HB 331

1	A bill to be entitled
2	An act relating to public health initiatives; amending s.
3	381.98, F.S.; establishing the Florida Public Health
4	Institute, Inc., and deleting provisions relating to the
5	Florida Public Health Foundation, Inc.; providing purposes
6	of the institute; providing for the institute to operate
7	as a not-for-profit corporation; revising composition of
8	the board of directors; removing obsolete language
9	relating to certain research; requiring annual reports to
10	the Legislature; amending ss. 381.855, 381.911, and
11	381.981, F.S.; conforming terminology; amending s.
12	499.029, F.S.; renaming the Cancer Drug Donation Program
13	as the Prescription Drug Donation Program; revising
14	definitions; expanding the drugs and supplies that may be
15	donated under the program; expanding the types of
16	facilities and practitioners that may participate in the
17	program; conforming provisions to changes in terminology;
18	removing obsolete language relating to the adoption of
19	initial rules; providing an effective date.
20
21	Be It Enacted by the Legislature of the State of Florida:
22
23	Section 1.  Section 381.98, Florida Statutes, is amended to
24	read:
25	381.98  The Florida Public Health Institute Foundation,
26	Inc.; establishment; purpose; mission; duties; board of
27	directors.--
28	(1)  The Florida Public Health Institute Foundation, Inc.,
29	referred to in this section as "the corporation," is established
30	for the purpose of advancing the knowledge and practice of
31	public health, including disseminating breakthrough findings in
32	biomedical research and promoting health awareness in this state
33	and providing services to the Department of Health.
34	(2)  The corporation's mission includes disseminating
35	information about innovative biomedical research and clinical
36	trials in this state as well as making Floridians and their
37	treatment providers aware of specified diseases and conditions
38	and available methods of preventing, diagnosing, treating, and
39	curing those diseases and conditions.
40	(2)(3)  The purpose and objective of the corporation shall
41	be to operate exclusively for charitable, scientific, and
42	educational purposes; to protect and improve the health and
43	well-being of Florida's people and environment through
44	partnerships committed to program innovation, education, applied
45	research, and policy development; and to engage in charitable
46	programs dedicated to improving the health of Floridians.
47	(3)(4)  The corporation shall be established as a not-for-
48	profit entity qualifying under s. 501(c)(3) of the Internal
49	Revenue Code. The corporation may receive, hold, invest, and
50	administer property and any moneys acquired from private, local,
51	state, and federal sources, as well as technical and
52	professional income generated or derived from the mission-
53	related activities of the corporation. The corporation shall
54	have all of the powers conferred upon corporations organized
55	under chapter 617.
56	(4)(5)  The corporation's duties include procuring funds
57	necessary for accomplishing the purpose and mission of the
58	corporation. The corporation shall strive to complement,
59	supplement, and enhance the missions of the various
60	organizations, entities, and departments that provide public
61	health initiatives represented on its board by serving as the
62	lead corporation in the state for promoting public health
63	awareness.
64	(5)(6)  The affairs of the corporation shall be managed by
65	an executive director appointed by a board of directors.
66	consisting of:
67	(6)(a)  The board of directors shall be elected in
68	accordance with the bylaws of the corporation and shall include,
69	but not be limited to, the following:
70	1.(a)  The State Surgeon General or his or her designee.
71	2.(b)  A representative of the Florida Public Health
72	Association former member of the Senate appointed by the
73	President of the Senate.
74	3.(c)  Representatives of local health departments, with at
75	least one representative each from the southern, central, and
76	northern geographic areas of the state A former member of the
77	House of Representatives appointed by the Speaker of the House
78	of Representatives.
79	4.(d)  Representatives of institutions of higher learning A
80	representative of the American Heart Association.
81	5.(e)  Representatives of the private health care provider
82	sector, industry or business groups, or philanthropic
83	foundations A representative of the American Cancer Society,
84	Florida Division, Inc.
85	(b)  The majority of board members may not be state
86	employees.
87	(f)  A representative of the American Lung Association of
88	Florida.
89	(g)  A representative of the American Diabetes Association,
90	South Coastal Region.
91	(h)  A representative of the Alzheimer's Association.
92	(i)  A representative of the Epilepsy Foundation.
