Florida Senate - 2015                                    SB 1052
       
       
        
       By Senator Brandes
       
       
       
       
       
       22-00658A-15                                          20151052__
    1                        A bill to be entitled                      
    2         An act relating to the Florida Right to Try Act;
    3         providing a short title; creating s. 385.213, F.S.;
    4         defining terms; authorizing a manufacturer of an
    5         investigational drug, biological product, or device to
    6         make such drug, product, or device available to
    7         certain eligible patients with a terminal illness
    8         without charge or for a specified cost; authorizing
    9         the manufacturer to require eligible patients to
   10         participate in certain data collection; specifying
   11         that an insurer, a health plan, or a government health
   12         care program is not required to provide coverage for
   13         the cost of such drug, product, or device; authorizing
   14         such entities to provide coverage under specified
   15         circumstances; specifying that such entities are not
   16         required to cover care or treatment needed as the
   17         result of the use of such drug, product, or device
   18         except under certain circumstances; specifying that
   19         the Department of Corrections and the Department of
   20         Juvenile Justice are not required to provide coverage
   21         for such drugs, products, or devices for individuals
   22         in the departments’ custody; prohibiting a state
   23         regulatory board or agency from taking action against
   24         the licenses of certain health care providers or
   25         against the licenses or Medicare certifications of
   26         certain health care institutions for specified actions
   27         with respect to an eligible patient’s access to,
   28         treatment with, or use of investigational drugs,
   29         biological products, or devices; specifying when an
   30         investigational drug, biological product, or device
   31         may continue to be offered by the manufacturer if the
   32         drug, product, or device is found to be ineffective
   33         under certain circumstances; requiring certain
   34         information relating to clinical trials to be provided
   35         to a patient taking an investigational drug,
   36         biological product, or device outside of the clinical
   37         trial; providing that the section does not create a
   38         private cause of action against certain manufacturers,
   39         entities, and individuals for any harm to an eligible
   40         patient which results from the use of an
   41         investigational drug, biological product, or device
   42         under certain circumstances; providing a criminal
   43         penalty for an official, employee, or agent of the
   44         state who blocks or attempts to block the access of an
   45         eligible patient to certain investigational drugs,
   46         biological products, or devices; creating s. 408.064,
   47         F.S.; requiring the Agency for Health Care
   48         Administration to establish and maintain a database
   49         that allows a state resident to electronically submit
   50         a plan that indicates his or her directives for
   51         compassionate and palliative care; requiring the
   52         database to serve as a clearinghouse of plan
   53         information that is accessible by certain health care
   54         providers; authorizing the agency to subscribe to or
   55         participate in a national or private clearinghouse in
   56         lieu of establishing and maintaining an independent
   57         clearinghouse; requiring the agency to publish and
   58         disseminate certain information and provide certain
   59         training relating to the clearinghouse; providing an
   60         effective date.
   61          
   62  Be It Enacted by the Legislature of the State of Florida:
   63  
   64         Section 1. This act may be cited as the “Florida Right to
   65  Try Act.”
   66         Section 2. Section 385.213, Florida Statutes, is created to
   67  read:
   68         385.213 Compassionate treatment; access to experimental
   69  treatments.—
   70         (1) DEFINITIONS.—As used in this section, the term:
   71         (a) “Eligible patient” means an individual who:
   72         1. Has a terminal illness, as determined by the
   73  individual’s physician and consulting physician;
   74         2. As determined by the individual’s physician, does not
   75  have any comparable or satisfactory United States Food and Drug
   76  Administration-approved option available to be diagnosed,
   77  monitored, or treated for the individual’s disease or condition,
   78  and the probable risk to the individual from the investigational
   79  drug, biological product, or device is not greater than the risk
   80  from the disease or condition;
   81         3. Has received a prescription or recommendation from the
   82  individual’s physician for an investigational drug, biological
   83  product, or device;
   84         4. Has provided written, informed consent in accordance
   85  with s. 766.103 for the use of an investigational drug,
   86  biological product, or device or, if the individual is a minor
   87  or lacks the mental capacity to provide informed consent, a
   88  parent’s or legal guardian’s written, informed consent on the
   89  individual’s behalf; and
   90         5. Has documentation from the individual’s physician
   91  indicating that the individual has met all the requirements of
   92  this section.
   93         (b) “Investigational drug, biological product, or device”
   94  means a drug, biological product, or device that has
   95  successfully completed phase one of a clinical trial but has not
   96  yet been approved for general use by the United States Food and
   97  Drug Administration.
   98         (c) “Physician” means the physician licensed under chapter
   99  458 or chapter 459 who provides medical care or treatment to the
  100  eligible patient for the terminal illness.
  101         (d) “Terminal illness” means a disease or condition that
  102  without life-sustaining procedures will result in the patient’s
