On Mar. 20, 2025, TN LEG enacted bill SB 282 (HB 192), was signed by the governor.
On Mar. 13, TN LEG passed bill to authorize individual therapy request.
TN LEG passed Bill SB 282 (HB 192) re Individualized investigational treatment act.
The act aims to authorize an eligible patient to be able to request individualized investigative treatments from a provider based on the patient's own genetic profile.
Bill amends Tennessee code annotated, TN LEG 63-6 in order to add a new Part 13.
Investigational Treatment
Enacts Individualized investigational treatment act, which authorizes a manufacturer operating within an eligible facility to make available certain treatments to a patient.
An eligible patient with a life-threatening or severely debilitating illness can request an individualized investigational treatment from eligible facility or operating manufacturer.
Patient must receive a recommendation from their treating physician after considering treatment options and give consent to use related drugs, biological products/devices.
Licensing board or disciplinary subcommittee must not take action against healthcare provider's license based solely on provider's recommendations to an eligible patient.
Entity responsible for Medicare certification must not act against healthcare provider's Medicare certification based on recommendation to have the investigational treatment.
Clarified bill does not expand coverage required of insurer under State insurance laws.
Legislative History
On Jan. 27, 2025, bill introduced in Senate; on Mar. 6, 2025, bill passed in Senate.
On Mar. 6, 2025, bill delivered to House; on Mar. 6, 2025, bill was passed in House.
On Mar. 12, 2025, bill was delivered to governor, and is pending governor's action.
Effectiveness
If approved, Act takes effect Jul. 1, 2025.
Mar. 20, 2025 TN LEG Bill Approval
On Mar. 20, 2025, TN LEG enacted bill SB 282 (HB 192), was signed by the governor.
Regulators
TN LEG
Entity Types
CNSM; Ins
Reference
Act, 3/20/2025; Bill SB0282, HB0192, 3/12/2025; Citation: TN LEG 63-6;
