28. Section 150.221 is amended by revising paragraphs (a)(2) and (b) to read as follows:
(a) * * *
(2) Instructions to issuers, providers, and facilities, as applicable.
* * * * *
(b) CMS may also negotiate a process to ensure that, to the extent practicable, as permitted by law, and as applicable, its records documenting issuer, provider, and facility compliance and other relevant areas of CMS's enforcement operations are made available to the State regulatory authority that will assume enforcement responsibility.