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Additionally, this single-arm case series study may not provide a confirmative treatment response and eliminate potential placebo effects

Finally, the applicant stated that, under the regulation at 419.66(a), CMS makes a pass-through payment for a medical device that meets the requirements in paragraph (b) of that section and that is described by a category of devices established by CMS under the criteria in paragraph (c) of that section, and that, further, according to 419.66(g), the pass-through period begins on the first date on which pass-through payment is made

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