1. A physician may prescribe or recommend an individualized investigational treatment or investigational drug, biological product or device to a patient if the physician has:
(a)Diagnosed the patient with a life-threatening or severely debilitating disease or condition;
(b)Discussed with the patient all available methods of treating the life-threatening or severely debilitating disease or condition that have been approved by the United States Food and Drug Administration and the patient and the physician have determined that no such method of treatment is adequate to treat the life-threatening or severely debilitating disease or condition of the patient;
(c)For an individualized investigational treatment, conducted an analysis of the patient’s genomic sequence, human chromosomes, deoxyr
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1. A physician may prescribe or recommend an individualized investigational treatment or investigational drug, biological product or device to a patient if the physician has:
(a) Diagnosed the patient with a life-threatening or severely debilitating disease or condition;
(b) Discussed with the patient all available methods of treating the life-threatening or severely debilitating disease or condition that have been approved by the United States Food and Drug Administration and the patient and the physician have determined that no such method of treatment is adequate to treat the life-threatening or severely debilitating disease or condition of the patient;
(c) For an individualized investigational treatment, conducted an analysis of the patient’s genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products or metabolites or an immunity panel, as applicable to the individualized investigational treatment; and
(d) Obtained informed, written consent to the use of the individualized investigational treatment or investigational drug, biological product or device, as applicable, from:
(1) The patient;
(2) If the patient is incompetent, the representative of the patient; or
(3) If the patient is less than 18 years of age, a parent or legal guardian of the patient.
2. An informed, written consent must be recorded on a form signed by the patient, or the representative or parent or legal guardian of the patient, as applicable. The form must:
(a) To the extent practicable, be in the preferred language of the patient, or the representative or parent or legal guardian of the patient, as applicable.
(b) Be in language that is at the reading level of an eighth grader or a pupil enrolled in a lower grade.
(c) Include or be accompanied by:
(1) An overview of the provisions of this section and NRS 454.690 , including, without limitation, a detailed description of the provisions of subsection 1 and the terms defined in subsection 8;
(2) A comprehensive explanation of all methods of treating the life-threatening or severely debilitating disease or condition of the patient that are currently approved by the United States Food and Drug Administration, including, without limitation, information concerning such methods published by the United States Food and Drug Administration, the National Institutes of Health or other federal agencies;
(3) A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, and the physician agree that no such method is likely to adequately treat the life-threatening or severely debilitating disease or condition of the patient;
(4) Clear identification of the specific individualized investigational treatment or investigational drug, biological product or device proposed to treat the life-threatening or severely debilitating disease or condition of the patient;
(5) A detailed description of the consequences of using the individualized investigational treatment or investigational drug, biological product or device, which must include, without limitation:
(I) A detailed description of the best and worst possible outcomes;
(II) A realistic and detailed description of the most likely outcome, in the opinion of the physician;
(III) A detailed description of relevant information that is not known about the individualized investigational treatment or investigational drug, biological product or device; and
(IV) A statement of the possibility that using the individualized investigational treatment or investigational drug, biological product or device may result in new, unanticipated, different or worse symptoms or the death of the patient occurring sooner than if the individualized investigational treatment or investigational drug, biological product or device is not used and a detailed description of any known new, different or worse symptoms the patient may suffer;
(6) A statement of the rights of the patient, including, without limitation, the rights to:
(I) Make an informed decision concerning the use of the individualized investigational treatment or investigational drug, biological product or device; and
(II) Withdraw from or refuse treatment using the individualized investigational treatment or investigational drug, biological product or device at any time;
(7) Information concerning resources that may be useful to the patient, including, without limitation, the contact information for agencies or organizations that may be able to provide support to the patient;
(8) A means by which the patient may contact the manufacturer of the individualized investigational treatment or investigational drug, biological product or device with any additional questions or concerns;
(9) A statement that a health insurer of the patient may not be required to pay for care or treatment of any condition resulting from the use of the individualized investigational treatment or investigational drug, biological product or device unless such care or treatment is specifically included in the policy of insurance covering the patient and that future benefits under the policy of insurance covering the patient may be affected by the patient’s use of the individualized investigational treatment or investigational drug, biological product or device; and
(10) A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, understands that the patient is liable for all costs resulting from the use of the individualized investigational treatment or investigational drug, biological product or device, including, without limitation, costs resulting from care or treatment of any condition resulting from the use of the individualized investigational treatment or investigational drug, biological product or device, and that such liability will be passed on to the estate of the patient upon the death of the patient.
3. A physician who prescribes or recommends an individualized investigational treatment or investigational drug, biological product or device to a patient shall provide to the patient a form that:
(a) To the extent practicable, is in the preferred language of the patient; and
(b) Contains:
(1) The name of the individualized investigational treatment or investigational drug, biological product or device;
(2) The instructions for use and, where applicable, the recommended dosage of the individualized investigational treatment or investigational drug, biological product or device;
(3) Where applicable, the investigational new drug number assigned by the United States Food and Drug Administration;
(4) The telephone number for the hotline established pursuant to subsection 4 of NRS 454.690 ;
(5) The contact information, telephone number, hours of operation and physical address of an emergency room or urgent care facility that is easily accessible to the patient if the patient experiences an adverse effect or symptom; and
(6) Any other information concerning the individualized investigational treatment or investigational drug, biological product or device that is relevant to the care of the patient.
4. Not later than 72 hours after the death or hospitalization of a patient which results from the use of an individualized investigational treatment or investigational drug, biological product or device, the physician who prescribed or recommended the individualized investigational treatment or investigational drug, biological product or device shall notify the Board.
5. On or before January 31 of each odd-numbered year, the Board shall submit to the Director of the Legislative Counsel Bureau for transmittal to the next regular session of the Legislature a summary of the information reported to the Board pursuant to subsection 4 and subsection 4 of NRS 454.690 during the immediately preceding biennium.
6. A physician is not subject to disciplinary action for prescribing or recommending an individualized investigational treatment or investigational drug, biological product or device when authorized to do so pursuant to subsection 1.
7. The Board may adopt regulations to ensure the safety and efficacy of individualized investigational treatments and investigational drugs, biological products and devices prescribed or recommended pursuant to this section.
8. As used in this section:
(a) “Individualized investigational treatment” has the meaning ascribed to it in NRS 454.690 .
(b) “Investigational drug, biological product or device” has the meaning ascribed to it in NRS 454.690 .
(c) “Life-threatening disease or condition” has the meaning ascribed to it in NRS 454.690 .
(d) “Severely debilitating disease or condition” has the meaning ascribed to it in NRS 454.690 .