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<chapter num="55" heading="Physician Assistants" title_num="10" subtitle_num="09">
  <regulation prefix="Regulation" num=".01" 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>“Advanced duties” means medical acts that require training and certification beyond the basic physician assistant education program.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Board” means the State Board of Physicians.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Delegation agreement” means a document that is executed by a licensed physician and a physician assistant containing the requirements of Health Occupation Article, §15-302, Annotated Code of Maryland, and COMAR 10.32.03.05.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Dispense” means to dispense starter dosages or drug samples.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Modification” means any change to the delegation agreement that governs the physician assistant’s performance of duties, including but not limited to practice location, scope of practice, change of supervising physician (primary or alternate), and prescriptive authority.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02.</text>
      </paragraph>
      <paragraph num="(9)">
        <text>“Physician assistant” means an individual who is licensed to practice medicine with physician supervision.</text>
      </paragraph>
      <paragraph num="(10)">
        <text>“Practice as a physician assistant” means the performance of medical acts that are:</text>
        <paragraph num="(a)">
          <text>Delegated by a supervising physician to a physician assistant;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Within the supervising physician’s scope of practice; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Appropriate to the physician assistant’s education, training, and experience.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(11)">
        <text>“Program” means the Maryland Medical Assistance Program.</text>
      </paragraph>
      <paragraph num="(12)">
        <text>“Provider” means a licensed physician assistant who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number.</text>
      </paragraph>
      <paragraph num="(13)">
        <text>“Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.</text>
      </paragraph>
      <paragraph num="(14)">
        <text>"Supervision” means the responsibility of the physician to exercise on-site supervision or to be able to provide immediate available direction for the physician assistants performing delegated medical acts, and includes:</text>
        <paragraph num="(a)">
          <text>Oversight of the physician assistant and acceptance of direct responsibility for the patient services and care rendered by the physician assistant;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Continuous availability to the physician assistant either in person, by telephone, by electronic means, or by some other form of telecommunication; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Designation of one or more alternate supervising physicians.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="License and Certification Requirements.">
    <paragraph num="A.">
      <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text>
    </paragraph>
    <paragraph num="B.">
      <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>
    <paragraph num="C.">
      <text>A physician having a written agreement to supervise a physician assistant shall:</text>
      <paragraph num="(1)">
        <text>Be licensed to practice medicine in the state in which the physician assistant is providing services;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Delegate only medical acts that are within the scope of the practice of the physician and are suitable to be performed by the physician assistant, taking into account the physician assistant’s education, training, and level of competence;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Accept Program reimbursement as payment in full for services provided;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Establish and review drug and other medical guidelines with the physician assistant;</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Participate with the physician assistant in reviewing and discussing medical diagnoses and the therapeutic and corrective measures employed in the practice setting;</text>
      </paragraph>
      <paragraph num="(6)">
        <text>Be available for consultation in person, by telephone, electronic means, or by some other form of telecommunication; and</text>
      </paragraph>
      <paragraph num="(7)">
        <text>Designate an alternate supervising physician if the physician identified in the delegation agreement temporarily becomes unavailable.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>For hospitals, correctional facilities, detention centers, or public health facilities, the primary supervising physician shall keep an ongoing list of all approved alternate supervising physicians within the alternate supervising physicians’ scopes of practice, with each alternate supervising physician’s signature and date.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Conditions for Participation.">
    <paragraph num="A.">
      <text>A physician assistant shall:</text>
      <paragraph num="(1)">
        <text>Meet all general provider requirements set forth in COMAR 10.09.36; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A physician assistant shall:</text>
      <paragraph num="(1)">
        <text>Have a written and executed delegation agreement with a licensed physician approved by the Board, or as required by the state in which services are provided; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If the primary supervising physician delegates the prescribing of controlled dangerous substances to a physician assistant, if required by applicable law, the physician assistant shall:</text>
        <paragraph num="(a)">
          <text>Obtain a Maryland Controlled Dangerous Substance (MCDS) license from the Maryland Division of Drug Control; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>After obtaining an MCDS license:</text>
          <paragraph num="(i)">
            <text>Register with the Drug Enforcement Administration (DEA); and</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Obtain a license from the DEA.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>To participate as a provider, the physician assistant shall submit to the Program a copy of the provider's:</text>
      <paragraph num="(1)">
        <text>Current approved delegation agreement; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Current license to practice in the state in which services are provided.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>Modification of Delegation Agreement.</text>
      <paragraph num="(1)">
        <text>If the provider's approved written delegation agreement with the physician is modified or terminated by either party, the physician assistant and supervising physician shall notify the Program within 5 days in writing.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If the delegation agreement is modified, the physician assistant and the supervising physician shall submit to the Program a copy of the modified or new written agreement.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>If the duties of the physician assistant are limited, reduced, or result in other changes of employment that might be grounds for disciplinary actions under Health Occupations Article, §15-314, Annotated Code of Maryland, the supervising physician, hospital, alternative health care system, or employer shall notify the Program immediately or within 5 days in writing.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>A physician assistant may practice in Maryland:</text>
      <paragraph num="(1)">
        <text>Only in accordance with the delegation agreement approved by the Board; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If out-of-State, only in accordance with the scope of practice allowed by the licensing authority in the state in which services are provided.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Covered Services.">
    <paragraph num="A.">
      <text>The Program covers medically necessary services rendered to participants in accordance with:</text>
      <paragraph num="(1)">
        <text>The functions allowed under:</text>
        <paragraph num="(a)">