93	(j)  A representative of the National Parkinson Foundation.
94	(k)  A representative of the March of Dimes, Florida
95	Chapter.
96	(l)  A representative of the Arthritis Foundation, Florida
97	Chapter.
98	(m)  A representative of the American Liver Foundation.
99	(n)  A representative of the Florida Council for Behavioral
100	Healthcare, Inc.
101	(o)  A representative of the Florida Alcohol and Drug Abuse
102	Association.
103	(p)  A representative of Pharmaceutical Research and
104	Manufacturers of America.
105	(q)  A representative of the Florida Public Health
106	Association.
107	(r)  A representative of the Florida Association of County
108	Health Officers.
109	(s)  A public health academician selected by the State
110	Health Officer.
111	(t)  A representative of the Florida Academy of Family
112	Physicians.
113	(u)  Three consumers who have demonstrated an interest in
114	protecting the public health appointed by the Florida Public
115	Health Association.
116	(v)  A representative of the Florida Association of Health
117	Plans.
118	(7)  Members of the board of directors shall serve for 2-
119	year terms and shall serve without compensation. Each
120	organization represented on the board of directors shall cover
121	the expenses of its representative.
122	(8)  The corporation, in consultation with the Department
123	of Health and the Florida Center for Universal Research to
124	Eradicate Disease, shall facilitate communication between
125	biomedical researchers and health care providers each month
126	according to the health awareness schedule established by the
127	Florida Public Health Foundation, Inc., in order to ensure
128	ongoing dialogue between researchers, treatment providers, and
129	the department.
130	(7)(9)  The corporation and the Department of Health shall
131	enter into partnerships with providers of continuing education
132	for health care practitioners, including, but not limited to,
133	hospitals and state and local medical organizations, to ensure
134	that practitioners are aware of the most recent and complete
135	diagnostic and treatment tools.
136	(8)(10)  The corporation may provide personnel to the
137	Department of Health for the purpose of performing duties and
138	responsibilities outlined in private and public grants received
139	by the Department of Health. These personnel are not state
140	employees and are not entitled to retirement credit and other
141	benefits provided to state employees under chapters 110 and 112.
142	These personnel shall perform services pursuant to an agreement
143	between the corporation and the Department of Health.
144	(9)(11)  The corporation may purchase goods, services, and
145	property for use by the Department of Health. These purchases
146	are not subject to the provisions of chapters 253, 255, and 287,
147	nor to the control or direction of the Department of
148	Environmental Protection or the Department of Management
149	Services.
150	(10)(12)  The corporation shall provide an annual report
151	concerning its activities and finances to the Florida Center for
152	Universal Research to Eradicate Disease and shall provide copies
153	of the annual report to the Governor, the President of the
154	Senate, and the Speaker of the House of Representatives.
155	Section 2.  Paragraph (a) of subsection (5) of section
156	381.855, Florida Statutes, is amended to read:
157	381.855  Florida Center for Universal Research to Eradicate
158	Disease.--
159	(5)  There is established within the center an advisory
160	council that shall meet at least annually.
161	(a)  The council shall consist of one representative from a
162	Florida not-for-profit institution engaged in basic and clinical
163	biomedical research and education which receives more than $10
164	million in annual grant funding from the National Institutes of
165	Health, to be appointed by the State Surgeon General from a
166	different institution each term, and one representative from and
167	appointed by each of the following entities:
168	1.  Enterprise Florida, Inc.
169	2.  BioFlorida.
170	3.  The Biomedical Research Advisory Council.
171	4.  The Florida Medical Foundation.
172	5.  Pharmaceutical Research and Manufacturers of America.
173	6.  The Florida Cancer Council.
174	7.  The American Cancer Society, Florida Division, Inc.
175	8.  The American Heart Association.
176	9.  The American Lung Association of Florida.
177	10.  The American Diabetes Association, South Coastal
178	Region.
179	11.  The Alzheimer's Association.
180	12.  The Epilepsy Foundation.
181	13.  The National Parkinson Foundation.
182	14.  The Florida Public Health Institute Foundation, Inc.
183	15.  The Florida Research Consortium.
