House File 802 H-1131 Amend House File 802 as follows: 1 1. By striking everything after the enacting clause and 2 inserting: 3 < Section 1. Section 144E.2, Code 2025, is amended to read 4 as follows: 5 144E.2 Definitions. 6 As used in this chapter : 7 1. “Eligible facility” means an institution operating under 8 a federalwide assurance for the protection of human subjects 9 pursuant to 42 U.S.C. §289(a) and 45 C.F.R. pt. 46, and 10 subject to the federalwide assurance laws, rules, policies, and 11 guidelines including renewals and updates. 12 1. 2. “Eligible patient” means an individual who meets all 13 of the following conditions specified under paragraph “a” or 14 “b” : 15 a. (1) Has a terminal illness, attested to by the patient’s 16 treating physician. 17 b. (2) Has considered and rejected or has tried and failed 18 to respond to all other treatment options approved by the 19 United States food and drug administration. 20 c. (3) Has received a recommendation from the individual’s 21 physician for an investigational drug, biological product, or 22 device. 23 d. (4) Has given written informed consent for the use of 24 the investigational drug, biological product, or device. 25 e. (5) Has documentation from the individual’s physician 26 that the individual meets the requirements of this subsection 27 paragraph “a” . 28 b. (1) Has a life-threatening or severely debilitating 29 illness, attested to by the patient’s treating physician. 30 (2) Has considered all other treatment options currently 31 approved by the United States food and drug administration. 32 (3) Has received a recommendation from the individual’s 33 physician for an individualized investigational treatment, 34 based on an analysis of the patient’s genomic sequence, human 35 -1- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 1/ 8 #1.

chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, 1 gene products such as enzymes and other types of proteins, or 2 metabolites. 3 (4) Has given written informed consent for the use of the 4 individualized investigational treatment. 5 (5) Has documentation from the individual’s physician that 6 the individual meets the requirements of this paragraph “b” . 7 3. “Individualized investigational treatment” means a drug, 8 biological product, or device that is unique to, and produced 9 exclusively for use by, an individual patient, based on the 10 individual patient’s own genetic profile. “Individualized 11 investigational treatment” includes but is not limited to 12 individualized gene therapy, antisense oligonucleotides, and 13 individualized neoantigen vaccines. 14 2. 4. “Investigational drug, biological product, or 15 device” means a drug, biological product, or device that has 16 successfully completed phase 1 of a United States food and drug 17 administration-approved clinical trial but has not yet been 18 approved for general use by the United States food and drug 19 administration and remains under investigation in a United 20 States food and drug administration-approved clinical trial. 21 3. 5. “Terminal illness” means a progressive disease 22 or medical or surgical condition that entails significant 23 functional impairment, that is not considered by a treating 24 physician to be reversible even with administration of 25 treatments approved by the United States food and drug 26 administration, and that, without life-sustaining procedures, 27 will result in death. 28 4. 6. “Written informed consent” means a written document 29 that is signed by the patient, a parent of a minor patient, or a 30 legal guardian or other legal representative of the patient and 31 attested to by the patient’s treating physician and a witness 32 and that includes , at a minimum, all of the following: 33 a. If the patient is an eligible patient as specified in 34 subsection 2, paragraph “a” : 35 -2- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 2/ 8

