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To enable CMS to calculate the benchmark period manufacturer price and inflation rebate amounts for these NDC-9s, we proposed at 428.202(c)(3) that for a Part D rebatable drug first approved or licensed on or before October 1, 2021, for which there are no quarters during the period beginning on January 1, 2021, and ending on September 30, 2021, for which AMP has been reported under section 1927(b)(3) of the Act, we would identify the payment amount benchmark period as the first calendar year, which would be no earlier than calendar year 2021, in which such drug has at least 1 quarter of AMP reported

As mentioned, the updated files will be made available for public review through the stand-alone non-rule PRA process

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