Bill Text: IA HF2231 | 2015-2016 | 86th General Assembly | Introduced
Bill Title: A bill for an act concerning the use of experimental treatments for patients with a terminal illness.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2016-02-15 - Subcommittee, Forristall, McConkey, and T. Moore. H.J. 225. [HF2231 Detail]
Download: Iowa-2015-HF2231-Introduced.html
House File 2231 - Introduced HOUSE FILE BY R. TAYLOR A BILL FOR 1 An Act concerning the use of experimental treatments for 2 patients with a terminal illness. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: TLSB 5612YH (3) 86 rh/nh PAG LIN 1 1 Section 1. NEW SECTION. 144E.1 Title. 1 2 This chapter shall be known and may be cited as the "Right 1 3 to Try Act". 1 4 Sec. 2. NEW SECTION. 144E.2 Definitions. 1 5 As used in this chapter: 1 6 1. "Eligible patient" means an individual who meets all of 1 7 the following conditions: 1 8 a. Has a terminal illness, attested to by the patient's 1 9 treating physician. 1 10 b. Has considered all other treatment options approved by 1 11 the United States food and drug administration. 1 12 c. Has received a recommendation from the individual's 1 13 physician for an investigational drug, biological product, or 1 14 device. 1 15 d. Has given written informed consent for the use of the 1 16 investigational drug, biological product, or device. 1 17 e. Has documentation from the individual's physician that 1 18 the individual meets the requirements of this subsection. 1 19 2. "Investigational drug, biological product, or device" 1 20 means a drug, biological product, or device that has 1 21 successfully completed phase 1 of a United States food and drug 1 22 administration=approved clinical trial but has not yet been 1 23 approved for general use by the United States food and drug 1 24 administration and remains under investigation in a United 1 25 States food and drug administration=approved clinical trial. 1 26 3. "Terminal illness" means a progressive disease or medical 1 27 or surgical condition that entails significant functional 1 28 impairment, that is not considered by a treating physician to 1 29 be reversible even with administration of treatments approved 1 30 by the United States food and drug administration, and that, 1 31 without life=sustaining procedures, will soon result in death. 1 32 4. "Written informed consent" means a written document that 1 33 is signed by the patient, a parent of a minor patient, or a 1 34 legal guardian or other legal representative of the patient and 1 35 attested to by the patient's treating physician and a witness 2 1 and that includes all of the following: 2 2 a. An explanation of the products and treatments approved by 2 3 the United States food and drug administration for the disease 2 4 or condition from which the patient suffers. 2 5 b. An attestation that the patient concurs with the 2 6 patient's treating physician in believing that all products 2 7 and treatments approved by the United States food and drug 2 8 administration are unlikely to prolong the patient's life. 2 9 c. Clear identification of the specific proposed 2 10 investigational drug, biological product, or device that the 2 11 patient is seeking to use. 2 12 d. A description of the best and worst potential outcomes 2 13 of using the investigational drug, biological product, or 2 14 device and a realistic description of the most likely outcome. 2 15 The description shall include the possibility that new, 2 16 unanticipated, different, or worse symptoms might result 2 17 and that death could be hastened by use of the proposed 2 18 investigational drug, biological product, or device. The 2 19 description shall be based on the treating physician's 2 20 knowledge of the proposed investigational drug, biological 2 21 product, or device in conjunction with an awareness of the 2 22 patient's condition. 2 23 e. A statement that the patient's health plan or third=party 2 24 administrator and provider are not obligated to pay for any 2 25 care or treatments consequent to the use of the investigational 2 26 drug, biological product, or device, unless they are 2 27 specifically required to do so by law or contract. 2 28 f. A statement that the patient's eligibility for hospice 2 29 care may be withdrawn if the patient begins curative treatment 2 30 with the investigational drug, biological product, or device 2 31 and that care may be reinstated if this treatment ends and the 2 32 patient meets hospice eligibility requirements. 2 33 g. A statement that the patient understands that the 2 34 patient is liable for all expenses consequent to the use of 2 35 the investigational drug, biological product, or device and 3 1 that this liability extends to the patient's estate unless 3 2 a contract between the patient and the manufacturer of the 3 3 investigational drug, biological product, or device states 3 4 otherwise. 3 5 Sec. 3. NEW SECTION. 144E.3 Manufacturer rights. 3 6 1. A manufacturer of an investigational drug, biological 3 7 product, or device may make available and an eligible patient 3 8 may request the manufacturer's investigational drug, biological 3 9 product, or device under this chapter. This chapter does not 3 10 require a manufacturer of an investigational drug, biological 3 11 product, or device to provide or otherwise make available the 3 12 investigational drug, biological product, or device to an 3 13 eligible patient. 3 14 2. A manufacturer described in subsection 1 may do any of 3 15 the following: 3 16 a. Provide an investigational drug, biological product, or 3 17 device to an eligible patient without receiving compensation. 3 18 b. Require an eligible patient to pay the costs of, or the 3 19 costs associated with, the manufacture of the investigational 3 20 drug, biological product, or device. 3 21 Sec. 4. NEW SECTION. 144E.4 Treatment coverage. 