Florida Senate - 2015 COMMITTEE AMENDMENT Bill No. PCS (592332) for CS for SB 1052 Ì399254>Î399254 LEGISLATIVE ACTION Senate . House Comm: RCS . 04/21/2015 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Fiscal Policy (Bean) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 499.0295, Florida Statutes, is created 6 to read: 7 499.0295 Experimental treatments for terminal conditions.— 8 (1) This section may be cited as the “Right to Try Act.” 9 (2) As used in this section, the term: 10 (a) “Eligible patient” means a person who: 11 1. Has a terminal condition that is attested to by the 12 patient’s physician and confirmed by a second independent 13 evaluation by a board-certified physician in an appropriate 14 specialty for that condition; 15 2. Has considered all other treatment options for the 16 terminal condition currently approved by the United States Food 17 and Drug Administration; 18 3. Has given written informed consent for the use of an 19 investigational drug, biological product, or device; and 20 4. Has documentation from his or her treating physician 21 that the patient meets the requirements of this paragraph. 22 (b) “Investigational drug, biological product, or device” 23 means a drug, biological product, or device that has 24 successfully completed phase 1 of a clinical trial but has not 25 been approved for general use by the United States Food and Drug 26 Administration and remains under investigation in a clinical 27 trial approved by the United States Food and Drug 28 Administration. 29 (c) “Terminal condition” means a progressive disease or 30 medical or surgical condition that causes significant functional 31 impairment, is not considered by a treating physician to be 32 reversible even with the administration of available treatment 33 options currently approved by the United States Food and Drug 34 Administration, and, without the administration of life 35 sustaining procedures, will result in death within 1 year after 36 diagnosis if the condition runs its normal course. 37 (d) “Written informed consent” means a document that is 38 signed by a patient, a parent of a minor patient, a court 39 appointed guardian for a patient, or a health care surrogate 40 designated by a patient and includes: 41 1. An explanation of the currently approved products and 42 treatments for the patient’s terminal condition. 43 2. An attestation that the patient concurs with his or her 44 physician in believing that all currently approved products and 45 treatments are unlikely to prolong the patient’s life. 46 3. Identification of the specific investigational drug, 47 biological product, or device that the patient is seeking to 48 use. 49 4. A realistic description of the most likely outcomes of 50 using the investigational drug, biological product, or device. 51 The description shall include the possibility that new, 52 unanticipated, different, or worse symptoms might result and 53 that death could be hastened by the proposed treatment. The 54 description shall be based on the physician’s knowledge of the 55 efficacy of proposed treatment for the patient’s terminal 56 condition. 57 5. A statement that the patient’s health plan or third 58 party administrator and physician are not obligated to pay for 59 care or treatment consequent to the use of the investigational 60 drug, biological product, or device unless required to do so by 61 law or contract. 62 6. A statement that the patient’s eligibility for hospice 63 care may be withdrawn if the patient begins treatment with the 64 investigational drug, biological product, or device and that 65 hospice care may be reinstated if the treatment ends and the 66 patient meets hospice eligibility requirements. 67 7. A statement that the patient understands he or she is 68 liable for all expenses consequent to the use of the 69 investigational drug, biological product, or device and that 70 liability extends to the patient’s estate, unless a contract 71 between the patient and the manufacturer of the investigational 72 drug, biological product, or device states otherwise. 73 (3) Upon the request of an eligible patient, a manufacturer 74 may: 75 (a) Make its investigational drug, biological product, or 76 device available under this section. 77 (b) Provide an investigational drug, biological product, or 78 device to an eligible patient without receiving compensation. 79 (c) Require an eligible patient to pay the costs of, or the 80 costs associated with, the manufacture of the investigational 81 drug, biological product, or device. 82 (4) A health plan, third-party administrator, or 83 governmental agency may provide coverage for the cost of, or the 84 cost of services related to the use of, an investigational drug, 85 biological product, or device. 86 (5) A hospital or health care facility licensed under 87 chapter 395 is not required to provide new or additional 88 services unless those services are approved by the hospital or 89 health care facility. 90 (6) If an eligible patient dies while using an 91 investigational drug, biological product, or device pursuant to 92 this section, the patient’s heirs are not liable for any 93 outstanding debt related to the patient’s use of the 94 investigational drug, biological product, or device. 95 (7) A licensing board may not revoke, fail to renew, 96 suspend, or take any action against a physician’s license issued 97 under chapter 458 or chapter 459 based solely on the physician’s 98 recommendations to an eligible patient regarding access to or 99 treatment with an investigational drug, biological product, or 100 device. A state entity responsible for Medicare certification 101 may not take action against a physician’s Medicare certification 102 based solely on the physician’s recommendation that an eligible 103 patient have access to an investigational drug, biological 104 product, or device. 105 (8) This section does not create a private cause of action 106 against the manufacturer of an investigational drug, biological 107 product, or device; against a person or entity involved in the 108 care of an eligible patient who is using the investigational 109 drug, biological product, or device; or for any harm to the 110 eligible patient that is a result of the use of the 111 investigational drug, biological product, or device if the 112 manufacturer or other person or entity complies in good faith 113 with the terms of this section and exercises reasonable care. 114 (9) This section does not expand the coverage an insurer 115 must provide under the Florida Insurance Code and does not 116 affect mandatory health coverage for participation in clinical 117 trials. 118 Section 2. This act shall take effect July 1, 2015. 119 120 ================= T I T L E A M E N D M E N T ================ 121 And the title is amended as follows: 122 Delete everything before the enacting clause 123 and insert: 124 A bill to be entitled 125 An act relating to experimental treatments for 126 terminal conditions; creating s. 499.0295, F.S.; 127 providing a short title; providing definitions; 128 providing conditions for a manufacturer to provide 129 certain drugs, products, or devices to an eligible 130 patient; specifying insurance coverage requirements 131 and exceptions; providing conditions for the provision 132 of certain services by a hospital or health care 133 facility; providing immunity from liability; providing 134 protection from disciplinary or legal action against a 135 physician who makes certain treatment recommendations; 136 providing that a cause of action may not be asserted 137 against the manufacturer of certain drugs, products, 138 or devices or a person or entity caring for a patient 139 using such drugs, products, or devices under certain 140 circumstances; providing applicability; providing an 141 effective date.