<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.24.01.09" title_num="10" subtitle_num="24" chapter_num="01" heading="Commission Decision and Action on CON Applications.">
  <paragraph num="A.">
    <text>Proposed Decision.</text>
    <paragraph num="(1)">
      <text>Preparation of Proposed Decision.</text>
      <paragraph num="(a)">
        <text>In a comparative or contested review, or in a review in which an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Executive Director shall appoint a single Commissioner, who may be assisted by the staff of the Commission, to act as reviewer and prepare a proposed decision for consideration by the Commission.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In all other reviews, Commission staff shall review the application and prepare a staff report and recommendation for consideration by the Commission.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Project Status Conference.</text>
      <paragraph num="(a)">
        <text>The reviewer or staff, as appropriate, may request that a project status conference be held before the issuance of a proposed decision or staff report, to apprise each applicant, interested party, and participating entity of those aspects of a proposed project that appear to be inconsistent with applicable standards and review criteria.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Following the project status conference, the reviewer or staff will send each applicant, interested party, and participating entity a summary of the project status conference that includes dates, as needed, for additional filings.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The applicant shall send to each interested party and participating entity a copy of proposed project changes made pursuant to the project status conference.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Each interested party and participating entity in the review of an application shall have 7 days to file comments on the proposed changes made pursuant to the project status conference.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Opportunity to Present Oral Argument. Each applicant and interested party in a contested or comparative review may request the opportunity to present oral argument to the reviewer before the reviewer prepares a proposed decision on the application for consideration by the full Commission, as follows:</text>
      <paragraph num="(a)">
        <text>The request shall be made within the time period for an applicant's response to comments under Regulation .08F(1) of this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The decision to grant oral argument is at the sole discretion of the reviewer;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The reviewer may set reasonable time limits for oral argument; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The reviewer may, if there is a genuine dispute as to the credibility of a material witness on a matter of fact, require the witness to answer questions on that matter under oath during the oral argument portion of a CON review.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A staff report and recommendation on a proposed project or a reviewer’s proposed decision on a project shall state the staff’s conclusion or the reviewer's finding as to whether:</text>
      <paragraph num="(a)">
        <text>Each relevant State Health Plan standard or review criterion set forth in Regulation .08G of this chapter:</text>
        <paragraph num="(i)">
          <text>Is met by the applicant;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Is not applicable to the project; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Is applicable to the project and is not met by the applicant;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>In a comparative review, one or more of the projects is preferred under a State Health Plan standard or criterion either as a result of consideration of a preference standard or because one or more of the projects was determined to be superior based on the reviewer’s consideration of the applicable criteria; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>To recommend that one or more of the projects be granted a CON.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Exceptions.</text>
    <paragraph num="(1)">
      <text>Pursuant to State Government Article, §10-216, Annotated Code of Maryland, each applicant and interested party who has submitted comments under Regulation .08F(1) of this chapter may submit written exceptions to a staff report and recommendation or a proposed decision and make oral argument to the Commission.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Schedule.</text>
      <paragraph num="(a)">
        <text>A proposed decision in a contested or comparative review shall be issued at least 30 days before the Commission meeting at which the proposed decision and order will be considered.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Upon issuance of a staff report or proposed decision, Commission staff shall issue a notice specifying the schedule for the submission of exceptions and any response, the date on which the Commission shall hear oral argument, and rules for conduct of the hearing.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff in a contested or comparative review shall specify that exceptions shall be filed on a date at least 10 days after the issuance of a proposed decision and any response to the exceptions filed on a date at least 7 days after the filing of exceptions. The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Exceptions Requirements.</text>
      <paragraph num="(a)">
        <text>Exceptions shall specifically identify each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Exceptions shall be limited to 25 pages, double-spaced, excluding attachments.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Responses to exceptions shall be limited to 15 pages, double-spaced, excluding attachments.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Oral arguments before the full Commission concerning the proposed decision are limited to 10 minutes per applicant and 10 minutes per interested party, unless extended by the Chair of the Commission. An applicant may reserve time for rebuttal.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Participation By Participating Entity In Certain Reviews After Issuance of a Staff Report or Reviewer's Proposed Decision.</text>
    <paragraph num="(1)">
      <text>Request by Participating Entity to Address the Commission.</text>
      <paragraph num="(a)">
        <text>After the issuance of a staff report or a reviewer's proposed decision, a participating entity may request the opportunity to address the Commission before Commission action on the application by submitting a written request at least 7 days before the scheduled Commission meeting that will consider an application, specifying the points that it wants to make.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The Chair of the Commission, after consultation with the Executive Director, may permit a participating entity, or combination of participating entities, to make an oral presentation to the Commission on matters it addressed in written comments on the application.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>At least 5 days before the scheduled Commission meeting that will consider an application, the Executive Director shall advise each applicant, interested party, and participating entity in a review whether the Chair will permit a participating entity or combination of participating entities to make an oral presentation to the Commission, and shall specify the format of the presentation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>An applicant may address the Commission in any review in which a participating entity is granted permission to address the Commission before action on an application.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Final Decision.</text>
    <paragraph num="(1)">
      <text>The Commission's final decision on a project shall contain findings of fact and conclusions of law and:</text>
      <paragraph num="(a)">
        <text>Approve the application;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Approve the application with conditions; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Deny the application.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The decision of the Commission shall be by a majority of the quorum present and voting.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Action on the Application.</text>
    <paragraph num="(1)">
      <text>The Commission shall act on an application for a CON not later than 150 days after the application has been docketed. If no evidentiary hearing is held, the Commission shall act on an application within 90 days after the docketing of the application. Staff shall report to the Commission the status of all projects where a staff report is not issued for Commission action within 90 days.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>With the exception of CON applications to establish a health care facility, relocate a health care facility, or establish cardiac surgery services or organ transplantation services at an existing acute general hospital, a CON application filed after October 1, 2019 shall be deemed approved if the application is uncontested and final action by the Commission does not occur within 120 days after the application is docketed.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>On motion by an applicant or an interested party, a review of a CON application may be stayed for a period not to exceed 6 months if the reviewer, or if a reviewer is not appointed, the Executive Director, determines that there is good cause for a stay.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The Commission shall notify the applicant, interested parties, participating entities, and the local health department of the Commission’s final decision.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The Commission may not render a final decision until:</text>
      <paragraph num="(a)">
        <text>A staff report and recommendation or a reviewer’s proposed decision has been provided to each party; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Each applicant and interested party has been given an opportunity to file exceptions and present oral argument before the Commission.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Judicial Review.</text>
    <paragraph num="(1)">
      <text>The Commission's final decision is subject to judicial review under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>In order to seek judicial review, a party must be an aggrieved party.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>For purposes of judicial review, the record of the proceeding shall include:</text>
      <paragraph num="(a)">
        <text>The application;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Requests to an applicant for additional information from Commission staff, the reviewer, the Commission, and responses to the requests;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Comments received from each interested party and responses from each applicant;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Reports or recommendations from staff;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Motions and responsive filings;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>The prehearing conference report, if any;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Prefiled testimony, if any;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>A recording or transcript of any hearing;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>The reviewer's proposed decision, all exceptions, and responses to exceptions; and</text>
      </paragraph>
      <paragraph num="(j)">
        <text>The Commission's final decision.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A decision of the Commission is a final decision for purposes of judicial review.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A request for reconsideration in accordance with Regulation .19 of this chapter will stay the final decision of the Commission for purposes of judicial review until the Commission decides the request for reconsideration.</text>
    </paragraph>
  </paragraph>
</regulation>