Current through Register Vol. 52, No. 6, March 21, 2025
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) Rental or purchase
for use in patient's home or nursing facility of:
(a) Oxygen, gaseous (tank
contained);
(2) Rental of
concentrators.
(3) Rental or
purchase of the following related respiratory equipment:
(a) Rental of equipment included in complete
oxygen set-up:
(b) Rental of portable oxygen unit;
(c) Rental or purchase of the following
tracheostomy equipment:
(iii) Humidity system,
complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar,
and compressor;
(d) Other related equipment:
(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;
(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;
(iii) Resuscitator bag,
manual.
(4)
Rental or purchase of an intermittent positive pressure breathing (IPPB)
machine (complete set-up) to include:
(h) Exhalation valve; and
(5) Rental or purchase of a nasal continuous
positive airway pressure (NCPAP) system (complete set-up) to include:
(a) Flow generating device;
(b) Valve mechanism to maintain
pressure;
(c) Nasal mask and
headgear; and
(d) Tubing and
reservoir.
(6) Repairs
to purchased respiratory equipment.
(7) Replacement items for purchased
equipment.
B. The items
in §A(1), (2), and (3)(a) and (b) of this regulation are covered when:
(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) 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) The patient's:
(a) Baseline study demonstrates sleep apnea
or disorderedbreathing 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
(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.
C. The items in
§A(5) of this regulation are covered when the patient's:
(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) Study of NCPAP demonstrates a greater
than 90 percent reduction in frequency of OSA or other DBE's, with improvement
in clinical symptoms.
D.
The items in §A(4) of this regulation are covered when the patient's
pulmonary function studies show:
(1) A vital
capacity of less than 1.5 liters (with a normal FEV1;
or
(2) An absolute
FEV1 of 1.5 liters or less.
E. The items in §A(3)(d)(i) and (ii) of
this regulation are covered when:
(1) The
patient's pulmonary function studies show an FEV1/FVC
percentage of 45 or less (calculated as FEV1 divided by
FVC); or
(2) Unable to test for
§E(1), of this regulation, other objective signs/symptoms of severe airway
obstruction.
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) The physician's initial order and plan of
treatment shall include:
(a) When prescribing
oxygen:
(i) Diagnosis and indication for
oxygen use;
(ii) Liter flow rate
per minute (at rest, and when exercising if prescribing portable
oxygen);
(iii) Number of hours to
be used during a 24-hour period;
(iv) Description of equipment to include
route of administration;
(v)
Rehabilitative goals;
(vi) Hospital
discharge or clinical summary;
(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.
(b) When prescribing aerosol equipment:
(i) Diagnosis and indication for
use;
(ii) Number of hours to be
used during a 24-hour period;
(iii)
Description of equipment to include route of administration;
(iv) Rehabilitative goals;
(v) Hospital discharge or clinical
summary;
(vi) Pulmonary function
study results.
(c) When
prescribing tracheostomy equipment:
(i)
Diagnosis and indication for use;
(ii) Description of equipment to include
quantity requested, period of time required, and approximate cost;
(iii) Rehabilitative goals.
(d) When prescribing an NCPAP
system:
(i) Diagnosis and indication for
use;
(ii) Specification of NCPAP
fixed level;
(iii) Rehabilitative
goals;
(iv) Clinical summary,
including appropriate sleep studies.
(2) The physician's subsequent orders shall
include:
(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;
(b) When
prescribing oxygen for sleep apnea, an update of the items listed in
§F(1)(a) of this regulation;
(c) When prescribing aerosol equipment, an
update of the items listed in §F(1)(b) of this regulation;
(d) When prescribing tracheostomy equipment,
an update of the items listed in §F(1)(c) of this regulation;
(e) When prescribing an NCPAP system, an
update of the items listed in §F(1)(d) of this regulation.
(3) The physician's subsequent
orders for oxygen when prescribing for sleep apnea shall be made within:
(a) One year of the effective date of the
initial preauthorization; or
(b) At
the time the patient's condition is changed by significant intervention, as
follows, not to exceed that 1-year period:
(i)
Significant weight loss of more than 10-15 percent;
(ii) Surgical intervention on upper
airway;
(iv) Positive airway
pressure.