<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.09.12.04" title_num="10" subtitle_num="09" chapter_num="12" heading="Covered Services.">
  <paragraph num="A.">
    <text>The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service:</text>
    <paragraph num="(1)">
      <text>Disposable medical supplies;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Durable medical equipment;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Repairs to purchased durable medical equipment;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Orthotic devices;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Repair of orthotic devices;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Replacement of orthotic devices;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Prosthetic devices which include:</text>
      <paragraph num="(a)">
        <text>Artificial eyes;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Breast prostheses, including surgical brassiere;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>Repair of prosthetic devices;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Replacement of prosthetic devices;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter;</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and</text>
    </paragraph>
    <paragraph num="(14)">
      <text>Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The items in §A of this regulation are covered when medically necessary for use in the recipient's:</text>
    <paragraph num="(1)">
      <text>Home;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>School; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Place of employment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Replacements under §A(10) are covered:</text>
    <paragraph num="(1)">
      <text>Once annually for devices less than 3 years old if the replacement is for the following reasons:</text>
      <paragraph num="(a)">
        <text>A change in the physiological condition of the patient;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>For devices more than 3 years old subject to §§B and C of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Documentation Required.</text>
    <paragraph num="(1)">
      <text>Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the:</text>
      <paragraph num="(a)">
        <text>Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Recertifications of continuous medical need;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Make, model, and serial number of the item, as applicable; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Documentation shall be retained for 6 years and be made available upon request by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements.</text>
  </paragraph>
</regulation>