For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare benefit category, 2) be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a malformed
body member, and 3) meet all other applicable Medicare statutory and
regulatory requirements.  
  
The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act 
1862(a)(1)(A) provisions.  
  
In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * Refer to the Supplier Manual for additional information on documentation requirements.

  * Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.  
  
DEFINITIONS:  
  
Apnea is defined as the cessation of airflow for at least 10 seconds.  
  
Hypopnea is defined as an abnormal respiratory event lasting at least 10
seconds associated with at least a 30% reduction in thoracoabdominal movement
or airflow as compared to baseline, and with at least a 4% decrease in oxygen
saturation.  
  
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. For purposes of this policy, respiratory effort related
arousals (RERAs) are not included in the calculation of the AHI. Sleep time
can only be measured in a Type I (facility based polysomnogram) or Type II
sleep study (see descriptions below).  
  
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. For purposes of this policy, respiratory effort
related arousals (RERAs) are not included in the calculation of the RDI. The
RDI is reported in Type III, Type IV, and other home sleep studies.  
  
If the AHI or RDI is calculated based on less than 2 hours of sleep or
recording time, the total number of recorded events used to calculate the AHI
or RDI (respectively) must be at least the number of events that would have
been required in a 2 hour period (i.e., must reach 30 events without symptoms
or 10 events with symptoms).  
  
INITIAL COVERAGE:

In this policy, the term PAP (positive airway pressure) device will refer to
both a single-level continuous positive airway pressure device (E0601) and a
bi-level respiratory assist device without back-up rate (E0470) when it is
used in the treatment of obstructive sleep apnea.

  1. An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A - C are met:  
  

    1. The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea.  
  

    2. The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):  
  

      1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,  
  

      2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:  
  

        1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
        2. Hypertension, ischemic heart disease, or history of stroke.

    3. The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

If a claim for an E0601 is submitted and all of the criteria above have not
been met, it will be denied as not reasonable and necessary.

  2. An E0470 device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D:

    4. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

Ineffective is defined as documented failure to meet therapeutic goals using
an E0601 during the titration portion of a facility-based study or during home
use despite optimal therapy (i.e., proper mask selection and fitting and
appropriate pressure settings).  
  
If E0470 is billed for a beneficiary with OSA and criteria A-D are not met, it
will be denied as not reasonable and necessary.  
  
A bi-level positive airway pressure device with back-up rate (E0471) is not
reasonable and necessary if the primary diagnosis is OSA. If an E0471 is
billed with a diagnosis of OSA, it will be denied as not reasonable and
necessary.  
  
If an E0601 device is tried and found ineffective during the initial facility-
based titration or home trial, substitution of an E0470 does not require a new
initial in-person clinical evaluation or a new sleep test.  
  
If an E0601 device has been used for more than 3 months and the beneficiary is
switched to an E0470, a new initial in-person clinical evaluation is required,
but a new sleep test is not required. A new 3 month trial would begin for use
of the E0470.  
  
Coverage, coding and documentation requirements for the use of E0470 and E0471
for diagnoses other than OSA are addressed in the Respiratory Assist Devices
(RAD) Local Coverage Determination (LCD) and related Policy Article (PA).  
  
 _Sleep Tests_

Coverage and Payment rules for diagnostic sleep tests may be found in the CMS
National Coverage Determination (NCD) 240.4.1 (CMS Pub.100-03, Chapter 1, Part
4), the applicable A/B MAC LCDs and Billing and Coding articles. The sleep
test must be either a polysomnogram performed in a facility-based laboratory
(Type I study) or an inpatient hospital-based or home-based sleep test (HST)
(Types II, III, IV, Other).

Coverage of a PAP device for the treatment of OSA is limited to claims where
the diagnosis of OSA is based upon all of the following:

  1. A sleep test (Type I, II, III, IV, Other) that meets the Medicare requirements for a valid sleep test as outlined in NCD 240.4.1 and the applicable A/B MAC LCD and Billing and Coding article; and,

  2. A sleep test that is approved by the Food and Drug Administration (FDA) as a diagnostic device; and,

  3. The sleep test results meet the coverage criteria in effect for the date of service of the claim for the PAP device; and,

  4. The sleep test is ordered by the beneficiary's treating practitioner; and,

  5. The sleep test is conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements. 

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

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 must conduct
a clinical re-evaluation and document that the beneficiary is benefiting from
PAP therapy.

