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[471] We have provided some flexibility on the title of the senior hospital executive who would attest to the file's accuracy and completeness, and indicated in the proposed rule (90 FR 33799) that we would expect the senior hospital official who is named as the attester in the file would be the same individual who would submit to CMS, if requested as part of CMS' monitoring oversight, a certification of the accuracy and completeness of the MRF data under 180.70(a)(2)(iv)

There is no TUE pathway available for it, regardless of the medical justification

The rich blood supply in muscle tissue enables rapid diffusion into systemic circulation within minutes

It is not a pharmaceutical, dietary supplement, or cosmetic product