency. The
591home health agency shall document the existence of the complaint
592and its resolution.
593     5.  The patient and his or her immediate family or
594representative must be informed of the right to report
595complaints via the statewide toll-free telephone number to the
596agency as required in s. 408.810.
597     (c)  Right to be informed and to participate in planning
598care and treatment.-
599     1.  The patient has the right to be informed, in advance,
600about the care to be furnished and of any changes in the care to
601be furnished. The home health agency shall advise the patient in
602advance of which disciplines will furnish care and the frequency
603of visits proposed to be furnished. The home health agency must
604advise the patient in advance of any change in the plan of care
605before the change is made.
606     2.  The patient has the right to participate in the
607planning of the care. The home health agency must advise the
608patient in advance of the right to participate in planning the
609care or treatment and in planning changes in the care or
610treatment. Each patient has the right to be informed of and to
611participate in the planning of his or her care. Each patient
612must be provided, upon request, a copy of the plan of care
613established and maintained for that patient by the home health
614agency.
615     (5)  When nursing services are ordered, the home health
616agency to which a patient has been admitted for care must
617provide the initial admission visit, all service evaluation
618visits, and the discharge visit by a direct employee. Services
619provided by others under contractual arrangements to a home
620health agency must be monitored and managed by the admitting
621home health agency. The admitting home health agency is fully
622responsible for ensuring that all care provided through its
623employees or contract staff is delivered in accordance with this
624part and applicable rules.
625     (6)  The skilled care services provided by a home health
626agency, directly or under contract, must be supervised and
627coordinated in accordance with the plan of care. The home health
628agency shall furnish skilled nursing services by or under the
629supervision of a registered nurse and in accordance with the
630plan of care. Any therapy services offered directly or under
631arrangement by the home health agency must be provided by a
632qualified therapist or by a qualified therapy assistant under
633the supervision of a qualified therapist and in accordance with
634the plan of care.
635     (a)  Physical therapy services.-Physical therapy services
636shall be furnished only by or under the supervision of a
637licensed physical therapist or licensed physical therapist
638assistant as required under chapter 486 and related applicable
639rules. A physical therapist assistant shall perform services
640planned, delegated, and supervised by the physical therapist,
641assist in preparing clinical notes and progress reports,
642participate in educating the patient and his or her family, and
643participate in in-service programs. This paragraph does not
644limit the services provided by a physician licensed under
645chapter 458 or chapter 459.
646     (b)  Occupational therapy services.-Occupational therapy
647services shall be furnished only by or under the supervision of
648a licensed occupational therapist or occupational therapy
649assistant as provided under part III of chapter 468 and related
650applicable rules. An occupational therapy assistant shall
651perform any services planned, delegated, and supervised by an
652occupational therapist, assist in preparing clinical notes and
653progress reports, participate in educating the patient and his
654or her family, and participate in in-service programs. This
655paragraph does not limit the services provided by a physician
656licensed under chapter 458 or chapter 459.
657     (c)  Speech therapy services.-Speech therapy services shall
658be furnished only by or under supervision of a qualified speech-
659language pathologist or audiologist as required in part I of
660chapter 468 and applicable rules.
661     (d)  Care follows a written plan of care.-The plan of care
662shall be reviewed by the physician or health professional who
663provided the treatment orders pursuant to subsection (2) and
664home health agency personnel as often as the severity of the
665patient's condition requires, but at least once every 60 days or
666more when there is a patient-elected transfer, a significant
667change in condition, or a discharge and return to the same home
668health agency during the 60-day episode. Professional staff of a
669home health agency shall promptly alert the physician or other
670health professional who provided the treatment orders of any
671change that suggests a need to alter the plan of care.
672     (e)  Administration of drugs and treatment.-Only
673professional staff of a home health agency may administer drugs
674and treatments as ordered by the physician or health
675professional pursuant to subsection (2), with the exception of
676influenza and pneumococcal polysaccharide vaccines, which may be
677administered according to the policy of the home health agency
678developed in consultation with a physician and after an
679assessment for contraindications. Verbal orders shall be in
680writing and signed and dated with the date of receipt by the
681registered nurse or qualified therapist who is responsible for
682furnishing or supervising the ordered service. A verbal order
683may be accepted only by personnel who are authorized to do so by
684applicable state laws, rules, and internal policies of the home
685health agency.
686     (7)  A registered nurse shall conduct the initial
687evaluation visit, regularly reevaluate the patient's nursing
688needs, initiate the plan of care and necessary revisions,
689furnish those services requiring substantial and specialized
690nursing skill, initiate appropriate preventive and
691rehabilitative nursing procedures, prepare clinical and progress
692notes, coordinate services, inform the physician and other
693personnel of changes in the patient's condition and needs,
694counsel the patient and his or her family in meeting nursing and
695related needs, participate in in-service programs, and supervise
696and teach other nursing personnel, unless the home health agency
697providing the home health aide services is not Medicare-
698certified or Medicaid-certified and does not provide skilled
699care or the patient is not receiving skilled care.
700     (8)  A licensed practical nurse shall furnish services in
701accordance with agency policies, prepare clinical and progress
702notes, assist the physician and registered nurse in performing
703specialized procedures, prepare equipment and materials for
704treatments observing aseptic technique as required, and assist
705the patient in learning appropriate self-care techniques.
706     (9)  A home health aide and certified nursing assistant
707shall provide services that are in the service provision plan
708provided in s. 400.491 and other services that the home health
709aide or certified nursing assistant is permitted to perform
710under state law. The duties of a home health aide or certified
711nursing assistant include the provision of hands-on personal
712care, performance of simple procedures as an extension of
713therapy or nursing services, assistance in ambulation or
714exercises, and assistance in administering medications that are
715ordinarily self-administered and are specified in agency rules.
716Any services by a home health aide which are offered by a home
717health agency must be provided by a qualified home health aide
718or certified nursing assistant.
719     (a)  Assignment and duties.-A home health aide or certified
720nursing assistant shall be assigned to a specific patient by a
721registered nurse, unless the home health agency providing the
722home health aide services is not Medicare-certified or Medicaid-
723certified and does not provide skilled care or the patient is
724not receiving skilled care. Written patient care instructions
725for the home health aide and certified nursing assistant must be
726prepared by the registered nurse or other appropriate
727professional who is responsible for the supervision of the home
728health aide and certified nursing assistant as stated in this
729section.
730     (b)  Supervision.-If a patient receives skilled nursing
731care, the registered nurse shall perform the supervisory visit.
732If the patient is not receiving skilled nursing care but is
733receiving physical therapy, occupational therapy, or speech-
734language pathology services, the appropriate therapist may
735provide the supervision. A registered nurse or other
736professional must make an onsite visit to the patient's home at
737least once every 2 weeks. The visit is not required while the
738aide is providing care.
739     (c)  Supervisory visits.-If home health aide services are
740provided to a patient who is not receiving skilled nursing care,
741physical or occupational therapy, or speech-language pathology
742services, a registered nurse must make a supervisory visit to
743the patient's home at least once every 60 days, unless the home
744health agency providing the home health aide services is not
745Medicare-certified or Medicaid-certified and does not provide
746skilled care, either directly or through contracts. The
747registered nurse shall ensure that the aide is properly caring
748for the patient and each supervisory visit must occur while the
749home health aide is providing patient care. In addition to the
750requirements in this subsection, a home health agency shall
751arrange for additional supervisory visits by a registered nurse
752to the home of a patient receiving home health aide services in
753accordance with the patient's direction, approval, and agreement
754to pay the charge for the visits.
755     (10)(7)  Home health agency personnel may withhold or
756withdraw cardiopulmonary resuscitation if presented with an
757order not to resuscitate executed pursuant to s. 401.45. The
758agency shall adopt rules providing for the implementation of
759such orders. Home health personnel and agencies shall not be
760subject to criminal prosecution or civil liability, nor be
761considered to have engaged in negligent or unprofessional
762conduct, for withholding or withdrawing cardiopulmonary
763resuscitation pursuant to such an order and rules adopted by the
764agency.
765     Section 15.  Paragraphs (f) and (g) of subsection (4) of
766section 400.9905, Florida Statutes, are amended to read:
767     400.9905  Definitions.-
768     (4)  "Clinic" means an entity at which health care services
769are provided to individuals and which tenders charges for
770reimbursement for such services, including a mobile clinic and a
771portable equipment provider. For purposes of this part, the term
772does not include and the licensure requirements of this part do
773not apply to:
774     (f)  A sole proprietorship, group practice, partnership, or
775corporation, or other legal entity that provides health care
776services by practitioners licensed under chapter 458, chapter
777459, chapter 461, chapter 466, or chapter 460 and subject to the
778limitations of s. 460.4167 physicians covered by s. 627.419,
779that is directly supervised by one or more of such physicians or
780physician assistants, and that is wholly owned by one or more of
781those physicians or physician assistants or by a physician or
782physician assistant or and the spouse, parent, child, or sibling
783of that physician or physician assistant. A certificate of
784exemption is valid only for the entity, persons, and location
785for which it was originally issued.
786     1.  An individual who is not a medical professional or
787family member listed in this paragraph may own up to 30 percent
788of a health care clinic entity that is exempt under this
789paragraph if the individual obtains prior approval from the
790agency for ownership of a percentage of a health care clinic.
791Such an individual is considered an "applicant" under s.
792400.991(5) and must meet all the requirements of that section
793and the level 2 background screening requirements of s. 408.809
794before being approved by the agency for ownership of a minority
795interest in a health care clinic.
