The proposed rules establish a two-tiered governance structure for experimental treatment centers.
As discussed in our prior Alert, Montana Senate Bill 535 established a framework for licensed experimental treatment centers to offer patients access to experimental treatments that have completed Phase I clinical trials but have not yet received full approval from the United States Food and Drug Administration (FDA). On April 10, 2026, the Montana Department of Public Health and Human Services published a notice of proposed rulemaking (MAR Notice No. 2026-427.1) proposing the adoption of 25 new rules to implement SB 535's licensing and operational requirements for experimental treatment centers. The public comment period ran through May 8, 2026. The proposed rules provide the regulatory detail that was notably absent from SB 535 itself, including requirements around center governance, staffing, patient protections, treatment oversight, adverse event reporting, physical plant standards and the ability for certain treatments to be administered outside the treatment center. This Alert highlights the key features of the proposed rules and their potential implications for entities considering entry into this space.
Center Governance: Administrator, Medical Director and Licensing
The proposed rules establish a two-tiered governance structure for experimental treatment centers. Each center must designate an administrator responsible for the daily operation of the center, including the development and oversight of all policies and procedures, human resource services, patient complaint processes and staff credentialing. The administrator must be available, physically or remotely, on a daily basis and may serve as administrator of multiple experimental treatment centers provided each is owned and operated by the same legal entity.
Each center must also retain a medical director who holds a current physician license in good standing with the Montana Board of Medical Examiners, has completed a three-year residency in internal medicine and has been licensed in Montana for at least one year. The medical director is responsible for overseeing treatment delivery, maintaining a comprehensive tracking system for all experimental treatments (including patient outcomes and the FDA approval status of each treatment) and overseeing the performance of the center's medical staff. Notably, the medical director also serves as the center's safety officer and heads the center's quality assurance and performance improvement program. The medical director may also serve as the center's administrator.
Applications for licensure must disclose, among other things, the name of the medical director, the qualifications of all professional staff, whether the applicant or any affiliate has operated a healthcare facility that was closed due to patient health and safety issues, whether the owner or any staff has been convicted of a felony, and whether the owner or staff was employed by a facility closed because of administrative or legal action. Applicants must also describe the general types of experimental treatments the center intends to provide and explain how the center will fulfill SB 535's health freedom and access requirement.
Patient Protections: Agreements, Informed Consent and Documentation
The proposed rules impose significant patient protection requirements. Before admission, each center must enter into a written patient agreement that includes, among other items, documentation of the patient's consent to treatment, the treatment name, form and clinical trial phase, a detailed description of all anticipated costs, acknowledgment regarding the patient's health insurance and the full text of the provisions contained in Montana Code Annotated Section 50-12-110 regarding immunity from suit. The patient agreement must be signed and dated by both the patient (or the patient's legal representative) and a licensed healthcare professional of the experimental treatment center before any treatment begins.
Patient files must be comprehensive, containing at a minimum full identification information, a history and physical completed within 12 months of the visit that includes documentation from the patient’s treating practitioner that the patient meets the requirements for access to experimental treatment and the practitioner’s recommendation for such access, documentation that the patient has evaluated and attempted other FDA-approved treatment options, informed consent, treatment plans and outcomes, and discharge notes. Separate treatment documentation must be maintained for each patient, tracking the treatment provided, expected outcomes, adverse side effects, remedies taken to mitigate such side effects and patient response to the same.
Experimental Treatment Review Board
One of the most notable features of the proposed rules is the requirement that each experimental treatment center establish or contract with an experimental treatment review board. The review board must consist of at least four members, including at least one Montana-licensed physician, at least one researcher with expertise in clinical outcome data and at least one ethicist. The credentials of all board members must be reported to the Montana Department of Public Health and Human Services. Critically, all board members must have no personal, financial, employment or ownership interest in the experimental treatment center or centers for which the board provides review services—or any other conflict of interest.
The review board is responsible for reviewing and approving treatment protocols, evaluating quality and safety outcomes, preparing at least annually a summary report (including aggregate safety data and recommendations for quality improvements) that is published on the center’s website or otherwise made publicly available for review, and evaluating each treatment to determine the level of risk to patients and whether the treatment is safe for administration outside the treatment center. The review board must also review adverse event data reported under the proposed adverse event reporting rules.
Notably, a center may be licensed provisionally without a review board in place, but may not provide any treatments or devices until a review board is established and provides the required safety evaluations as to the level of risk to patients and whether the treatment is safe for administration outside the treatment center. This provision acknowledges the practical challenges of establishing a review board while still ensuring that no patients are treated without this independent oversight mechanism.
