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<chapter num="96" heading="Remote Patient Monitoring" title_num="10" subtitle_num="09">
  <regulation prefix="Regulation" num=".01" heading="Purpose and Scope.">
    <paragraph num="A.">
      <text>This chapter applies to remote patient monitoring services reimbursed by the Maryland Medical Assistance Program effective January 1, 2018.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The purpose of providing medically necessary services via remote patient monitoring is to assist participants in managing and controlling their chronic conditions in order to reduce readmissions and emergency department visits and to improve quality of care</text>
    </paragraph>
    <paragraph num="C.">
      <text>The target populations are high-risk Maryland Medical Assistance Program participants with a chronic disease capable of monitoring via remote patient monitoring.</text>
    </paragraph>
  </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>“Certified nurse midwife” means an individual who meets the licensure and conditions of participation for certified nurse midwives set forth in COMAR 10.09.01.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Certified nurse practitioner” means an individual who meets the licensure and conditions of participation for certified nurse practitioners set forth in COMAR 10.09.01.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Department” means the Maryland Department of Health, which is the single State agency designated to administer the</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Episode” means the span of treatment during which remote patient monitoring services are rendered to eligible participants.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Home” means the place of residence occupied by the participant, other than a hospital, nursing facility, or other medical or psychiatric institution.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Home health agency" means a public or private agency or organization that meets the licensure requirements and conditions of participation of COMAR 10.09.04.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Maryland Medical Assistance Program” means the program of comprehensive medical, behavioral, and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Medically necessary” means that the service or benefit is:</text>
        <paragraph num="(a)">
          <text>Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Consistent with currently accepted standards of good medical practice;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Not primarily for the convenience of the consumer, family, or provider.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(9)">
        <text>“Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.</text>
      </paragraph>
      <paragraph num="(10)">
        <text>“Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02.</text>
      </paragraph>
      <paragraph num="(11)">
        <text>“Physician assistant” means an individual who meets the licensure requirements and conditions of participation set forth in COMAR 10.09.55.</text>
      </paragraph>
      <paragraph num="(12)">
        <text>“Program” means the Maryland Medical Assistance Program.</text>
      </paragraph>
      <paragraph num="(13)">
        <text>“Provider” means an individual or an organization who:</text>
        <paragraph num="(a)">
          <text>Meets the requirements of Regulations .03 and .04 of this chapter; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of a unique provider number.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(14)">
        <text>“Remote patient monitoring” means the use of synchronous or asynchronous digital technologies that collect or monitor medical, patient-reported, and other forms of health care data for Program participants at an originating site and electronically transmit that data to a distant site provider to enable the distant site provider to assess, diagnose, consult, treat, educate, provide care management, suggest self-management, or make recommendations regarding the Program participant’s health care.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="License Requirements.">
    <paragraph num="A.">
      <text>The provider shall:</text>
      <paragraph num="(1)">
        <text>Meet all license requirements as set forth in COMAR 10.09.36.02; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be licensed in the state in which the participant resides.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A home health agency shall be:</text>
      <paragraph num="(1)">
        <text>Licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Legally authorized to provide home health services in the jurisdiction in which the service is provided.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided.</text>
    </paragraph>
    <paragraph num="D.">
      <text>A certified nurse practitioner shall:</text>
      <paragraph num="(1)">
        <text>Hold a current license to practice registered nursing in Maryland, and be certified as a nurse practitioner by the Nursing Board; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Meet the nurse practitioner regulatory requirements of the state in which the services are provided.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>A physician assistant applying for provider status shall:</text>
      <paragraph num="(1)">
        <text>Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be in compliance with requirements set forth in COMAR 10.32.03;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Provider Conditions for Participation.">
    <paragraph num="A.">
      <text>To provide remote patient monitoring, the provider shall:</text>
      <paragraph num="(1)">
        <text>Be enrolled with an active status as a Maryland Medical Assistance Program provider on the date the service is rendered;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be a:</text>
        <paragraph num="(a)">
          <text>Physician;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Physician assistant;</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Certified nurse practitioner; or</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Home health agency when remote patient monitoring services are prescribed by a physician; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Meet the requirements for participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Medical Record Documentation. A remote patient monitoring provider shall:</text>
      <paragraph num="(1)">
        <text>Maintain documentation using either electronic or paper medical records;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Retain remote patient monitoring records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Submit the preauthorization on a form developed by the Department; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Include the participant’s consent to participate in remote patient monitoring.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Remote patient monitoring is not a substitute for delivery of care. Provider shall see patients in person periodically for follow-up care.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Participant Eligibility for Services.">