3 22 1. This chapter does not expand the coverage required of an 3 23 insurer under Title XIII, subtitle 1. 3 24 2. A health plan, third=party administrator, or 3 25 governmental agency may provide coverage for the cost of an 3 26 investigational drug, biological product, or device, or the 3 27 cost of services related to the use of an investigational drug, 3 28 biological product, or device under this chapter. 3 29 3. This chapter does not require any governmental agency 3 30 to pay costs associated with the use, care, or treatment of a 3 31 patient with an investigational drug, biological product, or 3 32 device. 3 33 4. This chapter does not require a hospital licensed under 3 34 chapter 135B or other health care facility to provide new or 3 35 additional services. 4 1 Sec. 5. NEW SECTION. 144E.5 Heirs not liable for treatment 4 2 debts. 4 3 If a patient dies while being treated by an investigational 4 4 drug, biological product, or device, the patient's heirs are 4 5 not liable for any outstanding debt related to the treatment 4 6 or lack of insurance due to the treatment, unless otherwise 4 7 required by law. 4 8 Sec. 6. NEW SECTION. 144E.6 Provider recourse. 4 9 1. The board of medicine created under chapter 147 shall 4 10 not revoke, fail to renew, suspend, or take any action 4 11 against a physician's license based solely on the physician's 4 12 recommendations to an eligible patient regarding access to or 4 13 treatment with an investigational drug, biological product, or 4 14 device. 4 15 2. To the extent consistent with federal law, an entity 4 16 responsible for Medicare certification shall not take action 4 17 against a physician's Medicare certification based solely on 4 18 the physician's recommendation that a patient have access to an 4 19 investigational drug, biological product, or device. 4 20 Sec. 7. NEW SECTION. 144E.7 State interference. 4 21 An official, employee, or agent of this state shall not 4 22 block or attempt to block an eligible patient's access to 4 23 an investigational drug, biological product, or device. 4 24 Counseling, advice, or a recommendation consistent with medical 4 25 standards of care from a licensed physician is not a violation 4 26 of this section. 4 27 Sec. 8. NEW SECTION. 144E.8 Private cause of action. 4 28 1. This chapter shall not create a private cause of 4 29 action against a manufacturer of an investigational drug, 4 30 biological product, or device or against any other person 4 31 or entity involved in the care of an eligible patient using 4 32 the investigational drug, biological product, or device 4 33 for any harm done to the eligible patient resulting from 4 34 the investigational drug, biological product, or device, if 4 35 the manufacturer or other person or entity is complying in 5 1 good faith with the terms of this chapter and has exercised 5 2 reasonable care. 5 3 2. This chapter shall not affect any mandatory health care 5 4 coverage for participation in clinical trials under Title XIII, 5 5 subtitle 1. 5 6 EXPLANATION 5 7 The inclusion of this explanation does not constitute agreement with 5 8 the explanation's substance by the members of the general assembly. 5 9 This bill, titled the "Right to Try Act", permits 5 10 manufacturers of investigational drugs, biological products, or 5 11 devices to make available, and eligible patients with terminal 5 12 illnesses to attempt treatment with, an investigational 5 13 drug, biological product, or device as long as they provided 5 14 written informed consent. The bill defines the terms "eligible 5 15 patient", "terminal illness", "investigational drug, biological 5 16 product, or device", and "written informed consent". 5 17 Under the bill, an eligible patient's physician must 5 18 acknowledge that the patient's illness is terminal and 5 19 recommend the patient try an investigational drug, biological 5 20 product, or device. The patient's written informed consent 5 21 must acknowledge that treatments currently approved by the 5 22 United Stated food and drug administration are unlikely to 5 23 prolong the patient's life. It must identify the specific 5 24 treatment sought and the potential best, worst, and expected 5 25 results from the treatment. It must acknowledge that the 5 26 patient's insurance is not required to pay for the treatment 5 27 and that any hospice service may refuse to accept the patient 5 28 after receiving the treatment. It must also acknowledge 5 29 that expenses will be credited to the patient, including the 5 30 patient's estate, unless an agreement with the manufacturer of 5 31 an investigational drug, biological product, or device states 5 32 otherwise. If the patient dies during treatment, the patient's 5 33 heirs are not liable for any remaining debts unless otherwise 5 34 required by law. 5 35 The manufacturer of an investigational drug, biological 6 1 product, or device may charge an eligible patient or provide 6 2 the treatment free of charge. Governmental entities are 6 3 not required to pay costs associated with the use, care, or 6 4 treatment of a patient with an investigational drug, biological 6 5 product, or device. The bill does not require hospitals 6 6 licensed under chapter 135B or other health care facilities to 6 7 provide new or additional services. 6 8 The board of medicine shall not take an adverse action 6 9 against a physician's license solely for recommending an 6 10 investigational drug, biological product, or device for the 6 11 physician's eligible patient. The bill does not create a new 6 12 private cause of action against any person or entity involved 6 13 in the care of an eligible patient using the investigational 6 14 drug, biological product, or device for any harm done to the 6 15 patient resulting from the treatment if the person or entity 6 16 is complying in good faith with the terms of the bill and has 6 17 exercised reasonable care. LSB 5612YH (3) 86 rh/nh
