<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05" citation="COMAR 10.09.51.05" title_num="10" subtitle_num="09" chapter_num="51" heading="Limitations.">
  <paragraph num="A.">
    <text>Covered audiology services, including hearing aids, cochlear implants, and auditory osseointegrated devices are limited to:</text>
    <paragraph num="(1)">
      <text>Unless the time limitation is waived by the Program, one audiology assessment per year;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The initial coverage of unilateral or bilateral hearing aids, cochlear implants, or auditory osseointegrated devices when the Department’s medical necessity criteria have been met;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>One replacement of unilateral or bilateral hearing aids:</text>
      <paragraph num="(a)">
        <text>Every 5 years for participants younger than 21 years old, unless the Program approves more frequent replacement; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Every 5 years for participants 21 years old or older, unless the Program approves more frequent replacement, but no more than 1 replacement extraneous to the devices’ warranty;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Replacement of hearing aids, cochlear implants and auditory osseointegrated device components that have been lost, stolen, or damaged beyond repair, after all warranties have expired;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Repairs and replacements that take place after all warranties have expired;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>A maximum of 76 batteries per participant per 12-month period for a unilateral hearing aid or osseointegrated devices, or 152 batteries per participant per 12-month period for bilateral hearing aids or osseointegrated devices purchased from the Department not more frequently than every 6 months, and in quantities of 38 or fewer for a unilateral hearing aid, or 76 or fewer for a bilateral hearing aid;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>A maximum of 238 disposable batteries for a unilateral cochlear implant per participant per 12-month period or 476 disposable batteries per 12-month period for a bilateral cochlear implant purchased not more frequently than every 6 months, and in quantities of 119 or fewer for a unilateral cochlear implant, or 238 or fewer for a bilateral cochlear implant;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Four replacement cochlear implant component rechargeable batteries per 12-month period for bilateral cochlear implants, and a maximum of two replacement rechargeable batteries for a unilateral cochlear implant per 12-month period;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Two cochlear implant replacement transmitter cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitter cable for a unilateral cochlear implant per 12-month period;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Two cochlear implant replacement headset cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement headset cable for a unilateral cochlear implant per 12-month period;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Two replacement cochlear implant transmitting coils per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitting coil for a unilateral cochlear implant per 12-month period;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Charges for routine follow-ups and adjustments which occur more than 60 days after the dispensing of a new hearing aid; and</text>
    </paragraph>
    <paragraph num="(13)">
      <text>A maximum of two unilateral earmolds or four bilateral earmolds per 12-month period unless a larger number is determined to be medically necessary.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Services which are not covered are:</text>
    <paragraph num="(1)">
      <text>Services not medically necessary;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Hearing aids and accessories not medically necessary;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Cochlear implant services and external components not medically necessary;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Cochlear implant services and external components provided less than 90 days after the surgery which are covered through the initial reimbursement;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Spare or backup cochlear implant components;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Spare or back-up auditory osseointegrated device components;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Replacement of hearing aids, equipment, cochlear implant components, and auditory osseointegrated device components if the existing devices are functional, repairable, and appropriately correct or ameliorate the problem or condition;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Spare or backup hearing aids, equipment, or supplies;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Repairs to spare or backup hearing aids, cochlear implants, auditory osseointegrated devices, equipment, or supplies;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Investigational or experimental services or devices, or both;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Replacement of improperly fitted earmold or earmolds unless the:</text>
      <paragraph num="(a)">
        <text>Replacement service is administered by someone other than the original provider; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Replacement service has not been claimed before;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(12)">
      <text>Additional professional fees and overhead charges for a new hearing aid when a dispensing fee claim has been made to the Program; and</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Loaner hearing aids.</text>
    </paragraph>
  </paragraph>
</regulation>