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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))

Fluctuating stock of the raw product (blood donations) along with local healthcare demands for blood products (PRBCs, platelets, plasma, etc.) affect the availability of WBT

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The measure should account for patients with cardiac arrest and patients who smoke tobacco to reduce factors outside of clinician control that influence measure performance

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