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Each strip is engineered to dissolve quickly when placed against oral mucosa, providing a consistent delivery format for researchers evaluating buccal administration characteristics

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This paragraph currently states that the manufacturer's average sales price must be calculated by the manufacturer every calendar quarter and submitted to CMS within 30 days of the close of the quarter

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Response: As part of establishing the Part B payment limit based on the quarterly submission of all sales under section 1847A(c)(5) of the Act, we will continue to monitor pricing changes and patient volumes for autologous cell-based immunotherapies and gene therapies

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