796     2.  If an individual who is not a medical professional or
797family member listed in this paragraph assumes ownership of an
798investment interest in a health care clinic without the prior
799approval of the agency, the health care clinic shall lose its
800exemption from licensure under this paragraph.
801     3.  Ownership of a health care clinic by an individual
802other than the physician or physician assistant, or by the
803spouse, parent, child, or sibling of the physician or physician
804assistant to whom the exemption was granted, may not exceed 30
805percent.
806     (g)  A sole proprietorship, group practice, partnership, or
807corporation that provides health care services by licensed
808health care practitioners under chapter 457, chapter 458,
809chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
810chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
811chapter 490, chapter 491, or part I, part III, part X, part
812XIII, or part XIV of chapter 468, or s. 464.012, which are
813wholly owned by one or more licensed health care practitioners,
814or the licensed health care practitioners set forth in this
815paragraph and the spouse, parent, child, or sibling of a
816licensed health care practitioner, so long as one of the owners
817who is a licensed health care practitioner is directly
818supervising health care services the business activities and is
819legally responsible for the entity's compliance with all federal
820and state laws. However, a health care practitioner who is a
821supervising owner may not supervise services beyond the scope of
822the practitioner's license, except that, for the purposes of
823this part, a clinic owned by a licensee in s. 456.053(3)(b) that
824provides only services authorized pursuant to s. 456.053(3)(b)
825may be supervised by a licensee specified in s. 456.053(3)(b). A
826certificate of exemption is valid only for the entity, persons,
827and location for which it was originally issued.
828     Section 16.  Subsection (11) of section 408.802, Florida
829Statutes, is repealed.
830     Section 17.  Paragraphs (e), (f), and (g) of subsection
831(15) of section 409.912, Florida Statutes, are repealed.
832     Section 18.  Subsection (13) of section 409.9122, Florida
833Statutes, is repealed.
834     Section 19.  Section 409.91255, Florida Statutes, is
835amended to read:
836     409.91255  Federally qualified health center access
837program.-
838     (1)  SHORT TITLE.-This section may be cited as the
839"Community Health Center Access Program Act."
840     (2)  LEGISLATIVE FINDINGS AND INTENT.-
841     (a)  The Legislature finds that, despite significant
842investments in health care programs, nearly 6 more than 2
843million low-income Floridians, primarily the working poor and
844minority populations, continue to lack access to basic health
845care services. Further, the Legislature recognizes that
846federally qualified health centers have a proven record of
847providing cost-effective, comprehensive primary and preventive
848health care and are uniquely qualified to address the lack of
849adequate health care services for the uninsured.
850     (b)  It is the intent of the Legislature to recognize the
851significance of increased federal investments in federally
852qualified health centers and to leverage that investment through
853the creation of a program to provide for the expansion of the
854primary and preventive health care services offered by federally
855qualified health centers. Further, such a program will support
856the coordination of federal, state, and local resources to
857assist such health centers in developing an expanded community-
858based primary care delivery system.
859     (3)  ASSISTANCE TO FEDERALLY QUALIFIED HEALTH CENTERS.-The
860agency shall administer Department of Health shall develop a
861program for the expansion of federally qualified health centers
862for the purpose of providing comprehensive primary and
863preventive health care and urgent care services that may reduce
864the morbidity, mortality, and cost of care among the uninsured
865population of the state. The program shall provide for
866distribution of financial assistance to federally qualified
867health centers that apply and demonstrate a need for such
868assistance in order to sustain or expand the delivery of primary
869and preventive health care services. In selecting centers to
870receive this financial assistance, the program:
871     (a)  Shall give preference to communities that have few or
872no community-based primary care services or in which the current
873services are unable to meet the community's needs. To assist in
874the assessment and identification of areas of critical need, a
875federally qualified health-center-based statewide assessment and
876strategic plan shall be developed by the Florida Association of
877Community Health Centers, Inc., every 5 years, beginning January
8781, 2011.
879     (b)  Shall require that primary care services be provided
880to the medically indigent using a sliding fee schedule based on
881income.
882     (c)  Shall promote allow innovative and creative uses of
883federal, state, and local health care resources.
884     (d)  Shall require that the funds provided be used to pay
885for operating costs of a projected expansion in patient
886caseloads or services or for capital improvement projects.
887Capital improvement projects may include renovations to existing
888facilities or construction of new facilities, provided that an
889expansion in patient caseloads or services to a new patient
890population will occur as a result of the capital expenditures.
891The agency department shall include in its standard contract
892document a requirement that any state funds provided for the
893purchase of or improvements to real property are contingent upon
894the contractor granting to the state a security interest in the
895property at least to the amount of the state funds provided for
896at least 5 years from the date of purchase or the completion of
897the improvements or as further required by law. The contract
898must include a provision that, as a condition of receipt of
899state funding for this purpose, the contractor agrees that, if
900it disposes of the property before the agency's department's
901interest is vacated, the contractor will refund the
902proportionate share of the state's initial investment, as
903adjusted by depreciation.
904     (e)  Shall May require in-kind support from other sources.
905     (f)  Shall promote May encourage coordination among
906federally qualified health centers, other private sector
907providers, and publicly supported programs.
908     (g)  Shall promote allow the development of community
909emergency room diversion programs in conjunction with local
910resources, providing extended hours of operation to urgent care
911patients. Diversion programs shall include case management for
912emergency room followup care.
913     (4)  EVALUATION OF APPLICATIONS.-A review panel shall be
914established, consisting of four persons appointed by the
915Secretary of Health Care Administration State Surgeon General
916and three persons appointed by the chief executive officer of
917the Florida Association of Community Health Centers, Inc., to
918review all applications for financial assistance under the
919program. Applicants shall specify in the application whether the
920program funds will be used for the expansion of patient
921caseloads or services or for capital improvement projects to
922expand and improve patient facilities. The panel shall use the
923following elements in reviewing application proposals and shall
924determine the relative weight for scoring and evaluating these
925elements:
926     (a)  The target population to be served.
927     (b)  The health benefits to be provided.
928     (c)  The methods that will be used to measure cost-
929effectiveness.
930     (d)  How patient satisfaction will be measured.
931     (e)  The proposed internal quality assurance process.
932     (f)  Projected health status outcomes.
933     (g)  How data will be collected to measure cost-
934effectiveness, health status outcomes, and overall achievement
935of the goals of the proposal.
936     (h)  All resources, including cash, in-kind, voluntary, or
937other resources that will be dedicated to the proposal.
938     (5)  ADMINISTRATION AND TECHNICAL ASSISTANCE.-The agency
939shall Department of Health may contract with the Florida
940Association of Community Health Centers, Inc., to develop and
941coordinate administer the program and provide technical
942assistance to the federally qualified health centers selected to
943receive financial assistance. The contracted entity shall be
944responsible for program support and assume all costs related to
945administration of this program.
946     Section 20.  Subsection (2) of section 429.075, Florida
947Statutes, is amended to read:
948     429.075  Limited mental health license.-An assisted living
949facility that serves three or more mental health residents must
950obtain a limited mental health license.
951     (2)  Facilities licensed to provide services to mental
952health residents shall provide appropriate supervision and
953staffing to provide for the health, safety, and welfare of such
954residents. Assisted living facilities within an area zoned for
955residential use in a municipality having a population of more
956than 400,000, which house persons identified as being part of a
957priority population that includes adult and adolescent residents
958who have severe and persistent mental illness, as described in
959s. 394.674, must maintain 24-hour security services provided by
960uniformed security personnel licensed under part III of chapter
961493.
962     Section 21.  Subsection (2) of section 429.12, Florida
963Statutes, is repealed.
964     Section 22.  Subsection (5) of section 429.23, Florida
965Statutes, is repealed.
966     Section 23.  Paragraph (a) of subsection (2) of section
967429.911, Florida Statutes, is repealed.
968     Section 24.  Dental workforce survey.-
969     (1)  Beginning in 2012, each person who applies for
970licensure renewal as a dentist or dental hygienist under chapter
971466, Florida Statutes, must, in conjunction with the renewal of
972such license under procedures and forms adopted by the Board of
973Dentistry and in addition to any other information that may be
974required from the applicant, furnish the following information
975to the Department of Health, working in conjunction with the
976board, in a dental workforce survey:
977     (a)  Licensee information, including, but not limited to:
978     1.  The name of the dental school or dental hygiene program
979that the dentist or dental hygienist graduated from and the year
980of graduation.
981     2.  The year that the dentist or dental hygienist began
982practicing or working in this state.
983     3.  The geographic location of the dentist's or dental
984hygienist's practice or address within the state.
985     4.  For a dentist in private practice:
986     a.  The number of full-time dental hygienists employed by
987the dentist during the reporting period.
988     b.  The number of full-time dental assistants employed by
989the dentist during the reporting period.
990     c.  The average number of patients treated per week by the
991dentist during the reporting period.
992     d.  The settings where the dental care was delivered.
993     5.  Anticipated plans of the dentist to change the status
994of his or her license or practice.
995     6.  The dentist's areas of specialty or certification.
996     7.  The year that the dentist completed a specialty program
997recognized by the American Dental Association.
998     8.  For a hygienist:
999     a.  The average number of patients treated per week by the
1000hygienist during the reporting period.
1001     b.  The settings where the dental care was delivered.
1002     9.  The dentist's memberships in professional
1003organizations.
1004     10.  The number of pro bono hours provided by the dentist
1005or dental hygienist during the last biennium.
