1. A. 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:

   1. (1) Rental or purchase for use in patient's home or nursing facility of:

      1. (a) Oxygen, gaseous (tank contained);
      2. (b) Oxygen, liquid.
   2. (2) Rental of concentrators.

   3. (3) Rental or purchase of the following related respiratory equipment:

      1. (a) Rental of equipment included in complete oxygen set-up:

         1. (i) Flow meter;
         2. (ii) Humidity jar;
         3. (iii) Nasal cannula;
         4. (iv) Oxygen face mask;
         5. (v) Regulator;
         6. (vi) Safety stand;
         7. (vii) Tubing;
      2. (b) Rental of portable oxygen unit;

      3. (c) Rental or purchase of the following tracheostomy equipment:

         1. (i) Trach tubes;
         2. (ii) Tracheostomy trays;
         3. (iii) Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor;
         4. (iv) Heater;
         5. (v) Water trap;

      4. (d) Other related equipment:

         1. (i) 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;
         2. (ii) 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;
         3. (iii) Resuscitator bag, manual.

   4. (4) Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include:

      1. (a) Compressor;
      2. (b) Medication cup;
      3. (c) Nebulizer;
      4. (d) Connector fitting;
      5. (e) Corrugated tubing;
      6. (f) Nebulizer hose;
      7. (g) Exhalation hose;
      8. (h) Exhalation valve; and
      9. (i) Mouthpiece.

   5. (5) Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include:

      1. (a) Flow generating device;
      2. (b) Valve mechanism to maintain pressure;
      3. (c) Nasal mask and headgear; and
      4. (d) Tubing and reservoir.
   6. (6) Repairs to purchased respiratory equipment.
   7. (7) Replacement items for purchased equipment.

2. B. The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when:

   1. (1) 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
   2. (2) 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

   3. (3) The patient's:

      1. (a) Baseline study demonstrates sleep apnea or disordered breathing events, or both, (hourly rates >30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation <85 percent by ear oximetry which is the equivalent to PaO₂ <50 mm Hg); and
      2. (b) 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 (>85 percent by ear oximetry which is equivalent to PaO₂ >50 mm Hg) throughout the night.

3. C. The items in §A(5) of this regulation are covered when the patient's:

   1. (1) 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
   2. (2) Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms.

4. D. The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show:

   1. (1) A vital capacity of less than 1.5 liters (with a normal FEV₁; or
   2. (2) An absolute FEV₁ of 1.5 liters or less.

5. E. The items in §A(3)(d)(i) and (ii) of this regulation are covered when:

   1. (1) The patient's pulmonary function studies show an FEV₁/FVC percentage of 45 or less (calculated as FEV₁ divided by FVC); or
   2. (2) Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction.

6. F. 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:

   1. (1) The physician's initial order and plan of treatment shall include:

      1. (a) When prescribing oxygen:

         1. (i) Diagnosis and indication for oxygen use;
         2. (ii) Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen);
         3. (iii) Number of hours to be used during a 24-hour period;
         4. (iv) Description of equipment to include route of administration;
         5. (v) Rehabilitative goals;
         6. (vi) Hospital discharge or clinical summary;
         7. (vii) 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.

      2. (b) When prescribing aerosol equipment:

         1. (i) Diagnosis and indication for use;
         2. (ii) Number of hours to be used during a 24-hour period;
         3. (iii) Description of equipment to include route of administration;
         4. (iv) Rehabilitative goals;
         5. (v) Hospital discharge or clinical summary;
         6. (vi) Pulmonary function study results.

      3. (c) When prescribing tracheostomy equipment:

         1. (i) Diagnosis and indication for use;
         2. (ii) Description of equipment to include quantity requested, period of time required, and approximate cost;
         3. (iii) Rehabilitative goals.

      4. (d) When prescribing an NCPAP system:

         1. (i) Diagnosis and indication for use;
         2. (ii) Specification of NCPAP fixed level;
         3. (iii) Rehabilitative goals;
         4. (iv) Clinical summary, including appropriate sleep studies.

   2. (2) The physician's subsequent orders shall include:

      1. (a) 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;
      2. (b) When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation;
      3. (c) When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation;
      4. (d) When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation;
      5. (e) When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation.

   3. (3) The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within:

      1. (a) One year of the effective date of the initial preauthorization; or

      2. (b) At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period:

         1. (i) Significant weight loss of more than 10—15 percent;
         2. (ii) Surgical intervention on upper airway;
         3. (iii) Tracheostomy;
         4. (iv) Positive airway pressure.

Authority: Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland

Effective date: January 1, 1984 (10:25 Md. R. 2268)

Regulation .01B amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109); April 5, 2010 (37:7 Md. R. 570)

Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568)

Regulation .03D amended effective April 5, 2010 (37:7 Md. R. 570)

Regulation .03H amended effective May 29, 1989 (16:10 Md. R. 1109)

Regulation .03P, .05, .06F, and .07D, F, G amended effective November 5, 1984 (11:22 Md. R. 1899)

Regulation .04 amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109)

Regulation .04B amended effective September 11, 2017 (44:18 Md. R. 866)

Regulation .04B, F amended effective April 5, 2010 (37:7 Md. R. 570)

Regulation .04F amended effective April 16, 2012 (39:7 Md. R. 492)

Regulation .05B amended effective May 2, 1988 (15:9 Md. R. 1108); April 5, 2010 (37:7 Md. R. 570); September 11, 2017 (44:18 Md. R. 866)

Regulation .06 amended effective October 27, 2003 (30:21 Md. R. 1529); April 5, 2010 (37:7 Md. R. 570)

Regulation .07 amended effective April 5, 2010 (37:7 Md. R. 570)

Regulation .07C, E, M amended effective July 4, 2016 (43:13 Md. R. 712)

Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984

Regulation .07D amended effective August 12, 1985 (12:16 Md. R. 1606)

Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129)

Regulation .07D amended effective May 2, 1988 (15:9 Md. R. 1108); October 27, 2003 (30:21 Md. R. 1529); April 2, 2012 (39:6 Md. R. 408): February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 473)

Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625)

Regulation .07O amended effective September 10, 1984 (11:18 Md. R. 1584)

Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)

Regulation .07O amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)

Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)

Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)