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In Chapter 17, section 20.1.3 and 20.4 of the Medicare Claims Processing Manual, we discuss calculations for pricing multiple-source drugs in Part B, as defined at section 1847A(c)(6)(C) of the Act, when the payment limits are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File

First, you need to understand the financial part of it

In StatPearls Internet

Rigorous safety monitoring, particularly long-term risk assessment for invasive procedures such as FMT, and strengthened regulatory oversight are requisite conditions for the safe and effective clinical implementation of microbial therapeutic products (OToole et al., 2017

doi: 10.1016/S1474-4422(08)70167-4 68 LeeC.YuD.KimH