          <text>The Physician Assistant’s Practice Act;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>COMAR 10.32.03; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>The physician assistant’s written delegation agreement with a physician; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>If out-of-State, those functions authorized in the state in which the services are provided.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>The services in §A of this regulation shall be described in the participant's medical record in sufficient detail to support the invoice submitted for those services.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Limitations.">
    <text>The Program does not cover the following under these regulations:</text>
    <paragraph num="A.">
      <text>Services not encompassed by the physician assistant’s written delegation agreement with the physician, if required by the state in which services are provided;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Services not medically necessary;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Services prohibited by the Board;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Services prohibited in the state in which services are provided;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Physician assistant services included as part of the cost of an inpatient facility, hospital outpatient department, or freestanding clinic;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Visits by or to the physician assistant solely for the purpose of the following:</text>
      <paragraph num="(1)">
        <text>Prescription, drug, or food supplement pickup;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Recording of an electrocardiogram;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Ascertaining the patient's weight;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Interpretation of laboratory tests or panels; or</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Prescribing or administering oral medications;</text>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>Drugs and supplies which are acquired by the licensed and certified physician assistant at no cost;</text>
    </paragraph>
    <paragraph num="H.">
      <text>Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take appropriate oral medications are documented in the patient's medical record;</text>
    </paragraph>
    <paragraph num="I.">
      <text>More than one visit per day per participant unless adequately documented as an emergency situation;</text>
    </paragraph>
    <paragraph num="J.">
      <text>Services paid under the free-standing dialysis program described in COMAR 10.09.22;</text>
    </paragraph>
    <paragraph num="K.">
      <text>Physician assistant billings for those laboratory or X-ray services performed by another facility, which shall bill the Program directly;</text>
    </paragraph>
    <paragraph num="L.">
      <text>Immunizations required for travel outside the continental United States;</text>
    </paragraph>
    <paragraph num="M.">
      <text>Acupuncture;</text>
    </paragraph>
    <paragraph num="N.">
      <text>Hypnosis;</text>
    </paragraph>
    <paragraph num="O.">
      <text>Travel expenses;</text>
    </paragraph>
    <paragraph num="P.">
      <text>Prescriptions and injections for central nervous system stimulants and anoretic agents when used for weight control;</text>
    </paragraph>
    <paragraph num="Q.">
      <text>Investigational or experimental drugs and procedures;</text>
    </paragraph>
    <paragraph num="R.">
      <text>Services denied by Medicare as not medically justified; and</text>
    </paragraph>
    <paragraph num="S.">
      <text>Services for which the patient specifically requests to see a physician.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Payment Procedures.">
    <paragraph num="A.">
      <text>The provider shall submit the request for payment in the format designated by the Department.</text>
    </paragraph>
    <paragraph num="B.">
      <text>The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by any properly completed forms required by the Department.</text>
    </paragraph>
    <paragraph num="C.">
      <text>The provider shall charge the Program the provider's customary charge to the general public for similar services and charge the provider's acquisition cost for injectable drugs or dispensed medical supplies. If the service is free to individuals not covered by Medicaid:</text>
      <paragraph num="(1)">
        <text>The provider:</text>
        <paragraph num="(a)">
          <text>May charge the Program; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Shall be reimbursed in accordance with §D of this regulation; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>The provider's reimbursement is not limited to the provider's customary charge.</text>
      </paragraph>
    </paragraph>
    <paragraph num="D.">
      <text>The Department shall reimburse the physician assistant for covered services at the lesser of:</text>
      <paragraph num="(1)">
        <text>The provider's customary charge unless the service is free to individuals not covered by Medicaid; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The maximum rates according to COMAR 10.09.02.07E.</text>
      </paragraph>
    </paragraph>
    <paragraph num="E.">
      <text>Payments on Medicare claims are authorized, if:</text>
      <paragraph num="(1)">
        <text>Services are covered by the Program;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>The provider accepts Medicare assignments;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Medicare makes direct payment to the provider;</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Medicare has determined that services were medically justified; and</text>
      </paragraph>
      <paragraph num="(5)">
        <text>Initial billing is made directly to Medicare according to Medicare guidelines.</text>
      </paragraph>
    </paragraph>
    <paragraph num="F.">
      <text>The Department shall make supplemental payments on Medicare claims subject to the following provisions:</text>
      <paragraph num="(1)">
        <text>Deductible insurance shall be paid in full; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Coinsurance shall be paid at the lesser of:</text>
        <paragraph num="(a)">
          <text>100 percent of the coinsurance amount; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The balance remaining after the Medicare payment is subtracted from the Medicaid rate.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="G.">
      <text>The provider may not bill the Program for:</text>
      <paragraph num="(1)">
        <text>Completion of forms and reports;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Broken or missed appointments;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Professional services rendered by mail; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Providing a copy of a participant's medical record when requested by another licensed provider on behalf of the participant.</text>
      </paragraph>
    </paragraph>
    <paragraph num="H.">
      <text>The Program may not make direct payment to participants.</text>
    </paragraph>
    <paragraph num="I.">
      <text>Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.</text>
    </paragraph>
    <paragraph num="J.">
      <text>Physician assistants who are employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Recovery and Reimbursement.">
    <text>Recovery and reimbursement are as set forth in COMAR 10.09.36.07.</text>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Cause for Suspension or Removal and Imposition of Sanctions.">
    <text>Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08.</text>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Appeal Procedures.">
    <text>Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.</text>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Interpretive Regulation.">
    <text>State regulations shall be interpreted in conformity with COMAR 10.09.36.10.</text>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: May 11, 2015 (42:9 Md. R. 647)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03A amended effective July 10, 2023 (50:13 Md. R. 512)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06 amended effective September 26, 2016 (43:19 Md. R. 1072)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .06G amended effective July 10, 2023 (50:13 Md. R. 512)</annotation>
  </annotations>
</chapter>