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<section article="ghg" article_name="Health - General" number="21-2C-13" 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">
    <text>If, under § 21–2C–07 of this subtitle, the Board finds that it is in the best interest of the State to establish a process for setting upper payment limits for prescription drug products that it determines have led or will lead to an affordability challenge, the Board, in conjunction with the Stakeholder Council, shall draft a plan of action for implementing the process in accordance with the requirements of this section.</text>
  </level>
  <level label="b">
    <text>The criteria for setting upper payment limits shall include consideration of:</text>
    <level label="1">
      <text>The cost of administering the prescription drug product;</text>
    </level>
    <level label="2">
      <text>The cost of delivering the prescription drug product to consumers;</text>
    </level>
    <level label="3">
      <text>The effect the upper payment limit will have on providers of 340B drugs;</text>
    </level>
    <level label="4">
      <text>For an upper payment limit on a drug that is designated as a drug for a rare disease or condition, the impact of the upper payment limit on patients with rare diseases; and</text>
    </level>
    <level label="5">
      <text>Other relevant administrative costs related to the prescription drug product.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>If the Board previously set an upper payment limit for a drug that becomes a current shortage, the Board may reconsider the previously set upper payment limit.</text>
    </level>
    <level label="2">
      <text>The Board may not:</text>
      <level label="i">
        <text>Apply a new upper payment limit to a drug in a current shortage;</text>
      </level>
      <level label="ii">
        <text>Enforce an upper payment limit against provider or pharmacy reimbursement requirements for Medicare Part C or Part D plans; or</text>
      </level>
      <level label="iii">
        <text>Count a pharmacy dispensing fee toward or subject a pharmacy dispensing fee to an upper payment limit.</text>
      </level>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>If a plan of action is drafted under subsection (a) of this section, the Board shall submit the plan of action to the Legislative Policy Committee of the General Assembly, in accordance with § 2–1257 of the State Government Article, for its approval.</text>
    </level>
    <level label="2">
      <text>The Legislative Policy Committee shall have 45 days to approve the plan of action.</text>
    </level>
    <level label="3">
      <text>If the Legislative Policy Committee does not approve the plan of action, the Board shall submit the plan to the Governor and the Attorney General for approval.</text>
    </level>
    <level label="4">
      <text>The Governor and the Attorney General shall have 45 days to approve the plan of action.</text>
    </level>
    <level label="5">
      <text>The Board may not set upper payment limits unless the plan is approved, in accordance with this subsection, by:</text>
      <level label="i">
        <text>The Legislative Policy Committee; or</text>
      </level>
      <level label="ii">
        <level label="1">
          <text>The Governor; and</text>
        </level>
        <level label="2">
          <text>The Attorney General.</text>
        </level>
      </level>
    </level>
  </level>
</section>
