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Wadden, PhD , can be reached at [email protected].
In addition, because the demonstration will operate outside the Part D benefit, the manufacturers wont be responsible for providing the manufacturer price discount on eligible GLP-1s (10% in the Part D initial benefit phase and 20% in the catastrophic phase.) While many prior section 402 demonstrations have had to conform to budget neutrality rules by the Office of Management and Budget (OMB), some demonstrations have been able to move forward without this requirement
And it is the approach that clinical trials used to produce the weight loss numbers that everyone references
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