House File 802 - Introduced HOUSE FILE 802 BY COMMITTEE ON HEALTH AND HUMAN SERVICES (SUCCESSOR TO HF 320) A BILL FOR An Act relating to the right to try Act. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 1518HV (2) 91 lh/ko
H.F. 802 Section 1. Section 144E.2, Code 2025, is amended to read as 1 follows: 2 144E.2 Definitions. 3 As used in this chapter : 4 1. Eligible facility means an institution operating under 5 a federalwide assurance for the protection of human subjects 6 pursuant to 42 U.S.C. 289(a) and 45 C.F.R. pt. 46, and 7 subject to the federalwide assurance laws, rules, policies, and 8 guidelines including renewals and updates. 9 1. 2. Eligible patient means an individual who meets all 10 of the following conditions specified under paragraph a or 11 b : 12 a. (1) Has a terminal illness, attested to by the patients 13 treating physician. 14 b. (2) Has considered and rejected or has tried and failed 15 to respond to all other treatment options approved by the 16 United States food and drug administration. 17 c. (3) Has received a recommendation from the individuals 18 physician for an investigational drug, biological product, or 19 device. 20 d. (4) Has given written informed consent for the use of 21 the investigational drug, biological product, or device. 22 e. (5) Has documentation from the individuals physician 23 that the individual meets the requirements of this subsection 24 paragraph a . 25 b. (1) Has a life-threatening or severely debilitating 26 illness, attested to by the patients treating physician. 27 (2) Has exhausted all other United States food and drug 28 administration-approved treatment options by contraindication, 29 potential or previous treatment failure, or actual or potential 30 adverse reaction. 31 (3) Has received a recommendation from the individuals 32 physician for an individualized investigational treatment, 33 based on an analysis of the patients genomic sequence, human 34 chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, 35 -1- LSB 1518HV (2) 91 lh/ko 1/ 9
H.F. 802 gene products such as enzymes and other types of proteins, or 1 metabolites. 2 (4) Has given written informed consent for the use of the 3 individualized investigational treatment. 4 (5) Has documentation from the individuals physician that 5 the individual meets the requirements of this paragraph b . 6 3. Individualized investigational treatment means a drug, 7 biological product, or device that is unique to, and produced 8 exclusively for use by, an individual patient, based on the 9 individual patients own genetic profile, and is provided in a 10 manner that is consistent with a federalwide assurance for the 11 protection of human subjects. Individualized investigational 12 treatment includes but is not limited to individualized 13 gene therapy, antisense oligonucleotides, and individualized 14 neoantigen vaccines. 15 2. 4. Investigational drug, biological product, or 16 device means a drug, biological product, or device that has 17 successfully completed phase 1 of a United States food and drug 18 administration-approved clinical trial but has not yet been 19 approved for general use by the United States food and drug 20 administration and remains under investigation in a United 21 States food and drug administration-approved clinical trial. 22 3. 5. Terminal illness means a progressive disease 23 or medical or surgical condition that entails significant 24 functional impairment, that is not considered by a treating 25 physician to be reversible even with administration of 26 treatments approved by the United States food and drug 27 administration, and that, without life-sustaining procedures, 28 will result in death. 29 4. 6. Written informed consent means a written document 30 that is signed by the patient, a parent of a minor patient, or a 31 legal guardian or other legal representative of the patient and 32 attested to by the patients treating physician and a witness 33 and that includes , at a minimum, all of the following: 34 a. If the patient is an eligible patient as specified in 35 -2- LSB 1518HV (2) 91 lh/ko 2/ 9
H.F. 802 subsection 2, paragraph a : 1 (1) An explanation of the products and treatments approved 2 by the United States food and drug administration for the 3 disease or condition from which the patient suffers. 4 b. (2) An attestation that the patient concurs with the 5 patients 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 patients life. 8 c. (3) Clear identification of the specific proposed 9 investigational drug, biological product, or device that the 10 patient is seeking to use. 11 d. (4) A description of the best and worst potential 12 outcomes of using the investigational drug, biological product, 13 or device and a realistic description of the most likely 14 outcome. The description shall include the possibility that 15 new, 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 physicians 19 knowledge of the proposed investigational drug, biological 20 product, or device in conjunction with an awareness of the 21 patients condition. 22 e. (5) A statement that the patients health plan or 23 third-party administrator and provider are not obligated to 24 pay for any care or treatments consequent to the use of the 25 investigational drug, biological product, or device, unless 26 they are specifically required to do so by law or contract. 27 f. (6) A statement that the patients eligibility for 28 hospice care may be withdrawn if the patient begins curative 29 treatment with the investigational drug, biological product, 30 or device and that hospice care may be reinstated if this 31 treatment ends and the patient meets hospice eligibility 32 requirements. 33 g. (7) A statement that the patient understands that the 34 patient is liable for all expenses consequent to the use of 35 -3- LSB 1518HV (2) 91 lh/ko 3/ 9
