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SB 152

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 Mark Pody

Allows eligible patients with severe chronic or terminal illnesses to access investigational stem cell treatments under physician recommendation and regulated conditions.

Rcvd. from S., held on H. desk.
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Bill Summary · SB 152

Summary of Bill: SB 152 (Session 114, Tennessee)

Purpose and Intent

  • Establishes a framework for access to investigational stem cell treatments for patients with severe chronic diseases or terminal illnesses.
  • Allows eligible patients to access and physicians to recommend an investigational stem cell treatment that is not yet FDA-approved, under regulated conditions.

Key Provisions and Changes

  • New Definitions (63-6-901):

    • Introduces new terms for this part:
    • “Investigational stem cell treatment”: adult stem cell treatment under a clinical trial and not FDA-approved for general use.
    • “Severe chronic disease”: a condition that may be treated, is never cured/eliminated, and causes significant functional impairment or severe pain.
    • “Terminal illness”: advanced disease with unfavorable prognosis where life-sustaining measures won’t result in recovery, or leads to permanent unconsciousness unlikely to recover.
    • Defines “Commissioner” as Tennessee’s Commissioner of Health.
    • Defines “Governmental entity” as the state or its agencies/subdivisions.

  • Patient Eligibility (63-6-902):

    • An eligible patient may access an investigational stem cell treatment if: 1) The patient has a severe chronic disease or terminal illness listed in the rules adopted under § 63-6-907 and certified by the treating physician. 2) The treating physician:
      • Has, after discussing all FDA-approved options, determined those options are unavailable or unlikely to alleviate the patient’s condition.
      • Has written a recommendation or prescription for a specific class of investigational stem cell treatment.

  • Informed Consent (63-6-903):

    • Written informed consent is required before receiving treatment.
    • If the patient is a minor or lacks mental capacity, a parent/guardian/conservator may consent.
    • The commissioner may develop a standard informed-consent form for physicians.

  • Relation to Other Law (63-6-904):

    • Does not affect existing coverage for enrollees in clinical trials under specific state law.
    • Does not authorize violations related to fetal tissue, fetal stem cells, adult stem cells, or human organs.

  • Licensing Protections (63-6-905):

    • Board of Medical Examiners and Board of Osteopathic Examination cannot revoke/suspend/deny a physician’s license solely because of recommendations for investigational stem cell treatments, provided care/recommendations meet the standard of care under this part.

  • Non-Interference by Government (63-6-906):

    • Government entities and officials cannot interfere with an eligible patient’s access to or use of an authorized investigational stem cell treatment.

  • Rules Authority (63-6-907):

    • The Commissioner must promulgate rules to implement this part, including designating the medical conditions that qualify as severe chronic disease or terminal illness, under the Uniform Administrative Procedures Act.

  • Effective Date:

    • Takes effect upon becoming law.

Affected Parties

  • Patients: Individuals with severe chronic diseases or terminal illnesses who have exhausted FDA-approved options and receive a physician’s written recommendation for a specific class of investigational stem cell treatment.
  • Physicians: May recommend or prescribe investigational stem cell treatments to eligible patients, provided standards are met.
  • Physician Licensure Boards: Protected from discipline solely for recommending such treatments if standards are followed.
  • Commissioner of Health: Responsible for rulemaking and developing informed-consent forms.
  • Governmental Entities: Restricted from interfering with eligible patients’ access to treatment.

Procedural and Timeline Aspects

  • The Commissioner has a defined rulemaking role to:
    • Designate qualifying medical conditions.
    • Develop an informed-consent form.
    • Establish procedures under the Uniform Administrative Procedures Act.
  • The act relies on the rulemaking process to operationalize eligibility criteria and eligible conditions.
  • Fiscal impact noted as not significant; expected to use existing resources without requiring new expenditures. No mandated insurance coverage for investigational treatments is created.

Fiscal Impact

  • Described as not significant.
  • Assumptions include:
    • Rulemaking and consent form development can be done with existing resources.
    • No impact on the Board of Medical Examiners or Board of Osteopathic Examination operations.
    • No requirement for health insurers to cover investigational treatments.
    • No significant effect on TennCare or Benefits Administration.

Status and Legislative History

  • Passed Senate: March 31, 2025 (Ayes 30, Nays 0).
  • House: Received from Senate and referred; status shows deliberation at House desk as of April 3, 2025.
  • Sponsors: Primary with Sen. Pody; Co-sponsor: Rep. Lynn (House sponsor).

This summary captures the bill’s core purpose, procedural mechanics, who is affected, and the anticipated fiscal impact based on the available text and the fiscal note. If you’d like, I can provide a one-page briefing for policymakers or a plain-language Q&A for patients and physicians.

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

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