Lawmakers weigh protections, oversight as they consider experimental-treatment center bill

Senate Bill 5 35 prompted a multi-hour debate in the House Health and Human Services Committee as witnesses described competing priorities: greater access to innovative therapies versus protections for patients and state oversight. Senator Ken Bogner, sponsor, said the bill streamlines licensing, clarifies definitions and allows Montana to "provide a business friendly environment that supports both safety and consumer protection."

Proponents from the biotech and longevity communities described potential health and economic benefits. Dylan Livingston, founder of the Alliance for Longevity Initiatives, said the bill would allow earlier access to treatments that target age-related biology and could position Montana as a hub for innovation. He described interventions such as senolytics and other geroscience approaches as examples of treatments that might be offered once they have passed phase‑1 clinical evaluation.

Jesse Luther summarized bill provisions including a $10,000 application fee, $5,000 annual renewal, a DPHHS rulemaking process for operational standards, exemptions in insurance code allowing direct patient agreements, and an enhanced informed-consent process that would require interactive discussions between patient and provider (the bill proposes a recorded/video discussion rather than only written consent).

Opponents pressed several concerns. Jean Branscum of the Montana Medical Association said the bill treats physicians differently from other providers by allowing a licensure exemption for out-of-state physicians working in these centers; she urged an amendment requiring Montana licensure or, alternately, a time-limited exemption (21 days) followed by licensing. "We would like to ask that the physicians that the bill be amended to recognize the need to have a license in Montana," Branscum said.

Other opponents pointed to ethical and oversight gaps: lack of institutional review boards, possible targeting of vulnerable populations by marketing, limited complaint and investigation access for Montana authorities when providers are licensed in other states, and DPHHS capacity constraints given staffing vacancies. Dr. Christine Dribdahl Smith, a Miles City family physician, said she was "deeply disturbed" by the possibility that physicians administering experimental treatments would not be required to hold Montana medical licenses.

Proponents responded that the bill applies only to treatments that have completed phase‑1 FDA review as defined under Montana's right-to-try framework and that the legislation includes immunity provisions that exclude gross negligence and willful acts. They also argued short-term licensure flexibility would encourage providers to serve Montanans and that anecdotal data collected could accelerate future FDA trial timelines.

Next steps: the hearing concluded with significant debate and requests for potential amendments to address licensure timing, DPHHS capacity, consent processes and oversight mechanisms. No formal vote on SB 5 35 was taken during this session.