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<chapter num="18" heading="Denials of Coverage Based on Medical Necessity" title_num="31" subtitle_num="10">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter applies to carriers and to private review agents to whom the internal grievance process has been delegated by a carrier.</text>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>Adverse Decision.</text>
        <paragraph num="(a)">
          <text>“Adverse decision” means a utilization review determination by a private review agent, a carrier, or a health care provider acting on behalf of a carrier that:</text>
          <paragraph num="(i)">
            <text>A proposed or delivered health care service which would otherwise be covered under the member's contract is not or was not medically necessary, appropriate, or efficient; and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>May result in noncoverage of the health care service.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>“Adverse decision” does not include a decision concerning a person's status as a member.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>“Carrier” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Complaint” means a protest filed with the Commissioner involving an adverse decision or grievance decision concerning a member.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Emergency case” means a case involving an adverse decision for which an expedited review is required under Regulation .05 of this chapter.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Filing date” means the earlier of:</text>
        <paragraph num="(a)">
          <text>5 days after the date of mailing; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The date of receipt.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(6)">
        <text>“Grievance” means a protest filed by a member, a member’s representative, or a health care provider on behalf of a member with a carrier through the carrier's internal grievance process regarding an adverse decision concerning the member.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Grievance decision” means a final determination by a carrier that arises from a grievance filed with the carrier under its internal grievance process regarding an adverse decision concerning a member.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Health Advocacy Unit” means the Health Education and Advocacy Unit in the Division of Consumer Protection of the Office of the Attorney General established under Commercial Law Article, Title 13, Subtitle 4A, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(9)">
        <text>“Health care provider” means:</text>
        <paragraph num="(a)">
          <text>An individual who is:</text>
          <paragraph num="(i)">
            <text>Licensed or otherwise authorized in this State to provide health care services in the ordinary course of business or practice of a profession, and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>A treating provider of a member; or</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(10)">
        <text>“Health care service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(11)">
        <text>Member.</text>
        <paragraph num="(a)">
          <text>“Member” means a person entitled to health care benefits under a policy, plan, or certificate issued or delivered in the State by a carrier.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Member” includes:</text>
          <paragraph num="(i)">
            <text>A subscriber; and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Unless preempted by federal law, a Medicare recipient.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(c)">
          <text>“Member” does not include a Medicaid recipient.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(12)">
        <text>“Member’s representative” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(13)">
        <text>“Private review agent” has the meaning stated in Insurance Article, §15-10B-01, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Repealed." />
  <regulation prefix="Regulation" num=".04" heading="Health Advocacy Unit Information in Notice of Adverse Decision.">
    <text>A carrier shall include in each notice of adverse decision the following disclosure in at least 12-point typeface, with the first sentence in bold capital typeface:</text>
    <text>"THERE IS HELP AVAILABLE TO YOU IF YOU WISH TO DISPUTE THE DECISION OF THE PLAN ABOUT PAYMENT FOR HEALTH CARE SERVICES. You may contact the Health Advocacy Unit of Maryland's Consumer Protection Division at (phone number, address, fax, e-mail).</text>
    <text>The Health Advocacy Unit can help you, your representative, and your health care provider prepare a grievance to file under the carrier's internal grievance procedure. That unit can also attempt to mediate a resolution to your dispute. The Health Advocacy Unit is not available to represent or accompany you during any proceeding of the internal grievance process.</text>
    <text>Additionally, you, your representative, or your health care provider may file a complaint with the Maryland Insurance Administration, without having to first file a grievance with the plan, if:</text>
    <paragraph num="(1)">
      <text>The plan has denied authorization for a health care service not yet provided to you; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>You, your representative, or your provider can show a compelling reason to file a complaint, including that a delay in receiving the health care service could result in loss of life, serious impairment to a bodily function, or serious dysfunction of a bodily organ or part, or the member remaining seriously mentally ill with symptoms that cause the member to be in danger to self or others. INFORMATION DESCRIBED IN THIS NOTICE MAY ALSO BE FOUND IN (cite policy, plan, certificate, enrollment materials, or other evidence of coverage)."</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Procedures for Emergency Cases.">
    <paragraph num="A.">
      <text>An expedited review of an adverse decision in accordance with this regulation is required if the:</text>
      <paragraph num="(1)">
        <text>Adverse decision is rendered for health care services that are proposed but have not been delivered; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Services are necessary to treat a condition or illness that, without immediate medical attention, would:</text>
        <paragraph num="(a)">
          <text>Seriously jeopardize the life or health of the member of the member’s ability to regain maximum functions;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Cause the member to be in danger to self or others; or</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Cause the member to continue using intoxicating substances in an imminently dangerous manner.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The content of any written notice by a carrier of an adverse decision or grievance decision under this regulation shall comply with Regulation .04 of this chapter and Insurance Article, §15-10A-02(f) and(i), Annotated Code of Maryland.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Establishment, Filing, and Reporting of Internal Grievance Process.">
    <paragraph num="A.">
      <text>Each carrier shall establish an internal grievance process.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Each carrier shall:</text>
      <paragraph num="(1)">
