HB 0371

CS

CHAMBER ACTION

1	The Health & Families Council recommends the following:
2
3	Council/Committee Substitute
4	Remove the entire bill and insert:
5	A bill to be entitled
6	An act relating to the Cancer Drug Donation Program;
7	creating s. 499.029, F.S.; providing a short title;
8	creating the Cancer Drug Donation Program; providing a
9	purpose; providing definitions; providing conditions for
10	the donation of cancer drugs and supplies to the program;
11	providing conditions for the acceptance of cancer drugs
12	and supplies into the program, inspection of cancer drugs
13	and supplies, and dispensing of cancer drugs and supplies
14	to eligible patients; requiring a participant facility
15	that accepts donated drugs and supplies through the
16	program to comply with certain state and federal laws;
17	authorizing a participant facility to charge fees under
18	certain conditions; requiring the Department of Health,
19	upon recommendation of the Board of Pharmacy, to adopt
20	certain rules; providing for the ineligibility of certain
21	persons to receive donated drugs; requiring the department
22	to establish and maintain a participant facility registry;
23	providing for the contents and availability of the
24	participant facility registry; providing immunity from
25	civil and criminal liability for donors or pharmaceutical
26	manufacturers in certain circumstances; providing that in
27	the event of conflict between the provisions in s.
28	499.029, F.S., and provisions in ch. 465 or ch. 499, F.S.,
29	the provisions in s. 499.029, F.S., shall control;
30	providing an appropriation; providing an effective date.
31
32	Be It Enacted by the Legislature of the State of Florida:
33
34	Section 1.  Section 499.029, Florida Statutes, is created
35	to read:
36	499.029  Cancer Drug Donation Program.--
37	(1)  This section may be cited as the "Cancer Drug Donation
38	Program Act."
39	(2)  There is created a Cancer Drug Donation Program within
40	the Department of Health for the purpose of authorizing and
41	facilitating the donation of cancer drugs and supplies to
42	eligible patients.
43	(3)  As used in this section:
44	(a)  "Cancer drug" means a prescription drug that has been
45	approved under s. 505 of the federal Food, Drug, and Cosmetic
46	Act and is used to treat cancer or its side effects or is used
47	to treat the side effects of a prescription drug used to treat
48	cancer or its side effects. "Cancer drug" does not include a
49	substance listed in Schedule II, Schedule III, Schedule IV, or
50	Schedule V of s. 893.03.
51	(b)  "Closed drug delivery system" means a system in which
52	the actual control of the unit-dose medication package is
53	maintained by the facility rather than by the individual
54	patient.
55	(c)  "Department" means the Department of Health.
56	(d)  "Donor" means a patient or patient representative who
57	donates cancer drugs or supplies needed to administer cancer
58	drugs that have been maintained within a closed drug delivery
59	system; health care facilities, nursing homes, hospices, or
60	hospitals with closed drug delivery systems; or pharmacies, drug
61	manufacturers, medical device manufacturers or suppliers, or
62	wholesalers of drugs or supplies, in accordance with this
63	section. "Donor" includes a physician licensed under chapter 458
64	or chapter 459 who receives cancer drugs or supplies directly
65	from a drug manufacturer, drug wholesaler, or pharmacy.
66	(e)  "Eligible patient" means a person who the department
67	determines is eligible to receive cancer drugs from the program.
68	(f)  "Health care facility" means a health care facility
69	licensed under chapter 395.
70	(g)  "Health care clinic" means a health care clinic
71	licensed under part XIII of chapter 400.
72	(h)  "Hospice" means a corporation licensed under part VI
73	of chapter 400.
74	(i)  "Hospital" means a facility as defined in s. 395.002
75	and licensed under chapter 395.
76	(j)  "Nursing home" means a facility licensed under part II
77	of chapter 400.
78	(k)  "Participant facility" means a class II hospital
79	pharmacy that has elected to participate in the program and that
80	accepts donated cancer drugs and supplies under the rules
81	adopted by the department for the program.
82	(l)  "Pharmacist" means a person licensed under chapter
83	465.
84	(m)  "Pharmacy" means an entity licensed under chapter 465.
85	(n)  "Prescribing practitioner" means a physician licensed
86	under chapter 458 or any other medical professional with
87	authority under state law to prescribe cancer medication.
88	(o)  "Prescription drug" means a drug as defined in s.
89	465.003(8).
90	(p)  "Program" means the Cancer Drug Donation Program
91	created by this section.
92	(q)  "Supplies" means any supplies used in the
93	administration of a cancer drug.
94	(4)  Any donor may donate cancer drugs or supplies to a
95	participant facility that elects to participate in the program
96	and meets criteria established by the department for such
97	participation. Cancer drugs or supplies may not be donated to a
98	specific cancer patient, and donated drugs or supplies may not
99	be resold by the program. Cancer drugs billed to and paid for by
100	Medicaid in long-term care facilities that are eligible for
101	return to stock under federal Medicaid regulations shall be
102	credited to Medicaid and are not eligible for donation under the
103	program. A participant facility may provide dispensing and
104	consulting services to individuals who are not patients of the
105	hospital.
106	(5)  The cancer drugs or supplies donated to the program
107	may be prescribed only by a prescribing practitioner for use by
108	an eligible patient and may be dispensed only by a pharmacist.
109	(6)(a)  A cancer drug may only be accepted or dispensed
110	under the program if the drug is in its original, unopened,
111	sealed container, or in a tamper-evident unit-dose packaging,
