(1) In order for a patient to access an individualized investigational treatment under this subchapter, a physician shall document in the patient's medical record and chart that the patient:(1) Has a life-threatening or severely debilitating illness;(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration;(3) Has received a recommendation from the physician for an individualized investigational treatment based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins, or metabolites;(4) (A) Has given written, informed consent for the use of the individualized investigational treatment.(B) If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide written, informed consent on the patient's behalf.(C) The written, informed consent shall include at a minimum:(i) An explanation of the currently approved products and treatments for the disease or condition of which the patient suffers;(ii) An attestation that the patient, or if the patient is a minor or lacks the mental capacity to concur, a parent or legal guardian, concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;(iii) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use;(iv) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome, including without limitation the possibility that new, unanticipated, different, or worse symptoms might result, and that death could be hastened by the individualized investigational treatment, which is based on the physician's knowledge of the individualized investigational treatment in conjunction with an awareness of the patient's condition;(v) 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 individualized investigational treatment, unless the patient's health plan or third-party administrator and provider are specifically required to do so by law or contract;(vi) A statement that the patient's eligibility for hospice care may be withdrawn if the patient receives an individualized investigational treatment and that hospice care may be reinstated if the individualized investigational treatment ends and the patient meets hospice eligibility requirements; and(vii) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the individualized investigational treatment states otherwise; and(5) Has received written documentation from a physician that the patient meets the requirements of this subchapter.
(1) Has a life-threatening or severely debilitating illness;
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration;
(3) Has received a recommendation from the physician for an individualized investigational treatment based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins, or metabolites;
(4) (A) Has given written, informed consent for the use of the individualized investigational treatment.(B) If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide written, informed consent on the patient's behalf.(C) The written, informed consent shall include at a minimum:(i) An explanation of the currently approved products and treatments for the disease or condition of which the patient suffers;(ii) An attestation that the patient, or if the patient is a minor or lacks the mental capacity to concur, a parent or legal guardian, concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;(iii) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use;(iv) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome, including without limitation the possibility that new, unanticipated, different, or worse symptoms might result, and that death could be hastened by the individualized investigational treatment, which is based on the physician's knowledge of the individualized investigational treatment in conjunction with an awareness of the patient's condition;(v) 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 individualized investigational treatment, unless the patient's health plan or third-party administrator and provider are specifically required to do so by law or contract;(vi) A statement that the patient's eligibility for hospice care may be withdrawn if the patient receives an individualized investigational treatment and that hospice care may be reinstated if the individualized investigational treatment ends and the patient meets hospice eligibility requirements; and(vii) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the individualized investigational treatment states otherwise; and
(A) Has given written, informed consent for the use of the individualized investigational treatment.
(B) If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide written, informed consent on the patient's behalf.
(C) The written, informed consent shall include at a minimum:(i) An explanation of the currently approved products and treatments for the disease or condition of which the patient suffers;(ii) An attestation that the patient, or if the patient is a minor or lacks the mental capacity to concur, a parent or legal guardian, concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;(iii) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use;(iv) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome, including without limitation the possibility that new, unanticipated, different, or worse symptoms might result, and that death could be hastened by the individualized investigational treatment, which is based on the physician's knowledge of the individualized investigational treatment in conjunction with an awareness of the patient's condition;(v) 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 individualized investigational treatment, unless the patient's health plan or third-party administrator and provider are specifically required to do so by law or contract;(vi) A statement that the patient's eligibility for hospice care may be withdrawn if the patient receives an individualized investigational treatment and that hospice care may be reinstated if the individualized investigational treatment ends and the patient meets hospice eligibility requirements; and(vii) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the individualized investigational treatment states otherwise; and
(i) An explanation of the currently approved products and treatments for the disease or condition of which the patient suffers;
(ii) An attestation that the patient, or if the patient is a minor or lacks the mental capacity to concur, a parent or legal guardian, concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;
(iii) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use;
(iv) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome, including without limitation the possibility that new, unanticipated, different, or worse symptoms might result, and that death could be hastened by the individualized investigational treatment, which is based on the physician's knowledge of the individualized investigational treatment in conjunction with an awareness of the patient's condition;
(v) 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 individualized investigational treatment, unless the patient's health plan or third-party administrator and provider are specifically required to do so by law or contract;
(vi) A statement that the patient's eligibility for hospice care may be withdrawn if the patient receives an individualized investigational treatment and that hospice care may be reinstated if the individualized investigational treatment ends and the patient meets hospice eligibility requirements; and
(vii) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the individualized investigational treatment states otherwise; and
(5) Has received written documentation from a physician that the patient meets the requirements of this subchapter.