SB535: Right to Try Montana

Patients who have evaluated FDA-approved options, have a health care provider recommendation, and provide informed consent.

• 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.

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.

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.

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.

Possibly. Payment arrangements are between the patient and the center/provider unless a payer elects to cover some costs.

No. Consent explicitly acknowledges that experimental treatments cannot be used to end a patient’s natural life.

DPHHS is responsible for licensing all health care facilities in Montana, including Experimental Treatment Centers.

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.

During the official public comment period, you can submit written comments or testify at a hearing. We will post dates/links here:

The Children, Families, Health & Health & Human Services Interim Committee oversees implementation updates and receives DPHHS’s September 1 annual report on the Insurance Premium Support Account.