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(iii) Sign and submit a data sharing agreement with CMS as set forth in paragraph (e)(1) of this section

The dose-response and mechanism are identical because the molecule is the same

Because Medicare is currently paying for most skin substitutes as biologicals using the methodology under section 1847A of the Act, each skin substitute product receives a unique billing code (typically, a Level II HCPCS code) and payment limit

It doesn't disrupt the balance of cells or tissues the way a non-salt solution can