<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.32.22.06" title_num="10" subtitle_num="32" chapter_num="22" heading="Enforcement.">
  <paragraph num="A.">
    <text>The Board shall conduct any necessary investigation regarding failure of a reporting entity to file a report required under this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Over the signature of an officer, the executive director, or the deputy director, the Board may issue subpoenas in connection with any investigation or proceeding to enforce this chapter.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Before submission of the final investigative report to the Board, the investigator shall inform the reporting entity of the allegation of failure to report and offer the reporting entity an opportunity to submit a written response. Any written response shall be made part of the investigative report. The investigative report is confidential and may not be released to any person except as provided in §E of this regulation.</text>
  </paragraph>
  <paragraph num="D.">
    <text>The final investigative report shall be submitted to the Board. The Board, after consideration of the investigative report, shall:</text>
    <paragraph num="(1)">
      <text>If it finds probable cause that the reporting entity failed to report as required by this chapter, vote to issue a notice of failure to file a report setting out the facts of the alleged failure and the recommended civil penalty as set out in §O of this regulation; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Dismiss the case.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>If the Board votes to issue a notice of failure to file a report, the Board shall mail by first class mail the notice of failure to file a report to the reporting entity involved. Upon this mailing, the Board shall make available to the reporting entity the investigative report, less the names of any confidential informants who will not be called as witnesses in the case.</text>
  </paragraph>
  <paragraph num="F.">
    <text>If the reporting entity does not request a hearing within 30 days of the date the notice of failure to file a report was mailed, the notice of failure to file a report shall become final and shall constitute a final disposition of the Board.</text>
  </paragraph>
  <paragraph num="G.">
    <text>A reporting entity which has timely filed a request for a hearing may choose to attend a settlement conference with a committee of the Board to attempt to resolve a case. If a settlement conference is convened:</text>
    <paragraph num="(1)">
      <text>The reporting entity may be represented by counsel;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Except for consideration of a proposed resolution of the case, the Board may not use any commentary, admissions, facts revealed, or positions taken at the settlement conference, unless the subject matter is available from other sources or is otherwise discovered;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>At the conclusion of the settlement conference, the committee shall recommend either:</text>
      <paragraph num="(a)">
        <text>Dismissing the notice of failure to file a report; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Upholding the notice of failure to file a report and imposing a civil penalty as set out in §O of this regulation.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>If the reporting entity agrees with the recommendation of the settlement committee, the Board shall consider the recommendation and either accept or reject it. The Board’s acceptance of the settlement committee’s recommendation constitutes the Board’s final disposition of the case.</text>
  </paragraph>
  <paragraph num="I.">
    <text>If a settlement is not reached or if the settlement committee’s recommendation is not approved by the Board, the case shall proceed to a hearing before the Board.</text>
  </paragraph>
  <paragraph num="J.">
    <text>The hearing ordinarily shall be limited to oral argument before the Board. The issues at the hearing are limited to whether a reporting entity:</text>
    <paragraph num="(1)">
      <text>Made a change as defined in this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Had reason to believe that the change was made, in whole or in part, because of a reason listed in Regulation .03B of this chapter;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Reported the change to the Board; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Reported the change within the time frames set out in this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>The Board chair or alternate presiding officer may reasonably limit the time for oral argument.</text>
  </paragraph>
  <paragraph num="L.">
    <text>The Board shall conduct an evidentiary hearing if the chair or alternate presiding officer finds that there is a substantial dispute concerning one or more of the material facts set out in §J of this regulation. If there is an evidentiary hearing, the Board chair or alternate presiding officer may:</text>
    <paragraph num="(1)">
      <text>Administer oaths or affirmations;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Issue subpoenas for relevant evidence;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Make all rulings on the admission of evidence;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Rule on motions;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Exclude repetitive or irrelevant evidence, require the parties to narrow the factual evidence to the relevant issues, and make any other rulings in order to focus and expedite the proceeding;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Require proffers of evidence in advance of the hearing and make evidentiary rulings before the commencement of the hearing; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Reasonably limit the time for presentations.</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>It is not a defense to the allegation of a failure to report that:</text>
    <paragraph num="(1)">
      <text>An employee of the reporting entity was not aware of:</text>
      <paragraph num="(a)">
        <text>The change made by the reporting entity; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The obligation to report; or</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The reporting entity was conducting its own proceeding to further evaluate the change or the reasons for the change.</text>
    </paragraph>
  </paragraph>
  <paragraph num="N.">
    <text>If the Board finds after the hearing that the reporting entity did not fail to file any report required by this chapter, the Board shall issue a final disposition dismissing the notice of failure to file a report.</text>
  </paragraph>
  <paragraph num="O.">
    <text>If the Board finds after a hearing that a reporting entity failed to file any report required by this chapter, the Board shall issue a final disposition with findings of fact, conclusions of law, and civil penalty. In its final disposition, the Board may impose a civil penalty as follows:</text>
    <paragraph num="(1)">
      <text>With respect to reports concerning physicians:</text>
      <paragraph num="(a)">
        <text>$2,500 for the first occurrence in a calendar year; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>$5,000 for any subsequent occurrence in a calendar year; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>With respect to reports concerning allied health providers:</text>
      <paragraph num="(a)">
        <text>$500 for the first occurrence in a calendar year; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>$1,000 for any subsequent occurrence in a calendar year.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="P.">
    <text>The Board disposition is the final administrative action on the matter.</text>
  </paragraph>
  <paragraph num="Q.">
    <text>A reporting entity that is dissatisfied with a final disposition of the Board may seek judicial review of the Board’s final disposition as provided in the Administrative Procedure Act. The disposition of the Board may not be stayed pending judicial review.</text>
  </paragraph>
  <paragraph num="R.">
    <text>The Board shall pay all monies collected pursuant to this chapter into the State’s General Fund. The Board may refer any uncollected civil penalties under this regulation to the Central Collection Unit of the State.</text>
  </paragraph>
  <paragraph num="S.">
    <text>The investigative and quasi-judicial procedures set out in this regulation, and the confidentiality provisions of Regulation .07 of this chapter, apply to licensed naturopathic doctors, other licensed health care providers, health care facilities located in the State, and State agencies with respect to any allegations that they failed to file a report required under Regulation .04 of this chapter.</text>
  </paragraph>
</regulation>