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<regulation prefix="Regulation" num=".09" citation="COMAR 14.35.16.09" title_num="14" subtitle_num="35" chapter_num="16" heading="Qualified Health Plan Certification — Covered Prescription Drugs and Formularies.">
  <paragraph num="A.">
    <text>An authorized carrier’s application under Regulation .04A of this chapter shall identify drugs covered under the health benefit plan’s medical benefit.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Drug Formulary List Location.</text>
    <paragraph num="(1)">
      <text>An authorized carrier shall provide the Internet address for the drug formulary for each health plan with the application submitted for the health benefit plan to the Exchange under Regulation .04A of this chapter.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Internet address required under §B(1) of this regulation shall link directly to the health benefit plan’s list of covered drugs without further navigation.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The health benefit plan’s list of covered drugs shall:</text>
      <paragraph num="(a)">
        <text>Include plain language drug category information for each drug category;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Include information on utilization management tools such as prior authorization, step therapy, quantity limitations, and generic substitutions; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Be up to date, accurate, and complete.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>An authorized carrier may classify a covered drug as a preventative drug covered at zero cost and shall identify any drugs so covered in its formulary.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Drug Exception Process.</text>
    <paragraph num="(1)">
      <text>An authorized carrier shall establish a drug exception process by which an enrollee can request access to a drug not on the plan’s formulary list in standard situations, as required by Insurance Article, §15-831(c), Annotated Code of Maryland, and 45 CFR §156.122(c).</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A carrier shall notify the enrollee of its coverage decision no later than 72 hours after receipt of the request for exception.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>A carrier shall follow the external review process established by the Administration for advice from an independent review organization for denied requests as described in COMAR 31.10.19.</text>
  </paragraph>
  <paragraph num="F.">
    <text>A carrier shall establish a process for the emergency review of denials that is compliant with State and federal statute and regulation.</text>
  </paragraph>
</regulation>