S.F. _____ 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 all other treatment options approved by 10 the United States food and drug administration. 11 c. Has received a recommendation from the individual’s 12 physician for an investigational drug, biological product, or 13 device. 14 d. Has given written informed consent for the use of the 15 investigational drug, biological product, or device. 16 e. Has documentation from the individual’s physician that 17 the individual meets the requirements of this subsection. 18 2. “Investigational drug, biological product, or device” 19 means a drug, biological product, or device that has 20 successfully completed phase 1 of a United States food and drug 21 administration-approved clinical trial but has not yet been 22 approved for general use by the United States food and drug 23 administration and remains under investigation in a United 24 States food and drug administration-approved clinical trial. 25 3. “Terminal illness” means a progressive disease or medical 26 or surgical condition that entails significant functional 27 impairment, that is not considered by a treating physician to 28 be reversible even with administration of treatments approved 29 by the United States food and drug administration, and that, 30 without life-sustaining procedures, will soon result in death. 31 4. “Written informed consent” means a written document that 32 is signed by the patient, a parent of a minor patient, or a 33 legal guardian or other legal representative of the patient and 34 attested to by the patient’s treating physician and a witness 35 -1- LSB 1642XC (1) 86 tr/nh 1/ 6

S.F. _____ and that includes all of the following: 1 a. An explanation of the products and treatments approved by 2 the United States food and drug administration for the disease 3 or condition from which the patient suffers. 4 b. An attestation that the patient concurs with the 5 patient’s treating physician in believing that all products 6 and treatments approved by the United States food and drug 7 administration are unlikely to prolong the patient’s life. 8 c. Clear identification of the specific proposed 9 investigational drug, biological product, or device that the 10 patient is seeking to use. 11 d. A description of the best and worst potential outcomes 12 of using the investigational drug, biological product, or 13 device and a realistic description of the most likely outcome. 14 The description shall include the possibility that new, 15 unanticipated, different, or worse symptoms might result 16 and that death could be hastened by use of the proposed 17 investigational drug, biological product, or device. The 18 description shall be based on the treating physician’s 19 knowledge of the proposed investigational drug, biological 20 product, or device in conjunction with an awareness of the 21 patient’s condition. 22 e. A statement that the patient’s health plan or third-party 23 administrator and provider are not obligated to pay for any 24 care or treatments consequent to the use of the investigational 25 drug, biological product, or device, unless they are 26 specifically required to do so by law or contract. 27 f. A statement that the patient’s eligibility for hospice 28 care may be withdrawn if the patient begins curative treatment 29 with the investigational drug, biological product, or device 30 and that care may be reinstated if this treatment ends and the 31 patient meets hospice eligibility requirements. 32 g. A statement that the patient understands that the 33 patient is liable for all expenses consequent to the use of 34 the investigational drug, biological product, or device and 35 -2- LSB 1642XC (1) 86 tr/nh 2/ 6

S.F. _____ that this liability extends to the patient’s estate unless 1 a contract between the patient and the manufacturer of the 2 investigational drug, biological product, or device states 3 otherwise. 4 Sec. 3. NEW SECTION . 144E.3 Manufacturer rights. 5 1. A manufacturer of an investigational drug, biological 6 product, or device may make available and an eligible patient 7 may request the manufacturer’s investigational drug, biological 8 product, or device under this chapter. This chapter does not 9 require a manufacturer of an investigational drug, biological 10 product, or device to provide or otherwise make available the 11 investigational drug, biological product, or device to an 12 eligible patient. 13 2. A manufacturer described in subsection 1 may do any of 14 the following: 15 a. Provide an investigational drug, biological product, or 16 device to an eligible patient without receiving compensation. 17 b. Require an eligible patient to pay the costs of, or the 18 costs associated with, the manufacture of the investigational 19 drug, biological product, or device. 20 Sec. 4. NEW SECTION . 144E.4 Treatment coverage. 21 1. This chapter does not expand the coverage required of an 22 insurer under Title XIII, subtitle 1. 23 2. A health plan, third-party administrator, or 24 governmental agency may provide coverage for the cost of an 25 investigational drug, biological product, or device, or the 26 cost of services related to the use of an investigational drug, 27 biological product, or device under this chapter. 28 3. This chapter does not require any governmental agency 29 to pay costs associated with the use, care, or treatment of a 30 patient with an investigational drug, biological product, or 31 device. 32 4. This chapter does not require a hospital licensed under 33 chapter 135B or other health care facility to provide new or 34 additional services. 35 -3- LSB 1642XC (1) 86 tr/nh 3/ 6

