HB 413 / SB 152

This bill creates a new part in Tennessee law authorizing patients with a qualifying severe chronic disease or terminal illness to obtain investigational adult stem-cell treatments that have not yet received full FDA approval. To qualify, a patient’s treating physician must attest that all other FDA-approved options have been considered and found unavailable or unlikely to provide meaningful benefit, and must recommend in writing a specific class of investigational stem-cell therapy. Patients (or their guardians) must sign a written informed-consent form, which the Department of Health may provide by rule.

Physicians who meet the standard of care and follow the part’s requirements are protected from disciplinary action—licensure boards may not revoke, suspend, or refuse to renew a license solely for recommending or prescribing these investigational treatments. Likewise, state or local government entities—and their officers, employees, or agents—are prohibited from interfering with eligible patients’ access to the authorized therapies. The Department of Health must adopt rules under the Uniform Administrative Procedures Act to designate which diseases qualify as severe chronic diseases or terminal illnesses.

By prohibiting licensure sanctions and government interference, the measure strengthens the doctor-patient relationship and expands medical freedom within Tennessee’s police powers. It does not mandate insurance coverage, alter existing fetal-tissue or human-organ regulations, or impose new spending obligations on state agencies. The bill takes effect immediately upon enactment.