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<regulation prefix="Regulation" num=".07" citation="COMAR 10.20.01.07" title_num="10" subtitle_num="20" chapter_num="01" heading="Provider Reimbursement.">
  <paragraph num="A.">
    <text>To qualify as a provider, a pharmacy shall:</text>
    <paragraph num="(1)">
      <text>Maintain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be a provider in the Maryland Medical Assistance Program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The Program shall reimburse for treatment directly related to a recipient's ESRD or a condition that is a direct result of the recipient's ESRD.</text>
  </paragraph>
  <paragraph num="C.">
    <text>The Program shall reimburse the incurred costs of prescription drugs and other pharmaceutical products determined to be medically necessary by the recipient's physician for treatment directly related to the recipient's ESRD or a condition that is a direct result of the recipient's ESRD.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Before invoicing the Program, providers of Program-approved services shall first seek reimbursement from all other payment sources of the recipient including, but not limited to, insurance coverage, Medicare, Medical Assistance, and PAC. If the other sources reject a claim or pay less than the amount allowed by the Program, the provider may then submit the claim to the Program for review.</text>
  </paragraph>
  <paragraph num="E.">
    <text>A pharmacy provider may invoice the Program for reimbursement of legend drugs covered through the major medical component of a recipient's third-party insurance. The Program shall then seek reimbursement from the recipient's major medical coverage.</text>
  </paragraph>
  <paragraph num="F.">
    <text>When a recipient who is a Medicare beneficiary is provided a service that is covered by Medicare and the Program, Program payment shall be limited to payment of the recipient's Medicare deductible and co-insurance amounts.</text>
  </paragraph>
  <paragraph num="G.">
    <text>The Program may not reimburse for Medical Assistance covered services if the recipient is a Medical Assistance recipient.</text>
  </paragraph>
  <paragraph num="H.">
    <text>When a service is covered by a recipient's health insurance plan under which the provider agrees to accept payment by the health insurance plan as payment in full for the service, payment may not be made by the Program.</text>
  </paragraph>
  <paragraph num="I.">
    <text>The Program may not make a direct payment to a recipient.</text>
  </paragraph>
  <paragraph num="J.">
    <text>Program reimbursement for outpatient dialysis treatment shall be consistent with the limits established and rates paid by Medicare.</text>
  </paragraph>
  <paragraph num="K.">
    <text>Program reimbursement for other than outpatient dialysis treatment shall be consistent with the limits established and rates or fees paid by the Maryland Medical Assistance Program for the service except as otherwise indicated in this regulation. For services reimbursed on a fee basis, only the Medical Assistance net reimbursement amount will be paid.</text>
  </paragraph>
  <paragraph num="L.">
    <text>Reimbursement for preauthorized out-of-State renal transplantation services may not exceed rates paid for the same or similar services in Maryland.</text>
  </paragraph>
  <paragraph num="M.">
    <text>Program reimbursement for pharmacy services is as follows:</text>
    <paragraph num="(1)">
      <text>The Program shall only pay for legend drugs and diabetic supplies itemized on the Kidney Disease Program of Maryland Reimbursable Drug List;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for legend drugs;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Drugs shall be reimbursed by the Program as follows:</text>
      <paragraph num="(a)">
        <text>Program payment for a legend drug shall be the lower of the provider's charge or the Medical Assistance allowable cost for the drug;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In addition to payment for the legend drug ingredient cost, the Program shall establish and pay a dispensing fee for legend drugs;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Duration of coverage for immunosuppressant drugs shall be consistent with Medicare policy;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The Program shall only pay for a generic equivalent unless a brand is specified as medically necessary by the prescribing physician;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The Program may not pay for more than a 34-day supply of an approved drug during a 26-day period;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>The Program may not pay for replacement of lost medications;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>The Program may pay for replacement of stolen medications when the claim is accompanied by a police report;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>A pharmacy provider shall maintain on file a hard copy of each prescription filled for a recipient; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>The Program may not pay for legend drugs which are not FDA approved for the prescribed usage or which the FDA has declared to be “less-than-effective”.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="N.">
    <text>Reimbursement for Epogen (Epoetin alfa), dispensed as part of the dialysis procedure, shall be consistent with Medicare rates. Reimbursement shall be limited to dialysis facilities.</text>
  </paragraph>
  <paragraph num="O.">
    <text>Reimbursement for Procrit (Epoetin alfa) shall be consistent with Medicare rates. Coverage is limited to active renal transplant recipients.</text>
  </paragraph>
  <paragraph num="P.">
    <text>The Program shall provide reimbursement for access surgery required by a recipient for dialysis treatment even though the access surgery may predate the recipient's date of certification for Program benefits as established in accordance with Regulation .03 of this chapter.</text>
  </paragraph>
  <paragraph num="Q.">
    <text>To receive reimbursement from the Program a provider shall:</text>
    <paragraph num="(1)">
      <text>Accept payment by the Program as payment in full and make no additional charge to any person for services covered by the Program;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Verify the recipient's Program eligibility each time a service is provided by viewing the recipient's Kidney Disease Program identification card with a valid through date;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Notify the Program immediately of any recipient or provider activity or circumstance that affects eligibility, benefits, or reimbursement;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Maintain the confidentiality of all recipient information;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Submit the request for payment for services rendered according to procedures established by the Program and in the form designated by the Program; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Maintain and make available administrative and medical records in accordance with the following requirements:</text>
      <paragraph num="(a)">
        <text>Administrative and medical records shall contain documentation that is sufficient in quantity, scope, and detail to confirm that services are provided in accordance with this chapter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Records shall be maintained for a minimum of 6 years; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Records shall be made available on request to the Department or the Department's designee.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>