1006     (b)  Information concerning the availability and trends
1007relating to critically needed services, including, but not
1008limited to, the following types of care provided by the dentist
1009or dental hygienist:
1010     1.  Dental care to children having special needs.
1011     2.  Geriatric dental care.
1012     3.  Dental services in emergency departments.
1013     4.  Medicaid services.
1014     5.  Other critically needed specialty areas, as determined
1015by the advisory body.
1016     (2)  In addition to the completed survey, the dentist or
1017dental hygienist must submit a statement that the information
1018provided is true and accurate to the best of his or her
1019knowledge and belief.
1020     (3)  Beginning in 2012, renewal of a license by a dentist
1021or dental hygienist licensed under chapter 466, Florida
1022Statutes, is not contingent upon the completion and submission
1023of the dental workforce survey; however, for any subsequent
1024license renewal, the board may not renew the license of any
1025dentist or dental hygienist until the survey required under this
1026section is completed and submitted by the licensee.
1027     (4)(a)  Beginning in 2012, the Board of Dentistry shall
1028issue a nondisciplinary citation to any dentist or dental
1029hygienist licensed under chapter 466, Florida Statutes, who
1030fails to complete the survey within 90 days after the renewal of
1031his or her license to practice as a dentist or dental hygienist.
1032     (b)  The citation must notify a dentist or dental hygienist
1033who fails to complete the survey required by this section that
1034his or her license will not be renewed for any subsequent
1035license renewal unless the dentist or dental hygienist completes
1036the survey.
1037     (c)  In conjunction with issuing the license renewal notice
1038required by s. 456.038, Florida Statutes, the board shall notify
1039each dentist or dental hygienist licensed under chapter 466,
1040Florida Statutes, who fails to complete the survey that the
1041survey must be completed before the subsequent license renewal.
1042     Section 25.  (1)  The Department of Health shall serve as
1043the coordinating body for the purpose of collecting and
1044regularly updating and disseminating dental workforce data. The
1045department shall work with multiple stakeholders, including the
1046Florida Dental Association and the Florida Dental Hygiene
1047Association, to assess and share with all communities of
1048interest all data collected in a timely fashion.
1049     (2)  The Department of Health shall maintain a current
1050database to serve as a statewide source of data concerning the
1051dental workforce. The department, in conjunction with the Board
1052of Dentistry, shall also:
1053     (a)  Develop strategies to maximize federal and state
1054programs that provide incentives for dentists to practice in
1055shortage areas that are federally designated. Strategies shall
1056include programs such as the Florida Health Services Corps
1057established under s. 381.0302, Florida Statutes.
1058     (b)  Work in conjunction with an advisory body to address
1059matters relating to the state's dental workforce. The advisory
1060body shall provide input on developing questions for the dentist
1061workforce survey. The advisory body shall include, but need not
1062be limited to, the State Surgeon General or his or her designee,
1063the dean of each dental school accredited in the United States
1064and based in this state or his or her designee, a representative
1065from the Florida Dental Association, a representative from the
1066Florida Dental Hygiene Association, a representative from the
1067Board of Dentistry, and a dentist from each of the dental
1068specialties recognized by the American Dental Association's
1069Commission on Dental Accreditation. Members of the advisory body
1070shall serve without compensation.
1071     (c)  Act as a clearinghouse for collecting and
1072disseminating information concerning the dental workforce.
1073     (3)  The Department of Health and the Board of Dentistry
1074shall adopt rules necessary to administer this section.
1075     Section 26.  It is the intent of the Legislature that the
1076Department of Health and the Board of Dentistry implement the
1077provisions of sections 16 through 20 of this act within existing
1078resources.
1079     Section 27.  Paragraphs (q) and (t) of subsection (2) of
1080section 499.01, Florida Statutes, are amended to read:
1081     499.01  Permits.-
1082     (2)  The following permits are established:
1083     (q)  Device manufacturer permit.-
1084     1.  A device manufacturer permit is required for any person
1085that engages in the manufacture, repackaging, or assembly of
1086medical devices for human use in this state, except that a
1087permit is not required if:
1088     a.  The person manufactures, repackages, or assembles only
1089those medical devices or components for such devices which are
1090exempt from registration pursuant to s. 499.015(8); or
1091     b.  The person is engaged only in manufacturing,
1092repackaging, or assembling a medical device pursuant to a
1093practitioner's order for a specific patient.
1094     2.1.  A manufacturer or repackager of medical devices in
1095this state must comply with all appropriate state and federal
1096good manufacturing practices and quality system rules.
1097     3.2.  The department shall adopt rules related to storage,
1098handling, and recordkeeping requirements for manufacturers of
1099medical devices for human use.
1100     (t)  Health care clinic establishment permit.-Effective
1101January 1, 2009, a health care clinic establishment permit is
1102required for the purchase of a prescription drug by a place of
1103business at one general physical location that provides health
1104care or veterinary services, which is owned and operated by a
1105business entity that has been issued a federal employer tax
1106identification number. For the purpose of this paragraph, the
1107term "qualifying practitioner" means a licensed health care
1108practitioner defined in s. 456.001, or a veterinarian licensed
1109under chapter 474, who is authorized under the appropriate
1110practice act to prescribe and administer a prescription drug.
1111     1.  An establishment must provide, as part of the
1112application required under s. 499.012, designation of a
1113qualifying practitioner who will be responsible for complying
1114with all legal and regulatory requirements related to the
1115purchase, recordkeeping, storage, and handling of the
1116prescription drugs. In addition, the designated qualifying
1117practitioner shall be the practitioner whose name, establishment
1118address, and license number is used on all distribution
1119documents for prescription drugs purchased or returned by the
1120health care clinic establishment. Upon initial appointment of a
1121qualifying practitioner, the qualifying practitioner and the
1122health care clinic establishment shall notify the department on
1123a form furnished by the department within 10 days after such
1124employment. In addition, the qualifying practitioner and health
1125care clinic establishment shall notify the department within 10
1126days after any subsequent change.
1127     2.  The health care clinic establishment must employ a
1128qualifying practitioner at each establishment.
1129     3.  In addition to the remedies and penalties provided in
1130this part, a violation of this chapter by the health care clinic
1131establishment or qualifying practitioner constitutes grounds for
1132discipline of the qualifying practitioner by the appropriate
1133regulatory board.
1134     4.  The purchase of prescription drugs by the health care
1135clinic establishment is prohibited during any period of time
1136when the establishment does not comply with this paragraph.
1137     5.  A health care clinic establishment permit is not a
1138pharmacy permit or otherwise subject to chapter 465. A health
1139care clinic establishment that meets the criteria of a modified
1140Class II institutional pharmacy under s. 465.019 is not eligible
1141to be permitted under this paragraph.
1142     6.  This paragraph does not apply to the purchase of a
1143prescription drug by a licensed practitioner under his or her
1144license. A professional corporation or limited liability company
1145composed of dentists and operating as authorized in s. 466.0285
1146may pay for prescription drugs obtained by a practitioner
1147licensed under chapter 466, and the licensed practitioner is
1148deemed the purchaser and owner of the prescription drugs.
1149     Section 28.  Subsections (32) through (54) of section
1150499.003, Florida Statutes, are renumbered as subsections (33)
1151through (55), respectively, present subsection (42) is amended,
1152and a new subsection (32) is added to that section, to read:
1153     499.003  Definitions of terms used in this part.-As used in
1154this part, the term:
1155     (32)  "Medical convenience kit" means a package or unit
1156that contains combination products as described in 21 C.F.R. s.
11573.2(e)(2).
1158     (43)(42)  "Prescription drug" means a prescription,
1159medicinal, or legend drug, including, but not limited to,
1160finished dosage forms or active ingredients subject to, defined
1161by, or described by s. 503(b) of the Federal Food, Drug, and
1162Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
1163(11), subsection (46) (45), or subsection (53) (52).
1164     Section 29.  Paragraph (a) of subsection (1) of section
1165409.9201, Florida Statutes, is amended to read:
1166     409.9201  Medicaid fraud.-
1167     (1)  As used in this section, the term:
1168     (a)  "Prescription drug" means any drug, including, but not
1169limited to, finished dosage forms or active ingredients that are
1170subject to, defined by, or described by s. 503(b) of the Federal
1171Food, Drug, and Cosmetic Act or by s. 465.003(8), s.
1172499.003(45)(45) or (53) (52), or s. 499.007(13).
1173
1174The value of individual items of the legend drugs or goods or
1175services involved in distinct transactions committed during a
1176single scheme or course of conduct, whether involving a single
1177person or several persons, may be aggregated when determining
1178the punishment for the offense.
1179     Section 30.  Subsection (3) of section 465.0265, Florida
1180Statutes, is amended to read:
1181     465.0265  Centralized prescription filling.-
1182     (3)  The filling, delivery, and return of a prescription by
1183one pharmacy for another pursuant to this section shall not be
1184construed as the filling of a transferred prescription as set
1185forth in s. 465.026 or as a wholesale distribution as set forth
1186in s. 499.003(54)(53).
1187     Section 31.  Paragraph (d) of subsection (4) of section
1188499.0121, Florida Statutes, is amended to read:
1189     499.0121  Storage and handling of prescription drugs;
1190recordkeeping.-The department shall adopt rules to implement
1191this section as necessary to protect the public health, safety,
1192and welfare. Such rules shall include, but not be limited to,
1193requirements for the storage and handling of prescription drugs
1194and for the establishment and maintenance of prescription drug
1195distribution records.