184	Section 3.  Section 381.911, Florida Statutes, is amended
185	to read:
186	381.911  Prostate Cancer Awareness Program.--
187	(1)  To the extent that funds are specifically made
188	available for this purpose, the Prostate Cancer Awareness
189	Program is established within the Department of Health. The
190	purpose of this program is to implement the recommendations of
191	January 2000 of the Florida Prostate Cancer Task Force to
192	provide for statewide outreach and health education activities
193	to ensure that men are aware of and appropriately seek medical
194	counseling for prostate cancer as an early-detection health care
195	measure.
196	(2)  For purposes of implementing the program, the
197	Department of Health and the Florida Public Health Institute
198	Foundation, Inc., may:
199	(a)  Conduct activities directly or enter into a contract
200	with a qualified nonprofit community education entity.
201	(b)  Seek any available gifts, grants, or funds from the
202	state, the Federal Government, philanthropic foundations, and
203	industry or business groups.
204	(3)  A prostate cancer advisory committee is created to
205	advise and assist the Department of Health and the Florida
206	Public Health Institute Foundation, Inc., in implementing the
207	program.
208	(a)  The State Surgeon General shall appoint the advisory
209	committee members, who shall consist of:
210	1.  Three persons from prostate cancer survivor groups or
211	cancer-related advocacy groups.
212	2.  Three persons who are scientists or clinicians from
213	public universities or research organizations.
214	3.  Three persons who are engaged in the practice of a
215	cancer-related medical specialty from health organizations
216	committed to cancer research and control.
217	(b)  Members shall serve without compensation but are
218	entitled to reimbursement, pursuant to s. 112.061, for per diem
219	and travel expenses incurred in the performance of their
220	official duties.
221	(4)  The program shall coordinate its efforts with those of
222	the Florida Public Health Institute Foundation, Inc.
223	Section 4.  Section 381.981, Florida Statutes, is amended
224	to read:
225	381.981  Health awareness campaigns.--
226	(1)  The Florida Public Health Institute Foundation, Inc.,
227	in consultation with the Department of Health, shall coordinate
228	monthly health awareness campaigns with national, state, and
229	local health care organizations and government entities
230	targeting a wide range of the public, including: parents;
231	teachers and other school employees; students in 4th through
232	12th grades, colleges, and universities; state agency employees;
233	county and local government employees; patients of county health
234	departments; Medicaid recipients; health care professionals and
235	providers; and the public in general.
236	(2)  The awareness campaigns shall include the provision of
237	educational information about preventing, detecting, treating,
238	and curing the following diseases or conditions. Additional
239	diseases and conditions that impact the public health may be
240	added by the board of directors of the Florida Public Health
241	Institute Foundation, Inc.; however, each of the following
242	diseases or conditions must be included in an awareness campaign
243	during at least 1 month in any 24-month period:
244	(a)  Cancer, including breast, prostate, cervical, ovarian,
245	colorectal, and skin cancer and leukemia.
246	(b)  Heart disease.
247	(c)  Stroke.
248	(d)  Lung disease, including asthma and smoking-relating
249	disease.
250	(e)  Neurological disorders and disease, including
251	Alzheimer's disease, Parkinson's disease, and epilepsy.
252	(f)  Gastrointestinal disease.
253	(g)  Kidney disease.
254	(h)  Diabetes.
255	(i)  Liver disease.
256	(j)  Autoimmune disorders.
257	(k)  Birth defects and prenatal care.
258	(l)  Obesity and malnutrition.
259	(m)  Sexually transmissible disease.
260	(n)  Hepatitis A, hepatitis B, and hepatitis C.
261	(o)  Arthritis.
262	(p)  Vaccine-preventable diseases.
263	(q)  Infectious diseases, including HIV/AIDS.
264	(r)  Substance abuse.
265	(s)  Mental illness.
266	(t)  Lupus.
267	(u)  Osteoporosis.
268	(3)  The health awareness campaigns shall be funded by the
269	Florida Public Health Institute Foundation, Inc., and the
270	Department of Health to the extent that funds are available from
271	public and private sources.
272	(4)  Health awareness information shall be disseminated
273	through all available methods, including print, audio, visual,
274	and electronic media.
