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The applicant also asserted that CMS's literal application of its example that a pacemaker is integral to the procedure of implantation of a pacemaker is overly simplistic and suggests that any feature beyond the basic function of a device could be considered non-integral. In addition, the applicant asserted that CMS has previously deviated from this approach when determining transitional pass-through payment status

They aren't alternatives to each other they're complementary research tools that address different research questions

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FDA concluded that chronic-insomnia studies were inconclusive and preliminary and that positive findings came from studies with weak methodology