Bill Text: FL S1052 | 2015 | Regular Session | Comm Sub
Bill Title: Experimental Treatments for Terminal Conditions
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2015-04-27 - Laid on Table, companion bill(s) passed, see CS/CS/HB 269 (Ch. 2015-107) [S1052 Detail]
Download: Florida-2015-S1052-Comm_Sub.html
Florida Senate - 2015 CS for CS for SB 1052
By the Committees on Fiscal Policy; and Health Policy; and
Senator Brandes
594-04436-15 20151052c2
1 A bill to be entitled
2 An act relating to experimental treatments for
3 terminal conditions; creating s. 499.0295, F.S.;
4 providing a short title; providing definitions;
5 providing conditions for a manufacturer to provide
6 certain drugs, products, or devices to an eligible
7 patient; specifying insurance coverage requirements
8 and exceptions; providing conditions for the provision
9 of certain services by a hospital or health care
10 facility; providing immunity from liability; providing
11 protection from disciplinary or legal action against a
12 physician who makes certain treatment recommendations;
13 providing that a cause of action may not be asserted
14 against the manufacturer of certain drugs, products,
15 or devices or a person or entity caring for a patient
16 using such drugs, products, or devices under certain
17 circumstances; providing applicability; providing an
18 effective date.
19
20 Be It Enacted by the Legislature of the State of Florida:
21
22 Section 1. Section 499.0295, Florida Statutes, is created
23 to read:
24 499.0295 Experimental treatments for terminal conditions.—
25 (1) This section may be cited as the “Right to Try Act.”
26 (2) As used in this section, the term:
27 (a) “Eligible patient” means a person who:
28 1. Has a terminal condition that is attested to by the
29 patient’s physician and confirmed by a second independent
30 evaluation by a board-certified physician in an appropriate
31 specialty for that condition;
32 2. Has considered all other treatment options for the
33 terminal condition currently approved by the United States Food
34 and Drug Administration;
35 3. Has given written informed consent for the use of an
36 investigational drug, biological product, or device; and
37 4. Has documentation from his or her treating physician
38 that the patient meets the requirements of this paragraph.
39 (b) “Investigational drug, biological product, or device”
40 means a drug, biological product, or device that has
41 successfully completed phase 1 of a clinical trial but has not
42 been approved for general use by the United States Food and Drug
43 Administration and remains under investigation in a clinical
44 trial approved by the United States Food and Drug
45 Administration.
46 (c) “Terminal condition” means a progressive disease or
47 medical or surgical condition that causes significant functional
48 impairment, is not considered by a treating physician to be
49 reversible even with the administration of available treatment
50 options currently approved by the United States Food and Drug
51 Administration, and, without the administration of life
52 sustaining procedures, will result in death within 1 year after
53 diagnosis if the condition runs its normal course.
54 (d) “Written informed consent” means a document that is
55 signed by a patient, a parent of a minor patient, a court
56 appointed guardian for a patient, or a health care surrogate
57 designated by a patient and includes:
58 1. An explanation of the currently approved products and
59 treatments for the patient’s terminal condition.
60 2. An attestation that the patient concurs with his or her
61 physician in believing that all currently approved products and
62 treatments are unlikely to prolong the patient’s life.
63 3. Identification of the specific investigational drug,
64 biological product, or device that the patient is seeking to
65 use.
66 4. A realistic description of the most likely outcomes of
67 using the investigational drug, biological product, or device.
68 The description shall include the possibility that new,
69 unanticipated, different, or worse symptoms might result and
70 that death could be hastened by the proposed treatment. The
71 description shall be based on the physician’s knowledge of the
72 efficacy of proposed treatment for the patient’s terminal
73 condition.
74 5. A statement that the patient’s health plan or third
75 party administrator and physician are not obligated to pay for
76 care or treatment consequent to the use of the investigational
77 drug, biological product, or device unless required to do so by
78 law or contract.
79 6. A statement that the patient’s eligibility for hospice
80 care may be withdrawn if the patient begins treatment with the
81 investigational drug, biological product, or device and that
82 hospice care may be reinstated if the treatment ends and the
83 patient meets hospice eligibility requirements.
84 7. A statement that the patient understands that he or she
85 is liable for all expenses consequent to the use of the
86 investigational drug, biological product, or device and that
87 liability extends to the patient’s estate, unless a contract
88 between the patient and the manufacturer of the investigational
89 drug, biological product, or device states otherwise.
90 (3) Upon the request of an eligible patient, a manufacturer
91 may:
92 (a) Make its investigational drug, biological product, or
93 device available under this section.
94 (b) Provide an investigational drug, biological product, or
95 device to an eligible patient without receiving compensation.
96 (c) Require an eligible patient to pay the costs of, or the
97 costs associated with, the manufacture of the investigational
98 drug, biological product, or device.
99 (4) A health plan, third-party administrator, or
100 governmental agency may provide coverage for the cost of, or the
101 cost of services related to the use of, an investigational drug,
102 biological product, or device.
103 (5) A hospital or health care facility licensed under
104 chapter 395 is not required to provide new or additional
105 services unless those services are approved by the hospital or
106 health care facility.
107 (6) If an eligible patient dies while using an
108 investigational drug, biological product, or device pursuant to
109 this section, the patient’s heirs are not liable for any
110 outstanding debt related to the patient’s use of the
111 investigational drug, biological product, or device.
112 (7) A licensing board may not revoke, fail to renew,
113 suspend, or take any action against a physician’s license issued
114 under chapter 458 or chapter 459 based solely on the physician’s
115 recommendations to an eligible patient regarding access to or
116 treatment with an investigational drug, biological product, or
117 device. A state entity responsible for Medicare certification
118 may not take action against a physician’s Medicare certification
119 based solely on the physician’s recommendation that an eligible
120 patient have access to an investigational drug, biological
121 product, or device.
122 (8) This section does not create a private cause of action
123 against the manufacturer of an investigational drug, biological
124 product, or device; against a person or entity involved in the
125 care of an eligible patient who is using the investigational
126 drug, biological product, or device; or for any harm to the
127 eligible patient that is a result of the use of the
128 investigational drug, biological product, or device if the
129 manufacturer or other person or entity complies in good faith
130 with the terms of this section and exercises reasonable care.
131 (9) This section does not expand the coverage an insurer
132 must provide under the Florida Insurance Code and does not
133 affect mandatory health coverage for participation in clinical
134 trials.
135 Section 2. This act shall take effect July 1, 2015.