1196     (4)  EXAMINATION OF MATERIALS AND RECORDS.-
1197     (d)  Upon receipt, a wholesale distributor must review
1198records required under this section for the acquisition of
1199prescription drugs for accuracy and completeness, considering
1200the total facts and circumstances surrounding the transactions
1201and the wholesale distributors involved. This includes
1202authenticating each transaction listed on a pedigree paper, as
1203defined in s. 499.003(37)(36).
1204     Section 32.  Paragraphs (a) and (b) of subsection (2) of
1205section 499.01211, Florida Statutes, are amended to read:
1206     499.01211  Drug Wholesale Distributor Advisory Council.-
1207     (2)  The State Surgeon General, or his or her designee, and
1208the Secretary of Health Care Administration, or her or his
1209designee, shall be members of the council. The State Surgeon
1210General shall appoint nine additional members to the council who
1211shall be appointed to a term of 4 years each, as follows:
1212     (a)  Three different persons each of whom is employed by a
1213different prescription drug wholesale distributor licensed under
1214this part which operates nationally and is a primary wholesale
1215distributor, as defined in s. 499.003(47)(46).
1216     (b)  One person employed by a prescription drug wholesale
1217distributor licensed under this part which is a secondary
1218wholesale distributor, as defined in s. 499.003(52)(51).
1219     Section 33.  Subsection (1) of section 499.03, Florida
1220Statutes, is amended to read:
1221     499.03  Possession of certain drugs without prescriptions
1222unlawful; exemptions and exceptions.-
1223     (1)  A person may not possess, or possess with intent to
1224sell, dispense, or deliver, any habit-forming, toxic, harmful,
1225or new drug subject to s. 499.003(33)(32), or prescription drug
1226as defined in s. 499.003(43)(42), unless the possession of the
1227drug has been obtained by a valid prescription of a practitioner
1228licensed by law to prescribe the drug. However, this section
1229does not apply to the delivery of such drugs to persons included
1230in any of the classes named in this subsection, or to the agents
1231or employees of such persons, for use in the usual course of
1232their businesses or practices or in the performance of their
1233official duties, as the case may be; nor does this section apply
1234to the possession of such drugs by those persons or their agents
1235or employees for such use:
1236     (a)  A licensed pharmacist or any person under the licensed
1237pharmacist's supervision while acting within the scope of the
1238licensed pharmacist's practice;
1239     (b)  A licensed practitioner authorized by law to prescribe
1240prescription drugs or any person under the licensed
1241practitioner's supervision while acting within the scope of the
1242licensed practitioner's practice;
1243     (c)  A qualified person who uses prescription drugs for
1244lawful research, teaching, or testing, and not for resale;
1245     (d)  A licensed hospital or other institution that procures
1246such drugs for lawful administration or dispensing by
1247practitioners;
1248     (e)  An officer or employee of a federal, state, or local
1249government; or
1250     (f)  A person that holds a valid permit issued by the
1251department pursuant to this part which authorizes that person to
1252possess prescription drugs.
1253     Section 34.  Paragraphs (i) and (m) of subsection (1) of
1254section 499.05, Florida Statutes, are amended to read:
1255     499.05  Rules.-
1256     (1)  The department shall adopt rules to implement and
1257enforce this part with respect to:
1258     (i)  Additional conditions that qualify as an emergency
1259medical reason under s. 499.003(54)(53)(b)2.
1260     (m)  The recordkeeping, storage, and handling with respect
1261to each of the distributions of prescription drugs specified in
1262s. 499.003(54)(53)(a)-(d).
1263     Section 35.  Subsection (1) of section 794.075, Florida
1264Statutes, is amended to read:
1265     794.075  Sexual predators; erectile dysfunction drugs.-
1266     (1)  A person may not possess a prescription drug, as
1267defined in s. 499.003(43)(42), for the purpose of treating
1268erectile dysfunction if the person is designated as a sexual
1269predator under s. 775.21.
1270     Section 36.  Paragraph (a) of subsection (6) of section
1271624.91, Florida Statutes, is amended to read:
1272     624.91  The Florida Healthy Kids Corporation Act.-
1273     (6)  BOARD OF DIRECTORS.-
1274     (a)  The Florida Healthy Kids Corporation shall operate
1275subject to the supervision and approval of a board of directors
1276chaired by the Chief Financial Officer or her or his designee,
1277and composed of 12 11 other members selected for 3-year terms of
1278office as follows:
1279     1.  The Secretary of Health Care Administration, or his or
1280her designee.
1281     2.  One member appointed by the Commissioner of Education
1282from the Office of School Health Programs of the Florida
1283Department of Education.
1284     3.  One member appointed by the Chief Financial Officer
1285from among three members nominated by the Florida Pediatric
1286Society.
1287     4.  One member, appointed by the Governor, who represents
1288the Children's Medical Services Program.
1289     5.  One member appointed by the Chief Financial Officer
1290from among three members nominated by the Florida Hospital
1291Association.
1292     6.  One member, appointed by the Governor, who is an expert
1293on child health policy.
1294     7.  One member, appointed by the Chief Financial Officer,
1295from among three members nominated by the Florida Academy of
1296Family Physicians.
1297     8.  One member, appointed by the Governor, who represents
1298the state Medicaid program.
1299     9.  One member, appointed by the Chief Financial Officer,
1300from among three members nominated by the Florida Association of
1301Counties.
1302     10.  The State Health Officer or her or his designee.
1303     11.  The Secretary of Children and Family Services, or his
1304or her designee.
1305     12.  One member, appointed by the Governor, from among
1306three members nominated by the Florida Dental Association.
1307     Section 37.  Section 381.0403, Florida Statutes, is amended
1308to read:
1309     381.0403  The Community Hospital Education Act.-
1310     (1)  SHORT TITLE.-This section shall be known and cited as
1311"The Community Hospital Education Act."
1312     (2)  LEGISLATIVE INTENT.-
1313     (a)  It is the intent of the Legislature that health care
1314services for the citizens of this state be upgraded and that a
1315program for continuing these services be maintained through a
1316plan for community medical education. The program is intended to
1317provide additional outpatient and inpatient services, a
1318continuing supply of highly trained physicians, and graduate
1319medical education.
1320     (b)  The Legislature further acknowledges the critical need
1321for increased numbers of primary care physicians to provide the
1322necessary current and projected health and medical services. In
1323order to meet both present and anticipated needs, the
1324Legislature supports an expansion in the number of family
1325practice residency positions. The Legislature intends that the
1326funding for graduate education in family practice be maintained
1327and that funding for all primary care specialties be provided at
1328a minimum of $10,000 per resident per year. Should funding for
1329this act remain constant or be reduced, it is intended that all
1330programs funded by this act be maintained or reduced
1331proportionately.
1332     (3)  PROGRAM FOR COMMUNITY HOSPITAL EDUCATION; STATE AND
1333LOCAL PLANNING.-
1334     (a)  There is established under the Department of Health a
1335program for statewide graduate medical education. It is intended
1336that continuing graduate medical education programs for interns
1337and residents be established on a statewide basis. The program
1338shall provide financial support for primary care specialty
1339interns and residents based on policies recommended and approved
1340by the Community Hospital Education Council, herein established,
1341and the Department of Health. Only those programs with at least
1342three residents or interns in each year of the training program
1343are qualified to apply for financial support. Programs with
1344fewer than three residents or interns per training year are
1345qualified to apply for financial support, but only if the
1346appropriate accrediting entity for the particular specialty has
1347approved the program for fewer positions. Programs added after
1348fiscal year 1997-1998 shall have 5 years to attain the requisite
1349number of residents or interns. When feasible and to the extent
1350allowed through the General Appropriations Act, state funds
1351shall be used to generate federal matching funds under Medicaid,
1352or other federal programs, and the resulting combined state and
1353federal funds shall be allocated to participating hospitals for
1354the support of graduate medical education. The department may
1355spend up to $75,000 of the state appropriation for
1356administrative costs associated with the production of the
1357annual report as specified in subsection (9), and for
1358administration of the program.
1359     (b)  For the purposes of this section, primary care
1360specialties include emergency medicine, family practice,
1361internal medicine, pediatrics, psychiatry,
1362obstetrics/gynecology, and combined pediatrics and internal
1363medicine, and other primary care specialties as may be included
1364by the council and Department of Health.
1365     (c)  Medical institutions throughout the state may apply to
1366the Community Hospital Education Council for grants-in-aid for
1367financial support of their approved programs. Recommendations
1368for funding of approved programs shall be forwarded to the
1369Department of Health.
1370     (d)  The program shall provide a plan for community
1371clinical teaching and training with the cooperation of the
1372medical profession, hospitals, and clinics. The plan shall also
1373include formal teaching opportunities for intern and resident
1374training. In addition, the plan shall establish an off-campus
1375medical faculty with university faculty review to be located
1376throughout the state in local communities.
1377     (4)  PROGRAM FOR GRADUATE MEDICAL EDUCATION INNOVATIONS.-
1378     (a)  There is established under the Department of Health a
1379program for fostering graduate medical education innovations.
1380Funds appropriated annually by the Legislature for this purpose
1381shall be distributed to participating hospitals or consortia of
1382participating hospitals and Florida medical schools or to a
1383Florida medical school for the direct costs of providing
1384graduate medical education in community-based clinical settings
1385on a competitive grant or formula basis to achieve state health
1386care workforce policy objectives, including, but not limited to:
1387     1.  Increasing the number of residents in primary care and
1388other high demand specialties or fellowships;
1389     2.  Enhancing retention of primary care physicians in
1390Florida practice;
1391     3.  Promoting practice in medically underserved areas of
1392the state;
1393     4.  Encouraging racial and ethnic diversity within the
1394state's physician workforce; and
1395     5.  Encouraging increased production of geriatricians.
