House File 225 - Introduced HOUSE FILE 225 BY BODEN 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 1934YH (3) 90 pf/rh
H.F. 225 Section 1. Section 144E.2, Code 2023, 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 28 C.F.R. pt. 46. 7 1. 2. Eligible patient means an individual who meets all 8 of the following conditions: 9 a. Has a terminal life-threatening or severely debilitating 10 illness, attested to by the patients treating physician. 11 b. Has considered and rejected or has tried and failed to 12 respond to all other treatment options currently approved by 13 the United States food and drug administration. 14 c. Has received a recommendation from the individuals 15 physician for an individualized investigational drug, 16 biological product, or device treatment based on an analysis 17 of the patients genomic sequence, human chromosomes, 18 deoxyribonucleic acid, ribonucleic acid, genes, gene products 19 such as enzymes and other types of proteins, or metabolites . 20 d. Has given written informed consent for the use of the 21 individualized investigational drug, biological product, or 22 device treatment . 23 e. Has documentation from the individuals physician that 24 the individual meets the requirements of this subsection . 25 2. Investigational drug, biological product, or device 26 means a drug, biological product, or device that has 27 successfully completed phase 1 of a United States food and drug 28 administration-approved clinical trial but has not yet been 29 approved for general use by the United States food and drug 30 administration and remains under investigation in a United 31 States food and drug administration-approved clinical trial. 32 3. Terminal illness means a progressive disease or medical 33 or surgical condition that entails significant functional 34 impairment, that is not considered by a treating physician to 35 -1- LSB 1934YH (3) 90 pf/rh 1/ 7
H.F. 225 be reversible even with administration of treatments approved 1 by the United States food and drug administration, and that, 2 without life-sustaining procedures, will result in death. 3 3. Individualized investigational treatment means a drug, 4 biological product, or device that is unique to and produced 5 exclusively for use by an individual patient based on the 6 individual patients own genetic profile. Individualized 7 investigational treatment includes but is not limited to 8 individualized gene therapy, antisense oligonucleotides, and 9 individualized neoantigen vaccines. 10 4. Written informed consent means a written document that 11 is signed by the patient, a parent of a minor patient, or a 12 legal guardian or other legal representative of the patient and 13 attested to by the patients treating physician and a witness 14 and that , at a minimum, includes all of the following: 15 a. An explanation of the products and treatments currently 16 approved by the United States food and drug administration 17 for the disease or condition life-threatening or severely 18 debilitating illness from which the patient suffers. 19 b. An attestation that the patient concurs with the 20 patients treating physician in believing that all products and 21 treatments currently approved by the United States food and 22 drug administration or conventionally recognized are unlikely 23 to prolong the patients life. 24 c. Clear identification of the specific proposed 25 individualized investigational drug, biological product, or 26 device treatment that the patient is seeking to use. 27 d. A description of the best and worst potential outcomes 28 of using the individualized investigational drug, biological 29 product, or device treatment and a realistic description of 30 the most likely outcome. The description shall include the 31 possibility that new, unanticipated, different, or worse 32 symptoms might result and that death could be hastened by 33 use of the proposed individualized investigational drug, 34 biological product, or device treatment . The description shall 35 -2- LSB 1934YH (3) 90 pf/rh 2/ 7
H.F. 225 be based on the treating physicians knowledge of the proposed 1 individualized investigational drug, biological product, 2 or device treatment in conjunction with an awareness of the 3 patients condition. 4 e. A statement that the patients health plan or third-party 5 administrator and provider are not obligated to pay for any 6 care or treatments consequent to the use of the individualized 7 investigational drug, biological product, or device treatment , 8 unless they are specifically required to do so by law or 9 contract. 10 f. A statement that the patients eligibility for hospice 11 care may be withdrawn if the patient begins curative treatment 12 with the individualized investigational drug, biological 13 product, or device treatment and that care may be reinstated if 14 this treatment ends and the patient meets hospice eligibility 15 requirements. 16 g. A statement that the patient understands that the 17 patient is liable for all expenses consequent to the use of 18 the individualized investigational drug, biological product, 19 or device treatment and that this liability extends to the 20 patients estate unless a contract between the patient and 21 the manufacturer of the individualized investigational drug, 22 biological product, or device treatment states otherwise. 23 Sec. 2. Section 144E.3, Code 2023, is amended to read as 24 follows: 25 144E.3 Manufacturer and eligible facility rights. 26 1. A manufacturer of an individualized investigational 27 drug, biological product, or device treatment operating 28 within an eligible facility and in compliance with all laws 29 applicable to an eligible facility may make available and an 30 eligible patient may request the manufacturers individualized 31 investigational drug, biological product, or device treatment 32 under this chapter . This chapter does not require a 33 manufacturer of an individualized investigational drug, 34 biological product, or device treatment to provide or otherwise 35 -3- LSB 1934YH (3) 90 pf/rh 3/ 7
