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(b) Instances when a new billing and payment code is assigned

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In 2007, CMS issued a program instruction, [447] as permitted under section 1847A(c)(5)(C) of the Act, stating that the payment limit for a single source drug or biological will be based on the pricing information for products produced or distributed under the applicable FDA approval (such as a New Drug Application (NDA) or Biologics License Application (BLA))

[788] For the CY 2025 performance period/2027 MIPS payment year, respondents would have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types