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<regulation prefix="Regulation" num=".01" citation="COMAR 10.67.07.01" title_num="10" subtitle_num="67" chapter_num="07" heading="Requirements to Detect and Prevent Fraud, Waste, and Abuse.">
  <paragraph num="A.">
    <text>An MCO or its responsible subcontractor shall implement and maintain arrangements or procedures that are designed to detect and prevent fraud, waste, and abuse, which includes a compliance program that has, at a minimum, the following elements:</text>
    <paragraph num="(1)">
      <text>Written policies, procedures, and standards of conduct that include the MCO’s commitment to comply with all applicable:</text>
      <paragraph num="(a)">
        <text>Requirements and standards under the contract; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Federal and State requirements including:</text>
        <paragraph num="(i)">
          <text>Written policies for all employees and those of any contractor or agent that provide detailed information about the False Claims Act and other Federal and State laws described in §1902(a)(68) of the Social Security Act; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Information about rights of employees to be protected as whistleblowers.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The designation of a compliance officer, who reports directly to the chief executive officer and the board of directors and is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements of the contract, and at minimum the following staff members:</text>
      <paragraph num="(a)">
        <text>An investigator who is responsible for fraud, waste, and abuse investigations;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An auditor who is responsible for identifying potential fraud, waste, and abuse through analysis of claims and related information; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>An analyst capable of reviewing data and codes who is responsible for reviewing and researching evidence of potential fraud, waste, and abuse.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Staffing and resources located in Maryland to identify and investigate potential fraud, waste, and abuse, which shall be based on criteria determined by the Department that may include but are not limited to:</text>
      <paragraph num="(a)">
        <text>Number of enrollees;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Number of claims received on an annual basis;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Volume of suspected fraudulent and abusive claims currently being detected;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Other factors relating to the vulnerability of the MCO to fraud and abuse; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>An assessment of optimal caseload which can be handled by an investigator on an annual basis.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The establishment of a regulatory compliance committee, which reports to the board of directors and to the MCO’s senior management level and is charged with overseeing the organization’s compliance program and its compliance with the requirements under the contract;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A system for training and educating the compliance officer, the organization’s senior management, and the organization’s employees regarding the federal and State standards and requirements under the contract;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Effective lines of communication between the compliance officer and the organization’s employees;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Enforcement of standards through well-publicized disciplinary guidelines;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Establishment and implementation of procedures and a system with dedicated staff for:</text>
      <paragraph num="(a)">
        <text>Routine internal monitoring and auditing of compliance risks;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prompt response to compliance issues as they are raised;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Investigation of potential compliance problems as identified in the course of self-evaluation and audits;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Correction of problems, identified under §A(7)(c) of this regulation, promptly and thoroughly, or coordination of suspected criminal acts with law enforcement agencies, to reduce the potential for recurrence; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Ongoing compliance with the requirements under the contract.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An MCO shall ensure that a subcontractor is legally qualified to furnish the services provided for in the subcontract.</text>
  </paragraph>
  <paragraph num="C.">
    <text>An MCO may not contract with the State unless conflict of interest safeguards at least equal to federal safeguards under section 27 of 41 U.S.C. §423, as amended, are in place.</text>
  </paragraph>
  <paragraph num="D.">
    <text>An MCO may not knowingly have a relationship of the type described in §E of this regulation with the following:</text>
    <paragraph num="(1)">
      <text>An individual or entity that is debarred, suspended, or otherwise excluded from:</text>
      <paragraph num="(a)">
        <text>Participating in procurement activities under the Federal Acquisition Regulation; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Participating in non-procurement activities under Executive Order Number 12549, 3 CFR 189 (1986); or</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>An individual or entity who is an affiliate, as defined in 48 CFR §2.101, of a person described in §D(1) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The relationships described in §D of this Regulation, are as follows:</text>
    <paragraph num="(1)">
      <text>A director, officer, or partner of the MCO;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A subcontractor of the MCO;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A person with beneficial ownership of 5 percent or more of the MCO’s equity; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A network provider or person with an employment, consulting or other arrangement with the MCO for the provision of items and services that is significant and material to the MCO’s obligations under its contract with the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>An MCO may not have a relationship with an individual or entity that is excluded from participation in any Federal health care program under §1128 or 1128A of the Social Security Act.</text>
  </paragraph>
  <paragraph num="G.">
    <text>An MCO shall monitor the Department’s correspondence and any database publicizing Department-initiated terminations of providers from the Program.</text>
  </paragraph>
  <paragraph num="H.">
    <text>An MCO shall terminate the contract of, or refrain from contracting with, providers terminated or excluded from participation in the Program.</text>
  </paragraph>
  <paragraph num="I.">
    <text>An MCO shall suspend payments to a network provider for which the Department has determined that there is a credible allegation of fraud in accordance with 42 CFR §455.23.</text>
  </paragraph>
  <paragraph num="J.">
    <text>An MCO shall establish a system to verify, by sampling or other methods, whether services that have been represented to have been delivered by network providers were received by enrollees and shall apply such verification processes at least annually.</text>
  </paragraph>
  <paragraph num="K.">
    <text>An MCO shall require and have a mechanism for a network provider to report to the MCO when it has received an overpayment and to:</text>
    <paragraph num="(1)">
      <text>Return the overpayment to the MCO within 60 calendar days after the date on which the overpayment was identified; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Notify the MCO in writing of the reason for the overpayment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>Overpayments to Providers and Subcontractors.</text>
    <paragraph num="(1)">
      <text>Overpayments recovered by an MCO, including those recovered due to waste, fraud and abuse, may be retained by the MCO, so long as it is reported to the Department.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If the Department, Federal government, or its agents identified the potential fraud, waste, or abuse that leads to recovery of funds paid to an MCO provider, and the MCO did not previously identify and report the provider for potential overpayments, the State shall have the right to recover from the MCO the entire amount of the overpayment.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The State shall have the sole right of recovery of an overpayment when the MCO has identified the overpayment and the MCO has not initiated recovery within 90 days after the completion of the MCO’s investigation.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The MCO shall have the right to appeal, pursuant to COMAR 10.67.10.02, the Department’s recovery of an overpayment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>The Department has the authority to recover any overpayments made to MCOs.</text>
  </paragraph>
  <paragraph num="N.">
    <text>An MCO shall ensure that all of its network providers are screened, enrolled, and revalidated by the State as Medicaid providers, in accordance with 42 CFR part 455, subparts B and E.</text>
  </paragraph>
</regulation>