112	except that a cancer drug packaged in single-unit doses may be
113	accepted and dispensed if the outside packaging is opened but
114	the single-unit-dose packaging is unopened with tamper-resistant
115	packaging intact.
116	(b)  A cancer drug may not be accepted or dispensed under
117	the program if the drug bears an expiration date that is less
118	than 6 months after the date the drug was donated or if the drug
119	appears to have been tampered with or mislabeled as determined
120	in paragraph (c).
121	(c)  Prior to being dispensed to an eligible patient, the
122	cancer drug or supplies donated under the program shall be
123	inspected by a pharmacist to determine that the drug and
124	supplies do not appear to have been tampered with or mislabeled.
125	(d)  A dispenser of donated cancer drugs or supplies may
126	not submit a claim or otherwise seek reimbursement from any
127	public or private third-party payor for donated cancer drugs or
128	supplies dispensed to any patient under the program, and a
129	public or private third-party payor is not required to provide
130	reimbursement to a dispenser for donated cancer drugs or
131	supplies dispensed to any patient under the program.
132	(7)(a)  A donation of cancer drugs or supplies shall be
133	made only at a participant facility. A participant facility may
134	decline to accept a donation. A participant facility that
135	accepts donated cancer drugs or supplies under the program shall
136	comply with all applicable provisions of state and federal law
137	relating to the storage and dispensing of the donated cancer
138	drugs or supplies.
139	(b)  A participant facility that voluntarily takes part in
140	the program may charge a handling fee sufficient to cover the
141	cost of preparation and dispensing of cancer drugs or supplies
142	under the program. The fee shall be established in rules adopted
143	by the department.
144	(8)  The department, upon the recommendation of the Board
145	of Pharmacy, shall adopt rules to carry out the provisions of
146	this section. Initial rules under this section shall be adopted
147	no later than 90 days after the effective date of this act. The
148	rules shall include, but not be limited to:
149	(a)  Eligibility criteria, including a method to determine
150	priority of eligible patients under the program.
151	(b)  Standards and procedures for participant facilities
152	that accept, store, distribute, or dispense donated cancer drugs
153	or supplies.
154	(c)  Necessary forms for administration of the program,
155	including, but not limited to, forms for use by entities that
156	donate, accept, distribute, or dispense cancer drugs or supplies
157	under the program.
158	(d)  The maximum handling fee that may be charged by a
159	participant facility that accepts and distributes or dispenses
160	donated cancer drugs or supplies.
161	(e)  Categories of cancer drugs and supplies that the
162	program will accept for dispensing; however, the department may
163	exclude any drug based on its therapeutic effectiveness or high
164	potential for abuse or diversion.
165	(f)  Maintenance and distribution of the participant
166	facility registry established in subsection (10).
167	(9)  A person who is eligible to receive cancer drugs or
168	supplies under the state Medicaid program or under any other
169	prescription drug program funded in whole or in part by the
170	state, by any other prescription drug program funded in whole or
171	in part by the Federal Government, or by any other prescription
172	drug program offered by a third-party insurer, unless benefits
173	have been exhausted, or a certain cancer drug or supply is not
174	covered by the prescription drug program, is ineligible to
175	participate in the program created under this section.
176	(10)  The department shall establish and maintain a
177	participant facility registry for the program. The participant
178	facility registry shall include the participant facility's name,
179	address, and telephone number. The department shall make the
180	participant facility registry available on the department's
181	website to any donor wishing to donate cancer drugs or supplies
182	to the program. The department's website shall also contain
183	links to cancer drug manufacturers that offer drug assistance
184	programs or free medication.
185	(11)  Any donor of cancer drugs or supplies, or any
186	participant in the program, who exercises reasonable care in
187	donating, accepting, distributing, or dispensing cancer drugs or
188	supplies under the program and the rules adopted under this
189	section shall be immune from civil or criminal liability and
190	from professional disciplinary action of any kind for any
191	injury, death, or loss to person or property relating to such
192	activities.
193	(12)  A pharmaceutical manufacturer is not liable for any
194	claim or injury arising from the transfer of any cancer drug
195	under this section, including, but not limited to, liability for
196	failure to transfer or communicate product or consumer
197	information regarding the transferred drug, as well as the
198	expiration date of the transferred drug.
199	(13)  If any conflict exists between the provisions in this
200	section and the provisions in this chapter or chapter 465, the
201	provisions in this section shall control the operation of the
202	Cancer Drug Donation Program.
203	Section 2.  There is hereby appropriated one full-time
204	equivalent position at salary rate 42,715 and recurring funding
205	from the Florida Drug, Device, and Cosmetic Trust Fund pursuant
206	to s. 499.057, Florida Statutes, in the sum of $65,308 for
207	fiscal year 2006-2007, for the purpose of implementing the
208	Cancer Drug Donation Program under s. 499.029, Florida Statutes,
209	as created by this act.
210	Section 3.  This act shall take effect July 1, 2006.

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