(1) An explanation of the products and treatments approved 1 by the United States food and drug administration for the 2 disease or condition from which the patient suffers. 3 b. (2) An attestation that the patient concurs with the 4 patient’s treating physician in believing that all products 5 and treatments approved by the United States food and drug 6 administration are unlikely to prolong the patient’s life. 7 c. (3) Clear identification of the specific proposed 8 investigational drug, biological product, or device that the 9 patient is seeking to use. 10 d. (4) A description of the best and worst potential 11 outcomes of using the investigational drug, biological product, 12 or device and a realistic description of the most likely 13 outcome. The description shall include the possibility that 14 new, unanticipated, different, or worse symptoms might result 15 and that death could be hastened by use of the proposed 16 investigational drug, biological product, or device. The 17 description shall be based on the treating physician’s 18 knowledge of the proposed investigational drug, biological 19 product, or device in conjunction with an awareness of the 20 patient’s condition. 21 e. (5) A statement that the patient’s health plan or 22 third-party administrator and provider are not obligated to 23 pay for any care or treatments consequent to the use of the 24 investigational drug, biological product, or device, unless 25 they are specifically required to do so by law or contract. 26 f. (6) A statement that the patient’s eligibility for 27 hospice care may be withdrawn if the patient begins curative 28 treatment with the investigational drug, biological product, 29 or device and that hospice care may be reinstated if this 30 treatment ends and the patient meets hospice eligibility 31 requirements. 32 g. (7) 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 -3- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 3/ 8

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 b. If the patient is an eligible patient as specified in 5 subsection 2, paragraph “b” : 6 (1) An explanation of the currently approved products and 7 treatments for the disease or condition from which the patient 8 suffers. 9 (2) An attestation that the patient concurs with the 10 patient’s treating physician in believing that all currently 11 approved and conventionally recognized products and treatments 12 are unlikely to prolong the patient’s life. 13 (3) Clear identification of the specific proposed 14 individualized investigational treatment that the patient is 15 seeking to use. 16 (4) A description of the best and worst potential outcomes 17 of using the individualized investigational treatment 18 and a realistic description of the most likely outcome. 19 The description shall include the possibility that new, 20 unanticipated, different, or worse symptoms might result 21 and that death could be hastened by use of the proposed 22 individualized investigational treatment. The description 23 shall be based on the treating physician’s knowledge of 24 the proposed individualized investigational treatment in 25 conjunction with an awareness of the patient’s condition. 26 (5) A statement that the patient’s health plan or 27 third-party administrator and provider are not obligated to 28 pay for any care or treatments consequent to the use of the 29 individualized investigational treatment, unless they are 30 specifically required to do so by law or contract. 31 (6) A statement that the patient’s eligibility for hospice 32 care may be withdrawn if the patient begins curative treatment 33 with the individualized investigational treatment and that 34 hospice care may be reinstated if this treatment ends and the 35 -4- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 4/ 8

patient meets hospice eligibility requirements. 1 (7) A statement that the patient understands that the 2 patient is liable for all expenses consequent to the use of 3 the individualized investigational treatment and that this 4 liability extends to the patient’s estate, unless a contract 5 between the patient and the manufacturer of the individualized 6 investigational treatment states otherwise. 7 Sec. 2. Section 144E.3, Code 2025, is amended to read as 8 follows: 9 144E.3 Manufacturer and eligible facility rights. 10 1. A manufacturer of an investigational drug, biological 11 product, or device or a manufacturer operating within, and in 12 compliance with all requirements applicable to, an eligible 13 facility may make available , and an eligible patient , as 14 applicable under section 144E.1, subsection 2, paragraph “a” 15 or “b” , may request from a manufacturer of an investigational 16 drug, biological product, or device, or a manufacturer 17 operating within, and in compliance with all requirements 18 applicable to, an eligible facility, the manufacturer’s 19 investigational drug, biological product, or device , or the 20 manufacturer’s individualized investigational treatment under 21 this chapter . This chapter does not require a manufacturer 22 of an investigational drug, biological product, or device , or 23 of an individualized investigational treatment to provide or 24 otherwise make available the investigational drug, biological 25 product, or device , or the individualized investigational 26 treatment to an eligible patient. 27 2. A An eligible facility, or a manufacturer described 28 in subsection 1 , that is in compliance with all applicable 29 requirements, may do any of the following: 30 a. Provide an investigational drug, biological product, 31 or device , or an individualized investigational treatment 32 to an eligible patient , as applicable under section 144E.1, 33 subsection 2, paragraph “a” or “b” , without receiving 34 compensation. 35 -5- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 5/ 8