275	Section 5.  Section 499.029, Florida Statutes, is amended
276	to read:
277	499.029  Prescription Cancer Drug Donation Program.--
278	(1)  This section may be cited as the "Prescription Cancer
279	Drug Donation Program Act."
280	(2)  There is created a Prescription Cancer Drug Donation
281	Program within the department for the purpose of authorizing and
282	facilitating the donation of prescription cancer drugs and
283	supplies to eligible patients.
284	(3)  As used in this section, the term:
285	(a)  "Cancer drug" means a prescription drug that has been
286	approved under s. 505 of the federal Food, Drug, and Cosmetic
287	Act and is used to treat cancer or its side effects or is used
288	to treat the side effects of a prescription drug used to treat
289	cancer or its side effects. "Cancer drug" does not include a
290	substance listed in Schedule II, Schedule III, Schedule IV, or
291	Schedule V of s. 893.03.
292	(a)(b)  "Closed drug delivery system" means a system in
293	which the actual control of the unit-dose medication package is
294	maintained by the facility rather than by the individual
295	patient.
296	(b)  "Dispensing practitioner" means a practitioner
297	registered under s. 465.0276.
298	(c)  "Donor" means a patient or patient representative who
299	donates prescription cancer drugs or supplies needed to
300	administer prescription cancer drugs that have been maintained
301	within a closed drug delivery system; health care facilities,
302	nursing homes, hospices, or hospitals with closed drug delivery
303	systems; or pharmacies, prescription drug manufacturers, medical
304	device manufacturers or suppliers, or wholesalers of
305	prescription drugs or supplies, in accordance with this section.
306	The term "Donor" includes a physician licensed under chapter 458
307	or chapter 459 who receives prescription cancer drugs or
308	supplies directly from a prescription drug manufacturer,
309	wholesale distributor, or pharmacy.
310	(d)  "Eligible patient" means a person who the department
311	determines is eligible to receive prescription cancer drugs from
312	the program.
313	(e)  "Participant facility" means a class II hospital
314	pharmacy or dispensing practitioner that has elected to
315	participate in the program and that accepts donated prescription
316	cancer drugs and supplies under the rules adopted by the
317	department for the program.
318	(f)  "Prescribing practitioner" means a physician licensed
319	under chapter 458 or chapter 459 or any other medical
320	professional with authority under state law to prescribe drugs
321	cancer medication.
322	(g)  "Prescription drug" does not include a substance
323	listed in Schedule II, Schedule III, Schedule IV, or Schedule V
324	of s. 893.03.
325	(h)(g)  "Program" means the Prescription Cancer Drug
326	Donation Program created by this section.
327	(i)(h)  "Supplies" means any supplies used in the
328	administration of a prescription cancer drug.
329	(4)  Any donor may donate prescription cancer drugs or
330	supplies to a participant facility that elects to participate in
331	the program and meets criteria established by the department for
332	such participation. Prescription Cancer drugs or supplies may
333	not be donated to a specific cancer patient, and donated
334	prescription drugs or supplies may not be resold by the
335	participant program. Prescription Cancer drugs billed to and
336	paid for by Medicaid in long-term care facilities that are
337	eligible for return to stock under federal Medicaid regulations
338	shall be credited to Medicaid and are not eligible for donation
339	under the program. A participant facility may provide dispensing
340	and counseling consulting services to an eligible patient
341	individuals who is are not a patient patients of the participant
342	hospital.
343	(5)  The prescription cancer drugs or supplies donated to
344	the program may be prescribed only by a prescribing practitioner
345	for use by an eligible patient and may be dispensed only by a
346	pharmacist or dispensing practitioner.
347	(6)(a)  A prescription cancer drug may only be accepted or
348	dispensed under the program if the drug is in its original,
349	unopened, sealed container, or in a tamper-evident unit-dose
350	packaging, except that a prescription cancer drug packaged in
351	single-unit doses may be accepted and dispensed if the outside
352	packaging is opened but the single-unit-dose packaging is
353	unopened with tamper-resistant packaging intact.
354	(b)  A prescription cancer drug may not be accepted or
355	dispensed under the program if the drug bears an expiration date
356	that is less than 6 months after the date the drug was donated
357	or if the drug appears to have been tampered with or mislabeled
358	as determined in paragraph (c).
