Or. Admin. Code § 410-122-0202 - Positive Airway Pressure (PAP) Devices for Adult Obstructive Sleep Apnea
(1) The Division
may cover a positive airway pressure (PAP) device for treatment of obstructive
sleep apnea (OSA) when:
(a) The client has a
face-to-face clinical evaluation by the treating practitioner prior to a sleep
test to assess the client for obstructive sleep apnea; and
(b) The client has a polysomnogram performed
in a facility-based laboratory or a home sleep test that demonstrates positive
diagnosis of OSA with either of the following:
(A) The apnea-hypopnea index (AHI) or
Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per
hour; or
(B) The AHI or RDI is
between 5 and 14 events with additional symptoms including one or more of the
following:
(i) Excessive daytime sleepiness as
documented by a score of greater than 10 on the Epworth Sleepiness Scale or
daytime sleepiness interfering with ADLs that is not attributable to another
modifiable sedating condition (e.g. narcotic dependence); or
(ii) Documented hypertension; or
(iii) Ischemic heart disease; or
(iv) History of stroke.
(c) The client or their caregiver
has received instruction from the supplier of the PAP device and accessories in
the proper use and care of the equipment.
(d) The client meets criteria listed in
section (2) of this rule for the particular device to be used.
(2) Continuous Positive Airway
Pressure (CPAP) or Auto-titrating Continuous Positive Airway Pressure (APAP)
devices:
(a) A CPAP/APAP device (E0601) may be
covered for clients with OSA when criteria in (1)(a)-(c) are met;
(b) A three-month trial (rental) period for
PAP devices is required to determine benefit and ongoing coverage of the
device;
(c) Rental charges apply
toward purchase.
(3)
Respiratory Assist devices:
(a) A respiratory
assist device (RAD) without backup rate (E0470) may be covered for clients with
OSA when:
(A) Criteria in (1)(a)-(c) of this
rule are met, and
(B) A CPAP/APAP
device (E0601) has been tried and proven ineffective. Ineffective use is
defined as documented failure to meet therapeutic goals using a CPAP/APAP
device during the titration period of a facility-based study or during home use
despite optimal therapy (i.e., proper mask selection and fitting and
appropriate pressure settings);
(b) If a CPAP/APAP device is tried and found
ineffective during the initial facility-based titration or three-month home
trial, substitution of a RAD does not require a new face-to-face clinical
evaluation or sleep test;
(c) If a
CPAP/APAP device has been used for more than three months and the client is
switched to a RAD, a clinical re-evaluation must occur, but a new sleep test is
not required. A new three-month trial would begin for use of the RAD;
(d) Coverage, coding, and documentation
requirements for the use of RADs for diagnoses other than OSA are addressed in
410-122-0205 Respiratory Assist
Devices.
(e) A RAD with backup rate
(E0471) is not medically indicated for the treatment of obstructive sleep
apnea.
(4) For a client
using a PAP device prior to Oregon Health Plan (OHP) enrollment, continuing
coverage for the device and related accessories may be authorized on a
case-by-case basis by the appropriate authorizing unit.
(5) Continued Coverage of PAP device:
(a) Ongoing rental of a PAP device (E0470 or
E0601) beyond the three-month trial period is an option in lieu of purchase
when medically appropriate, cost effective, and conditions of coverage have
been met;
(b) Continued coverage of
a PAP device (E0470 or E0601) beyond the first three months of therapy requires
that, no sooner than the 31st day but no later than the 91st day after
initiating therapy, the treating practitioner shall conduct a face-to-face
clinical re-evaluation and document that the client is benefiting from PAP
therapy;
(c) If the clinical
re-evaluation does not occur until after the 91st day but the evaluation
demonstrates that the client is benefiting from PAP therapy as defined in
criteria, continued coverage of the PAP device will commence with the date of
that re-evaluation;
(d) If a
CPAP/APAP has been used more than three months and the client is switched to a
RAD, then the clinical re-evaluation shall occur between the 31st and 91st day
following initiation of the RAD;
(e) Clients who fail the 3-month trial may be
eligible to re-qualify for a PAP device but must have both:
(i) Face-to-face clinical re-evaluation by
the treating practitioner to determine etiology of the failure to respond to
PAP therapy; and
(ii) Repeat sleep
test in a facility-based setting if deemed necessary by the treating
practitioner. This may be a repeat diagnostic titration or split-night
study.
