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CMS finalized a definition of the term bundled arrangement to state that bundled arrangement means an arrangement regardless of physical packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or another product or some other performance requirement (for example, the achievement of market share, inclusion of tier placement on a formulary), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs or biologicals been purchased separately or outside the bundled arrangement. To remain consistent with the Medicare Drug Rebate Program, the agency removed purchasing patterns and prior purchases from the definition in the proposed rule

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