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(2) For a qualifying medical device as defined in paragraph (b) of this section, the amount of payment is the amount of the hospital's charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule amount, subject to paragraph (c)(3) of this section

This distinction affects safety, regulation, and side effects

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Physical Examination: A detailed physical examination of the periorbital area is conducted to assess the color, depth, and extent of the dark circles