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CMS may move a drug or biological product from a grouped billing and payment code to a unique billing and payment code in instances where the ( drug is either approved through the pathway established under section 505(b)(2) of the FD&C Act (hereinafter section 505(b)(2) drug products) that CMS initially assigned to the same billing and payment code as its reference drug for a period of time, or the drug was previously a multiple source drug but is now a single source drug that was moved to its own billing and payment code

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