Bill Text: FL S0710 | 2018 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Prescription Drug Donation Repository Program
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Failed) 2018-03-10 - Died in Messages [S0710 Detail]
Download: Florida-2018-S0710-Comm_Sub.html
Bill Title: Prescription Drug Donation Repository Program
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Failed) 2018-03-10 - Died in Messages [S0710 Detail]
Download: Florida-2018-S0710-Comm_Sub.html
Florida Senate - 2018 CS for SB 710 By the Committee on Health Policy; and Senator Book 588-01792-18 2018710c1 1 A bill to be entitled 2 An act relating to the Prescription Drug Donation 3 Program; amending s. 499.029, F.S.; renaming the 4 Cancer Drug Donation Program as the Prescription Drug 5 Donation Program; authorizing the donation of 6 prescription drugs, including cancer drugs, and 7 supplies to eligible patients; revising definitions; 8 authorizing nursing home facilities to participate in 9 the program; providing an effective date. 10 11 Be It Enacted by the Legislature of the State of Florida: 12 13 Section 1. Section 499.029, Florida Statutes, is amended to 14 read: 15 499.029 PrescriptionCancerDrug Donation Program.— 16 (1) This section may be cited as the “PrescriptionCancer17 Drug Donation Program Act.” 18 (2) There is created a PrescriptionCancerDrug Donation 19 Program within the department for the purpose of authorizing and 20 facilitating the donation of prescriptioncancerdrugs and 21 supplies to eligible patients. 22 (3) As used in this section: 23 (a) “Cancer drug” means a prescription drug that has been 24 approved under s. 505 of the Federal Food, Drug, and Cosmetic 25 Act and is used to treat cancer or its side effects or is used 26 to treat the side effects of a prescription drug used to treat 27 cancer or its side effects. The term“Cancer drug”does not 28 include a substance listed in Schedule II, Schedule III, 29 Schedule IV, or Schedule V of s. 893.03. 30 (b) “Closed drug delivery system” means a system in which 31 the actual control of the unit-dose medication package is 32 maintained by the facility rather than by the individual 33 patient. 34 (c) “Donor” means a patient or patient representative who 35 donates prescriptioncancerdrugs or supplies needed to 36 administer prescriptioncancerdrugs that have been maintained 37 within a closed drug delivery system; health care facilities, 38 nursing home facilitieshomes, hospices, or hospitals with 39 closed drug delivery systems; or pharmacies, drug manufacturers, 40 medical device manufacturers or suppliers, or wholesalers of 41 drugs or supplies, in accordance with this section. The term 42“Donor”includes a physician licensed under chapter 458 or 43 chapter 459 who receives prescriptioncancerdrugs or supplies 44 directly from a drug manufacturer, wholesale distributor, or 45 pharmacy. 46 (d) “Eligible patient” means a person who the department 47 determines is eligible to receive prescriptioncancerdrugs from 48 the program. 49 (e) “Participant facility” means a hospital that operates a 50 class II institutionalhospitalpharmacy or a nursing home 51 facility licensed under part II of chapter 400 with a closed 52 drug delivery system that has elected to participate in the 53 program and that accepts donated prescriptioncancerdrugs and 54 supplies under the rules adopted by the department for the 55 program. 56 (f) “Prescribing practitioner” means a physician licensed 57 under chapter 458 or chapter 459 or any other medical 58 professional with authority under state law to prescribe 59 prescription drugscancer medication. 60 (g) “Prescription drug” has the same meaning as provided in 61 s. 499.003, and includes cancer drugs. The term does not include 62 a substance listed in Schedule II, Schedule III, Schedule IV, or 63 Schedule V of s. 893.03. 64 (h)(g)“Program” means the PrescriptionCancerDrug 65 Donation Program created by this section. 66 (i)(h)“Supplies” means any supplies used in the 67 administration of a prescriptioncancerdrug. 68 (4) Any donor may donate prescriptioncancerdrugs or 69 supplies to a participant facility that elects to participate in 70 the program and meets criteria established by the department for 71 such participation. PrescriptionCancerdrugs or supplies may 72 not be donated to a specificcancerpatient, and donated drugs 73 or supplies may not be resold by the program. Prescription 74Cancerdrugs billed to and paid for by Medicaid in long-term 75 care facilities that are eligible for return to stock under 76 federal Medicaid regulations shall be credited to Medicaid and 77 are not eligible for donation under the program. A participant 78 facility may provide dispensing and consulting services to 79 individuals who are not patients of the hospital or nursing home 80 facility. 81 (5) The prescriptioncancerdrugs or supplies donated to 82 the program may be prescribed only by a prescribing practitioner 83 for use by an eligible patient and may be dispensed only by a 84 pharmacist. 85 (6)(a) A prescriptioncancerdrug may only be accepted or 86 dispensed under the program if the drug is in its original, 87 unopened, sealed container, or in a tamper-evident unit-dose 88 packaging, except that a prescriptioncancerdrug packaged in 89 single-unit doses may be accepted and dispensed if the outside 90 packaging is opened but the single-unit-dose packaging is 91 unopened with tamper-resistant packaging intact. 