S.F. _____ Sec. 5. NEW SECTION . 144E.5 Heirs not liable for treatment 1 debts. 2 If a patient dies while being treated by an investigational 3 drug, biological product, or device, the patient’s heirs are 4 not liable for any outstanding debt related to the treatment 5 or lack of insurance due to the treatment, unless otherwise 6 required by law. 7 Sec. 6. NEW SECTION . 144E.6 Provider recourse. 8 1. The board of medicine created under chapter 147 shall 9 not revoke, fail to renew, suspend, or take any action 10 against a physician’s license based solely on the physician’s 11 recommendations to an eligible patient regarding access to or 12 treatment with an investigational drug, biological product, or 13 device. 14 2. To the extent consistent with federal law, an entity 15 responsible for Medicare certification shall not take action 16 against a physician’s Medicare certification based solely on 17 the physician’s recommendation that a patient have access to an 18 investigational drug, biological product, or device. 19 Sec. 7. NEW SECTION . 144E.7 State interference. 20 An official, employee, or agent of this state shall not 21 block or attempt to block an eligible patient’s access to 22 an investigational drug, biological product, or device. 23 Counseling, advice, or a recommendation consistent with medical 24 standards of care from a licensed physician is not a violation 25 of this section. 26 Sec. 8. NEW SECTION . 144E.8 Private cause of action. 27 1. This chapter shall not create a private cause of 28 action against a manufacturer of an investigational drug, 29 biological product, or device or against any other person 30 or entity involved in the care of an eligible patient using 31 the investigational drug, biological product, or device 32 for any harm done to the eligible patient resulting from 33 the investigational drug, biological product, or device, if 34 the manufacturer or other person or entity is complying in 35 -4- LSB 1642XC (1) 86 tr/nh 4/ 6

S.F. _____ good faith with the terms of this chapter and has exercised 1 reasonable care. 2 2. This chapter shall not affect any mandatory health care 3 coverage for participation in clinical trials under Title XIII, 4 subtitle 1. 5 EXPLANATION 6 The inclusion of this explanation does not constitute agreement with 7 the explanation’s substance by the members of the general assembly. 8 This bill, titled the “Right to Try Act”, permits 9 manufacturers of investigational drugs, biological products, or 10 devices to make available, and eligible patients with terminal 11 illnesses to attempt treatment with, an investigational 12 drug, biological product, or device as long as they provided 13 written informed consent. The bill defines the terms “eligible 14 patient”, “terminal illness”, “investigational drug, biological 15 product, or device”, and “written informed consent”. 16 Under the bill, an eligible patient’s physician must 17 acknowledge that the patient’s illness is terminal and 18 recommend the patient try an investigational drug, biological 19 product, or device. The patient’s written informed consent 20 must acknowledge that treatments currently approved by the 21 United Stated food and drug administration are unlikely to 22 prolong the patient’s life. It must identify the specific 23 treatment sought and the potential best, worst, and expected 24 results from the treatment. It must acknowledge that the 25 patient’s insurance is not required to pay for the treatment 26 and that any hospice service may refuse to accept the patient 27 after receiving the treatment. It must also acknowledge 28 that expenses will be credited to the patient, including the 29 patient’s estate, unless an agreement with the manufacturer of 30 an investigational drug, biological product, or device states 31 otherwise. If the patient dies during treatment, the patient’s 32 heirs are not liable for any remaining debts unless otherwise 33 required by law. 34 The manufacturer of an investigational drug, biological 35 -5- LSB 1642XC (1) 86 tr/nh 5/ 6

S.F. _____ product, or device may charge an eligible patient or provide 1 the treatment free of charge. Governmental entities are 2 not required to pay costs associated with the use, care, or 3 treatment of a patient with an investigational drug, biological 4 product, or device. The bill does not require hospitals 5 licensed under chapter 135B or other health care facilities to 6 provide new or additional services. 7 The board of medicine shall not take an adverse action 8 against a physician’s license solely for recommending an 9 investigational drug, biological product, or device for the 10 physician’s eligible patient. The bill does not create a new 11 private cause of action against any person or entity involved 12 in the care of an eligible patient using the investigational 13 drug, biological product, or device for any harm done to the 14 patient resulting from the treatment if the person or entity 15 is complying in good faith with the terms of the bill and has 16 exercised reasonable care. 17 -6- LSB 1642XC (1) 86 tr/nh 6/ 6