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A combination concept (tesofensine + metoprolol) has received orphan drug designation for Prader-Willi Syndrome, but this does not constitute approval

We typically issue the OPPS/ASC final rule with comment period by November 1 of each year to both comply with the statutory requirement under section 1833(t)(9)(A) of the Act to annually review and update these payment systems on a calendar year basis and ensure 60-days' notice so that the payment policies for these systems are effective on January 1, the first day of the calendar year to which the policies are intended to apply

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However, logistically, anesthetic medications are often easier to obtain quickly, so they can be started first