H.F. 802 the investigational drug, biological product, or device and 1 that this liability extends to the patients estate unless 2 a contract between the patient and the manufacturer of the 3 investigational drug, biological product, or device states 4 otherwise. 5 b. If the patient is an eligible patient as specified in 6 subsection 2, paragraph b : 7 (1) An explanation of the currently approved products and 8 treatments for the disease or condition from which the patient 9 suffers. 10 (2) An attestation that the patient concurs with the 11 patients treating physician in believing that all currently 12 approved and conventionally recognized products and treatments 13 are unlikely to prolong the patients life. 14 (3) Clear identification of the specific proposed 15 individualized investigational treatment that the patient is 16 seeking to use. 17 (4) A description of the best and worst potential outcomes 18 of using the individualized investigational treatment 19 and a realistic description of the most likely outcome. 20 The description shall include the possibility that new, 21 unanticipated, different, or worse symptoms might result 22 and that death could be hastened by use of the proposed 23 individualized investigational treatment. The description 24 shall be based on the treating physicians knowledge of 25 the proposed individualized investigational treatment in 26 conjunction with an awareness of the patients condition. 27 (5) A statement that the patients health plan or 28 third-party administrator and provider are not obligated to 29 pay for any care or treatments consequent to the use of the 30 individualized investigational treatment, unless they are 31 specifically required to do so by law or contract. 32 (6) A statement that the patients eligibility for hospice 33 care may be withdrawn if the patient begins curative treatment 34 with the individualized investigational treatment and that 35 -4- LSB 1518HV (2) 91 lh/ko 4/ 9
H.F. 802 hospice care may be reinstated if this treatment ends and the 1 patient meets hospice eligibility requirements. 2 (7) A statement that the patient understands that the 3 patient is liable for all expenses consequent to the use of 4 the individualized investigational treatment and that this 5 liability extends to the patients estate, unless a contract 6 between the patient and the manufacturer of the individualized 7 investigational treatment states otherwise. 8 Sec. 2. Section 144E.3, Code 2025, is amended to read as 9 follows: 10 144E.3 Manufacturer and eligible facility rights. 11 1. A manufacturer of an investigational drug, biological 12 product, or device or a manufacturer operating within, and in 13 compliance with all requirements applicable to, an eligible 14 facility may make available , and an eligible patient , as 15 applicable under section 144E.1, subsection 2, paragraph a 16 or b , may request from a manufacturer of an investigational 17 drug, biological product, or device, or a manufacturer 18 operating within, and in compliance with all requirements 19 applicable to, an eligible facility, the manufacturers 20 investigational drug, biological product, or device , or the 21 manufacturers individualized investigational treatment under 22 this chapter . This chapter does not require a manufacturer 23 of an investigational drug, biological product, or device , or 24 of an individualized investigational treatment to provide or 25 otherwise make available the investigational drug, biological 26 product, or device , or the individualized investigational 27 treatment to an eligible patient. 28 2. A An eligible facility, or a manufacturer described 29 in subsection 1 , that is in compliance with all applicable 30 requirements, may do any of the following: 31 a. Provide an investigational drug, biological product, 32 or device , or an individualized investigational treatment 33 to an eligible patient , as applicable under section 144E.1, 34 subsection 2, paragraph a or b , without receiving 35 -5- LSB 1518HV (2) 91 lh/ko 5/ 9
H.F. 802 compensation. 1 b. Require an eligible patient , as applicable under section 2 144E.1, subsection 2, paragraph a or b , to pay the costs 3 of, or the costs associated with, the manufacture of the 4 investigational drug, biological product, or device , or the 5 individualized investigational treatment . 6 Sec. 3. Section 144E.4, Code 2025, is amended to read as 7 follows: 8 144E.4 Treatment coverage. 9 1. This chapter does not expand the coverage required of an 10 insurer under Title XIII, subtitle 1 . 11 2. A health plan, third-party administrator, or 12 governmental agency may , but is not required to, provide 13 coverage for the cost of an investigational drug, biological 14 product, or device, or the cost of an individualized 15 investigational treatment, the cost of services related to the 16 use of an investigational drug, biological product, or device , 17 or the cost of services related to the use of an individualized 18 investigational treatment under this chapter . 19 3. This chapter does not require any governmental agency 20 to pay costs associated with the use, care, or treatment of a 21 patient with an investigational drug, biological product, or 22 device , or an individualized investigational treatment . 23 4. This chapter does not require a hospital licensed under 24 chapter 135B or other health care facility to provide new or 25 additional services , unless approved by the hospital or other 26 health care facility . 27 Sec. 4. Section 144E.5, Code 2025, is amended to read as 28 follows: 29 144E.5 Heirs not liable for treatment debts. 30 If a patient dies while being treated by with an 31 investigational drug, biological product, or device, or 32 an individualized investigational treatment, the patients 33 heirs are not liable for any outstanding debt related to the 34 treatment or lack of insurance due to the treatment , unless 35 -6- LSB 1518HV (2) 91 lh/ko 6/ 9
