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For a detailed explanation of the direct PE methodology, including examples, we referred readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology in the CY 2007 PFS proposed rule (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629)

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FDA found no studies supporting the nominated subcutaneous route and concluded that the available evidence was insufficient to establish effectiveness for chronic insomnia, narcolepsy, or opioid withdrawal