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<section article="ghg" article_name="Health - General" number="21-2C-16" future_version_removed="true" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2C" subtitle_name="Prescription Drug Affordability Board">
  <level label="a">
    <level label="1">
      <text>The Board, in consultation with the Stakeholder Council, shall determine whether, in addition to setting upper payment limits in accordance with § 21–2C–14 of this subtitle, it is in the best interest of the State for the Board to establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge.</text>
    </level>
    <level label="2">
      <text>When making a determination under paragraph (1) of this subsection, the Board shall consider, if applicable:</text>
      <level label="i">
        <text>Contract and budget data provided to the Board that demonstrates savings to the State or local governments as a result of upper payment limits set in accordance with § 21–2C–14 of this subtitle;</text>
      </level>
      <level label="ii">
        <text>Success of setting upper payment limits in other states; and</text>
      </level>
      <level label="iii">
        <text>Expected savings from Medicare Maximum Fair Prices set by the Centers for Medicare and Medicaid Services.</text>
      </level>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>If the Board makes an affirmative determination under subsection (a) of this section, the Board, in consultation with the Stakeholder Council, shall establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge.</text>
    </level>
    <level label="2">
      <text>The process established under paragraph (1) of this subsection shall:</text>
      <level label="i">
        <text>To the extent appropriate, use the plan of action approved under § 21–2C–13(d) of this subtitle; and</text>
      </level>
      <level label="ii">
        <text>Otherwise comply with the requirements for setting upper payment limits established under this subtitle.</text>
      </level>
    </level>
    <level label="3">
      <text>Before establishing an upper payment limit that applies to the Maryland Medical Assistance Program, the Board shall confer with the Maryland Medical Assistance Program to approve the application of the upper payment limit by assessing whether the proposed upper payment limit will:</text>
      <level label="i">
        <text>Conflict with the Medicaid Drug Rebates Program, the Covered Outpatient Drug Rule (CMS–2345–FC), or any other federal requirements as applicable; and</text>
      </level>
      <level label="ii">
        <text>Require additional funding to be allocated to the Maryland Medical Assistance Program budget.</text>
      </level>
    </level>
  </level>
</section>