  103  death in the near future or a state of permanent unconsciousness
  104  from which recovery is unlikely.
  105         (2) AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL
  106  PRODUCTS, OR DEVICES.—
  107         (a) A manufacturer of an investigational drug, biological
  108  product, or device may make the investigational drug, biological
  109  product, or device, available to an eligible patient. A
  110  manufacturer may:
  111         1. Provide the investigational drug, biological product, or
  112  device to an eligible patient without charge or require the
  113  eligible patient to pay the cost of, or the cost associated
  114  with, the manufacture of the investigational drug, biological
  115  product, or device.
  116         2. Require an eligible patient to participate in data
  117  collection relating to the eligible patient’s use of the
  118  investigational drug, biological product, or device.
  119         (b) This section does not require:
  120         1. An insurer, a health plan, or a government health care
  121  program to provide coverage for:
  122         a. The cost of an investigational drug, biological product,
  123  or device provided to an eligible patient. An insurer, a health
  124  plan, or a government health care program may elect to provide
  125  coverage for an investigational drug, biological product, or
  126  device that is not part of a clinical trial.
  127         b. Care or treatment needed as a result of an eligible
  128  patient’s use of an investigational drug, biological product, or
  129  device unless the use is part of an approved clinical trial.
  130         2.The Department of Corrections or the Department of
  131  Juvenile Justice to provide coverage for an investigational
  132  drug, biological product, or device for individuals in the
  133  custody of the Department of Corrections or the Department of
  134  Juvenile Justice.
  135         (3) ACTION AGAINST PROVIDER LICENSURE PROHIBITED.
  136  Notwithstanding any other law, a state regulatory board or
  137  agency:
  138         (a) May not take any action against a health care
  139  provider’s license issued under chapter 458 or chapter 459 based
  140  solely on the health care provider’s recommendation to an
  141  eligible patient regarding access to or treatment with an
  142  investigational drug, biological product, or device.
  143         (b) May not, with respect to a health care institution
  144  licensed in this state, take any action against the
  145  institution’s:
  146         1. License based solely on the institution’s participation
  147  in the treatment with, or in any other use of, an
  148  investigational drug, biological product, or device.
  149         2. Medicare certification based solely on a health care
  150  provider’s recommendation to an eligible patient regarding
  151  access to an investigational drug, biological product, or
  152  device.
  153         (4) CLINICAL TRIALS.—
  154         (a) If a clinical trial of an investigational drug,
  155  biological product, or device is not effective for a certain
  156  patient or condition and the trial is closed due to lack of
  157  efficacy, the manufacturer or health care provider may continue
  158  to offer the investigational drug, biological product, or device
  159  for a different condition to the patient or to new patients.
  160         (b) If the United States Food and Drug Administration or
  161  the safety committee for a clinical trial provides notice of
  162  information for an investigational drug, biological product, or
  163  device that is being taken by a patient outside of the clinical
  164  trial, the manufacturer of such drug, product, or device or the
  165  patient’s physician shall notify the patient of the information.
  166         (5) NO CAUSE OF ACTION.—This section does not create a
  167  private cause of action against a manufacturer of an
  168  investigational drug, biological product, or device or against
  169  an entity or individual involved in the care of an eligible
  170  patient for any harm to the eligible patient which results from
  171  the use of the investigational drug, biological product, or
  172  device if the manufacturer, entity, or individual is complying
  173  in good faith with this section, unless the manufacturer,
  174  entity, or individual failed to exercise reasonable care.
  175         (6) PENALTY.—An official, employee, or agent of the state
  176  who blocks or attempts to block the access of an eligible
  177  patient to an investigational drug, biological product, or
  178  device that has been recommended to the eligible patient by his
  179  or her physician and that has not been banned or removed from a
  180  clinical trial as unsafe by the United States Food and Drug
  181  Administration commits a misdemeanor of the second degree,
  182  punishable as provided in s. 775.082 or s. 775.083.
  183         Section 3. Section 408.064, Florida Statutes, is created to
  184  read:
  185         408.064 Clearinghouse for compassionate and palliative care
  186  plans.—
  187         (1) The agency shall establish and maintain a reliable and
  188  secure database that allows a resident of this state to
  189  electronically submit a plan that indicates his or her
  190  directives for compassionate and palliative care. The database
  191  shall serve as a clearinghouse of plan information that may be
  192  accessed by a health care provider who is treating the resident.
  193  The agency shall seek advice from residents, compassionate and
  194  palliative care providers, and health care facilities for the
  195  development and implementation of the clearinghouse.
  196         (2) The agency may subscribe to or otherwise participate in
  197  a national or private clearinghouse that will accomplish the
  198  requirements under subsection (1) in lieu of establishing and
  199  maintaining an independent clearinghouse for this state’s
  200  residents.
  201         (3) The agency shall publish and disseminate information to
  202  the residents of this state regarding the availability of the
  203  clearinghouse. The agency must also provide training to health
  204  care providers and health care facilities in this state on how
  205  to access plans through the clearinghouse.
  206         Section 4. This act shall take effect July 1, 2015.