HB 371

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

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