45 C.F.R. § 150.211
If CMS is satisfied that there is a reasonable question whether there has been a failure to substantially enforce PHS Act requirements, CMS sends, in writing, the notice described in § 150.213 of this part, to the following State officials:
[64 FR 45795, Aug. 20, 1999, as amended at 78 FR 13440, Feb. 27, 2013]