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In light of a novel nalmefene product, Opvee, receiving FDA approval as an opioid antagonist medication for the emergency treatment of known or suspected opioid overdose, we are proposing to make payment for this new drug under the Medicare OTP benefit

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( (iii) If a Part B rebatable biosimilar biological product that is currently in shortage experiences a severe supply chain disruption, CMS will reduce the rebate amount as described in paragraph (b)(1) of this section and will not grant a reduction under 427.401 during those applicable calendar quarters