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.