<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 14.01.04.02" title_num="14" subtitle_num="01" chapter_num="04" heading="Identifying Drugs Eligible for Cost Review.">
  <paragraph num="A.">
    <text>The Board shall apply the metrics specified in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, and this regulation to the following data sets to identify drugs eligible for selection for a cost review study:</text>
    <paragraph num="(1)">
      <text>The claims data in the MCDB;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Available subsets of claims data in the MCDB, such as the commercial market, Medicaid, and Medicare; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The data obtained from governmental and commercial databases, other databases, and other data sets as available.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The Board may identify the prescription drug products that meet these statutory metrics and regulatory criteria on at least an annual basis.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Data Management.</text>
    <paragraph num="(1)">
      <text>For any metric requiring adjustment for inflation, the adjustment for inflation shall be based on the Consumer Price Index for All Urban Consumers (CPI-U) as reported by the U.S. Bureau of Labor Statistics.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>For any data-based metric, the Board may account for data errors and outliers.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>To the extent practicable, and in addition to the statutory metrics set forth in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, the Board may consider the following additional metrics and criteria to identify prescription drug products eligible for selection for a cost review study:</text>
    <paragraph num="(1)">
      <text>Aggregated Spending and Pricing Data:</text>
      <paragraph num="(a)">
        <text>The 100 prescription drug products with the highest total gross spending in the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The 100 prescription drug products with the highest total gross spending per patient in the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The 100 prescription drug products with the highest percent change increase in WAC over the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The 100 prescription drug products with the highest percent change increase in WAC over the most recent available 5-year period;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The 100 prescription drug products with the highest dollar increase in WAC per year or course of treatment over the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>The 100 prescription drug products with the highest dollar increase in WAC over the most recent available 5-year period; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>The 100 prescription drug products with the highest percent change increase in total gross spending;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Patient Out-of-Pocket Costs:</text>
      <paragraph num="(a)">
        <text>The 100 prescription drug products with the highest total patient out-of-pocket costs in the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The 100 prescription drug products with the highest average patient total out-of-pocket costs in the most recent available calendar year;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The 100 prescription drug products ranked at the 50th percentile for patient total out-of-pocket costs in the most recent available calendar year; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The 100 prescription drug products ranked at the 90th percentile for patient total out-of-pocket costs; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Any prescription drug product added by the Board to the list of prescription drug products eligible for cost review under this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>At an open meeting, a Board member may propose one or more additional prescription drug products for inclusion on the list of drugs eligible for cost review by:</text>
    <paragraph num="(1)">
      <text>Moving that the prescription drug product or products be added to the eligible list; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identifying how the prescription drug product or products may create affordability challenges for the State health care system or patients.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>After discussion at an open meeting, the Board may vote to add one or more prescription drug products to the list of drugs eligible for selection for a cost review study.</text>
  </paragraph>
</regulation>