359	(c)  Before Prior to being dispensed to an eligible
360	patient, the prescription cancer drug or supplies donated under
361	the program shall be inspected by a pharmacist or dispensing
362	practitioner to determine that the drug and supplies do not
363	appear to have been tampered with or mislabeled.
364	(d)  A dispenser of donated prescription cancer drugs or
365	supplies may not submit a claim or otherwise seek reimbursement
366	from any public or private third-party payor for donated
367	prescription cancer drugs or supplies dispensed to any patient
368	under the program, and a public or private third-party payor is
369	not required to provide reimbursement to a dispenser for donated
370	prescription cancer drugs or supplies dispensed to any patient
371	under the program.
372	(7)(a)  A donation of prescription cancer drugs or supplies
373	shall be made only at a participant's participant facility. A
374	participant facility may decline to accept a donation. A
375	participant facility that accepts donated prescription cancer
376	drugs or supplies under the program shall comply with all
377	applicable provisions of state and federal law relating to the
378	storage and dispensing of the donated prescription cancer drugs
379	or supplies.
380	(b)  A participant facility that voluntarily takes part in
381	the program may charge a handling fee sufficient to cover the
382	cost of preparation and dispensing of prescription cancer drugs
383	or supplies under the program. The fee shall be established in
384	rules adopted by the department.
385	(8)  The department, upon the recommendation of the Board
386	of Pharmacy, shall adopt rules to carry out the provisions of
387	this section. Initial rules under this section shall be adopted
388	no later than 90 days after the effective date of this act. The
389	rules shall include, but not be limited to:
390	(a)  Eligibility criteria, including a method to determine
391	priority of eligible patients under the program.
392	(b)  Standards and procedures for participants participant
393	facilities that accept, store, distribute, or dispense donated
394	prescription cancer drugs or supplies.
395	(c)  Necessary forms for administration of the program,
396	including, but not limited to, forms for use by entities that
397	donate, accept, distribute, or dispense prescription cancer
398	drugs or supplies under the program.
399	(d)  The maximum handling fee that may be charged by a
400	participant facility that accepts and distributes or dispenses
401	donated prescription cancer drugs or supplies.
402	(e)  Categories of prescription cancer drugs and supplies
403	that the program will accept for dispensing; however, the
404	department may exclude any drug based on its therapeutic
405	effectiveness or high potential for abuse or diversion.
406	(f)  Maintenance and distribution of the participant
407	facility registry established in subsection (10).
408	(9)  A person who is eligible to receive prescription
409	cancer drugs or supplies under the state Medicaid program or
410	under any other prescription drug program funded in whole or in
411	part by the state, by any other prescription drug program funded
412	in whole or in part by the Federal Government, or by any other
413	prescription drug program offered by a third-party insurer,
414	unless benefits have been exhausted, or a certain prescription
415	cancer drug or supply is not covered by the prescription drug
416	program, is ineligible to participate in the program created
417	under this section.
418	(10)  The department shall establish and maintain a
419	participant facility registry for the program. The participant
420	facility registry shall include the participant's participant
421	facility's name, address, and telephone number. The department
422	shall make the participant facility registry available on the
423	department's website to any donor wishing to donate prescription
424	cancer drugs or supplies to the program. The department's
425	website shall also contain links to prescription cancer drug
426	manufacturers that offer drug assistance programs or free
427	medication.
428	(11)  Any donor of prescription cancer drugs or supplies,
429	or any participant in the program, who exercises reasonable care
430	in donating, accepting, distributing, or dispensing prescription
431	cancer drugs or supplies under the program and the rules adopted
432	under this section is shall be immune from civil or criminal
433	liability and from professional disciplinary action of any kind
434	for any injury, death, or loss to person or property relating to
435	such activities.
436	(12)  A pharmaceutical manufacturer is not liable for any
437	claim or injury arising from the transfer of any prescription
438	cancer drug under this section, including, but not limited to,
439	liability for failure to transfer or communicate product or
440	consumer information regarding the transferred drug, as well as
441	the expiration date of the transferred drug.
442	(13)  If any conflict exists between the provisions in this
443	section and the provisions in this chapter or chapter 465, the
444	provisions in this section shall control the operation of the
445	Cancer Drug Donation program.
446	Section 6.  This act shall take effect July 1, 2009.
447

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