To identify the payment amount benchmark period for a Part D rebatable drug, CMS would use the FDA approval date or the first marketed date reported under section 1927(b)(3)(A)(v) of the Act, as applicable
CMS understands it is possible that a manufacturer may not have sales or monthly units of a COD to report to the Medicaid Drug Programs system for a calendar quarter because, for example, there may be a temporary interruption in sales of the COD, or there may be no sales immediately after the drug is first approved or licensed by the FDA
(iii) If the quality measure reached extremely topped out status
and the NIH Distinguished Scholars Program, designed to promote and enhance DEIA within the NIH intramural program (864)
Additionally, in the definition of opioid use disorder treatment service at 410.67(b), we are proposing to codify telecommunications flexibilities for initiation of treatment with methadone at paragraph (vi)(A)( 2 )