Comment on FR Doc # 2026-12676

Thank you for the opportunity to comment. If beneficiary‑inducement exceptions and anti‑kickback safe harbors are not updated to address clinical‑trial‑related remuneration, significant policy consequences may follow. Current rules create uncertainty that discourages sponsors and providers from offering necessary supports such as transportation, lodging, childcare, and cost‑sharing assistance. Without regulatory clarity, participation will continue to skew toward individuals with financial means, undermining equitable enrollment, slowing scientific progress, and limiting the generalizability of research findings. The absence of updated protections also increases administrative burden, as organizations must seek individualized advisory opinions rather than relying on clear, prospective guidance. • Types of remuneration that support participation: Transportation, lodging, childcare, meal stipends, and cost‑sharing assistance meaningfully improve enrollment and retention, particularly for Medicare and Medicaid beneficiaries. • Fraud‑and‑abuse risks: Risks are low when remuneration is tied solely to research participation, is not linked to referrals or clinical decision‑making and is offered uniformly to all eligible participants. • Safeguards: Reasonable caps, documentation of need, uniform eligibility criteria, and prohibitions on linking payments to volume or value of services would effectively mitigate risk. • Whether new safe harbors or CMP exceptions are needed: Yes. A narrowly tailored safe harbor specific to clinical‑trial remuneration would provide clarity, reduce reliance on advisory opinions, and promote equitable access. • Whether guidance alone is sufficient: Guidance is helpful but not durable. Regulatory amendments are necessary to provide long‑term certainty for sponsors, investigators, and beneficiaries. Thank you for considering these comments as you evaluate potential updates to the safe harbor and CMP frameworks.