H.F. 225 make available the individualized investigational drug, 1 biological product, or device treatment to an eligible patient. 2 2. A An eligible facility or a manufacturer described in 3 subsection 1 may do any of the following: 4 a. Provide an individualized investigational drug, 5 biological product, or device treatment to an eligible patient 6 without receiving compensation. 7 b. Require an eligible patient to pay the costs of, or the 8 costs associated with, the manufacture of the individualized 9 investigational drug, biological product, or device treatment . 10 Sec. 3. Section 144E.4, Code 2023, is amended to read as 11 follows: 12 144E.4 Treatment coverage. 13 1. This chapter does not expand the coverage required of an 14 insurer under Title XIII, subtitle 1 . 15 2. A health plan, third-party administrator, or 16 governmental agency may provide coverage for the cost of an 17 individualized investigational drug, biological product, or 18 device treatment , or the cost of services related to the use of 19 an individualized investigational drug, biological product, or 20 device treatment under this chapter . 21 3. This chapter does not require any governmental agency 22 to pay costs associated with the use, care, or treatment of a 23 patient with an individualized investigational drug, biological 24 product, or device treatment . 25 4. This chapter does not require a hospital licensed under 26 chapter 135B or other health care facility to provide new or 27 additional services , unless approved by the hospital or health 28 care facility . 29 Sec. 4. Section 144E.5, Code 2023, is amended to read as 30 follows: 31 144E.5 Heirs not liable for treatment debts. 32 If a patient dies while being treated by an individualized 33 investigational drug, biological product, or device treatment , 34 the patients heirs are not liable for any outstanding debt 35 -4- LSB 1934YH (3) 90 pf/rh 4/ 7
H.F. 225 related to the treatment or lack of insurance due to the 1 treatment, unless otherwise required by law. 2 Sec. 5. Section 144E.6, Code 2023, is amended to read as 3 follows: 4 144E.6 Provider recourse. 5 1. To the extent consistent with state law, the board of 6 medicine created under chapter 147 shall not revoke, fail 7 to renew, suspend, or take any action against a physicians 8 license based solely on the physicians recommendations to 9 an eligible patient regarding access to or treatment with an 10 individualized investigational drug, biological product, or 11 device treatment . 12 2. To the extent consistent with federal law, an entity 13 responsible for Medicare certification shall not take action 14 against a physicians Medicare certification based solely on 15 the physicians recommendation that a patient have access to 16 an individualized investigational drug, biological product, or 17 device treatment . 18 Sec. 6. Section 144E.7, Code 2023, is amended to read as 19 follows: 20 144E.7 State interference. 21 An official, employee, or agent of this state shall not 22 block or attempt to block an eligible patients access to an 23 individualized investigational drug, biological product, or 24 device treatment . Counseling, advice, or a recommendation 25 consistent with medical standards of care from a licensed 26 physician is not a violation of this section . 27 Sec. 7. Section 144E.8, Code 2023, is amended to read as 28 follows: 29 144E.8 Private cause of action. 30 1. This chapter shall not create a private cause of action 31 against a manufacturer of an individualized investigational 32 drug, biological product, or device treatment or against any 33 other person or entity involved in the care of an eligible 34 patient using the individualized investigational drug, 35 -5- LSB 1934YH (3) 90 pf/rh 5/ 7
H.F. 225 biological product, or device treatment for any harm done 1 to the eligible patient resulting from the individualized 2 investigational drug, biological product, or device treatment , 3 if the manufacturer or other person or entity is complying in 4 good faith with the terms of this chapter and has exercised 5 reasonable 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 Sec. 8. REPEAL. Section 144E.9, Code 2023, is repealed. 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 is instead, in part, a 17 person who has a life-threatening or severely debilitating 18 illness. 19 Under current law, the Code chapter applies to an 20 investigational drug, biological product, or device 21 meaning a drug, biological product, or device that has 22 successfully completed phase I of a United States food and drug 23 administration (FDA)-approved clinical trial but has not yet 24 been approved for general use by the FDA and that remains under 25 investigation in an FDA-approved clinical trial. Under the 26 bill, the Code chapter instead applies to an individualized 27 investigational treatment, meaning a drug, biological product, 28 or device that is unique to and produced exclusively for use 29 by an individual patient based on the individual patients 30 own genetic profile and includes individualized gene therapy, 31 antisense oligonucleotides, and individualized neoantigen 32 vaccines. 33 The bill amends the definition under the Code chapter for 34 written informed consent to reflect the changes made to 35 -6- LSB 1934YH (3) 90 pf/rh 6/ 7
H.F. 225 eligible patient and the application of the Code chapter to 1 individualized investigational treatments. 2 The bill provides a definition of eligible facility to 3 mean an institution that is operating under a federalwide 4 assurance for the protection of human subjects pursuant 5 to federal law. The bill amends provisions relating to 6 a manufacturers rights under the Code chapter to provide 7 that a manufacturer of an individualized investigational 8 treatment operating within an eligible facility and in 9 compliance with all laws applicable to an eligible facility 10 may make available, and an eligible patient may request, the 11 manufacturers individualized investigational treatment under 12 the Code chapter. However, the Code chapter does not require 13 a manufacturer of an individualized investigational treatment 14 to provide or otherwise make available the individualized 15 investigational treatment to an eligible patient. The bill 16 provides that an eligible facility or a manufacturer may 17 provide an individualized investigational treatment to an 18 eligible patient without receiving compensation, or require an 19 eligible patient to pay the costs of, or the costs associated 20 with, the manufacture of the individualized investigational 21 treatment. 22 The bill makes other conforming changes in the Code chapter 23 to reflect the bill provisions. 24 The bill repeals Code section 144E.9, which provides that 25 the Code chapter shall not be construed to allow a patients 26 treating physician to assist the patient in committing or 27 attempting to commit suicide. 28 -7- LSB 1934YH (3) 90 pf/rh 7/ 7