| 1 | The Health Care General Committee recommends the following: |
| 2 |
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| 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. 381.94, 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, pharmaceutical |
| 26 | manufacturers, or cancer supply manufacturers in certain |
| 27 | circumstances; providing that in the event of conflict |
| 28 | between the provisions in s. 381.94, F.S., and provisions |
| 29 | in ch. 465 or ch. 499, F.S., the provisions in s. 381.94, |
| 30 | F.S., shall control; providing an effective date. |
| 31 |
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| 32 | Be It Enacted by the Legislature of the State of Florida: |
| 33 |
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| 34 | Section 1. Section 381.94, Florida Statutes, is created to |
| 35 | read: |
| 36 | 381.94 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. A participant facility may provide |
| 100 | dispensing and consulting services to individuals who are not |
| 101 | patients of the 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 facility in the program, that exercises reasonable |
| 183 | care in donating, accepting, distributing, or dispensing cancer |
| 184 | drugs or supplies under the program and the rules adopted under |
| 185 | this section shall be immune from civil or criminal liability |
| 186 | and 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 or cancer supply manufacturer is not |
| 190 | liable for any claim or injury arising from the donation and use |
| 191 | of any cancer drug under this section, including, but not |
| 192 | limited to, liability for failure to transfer or communicate |
| 193 | product or consumer information regarding the donated drug or |
| 194 | supply, as well as the expiration date of the donated drug or |
| 195 | supply. |
| 196 | (13) If any conflict exists between the provisions in this |
| 197 | section and the provisions in chapter 465 or chapter 499, the |
| 198 | provisions in this section shall control the operation of the |
| 199 | Cancer Drug Donation Program. |
| 200 | Section 2. This act shall take effect July 1, 2006. |