1396     (b)  Participating hospitals or consortia of participating
1397hospitals and Florida medical schools or a Florida medical
1398school providing graduate medical education in community-based
1399clinical settings may apply to the Community Hospital Education
1400Council for funding under this innovations program, except when
1401such innovations directly compete with services or programs
1402provided by participating hospitals or consortia of
1403participating hospitals, or by both hospitals and consortia.
1404Innovations program funding shall provide funding based on
1405policies recommended and approved by the Community Hospital
1406Education Council and the Department of Health.
1407     (c)  Participating hospitals or consortia of participating
1408hospitals and Florida medical schools or Florida medical schools
1409awarded an innovations grant shall provide the Community
1410Hospital Education Council and Department of Health with an
1411annual report on their project.
1412     (4)(5)  FAMILY PRACTICE RESIDENCIES.-In addition to the
1413programs established in subsection (3), the Community Hospital
1414Education Council and the Department of Health shall establish
1415an ongoing statewide program of family practice residencies. The
1416administration of this program shall be in the manner described
1417in this section.
1418     (5)(6)  COUNCIL AND DIRECTOR.-
1419     (a)  There is established the Community Hospital Education
1420Council, hereinafter referred to as the council, which shall
1421consist of 11 members, as follows:
1422     1.  Seven members must be program directors of accredited
1423graduate medical education programs or practicing physicians who
1424have faculty appointments in accredited graduate medical
1425education programs. Six of these members must be board certified
1426or board eligible in family practice, internal medicine,
1427pediatrics, emergency medicine, obstetrics-gynecology, and
1428psychiatry, respectively, and licensed pursuant to chapter 458.
1429No more than one of these members may be appointed from any one
1430specialty. One member must be licensed pursuant to chapter 459.
1431     2.  One member must be a representative of the
1432administration of a hospital with an approved community hospital
1433medical education program;
1434     3.  One member must be the dean of a medical school in this
1435state; and
1436     4.  Two members must be consumer representatives.
1437
1438All of the members shall be appointed by the Governor for terms
1439of 4 years each.
1440     (b)  Council membership shall cease when a member's
1441representative status no longer exists. Members of similar
1442representative status shall be appointed to replace retiring or
1443resigning members of the council.
1444     (c)  The State Surgeon General shall designate an
1445administrator to serve as staff director. The council shall
1446elect a chair from among its membership. Such other personnel as
1447may be necessary to carry out the program shall be employed as
1448authorized by the Department of Health.
1449     (6)(7)  DEPARTMENT OF HEALTH; STANDARDS.-
1450     (a)  The Department of Health, with recommendations from
1451the council, shall establish standards and policies for the use
1452and expenditure of graduate medical education funds appropriated
1453pursuant to subsection (7) (8) for a program of community
1454hospital education. The Department of Health shall establish
1455requirements for hospitals to be qualified for participation in
1456the program which shall include, but not be limited to:
1457     1.  Submission of an educational plan and a training
1458schedule.
1459     2.  A determination by the council to ascertain that each
1460portion of the program of the hospital provides a high degree of
1461academic excellence and is accredited by the Accreditation
1462Council for Graduate Medical Education of the American Medical
1463Association or is accredited by the American Osteopathic
1464Association.
1465     3.  Supervision of the educational program of the hospital
1466by a physician who is not the hospital administrator.
1467     (b)  The Department of Health shall periodically review the
1468educational program provided by a participating hospital to
1469assure that the program includes a reasonable amount of both
1470formal and practical training and that the formal sessions are
1471presented as scheduled in the plan submitted by each hospital.
1472     (c)  In years that funds are transferred to the Agency for
1473Health Care Administration, the Department of Health shall
1474certify to the Agency for Health Care Administration on a
1475quarterly basis the number of primary care specialty residents
1476and interns at each of the participating hospitals for which the
1477Community Hospital Education Council and the department
1478recommends funding.
1479     (7)(8)  MATCHING FUNDS.-State funds shall be used to match
1480funds from any local governmental or hospital source. The state
1481shall provide up to 50 percent of the funds, and the community
1482hospital medical education program shall provide the remainder.
1483However, except for fixed capital outlay, the provisions of this
1484subsection shall not apply to any program authorized under the
1485provisions of subsection (5) for the first 3 years after such
1486program is in operation.
1487     (9)  ANNUAL REPORT ON GRADUATE MEDICAL EDUCATION;
1488COMMITTEE.-The Executive Office of the Governor, the Department
1489of Health, and the Agency for Health Care Administration shall
1490collaborate to establish a committee that shall produce an
1491annual report on graduate medical education. The committee shall
1492be comprised of 11 members: five members shall be deans of the
1493medical schools or their designees; the Governor shall appoint
1494two members, one of whom must be a representative of the Florida
1495Medical Association who has supervised or currently supervises
1496residents or interns and one of whom must be a representative of
1497the Florida Hospital Association; the Secretary of Health Care
1498Administration shall appoint two members, one of whom must be a
1499representative of a statutory teaching hospital and one of whom
1500must be a physician who has supervised or is currently
1501supervising residents or interns; and the State Surgeon General
1502shall appoint two members, one of whom must be a representative
1503of a statutory family practice teaching hospital and one of whom
1504must be a physician who has supervised or is currently
1505supervising residents or interns. With the exception of the
1506deans, members shall serve 4-year terms. In order to stagger the
1507terms, the Governor's appointees shall serve initial terms of 4
1508years, the State Surgeon General's appointees shall serve
1509initial terms of 3 years, and the Secretary of Health Care
1510Administration's appointees shall serve initial terms of 2
1511years. A member's term shall be deemed terminated when the
1512member's representative status no longer exists. Once the
1513committee is appointed, it shall elect a chair to serve for a 1-
1514year term. The report shall be provided to the Governor, the
1515President of the Senate, and the Speaker of the House of
1516Representatives by January 15 annually. Committee members shall
1517serve without compensation. The report shall address the
1518following:
1519     (a)  The role of residents and medical faculty in the
1520provision of health care.
1521     (b)  The relationship of graduate medical education to the
1522state's physician workforce.
1523     (c)  The costs of training medical residents for hospitals,
1524medical schools, teaching hospitals, including all hospital-
1525medical affiliations, practice plans at all of the medical
1526schools, and municipalities.
1527     (d)  The availability and adequacy of all sources of
1528revenue to support graduate medical education and recommend
1529alternative sources of funding for graduate medical education.
1530     (e)  The use of state and federal appropriated funds for
1531graduate medical education by hospitals receiving such funds.
1532     (9)(10)  RULEMAKING.-The department has authority to adopt
1533rules pursuant to ss. 120.536(1) and 120.54 to implement the
1534provisions of this section.
1535     Section 38.  Section 381.4018, Florida Statutes, is amended
1536to read:
1537     381.4018  Physician workforce assessment and development.-
1538     (1)  DEFINITIONS.-As used in this section, the term:
1539     (a)  "Consortium" or "consortia" means a combination of
1540statutory teaching hospitals, specialty children's hospitals,
1541statutory rural hospitals, other hospitals, accredited medical
1542schools, clinics operated by the department, clinics operated by
1543the Department of Veterans' Affairs, area health education
1544centers, community health centers, federally qualified health
1545centers, prison clinics, local community clinics, or other
1546programs. At least one member of the consortium shall be a
1547sponsoring institution accredited or currently seeking
1548accreditation by the Accreditation Council for Graduate Medical
1549Education or the American Osteopathic Association.
1550     (b)  "Council" means the Physician Workforce Advisory
1551Council.
1552     (c)  "Department" means the Department of Health.
1553     (d)  "Graduate medical education program" means a program
1554accredited by the Accreditation Council for Graduate Medical
1555Education or the American Osteopathic Association.
1556     (e)  "Primary care specialty" means emergency medicine,
1557family practice, internal medicine, pediatrics, psychiatry,
1558geriatrics, general surgery, obstetrics and gynecology, and
1559combined pediatrics and internal medicine and other specialties
1560as determined by the Physician Workforce Advisory Council or the
1561Department of Health.
1562     (2)(1)  LEGISLATIVE INTENT.-The Legislature recognizes that
1563physician workforce planning is an essential component of
1564ensuring that there is an adequate and appropriate supply of
1565well-trained physicians to meet this state's future health care
1566service needs as the general population and elderly population
1567of the state increase. The Legislature finds that items to
1568consider relative to assessing the physician workforce may
1569include physician practice status; specialty mix; geographic
1570distribution; demographic information, including, but not
1571limited to, age, gender, race, and cultural considerations; and
1572needs of current or projected medically underserved areas in the
1573state. Long-term strategic planning is essential as the period
1574from the time a medical student enters medical school to
1575completion of graduate medical education may range from 7 to 10
1576years or longer. The Legislature recognizes that strategies to
1577provide for a well-trained supply of physicians must include
1578ensuring the availability and capacity of quality graduate
1579medical schools and graduate medical education programs in this
1580state, as well as using new or existing state and federal
1581programs providing incentives for physicians to practice in
1582needed specialties and in underserved areas in a manner that
1583addresses projected needs for physician manpower.