b. Require an eligible patient , as applicable under section 1 144E.1, subsection 2, paragraph “a” or “b” , to pay the costs 2 of, or the costs associated with, the manufacture of the 3 investigational drug, biological product, or device , or the 4 individualized investigational treatment . 5 Sec. 3. Section 144E.4, Code 2025, is amended to read as 6 follows: 7 144E.4 Treatment coverage. 8 1. This chapter does not expand the coverage required of an 9 insurer under Title XIII, subtitle 1 . 10 2. A health plan, third-party administrator, or 11 governmental agency may , but is not required to, provide 12 coverage for the cost of an investigational drug, biological 13 product, or device, or the cost of an individualized 14 investigational treatment, the cost of services related to the 15 use of an investigational drug, biological product, or device , 16 or the cost of services related to the use of an individualized 17 investigational treatment under this chapter . 18 3. This chapter does not require any governmental agency 19 to pay costs associated with the use, care, or treatment of a 20 patient with an investigational drug, biological product, or 21 device , or an individualized investigational treatment . 22 4. This chapter does not require a hospital licensed under 23 chapter 135B or other health care facility to provide new or 24 additional services , unless approved by the hospital or other 25 health care facility . 26 Sec. 4. Section 144E.5, Code 2025, is amended to read as 27 follows: 28 144E.5 Heirs not liable for treatment debts. 29 If a patient dies while being treated by with an 30 investigational drug, biological product, or device, or 31 an individualized investigational treatment, the patient’s 32 heirs are not liable for any outstanding debt related to the 33 treatment or lack of insurance due to the treatment , unless 34 otherwise required by law . 35 -6- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 6/ 8

Sec. 5. Section 144E.6, Code 2025, is amended to read as 1 follows: 2 144E.6 Provider recourse. 3 1. To the extent consistent with state law, the board of 4 medicine created under chapter 147 shall not revoke, fail 5 to renew, suspend, or take any action against a physician’s 6 license based solely on the physician’s recommendations to 7 an eligible patient regarding access to or treatment with an 8 investigational drug, biological product, or device , or an 9 individualized investigational treatment . 10 2. To the extent consistent with federal law, an entity 11 responsible for Medicare certification shall not take action 12 against a physician’s Medicare certification based solely on 13 the physician’s recommendation that a patient have access to 14 an investigational drug, biological product, or device , or an 15 individualized investigational treatment . 16 Sec. 6. Section 144E.7, Code 2025, is amended to read as 17 follows: 18 144E.7 State interference. 19 An official, employee, or agent of this state shall not 20 block or attempt to block an eligible patient’s access to an 21 investigational drug, biological product, or device , or to an 22 individualized investigational treatment . Counseling, advice, 23 or a recommendation consistent with medical standards of care 24 from a licensed physician is not a violation of this section . 25 Sec. 7. Section 144E.8, Code 2025, is amended to read as 26 follows: 27 144E.8 Private cause of action. 28 1. This chapter shall not create a private cause of action 29 against a manufacturer of an investigational drug, biological 30 product, or device , or an individualized investigational 31 treatment, against an eligible facility, or against any other 32 person or entity involved in the care of an eligible patient 33 using the investigational drug, biological product, or device , 34 or the individualized investigational treatment for any harm 35 -7- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 7/ 8

done to the eligible patient resulting from the investigational 1 drug, biological product, or device, or the individualized 2 investigational treatment, if the manufacturer , eligible 3 facility, or other person or entity is complying in good faith 4 with the terms of this chapter and has exercised reasonable 5 care. 6 2. This chapter shall not affect any mandatory health care 7 coverage for participation in clinical trials under Title XIII, 8 subtitle 1 . > 9 ______________________________ BARKER of Story -8- HF 802.1037 (1) 91 amending this HF 802 to CONFORM to SF 233 lh/ko 8/ 8