(6)
Accessories:
(a) Accessories used with a PAP
device are covered when the coverage criteria for the device are met;
(b) Accessories are separately reimbursable
at the time of initial issue and when replaced;
(c) Either a non-heated (E0561) or heated
(E0562) humidifier is covered when ordered by the treating practitioner for use
with a covered PAP device (E0470, E0601);
(d) The following represents the usual
maximum number of accessories expected to be medically appropriate:
(A) A4604 - 1 per 3 months;
(B) A7027 - 1 per 3 months;
(C) A7028 - 2 per month;
(D) A7029 - 2 per month;
(E) A7030 - 1 per 3 months;
(F) A7031 - 1 per month;
(G) A7032 - 2 per month;
(H) A7033 - 2 per month;
(I) A7034 - 1 per 3 months;
(J) A7035 - 1 per 6 months;
(K) A7036 - 1 per 6 months;
(L) A7037 - 1 per 3 months;
(M) A7038 - 2 per month;
(N) A7039 - 1 per 6 months;
(O) A7046 - 1 per 6 months.
(7) Payment
Authorization:
(a) From the initial date of
service through the second date of service, prior authorization (PA) is not
required for PAP device rental and related accessories. The provider is
responsible to ensure all rule requirements are met;
(b) Payment authorization (i.e., a payment
authorization number for billing) is required prior to submitting claims and
will be given once all required documentation has been received and any other
applicable rule requirements have been met;
(c) Payment authorization is obtained from
the same authorizing authority as specified in
410-122-0040;
(d) All subsequent services starting with the
third date of service require PA;
(e) An order refill does not have to be
approved by the ordering practitioner. However, a client or their caregiver
must request specific ongoing PAP supplies and accessories, subject to rule
limitations and requirements, before they are dispensed. The DMEPOS provider
shall not automatically dispense a quantity of supplies and accessories on a
predetermined regular basis, even if the client has "authorized" this in
advance;
(f) It is the provider's
responsibility to monitor appropriate and effective use of the device as
ordered by the treating practitioner. When the equipment is not being used as
prescribed, the provider shall stop billing for the equipment and related
accessories and supplies.
(8) Guidelines:
(a) Polysomnography is the continuous and
simultaneous monitoring and recording of various physiological and
pathophysiological parameters of sleep with practitioner review,
interpretation, and report. It shall include sleep staging, which is defined to
include a 1-4 lead electroencephalogram (EEG), electro-oculogram (EOG),
submental electromyogram (EMG) and an electrocardiogram (ECG). It shall also
include at least the following additional parameters of sleep: airflow,
respiratory effort, and oxygen saturation by oximetry. It may be performed as
either a whole night study for diagnosis only or as a split night study to
diagnose and initially evaluate treatment;
(b) Polysomnographic and home studies shall
be ordered by the client's treating practitioner, conducted by an entity that
qualifies as a Medicare provider of sleep tests, and in compliance with all
applicable state regulatory requirements;
(c) Polysomnographic studies and home sleep
tests shall be scored according to the recommended rules as described in the
American Academy of Sleep Medicine (AASM) Manual for Scoring of Sleep and
Associated Events;
(d)
Polysomnographic studies may not be performed by a DMEPOS provider;
(e) Home sleep tests are performed unattended
in the client's home using a portable monitoring device that meets the
following criteria:
(A) Type II device -
Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart
rate, airflow, respiratory movement/effort, and oxygen saturation; or
(B) Type III device - Monitors and records a
minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart
rate, and oxygen saturations; or
(C) Type IV device - Monitors and records a
minimum of three (3) channels, one of which is airflow; or
(D) Other - Devices that monitor and record a
minimum of three (3) channels that include actigraphy, oximetry, and peripheral
arterial tone;
(f) For
all PAP devices, clients who undergo a home sleep study shall, prior to having
the test, receive instruction on how to properly apply a portable sleep
monitoring device. This instruction shall be provided by the entity conducting
the home sleep test and may not be performed by a DME supplier.
