HB 371

1
A bill to be entitled
2An act relating to the Cancer Drug Donation Program;
3creating s. 499.029, F.S.; providing a short title;
4creating the Cancer Drug Donation Program; providing a
5purpose; providing definitions; providing conditions for
6the donation of cancer drugs and supplies to the program;
7providing conditions for the acceptance of cancer drugs
8and supplies into the program, inspection of cancer drugs
9and supplies, and dispensing of cancer drugs and supplies
10to eligible patients; requiring a participant facility
11that accepts donated drugs and supplies through the
12program to comply with certain state and federal laws;
13authorizing a participant facility to charge fees under
14certain conditions; requiring the Department of Health,
15upon recommendation of the Board of Pharmacy, to adopt
16certain rules; providing for the ineligibility of certain
17persons to receive donated drugs; requiring the department
18to establish and maintain a participant facility registry;
19providing for the contents and availability of the
20participant facility registry; providing immunity from
21civil and criminal liability for donors or pharmaceutical
22manufacturers in certain circumstances; providing that in
23the event of conflict between the provisions in s.
24499.029, F.S., and provisions in ch. 465 or ch. 499, F.S.,
25the provisions in s. 499.029, F.S., shall control;
26providing an appropriation; providing an effective date.
27
28Be It Enacted by the Legislature of the State of Florida:
29
30     Section 1.  Section 499.029, Florida Statutes, is created
31to read:
32     499.029  Cancer Drug Donation Program.--
33     (1)  This section may be cited as the "Cancer Drug Donation
34Program Act."
35     (2)  There is created a Cancer Drug Donation Program within
36the Department of Health for the purpose of authorizing and
37facilitating the donation of cancer drugs and supplies to
38eligible patients.
39     (3)  As used in this section:
40     (a)  "Cancer drug" means a prescription drug that has been
41approved under s. 505 of the federal Food, Drug, and Cosmetic
42Act and is used to treat cancer or its side effects or is used
43to treat the side effects of a prescription drug used to treat
44cancer or its side effects. "Cancer drug" does not include a
45substance listed in Schedule II, Schedule III, Schedule IV, or
46Schedule V of s. 893.03.
47     (b)  "Closed drug delivery system" means a system in which
48the actual control of the unit-dose medication package is
49maintained by the facility rather than by the individual
50patient.
51     (c)  "Department" means the Department of Health.
52     (d)  "Donor" means a patient or patient representative who
53donates cancer drugs or supplies needed to administer cancer
54drugs that have been maintained within a closed drug delivery
55system; health care facilities, nursing homes, hospices, or
56hospitals with closed drug delivery systems; or pharmacies, drug
57manufacturers, medical device manufacturers or suppliers, or
58wholesalers of drugs or supplies, in accordance with this
59section. "Donor" includes a physician licensed under chapter 458
60or chapter 459 who receives cancer drugs or supplies directly
61from a drug manufacturer, drug wholesaler, or pharmacy.
62     (e)  "Eligible patient" means a person who the department
63determines is eligible to receive cancer drugs from the program.
64     (f)  "Health care facility" means a health care facility
65licensed under chapter 395.
66     (g)  "Health care clinic" means a health care clinic
67licensed under part XIII of chapter 400.
68     (h)  "Hospice" means a corporation licensed under part VI
69of chapter 400.
70     (i)  "Hospital" means a facility as defined in s. 395.002
71and licensed under chapter 395.
72     (j)  "Nursing home" means a facility licensed under part II
73of chapter 400.
74     (k)  "Participant facility" means a class II hospital
75pharmacy that has elected to participate in the program and that
76accepts donated cancer drugs and supplies under the rules
77adopted by the department for the program.
78     (l)  "Pharmacist" means a person licensed under chapter
79465.
80     (m)  "Pharmacy" means an entity licensed under chapter 465.
81     (n)  "Prescribing practitioner" means a physician licensed
82under chapter 458 or any other medical professional with
83authority under state law to prescribe cancer medication.
84     (o)  "Prescription drug" means a drug as defined in s.
85465.003(8).
86     (p)  "Program" means the Cancer Drug Donation Program
87created by this section.
88     (q)  "Supplies" means any supplies used in the
89administration of a cancer drug.
90     (4)  Any donor may donate cancer drugs or supplies to a
91participant facility that elects to participate in the program
92and meets criteria established by the department for such
93participation. Cancer drugs or supplies may not be donated to a
94specific cancer patient, and donated drugs or supplies may not
95be resold by the program. Cancer drugs billed to and paid for by
96Medicaid in long-term care facilities that are eligible for
97return to stock under federal Medicaid regulations shall be
98credited to Medicaid and are not eligible for donation under the
99program. A participant facility may provide dispensing and
100consulting services to individuals who are not patients of the
101hospital.
102     (5)  The cancer drugs or supplies donated to the program
103may be prescribed only by a prescribing practitioner for use by
104an eligible patient and may be dispensed only by a pharmacist.
