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Global Budgeting

A method of constraining costs wherein multiple providers are expected not to exceed a certain spending target (for example, the SGR), or where a provider is given a “global budget” to provide care for a certain population.

Biosimilars User Fee Act

Creates an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. This pathway is…