Senate Bill sb1310c1

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    Florida Senate - 2006                           CS for SB 1310

    By the Committee on Health Care; and Senator Clary





    587-2086-06

  1                      A bill to be entitled

  2         An act relating to the Cancer Drug Donation

  3         Program; creating s. 381.94, F.S.; providing a

  4         short title; creating the Cancer Drug Donation

  5         Program; providing a purpose; providing

  6         definitions; providing eligibility criteria for

  7         cancer patients for the Cancer Drug Donation

  8         Program; providing conditions for the donation

  9         of cancer drugs and supplies to the program;

10         providing conditions for the acceptance of

11         cancer drugs and supplies into the program,

12         inspection of cancer drugs and supplies, and

13         dispensing of cancer drugs and supplies to

14         eligible patients; requiring a participant

15         facility that accepts donated drugs and

16         supplies through the program to comply with

17         certain state and federal laws; authorizing a

18         participant facility to charge fees under

19         certain conditions; requiring the Department of

20         Health, upon recommendation of the Board of

21         Pharmacy, to adopt certain rules; providing for

22         the ineligibility of certain persons to receive

23         donated drugs; requiring the department to

24         establish and maintain a participant facility

25         registry; providing for the contents and

26         availability of the participant facility

27         registry; providing immunity from civil

28         liability for pharmaceutical manufacturers in

29         certain circumstances; providing that in the

30         event of conflict between the provisions in s.

31         381.94, F.S., and provisions in ch. 465 or ch.

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1         499, F.S., the provisions in s. 381.94, F.S.,

 2         shall control; providing an appropriation;

 3         providing an effective date.

 4  

 5  Be It Enacted by the Legislature of the State of Florida:

 6  

 7         Section 1.  Section 381.94, Florida Statutes, is

 8  created to read:

 9         381.94  Cancer Drug Donation Program.--

10         (1)  This section may be cited as the "Cancer Drug

11  Donation Program Act."

12         (2)  There is created a Cancer Drug Donation Program

13  within the Department of Health for the purpose of authorizing

14  and facilitating the donation of cancer drugs and supplies to

15  eligible patients.

16         (3)  As used in this section, the term:

17         (a)  "Cancer drug" means a prescription drug that has

18  been approved under s. 505 of the federal Food, Drug, and

19  Cosmetic Act and is used to treat cancer or its side effects

20  or is used to treat the side effects of a prescription drug

21  used to treat cancer or its side effects. "Cancer drug" does

22  not include a substance listed in Schedule II, Schedule III,

23  Schedule IV, or Schedule V of s. 893.03.

24         (b)  "Closed drug delivery system" means a system in

25  which the actual control of the unit-dose medication package

26  is maintained by the facility rather than by the individual

27  patient.

28         (c)  "Department" means the Department of Health.

29         (d)  "Donor" means a patient or patient representative

30  who donates cancer drugs or supplies needed to administer

31  cancer drugs that have been maintained within a closed drug

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1  delivery system; health care facilities, nursing homes,

 2  hospices, or hospitals with closed drug delivery systems; or

 3  pharmacies, drug manufacturers, medical device manufacturers

 4  or suppliers, or wholesalers of drugs or supplies, in

 5  accordance with this section. "Donor" includes a physician

 6  licensed under chapter 458 or chapter 459 who receives cancer

 7  drugs or supplies directly from a drug manufacturer, drug

 8  wholesaler, or pharmacy.

 9         (e)  "Eligible patient" means a person who is a

10  resident of the state, has a diagnosis of cancer from a

11  physician licensed under chapter 458 or chapter 459, holds a

12  valid prescription for a cancer drug, and is not deemed

13  ineligible under subsection (9) to receive a cancer drug.

14         (f)  "Health care facility" means a health care

15  facility licensed under chapter 395.

16         (g)  "Health care clinic" means a health care clinic

17  licensed under part XIII of chapter 400.

18         (h)  "Hospice" means a corporation licensed under part

19  VI of chapter 400.

20         (i)  "Hospital" means a facility as defined in s.

21  395.002 and licensed under chapter 395.

22         (j)  "Nursing home" means a facility licensed under

23  part II of chapter 400.

24         (k)  "Participant facility" means a class II hospital

25  pharmacy that has elected to participate in the program and

26  that accepts donated cancer drugs and supplies under the rules

27  adopted by the department for the program.

28         (l)  "Pharmacist" means a person licensed under chapter

29  465.

30         (m)  "Pharmacy" means an entity licensed under chapter

31  465.

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    Florida Senate - 2006                           CS for SB 1310
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 1         (n)  "Prescribing practitioner" means a physician

 2  licensed under chapter 458 or any other medical professional

 3  with authority under state law to prescribe cancer medication.

 4         (o)  "Prescription drug" means a drug as defined in s.

 5  465.003(8).

 6         (p)  "Program" means the Cancer Drug Donation Program

 7  created by this section.

 8         (q)  "Supplies" means any supplies used in the

 9  administration of a cancer drug.

10         (4)  Any donor may donate cancer drugs or supplies to a

11  participant facility that elects to participate in the program

12  and agrees to comply with requirements of this section and

13  rules established by the department for such participation.

14  Cancer drugs or supplies may not be donated to a specific

15  cancer patient, and donated drugs or supplies may not be

16  resold by the program. A participant facility may provide

17  dispensing and consulting services to individuals who are not

18  patients of the hospital.

