House Amendment to Senate File 233 S-3038 Amend Senate File 233, as passed by the Senate, 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 exhausted all other United States food and drug 31 administration-approved treatment options by contraindication, 32 potential or previous treatment failure, or actual or potential 33 adverse reaction. 34 (3) Has received a recommendation from the individual’s 35 -1- SF 233.1125.H (1) 91 md 1/ 8 #1.

physician for an individualized investigational treatment, 1 based on an analysis of the patient’s genomic sequence, human 2 chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, 3 gene products such as enzymes and other types of proteins, or 4 metabolites. 5 (4) Has given written informed consent for the use of the 6 individualized investigational treatment. 7 (5) Has documentation from the individual’s physician that 8 the individual meets the requirements of this paragraph “b” . 9 3. “Individualized investigational treatment” means a drug, 10 biological product, or device that is unique to, and produced 11 exclusively for use by, an individual patient, based on the 12 individual patient’s own genetic profile, and is provided in a 13 manner that is consistent with a federalwide assurance for the 14 protection of human subjects. “Individualized investigational 15 treatment” includes but is not limited to individualized 16 gene therapy, antisense oligonucleotides, and individualized 17 neoantigen vaccines. 18 2. 4. “Investigational drug, biological product, or 19 device” 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. 5. “Terminal illness” means a progressive disease 26 or medical or surgical condition that entails significant 27 functional impairment, that is not considered by a treating 28 physician to be reversible even with administration of 29 treatments approved by the United States food and drug 30 administration, and that, without life-sustaining procedures, 31 will result in death. 32 4. 6. “Written informed consent” means a written document 33 that 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 -2- SF 233.1125.H (1) 91 md 2/ 8

attested to by the patient’s treating physician and a witness 1 and that includes , at a minimum, all of the following: 2 a. If the patient is an eligible patient as specified in 3 subsection 2, paragraph “a” : 4 (1) An explanation of the products and treatments approved 5 by the United States food and drug administration for the 6 disease or condition from which the patient suffers. 7 b. (2) An attestation that the patient concurs with the 8 patient’s treating physician in believing that all products 9 and treatments approved by the United States food and drug 10 administration are unlikely to prolong the patient’s life. 11 c. (3) Clear identification of the specific proposed 12 investigational drug, biological product, or device that the 13 patient is seeking to use. 14 d. (4) A description of the best and worst potential 15 outcomes of using the investigational drug, biological product, 16 or device and a realistic description of the most likely 17 outcome. The description shall include the possibility that 18 new, unanticipated, different, or worse symptoms might result 19 and that death could be hastened by use of the proposed 20 investigational drug, biological product, or device. The 21 description shall be based on the treating physician’s 22 knowledge of the proposed investigational drug, biological 23 product, or device in conjunction with an awareness of the 24 patient’s condition. 25 e. (5) A statement that the patient’s health plan or 26 third-party administrator and provider are not obligated to 27 pay for any care or treatments consequent to the use of the 28 investigational drug, biological product, or device, unless 29 they are specifically required to do so by law or contract. 30 f. (6) A statement that the patient’s eligibility for 31 hospice care may be withdrawn if the patient begins curative 32 treatment with the investigational drug, biological product, 33 or device and that hospice care may be reinstated if this 34 treatment ends and the patient meets hospice eligibility 35 -3- SF 233.1125.H (1) 91 md 3/ 8

requirements. 1 g. (7) A statement that the patient understands that the 2 patient is liable for all expenses consequent to the use of 3 the investigational drug, biological product, or device and 4 that this liability extends to the patient’s estate unless 5 a contract between the patient and the manufacturer of the 6 investigational drug, biological product, or device states 7 otherwise. 8 b. If the patient is an eligible patient as specified in 9 subsection 2, paragraph “b” : 10 (1) An explanation of the currently approved products and 11 treatments for the disease or condition from which the patient 12 suffers. 13 (2) An attestation that the patient concurs with the 14 patient’s treating physician in believing that all currently 15 approved and conventionally recognized products and treatments 16 are unlikely to prolong the patient’s life. 17 (3) Clear identification of the specific proposed 18 individualized investigational treatment that the patient is 19 seeking to use. 20 (4) A description of the best and worst potential outcomes 21 of using the individualized investigational treatment 22 and a realistic description of the most likely outcome. 23 The description shall include the possibility that new, 24 unanticipated, different, or worse symptoms might result 25 and that death could be hastened by use of the proposed 26 individualized investigational treatment. The description 27 shall be based on the treating physician’s knowledge of 28 the proposed individualized investigational treatment in 29 conjunction with an awareness of the patient’s condition. 30 (5) A statement that the patient’s health plan or 31 third-party administrator and provider are not obligated to 32 pay for any care or treatments consequent to the use of the 33 individualized investigational treatment, unless they are 34 specifically required to do so by law or contract. 35 -4- SF 233.1125.H (1) 91 md 4/ 8

