Senate File 404 - Enrolled Senate File 404 AN ACT RELATING TO THE USE OF EXPERIMENTAL TREATMENTS FOR PATIENTS WITH A TERMINAL ILLNESS. BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: Section 1. NEW SECTION . 144E.1 Title. This chapter shall be known and may be cited as the “Right to Try Act” . Sec. 2. NEW SECTION . 144E.2 Definitions. As used in this chapter: 1. “Eligible patient” means an individual who meets all of the following conditions: a. Has a terminal illness, attested to by the patient’s treating physician. b. Has considered and rejected or has tried and failed to respond to all other treatment options approved by the United States food and drug administration. c. Has received a recommendation from the individual’s physician for an investigational drug, biological product, or device. d. Has given written informed consent for the use of the investigational drug, biological product, or device. e. Has documentation from the individual’s physician that the individual meets the requirements of this subsection. 2. “Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed phase 1 of a United States food and drug

Senate File 404, p. 2 administration-approved clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial. 3. “Terminal illness” means a progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of treatments approved by the United States food and drug administration, and that, without life-sustaining procedures, will result in death. 4. “Written informed consent” means a written document that is signed by the patient, a parent of a minor patient, or a legal guardian or other legal representative of the patient and attested to by the patient’s treating physician and a witness and that includes all of the following: a. An explanation of the products and treatments approved by the United States food and drug administration for the disease or condition from which the patient suffers. b. An attestation that the patient concurs with the patient’s treating physician in believing that all products and treatments approved by the United States food and drug administration are unlikely to prolong the patient’s life. c. Clear identification of the specific proposed investigational drug, biological product, or device that the patient is seeking to use. d. A description of the best and worst potential outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by use of the proposed investigational drug, biological product, or device. The description shall be based on the treating physician’s knowledge of the proposed investigational drug, biological product, or device in conjunction with an awareness of the patient’s condition. e. A statement that the patient’s health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational

Senate File 404, p. 3 drug, biological product, or device, unless they are specifically required to do so by law or contract. f. A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements. g. A statement that the patient understands that the patient is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that this liability extends to the patient’s estate unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise. Sec. 3. NEW SECTION . 144E.3 Manufacturer rights. 1. A manufacturer of an investigational drug, biological product, or device may make available and an eligible patient may request the manufacturer’s investigational drug, biological product, or device under this chapter. This chapter does not require a manufacturer of an investigational drug, biological product, or device to provide or otherwise make available the investigational drug, biological product, or device to an eligible patient. 2. A manufacturer described in subsection 1 may do any of the following: a. Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation. b. Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device. Sec. 4. NEW SECTION . 144E.4 Treatment coverage. 1. This chapter does not expand the coverage required of an insurer under Title XIII, subtitle 1. 2. A health plan, third-party administrator, or governmental agency may provide coverage for the cost of an investigational drug, biological product, or device, or the cost of services related to the use of an investigational drug, biological product, or device under this chapter. 3. This chapter does not require any governmental agency

Senate File 404, p. 4 to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device. 4. This chapter does not require a hospital licensed under chapter 135B or other health care facility to provide new or additional services. Sec. 5. NEW SECTION . 144E.5 Heirs not liable for treatment debts. If a patient dies while being treated by an investigational drug, biological product, or device, the patient’s heirs are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment, unless otherwise required by law. Sec. 6. NEW SECTION . 144E.6 Provider recourse. 1. To the extent consistent with state law, the board of medicine created under chapter 147 shall not revoke, fail to renew, suspend, or take any action against a physician’s license based solely on the physician’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device. 2. To the extent consistent with federal law, an entity responsible for Medicare certification shall not take action against a physician’s Medicare certification based solely on the physician’s recommendation that a patient have access to an investigational drug, biological product, or device. Sec. 7. NEW SECTION . 144E.7 State interference. An official, employee, or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device. Counseling, advice, or a recommendation consistent with medical standards of care from a licensed physician is not a violation of this section. Sec. 8. NEW SECTION . 144E.8 Private cause of action. 1. This chapter shall not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from

Senate File 404, p. 5 the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this chapter and has exercised reasonable care. 2. This chapter shall not affect any mandatory health care coverage for participation in clinical trials under Title XIII, subtitle 1. Sec. 9. NEW SECTION . 144E.9 Assisting suicide. This chapter shall not be construed to allow a patient’s treating physician to assist the patient in committing or attempting to commit suicide as prohibited in section 707A.2. ______________________________ JACK WHITVER President of the Senate ______________________________ LINDA UPMEYER Speaker of the House I hereby certify that this bill originated in the Senate and is known as Senate File 404, Eighty-seventh General Assembly. ______________________________ W. CHARLES SMITHSON Secretary of the Senate Approved _______________, 2017 ______________________________ TERRY E. BRANSTAD Governor