Comment from K Stanton

I urge regulators to closely scrutinize the use of proprietary opioid-risk scoring and surveillance tools such as NarxCare, Narx Scores, and similar predictive analytics systems when they are used to influence medical treatment decisions for pain patients. These systems raise substantial concerns regarding transparency, validation, patient safety, and due process. 1. Black-Box Clinical Decision-Making Patients may be denied treatment, tapered, stigmatized, or dismissed from care based on proprietary scores they cannot review, understand, challenge, or correct. Clinical decisions affecting access to medically necessary pain treatment should not rely on opaque algorithms shielded from scrutiny as trade secrets. 2. Insufficient Independent Validation Publicly available information does not adequately establish that these tools have acceptable false-positive and false-negative rates, improve patient outcomes, or accurately distinguish between medically appropriate opioid therapy and misuse risk. Complex chronic pain patients are especially vulnerable to misclassification due to multiple diagnoses, specialist involvement, surgeries, medication changes, or long-term stable treatment. 3. Documented Risk of Patient Harm When clinicians react to algorithmic flags instead of individualized patient assessment, legitimate pain patients may face undertreatment, involuntary tapering, delayed surgery, emergency care refusal, pharmacy refusal, or dismissal from care. As a chronic pain patient, I have personally experienced forced interruption of long-term prescribed opioid therapy due to provider negligence. During a 13-day lapse in medication access, withdrawal symptoms were not the primary issue; the overwhelming and uncontrolled return of severe underlying pain from my diagnosed conditions was far worse. This experience demonstrated that my medication was treating serious, life-altering pathology, not merely preventing dependence. Policies or software systems that destabilize legitimate patients can produce profound suffering and functional collapse. 4. Conflict with Federal Guidance The CDC’s 2022 opioid prescribing guideline explicitly states that it is not intended to be applied as inflexible policy or rigid standard of care. HHS warns that inappropriate tapering or discontinuation can cause worsened pain, withdrawal, psychological distress, suicidality, and transition to unsafe alternatives. Algorithmic risk scoring may encourage exactly the type of non-individualized, fear-based opioid management federal agencies have warned against. 5. Erosion of Physician Judgment No software score can substitute for individualized physician assessment of diagnosis, treatment response, functional status, adverse effects, quality of life, and medical necessity. These tools should never override clinician judgment or function as de facto prescribing limits. Dr. Richard A. Lawhern and other patient-safety advocates have extensively documented the harms caused when opioid policy is driven by rigid thresholds, surveillance metrics, and fear rather than individualized medicine. Risk-scoring software threatens to repeat and automate those same harms at scale. Requested Regulatory Safeguards: - Prohibit use of algorithmic opioid-risk scores as sole or primary justification for denying, tapering, discontinuing, or restricting prescribed pain treatment. - Require independent external validation and publication of methodology before clinical deployment. - Require disclosure to patients when such tools influence treatment decisions. - Establish formal patient appeal and correction mechanisms for inaccurate or misleading risk assessments. - Prohibit proprietary trade-secret protections from shielding clinically consequential scoring methods from regulatory review. - Affirm that algorithmic tools may supplement but never replace individualized medical judgment. Pain management is a matter of medical ethics, patient safety, and human dignity. Patients with legitimate acute, chronic, post-surgical, traumatic, cancer-related, and disabling pain deserve individualized care—not secret algorithmic profiling. Thank you for your consideration of this matter.