For PAP devices with initial dates of service on or after November 1, 2008,
documentation of clinical benefit is demonstrated by:

1\. In-person clinical re-evaluation by the treating practitioner with
documentation that symptoms of obstructive sleep apnea are improved; and,

2\. Objective evidence of adherence to use of the PAP device, reviewed by the
treating practitioner.

Adherence to therapy is defined as use of PAP 4 hours per night on 70% of
nights during a consecutive thirty (30) day period anytime during the first
three (3) months of initial usage.  
  
If the above criteria are not met, continued coverage of a PAP device and
related accessories will be denied as not reasonable and necessary.  
  
If the treating practitioner re-evaluation does not occur until after the 91st
day but the evaluation demonstrates that the beneficiary is benefiting from
PAP therapy as defined in criteria 1 and 2 above, continued coverage of the
PAP device will commence with the date of that re-evaluation.

Beneficiaries who fail the initial 12 week trial are eligible to re-qualify
for a PAP device but must have both:

  1. In-person clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to PAP therapy; and,

  2. Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.

If an E0601 device is tried and found ineffective during the initial facility-
based titration or home trial, substitution of an E0470 does not change the
length of the trial unless there is less than 30 days remaining in the trial
period. If more than 30 days remain in the trial period, the clinical re-
evaluation would still occur between the 31st and 91st day following the
initiation of an E0601 and objective documentation of adherence on the E0470
would need to occur prior to the 91st day following initiation of the E0601.
If less than 30 days remain in the trial period, the clinical re-evaluation
and objective documentation of adherence must occur before the 120th day
following the initiation of the E0601.

If an E0601 device was used for more than 3 months and the beneficiary was
then switched to an E0470, the clinical re-evaluation must occur between the
31st and 91st day following the initiation of the E0470. There would also need
to be documentation of adherence to therapy during the 3 month trial with the
E0470.  
  
If there is discontinuation of usage of a PAP device at any time, the supplier
is expected to ascertain this and stop billing for the equipment and related
accessories and supplies.  
  
For a PAP device dispensed prior to November 1, 2008, if the initial Medicare
coverage criteria in effect at the time were met and the criteria for coverage
after the first 3 months that were in effect at the time were met, the device
will continue to be covered for dates of service on or after November 1, 2008
as long as the beneficiary continues to use the device.  
  
CONCURRENT USE OF OXYGEN WITH PAP THERAPY:  
  
Some beneficiaries may require the simultaneous use of home oxygen therapy and
oxygen equipment with a PAP device. To be considered for simultaneous
coverage, all requirements in the "Coverage Indications, Limitations and/or
Medical Necessity" sections of both the Oxygen and Oxygen Equipment and
Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep
Apnea LCDs must be met. Consequently, in addition to this LCD, suppliers
should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article
for additional coverage, coding and documentation requirements.  
  
For beneficiaries with OSA to be considered for oxygen therapy and oxygen
equipment, the OSA must be sufficiently treated such that the underlying
condition resulting in hypoxemia is unmasked. This must be demonstrated before
oxygen saturation results obtained during polysomnography are considered
qualifying for oxygen therapy and oxygen equipment.

For beneficiaries with OSA, a qualifying oxygen saturation test for the
purposes of Medicare home oxygen and oxygen equipment reimbursement may only
occur during a titration polysomnographic study (either split-night or stand-
alone). The titration PSG is one in which all of the following criteria are
met:

      1\. The titration is conducted over a minimum of two (2) hours; and,

      2\. During titration:

A. The AHI/RDI is reduced to less than or equal to an average of ten (10)
events per hour; or,

B. If the initial AHI/RDI was less than an average of ten (10) events per
hour, the titration demonstrates further reduction in the AHI/RDI; and,

  3. Nocturnal oximetry conducted for the purpose of oxygen and oxygen equipment reimbursement qualification may only be performed after optimal PAP settings have been determined and the beneficiary is using the PAP device at those settings; and,

  4. The nocturnal oximetry conducted during the PSG demonstrates an oxygen saturation of  88%.

To be eligible for Medicare coverage and payment for home oxygen therapy and
oxygen equipment for concurrent use with PAP therapy, the beneficiary must
meet all other coverage requirements for oxygen therapy and oxygen equipment.
Beneficiaries that qualify for oxygen therapy based on testing conducted only
during the course of a sleep test are eligible only for reimbursement of
stationary equipment.

