<?xml version='1.0' encoding='utf-8'?>
<section article="gin" article_name="Insurance" number="15-847" title_number="15" title_name="Health Insurance" subtitle_number="8" subtitle_name="Required Health Insurance Benefits">
  <level label="a">
    <level label="1">
      <text>In this section the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <level label="i">
        <text>“Complex or chronic medical condition” means a physical, behavioral, or developmental condition that:</text>
        <level label="1">
          <text>may have no known cure;</text>
        </level>
        <level label="2">
          <text>is progressive; or</text>
        </level>
        <level label="3">
          <text>can be debilitating or fatal if left untreated or undertreated.</text>
        </level>
      </level>
      <level label="ii">
        <text>“Complex or chronic medical condition” includes:</text>
        <level label="1">
          <text>multiple sclerosis;</text>
        </level>
        <level label="2">
          <text>hepatitis C; and</text>
        </level>
        <level label="3">
          <text>rheumatoid arthritis.</text>
        </level>
      </level>
    </level>
    <level label="3">
      <text>“Managed care system” means a system of cost containment methods that an insurer, a nonprofit health service plan, or a health maintenance organization uses to review and preauthorize drugs prescribed by a health care provider for a covered individual to control utilization, quality, and claims.</text>
    </level>
    <level label="4">
      <level label="i">
        <text>“Rare medical condition” means a disease or condition that affects fewer than:</text>
        <level label="1">
          <text>200,000 individuals in the United States; or</text>
        </level>
        <level label="2">
          <text>approximately 1 in 1,500 individuals worldwide.</text>
        </level>
      </level>
      <level label="ii">
        <text>“Rare medical condition” includes:</text>
        <level label="1">
          <text>cystic fibrosis;</text>
        </level>
        <level label="2">
          <text>hemophilia; and</text>
        </level>
        <level label="3">
          <text>multiple myeloma.</text>
        </level>
      </level>
    </level>
    <level label="5">
      <level label="i">
        <text>“Specialty drug” means a prescription drug that:</text>
        <level label="1">
          <text>is prescribed for an individual with a complex or chronic medical condition or a rare medical condition;</text>
        </level>
        <level label="2">
          <text>costs $600 or more for up to a 30–day supply;</text>
        </level>
        <level label="3">
          <text>is not typically stocked at retail pharmacies; and</text>
        </level>
        <level label="4">
          <level label="A">
            <text>requires a difficult or unusual process of delivery to the patient in the preparation, handling, storage, inventory, or distribution of the drug; or</text>
          </level>
        </level>
        <level label="B">
          <text>requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug.</text>
        </level>
      </level>
      <level label="ii">
        <text>“Specialty drug” does not include a prescription drug prescribed to treat diabetes, HIV, or AIDS.</text>
      </level>
    </level>
  </level>
  <level label="b">
    <text>This section applies to:</text>
    <level label="1">
      <text>insurers and nonprofit health service plans that provide coverage for prescription drugs under individual, group, or blanket health insurance policies or contracts that are issued or delivered in the State; and</text>
    </level>
    <level label="2">
      <text>health maintenance organizations that provide coverage for prescription drugs under individual or group contracts that are issued or delivered in the State.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>Subject to paragraph (2) of this subsection, an entity subject to this section may not impose a copayment or coinsurance requirement on a covered specialty drug that exceeds $150 for up to a 30–day supply of the specialty drug.</text>
    </level>
    <level label="2">
      <text>On July 1 of each year, the limit on the copayment or coinsurance requirement on a covered specialty drug shall increase by a percentage equal to the percentage change from the preceding year in the medical care component of the March Consumer Price Index for All Urban Consumers, Washington Metropolitan Area, from the U.S. Department of Labor, Bureau of Labor Statistics.</text>
    </level>
  </level>
  <level label="d">
    <text>Subject to subsection (h) of this section and § 15–805 of this subtitle, notwithstanding § 15–806 of this subtitle, and except as provided in § 15–847.2 of this subtitle, this article or regulations adopted under this article do not preclude an entity subject to this section from requiring a covered specialty drug to be obtained through:</text>
    <level label="1">
      <text>a designated pharmacy or other source authorized under the Health Occupations Article to dispense or administer prescription drugs; or</text>
    </level>
    <level label="2">
      <text>a pharmacy participating in the entity’s provider network, if the entity determines that the pharmacy:</text>
      <level label="i">
        <text>meets the entity’s performance standards; and</text>
      </level>
      <level label="ii">
        <text>accepts the entity’s network reimbursement rates.</text>
      </level>
    </level>
  </level>
  <level label="e">
    <level label="1">
      <text>A pharmacy registered under § 340B of the federal Public Health Services Act may apply to an entity subject to this section to be a designated pharmacy under subsection (d)(1) of this section for the purpose of enabling the pharmacy’s patients with hepatitis C to receive the copayment or coinsurance maximum provided for in subsection (c) of this section if:</text>
      <level label="i">
        <text>the pharmacy is owned by a federally qualified health center, as defined in 42 U.S.C. § 254B;</text>
      </level>
      <level label="ii">
        <text>the federally qualified health center provides integrated and coordinated medical and pharmaceutical services to hepatitis C patients; and</text>
      </level>
      <level label="iii">
        <text>the prescription drugs are covered specialty drugs for the treatment of hepatitis C.</text>
      </level>
    </level>
    <level label="2">
      <text>An entity subject to this section may not unreasonably withhold approval of a pharmacy’s application under paragraph (1) of this subsection.</text>
    </level>
  </level>
  <level label="f">
    <text>An entity subject to this section may provide coverage for specialty drugs through a managed care system.</text>
  </level>
  <level label="g">
    <level label="1">
      <text>A determination by an entity subject to this section that a prescription drug is not a specialty drug is considered a coverage decision under § 15–10D–01 of this title.</text>
    </level>
    <level label="2">
      <text>For complaints filed with the Commissioner under this subsection, if the entity made its determination that a prescription drug is not a specialty drug on the basis that the prescription drug did not meet the criteria listed in subsection (a)(5)(i) of this section:</text>
      <level label="i">
        <text>the Commissioner may seek advice from an independent review organization or medical expert on the list compiled under § 15–10A–05(b) of this title; and</text>
      </level>
      <level label="ii">
        <text>the expenses for any advice provided by an independent review organization or medical expert shall be paid for as provided under § 15–10A–05(h) of this title.</text>
      </level>
    </level>
  </level>
  <level label="h">
    <text>This section may not be construed to supersede the authority of the Health Services Cost Review Commission to set rates for specialty drugs administered to patients in a setting regulated by the Health Services Cost Review Commission.</text>
  </level>
</section>
