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CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives ( 1001.952(ii)(2) of this title) is available to protect remuneration furnished in the prepaid shared savings option of the Shared Savings Program in the form of direct beneficiary services that meets all safe harbor requirements set forth in 1001.952(ii) of this title

First marketed date means the earliest date of first sale of any NDC-11 within a billing and payment code among all products and package sizes under the same FDA application

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