Tennessee Code Title 63. Professions of the Healing Arts § 63-6-1302

(A) Has a life-threatening or severely debilitating illness, attested to by a treating physician;

(B) Has, in consultation with a treating physician, considered all other treatment options currently approved by the United States food and drug administration;

(C) Has received a recommendation from the treating physician for use of an individualized investigational treatment for treatment of the life-threatening or severely debilitating illness;

(D) Has given written, informed consent for the use of the investigational drug, biological product, or device;  and

(E) Has documentation from the patient's physician that the patient meets the requirements of this subdivision (2);

(A) Means drugs, biological products, or devices that are unique to and produced exclusively for use for an individual patient, based on the patient's own genetic profile;  and

(B) Includes individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines;

(A) An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;

(B) An attestation that the patient concurs with the patient's physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;

(C) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use;

(D) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome.  The description must include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment.  The description must be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition;

(E) A release of liability relative to the treating physician, licensed healthcare providers, hospital, and manufacturer of the individualized investigational treatment;

(F) 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 they are specifically required to do so by law or contract;

(G) A statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational treatment and that care may be reinstated if such treatment ends and the patient meets hospice eligibility requirements;  and

(H) A statement that the patient understands that the patient 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.