Comment from The Doctor Patient Forum

I am submitting this comment on behalf of The Doctor Patient Forum, a national nonprofit representing patients and clinicians affected by pain care policy and algorithm-driven decision tools like NarxCare. I have attached a pdf document of a recent article from Medscape Medical News titled “Hidden Formula, High Stakes: Clinicians Push FDA on NarxCare” (published May 22, 2025) to be included in the public docket. This article provides independent national coverage of the concerns raised in this citizen petition, including quotes from clinicians, policy experts, and patient advocates. It confirms that NarxCare is being used in at least 20 states, often without patients’ knowledge, and highlights the urgent need for transparency and regulatory oversight. Key points include: •Patients can be denied care based on secret algorithmic scores with no way to see or challenge their data. •Experts, including from the AMA and National Pain Advocacy Center, express serious concerns about misuse and harm. •Bamboo Health continues to withhold its algorithm from peer review while claiming exemption from FDA oversight. The attached PDF offers additional support for why the FDA should review NarxCare as a software product that may qualify as a medical device under current regulations. This tool has direct clinical impact, and the public deserves transparency and accountability. We respectfully urge the FDA to take this petition seriously and to evaluate whether NarxCare qualifies as software as a medical device (SaMD), so that it can be properly regulated with adequate oversight. As FDA Commissioner Dr. Marty Makary has emphasized, restoring public trust in healthcare requires radical transparency, and this must include the tools used to make life-altering medical decisions.