(6) A statement that the patient’s eligibility for hospice 1 care may be withdrawn if the patient begins curative treatment 2 with the individualized investigational treatment and that 3 hospice care may be reinstated if this treatment ends and the 4 patient meets hospice eligibility requirements. 5 (7) A statement that the patient understands that the 6 patient is liable for all expenses consequent to the use of 7 the individualized investigational treatment and that this 8 liability extends to the patient’s estate, unless a contract 9 between the patient and the manufacturer of the individualized 10 investigational treatment states otherwise. 11 Sec. 2. Section 144E.3, Code 2025, is amended to read as 12 follows: 13 144E.3 Manufacturer and eligible facility rights. 14 1. A manufacturer of an investigational drug, biological 15 product, or device or a manufacturer operating within, and in 16 compliance with all requirements applicable to, an eligible 17 facility may make available , and an eligible patient , as 18 applicable under section 144E.1, subsection 2, paragraph “a” 19 or “b” , may request from a manufacturer of an investigational 20 drug, biological product, or device, or a manufacturer 21 operating within, and in compliance with all requirements 22 applicable to, an eligible facility, the manufacturer’s 23 investigational drug, biological product, or device , or the 24 manufacturer’s individualized investigational treatment under 25 this chapter . This chapter does not require a manufacturer 26 of an investigational drug, biological product, or device , or 27 of an individualized investigational treatment to provide or 28 otherwise make available the investigational drug, biological 29 product, or device , or the individualized investigational 30 treatment to an eligible patient. 31 2. A An eligible facility, or a manufacturer described 32 in subsection 1 , that is in compliance with all applicable 33 requirements, may do any of the following: 34 a. Provide an investigational drug, biological product, 35 -5- SF 233.1125.H (1) 91 md 5/ 8

or device , or an individualized investigational treatment 1 to an eligible patient , as applicable under section 144E.1, 2 subsection 2, paragraph “a” or “b” , without receiving 3 compensation. 4 b. Require an eligible patient , as applicable under section 5 144E.1, subsection 2, paragraph “a” or “b” , to pay the costs 6 of, or the costs associated with, the manufacture of the 7 investigational drug, biological product, or device , or the 8 individualized investigational treatment . 9 Sec. 3. Section 144E.4, Code 2025, is amended to read as 10 follows: 11 144E.4 Treatment coverage. 12 1. This chapter does not expand the coverage required of an 13 insurer under Title XIII, subtitle 1 . 14 2. A health plan, third-party administrator, or 15 governmental agency may , but is not required to, provide 16 coverage for the cost of an investigational drug, biological 17 product, or device, or the cost of an individualized 18 investigational treatment, the cost of services related to the 19 use of an investigational drug, biological product, or device , 20 or the cost of services related to the use of an individualized 21 investigational treatment under this chapter . 22 3. This chapter does not require any governmental agency 23 to pay costs associated with the use, care, or treatment of a 24 patient with an investigational drug, biological product, or 25 device , or an individualized investigational treatment . 26 4. This chapter does not require a hospital licensed under 27 chapter 135B or other health care facility to provide new or 28 additional services , unless approved by the hospital or other 29 health care facility . 30 Sec. 4. Section 144E.5, Code 2025, is amended to read as 31 follows: 32 144E.5 Heirs not liable for treatment debts. 33 If a patient dies while being treated by with an 34 investigational drug, biological product, or device, or 35 -6- SF 233.1125.H (1) 91 md 6/ 8

an individualized investigational treatment, the patient’s 1 heirs are not liable for any outstanding debt related to the 2 treatment or lack of insurance due to the treatment , unless 3 otherwise required by law . 4 Sec. 5. Section 144E.6, Code 2025, is amended to read as 5 follows: 6 144E.6 Provider recourse. 7 1. To the extent consistent with state law, the board of 8 medicine created under chapter 147 shall not revoke, fail 9 to renew, suspend, or take any action against a physician’s 10 license based solely on the physician’s recommendations to 11 an eligible patient regarding access to or treatment with an 12 investigational drug, biological product, or device , or an 13 individualized investigational treatment . 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 18 an investigational drug, biological product, or device , or an 19 individualized investigational treatment . 20 Sec. 6. Section 144E.7, Code 2025, is amended to read as 21 follows: 22 144E.7 State interference. 23 An official, employee, or agent of this state shall not 24 block or attempt to block an eligible patient’s access to an 25 investigational drug, biological product, or device , or to an 26 individualized investigational treatment . Counseling, advice, 27 or a recommendation consistent with medical standards of care 28 from a licensed physician is not a violation of this section . 29 Sec. 7. Section 144E.8, Code 2025, is amended to read as 30 follows: 31 144E.8 Private cause of action. 32 1. This chapter shall not create a private cause of action 33 against a manufacturer of an investigational drug, biological 34 product, or device , or an individualized investigational 35 -7- SF 233.1125.H (1) 91 md 7/ 8

treatment, against an eligible facility, or against any other 1 person or entity involved in the care of an eligible patient 2 using the investigational drug, biological product, or device , 3 or the individualized investigational treatment for any harm 4 done to the eligible patient resulting from the investigational 5 drug, biological product, or device, or the individualized 6 investigational treatment, if the manufacturer , eligible 7 facility, or other person or entity is complying in good faith 8 with the terms of this chapter and has exercised reasonable 9 care. 10 2. This chapter shall not affect any mandatory health care 11 coverage for participation in clinical trials under Title XIII, 12 subtitle 1 . > 13 -8- SF 233.1125.H (1) 91 md 8/ 8