(1) An eligible patient may obtain an investigational drug through an agreement with the investigational drug's manufacturer and the eligible patient's physician that provides: (a) for the transfer of the investigational drug from the manufacturer to the physician; and (b) that the physician will administer the investigational drug to the patient.
(a) for the transfer of the investigational drug from the manufacturer to the physician; and
(b) that the physician will administer the investigational drug to the patient.
(2) An eligible patient may obtain an investigational device through an agreement with the investigational device's manufacturer and the eligible patient's physician that provides: (a) for the transfer of the investigational device from the manufacturer to the physician; and (b) that the physician will use the investigational device to treat the patient.
(a) for the transfer of the investigational device from the manufacturer to the physician; and
(b) that the physician will use the investigational device to treat the patient.
(3) An agreement described in Subsection (1) or (2), between an eligible patient, a physician, and a manufacturer, shall include an informed consent document that, based on the physician's knowledge of the relevant investigational drug or investigational device: (a) describes the possible positive and negative outcomes the eligible patient could experience if the physician treats the eligible patient with the investigational drug or investigational device, including that the investigational drug or investigational device could increase the possibility of death; (b) states that an insurer is not required to cover the cost of providing the investigational drug or investigational device to the patient; (c) states that, subject to Section 58-85-105, an insurer may deny coverage for the eligible patient; and (d) states that the patient may be liable for all expenses caused by the physician treating the patient with the investigational drug or investigational device, unless the agreement provides otherwise.
(a) describes the possible positive and negative outcomes the eligible patient could experience if the physician treats the eligible patient with the investigational drug or investigational device, including that the investigational drug or investigational device could increase the possibility of death;
(b) states that an insurer is not required to cover the cost of providing the investigational drug or investigational device to the patient;
(c) states that, subject to Section 58-85-105, an insurer may deny coverage for the eligible patient; and
(d) states that the patient may be liable for all expenses caused by the physician treating the patient with the investigational drug or investigational device, unless the agreement provides otherwise.
(4) A physician or an eligible patient shall notify the eligible patient's insurer of the day on which the physician treated an eligible patient with an investigational drug or investigational device, and the investigational drug or device used, under an agreement described in Subsection (1) or (2).
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with easy access to affordable legal services through a network of independent law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our network law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.