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of this final rule, in light of our careful review of the applicable statutory provisions governing products paid under the ASP methodology under 1847A of the Act, the different FDA regulatory frameworks used for these products, and the skyrocketing increase in Medicare spending for such products, we proposed to pay separately for specific skin substitute products (other than products licensed under section 351 of the PHS Act, which will continue to be paid as biologicals under the ASP methodology in section 1847A of the Act) that are eligible for Medicare coverage during a covered application procedure in the non-facility setting as incident-to supplies in accordance with section 1861(s)(2)(A) of the Act

C., & Zierath, J

Other potential side effects include headaches and digestive discomfort

Regulatory bodies (FDA) have not evaluated or approved BPC-157 for any indication, meaning no maximum safe duration exists under validated clinical guidelines