House File 2203 - Reprinted HOUSE FILE 2203 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO HF 2010) (As Amended and Passed by the House March 2, 2022 ) A BILL FOR An Act relating to health care including protections for health 1 care providers against disciplinary actions for acts or 2 omissions related to COVID-19 and to experimental treatments 3 for terminally ill persons, and including effective date 4 provisions. 5 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 6 HF 2203 (4) 89 pf/rh/md
H.F. 2203 Section 1. Section 144E.2, subsection 1, paragraphs a, c, 1 and e, Code 2022, are amended to read as follows: 2 a. Has a terminal illness, attested to by the patient’s a 3 treating physician , or is receiving mechanical ventilation to 4 prolong life . 5 c. Has received a recommendation from the individual’s a 6 physician for an investigational drug, biological product, or 7 device. 8 e. Has documentation from the individual’s a physician that 9 the individual meets the requirements of this subsection . 10 Sec. 2. Section 144E.2, subsection 2, Code 2022, is amended 11 to read as follows: 12 2. “Investigational drug, biological product, or device” 13 means a any of the following: 14 a. A drug, biological product, or device that has 15 successfully completed phase 1 of a United States food and drug 16 administration-approved clinical trial but has not yet been 17 approved for general use by the United States food and drug 18 administration and remains under investigation in a United 19 States food and drug administration-approved clinical trial. 20 b. An off-label use of a drug. 21 Sec. 3. Section 144E.2, Code 2022, is amended by adding the 22 following new subsection: 23 NEW SUBSECTION . 2A. “Off-label use of a drug” means 24 the legal, prescribed use of a drug in a manner different 25 from that described on the United States food and drug 26 administration-approved drug label, including the use of a 27 drug for a different disease or medical condition or giving 28 a drug at a different dose or through a different route of 29 administration other than that approved by the United States 30 food and drug administration. 31 Sec. 4. Section 144E.2, subsection 4, unnumbered paragraph 32 1, Code 2022, is amended to read as follows: 33 “Written informed consent” means a written document that 34 is signed by the patient, a parent of a minor patient, or a 35 -1- HF 2203 (4) 89 pf/rh/md 1/ 4
H.F. 2203 legal guardian or other legal representative of the patient and 1 attested to by the patient’s a treating physician and a witness 2 and that includes all of the following: 3 Sec. 5. Section 144E.2, subsection 4, paragraphs b and d, 4 Code 2022, are amended to read as follows: 5 b. An attestation that the patient concurs with the 6 patient’s a treating physician in believing that all products 7 and treatments approved by the United States food and drug 8 administration are unlikely to prolong the patient’s life. 9 d. A description of the best and worst potential outcomes 10 of using the investigational drug, biological product, or 11 device and a realistic description of the most likely outcome. 12 The description shall include the possibility that new, 13 unanticipated, different, or worse symptoms might result 14 and that death could be hastened by use of the proposed 15 investigational drug, biological product, or device. The 16 description shall be based on the a treating physician’s 17 knowledge of the proposed investigational drug, biological 18 product, or device in conjunction with an awareness of the 19 patient’s condition. 20 Sec. 6. Section 144E.4, Code 2022, is amended by adding the 21 following new subsection: 22 NEW SUBSECTION . 5. This chapter does not create a duty 23 for a hospital licensed under chapter 135B to credential any 24 physician. 25 Sec. 7. Section 144E.8, subsection 1, Code 2022, is amended 26 to read as follows: 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 , against a physician, health care 30 practitioner, or facility that provides necessary follow-up 31 care, or against any other person or entity involved in the 32 care of an eligible patient using the investigational drug, 33 biological product, or device for any harm done to the eligible 34 patient resulting from the investigational drug, biological 35 -2- HF 2203 (4) 89 pf/rh/md 2/ 4
H.F. 2203 product, or device, if the manufacturer or other person or 1 entity is complying in good faith with the terms of this 2 chapter and has exercised reasonable care. 3 Sec. 8. Section 144E.9, Code 2022, is amended to read as 4 follows: 5 144E.9 Assisting suicide. 6 This chapter shall not be construed to allow a patient’s 7 treating physician to assist the a patient in committing or 8 attempting to commit suicide as prohibited in section 707A.2 . 9 Sec. 9. Section 686D.6, Code 2022, is amended to read as 10 follows: 11 686D.6 Liability of and disciplinary actions against health 12 care providers. 13 1. A health care provider shall not be liable for civil 14 damages or subject to disciplinary action by the health 15 care provider’s licensing board for causing or contributing, 16 directly or indirectly, to the death or injury of an individual 17 as a result of the health care provider’s acts or omissions 18 while providing or arranging health care in support of the 19 state’s response to COVID-19. This subsection shall apply to 20 all of the following: 21 a. Injury or death resulting from screening, assessing, 22 diagnosing, caring for, or treating individuals with a 23 suspected or confirmed case of COVID-19. 24 b. Prescribing, administering, or dispensing a 25 pharmaceutical for off-label use to treat a patient with a 26 suspected or confirmed case of COVID-19. 27 c. Acts or omissions while providing health care to 28 individuals unrelated to COVID-19 when those acts or omissions 29 support the state’s response to COVID-19, including any of the 30 following: 31 (1) Delaying or canceling nonurgent or elective dental, 32 medical, or surgical procedures, or altering the diagnosis or 33 treatment of an individual in response to any federal or state 34 statute, regulation, order, or public health guidance. 35 -3- HF 2203 (4) 89 pf/rh/md 3/ 4
H.F. 2203 (2) Diagnosing or treating patients outside the normal 1 scope of the health care provider’s license or practice. 2 (3) Using medical devices, equipment, or supplies outside 3 of their normal use for the provision of health care, including 4 using or modifying medical devices, equipment, or supplies for 5 an unapproved use. 6 (4) Conducting tests or providing treatment to any 7 individual outside the premises of a health care facility. 8 (5) Acts or omissions undertaken by a health care provider 9 because of a lack of staffing, facilities, medical devices, 10 equipment, supplies, or other resources attributable to 11 COVID-19 that renders the health care provider unable to 12 provide the level or manner of care to any person that 13 otherwise would have been required in the absence of COVID-19. 14 (6) Acts or omissions undertaken by a health care provider 15 relating to use or nonuse of personal protective equipment. 16 2. This section shall not relieve any person of liability 17 for civil damages or a health care provider from disciplinary 18 action by the health care provider’s licensing board for any 19 act or omission which constitutes recklessness or willful 20 misconduct. 21 Sec. 10. EFFECTIVE DATE. This Act, being deemed of 22 immediate importance, takes effect upon enactment. 23 -4- HF 2203 (4) 89 pf/rh/md 4/ 4