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<regulation prefix="Regulation" num=".01" citation="COMAR 10.09.12.01" title_num="10" subtitle_num="09" chapter_num="12" 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>“Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product:</text>
      <paragraph num="(a)">
        <text>For a specific recipient according to the description and orders of a physician; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>In such a way that the equipment can only be used by the specific recipient.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>“Department” means Maryland Department of Health as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Durable medical equipment” means equipment which satisfies all of the following requirements:</text>
      <paragraph num="(a)">
        <text>It can withstand repeated use;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>It is used to serve a medically necessary purpose; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>It has no practical use in the absence of illness, injury, disability, or health condition.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>“Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Invoice” means a form designated by the Department for use by providers in submitting bills for payment.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Maximum allowable reimbursement” means the payment limitation established by the Department.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(12)">
      <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 current 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="(13)">
      <text>“Medicare” means Medicare as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(14)">
      <text>“Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02.</text>
    </paragraph>
    <paragraph num="(15)">
      <text>“Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body.</text>
    </paragraph>
    <paragraph num="(16)">
      <text>“Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient.</text>
    </paragraph>
    <paragraph num="(17)">
      <text>“Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed.</text>
    </paragraph>
    <paragraph num="(18)">
      <text>“Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient.</text>
    </paragraph>
    <paragraph num="(19)">
      <text>“Prescriber order” means a document on the prescriber's letterhead or prescription form which details the:</text>
      <paragraph num="(a)">
        <text>Patient name and Medical Assistance number;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Estimated quantity of the item;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Length of time of need;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Prescriber’s signature.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(20)">
      <text>“Prescription” means a written order for medical supplies or equipment, signed by the prescriber.</text>
    </paragraph>
    <paragraph num="(21)">
      <text>“Program” means program as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(22)">
      <text>“Prosthetic device” means:</text>
      <paragraph num="(1)">
        <text>An artificial device to replace, in whole or in part, a leg, arm, or eye; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>An artificial breast, including surgical brassiere.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(23)">
      <text>“Provider” means provider as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(24)">
      <text>“Recipient” means recipient as defined in COMAR 10.09.36.01.</text>
    </paragraph>
    <paragraph num="(25)">
      <text>Wholesale cost.</text>
      <paragraph num="(a)">
        <text>“Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Wholesale cost” includes, but is not limited to:</text>
        <paragraph num="(i)">
          <text>Shipping;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Handling; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Insurance costs.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>“Wholesale cost” does not include associated costs such as:</text>
        <paragraph num="(i)">
          <text>Evaluation;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Assembly by the provider;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Fitting and adjustment; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Delivery to the recipient.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>