1584     (3)(2)  PURPOSE.-The department of Health shall serve as a
1585coordinating and strategic planning body to actively assess the
1586state's current and future physician workforce needs and work
1587with multiple stakeholders to develop strategies and
1588alternatives to address current and projected physician
1589workforce needs.
1590     (4)(3)  GENERAL FUNCTIONS.-The department shall maximize
1591the use of existing programs under the jurisdiction of the
1592department and other state agencies and coordinate governmental
1593and nongovernmental stakeholders and resources in order to
1594develop a state strategic plan and assess the implementation of
1595such strategic plan. In developing the state strategic plan, the
1596department shall:
1597     (a)  Monitor, evaluate, and report on the supply and
1598distribution of physicians licensed under chapter 458 or chapter
1599459. The department shall maintain a database to serve as a
1600statewide source of data concerning the physician workforce.
1601     (b)  Develop a model and quantify, on an ongoing basis, the
1602adequacy of the state's current and future physician workforce
1603as reliable data becomes available. Such model must take into
1604account demographics, physician practice status, place of
1605education and training, generational changes, population growth,
1606economic indicators, and issues concerning the "pipeline" into
1607medical education.
1608     (c)  Develop and recommend strategies to determine whether
1609the number of qualified medical school applicants who might
1610become competent, practicing physicians in this state will be
1611sufficient to meet the capacity of the state's medical schools.
1612If appropriate, the department shall, working with
1613representatives of appropriate governmental and nongovernmental
1614entities, develop strategies and recommendations and identify
1615best practice programs that introduce health care as a
1616profession and strengthen skills needed for medical school
1617admission for elementary, middle, and high school students, and
1618improve premedical education at the precollege and college level
1619in order to increase this state's potential pool of medical
1620students.
1621     (d)  Develop strategies to ensure that the number of
1622graduates from the state's public and private allopathic and
1623osteopathic medical schools is are adequate to meet physician
1624workforce needs, based on the analysis of the physician
1625workforce data, so as to provide a high-quality medical
1626education to students in a manner that recognizes the uniqueness
1627of each new and existing medical school in this state.
1628     (e)  Pursue strategies and policies to create, expand, and
1629maintain graduate medical education positions in the state based
1630on the analysis of the physician workforce data. Such strategies
1631and policies must take into account the effect of federal
1632funding limitations on the expansion and creation of positions
1633in graduate medical education. The department shall develop
1634options to address such federal funding limitations. The
1635department shall consider options to provide direct state
1636funding for graduate medical education positions in a manner
1637that addresses requirements and needs relative to accreditation
1638of graduate medical education programs. The department shall
1639consider funding residency positions as a means of addressing
1640needed physician specialty areas, rural areas having a shortage
1641of physicians, and areas of ongoing critical need, and as a
1642means of addressing the state's physician workforce needs based
1643on an ongoing analysis of physician workforce data.
1644     (f)  Develop strategies to maximize federal and state
1645programs that provide for the use of incentives to attract
1646physicians to this state or retain physicians within the state.
1647Such strategies should explore and maximize federal-state
1648partnerships that provide incentives for physicians to practice
1649in federally designated shortage areas. Strategies shall also
1650consider the use of state programs, such as the Florida Health
1651Service Corps established pursuant to s. 381.0302 and the
1652Medical Education Reimbursement and Loan Repayment Program
1653pursuant to s. 1009.65, which provide for education loan
1654repayment or loan forgiveness and provide monetary incentives
1655for physicians to relocate to underserved areas of the state.
1656     (g)  Coordinate and enhance activities relative to
1657physician workforce needs, undergraduate medical education, and
1658graduate medical education, and reentry of retired military and
1659other physicians into the physician workforce provided by the
1660Division of Medical Quality Assurance, the Community Hospital
1661Education Program and the Graduate Medical Education Committee
1662established pursuant to s. 381.0403, area health education
1663center networks established pursuant to s. 381.0402, and other
1664offices and programs within the department of Health as
1665designated by the State Surgeon General.
1666     (h)  Work in conjunction with and act as a coordinating
1667body for governmental and nongovernmental stakeholders to
1668address matters relating to the state's physician workforce
1669assessment and development for the purpose of ensuring an
1670adequate supply of well-trained physicians to meet the state's
1671future needs. Such governmental stakeholders shall include, but
1672need not be limited to, the State Surgeon General or his or her
1673designee, the Commissioner of Education or his or her designee,
1674the Secretary of Health Care Administration or his or her
1675designee, and the Chancellor of the State University System or
1676his or her designee from the Board of Governors of the State
1677University System, and, at the discretion of the department,
1678other representatives of state and local agencies that are
1679involved in assessing, educating, or training the state's
1680current or future physicians. Other stakeholders shall include,
1681but need not be limited to, organizations representing the
1682state's public and private allopathic and osteopathic medical
1683schools; organizations representing hospitals and other
1684institutions providing health care, particularly those that
1685currently provide or have an interest in providing accredited
1686medical education and graduate medical education to medical
1687students and medical residents; organizations representing
1688allopathic and osteopathic practicing physicians; and, at the
1689discretion of the department, representatives of other
1690organizations or entities involved in assessing, educating, or
1691training the state's current or future physicians.
1692     (i)  Serve as a liaison with other states and federal
1693agencies and programs in order to enhance resources available to
1694the state's physician workforce and medical education continuum.
1695     (j)  Act as a clearinghouse for collecting and
1696disseminating information concerning the physician workforce and
1697medical education continuum in this state.
1698     (5)  PHYSICIAN WORKFORCE ADVISORY COUNCIL.-There is created
1699in the department the Physician Workforce Advisory Council, an
1700advisory council as defined in s. 20.03. The council shall
1701comply with the requirements of s. 20.052, except as otherwise
1702provided in this section.
1703     (a)  The council shall consist of 19 members. Members
1704appointed by the State Surgeon General shall include:
1705     1.  A designee from the department who is a physician
1706licensed under chapter 458 or chapter 459 and recommended by the
1707State Surgeon General.
1708     2.  An individual who is affiliated with the Science
1709Students Together Reaching Instructional Diversity and
1710Excellence program and recommended by the area health education
1711center network.
1712     3.  Two individuals who are recommended by the Council of
1713Florida Medical School Deans, one who represents a college of
1714allopathic medicine and one who represents a college of
1715osteopathic medicine.
1716     4.  One individual who is recommended by the Florida
1717Hospital Association and represents a hospital that is licensed
1718under chapter 395, has an accredited graduate medical education
1719program, and is not a statutory teaching hospital.
1720     5.  One individual who represents a statutory teaching
1721hospital as defined in s. 408.07 and is recommended by the
1722Safety Net Hospital Alliance.
1723     6.  One individual who represents a family practice
1724teaching hospital as defined in s. 395.805 and is recommended by
1725the Council of Family Medicine and Community Teaching Hospitals.
1726     7.  Two individuals who are recommended by the Florida
1727Medical Association, one who represents a primary care specialty
1728and one who represents a nonprimary care specialty.
1729     8.  Two individuals who are recommended by the Florida
1730Osteopathic Medical Association, one who represents a primary
1731care specialty and one who represents a nonprimary care
1732specialty.
1733     9.  Two individuals who are program directors of accredited
1734graduate medical education programs, one who represents a
1735program that is accredited by the Accreditation Council for
1736Graduate Medical Education and one who represents a program that
1737is accredited by the American Osteopathic Association.
1738     10.  An individual who is recommended by the Florida
1739Association of Community Health Centers and represents a
1740federally qualified health center located in a rural area as
1741defined in s. 381.0406(2)(a).
1742     11.  An individual who is recommended by the Florida
1743Academy of Family Physicians.
1744     12.  An individual who is recommended by the Florida
1745Alliance for Health Professions Diversity.
1746     13.  The Chancellor of the State University System or his
1747or her designee.
1748     14.  A layperson member as determined by the State Surgeon
1749General.
1750
1751Each entity authorized to make recommendations under this
1752subsection shall make at least two recommendations to the State
1753Surgeon General for each appointment to the council. The State
1754Surgeon General shall name one appointee for each position from
1755the recommendations made by each authorized entity.
1756     (b)  Each council member shall be appointed to a 4-year
1757term. An individual may not serve more than two terms. Any
1758council member may be removed from office for malfeasance,
1759misfeasance, neglect of duty, incompetence, permanent inability
1760to perform official duties, or pleading guilty or nolo
1761contendere to, or being found guilty of, a felony. Any council
1762member who meets the criteria for removal, or who is otherwise
1763unwilling or unable to properly fulfill the duties of the
1764office, shall be succeeded by an individual chosen by the State
1765Surgeon General to serve out the remainder of the council
1766member's term. If the remainder of the replaced council member's
1767term is less than 18 months, notwithstanding the provisions of
1768this paragraph, the succeeding council member may be reappointed
1769twice by the State Surgeon General.
1770     (c)  The chair of the council is the State Surgeon General,
1771who shall designate a vice chair from the membership of the
1772council to serve in the absence of the State Surgeon General. A
1773vacancy shall be filled for the remainder of the unexpired term
1774in the same manner as the original appointment.
1775     (d)  Council members are not entitled to receive
1776compensation or reimbursement for per diem or travel expenses.
1777     (e)  The council shall meet at least twice a year in person
1778or by teleconference.