        <text>File with the Commissioner its internal grievance process not more than 30 days after the effective date of this chapter;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>File with the Commissioner each amendment to its internal process at least 30 days before its intended use;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Include with the filing the circumstances, if any, under which the internal grievance process will be delegated to a private review agent;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Include with the filing a copy of the applicable part of the policy, plan, certificate, enrollment materials, or other evidence of coverage that shows the information required under Insurance Article, §15-10A-02(k), Annotated Code of Maryland; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Submit to the Health Advocacy Unit the document describing the details of its internal grievance process and procedures that the carrier will send to a member, member’s representative, or health care provider when the member, member’s representative, or provider contacts the carrier about an adverse decision.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Each carrier shall submit its internal grievance process and any amendments to the Health Advocacy Unit not later than the date on which the carrier begins to use the process or amendment.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Requirements for Internal Grievance Process.">
    <text>An internal grievance process shall:</text>
    <paragraph num="A.">
      <text>Meet the requirements established under this chapter; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Include an expedited procedure for use in an emergency case for purposes of rendering a grievance decision within 24 hours after filing the grievance pursuant to the carrier's internal grievance process, that includes an explanation about:</text>
      <paragraph num="(1)">
        <text>Who will make the determination whether an emergency case exists when a grievance asserts an emergency case,</text>
      </paragraph>
      <paragraph num="(2)">
        <text>How the determination will be made about the existence of an emergency case,</text>
      </paragraph>
      <paragraph num="(3)">
        <text>How the disclosure to the member, the member’s representative, or health care provider required by Insurance Article, §15-10A-02(g), Annotated Code of Maryland, will be provided when the grievance asserts that an emergency case exists; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>How the notice to the member and, if applicable, the member’s representative and health care provider required by Insurance Article, §15-10A-02(i), Annotated Code of Maryland, will be provided when the grievance asserts that an emergency case exists.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Time for Rendering Final Decisions Resulting from Internal Grievance Process.">
    <paragraph num="A.">
      <text>Except as otherwise provided in this regulation, a carrier shall render a final decision on a grievance that involves a:</text>
      <paragraph num="(1)">
        <text>Prospective denial in a nonemergency case within 30 working days after the filing date; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Retrospective denial within 45 working days after the filing date.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>With the written consent of the member, member’s representative, or health care provider who filed a grievance on behalf of the member, a carrier may extend the period for making a final decision for an additional period of not longer than 30 working days.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Repealed." />
  <regulation prefix="Regulation" num=".10" heading="Repealed." />
  <regulation prefix="Regulation" num=".11" heading="Demonstration of Compelling Reason to File Complaint.">
    <paragraph num="A.">
      <text>A member, a member’s representative, or a health care provider on behalf of a member may file a complaint without first exhausting the internal grievance process of a carrier if the complaint demonstrates to the satisfaction of the Commissioner a compelling reason to do so. A compelling reason includes showing that the potential delay in receipt of a health care service until after the member or health care provider exhausts the internal grievance process and obtains a final decision under the grievance process could result in:</text>
      <paragraph num="(1)">
        <text>Loss of life;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Serious impairment to a bodily function;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Serious dysfunction of a bodily organ;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>The member remaining seriously mentally ill or using intoxicating substances with symptoms that cause the member to be in danger to self or others; or</text>
      </paragraph>
      <paragraph num="(5)">
        <text>The member continuing to experience severe withdrawal symptoms.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A member is considered to be in danger to self or others if the member is unable to function in activities of daily living or care for self without imminent dangerous consequences.</text>
    </paragraph>
    <paragraph num="C.">
      <text>In a case involving a retrospective denial, there is no compelling reason to allow a member, a member’s representative, or a health care provider on behalf of a member to file a complaint without first exhausting the internal grievance process of a carrier.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".12" heading="General Procedures for Complaints.">
    <paragraph num="A.">
      <text>Consent Form.</text>
      <paragraph num="(1)">
        <text>For services rendered on or after January 1, 1999, the Commissioner shall request the signed consent of the member that filed the complaint, or a legally authorized designee of the member, authorizing the release of the member's medical records to the Commissioner or the Commissioner's designee that are needed in order for the Commissioner to make a final decision on the complaint.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The Commissioner may refuse to investigate a complaint if the member or legally authorized designee of the member fails to sign a consent form.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>In the case of alcohol and drug abuse, the member shall deliver the member's medical records to the Health Advocacy Unit or to the Commissioner, or to both, pursuant to federal law and regulations.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The Commissioner may refer complaints not within the Commissioner's jurisdiction to the Health Advocacy Unit or any other appropriate federal or state government agency or unit for disposition or resolution.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Insurance Article, §2-109 and Title 15, Subtitle 10A, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date:</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .01—.15 adopted as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); adopted permanently effective March 22, 1999 (26:6 Md. R. 490)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective April 11, 2005 (32:7 Md. R. 686)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective April 16, 2012 (39:7 Md. R. 496)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05A amended effective July 30, 2018 (45:15 Md. R. 728)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .11 amended effective July 30, 2018 (45:15 Md. R. 728)</annotation>
  </annotations>
</chapter>