Adverse Event Reporting and Safety
The proposed rules require experimental treatment centers to report any adverse events to the Department within five days. An adverse event is considered “serious” if, in the medical director’s opinion, it results in death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity, or a congenital anomaly or birth defect. Each report must include the type of experimental treatment involved, the nature and severity of the adverse event, the date of occurrence, any corrective actions taken and information about the patient's medical condition. Adverse event data must also be reported to the center's quality assurance and performance improvement program. Because SB 535 was silent on reporting adverse events, this requirement addresses a possible safety concern—and is even more rigorous than the adverse reporting requirements of FDA’s own expanded access program.
Centers must also maintain an infection prevention and control program directed by a qualified infection control officer, a safety program addressing the organization's environment of care for all patients, staff and visitors, and for centers performing procedures requiring anesthesia, compliance with detailed anesthesia risk and evaluation requirements, including restrictions on flammable anesthesia and requirements for qualified anesthesiologists or certified registered nurse anesthetists.
Investigational Medical Devices
The proposed rules include specific provisions for experimental treatment centers intending to provide access to investigational medical devices. Such centers must maintain specialized equipment and facilities for device implantation, removal or administration, establish device-specific informed consent procedures addressing risks of device implantation and removal, long-term monitoring requirements, compatibility with other devices, and data collection and cybersecurity capabilities of smart devices. Centers must maintain a registry of all investigational medical devices administered to patients for a minimum of five years, tracking the purpose of treatment, device identifiers, patient outcomes and any adverse events. For internet-connected or smart devices, the center must address cybersecurity, patient data privacy and patient access to device-generated data.
Agreements with Outside Entities and Medical Practitioners
When the experimental treatment review board determines that a treatment or device poses minimal potential risk and is safe for administration outside the center, the proposed rules permit the center to make that treatment or device available to private practicing physicians through a written agreement. The agreement must specify, at a minimum, the approved disease or health condition, require the physician to document treatment outcomes, require reporting of adverse side effects to the center within 24 hours, and obligate the physician to share all treatment documentation and test results with the contracted center. Agreements must be renewed annually and terminated when a treatment clears FDA approval and no longer meets experimental treatment criteria.
Physical Plant Requirements
The proposed rules distinguish between outpatient and inpatient experimental treatment centers, imposing tailored physical plant requirements for each such as room size, required patient bed clearance and corridor size. The proposed rules also take into consideration outpatient and inpatient experimental treatments centers that operate within another licensed healthcare facility. Such centers must be operated as distinct and separate units of the facility with separate staff and segregated storage for experimental treatment medications, devices and equipment that is inaccessible to staff of the healthcare facility.
Reporting Requirements
Licensees are required to make an annual report to the Department of Public Health and Human Services by January 31 of the subsequent calendar year through the Department’s electronic licensing system, which includes a review of quality assurance systems and adverse event reporting. Failure to comply with reporting requirements by the January 31 deadline can result in relegation to a provisional license, or the Department may take further adverse licensing action for repeated noncompliance.
Key Takeaways and Implications
The proposed rules represent a significant step toward establishing regulatory infrastructure for Montana's experimental treatment centers. While SB 535 provided the statutory authority, the draft rules now fill in the operational details that will govern how these centers are licensed, staffed and operated in practice. Several aspects are worth highlighting for stakeholders.
The experimental treatment review board requirement introduces an independent oversight mechanism that may help address some of the safety concerns identified in our prior Alert. However, because review boards can be shared among centers and independently contracted, questions may remain about the consistency and rigor of oversight across the state.
While the ability to administer certain experimental treatments that have been evaluated by an experimental treatment review board to be safe or carry minimal risk by private physicians outside the center represents a further expansion of access, this may distribute risk among a broader set of treatment providers who may be less equipped to manage adverse events arising from experimental treatments.
The provisions regarding investigational medical devices, including smart and internet-connected devices, address a rapidly evolving area of technology and introduce cybersecurity and data privacy obligations that entities should carefully evaluate alongside existing federal requirements.
Finally, stakeholders should be aware that the risks presented in our previous Alert, such as whether administration of experimental treatments at an experimental treatment center is entitled to safe harbor protection from patent infringement under 35 U.S.C. §271(e)(1), are still fully applicable. Entities considering establishing or investing in experimental treatment centers should continue to evaluate the full spectrum of legal, regulatory and business risks, including those that extend beyond Montana's proposed regulatory framework.
The comment period for the proposed rules closed on May 8, 2026, and it is expected that the final promulgated rules will be published in due course.
For More Information
If you have any questions about this Alert, please contact Vicki G. Norton, Ph.D., Brandon A. Chan, Ph.D., any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.