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If the expected service is sufficient to justify listing for reimbursement, the guidance of CNEDi - MTS will also be based on the ASA in relation to a comparable product, considered to be the current gold standard, whether or not this gold standard is reimbursed. If I were to ask you, "Who is the buyer of your medical devices. Don't get hung up on the "edifice complex"--many outstanding agencies have very modest offices.  My website -  http://thedailyroto.com/