Overnight oximetry performed as part of home sleep testing or as part of any
other home testing is not considered as eligible to be used for qualification
for reimbursement of home oxygen and oxygen equipment (see the "Overnight
Oximetry Studies" section of the Oxygen and Oxygen Equipment LCD for
additional information).  
  

REPLACEMENT:  
  
This section applies to PAP devices initially provided and covered while the
beneficiary was in Medicare fee-for-service (FFS).  
  
If a PAP device is replaced during the 5 year reasonable useful lifetime (RUL)
because of loss, theft, or irreparable damage due to a specific incident,
there is no requirement for a new clinical evaluation, sleep test, or trial
period.  
  
If a PAP device is replaced following the 5 year RUL, there must be an in-
person evaluation by their treating practitioner that documents that the
beneficiary continues to use and benefit from the PAP device. There is no
requirement for a new sleep test or trial period.  
  

BENEFICIARIES ENTERING MEDICARE:

For beneficiaries who received a PAP device prior to enrollment in fee for
service (FFS) Medicare and are seeking Medicare coverage of either rental of
the device, a replacement PAP device and/or accessories, both of the following
coverage requirements must be met:

  1. Sleep test - There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and,

  2. Clinical Evaluation - Following enrollment in FFS Medicare, the beneficiary must have an in-person evaluation by their treating practitioner who documents in the beneficiary's medical record that:

         A. The beneficiary has a diagnosis of obstructive sleep apnea; and,

         B. The beneficiary continues to use the PAP device.

If either criteria 1 or 2 above are not met, the claim will be denied as not
reasonable and necessary.  
  
In these situations, there is no requirement for a clinical re-evaluation or
for objective documentation of adherence to use of the device.

  
ACCESSORIES:  
  
Accessories used with a PAP device are covered when the coverage criteria for
the device are met. If the coverage criteria are not met, the accessories will
be denied as not reasonable and necessary.  
  
The following table represents the usual maximum amount of accessories
expected to be reasonable and necessary:  
  

A4604 | 1 per 3 months  
---|---  
A7027 | 1 per 3 months  
A7028 | 2 per 1 month  
A7029 | 2 per 1 month  
A7030 | 1 per 3 months  
A7031 | 1 per 1 month  
A7032 | 2 per 1 month  
A7033 | 2 per 1 month  
A7034 | 1 per 3 months  
A7035 | 1 per 6 months  
A7036 | 1 per 6 months  
A7037 | 1 per 3 months  
A7038 | 2 per 1 month  
A7039 | 1 per 6 months  
A7046 | 1 per 6 months  
  
  
Quantities of supplies greater than those described in the policy as the usual
maximum amounts will be denied as not reasonable and necessary.  
  
GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.

  
REFILL REQUIREMENTS  
  
For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products (A4604,
A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037,
A7038, A7039, A7044, A7045, A7046) that are supplied as refills to the
original order, suppliers must contact the beneficiary, and document an
affirmative response, prior to dispensing the refill and not automatically
ship on a pre-determined basis, even if authorized by the beneficiary. This
shall be done to ensure that the refilled item remains reasonable and
necessary, existing supplies are expected to end, and to confirm any changes
or modifications to the order. Contact with the beneficiary or designee
regarding refills must take place no sooner than 30 calendar days prior to the
expected end of the current supply. For delivery of refills, the supplier must
deliver the DMEPOS product no sooner than 10 calendar days prior to the
expected end of the current supply. This is regardless of which delivery
method is utilized.  
  
For all DMEPOS items that are provided on a recurring basis, suppliers are
required to have contact with the beneficiary or caregiver/designee and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response from a beneficiary. Items delivered without a valid, documented
refill request will be denied as not reasonable and necessary.  
  
Suppliers must not dispense a quantity of supplies exceeding a beneficiary's
expected utilization. Suppliers must stay attuned to changed or atypical
utilization patterns on the part of their clients. Suppliers must verify with
the treating practitioners that any changed or atypical utilization is
warranted.  
  
Regardless of utilization, a supplier must not dispense more than a three (3)
- month quantity at a time.  
  
Either a non-heated (E0561) or heated (E0562) humidifier is covered when
ordered by the treating practitioner for use with a covered PAP (E0470 or
E0601) device.