1779     (f)  The council shall:
1780     1.  Advise the State Surgeon General and the department on
1781matters concerning current and future physician workforce needs
1782in this state;
1783     2.  Review survey materials and the compilation of survey
1784information;
1785     3.  Annually review the number, location, cost, and
1786reimbursement of graduate medical education programs and
1787positions;
1788     4.  Provide recommendations to the department regarding the
1789survey completed by physicians licensed under chapter 458 or
1790chapter 459;
1791     5.  Assist the department in preparing the annual report to
1792the Legislature pursuant to ss. 458.3192 and 459.0082;
1793     6.  Assist the department in preparing an initial strategic
1794plan, conduct ongoing strategic planning in accordance with this
1795section, and provide ongoing advice on implementing the
1796recommendations;
1797     7.  Monitor and provide recommendations regarding the need
1798for an increased number of primary care or other physician
1799specialties to provide the necessary current and projected
1800health and medical services for the state; and
1801     8.  Monitor and make recommendations regarding the status
1802of the needs relating to graduate medical education in this
1803state.
1804     (6)  PHYSICIAN WORKFORCE GRADUATE MEDICAL EDUCATION
1805INNOVATION PILOT PROJECTS.-
1806     (a)  The Legislature finds that:
1807     1.  In order to ensure a physician workforce that is
1808adequate to meet the needs of this state's residents and its
1809health care system, policymakers must consider the education and
1810training of future generations of well-trained health care
1811providers.
1812     2.  Physicians are likely to practice in the state where
1813they complete their graduate medical education.
1814     3.  It can directly affect the makeup of the physician
1815workforce by selectively funding graduate medical education
1816programs to provide needed specialists in geographic areas of
1817the state that have a deficient number of such specialists.
1818     4.  Developing additional positions in graduate medical
1819education programs is essential to the future of this state's
1820health care system.
1821     5.  It was necessary in 2007 to pass legislation that
1822provided for an assessment of the status of this state's current
1823and future physician workforce. The department is collecting and
1824analyzing information on an ongoing basis to assess this state's
1825physician workforce needs, and such assessment may facilitate
1826the determination of graduate medical education needs and
1827strategies for the state.
1828     (b)  There is established under the department a program to
1829foster innovative graduate medical education pilot projects that
1830are designed to promote the expansion of graduate medical
1831education programs or positions to prepare physicians to
1832practice in needed specialties and underserved areas or settings
1833and to provide demographic and cultural representation in a
1834manner that addresses current and projected needs for this
1835state's physician workforce. Funds appropriated annually by the
1836Legislature for this purpose shall be distributed to
1837participating hospitals, medical schools, other sponsors of
1838graduate medical education programs, consortia engaged in
1839developing new graduate medical education programs or positions
1840in those programs, or pilot projects providing innovative
1841graduate medical education in community-based clinical settings.
1842Pilot projects shall be selected on a competitive grant basis,
1843subject to available funds.
1844     (c)  Pilot projects shall be designed to meet one or more
1845of this state's physician workforce needs, as determined
1846pursuant to this section, including, but not limited to:
1847     1.  Increasing the number of residencies or fellowships in
1848primary care or other needed specialties.
1849     2.  Enhancing the retention of primary care physicians or
1850other needed specialties in this state.
1851     3.  Promoting practice in rural or medically underserved
1852areas of the state.
1853     4.  Encouraging racial and ethnic diversity within the
1854state's physician workforce.
1855     5.  Encouraging practice in community health care or other
1856ambulatory care settings.
1857     6.  Encouraging practice in clinics operated by the
1858department, including, but not limited to, county health
1859departments, clinics operated by the Department of Veterans'
1860Affairs, prison clinics, or similar settings of need.
1861     7.  Encouraging the increased production of geriatricians.
1862     (d)  Priority shall be given to a proposal for a pilot
1863project that:
1864     1.  Demonstrates a collaboration of federal, state, and
1865local entities that are public or private.
1866     2.  Obtains funding from multiple sources.
1867     3.  Focuses on enhancing graduate medical education in
1868rural or underserved areas.
1869     4.  Focuses on enhancing graduate medical education in
1870ambulatory or community-based settings other than a hospital
1871environment.
1872     5.  Includes the use of technology, such as electronic
1873medical records, distance consultation, and telemedicine, to
1874ensure that residents are better prepared to care for patients
1875in this state, regardless of the community in which the
1876residents practice.
1877     6.  Is designed to meet multiple policy needs as enumerated
1878in subsection (4).
1879     7.  Uses a consortium to provide for graduate medical
1880education experiences.
1881     (e)  The department shall adopt by rule appropriate
1882performance measures to use in order to consistently evaluate
1883the effectiveness, safety, and quality of the programs, as well
1884as the impact of each program on meeting this state's physician
1885workforce needs.
1886     (f)  Participating pilot projects shall submit to the
1887department an annual report on the project in a manner required
1888by the department.
1889     (g)  Funding provided to a pilot project may be used only
1890for the direct costs of providing graduate medical education.
1891Accounting of such costs and expenditures shall be documented in
1892the annual report.
1893     (h)  State funds shall be used to supplement funds from any
1894local government, community, or private source. The state may
1895provide up to 50 percent of the funds, and local governmental
1896grants or community or private sources shall provide the
1897remainder of the funds.
1898     (7)  RULEMAKING.-The department shall adopt rules as
1899necessary to administer this section.
1900     Section 39.  Paragraph (l) of subsection (4) of section
1901400.9905, Florida Statutes, is amended to read:
1902     400.9905  Definitions.-
1903     (4)  "Clinic" means an entity at which health care services
1904are provided to individuals and which tenders charges for
1905reimbursement for such services, including a mobile clinic and a
1906portable equipment provider. For purposes of this part, the term
1907does not include and the licensure requirements of this part do
1908not apply to:
1909     (l)  Orthotic, or prosthetic, pediatric cardiology, or
1910perinatology clinical facilities that are a publicly traded
1911corporation or that are wholly owned, directly or indirectly, by
1912a publicly traded corporation. As used in this paragraph, a
1913publicly traded corporation is a corporation that issues
1914securities traded on an exchange registered with the United
1915States Securities and Exchange Commission as a national
1916securities exchange.
1917     Section 40.  Section 458.3192, Florida Statutes, is amended
1918to read:
1919     458.3192  Analysis of survey results; report.-
1920     (1)  Each year, the Department of Health shall analyze the
1921results of the physician survey required by s. 458.3191 and
1922determine by geographic area and specialty the number of
1923physicians who:
1924     (a)  Perform deliveries of children in this state Florida.
1925     (b)  Read mammograms and perform breast-imaging-guided
1926procedures in this state Florida.
1927     (c)  Perform emergency care on an on-call basis for a
1928hospital emergency department.
1929     (d)  Plan to reduce or increase emergency on-call hours in
1930a hospital emergency department.
1931     (e)  Plan to relocate their allopathic or osteopathic
1932practice outside the state.
1933     (f)  Practice medicine in this state.
1934     (g)  Plan to reduce or modify the scope of their practice.
1935     (2)  The Department of Health must report its findings to
1936the Governor, the President of the Senate, and the Speaker of
1937the House of Representatives by November 1 each year. The
1938department shall also include in its report findings,
1939recommendations, and strategic planning activities as provided
1940in s. 381.4018. The department may also include other
1941information requested by the Physician Workforce Advisory
1942Council.
1943     Section 41.  Section 459.0082, Florida Statutes, is amended
1944to read:
1945     459.0082  Analysis of survey results; report.-
1946     (1)  Each year, the Department of Health shall analyze the
1947results of the physician survey required by s. 459.0081 and
1948determine by geographic area and specialty the number of
1949physicians who:
1950     (a)  Perform deliveries of children in this state Florida.
1951     (b)  Read mammograms and perform breast-imaging-guided
1952procedures in this state Florida.
1953     (c)  Perform emergency care on an on-call basis for a
1954hospital emergency department.
1955     (d)  Plan to reduce or increase emergency on-call hours in
1956a hospital emergency department.
1957     (e)  Plan to relocate their allopathic or osteopathic
1958practice outside the state.
1959     (f)  Practice medicine in this state.
1960     (g)  Plan to reduce or modify the scope of their practice.
1961     (2)  The Department of Health must report its findings to
1962the Governor, the President of the Senate, and the Speaker of
1963the House of Representatives by November 1 each year. The
1964department shall also include in its report findings,
1965recommendations, and strategic planning activities as provided
1966in s. 381.4018. The department may also include other
1967information requested by the Physician Workforce Advisory
1968Council.
1969     Section 42.  Section 458.315, Florida Statutes, is amended
1970to read:
1971     458.315  Temporary certificate for practice in areas of
1972critical need.-
1973     (1)  Any physician who:
1974     (a)  Is licensed to practice in any jurisdiction in the
1975United States and other state, whose license is currently valid;
1976or,
1977     (b)  Has served as a physician in the United States Armed
1978Forces for at least 10 years and received an honorable discharge
1979from the military;
1980
1981and who pays an application fee of $300 may be issued a
1982temporary certificate for to practice in areas of communities of
1983Florida where there is a critical need for physicians.
1984     (2)  A certificate may be issued to a physician who:
1985     (a)  Practices in an area of critical need;
1986     (b)  Will be employed by or practice in a county health
1987department, correctional facility, Department of Veterans'
1988Affairs clinic, community health center funded by s. 329, s.
1989330, or s. 340 of the United States Public Health Services Act,
1990or other agency or institution that is approved by the State
1991Surgeon General and provides health care to meet the needs of
1992underserved populations in this state; or
1993     (c)  Will practice for a limited time to address critical
1994physician-specialty, demographic, or geographic needs for this
1995state's physician workforce as determined by the State Surgeon
1996General entity that provides health care to indigents and that
1997is approved by the State Health Officer.
