PATIENT ELIGIBILITY.

A patient is eligible to access and use an investigational drug, biological product, or device under this chapter if:

(1) the patient has a severe chronic disease the commissioner designates under Section 490.002 that the patient's treating physician confirms in writing;

(2) the use of the investigational drug, biological product, or device is consistent with this chapter and rules adopted under this chapter; and

(3) the patient's physician:

(A) in consultation with the patient, considers all other treatment options the United States Food and Drug Administration has currently approved and determines those treatment options are unavailable or unlikely to provide relief for the significant impairment or severe pain associated with the patient's severe chronic disease; and

(B) recommends or prescribes in writing the patient's use of a specific class of investigational drug, biological product, or device.