SB535: RIGHT TO TRY MONTANA

Image Credit: Alexis Bonogofsky

BILL SUMMARY

SB 535 updates Montana’s Right to Try framework by establishing a regulatory structure and licensing pathway for Experimental Treatment Centers to provide experimental treatments, including investigational drugs, biologics, devices, or other therapies that have completed Phase 1 safety trials. The law provides some licensing requirements for Experimental Treatment Centers, and provides authority to the Department of Public Health & Human Services (DPHHS) to create regulations that:  set operating standards, policies and procedures, safety and oversight requirements, inspections, and data/quality sytems, including outcome monitoring for adverse event reporting for these centers. SB 535 includes provisions that require informed consent, patient eligibility, and provider protections, while clarifying how patients may access (and pay for) this type of care.

Key points at a glance:

  • Effective immediately: SB 535 took effect May 13, 2025; DPHHS rulemaking will provide an application process and clarify operational details (see Status & Updates below).
  • Licensing required:  Experimental Treatment Centers must be licensed by DPHHS; application fee $10,000 and annual renewal $5,000.
  • Health Freedom & Access Requirement: Centers must allocate 2% of net annual profits to expand access, either by providing free care to qualifying Montana residents or contributing to the new Insurance Premium Support Account.
  • Insurance Premium Support Account: Funds (including center contributions) help eligible Montanans (139%–400% FPL) pay marketplace health insurance premiums; DPHHS reports annually to the Children, Families, Health & Human Services Interim Committee.
  • Patient eligibility & consent: Access requires patients to have evaluated other treatment options currently approved by the FDA, received a recommendation from their health care provider, and provided informed consent.
  • Center protections: the state may not block lawful access to experimental treatments.

status & updates

Timeline (at a glance): Bill Enacted → DPHHS Draft Rules → Public Comment → Interim Committee Review → Final Rules/Guidance → Ongoing Licensing & Reporting

Public Participation Opportunities
When draft rules are noticed, interested parties are encouraged to submit written comments or testify at hearings.  It will be helpful for the Department to hear from members of the public that support the Right to Try and the framework established in SB 535.

    • Next Comment Window: [Will provide dates when notified]
    • How to Participate: [Will add DPHHS comment portal or email when notified]
    • Sign up for Alerts: [Your sign-up form link]

Rulemaking (DPHHS)
DPHHS is responsible for adopting rules that include minimum operational standards, written policies/procedures, oversight mechanisms, inspections, facility safety standards, and data collection & quality assurance (including outcome monitoring and adverse event reporting).

    • Draft Rules: [Pending / will link when posted]
    • Public Hearing(s): [Will provide date/time/location once notified]
    • Written comment period: [Will provide date/time/location once notified]
    • Final Rules Target: [Will provide when available]

Legislative Oversight
The Children, Families, Health & Human Services Interim Committee (CFHHS) oversees implementation updates and is tasked with reviewing the administrative rules once published.  Once the program is implemented, DPHHS is to report to the CFHHS regarding the status of  the Insurance Premium Support Account.

    • Recent/Upcoming Agendas: [Link]
    • Committee Materials: [Link]

FREQUENTLY ASKED QUESTIONS

  • Who qualifies for experimental treatment under SB 535?
    • Patients who have evaluated FDA-approved options, have a health care provider recommendation, and provide informed consent.
  • What is required for informed consent?
    • At a minimum, informed consent under the right to try law must include the following:  an explanation of currently approved products or treatments relevant to the patient’s disease or desired health outcome; an attestation that the patient agrees that currently approved products or treatments are unlikely to achieve the desired health outcome; clear identification of the specific experimental treatment desired by the patient; a description of the best, worst, and most likely outcomes of receiving the experimental treatment; an acknowledgement that the patient’s health plan is not obligated to pay for the experimental treatment or any subsequent treatments; an acknowledgement that the patient is liable for all expenses related to the experimental treatment; an acknowledgement that experimental treatments cannot be used to assist with ending the patient’s life; and where applicable a statement regarding how curative experimental treatment may impact hospice care.  Informed consent may be written, provided through interactive discussions that are recorded, or some combination of each.  Informed consent must be signed by the patient or a parent or legal guardian.   
  • What is an experimental treatment under Montana’s Right to Try?
    • An “experimental treatment” is the provision of an investigational drug, biological product, device, or other treatment by a health care provider that has completed Phase 1 of an FDA approved clinical trial and is either still under FDA-approved investigation in a clinical trial or has a documented safety record from a qualified medical institution.
  • Is an experimental treatment the same thing as a clinical research trial?
    • No. Experimental treatments are not the same as clinical research trials, but both are closely related.  Experimental treatments that have completed phase I of a clinical trial may be provided to patients in accordance with Montana law.  Clinical research trials are regulated by the United States Food and Drug Administration.  
  • Will insurance cover experimental treatments?
    • No. SB 535 does not require coverage; however payers may choose to cover costs. The Insurance Premium Support Account is specifically for marketplace premiums, not treatment costs. It is important to note that any conditions that arise as a result of an uncovered experimental treatment are also generally not covered by insurance.
  • Are there costs to the patient?
    • Possibly. Payment arrangements are between the patient and the center/provider unless a payer elects to cover some costs.
  • Can experimental treatment be used to hasten death?
    • No. Consent explicitly acknowledges that experimental treatments cannot be used to end a patient’s natural life.
  • Who writes the rules?
    • DPHHS is responsible for licensing all health care facilities in Montana, including Experimental Treatment Centers. 
  • What is the difference between SB 535 and the Rules?
    • SB 535 established the statutory framework allowing for Experimental Treatment Centers and the provision of experimental treatments in Montana.  The bill granted specific authority to DPHHS to draft further regulations regarding licensure of Experimental Treatment Centers, including:  minimal operational standards, written policies and procedures; oversight mechanisms; facility inspections; facility safety standards; and data collection and quality assurance systems, including outcome monitoring and adverse event reporting.  Neither statute nor administrative rule will necessarily answer every question that may arise regarding experimental treatments. It is important to understand that rules can only be promulgated under specific legal authority. If a department exceeds that authority and creates rules beyond what the law permits, such actions would be improper and likely unlawful. 
  • How can I comment?
    • During the official public comment period, you can submit written comments or testify at a hearing. We will post dates/links here:
  • What does the Interim Committee do?
    • The Children, Families, Health & Human Services Interim Committee oversees implementation updates and receives DPHHS’s September 1 annual report on the Insurance Premium Support Account.

bill text

Full Text Senate Bill: 

https://bills.legmt.gov/#/laws/bill/2/LC0780?open_tab=bill

CONTACT

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