(g) No aspect of a home sleep test, including
but not limited to delivery and/or pickup of the device, may be performed by
the DME supplier.
(h) Apnea is
defined as the cessation of airflow for at least 10 seconds and documented on a
polysomnogram or home sleep monitoring equipment;
(i) Hypopnea is defined as an abnormal
respiratory event lasting at least 10 seconds with at least a 30 percent
reduction in thoracoabdominal movement or airflow as compared to baseline and
with at least a 4 percent decrease in oxygen saturation;
(j) The apnea-hypopnea index (AHI) is defined
as the average number of episodes of apnea and hypopnea per hour of sleep
without the use of a positive airway pressure device. Respiratory effort
related arousals (RERAs) are not included in the calculation of the
AHI;
(k) The respiratory
disturbance index (RDI) is defined as the average number of apneas plus
hypopneas per hour of recording without the use of a positive airway pressure
device. Respiratory effort related arousals (RERAs) are not included in the
calculation of the RDI;
(l) If the
AHI or RDI is calculated based on less than two hours of sleep or recording
time, the total number of recorded events used to calculate the AHI or RDI
(respectively) shall be at least the number of events that would have been
required in a two-hour period (i.e., must reach >30 events without symptoms
or >10 events with symptoms);
(m) Adherence to therapy is defined as use of
PAP four hours or more per night on 70 percent of nights during a consecutive
thirty-day period anytime during the first three months of initial
usage.
(9) Documentation
Requirements:
(a) Initial coverage:
(A) For CPAP/APAP device, submit the
facility-based polysomnogram report or home sleep study report that supports a
diagnosis of OSA prior to the third date of service;
(B) For a RAD, submit specific documentation
from the treating practitioner that a CPAP was tried and shown to be
ineffective;
(b) For
extended rental use or purchase of a PAP device beyond the first three months
of initial therapy, submit the following documentation no sooner than the 61st
day after initiating therapy and prior to the fourth date of service:
(A) Documentation of the face-to-face
clinical re-evaluation by the treating practitioner that supports clinical
benefit including client tolerance, compliance and efficacy, and demonstrates
symptoms of OSA are improved; and
(B) Objective evidence of adherence to use of
the PAP device, including a summary of PAP compliance report through a direct
download of usage date; or
(C) When
objective data does not support compliance and efficacy, a face-to-face visit
with the treating practitioner clearly specifying a treatment plan with
measurable goals to improve adherence to treatment; and
(D) Any other medical documentation that
supports indications of coverage;
(E) If a CPAP/APAP device has been used more
than three months and the client is switched to a RAD, documentation of
adherence to therapy shall be submitted during the three-month trial with the
RAD;
(c) For a client
using a PAP device prior to OHP enrollment, submit the following:
(A) Documentation of clinical benefit
including client tolerance, compliance and efficacy, and that symptoms of OSA
are improved from the client's treating practitioner; and
(B) A facility-based polysomnogram report or
home sleep test as described in this rule and scored as described in (1)(b)
that supports a diagnosis of OSA, if available.
(10) Table 122-0202 - PAP Devices.
Notes
Tables referenced are available from the agency.
To view attachments referenced in rule text, click here to view rule.
Statutory/Other Authority: ORS 414.065
Statutes/Other Implemented: ORS 414.065
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.