105     (6)(a)  A cancer drug may only be accepted or dispensed
106under the program if the drug is in its original, unopened,
107sealed container, or in a tamper-evident unit-dose packaging,
108except that a cancer drug packaged in single-unit doses may be
109accepted and dispensed if the outside packaging is opened but
110the single-unit-dose packaging is unopened with tamper-resistant
111packaging intact.
112     (b)  A cancer drug may not be accepted or dispensed under
113the program if the drug bears an expiration date that is less
114than 6 months after the date the drug was donated or if the drug
115appears to have been tampered with or mislabeled as determined
116in paragraph (c).
117     (c)  Prior to being dispensed to an eligible patient, the
118cancer drug or supplies donated under the program shall be
119inspected by a pharmacist to determine that the drug and
120supplies do not appear to have been tampered with or mislabeled.
121     (d)  A dispenser of donated cancer drugs or supplies may
122not submit a claim or otherwise seek reimbursement from any
123public or private third-party payor for donated cancer drugs or
124supplies dispensed to any patient under the program, and a
125public or private third-party payor is not required to provide
126reimbursement to a dispenser for donated cancer drugs or
127supplies dispensed to any patient under the program.
128     (7)(a)  A donation of cancer drugs or supplies shall be
129made only at a participant facility. A participant facility may
130decline to accept a donation. A participant facility that
131accepts donated cancer drugs or supplies under the program shall
132comply with all applicable provisions of state and federal law
133relating to the storage and dispensing of the donated cancer
134drugs or supplies.
135     (b)  A participant facility that voluntarily takes part in
136the program may charge a handling fee sufficient to cover the
137cost of preparation and dispensing of cancer drugs or supplies
138under the program. The fee shall be established in rules adopted
139by the department.
140     (8)  The department, upon the recommendation of the Board
141of Pharmacy, shall adopt rules to carry out the provisions of
142this section. Initial rules under this section shall be adopted
143no later than 90 days after the effective date of this act. The
144rules shall include, but not be limited to:
145     (a)  Eligibility criteria, including a method to determine
146priority of eligible patients under the program.
147     (b)  Standards and procedures for participant facilities
148that accept, store, distribute, or dispense donated cancer drugs
149or supplies.
150     (c)  Necessary forms for administration of the program,
151including, but not limited to, forms for use by entities that
152donate, accept, distribute, or dispense cancer drugs or supplies
153under the program.
154     (d)  The maximum handling fee that may be charged by a
155participant facility that accepts and distributes or dispenses
156donated cancer drugs or supplies.
157     (e)  Categories of cancer drugs and supplies that the
158program will accept for dispensing; however, the department may
159exclude any drug based on its therapeutic effectiveness or high
160potential for abuse or diversion.
161     (f)  Maintenance and distribution of the participant
162facility registry established in subsection (10).
163     (9)  A person who is eligible to receive cancer drugs or
164supplies under the state Medicaid program or under any other
165prescription drug program funded in whole or in part by the
166state, by any other prescription drug program funded in whole or
167in part by the Federal Government, or by any other prescription
168drug program offered by a third-party insurer, unless benefits
169have been exhausted, or a certain cancer drug or supply is not
170covered by the prescription drug program, is ineligible to
171participate in the program created under this section.
172     (10)  The department shall establish and maintain a
173participant facility registry for the program. The participant
174facility registry shall include the participant facility's name,
175address, and telephone number. The department shall make the
176participant facility registry available on the department's
177website to any donor wishing to donate cancer drugs or supplies
178to the program. The department's website shall also contain
179links to cancer drug manufacturers that offer drug assistance
180programs or free medication.
181     (11)  Any donor of cancer drugs or supplies, or any
182participant in the program, who exercises reasonable care in
183donating, accepting, distributing, or dispensing cancer drugs or
184supplies under the program and the rules adopted under this
185section shall be immune from civil or criminal liability and
186from professional disciplinary action of any kind for any
187injury, death, or loss to person or property relating to such
188activities.
189     (12)  A pharmaceutical manufacturer is not liable for any
190claim or injury arising from the transfer of any cancer drug
191under this section, including, but not limited to, liability for
192failure to transfer or communicate product or consumer
193information regarding the transferred drug, as well as the
194expiration date of the transferred drug.
195     (13)  If any conflict exists between the provisions in this
196section and the provisions in this chapter or chapter 465, the
197provisions in this section shall control the operation of the
198Cancer Drug Donation Program.
199     Section 2.  There is hereby appropriated one full-time
200equivalent position at salary rate 42,715 and recurring funding
201from the Florida Drug, Device, and Cosmetic Trust Fund pursuant
202to s. 499.057, Florida Statutes, in the sum of $65,308 for
203fiscal year 2006-2007, for the purpose of implementing the
204Cancer Drug Donation Program under s. 499.029, Florida Statutes,
205as created by this act.
206     Section 3.  This act shall take effect July 1, 2006.


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