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HB 413

Health Care - As introduced, authorizes a patient with a severe chronic disease or terminal illness to access, and a physician to recommend, investigational stem cell treatment; requires the commissioner of health to promulgate rules to, among other things, list the medical conditions that constitute a qualifying severe chronic disease or terminal illness. - Amends TCA Title 53; Title 63 and Title 68.

114th Regular Session (2025-2026) Introduced by Susan Lynn

Tennessee bill authorizes patients with severe chronic/terminal illness to access unapproved investigational stem cell treatments with physician recommendation, delegating regulation details to health commissioner.

Action Def. in s/c Health Subcommittee to 3/18/2026
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Bill Summary · HB 413

Legislative bill overview

HB 413 permits patients with severe chronic or terminal diseases to access investigational stem cell treatments that haven't completed FDA approval, with physician recommendation. It requires Tennessee's health commissioner to establish rules defining which medical conditions qualify and presumably set safety/oversight standards for these treatments.

Why is this important

This bill addresses the "right to try" debate—balancing patient autonomy to pursue experimental hope against consumer protection from unproven or fraudulent treatments. Stem cell therapy is a rapidly evolving field with genuine research promise but also significant history of unregulated clinics making unfounded claims to desperate patients, particularly for conditions like spinal cord injury and Parkinson's disease.

Potential points of contention

  • Regulatory clarity: The bill delegates extensive authority to the health commissioner without specifying what safety standards, informed consent requirements, or tracking mechanisms must exist, creating ambiguity about actual protections
  • "Investigational" definition: Unclear whether treatments must have any clinical trial data or FDA engagement, or if any unproven stem cell procedure qualifies, potentially enabling predatory practitioners
  • Patient vulnerability: Terminally and chronically ill patients may have reduced capacity to make fully informed decisions, raising ethical concerns about exploitation regardless of legal access

Compiled from official sources — confirm details with the bill’s official record.

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