1998     (3)  The Board of Medicine may issue this temporary
1999certificate with the following restrictions:
2000     (a)(1)  The State Surgeon General board shall determine the
2001areas of critical need, and the physician so certified may
2002practice in any of those areas for a time to be determined by
2003the board. Such areas shall include, but are not be limited to,
2004health professional shortage areas designated by the United
2005States Department of Health and Human Services.
2006     1.(a)  A recipient of a temporary certificate for practice
2007in areas of critical need may use the certificate license to
2008work for any approved entity employer in any area of critical
2009need or as authorized by the State Surgeon General approved by
2010the board.
2011     2.(b)  The recipient of a temporary certificate for
2012practice in areas of critical need shall, within 30 days after
2013accepting employment, notify the board of all approved
2014institutions in which the licensee practices and of all approved
2015institutions where practice privileges have been denied.
2016     (b)(2)  The board may administer an abbreviated oral
2017examination to determine the physician's competency, but a no
2018written regular examination is not required necessary. Within 60
2019days after receipt of an application for a temporary
2020certificate, the board shall review the application and issue
2021the temporary certificate, or notify the applicant of denial, or
2022notify the applicant that the board recommends additional
2023assessment, training, education, or other requirements as a
2024condition of certification. If the applicant has not actively
2025practiced during the prior 3 years and the board determines that
2026the applicant may lack clinical competency, possess diminished
2027or inadequate skills, lack necessary medical knowledge, or
2028exhibit patterns of deficits in clinical decisionmaking, the
2029board may:
2030     1.  Deny the application;
2031     2.  Issue a temporary certificate with reasonable
2032restrictions that may include, but are not limited to, a
2033requirement for the applicant to practice under the supervision
2034of a physician approved by the board; or
2035     3.  Issue a temporary certificate upon receipt of
2036documentation confirming that the applicant has met any
2037reasonable conditions of the board which may include, but are
2038not limited to, completing continuing education or undergoing an
2039assessment of skills and training.
2040     (c)(3)  Any certificate issued under this section is shall
2041be valid only so long as the State Surgeon General determines
2042that the reason area for which it was is issued remains a an
2043area of critical need to the state. The Board of Medicine shall
2044review each temporary certificateholder the service within said
2045area not less than annually to ascertain that the
2046requirements of the Medical Practice Act and its adopted the
2047rules and regulations promulgated thereunder are being complied
2048with. If it is determined that such minimum requirements are not
2049being met, the board shall forthwith revoke such certificate or
2050shall impose restrictions or conditions, or both, as a condition
2051of continued practice under the certificate.
2052     (d)(4)  The board may shall not issue a temporary
2053certificate for practice in an area of critical need to any
2054physician who is under investigation in any jurisdiction in the
2055United States another state for an act that which would
2056constitute a violation of this chapter until such time as the
2057investigation is complete, at which time the provisions of s.
2058458.331 shall apply.
2059     (4)(5)  The application fee and all licensure fees,
2060including neurological injury compensation assessments, shall be
2061waived for those persons obtaining a temporary certificate to
2062practice in areas of critical need for the purpose of providing
2063volunteer, uncompensated care for low-income residents
2064Floridians. The applicant must submit an affidavit from the
2065employing agency or institution stating that the physician will
2066not receive any compensation for any service involving the
2067practice of medicine.
2068     Section 43.  Section 459.0076, Florida Statutes, is created
2069to read:
2070     459.0076  Temporary certificate for practice in areas of
2071critical need.-
2072     (1)  Any physician who:
2073     (a)  Is licensed to practice in any jurisdiction in the
2074United States and whose license is currently valid; or
2075     (b)  Has served as a physician in the United States Armed
2076Forces for at least 10 years and received an honorable discharge
2077from the military;
2078
2079and who pays an application fee of $300 may be issued a
2080temporary certificate for practice in areas of critical need.
2081     (2)  A certificate may be issued to a physician who:
2082     (a)  Will practice in an area of critical need;
2083     (b)  Will be employed by or practice in a county health
2084department, correctional facility, Department of Veterans'
2085Affairs clinic, community health center funded by s. 329, s.
2086330, or s. 340 of the United States Public Health Services Act,
2087or other agency or institution that is approved by the State
2088Surgeon General and provides health care to meet the needs of
2089underserved populations in this state; or
2090     (c)  Will practice for a limited time to address critical
2091physician-specialty, demographic, or geographic needs for this
2092state's physician workforce as determined by the State Surgeon
2093General.
2094     (3)  The Board of Osteopathic Medicine may issue this
2095temporary certificate with the following restrictions:
2096     (a)  The State Surgeon General shall determine the areas of
2097critical need. Such areas include, but are not limited to,
2098health professional shortage areas designated by the United
2099States Department of Health and Human Services.
2100     1.  A recipient of a temporary certificate for practice in
2101areas of critical need may use the certificate to work for any
2102approved entity in any area of critical need or as authorized by
2103the State Surgeon General.
2104     2.  The recipient of a temporary certificate for practice
2105in areas of critical need shall, within 30 days after accepting
2106employment, notify the board of all approved institutions in
2107which the licensee practices and of all approved institutions
2108where practice privileges have been denied.
2109     (b)  The board may administer an abbreviated oral
2110examination to determine the physician's competency, but a
2111written regular examination is not required. Within 60 days
2112after receipt of an application for a temporary certificate, the
2113board shall review the application and issue the temporary
2114certificate, notify the applicant of denial, or notify the
2115applicant that the board recommends additional assessment,
2116training, education, or other requirements as a condition of
2117certification. If the applicant has not actively practiced
2118during the prior 3 years and the board determines that the
2119applicant may lack clinical competency, possess diminished or
2120inadequate skills, lack necessary medical knowledge, or exhibit
2121patterns of deficits in clinical decisionmaking, the board may:
2122     1.  Deny the application;
2123     2.  Issue a temporary certificate having reasonable
2124restrictions that may include, but are not limited to, a
2125requirement for the applicant to practice under the supervision
2126of a physician approved by the board; or
2127     3.  Issue a temporary certificate upon receipt of
2128documentation confirming that the applicant has met any
2129reasonable conditions of the board, which may include, but are
2130not limited to, completing continuing education or undergoing an
2131assessment of skills and training.
2132     (c)  Any certificate issued under this section is valid
2133only so long as the State Surgeon General determines that the
2134reason for which it was issued remains a critical need to the
2135state. The Board of Osteopathic Medicine shall review each
2136temporary certificateholder not less than annually to ascertain
2137that the minimum requirements of the Osteopathic Medical
2138Practice Act and its adopted rules are being complied with. If
2139it is determined that such minimum requirements are not being
2140met, the board shall revoke such certificate or shall impose
2141restrictions or conditions, or both, as a condition of continued
2142practice under the certificate.
2143     (d)  The board may not issue a temporary certificate for
2144practice in an area of critical need to any physician who is
2145under investigation in any jurisdiction in the United States for
2146an act that would constitute a violation of this chapter until
2147such time as the investigation is complete, at which time the
2148provisions of s. 459.015 apply.
2149     (4)  The application fee and all licensure fees, including
2150neurological injury compensation assessments, shall be waived
2151for those persons obtaining a temporary certificate to practice
2152in areas of critical need for the purpose of providing
2153volunteer, uncompensated care for low-income residents. The
2154applicant must submit an affidavit from the employing agency or
2155institution stating that the physician will not receive any
2156compensation for any service involving the practice of medicine.
2157     Section 44.  Paragraph (i) is added to subsection (3) of
2158section 499.01212, Florida Statutes, to read:
2159     499.01212  Pedigree paper.-
2160     (3)  EXCEPTIONS.-A pedigree paper is not required for:
2161     (i)  The wholesale distribution of prescription drugs
2162within a medical convenience kit if:
2163     1.  The medical convenience kit is assembled in an
2164establishment that is registered with the United States Food and
2165Drug Administration as a medical device manufacturer;
2166     2.  The medical convenience kit manufacturer is an
2167authorized distributor of record, as defined by 21 C.F.R. s.
2168203.3, for the manufacturer of the specific drugs contained
2169within the kit; and
2170     3.  The drugs contained in the medical convenience kit are:
2171     a.  Intravenous solutions intended for the replenishment of
2172fluids and electrolytes;
2173     b.  Products intended to maintain the equilibrium of water
2174and minerals in the body;
2175     c.  Products intended for irrigation or reconstitution;
2176     d.  Anesthetics; or
2177     e.  Anticoagulants.
2178
2179This paragraph does not apply to a medical convenience kit
2180containing any controlled substance that appears in any schedule
2181contained in or subject to chapter 893 or the Federal
2182Comprehensive Drug Abuse Prevention and Control Act of 1970.
2183     Section 45.  Subsection (1) of section 465.0251, Florida
2184Statutes, is reenacted to read:
2185     465.0251  Generic drugs; removal from formulary under
2186specified circumstances.-
2187     (1)  The Board of Pharmacy and the Board of Medicine shall
2188remove any generic named drug product from the formulary
2189established by s. 465.025(6), if every commercially marketed
2190equivalent of that drug product is "A" rated as therapeutically
2191equivalent to a reference listed drug or is a reference listed
2192drug as referred to in "Approved Drug Products with Therapeutic
2193Equivalence Evaluations" (Orange Book) published by the United
2194States Food and Drug Administration.
2195     Section 46.  This act shall take effect July 1, 2010.


CODING: Words stricken are deletions; words underlined are additions.