92 (b) A prescriptioncancerdrug may not be accepted or 93 dispensed under the program if the drug bears an expiration date 94 that is less than 6 months after the date the drug was donated 95 or if the drug appears to have been tampered with or mislabeled 96 as determined in paragraph (c). 97 (c) Prior to being dispensed to an eligible patient, the 98 prescriptioncancerdrug or supplies donated under the program 99 shall be inspected by a pharmacist to determine that the drug 100 and supplies do not appear to have been tampered with or 101 mislabeled. 102 (d) A dispenser of donated prescriptioncancerdrugs or 103 supplies may not submit a claim or otherwise seek reimbursement 104 from any public or private third-party payor for donated 105 prescriptioncancerdrugs or supplies dispensed to any patient 106 under the program, and a public or private third-party payor is 107 not required to provide reimbursement to a dispenser for donated 108 prescriptioncancerdrugs or supplies dispensed to any patient 109 under the program. 110 (7)(a) A donation of prescriptioncancerdrugs or supplies 111 shall be made only at a participant facility. A participant 112 facility may decline to accept a donation. A participant 113 facility that accepts donated prescriptioncancerdrugs or 114 supplies under the program shall comply with all applicable 115 provisions of state and federal law relating to the storage and 116 dispensing of the donated prescriptioncancerdrugs or supplies. 117 (b) A participant facility that voluntarily takes part in 118 the program may charge a handling fee sufficient to cover the 119 cost of preparation and dispensing of prescriptioncancerdrugs 120 or supplies under the program. The fee shall be established in 121 rules adopted by the department. 122 (8) The department, upon the recommendation of the Board of 123 Pharmacy, shall adopt rules to carry out the provisions of this 124 section.Initial rules under this section shall be adopted no125later than 90 days after the effective date of this act.The 126 rules shall include, but not be limited to: 127 (a) Eligibility criteria, including a method to determine 128 priority of eligible patients under the program. 129 (b) Standards and procedures for participant facilities 130 that accept, store, distribute, or dispense donated prescription 131cancerdrugs or supplies. 132 (c) Necessary forms for administration of the program, 133 including, but not limited to, forms for use by entities that 134 donate, accept, distribute, or dispense prescriptioncancer135 drugs or supplies under the program. 136 (d) The maximum handling fee that may be charged by a 137 participant facility that accepts and distributes or dispenses 138 donated prescriptioncancerdrugs or supplies. 139 (e) Categories of prescriptioncancerdrugs and supplies 140 that the program will accept for dispensing; however, the 141 department may exclude any drug based on its therapeutic 142 effectiveness or high potential for abuse or diversion. 143 (f) Maintenance and distribution of the participant 144 facility registry established in subsection (10). 145 (9) A person who is eligible to receive prescriptioncancer146 drugs or supplies under the state Medicaid program or under any 147 other prescription drug program funded in whole or in part by 148 the state, by any other prescription drug program funded in 149 whole or in part by the Federal Government, or by any other 150 prescription drug program offered by a third-party insurer, 151 unless benefits have been exhausted, or a certain prescription 152cancerdrug or supply is not covered by the prescription drug 153 program, is ineligible to participate in the program created 154 under this section. 155 (10) The department shall establish and maintain a 156 participant facility registry for the program. The participant 157 facility registry shall include the participant facility’s name, 158 address, and telephone number. The department shall make the 159 participant facility registry available on the department’s 160 website to any donor wishing to donate prescriptioncancerdrugs 161 or supplies to the program. The department’s website shall also 162 contain links to prescriptioncancerdrug manufacturers that 163 offer drug assistance programs or free medication. 164 (11) Any donor of prescriptioncancerdrugs or supplies, or 165 any participant in the program, who exercises reasonable care in 166 donating, accepting, distributing, or dispensing prescription 167cancerdrugs or supplies under the program and the rules adopted 168 under this section shall be immune from civil or criminal 169 liability and from professional disciplinary action of any kind 170 for any injury, death, or loss to person or property relating to 171 such activities. 172 (12) A pharmaceutical manufacturer is not liable for any 173 claim or injury arising from the transfer of any prescription 174cancerdrug under this section, including, but not limited to, 175 liability for failure to transfer or communicate product or 176 consumer information regarding the transferred drug, as well as 177 the expiration date of the transferred drug. 178 (13) If any conflict exists between the provisions in this 179 section and the provisions in this chapter or chapter 465, the 180 provisions in this section shall control the operation of the 181 PrescriptionCancerDrug Donation Program. 182 Section 2. This act shall take effect July 1, 2018.