19         (5)  The cancer drugs or supplies donated to the

20  program may be prescribed only by a prescribing practitioner

21  for use by an eligible patient and may be dispensed only by a

22  pharmacist.

23         (6)(a)  A cancer drug may only be accepted or dispensed

24  under the program if the drug is in its original, unopened,

25  sealed container, or in a tamper-evident unit-dose packaging,

26  except that a cancer drug packaged in single-unit doses may be

27  accepted and dispensed if the outside packaging is opened but

28  the single-unit-dose packaging is unopened with

29  tamper-resistant packaging intact.

30         (b)  A cancer drug may not be accepted or dispensed

31  under the program if the drug bears an expiration date that is

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1  less than 6 months after the date the drug was donated or if

 2  the drug appears to have been tampered with or mislabeled as

 3  determined in paragraph (c).

 4         (c)  Prior to being dispensed to an eligible patient,

 5  the cancer drug or supplies donated under the program shall be

 6  inspected by a pharmacist to determine that the drug and

 7  supplies do not appear to have been tampered with or

 8  mislabeled.

 9         (d)  A dispenser of donated cancer drugs or supplies

10  may not submit a claim or otherwise seek reimbursement from

11  any public or private third-party payor for donated cancer

12  drugs or supplies dispensed to any patient under the program,

13  and a public or private third-party payor is not required to

14  provide reimbursement to a dispenser for donated cancer drugs

15  or supplies dispensed to any patient under the program.

16         (7)(a)  A donation of cancer drugs or supplies shall be

17  made only at a participant facility. A participant facility

18  may decline to accept a donation. A participant facility that

19  accepts donated cancer drugs or supplies under the program

20  shall comply with all applicable provisions of state and

21  federal law relating to the storage and dispensing of the

22  donated cancer drugs or supplies.

23         (b)  A participant facility that voluntarily takes part

24  in the program may charge a handling fee sufficient to cover

25  the cost of preparation and dispensing of cancer drugs or

26  supplies under the program. The fee shall be established in

27  rules adopted by the department.

28         (8)  The department, upon the recommendation of the

29  Board of Pharmacy, shall adopt rules to carry out the

30  provisions of this section. Initial rules under this section

31  shall be adopted no later than 90 days after the effective

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1  date of this act. The rules shall include, but not be limited

 2  to:

 3         (a)  Standards and procedures for participant

 4  facilities that accept, store, distribute, or dispense donated

 5  cancer drugs or supplies.

 6         (b)  Necessary forms for administration of the program,

 7  including, but not limited to, forms for use by entities that

 8  donate, accept, distribute, or dispense cancer drugs or

 9  supplies under the program.

10         (c)  The maximum handling fee that may be charged by a

11  participant facility that accepts and distributes or dispenses

12  donated cancer drugs or supplies.

13         (d)  Categories of cancer drugs and supplies that the

14  program will accept for dispensing; however, the department

15  may exclude any drug based on its therapeutic effectiveness or

16  high potential for abuse or diversion.

17         (e)  Maintenance and distribution of the participant

18  facility registry established in subsection (10).

19         (9)  A person who is eligible to receive cancer drugs

20  or supplies under the state Medicaid program or under any

21  other prescription drug program funded in whole or in part by

22  the state, by any other prescription drug program funded in

23  whole or in part by the Federal Government, or by any other

24  prescription drug program offered by a third-party insurer,

25  unless benefits have been exhausted, or a certain cancer drug

26  or supply is not covered by the prescription drug program, is

27  ineligible to participate in the program created under this

28  section.

29         (10)  The department shall establish and maintain a

30  participant facility registry for the program. The participant

31  facility registry shall include the participant facility's

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1  name, address, and telephone number. The department shall make

 2  the participant facility registry available on the

 3  department's website to any donor wishing to donate cancer

 4  drugs or supplies to the program. The department's website

 5  shall also contain links to cancer drug manufacturers that

 6  offer drug assistance programs or free medication.

 7         (11)  A pharmaceutical manufacturer is not liable for

 8  any claim or injury arising from the transfer of any cancer

 9  drug under this section, including, but not limited to,

10  liability for failure to transfer or communicate product or

11  consumer information regarding the transferred drug, as well

12  as the expiration date of the transferred drug.

13         (12)  If any conflict exists between the provisions in

14  this section and the provisions in chapter 465 or chapter 499,

15  the provisions in this section shall control the operation of

16  the Cancer Drug Donation Program.

17         Section 2.  There is appropriated one full-time

18  equivalent position at the salary rate of $42,715 and

19  recurring funding from the General Revenue Fund in the sum of

20  $65,308 for fiscal year 2006-2007, for the purpose of

21  implementing the Cancer Drug Donation Program under s. 381.94,

22  Florida Statutes, as created by this act.

23         Section 3.  This act shall take effect July 1, 2006.

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    Florida Senate - 2006                           CS for SB 1310
    587-2086-06




 1          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
 2                         Senate Bill 1310

 3                                 

 4  The bill revises relevant definitions and duties of the
    Department of Health to implement the Cancer Drug Donation
 5  Program. The bill establishes eligibility criteria for
    patients for the program and provides an appropriation for the
 6  Department of Health to implement the program. The bill
    eliminates an immunity from civil or criminal liability and
 7  from professional disciplinary action of any kind for any
    injury, death, or loss to person or property relating to
 8  donating, accepting, distributing, or dispensing cancer drugs
    or supplies under the program.
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