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<subtitle num="66" heading="Office of the Inspector General" title_num="10" title_heading="Maryland Department of Health">
  <chapter num="01" heading="Civil Money Remedy">
    <regulation prefix="Regulation" num=".01" heading="Scope.">
      <text>This chapter establishes standards for civil money remedies against any provider of health care services or health care supplies or equipment if the Office of the Inspector General finds there are grounds under Health General Article, §2-504.1, Annotated Code of Maryland, to impose a civil money remedy.</text>
    </regulation>
    <regulation prefix="Regulation" num=".02" heading="Definitions.">
      <paragraph num="A.">
        <text>The following terms have the meaning indicated.</text>
      </paragraph>
      <paragraph num="B.">
        <text>Terms Defined.</text>
        <paragraph num="(1)">
          <text>“Civil money remedy” means a monetary remedy authorized by Health-General Article, §2-504.1, Annotated Code of Maryland, and imposed for a violation of statute or regulation governing the conditions of payment for any service or item for which the provider submitted a claim for payment and received payment.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>“Department” means the Maryland Department of Health.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>“Hearing” means a contested case hearing as defined by the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text>
        </paragraph>
        <paragraph num="(4)">
          <text>“Identified recovery” means the total dollar amount of claims identified by the OIG as paid to the provider for a service or item not provided in accordance with applicable statute and regulations.</text>
        </paragraph>
        <paragraph num="(5)">
          <text>"Inspector General” means the Inspector General, or the designated Assistant Inspector General, within the Department of Health and Mental Hygiene.</text>
        </paragraph>
        <paragraph num="(6)">
          <text>“Office of Administrative Hearings (OAH)” means the independent unit in the Executive Branch of State government authorized to conduct hearings in contested cases, pursuant to the Administrative Procedure Act and this chapter.</text>
        </paragraph>
        <paragraph num="(7)">
          <text>“OIG” means the Office of the Inspector General within the Department of Health and Mental Hygiene.</text>
        </paragraph>
        <paragraph num="(8)">
          <text>“Violation” means the provision of a service that does not comply with applicable statutes or regulations or both.</text>
        </paragraph>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".03" heading="Civil Money Remedy — Imposition.">
      <paragraph num="A.">
        <text>A civil money remedy may be imposed against a provider for violation of a State or federal law governing the conditions of payment for any service or item for which the provider submitted a claim for payment and received payment.</text>
      </paragraph>
      <paragraph num="B.">
        <text>It is within the sole discretion of the Inspector General as to whether a civil money remedy is imposed.</text>
      </paragraph>
      <paragraph num="C.">
        <text>A civil money remedy may not be imposed if otherwise prohibited by State or federal law.</text>
      </paragraph>
      <paragraph num="D.">
        <text>A civil money remedy imposed under this chapter:</text>
        <paragraph num="(1)">
          <text>Is in lieu of full payment or full adjustment of the paid claim and not in addition to repayment of the claim;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>May not be less than the federal financial participation share of the identified improper claim amount unless good cause is shown;</text>
        </paragraph>
        <paragraph num="(3)">
          <text>May not exceed the amount of reimbursement that the provider received for the paid claim;</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Is only available if the provider has not been subjected to a:</text>
          <paragraph num="(a)">
            <text>Repayment penalty or fine;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Criminal action; or</text>
          </paragraph>
          <paragraph num="(c)">
            <text>Civil false claims action under either federal or State law for the same claim; and</text>
          </paragraph>
        </paragraph>
        <paragraph num="(5)">
          <text>May not be imposed if the claim was included in the universe of claims under an extrapolation calculation.</text>
        </paragraph>
      </paragraph>
      <paragraph num="E.">
        <text>A claim may be made on the basis of more than one violation, but there shall be only one civil money remedy per claim, regardless of the number of violations on which the claim is based.</text>
      </paragraph>
      <paragraph num="F.">
        <text>In determining whether a civil money remedy is to be imposed and in setting the amount of the civil money remedy, the Inspector General shall consider:</text>
        <paragraph num="(1)">
          <text>The number, nature, and seriousness of the violation or violations;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>The provider’s history of compliance;</text>
        </paragraph>
        <paragraph num="(3)">
          <text>The efforts made by the provider to correct the violations and any continuation of conduct after notification of possible violations;</text>
        </paragraph>
        <paragraph num="(4)">
          <text>The provider’s level of cooperation with the Department or Inspector General as it relates to the review of the claim;</text>
        </paragraph>
        <paragraph num="(5)">
          <text>The degree of risk to the health, life, or safety of consumers as a result of the violations; and</text>
        </paragraph>
        <paragraph num="(6)">
          <text>Any other reasonable factors as fairness may require.</text>
        </paragraph>
      </paragraph>
      <paragraph num="G.">
        <text>The Inspector General shall give special consideration to the extent to which the provider’s size, operations, or financial condition:</text>
        <paragraph num="(1)">
          <text>May have contributed to the violations; and</text>
        </paragraph>
        <paragraph num="(2)">
          <text>May affect the provider’s ability to provide care and continue operations after payment of a civil money remedy.</text>
        </paragraph>
      </paragraph>
      <paragraph num="H.">
        <text>If the civil money remedy is imposed under this chapter, the Inspector General shall issue a written notice and order to the provider that:</text>
        <paragraph num="(1)">
          <text>States the total amount of the civil money remedies being imposed; and</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Includes the following information:</text>
          <paragraph num="(a)">
            <text>The basis on which the order is made;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Each regulation or statute violated;</text>
          </paragraph>
          <paragraph num="(c)">
            <text>The amount of each civil money remedy imposed for each claim;</text>
          </paragraph>
          <paragraph num="(d)">
            <text>The number of claims and total value of the claims identified with errors;</text>
          </paragraph>
          <paragraph num="(e)">
            <text>The manner in which the amount of the civil money remedy was calculated; and</text>
          </paragraph>
          <paragraph num="(f)">
            <text>The provider’s appeal rights.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="I.">
        <text>The notice and order shall be sent to the provider by certified mail.</text>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".04" heading="Civil Money Remedy — Appeal.">
      <paragraph num="A.">
        <text>A provider aggrieved by the imposition of a civil money remedy may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="B.">
        <text>The Inspector General has the burden of proof with respect to the basis for the imposition of the civil money remedy.</text>
      </paragraph>
      <paragraph num="C.">
        <text>The Office of Administrative Hearings shall render a final decision within 30 days of the hearing.</text>
      </paragraph>
      <paragraph num="D.">
        <text>An order that imposes a civil money remedy is final when the provider has exhausted all opportunities to contest the civil money remedy in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="E.">
        <text>After exhaustion of all appeals, a provider shall pay a civil money remedy to the Department within 10 days after the provider receives a final order that affirms the imposition of the civil money remedy unless the Inspector General negotiates and approves a repayment schedule.</text>
      </paragraph>
      <paragraph num="F.">
        <text>If a provider does not pay the civil money remedy to the Department after receiving the final order or according to a negotiated repayment schedule, the State may deduct the amount of the civil money remedy from any sum that is then or later owed by the State to the provider, pursuant to State Finance and Procurement Article, §7-222, Annotated Code of Maryland.</text>
      </paragraph>
    </regulation>
    <annotations>
      <annotation type="Authority">Health-General Article, §2-504.1, Annotated Code of Maryland</annotation>
      <annotation type="History" subtype="Administrative History">Effective date: July 17, 2017 (44:14 Md. R. 655)</annotation>
    </annotations>
  </chapter>
</subtitle>