covered entity
(B)In this subsection, the term “covered entity” means an entity described in. (C)If the Secretary does not establish a mechanism underwithin 12 months of, the following requirements shall apply: (i)Each covered entity shall inform the single State agency underwhen it is seeking reimbursement from the State plan for medical assistance described inwith respect to a unit of any covered outpatient drug which is subject to an agreement under. (ii)Each such single State agency shall provide a means by which a covered entity shall indicate on any drug reimbursement claims form (or format, where electronic claims management is used) that a unit of the drug that is the subject of the form is subject to an agreement under, and not submit to any manufacturer a claim for a rebate payment under subsection (b) with respect to such a drug. (D)In determining whether an agreement under subparagraph (A) meets the requirements of, the Secretary shall not take into account any amendments to such section that are enacted after. (E)A manufacturer is deemed to meet the requirements of this paragraph if the manufacturer establishes to the satisfaction of the Secretary that the manufacturer would comply (and has offered to comply) with the provisions of(as in effect immediately after) and would have entered into an agreement under such section (as such section was in effect at such time), but for a legislative change in such section after.