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Once exposed to room temperature for extended periods, the vial should not be returned to refrigerated storage and used beyond the 21-day window

Response: We are confirming that our proposed policy as noted in the CY 2025 PFS proposed rule (89 FR 61739) would only apply to the certification in those cases where the patient has an order or referral for physical therapy, occupational therapy, or speech-language pathology services

We are finalizing without modification our proposed policy on withholding or termination of prepaid shared savings payments at new 425.640(h)

Nutraceuticals: Zinc L-Carnosine, Quercetin (EMIQ), Tributyrin (butyrate source), Sodium Bicarbonate