Senate File 2198 - Reprinted SENATE FILE 2198 BY COMMITTEE ON STATE GOVERNMENT (SUCCESSOR TO SSB 1264) (As Amended and Passed by the Senate February 23, 2016 ) A BILL FOR An Act relating to the use of experimental treatments for 1 patients with a terminal illness. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 SF 2198 (2) 86 tr/nh/jh
S.F. 2198 Section 1. NEW SECTION . 144E.1 Title. 1 This chapter shall be known and may be cited as the “Right 2 to Try Act” . 3 Sec. 2. NEW SECTION . 144E.2 Definitions. 4 As used in this chapter: 5 1. “Eligible patient” means an individual who meets all of 6 the following conditions: 7 a. Has a terminal illness, attested to by the patient’s 8 treating physician. 9 b. Has considered and rejected or has tried and failed to 10 respond to all other treatment options approved by the United 11 States food and drug administration. 12 c. Has received a recommendation from the individual’s 13 physician for an investigational drug, biological product, or 14 device. 15 d. Has given written informed consent for the use of the 16 investigational drug, biological product, or device. 17 e. Has documentation from the individual’s physician that 18 the individual meets the requirements of this subsection. 19 2. “Investigational drug, biological product, or device” 20 means a drug, biological product, or device that has 21 successfully completed phase 1 of a United States food and drug 22 administration-approved clinical trial but has not yet been 23 approved for general use by the United States food and drug 24 administration and remains under investigation in a United 25 States food and drug administration-approved clinical trial. 26 3. “Terminal illness” means a progressive disease or medical 27 or surgical condition that entails significant functional 28 impairment, that is not considered by a treating physician to 29 be reversible even with administration of treatments approved 30 by the United States food and drug administration, and that, 31 without life-sustaining procedures, will result in death. 32 4. “Written informed consent” means a written document that 33 is signed by the patient, a parent of a minor patient, or a 34 legal guardian or other legal representative of the patient and 35 -1- SF 2198 (2) 86 tr/nh/jh 1/ 5
S.F. 2198 attested to by the patient’s treating physician and a witness 1 and that includes all of the following: 2 a. An explanation of the products and treatments approved by 3 the United States food and drug administration for the disease 4 or condition from which the patient suffers. 5 b. An attestation that the patient concurs with the 6 patient’s treating physician in believing that all products 7 and treatments approved by the United States food and drug 8 administration are unlikely to prolong the patient’s life. 9 c. Clear identification of the specific proposed 10 investigational drug, biological product, or device that the 11 patient is seeking to use. 12 d. A description of the best and worst potential outcomes 13 of using the investigational drug, biological product, or 14 device and a realistic description of the most likely outcome. 15 The description shall include the possibility that new, 16 unanticipated, different, or worse symptoms might result 17 and that death could be hastened by use of the proposed 18 investigational drug, biological product, or device. The 19 description shall be based on the treating physician’s 20 knowledge of the proposed investigational drug, biological 21 product, or device in conjunction with an awareness of the 22 patient’s condition. 23 e. A statement that the patient’s health plan or third-party 24 administrator and provider are not obligated to pay for any 25 care or treatments consequent to the use of the investigational 26 drug, biological product, or device, unless they are 27 specifically required to do so by law or contract. 28 f. A statement that the patient’s eligibility for hospice 29 care may be withdrawn if the patient begins curative treatment 30 with the investigational drug, biological product, or device 31 and that care may be reinstated if this treatment ends and the 32 patient meets hospice eligibility requirements. 33 g. A statement that the patient understands that the 34 patient is liable for all expenses consequent to the use of 35 -2- SF 2198 (2) 86 tr/nh/jh 2/ 5
S.F. 2198 the investigational drug, biological product, or device and 1 that this liability extends to the patient’s estate unless 2 a contract between the patient and the manufacturer of the 3 investigational drug, biological product, or device states 4 otherwise. 5 Sec. 3. NEW SECTION . 144E.3 Manufacturer rights. 6 1. A manufacturer of an investigational drug, biological 7 product, or device may make available and an eligible patient 8 may request the manufacturer’s investigational drug, biological 9 product, or device under this chapter. This chapter does not 10 require a manufacturer of an investigational drug, biological 11 product, or device to provide or otherwise make available the 12 investigational drug, biological product, or device to an 13 eligible patient. 14 2. A manufacturer described in subsection 1 may do any of 15 the following: 16 a. Provide an investigational drug, biological product, or 17 device to an eligible patient without receiving compensation. 18 b. Require an eligible patient to pay the costs of, or the 19 costs associated with, the manufacture of the investigational 20 drug, biological product, or device. 21 Sec. 4. NEW SECTION . 144E.4 Treatment coverage. 22 1. This chapter does not expand the coverage required of an 23 insurer under Title XIII, subtitle 1. 24 2. A health plan, third-party administrator, or 25 governmental agency may provide coverage for the cost of an 26 investigational drug, biological product, or device, or the 27 cost of services related to the use of an investigational drug, 28 biological product, or device under this chapter. 29 3. This chapter does not require any governmental agency 30 to pay costs associated with the use, care, or treatment of a 31 patient with an investigational drug, biological product, or 32 device. 33 4. This chapter does not require a hospital licensed under 34 chapter 135B or other health care facility to provide new or 35 -3- SF 2198 (2) 86 tr/nh/jh 3/ 5
S.F. 2198 additional services. 1 Sec. 5. NEW SECTION . 144E.5 Heirs not liable for treatment 2 debts. 3 If a patient dies while being treated by an investigational 4 drug, biological product, or device, the patient’s heirs are 5 not liable for any outstanding debt related to the treatment 6 or lack of insurance due to the treatment, unless otherwise 7 required by law. 8 Sec. 6. NEW SECTION . 144E.6 Provider recourse. 9 1. To the extent consistent with state law, the board of 10 medicine created under chapter 147 shall not revoke, fail 11 to renew, suspend, or take any action against a physician’s 12 license based solely on the physician’s recommendations to 13 an eligible patient regarding access to or treatment with an 14 investigational drug, biological product, or device. 15 2. To the extent consistent with federal law, an entity 16 responsible for Medicare certification shall not take action 17 against a physician’s Medicare certification based solely on 18 the physician’s recommendation that a patient have access to an 19 investigational drug, biological product, or device. 20 Sec. 7. NEW SECTION . 144E.7 State interference. 21 An official, employee, or agent of this state shall not 22 block or attempt to block an eligible patient’s access to 23 an investigational drug, biological product, or device. 24 Counseling, advice, or a recommendation consistent with medical 25 standards of care from a licensed physician is not a violation 26 of this section. 27 Sec. 8. NEW SECTION . 144E.8 Private cause of action. 28 1. This chapter shall not create a private cause of 29 action against a manufacturer of an investigational drug, 30 biological product, or device or against any other person 31 or entity involved in the care of an eligible patient using 32 the investigational drug, biological product, or device 33 for any harm done to the eligible patient resulting from 34 the investigational drug, biological product, or device, if 35 -4- SF 2198 (2) 86 tr/nh/jh 4/ 5
S.F. 2198 the manufacturer or other person or entity is complying in 1 good faith with the terms of this chapter and has exercised 2 reasonable care. 3 2. This chapter shall not affect any mandatory health care 4 coverage for participation in clinical trials under Title XIII, 5 subtitle 1. 6 -5- SF 2198 (2) 86 tr/nh/jh 5/ 5