H.F. 802 otherwise required by law . 1 Sec. 5. Section 144E.6, Code 2025, is amended to read as 2 follows: 3 144E.6 Provider recourse. 4 1. To the extent consistent with state law, the board of 5 medicine created under chapter 147 shall not revoke, fail 6 to renew, suspend, or take any action against a physicians 7 license based solely on the physicians recommendations to 8 an eligible patient regarding access to or treatment with an 9 investigational drug, biological product, or device , or an 10 individualized investigational treatment . 11 2. To the extent consistent with federal law, an entity 12 responsible for Medicare certification shall not take action 13 against a physicians Medicare certification based solely on 14 the physicians recommendation that a patient have access to 15 an investigational drug, biological product, or device , or an 16 individualized investigational treatment . 17 Sec. 6. Section 144E.7, Code 2025, is amended to read as 18 follows: 19 144E.7 State interference. 20 An official, employee, or agent of this state shall not 21 block or attempt to block an eligible patients access to an 22 investigational drug, biological product, or device , or to an 23 individualized investigational treatment . Counseling, advice, 24 or a recommendation consistent with medical standards of care 25 from a licensed physician is not a violation of this section . 26 Sec. 7. Section 144E.8, Code 2025, is amended to read as 27 follows: 28 144E.8 Private cause of action. 29 1. This chapter shall not create a private cause of action 30 against a manufacturer of an investigational drug, biological 31 product, or device , or an individualized investigational 32 treatment, against an eligible facility, or against any other 33 person or entity involved in the care of an eligible patient 34 using the investigational drug, biological product, or device , 35 -7- LSB 1518HV (2) 91 lh/ko 7/ 9
H.F. 802 or the individualized investigational treatment for any harm 1 done to the eligible patient resulting from the investigational 2 drug, biological product, or device, or the individualized 3 investigational treatment, if the manufacturer , eligible 4 facility, or other person or entity is complying in good faith 5 with the terms of this chapter and has exercised reasonable 6 care. 7 2. This chapter shall not affect any mandatory health care 8 coverage for participation in clinical trials under Title XIII, 9 subtitle 1 . 10 EXPLANATION 11 The inclusion of this explanation does not constitute agreement with 12 the explanations substance by the members of the general assembly. 13 This bill relates to Code chapter 144E, the right to try Act. 14 Under current law, an eligible patient under the Code 15 chapter is, in part, a person who has a terminal illness. 16 Under the bill, an eligible patient also includes an 17 individual who has a life-threatening or severely debilitating 18 illness, who has exhausted all other treatment options, who 19 has received a recommendation from the individuals physician 20 for individualized investigational treatment, who has given 21 written informed consent, and who has documentation from 22 the individuals physician that the individual meets these 23 requirements. 24 Under current law, the Code chapter applies to an 25 investigational drug, biological product, or device, 26 meaning a drug, biological product, or device that has 27 successfully completed phase I of a United States food and 28 drug administration (FDA)-approved clinical trial but has not 29 yet been approved for general use by the FDA and that remains 30 under investigation in an FDA-approved clinical trial. Under 31 the bill, the Code chapter also applies to an individualized 32 investigational treatment, meaning a drug, biological product, 33 or device that is unique to and produced exclusively for use 34 by an individual patient based on the individual patients 35 -8- LSB 1518HV (2) 91 lh/ko 8/ 9
H.F. 802 own genetic profile and includes individualized gene therapy, 1 antisense oligonucleotides, and individualized neoantigen 2 vaccines. 3 The bill amends the definition for written informed 4 consent to reflect the changes made to eligible patient 5 and the application of the Code chapter to individualized 6 investigational treatments. 7 Eligible facility is defined as an institution that is 8 operating under a federalwide assurance for the protection 9 of human subjects pursuant to federal law. The bill amends 10 provisions relating to a manufacturers rights under the 11 Code chapter to also apply to eligible facilities. The bill 12 provides that a manufacturer of an investigational drug, 13 biological product, or device or a manufacturer operating 14 within, and in compliance with all requirements applicable 15 to, an eligible facility may make available, and an eligible 16 patient may request from a manufacturer of an investigational 17 drug, biological product, or device, or a manufacturer 18 operating within, and in compliance with all requirements 19 applicable to, an eligible facility, the manufacturers 20 investigational drug, biological product, or device, or the 21 manufacturers individualized investigational treatment. 22 However, the Code chapter does not require a manufacturer of 23 an individualized investigational treatment to provide or 24 otherwise make available the individualized investigational 25 treatment to an eligible patient. The bill provides that an 26 eligible facility or a manufacturer that is in compliance with 27 all applicable requirements may provide an individualized 28 investigational treatment to an eligible patient without 29 receiving compensation, or require an eligible patient to pay 30 the costs of, or the costs associated with, the manufacture of 31 the individualized investigational treatment. 32 The bill makes conforming changes in the Code chapter. 33 -9- LSB 1518HV (2) 91 lh/ko 9/ 9