Florida Senate - 2018                                     SB 710
       By Senator Book
       32-00939-18                                            2018710__
    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.
   11  Be It Enacted by the Legislature of the State of Florida:
   13         Section 1. Section 499.029, Florida Statutes, is amended to
   14  read:
   15         499.029 Prescription Cancer Drug Donation Program.—
   16         (1) This section may be cited as the “Prescription Cancer
   17  Drug Donation Program Act.”
   18         (2) There is created a Prescription Cancer Drug Donation
   19  Program within the department for the purpose of authorizing and
   20  facilitating the donation of prescription cancer drugs 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 prescription cancer drugs or supplies needed to
   36  administer prescription cancer drugs that have been maintained
   37  within a closed drug delivery system; health care facilities,
   38  nursing home facilities homes, 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 prescription cancer drugs 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 prescription cancer drugs from
   48  the program.
   49         (e) “Participant facility” means a hospital that operates a
   50  class II institutional hospital pharmacy 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 prescription cancer drugs 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 drugs cancer medication.
   60         (g)“Prescription drug” has the same meaning as provided in
   61  s. 499.003, and includes cancer drugs.
   62         (h)(g) “Program” means the Prescription Cancer Drug
   63  Donation Program created by this section.
   64         (i)(h) “Supplies” means any supplies used in the
   65  administration of a prescription cancer drug.
   66         (4) Any donor may donate prescription cancer drugs or
   67  supplies to a participant facility that elects to participate in
   68  the program and meets criteria established by the department for
   69  such participation. Prescription Cancer drugs or supplies may
   70  not be donated to a specific cancer patient, and donated drugs
   71  or supplies may not be resold by the program. Prescription
   72  Cancer drugs billed to and paid for by Medicaid in long-term
   73  care facilities that are eligible for return to stock under
   74  federal Medicaid regulations shall be credited to Medicaid and
   75  are not eligible for donation under the program. A participant
   76  facility may provide dispensing and consulting services to
   77  individuals who are not patients of the hospital or nursing home
   78  facility.
   79         (5) The prescription cancer drugs or supplies donated to
   80  the program may be prescribed only by a prescribing practitioner
   81  for use by an eligible patient and may be dispensed only by a
   82  pharmacist.
   83         (6)(a) A prescription cancer drug may only be accepted or
   84  dispensed under the program if the drug is in its original,
   85  unopened, sealed container, or in a tamper-evident unit-dose
   86  packaging, except that a prescription cancer drug packaged in
   87  single-unit doses may be accepted and dispensed if the outside
   88  packaging is opened but the single-unit-dose packaging is
   89  unopened with tamper-resistant packaging intact.
   90         (b) A prescription cancer drug may not be accepted or
   91  dispensed under the program if the drug bears an expiration date
   92  that is less than 6 months after the date the drug was donated
   93  or if the drug appears to have been tampered with or mislabeled
   94  as determined in paragraph (c).
   95         (c) Prior to being dispensed to an eligible patient, the
   96  prescription cancer drug or supplies donated under the program
   97  shall be inspected by a pharmacist to determine that the drug
   98  and supplies do not appear to have been tampered with or
   99  mislabeled.
  100         (d) A dispenser of donated prescription cancer drugs or
  101  supplies may not submit a claim or otherwise seek reimbursement
  102  from any public or private third-party payor for donated
  103  prescription cancer drugs or supplies dispensed to any patient
  104  under the program, and a public or private third-party payor is
  105  not required to provide reimbursement to a dispenser for donated
  106  prescription cancer drugs or supplies dispensed to any patient
  107  under the program.
  108         (7)(a) A donation of prescription cancer drugs or supplies
  109  shall be made only at a participant facility. A participant
  110  facility may decline to accept a donation. A participant
  111  facility that accepts donated prescription cancer drugs or
  112  supplies under the program shall comply with all applicable
  113  provisions of state and federal law relating to the storage and
  114  dispensing of the donated prescription cancer drugs or supplies.
  115         (b) A participant facility that voluntarily takes part in
  116  the program may charge a handling fee sufficient to cover the
  117  cost of preparation and dispensing of prescription cancer drugs
  118  or supplies under the program. The fee shall be established in
  119  rules adopted by the department.
  120         (8) The department, upon the recommendation of the Board of
  121  Pharmacy, shall adopt rules to carry out the provisions of this
  122  section. Initial rules under this section shall be adopted no
  123  later than 90 days after the effective date of this act. The
  124  rules shall include, but not be limited to:
  125         (a) Eligibility criteria, including a method to determine
  126  priority of eligible patients under the program.
  127         (b) Standards and procedures for participant facilities
  128  that accept, store, distribute, or dispense donated prescription
  129  cancer drugs or supplies.
  130         (c) Necessary forms for administration of the program,
  131  including, but not limited to, forms for use by entities that
  132  donate, accept, distribute, or dispense prescription cancer
  133  drugs or supplies under the program.
  134         (d) The maximum handling fee that may be charged by a
  135  participant facility that accepts and distributes or dispenses
  136  donated prescription cancer drugs or supplies.
  137         (e) Categories of prescription cancer drugs and supplies
  138  that the program will accept for dispensing; however, the
  139  department may exclude any drug based on its therapeutic
  140  effectiveness or high potential for abuse or diversion.
  141         (f) Maintenance and distribution of the participant
  142  facility registry established in subsection (10).
  143         (9) A person who is eligible to receive prescription cancer
  144  drugs or supplies under the state Medicaid program or under any
  145  other prescription drug program funded in whole or in part by
  146  the state, by any other prescription drug program funded in
  147  whole or in part by the Federal Government, or by any other
  148  prescription drug program offered by a third-party insurer,
  149  unless benefits have been exhausted, or a certain prescription
  150  cancer drug or supply is not covered by the prescription drug
  151  program, is ineligible to participate in the program created
  152  under this section.
  153         (10) The department shall establish and maintain a
  154  participant facility registry for the program. The participant
  155  facility registry shall include the participant facility’s name,
  156  address, and telephone number. The department shall make the
  157  participant facility registry available on the department’s
  158  website to any donor wishing to donate prescription cancer drugs
  159  or supplies to the program. The department’s website shall also
  160  contain links to prescription cancer drug manufacturers that
  161  offer drug assistance programs or free medication.
  162         (11) Any donor of prescription cancer drugs or supplies, or
  163  any participant in the program, who exercises reasonable care in
  164  donating, accepting, distributing, or dispensing prescription
  165  cancer drugs or supplies under the program and the rules adopted
  166  under this section shall be immune from civil or criminal
  167  liability and from professional disciplinary action of any kind
  168  for any injury, death, or loss to person or property relating to
  169  such activities.
  170         (12) A pharmaceutical manufacturer is not liable for any
  171  claim or injury arising from the transfer of any prescription
  172  cancer drug under this section, including, but not limited to,
  173  liability for failure to transfer or communicate product or
  174  consumer information regarding the transferred drug, as well as
  175  the expiration date of the transferred drug.
  176         (13) If any conflict exists between the provisions in this
  177  section and the provisions in this chapter or chapter 465, the
  178  provisions in this section shall control the operation of the
  179  Prescription Cancer Drug Donation Program.
  180         Section 2. This act shall take effect July 1, 2018.