    <text>A participant is eligible to receive remote patient monitoring services if:</text>
    <paragraph num="A.">
      <text>The participant is enrolled in the Maryland Medical Assistance Program on the date the service is rendered;</text>
    </paragraph>
    <paragraph num="B.">
      <text>The participant consents to remote patient monitoring services and has the capability to utilize the monitoring tools and take actions to improve self-management of the chronic disease;</text>
    </paragraph>
    <paragraph num="C.">
      <text>The participant has the internet connections necessary to host the equipment in the home;</text>
    </paragraph>
    <paragraph num="D.">
      <text>The participant is at risk for avoidable hospital utilization due to a poorly controlled chronic disease capable of being monitored via remote patient monitoring; and</text>
    </paragraph>
    <paragraph num="E.">
      <text>The provision of remote patient monitoring may reduce the risk of preventable hospital utilization and promote improvement in control of the chronic condition</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Covered Services.">
    <paragraph num="A.">
      <text>Remote patient monitoring services include:</text>
      <paragraph num="(1)">
        <text>Installation;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Education for the participant in the use of the equipment; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Daily monitoring of vital signs and other medical statistics.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The remote patient monitoring provider shall establish an intervention process to address abnormal data measurements in an effort to prevent avoidable hospital utilization.</text>
    </paragraph>
    <paragraph num="C.">
      <text>Physician, nurse practitioner, and physician assistant providers who establish remote patient monitoring programs shall be responsible for:</text>
      <paragraph num="(1)">
        <text>Establishing criteria for reporting abnormal measurements;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Informing the participant of abnormal results; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Monitoring results and improvements in patient’s ability to self-manage chronic conditions.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Medical interventions by a physician, nurse practitioner, or physician assistant based on abnormal results shall be reimbursed according to COMAR 10.09.02.07.</text>
    </paragraph>
    <paragraph num="E.">
      <text>A home health agency shall:</text>
      <paragraph num="(1)">
        <text>Have an order by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner who has examined the patient and with whom the patient has an established, documented and ongoing relationship;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Report abnormal measurements to the participant and to the ordering provider; and</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Send the ordering provider a weekly summary of monitoring results, including improvement in patient’s ability to self-manage chronic conditions.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Limitations.">
    <paragraph num="A.">
      <text>Remote patient monitoring services are only covered for participants who meet the eligibility criteria specified in Regulation .05 of this chapter.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The Program does not cover:</text>
      <paragraph num="(1)">
        <text>Remote patient monitoring equipment;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Upgrades to remote patient monitoring equipment;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>The internet connections necessary to transmit the results of remote patient monitoring services to the provider’s offices; or</text>
      </paragraph>
      <paragraph num="(4)">
        <text>More than:</text>
        <paragraph num="(a)">
          <text>2 months of remote patient monitoring services per episode; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Two episodes per year per participant.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Home health agencies may only be reimbursed for remote patient monitoring when the service is ordered by a physician.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Preauthorization Requirements.">
    <text>The Department may preauthorize services when the provider submits to the Department adequate documentation demonstrating the:</text>
    <paragraph num="A.">
      <text>Participant’s condition meets the criteria listed in Regulation .05 of this chapter; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Participant has not already been preauthorized for two episodes during the past rolling calendar year.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Payment Methodology.">
    <paragraph num="A.">
      <text>After providing the services outlined in Regulation .06 of this chapter, the remote patient monitoring provider shall submit the request for payment using the format designated by the Department.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Home health agencies shall:</text>
      <paragraph num="(1)">
        <text>Bill on a UB04; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be paid a monthly rate.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Physicians, nurse practitioners, and physician assistants who provide remote patient monitoring shall:</text>
      <paragraph num="(1)">
        <text>Bill using a CMS 1500 or an 837P; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Be paid a monthly rate.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Professionals following up on abnormal results from remote patient monitoring shall be paid the lesser of:</text>
      <paragraph num="(1)">
        <text>Provider’s customary charge unless the service is free to individuals not covered by Medicaid; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The Department’s professional fee schedule as found in COMAR 10.09.02.07.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Recovery and Reimbursement.">
    <text>Recovery and reimbursement shall be in accordance with COMAR 10.09.36.07.</text>
  </regulation>
  <regulation prefix="Regulation" num=".11" heading="Cause for Suspension or Removal and Imposition of Sanctions.">
    <text>Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36.08.</text>
  </regulation>
  <regulation prefix="Regulation" num=".12" heading="Appeal Procedures.">
    <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so in accordance with COMAR 10.09.36.09.</text>
  </regulation>
  <regulation prefix="Regulation" num=".13" heading="Interpretive Regulation.">
    <text>Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.</text>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §15-103(b), Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: January 1, 2018 (44:26 Md. R. 1215)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01C amended effective July 24, 2023 (50:14 Md. R. 593)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 24, 2023 (50:14 Md. R. 593)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 24, 2023 (50:14 Md. R. 593)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06E amended effective July 24, 2023 (50:14 Md. R. 593)</annotation>
  </annotations>
</chapter>