ArkansasSB1362025 Regular SessionSenateWALLET

TO CREATE THE RIGHT TO TRY INDIVIDUALIZED INVESTIGATIONAL TREATMENT ACT; AND TO ENSURE THAT PATIENTS HAVE ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT.

Sponsored By: Zack Gramlich (Republican), Justin Boyd (Republican)

Enacted

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Bill Overview

Analyzed Economic Effects

5 provisions identified: 1 benefits, 0 costs, 4 mixed.

New personalized treatment options for patients

Arkansas creates a path to experimental drugs, biological products, or devices made only for one patient using genetic or related biological information. Patients must have a life-threatening illness or one causing major, lasting harm, and must consider all FDA-approved treatments. An Arkansas-licensed physician must recommend the treatment based on that biological information and document eligibility in the medical record. The patient must give written informed consent; a parent or legal guardian can consent for minors or patients lacking mental capacity. Consent must explain approved treatments and state that they are unlikely to prolong life. It must identify the proposed treatment and explain best, worst, and likely outcomes, including worse symptoms or earlier death. Manufacturers must operate within facilities covered by federal human-subject protections anchored to rules in effect on January 1, 2025, with applicable updates.

Patient treatment costs and heirs' protection

Manufacturers or eligible facilities can provide treatment free or charge only actual out-of-pocket manufacturing costs, with no stated dollar cap. Written consent must warn that patients may owe all treatment-related expenses. That debt may reach the patient's estate unless a manufacturer contract says otherwise. If a patient dies during treatment, heirs do not owe outstanding treatment debt to the manufacturer. Consent must also warn that hospice eligibility may end during treatment and may return when treatment ends.

Treatment access protected, provider participation stays voluntary

State agencies and officials cannot block eligible patients from accessing personalized experimental treatment. Participation cannot be grounds for state licensing action against providers or state action against a hospital's Medicare certification. Manufacturers do not have to supply treatment, and licensed medical professionals do not have to participate in related care. Hospitals do not have to add related services unless they approve them. Counseling, advice, and recommendations that follow medical standards do not violate this law.

Treatment participants gain limits on lawsuits

Treatment participants receive protection from civil liability for treatment-related loss, damage, or injury. This includes manufacturers, distributors, prescribers, and care providers. They must substantially follow the law in good faith and use reasonable care. This limits patients' ability to recover damages, but does not protect gross negligence or willful misconduct.

Patients keep coverage, without guaranteed treatment payment

Insurers can cover personalized experimental treatment, but this law does not require them to pay for it. They cannot deny otherwise-covered items or services solely because a patient receives this treatment. Existing coverage duties under law or contract, including required clinical-trial coverage, remain unchanged. Arkansas Medicaid and the Department of Human Services do not have to add coverage or funding. Written consent must explain that health plans, other payers, and providers need not pay unless law or contract requires it.

Sponsors & Cosponsors

Sponsors

  • Zack Gramlich

    Republican • House

  • Justin Boyd

    Republican • Senate

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

All Roll Calls

Yes: 128 • No: 1

House vote • 2/26/2025

House Vote - Wednesday, February 26, 2025 3:19:37 PM

Yes: 95 • No: 1

Senate vote • 2/6/2025

Senate Vote - Thursday, February 6, 2025 10:22:57 AM

Yes: 33 • No: 0

Actions Timeline

  1. Notification that SB136 is now Act 201

    2/27/2025Senate
  2. DELIVERED TO GOVERNOR.

    2/26/2025Senate
  3. Reported correctly enrolled and ordered delivered to the Governor.

    2/26/2025Senate
  4. ORDERED ENROLLED

    2/26/2025Senate
  5. Returned from the House as passed.

    2/26/2025Senate
  6. Returned to the Senate as passed.

    2/26/2025House
  7. Read the third time and passed and ordered transmitted to the Senate.

    2/26/2025House
  8. Returned by the Committee Do Pass

    2/25/2025House
  9. Read the first time, rules suspended, read the second time and referred to the Committee on PUBLIC HEALTH, WELFARE AND LABOR COMMITTEE- HOUSE

    2/6/2025House
  10. RECEIVED FROM THE SENATE

    2/6/2025House
  11. Ordered immediately transmitted to the House.

    2/6/2025Senate
  12. Read the third time and passed.

    2/6/2025Senate
  13. Returned by the Committee, with the recommendation that it Do Pass

    2/5/2025Senate
  14. Read first time, rules suspended, read second time, referred to PUBLIC HEALTH, WELFARE AND LABOR COMMITTEE - SENATE

    1/28/2025Senate
  15. Filed

    1/28/2025Senate

Bill Text

  • SB136 - Introduced

    1/28/2025

  • Act Version

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