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All compounds are supplied for research use only (RUO)

B., Rule, A

Liu, Q., Busby, J

As applicable under this paragraph, CMS will use information reported by a manufacturer under section 1927(b)(3) of the Act, including without limitation the date of FDA approval or licensure and the first marketed date, to identify the payment amount benchmark period as set forth in paragraphs (c)(1) and (2) of this section, subject to paragraphs (c)(3) through (5) of this section: (1) For a Part D rebatable drug first approved or licensed by the FDA on or before October 1, 2021, the payment amount benchmark period is the period beginning on January 1, 2021, and ending on September 30, 2021