<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05-1" citation="COMAR 10.09.03.05-1" title_num="10" subtitle_num="09" chapter_num="03" heading="Expanded Limitations.">
  <paragraph num="A.">
    <text>A drug is not covered for State-only participants if:</text>
    <paragraph num="(1)">
      <text>The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c));</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Program has provided notice to the manufacturer of the manufacturer's failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The manufacturer has failed to demonstrate to the Secretary that the drug’s availability is essential to State-Only participants.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid.</text>
  </paragraph>
</regulation>