SB 152

PATIENT ELIGIBILITY This bill authorizes a patient to access and use an investigational stem cell treatment , which is under investi gation in a clinical trial to human participants and h as not yet been approved for general use by the United States food and drug administration (FDA) ; if all of the following criteria is met:  The patient has a severe chronic disease or terminal illness that is listed in the rules adopted by the commissioner of health ("commissioner"") and attested to by the patient's treating physician .  The patient's treating physician (i) i n consultation with the patient, has considered all other treatment options currently approved by the FDA and determined that those treatment options are unavailable or unlikely to alleviate the significant impairment or severe pain associated with the severe chronic disease or terminal illness; and (ii) h as recommended or prescribed in writing that the patient use a specific class of investigational stem cell treatment. INFORMED CONSENT Before receiving an investigational stem cell treatment, this bill requires an eligible patient to sign a written informed consent. If the patient i s a minor or lacks the mental capacity to provide informed consent, then a parent, guardian, or conservator may provide informed consent on the patient's behalf. This bill authorizes t he commissioner to develop and make available to physicians a form for such informed consent. EFFECT ON OTHER LAW This bill clarifies that it does not (i) affect the insurance coverage of enrollees in clinical trials or (ii) affect or authorize a person to violate any law regulating the possession, use, or transfer of feta l tissue, fetal stem cells, adult stem cells, or human organs. PROHIBITED ACTIONS This bill prohibits the board of medical examiners and the board of osteopathic examination from revok ing, fail ing to renew, suspend ing, or tak ing action against a physician's license based solely on the physician's recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment if the care provided or recommendations made to the patient meet the standard of care and the requirements of this bill . This bill also prohibits a governmental entity or an officer, employee, or agent of a governmental entity from interfer ing with an eligible patient's access to, or use of, an investigational stem cell treatment authorized under this bill . RULEMAKING This bill requires the commissioner to promulgate rules to effectuate this bill . Such rules must include designating the medical conditions that constitute a severe chronic disease or terminal illness for purposes of this bill ."