<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.09.18.04" title_num="10" subtitle_num="09" chapter_num="18" heading="Covered Services.">
  <paragraph num="A.">
    <text>The following medically necessary items and services are covered for pulmonary use in the patient's home or nursing facility pursuant to §§B, C, D, and E of this regulation:</text>
    <paragraph num="(1)">
      <text>Rental or purchase for use in patient's home or nursing facility of:</text>
      <paragraph num="(a)">
        <text>Oxygen, gaseous (tank contained);</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Oxygen, liquid.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Rental of concentrators.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Rental or purchase of the following related respiratory equipment:</text>
      <paragraph num="(a)">
        <text>Rental of equipment included in complete oxygen set-up:</text>
        <paragraph num="(i)">
          <text>Flow meter;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Humidity jar;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Nasal cannula;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Oxygen face mask;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Regulator;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Safety stand;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Tubing;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Rental of portable oxygen unit;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Rental or purchase of the following tracheostomy equipment:</text>
        <paragraph num="(i)">
          <text>Trach tubes;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Tracheostomy trays;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Heater;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Water trap;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Other related equipment:</text>
        <paragraph num="(i)">
          <text>Rental or purchase of aerosol compressor (complete set-up) to include compressor unit, medication cup, connector fitting, tubing, hand-held nebulizer, and mouthpiece, face mask, or tracheostomy collar or T-tube;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Rental or purchase of ultrasonic nebulizer (complete set-up) to include ultrasonic aerosol chamber with blower, medication cup, connector fitting, corrugated tubing, and mouthpiece, face mask, or tracheostomy collar or T-tube;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Resuscitator bag, manual.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include:</text>
      <paragraph num="(a)">
        <text>Compressor;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Medication cup;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Nebulizer;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Connector fitting;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Corrugated tubing;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Nebulizer hose;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Exhalation hose;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Exhalation valve; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Mouthpiece.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include:</text>
      <paragraph num="(a)">
        <text>Flow generating device;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Valve mechanism to maintain pressure;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Nasal mask and headgear; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Tubing and reservoir.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Repairs to purchased respiratory equipment.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Replacement items for purchased equipment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when:</text>
    <paragraph num="(1)">
      <text>The patient's current stable arterial blood gas results (at rest, using room air) for PaO2 are 60 mm Hg or less after optimal treatment; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The patient’s saturation level is 88 percent or less on room air or less than 93 percent for patients younger than 21 years old; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The patient's:</text>
      <paragraph num="(a)">
        <text>Baseline study demonstrates sleep apnea or disordered  breathing events, or both, (hourly rates &gt;30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation &lt;85 percent by ear oximetry which is the equivalent to PaO2 &lt;50 mm Hg); and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Repeat study on supplemental oxygen demonstrates either a 30 percent reduction in the number of apneic episodes or disordered breathing events, or both, or improved oxyhemoglobin saturation (&gt;85 percent by ear oximetry which is equivalent to PaO2 &gt;50 mm Hg) throughout the night.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The items in §A(5) of this regulation are covered when the patient's:</text>
    <paragraph num="(1)">
      <text>Baseline study demonstrates more than 30 episodes per hour of obstructive sleep apnea (OSA), each lasting 10 seconds or more, or other disordered breathing events (DBE's), with evidence of clinical impairment (that is, daytime hypersomnolence or cor pulmonale); and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show:</text>
    <paragraph num="(1)">
      <text>A vital capacity of less than 1.5 liters (with a normal FEV1; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An absolute FEV1 of 1.5 liters or less.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The items in §A(3)(d)(i) and (ii) of this regulation are covered when:</text>
    <paragraph num="(1)">
      <text>The patient's pulmonary function studies show an FEV1/FVC percentage of 45 or less (calculated as FEV1 divided by FVC); or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>The items in §A(1)—(5) of this regulation are covered when they are ordered in writing, by a physician, including documentation that a face-to-face encounter occurred within 6 months before ordering prescribed services, as follows:</text>
    <paragraph num="(1)">
      <text>The physician's initial order and plan of treatment shall include:</text>
      <paragraph num="(a)">
        <text>When prescribing oxygen:</text>
        <paragraph num="(i)">
          <text>Diagnosis and indication for oxygen use;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen);</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Number of hours to be used during a 24-hour period;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Description of equipment to include route of administration;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Rehabilitative goals;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Hospital discharge or clinical summary;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Current stable arterial blood gas results to include PaO2, PaCO2, and Ph on room air and on oxygen at rest, and, if prescribing portable oxygen, when exercising, or sleep apnea study results.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>When prescribing aerosol equipment:</text>
        <paragraph num="(i)">
          <text>Diagnosis and indication for use;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Number of hours to be used during a 24-hour period;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Description of equipment to include route of administration;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Rehabilitative goals;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Hospital discharge or clinical summary;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Pulmonary function study results.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>When prescribing tracheostomy equipment:</text>
        <paragraph num="(i)">
          <text>Diagnosis and indication for use;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Description of equipment to include quantity requested, period of time required, and approximate cost;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Rehabilitative goals.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>When prescribing an NCPAP system:</text>
        <paragraph num="(i)">
          <text>Diagnosis and indication for use;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Specification of NCPAP fixed level;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Rehabilitative goals;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Clinical summary, including appropriate sleep studies.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The physician's subsequent orders shall include:</text>
      <paragraph num="(a)">
        <text>When prescribing oxygen for other than sleep apnea, an update of the items listed in §F(1)(a) of this regulation if the patient's condition regarding the need for oxygen has changed since the previous orders;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within:</text>
      <paragraph num="(a)">
        <text>One year of the effective date of the initial preauthorization; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period:</text>
        <paragraph num="(i)">
          <text>Significant weight loss of more than 10—15 percent;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Surgical intervention on upper airway;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Tracheostomy;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Positive airway pressure.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>