§ 21-2B-01

(a) In this subtitle the following words have the meanings indicated.

(b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article.

(c) “Eligible facility” means an institution operating under a federalwide assurance for the protection of human subjects in accordance with 42 U.S.C. § 289(a) and 28 C.F.R. Part 46.

(d) “Eligible patient” means an individual who:

(1) Has a life–threatening or severely debilitating illness, attested to by the individual’s treating physician;

(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration;

(3) Has received a recommendation from the individual’s physician for an individualized investigational treatment based on analysis of the individual’s genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products, including enzymes and other types of proteins, or metabolites;

(4) (i) Has given informed consent for the use of the individualized investigational treatment; or

(ii) If the individual is a minor or lacks the mental capacity to provide informed consent, has a parent or legal guardian who has given informed consent on the individual’s behalf for the use of the individualized investigational treatment; and

(5) Has documentation from the individual’s physician that the individual meets the requirements of items (1) through (4) of this subsection.

(e) “Health occupations board” means a board established under the Health Occupations Article that issues licenses to practice a health occupation in the State.

(f) (1) “Individualized investigational treatment” means a drug, biological product, or device that is unique to and produced exclusively for use by an individual based on the genetic profile of the individual.

(2) “Individualized investigational treatment” includes individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines.

(g) “Informed consent” means a written document prepared using the informed consent form developed by the Office of the Attorney General in accordance with § 21–2B–02(b)(1) of this subtitle that:

(1) Is signed by the patient or a parent or legal guardian of the patient;

(2) Is attested to by the patient’s treating physician and a witness; and

(3) At a minimum:

(i) Explains the currently approved products and treatments for the life–threatening or severely debilitating illness from which the patient suffers, including alternative procedures or courses of treatment, if known to the treating physician, that might be advantageous to the patient;

(ii) Attests to the fact that the patient concurs with the patient’s treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life;

(iii) Identifies clearly the specific proposed individualized investigational treatment that the patient is seeking to use;

(iv) Informs the provider and eligible patient of any known, anticipated, or reasonably foreseeable side effects, risks, or reported patient discomfort that is likely related to the treatment;

(v) Describes the best and worst potential outcomes of using the individualized investigational treatment with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment, based on the treating physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition;

(vi) Makes clear that the patient’s carrier and health care provider are not obligated to pay for any care or treatments that are necessary as a result of the use of the individualized investigational treatment except as required by federal or State law or contract;

(vii) Makes clear that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational treatment and that hospice care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements;

(viii) States that the patient understands that the patient may be liable for all expenses relating to the use of the individualized investigational treatment and that this liability extends to the patient’s estate, but not the heirs or legatees of the patient; and

(ix) Includes a statement describing the extent to which confidentiality of records that identify the patient will be maintained.

(h) “Life–threatening” has the meaning stated in 21 C.F.R. § 312.81.

(i) “Severely debilitating” has the meaning stated in 21 C.F.R. § 312.81.