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Data describe a controlled population: The tolerability record reflects supervised use of a defined clinical formulation in monitored celiac patients not unsupervised use of research-grade powder, other populations, other doses, or use beyond trial durations

of the CY 2025 OPPS/ASC final rule with comment period (89 FR 94342 through 94361), section 4135(a) and (b) of the CAA, 2023, titled Access to Non-Opioid Treatments for Pain Relief, amended sections 1833(t)(16) and 1833(i) of the Act, respectively, to provide for temporary separate payments for non-opioid treatments for pain relief